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Is Africa the New Asia for Western MedTechs?

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Medical Technology

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GE HealthCare, Siemens Healthineers, and Philips Healthcare entered the Chinese market in the 1980s and prospered
The once-booming era for Western MedTechs in China has slowed and become challenging
Latecomers to the Chinese MedTech market face geopolitical uncertainty, changing market dynamics, domestic competition, stringent regulations, IP risks, and healthcare reforms
Due to these obstacles and the Chinese’s economy slowing MedTechs are seeking international growth opportunities beyond China and Asia
Africa is emerging as the new frontier driven by its burgeoning population, growing middleclass, economic growth, abundant natural resources, and Beijing’s investement
MedTech pioneers in China, such as GE HealthCare, Siemens Healthineers, and Philips Healthcare, are early entrants in the African market
Prudential plc, an insurance giant, has made a vast strategic bet on Africa’s growth potential
Given insurers are healthcare payers, should MedTechs view Africa as the new Asia?

Is Africa the New Asia for Western MedTechs?

Preface

In the realm of international expansion for Western MedTech companies, Asia, particularly China, has historically been a key focus due to its vast size and rapid economic growth. However, the shifting global economic and geopolitical landscape suggests a re-evaluation. Is Africa positioned to emerge as the next hub of opportunity and growth for MedTech enterprises? China's remarkable economic ascent, initiated by reforms in 1978, accelerated it to the status of the world's second-largest economy, following the US. Western MedTechs that ventured into China's market in the 1980s prospered. Yet, those who hesitated due to concerns, including intellectual property (IP) theft, now face mounting challenges, which include geopolitical uncertainties, evolving Chinese attitudes towards Western corporations, a limited understanding of the Chinese market, and China's ambition to lead global technology by 2030. The recent deceleration in China's economic growth adds to the apprehensions of Western businesses. Moreover, China's rapid economic expansion has led to an aging population, characterized by declining birth rates, and increased life expectancy. By 2040, those aged ≥60 are projected to reach ~402m, constituting ~28% of the nation’s population. This demographic shift, with a shrinking workforce and a rising number of elderly consumers, is expected to exert downward pressure on China’s GDP growth, while straining public budgets with escalating healthcare and retirement costs. Given this evolving landscape, it becomes prudent to explore whether the once-promising prospects for Western companies in China and Asia are diminishing, prompting an examination of alternative international markets. While established MedTech players in China continue to provide essential healthcare products and services, they may benefit from contemplating strategic adjustments and, in many cases, restructuring their commercial operations to adapt to the changing dynamics of the Chinese market. Notably, some companies view Africa as a promising new frontier. Early entrants into the Asian medical device market, such as GE HealthCare, Siemens Healthineers, and Philips Healthcare, have already established footholds in Africa. Could Africa be on the verge of becoming the new frontier, reminiscent of what Asia once represented?

In this Commentary

This Commentary is divided into two sections. In Section 1, we briefly mention the early successes of prominent MedTech companies in the Chinese market during the 1980s. The section also notes that because geopolitical tensions between Beijing and Washington have increased, and recently China's economic growth has slowed, some Western MedTechs are seeking alternative growth regions to expand their international presence and reinvigorate their stagnant market values. Section 2 challenges popular perceptions by proposing that Africa could emerge as the new frontier for the MedTech industry. Despite Africa's enduring challenges, including political instability, corruption, poverty, and limited literacy, it seems to have potential. Albeit from a low start, Africa is projected to be the world's fastest-growing region in 2023, characterized by a youthful population, abundant natural resources crucial for renewable technologies, and an emerging middleclass. Decades ago, Beijing recognized Africa's potential, and more recently, a group of MedTechs, including early entrants to China, have established a presence in the African market. The section concludes by noting the strategic entry of a giant insurance company into the continent. Given the role insurers play in healthcare expansion and the demand for medical technology this maybe a positive omen for the MedTech industry, with Africa as its new frontier.

Part 1
MedTech pioneers in China

In the 1980s, as China underwent transformative economic reforms under President Deng Xiaoping, several Western MedTechs, including GE HealthCare, Siemens Healthineers, and Philips Healthcare, entered China, and capitalized on the nation's economic growth and modernization over the ensuing decades. GE HealthCare, equipped with medical imaging devices and healthcare solutions, forged relationships with Chinese hospitals and research institutions. Siemens Healthineers, a leader in imaging and laboratory diagnostics, followed suit in the late 1980s, emphasizing local R&D and strategic partnerships with Chinese healthcare providers. Philips Healthcare, with its diverse range of patient monitoring systems and diagnostic imaging equipment, also made its mark.

These companies showed their ability to adapt and succeed by adjusting their products to fit the needs of local customers and by encouraging new ideas through partnerships. Initially, they embraced expansion-type business models with multiply marketing and sales tiers, which emphasized rapid growth over stringent financial discipline. The plan worked well because China's medical technology sector was thriving, and experienced annual growth rates of ~10 to ~15% during the first two decades of the 21st century. However, since then, things have changed. Now, the focus is on making operations smoother and more efficient, which has meant reducing the number of marketing and sales layers between enterprises and their principal customers.

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Recent Western MedTech entrants, attracted by the vast Chinese market, faced heightened scrutiny and regulatory obstacles. Their limited knowledge of local markets and different administrations hindered their growth, which was compounded by concerns about safeguarding their IP. Meanwhile, Chinese MedTech firms rapidly advanced, increasing competition for Western latecomers. As of December 2022, the number of Chinese medical device companies amounted to 32,632. The once-lucrative "gold rush" in China for Western MedTechs has faded due to shifting sentiments, regulatory hurdles, and local competition. As China pursues global technological leadership by 2030, Western firms are likely to encounter mounting challenges. To sustain international expansion, they should consider exploring alternative global markets where they can leverage their expertise and resources more effectively. This suggests a turning point, highlighting the need for strategic diversification and adaptation to evolving global dynamics in the MedTech industry.

Headwinds for MedTechs expanding in China

Here we describe some of the headwinds facing Western MedTechs attempting to increase their footprints in the Chinese market.

Geopolitical Uncertainty
Ongoing geopolitical tensions, such the political status of Taiwan, which Beijing claims is a province of the People's Republic of China, whereas Taiwan’s current Tsai Ing-wen administration maintains it is an independent country, and South China Sea disputes, which involve conflicting island and maritime claims by China, Taiwan, Brunei, Malaysia, the Philippines, and Vietnam. These and other geopolitical uncertainties pose risks, particularly for late entrants to the Chinese market. However, despite these tensions, US-China trade remains strong, but doing business in China has become increasingly challenging.

Changed Market Dynamics
China's healthcare landscape has evolved driven by the largest middleclass cohort in the world. Beijing has increased healthcare spending, which has intensified competition in the MedTech sector. Trade conflicts between the US and China add complexity to market dynamics. Relationships between the two countries deteriorated in January 2018, when American President Donald Trump began setting tariffs and other trade barriers on China. The objective was to force Beijing to make changes to what the US says are longstanding unfair trade practices and IP theft. A recent example of such tensions occurred in September 2023, during a visit to China by US Secretary of Commerce Gina Raimondo, who oversees regulating technology. The Chinese tech giant Huawei chose this time to release its new smartphone, powered by an advanced chip. This shocked American industry experts who could not understand how Huawei could have obtained such an advanced chip following efforts by the US to restrict China’s access to foreign chip technology.

Domestic Competition
Chinese MedTech companies (>32,000) have rapidly gained market share, technical sophistication, and innovation capacity. They understand local customer needs and regulations better, posing increasing competition for Western counterparts. In 2021, China’s 134 listed MedTech companies generated US$44bn in revenues, a compound annual growth rate (CAGR) of 36% since 2019, ~3X the market’s overall rate of growth. More than five Chinese MedTechs have obtained the US Food and Drug Administration’s (FDA) breakthrough designation, with innovations like the VenusP-Valve, which has already been approved in >30 countries, and in April 2022, secured EU’s CE marking under its Medical Devices Regulation (MDR). This suggests that Western corporations will not only encounter heightened domestic competition but are likely to face increasing competition from Chinese MedTechs in the global arena.

Regulatory challenges
Regulatory hurdles in China pose challenges for Western MedTechs. Adherence to regulations, standards, and compliance measures, often different from Western counterparts, necessitates an in-depth understanding and adaptation. Central to China's regulatory framework is the National Medical Products Administration (NMPA), which is akin to the FDA. It prioritizes safety, efficacy, and quality in evaluating medical device registrations for market entry. While global acceptance of real-world evidence (RWE) in healthcare is rising, China is in the early stages of embracing the concept. Notably, a 2020 NMPA draft guideline hinted at the potential utilization of RWE from Boao Lecheng. Situated in Hainan, an island province in the nation’s southernmost point, Boao Lecheng has become a medical innovation hub, focusing on technology, high-quality healthcare, and medical tourism. It actively promotes advanced clinical research, housing globally recognized medical institutions like the Raffles Medical Group and Brigham and Women’s Hospital (BWH). The collaboration between Western MedTechs and initiatives like Boao Lecheng holds promise in tackling China's regulatory complexities.

Intellectual property (IP) risks
Protecting IP is a concern for Western MedTechs in China. Enforcing IP rights can be challenging due to factors like judicial protectionism, evidence gathering obstacles, modest damage awards, and perceived foreign bias. China follows a "first-to-file" principle for IP registration, granting ownership to the first registrant. Foreign companies also face pressure from government and state-owned enterprises to transfer technology for market access, investment opportunities, or approvals. Some are compelled to license technology at below-market rates. Despite China's efforts to enhance IP protection, concerns persist. Corporations need to balance IP protection with local engagement and government cooperation to navigate China's complex IP landscape effectively.

Healthcare reforms
China's healthcare system has undergone a significant transformation driven by various factors, including increasing incomes, heightened health awareness among its citizens, and a rapidly aging demographic. The government has placed substantial emphasis on healthcare, as evidenced by its ambitious goals outlined in the Healthy China 2030 plan. This plan envisions the nation's healthcare market reaching a value of ~RMB16trn (~US$2.4trn) by 2030. China's dedication to enhancing healthcare is underscored by the establishment of a comprehensive health insurance system that now provides coverage to ~96% of the population, benefiting >1.36bn individuals. According to a 2023 McKinsey Report, China's MedTech sector, which was valued at ~US$70bn in 2021, is poised to potentially double in size by 2030. Such growth would elevate China's MedTech market share to ~20% of the global market. To thrive in this burgeoning market, enterprises must be agile in adapting to changes, forge strategic partnerships, and effectively navigate the evolving healthcare landscape.

Navigating China’s Diversity
Succeeding in the Chinese market hinges on effective communication and a deep understanding of Chinese culture. China's administrative divisions include 23 provinces, five autonomous regions (Inner Mongolia, Guangxi, Tibet, Ningxia, and Xinjiang), four municipalities (Beijing, Tianjin, Shanghai, and Chongqing), and two Special Administrative Regions (Hong Kong and Macao). Furthermore, China boasts 129 dialects, with Mandarin as the standard and Chaoshan as predominant in the Guangdong region. Given this diversity, Western MedTech companies often grapple with cultural and linguistic barriers. Establishing vital connections within China's intricate administrative and business landscape can prove challenging. Therefore, crafting effective market entry and expansion strategies is imperative. Chinese consumers have preferences and expectations when it comes to medical technology. Western companies must be ready to adapt their offerings to align with these preferences, a critical factor in gaining market acceptance. Failing to do so can hinder market penetration and long-term success.

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Data Privacy and Security Concerns
Data privacy and security are concerns in China. Entrants must navigate stringent data protection regulations, which may differ significantly from Western standards. Building trust with healthcare providers and patients is essential to address these concerns. Failure to do so can lead to regulatory issues, damage brand reputation, and erode customer trust.

Reassessing global strategies amid China's economic slowdown

China, as the world's second-largest economy, has been a pivotal market for major Western MedTech companies. However, the current economic climate calls for a strategic re-evaluation. China's economy has recently experienced a slowdown, with repercussions felt not only in neighbouring nations but also globally. South Korea, a historical driver of global growth, faces its longest factory activity decline in nearly two decades. Other major Asian exporters are also dealing with sluggish demand, and Japan's manufacturing activity has declined, with Taiwan reporting contracting output and weakened foreign demand. In September 2023, concerns grew as China experienced deflation, raising questions about currency stability, challenges in the property sector, and high local government debt. China's decision to not stimulate its economy further exacerbated the situation, impacting key financial hubs like Hong Kong and Singapore, as well as satellite economies. This economic slowdown in China is expected to persist and likely have far-reaching global consequences. Businesses worldwide, including those in the US and Europe, heavily reliant on China for growth, should explore alternative regions for sustainable value and expansion. Western MedTech companies need to carefully assess the challenges and costs associated with further expansion in China.

An alternative strategy emerges; companies should consider complementing their Asian focus and explore the growing economies of Africa. Just as early MedTech pioneers capitalized on Asia's rapid expansion, companies today should contemplate laying the groundwork for a fresh international strategy in Africa. The continent has potential, and a proactive approach could yield sustainable growth opportunities, helping to mitigate the impact of China's economic challenges and slowdown on global ambitions.

Part 2
Africa's Ascendance

With a few notable exceptions, Western MedTech executives tend to overlook Africa due to its challenging socio-economic conditions, which include political instability, corruption, extreme poverty affecting ~50% of the population, limited access to necessities, and a high illiteracy rate of ~40%. Notwithstanding, China has long recognized Africa's potential, which mainly revolves around Africa's abundant natural resources, which constitute ~30% of the world's mineral reserves, including critical resources for renewable and low-carbon technologies. For instance, Zambia leads in unrefined copper exports, Guinea boasts the world's largest bauxite reserves, and South Africa contributes ~90% of the world’s platinum group metal reserves. Furthermore, Africa has the world's youngest population, with substantial projected growth.

Asia plays a pivotal role in Africa's trade dynamics, accounting for >42% of its exports and >45% of its imports, surpassing Europe in both cases. According to a 2023, Business Insider Report, Africa is poised to become the world's fastest-growing region, with six of the ten fastest-growing economies located on the continent, albeit starting from a relatively low economic base. In addition to its mineral wealth, the continent's path to economic success is partly based on developing an export-led manufacturing economy, akin to China's transformation in the 1980s. This, already in progress, has the potential to lift >0.5bn people out of poverty, create >100m jobs, and establish a substantial and rapidly growing middleclass that will demand improved services, including healthcare.

Currently, Africa's manufacturing sector contributes only ~9% to the continent's gross domestic product (GDP) and ~2% to global manufacturing output. However, the African Union has placed manufacturing at the forefront of its Agenda 2063, a strategic framework supported by all 55 African countries, aimed at achieving socio-economic transformation over the next 50 years. This commitment gains significance amid escalating trade tensions between the US and China, which have global economic implications. Africa has weathered recent shocks, including weakened external demand, global inflation, higher borrowing costs, and adverse weather events, which have hindered its post-pandemic recovery. Nonetheless, in the coming decades, the "Made in Africa" label may come to symbolize quality products, solidifying the continent's position as a prominent player in global manufacturing, akin to how "Made in China" became synonymous with quality two decades ago.

China’s impact on African manufacturing

China has been instrumental in the economic transformation of African nations, which partly stems from the Chinese strategy to relocate its low-level manufacturing operations to Africa. As China's domestic manufacturers have advanced technically, they have systematically shifted their basic manufacturing capabilities to African countries. This provides Africa with an opportunity to mirror China's journey from standard manufacturing to advanced production processes over several decades.

Chinese companies have made substantial investments in labour-intensive manufacturing facilities notably in Ethiopia. This has created jobs and fueled the growth of local manufacturing sectors. For instance, the Huajian Group, a leading Chinese footwear manufacturer, established plants in Ethiopia in 2012, employing >7,000 people and producing ~5m shoes annually. The Group’s partner in this project is the China-Africa Development Fund (CADFund), a private equity facility promoting Chinese investment in the continent. Huajian also invested in Ethiopia's Jimma industrial park, contributing US$100m to build shoe and coffee processing plants and a technical education centre.

As Chinese enterprises expanded in Africa, they provided training to local workforces, and transferred their manufacturing expertise. This collaborative effort is helping to develop a skilled labour pool important for sustaining manufacturing growth. Notably, Ethiopia's Eastern Industrial Zone, supported by Chinese investment, evolved into a thriving manufacturing hub, attracting both domestic and foreign investors. Additionally, Beijing's Belt and Road Initiative has led to significant infrastructure developments across Africa, including roads and ports, which further stimulate the continent's manufacturing sector. China’s investment in Africa stands out due to its tangible presence, in contrast to other nations whose involvement in the continent is characterized by distant and arms-length financial engagements. With the influx of such investments, technology transfers, and ongoing skill development, some African nations are positioned to follow China's path towards a manufacturing transformation.

MedTech’s early entrants to the African market

For years, support for Africa’s healthcare tended to concentrate on education and malaria nets. In recent years however, as developed-world disorders, like cancer and heart disease, grew in Africa so medical technology companies increasingly found a market in supplying devices to private healthcare operators and investing in healthcare initiatives through partnerships with governments. US President George W. Bush recognised Africa’s strategic importance, emphasising investments for development and health initiatives, including the President’s Emergency Plan for AIDS Relief (PEPFAR), which, announced in 2003, reflected a commitment to fostering stability and wellbeing on the continent. Since then, American governments have not shown much interest in Africa. However, the MedTechs that entered the Chinese market ~4 decades ago and prospered, have established footprints in the African market by adapting their products and services to local needs, building partnerships with local healthcare providers, and addressing challenges such as infrastructure limitations and affordability. Their presence caters to Africa’s large and growing middleclass and has contributed to the improvement of healthcare standards in the region.

Philips Healthcare has made inroads into the African market and operates in several African countries, including South Africa, Kenya, and Nigeria. One of the advantages they offer is a wide range of medical devices and equipment tailored to different healthcare settings, from high-end hospitals to remote clinics. Their focus on technology that can operate efficiently even in areas with unreliable power grids has been instrumental in their success. GE HealthCare has a presence in countries like South Africa, Nigeria, and Egypt. Their commercial advantage is in their commitment to providing innovative medical technologies across various healthcare domains, from diagnostic imaging to healthcare IT solutions. The company collaborates with local healthcare providers and governments to build sustainable healthcare infrastructures. Siemens Healthineers is active in South Africa, Kenya, and Ghana. The company’s advantage stems from their portfolio of medical equipment, laboratory diagnostics, and digital health solutions. They often tailor their offerings to meet the specific needs and budgets of healthcare providers in Africa, contributing to improved patient care and diagnostic accuracy.

Unveiling MedTech opportunities: the impact of insurers

Large insurance firms wield significant influence in shaping the trajectory of the medical technology industry. They play a pivotal role in extending health insurance coverage to middle-class populations worldwide, not only bolstering healthcare systems but also driving the demand for medical technology. In essence, these insurance giants act as catalysts for the MedTech industry's growth.

A case in point is Prudential plc., a global insurance powerhouse with >23,000 employees and 2021 annual revenues of >US$70bn. The company holds dual listings on the London and Hong Kong Stock Exchanges and is a constituent of the FTSE 100 Index. It also maintains secondary listings on the New York Stock Exchange and the Singapore Exchange. In February 2023, shortly after Anil Wadhwani assumed the role of Prudential's new CEO, he publicly declared his intent to chart a new course and focus on Africa for growth. Wadhwani highlighted that the growth drivers in Africa today closely resemble the trends previously witnessed by the company in Asia: rapidly expanding middle-class populations with a growing appetite for insurance and enhanced services, including healthcare. He emphasized that Africa would complement Prudential's expanding Asian presence. IMF's 2023 reports indicate that countries such as South Africa, Ghana, Kenya, Ethiopia, Côte d'Ivoire, and Rwanda are prime candidates for substantial future growth. It is increasingly plausible that Africa could emerge as the next frontier for MedTech companies, thanks to the leadership of individuals like Anil Wadhwani, who steer insurance giants toward new horizons.

Takeaways

In recent years, Western MedTechs have witnessed a significant transformation in China's healthcare landscape, driven by changing demographics and an increased emphasis on technological self-reliance. Notably, industry giants such as GE HealthCare, Siemens Healthineers, and Philips Healthcare, which established a presence in China during the 1980s, are now extending their reach into Africa with hopes of replicating their prior successes. While some may view this expansion as unconventional due to factors like political instability, corruption, and poverty, the continent has potential. Africa's attraction for MedTechs includes some of its countries with significant economic growth potential, a burgeoning youthful population, a growing middleclass, and abundant natural resources that align with the evolving demands of a rapidly expanding global green economy. Much like the historical pattern of MedTech companies venturing into Asia, a similar trend is emerging in Africa among a select group of firms. Another critical point to consider is the emerging role of insurance companies as potential guides in this new journey. These insurers are participating in the continent’s healthcare expansion and innovation, and where they lead, MedTech companies should consider following. The growing middleclass, equipped with medical insurance, will eventually exert pressure on healthcare systems in the region to enhance access to quality care. This, in turn, will expand the market for medical devices. Despite the complexities and contradictions that Africa presents, it represents an opportunity that warrants consideration. The question of whether Africa will become the new Asia suggests the need for MedTechs to embrace a new era where innovation and progress thrive on the courage to venture beyond the familiar. By doing so, corporations can discover a promising landscape for growth and innovation, tapping into Africa’s underserved opportunities and playing a role in enhancing global healthcare.

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Forging a path for digital excellence in the MedTech Industry

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Medical Technology

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Artificial Intelligence

The MedTech industry faces a pivotal moment as it confronts the challenge of adopting transformative technologies amidst a rapidly changing healthcare ecosystem
Despite progress in other sectors, MedTech has shown reluctance to fully integrate digitalization, potentially hindering its growth and competitiveness
There have been some notable exceptions such as Medtronic, Siemens Healthineers and Philips
Many large diversified MedTechs could unlock growth and value by capitalizing on the potential synergies between traditional medical devices and innovative digital solutions and services
The convergence of digital offerings with legacy medical devices provides opportunities for improved patient care, operational efficiency and R&D innovation
There is a pressing need for MedTechs to comprehensively embrace digitalization to avoid reduced competitiveness, limited growth, and diminished value enhancement

Forging a path for digital excellence in the MedTech Industry

In an era of rapid technological advancement, the medical technology (MedTech) industry is at a crossroads. While numerous other sectors have enthusiastically embraced digitalization and moved forward, the MedTech sector, barring a few notable exceptions, has been hesitant to embrace these transformative technologies. However, the time has come for large diversified MedTechs to recognize the opportunities that digitalization offers for growth and value creation. The convergence of traditional medical devices with digital solutions and services presents an opportunity for the industry to improve patient care, streamline operations, and drive innovation. Failing to fully integrate digitalization into their operations in a timely way may lead to unexpected consequences, including a shorter window of competitiveness and a struggle to enhance growth rates and augment value. The reluctance of many MedTechs to adapt now could translate into a significant handicap in the rapidly evolving landscape of healthcare technology.

In this Commentary

In this Commentary, we tackle four questions: (i) What is digitalization? (ii) Why is digitalization important for MedTechs? (iii) Which MedTechs have implemented successful digitalization strategies? and (iv) What defines an effective digitalization strategy? In addressing the fourth question, we present a strategy that encompasses 20 'essentials', which are not meant to follow a linear, sequential path. Instead, they are orchestrated by agile cross-functional teams, collaborating and pooling resources. Together, these teams oversee the execution of various elements of the strategy, while assuming responsibility for its overall effectiveness. This approach signals a departure from hierarchical departments and advocates a matrix-style organizational structure characterized by a web of interconnected reporting relationships. This structure goes beyond the confines of the conventional linear framework and incorporates specialized clusters, akin to "nests," each housing unique competencies, spanning multiple dimensions, and encompassing responsibility, authority, collaboration, and accountability.

1. What is digitalization?

Digitalization, also referred to as digital transformation, involves harnessing digital technologies to improve and refine business operations, processes, and services. By integrating digital tools across all facets of an organization, digitalization streamlines workflows, amplifies customer experiences, and achieves strategic goals. This includes automating tasks, utilizing data analytics for informed decision-making, and leveraging cloud computing for scalable and flexible operations. The Internet of Things (IoT) facilitates data exchange through connected devices, while artificial intelligence (AI), machine learning (ML) and large language models (LLM) empower computers to perform tasks requiring human-like intelligence. Virtual and augmented reality (VR/AR) enrich experiences, while cybersecurity measures are important to safeguard digital assets.

2. Why is digitalization important for MedTechs?

Digitalization is important for the MedTech industry since it acts as a driver for significant and positive change. By fully embracing this transformation, the industry develops the ability to use data and analytics to create innovative medical solutions and services. These are built on insights and predictions obtained from large amounts of information. Apart from these benefits, digitalization also affects the core of how clinical operations work. It makes workflows more efficient and frees-up healthcare professionals to focus more on taking care of patients. One significant development is the rise of collaborative telehealth platforms, which play a role in improving the quality and efficiency of healthcare delivery. Additionally, the power of technologies like AI, and ML becomes more evident. These advanced tools, driven by their ability to rapidly analyse vast data sets and make predictions, contribute to breakthroughs in care with the potential to improve patient outcomes while reducing costs.

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The collaboration between smart devices and blockchain technology becomes important in a digital transformation, enhancing patient safety, and ensuring regulatory compliance. As the MedTech sector embraces digitalization, it enables companies to succeed in value-based healthcare environments, which results in quality care becoming more accessible and affordable. This is partly made possible through remote monitoring and proactive interventions that overcome distance. A distinctive aspect of digitalization is the ability to provide personalized care. Focusing on creating solutions and services tailored to individual needs helps to create an innovative environment within MedTechs, which can be leveraged to drive continuous growth and value creation. As digitalization becomes more influential, the MedTech industry should move closer to personalized health, which means care is centered around patients, innovation is continuous, and growth is more certain.

3. Which MedTechs have implemented successful digitalization strategies?

There are several large MedTechs that have successfully leveraged digitalization strategies to gain access to new revenue streams. Here we briefly describe just three. Philips is known for its diverse healthcare products and services, including imaging systems, patient monitoring, and home healthcare solutions and services. They have successfully utilized digitalization by creating a connected ecosystem of devices that capture and transmit patient data, enabling real-time monitoring and personalized care. Their strategy also includes software solutions for data analysis, predictive analytics, and telehealth, contributing to the creation of new revenue streams beyond traditional medical devices. Siemens Healthineers focuses on medical imaging, laboratory diagnostics, and advanced healthcare IT. Their digitalization strategy involves offering integrated solutions that connect medical devices, data analytics, and telemedicine platforms. For instance, their cloud-based platforms enable healthcare providers to store, share, and analyze medical images and patient data, resulting in streamlined workflows and new revenue opportunities through data-driven insights. Medtronic, a global leader in medical technology, offering a wide range of products and services in various medical specialties, has successfully embraced digitalization by incorporating smart technologies into their devices, such as pacemakers and insulin pumps, allowing remote monitoring and data collection. This has improved patient care and given the company access to new revenue streams through subscription-based services for data analytics and remote monitoring.

4. What defines an effective digitalization strategy?

In today’s business climate, developing an effective digital strategy has shifted from being a ‘nice to have’ to a necessity. As MedTechs navigate the dynamic technology landscape, digitalization has become a priority. In this section, we present a 20 'essentials' for crafting and implementing a digitalization strategy. These are not linear, but collectively constitute a path towards a digital transformation for a large diversified MedTech company.

1. Crafting a Cohesive Vision

Digitalization starts with an evaluation of a company's existing products, services, processes, and technologies. This forms the basis upon which a vision and strategic goals are constructed. The main objective here is to align a company's aspirations with the dynamic MedTech landscape, creating a basis for innovation. Digitalization entails more than the integration of peripheral technologies. It is a paradigm shift. The initiation of a digitalization vision depends upon sound long-term strategic objectives. This involves not only envisioning the transformative potential of digitalization within an organization but also projecting its impact, whether that be improved patient experiences, data-driven operational enhancements, or the exploration of new revenue streams. As this vision takes shape, often in the form of a story that everyone in an organization can buy-into, it should steer decisions and guide investments throughout the entire digital transformation process. Further, it provides tangible benchmarks against which progress can be gauged and strategies can be refined. It is important that digitalization goals are aligned to the evolving needs of healthcare. MedTechs should harness the power of digitalization to meet the expectations of patients and adapt to dynamic clinical practices. This requires reconciling digital innovations with a company’s core values. A comprehensive and forward-looking vision (story) functions to safeguard a company's strengths against potential challenges. This first step toward a digitalization strategy serves to position a company for sustainable growth and enduring value creation.

2. Leadership commitment
The significance of securing buy-in from senior leadership teams lies in its assurance of resources, funding, and support, which are vital for the success of such an initiative. The endorsement from executives, beyond being a signal of change, serves as a catalyst for the allocation of both financial and human resources and has a substantial impact on the direction and depth of a digitalization strategy. By wholeheartedly supporting such an initiative, leaders disseminate not only a positive message about the importance attached to digitalization, but they also foster employee engagement, subsequently paving the way for the potential integration of digitalization across an entire company.

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3. Cross-functional synergy

Creating cross-functional teams is central for driving change, and should span departments like IT, R&D, operations, marketing, and regulatory affairs. The nature of a MedTech's digitalization strategy requires diverse expertise to successfully release technology's full potential. IT professionals contribute technical knowhow, which ensures the implementation and integration into existing infrastructure. R&D members provide visionary insights, encouraging innovative solutions and services. Operations specialists optimize processes for digital efficiency. Marketers strategize effective communications of digital progress. Regulatory experts ensure compliance and ethical considerations. Each contribution plays a distinct yet interconnected role, fostering collaborative brainstorming, shared goals, and pooled talents within a developing culture of agility and innovative. This approach breaks down silos, and aims to create a unified, technology-optimized future. Cross-functional teams act as the driving force to transform digital potential into a tangible reality.

4. Informed market insight

Market and consumer research is an important element of the strategy, as it uncovers customer needs, preferences, and pain points in digital healthcare. Such insights form the basis for tailored technologies that cater to specific needs, increasing patient engagement and satisfaction. Additionally, a successful digitalization strategy needs to identify and adapt to evolving trends in the digital MedTech sector. This entails monitoring emerging technologies, shifts in consumer behaviour, and advances in medical practices. Equally important is analyzing the competitive landscape to benchmark offerings and drive innovation. When companies are aligned to market dynamics, they are more likely to become digital leaders, fostering continuous improvement and innovation.

5. Technology assessment
Assessing a company's existing technology infrastructure helps to gauge whether a strategy can effectively leverage current investments and assets. Simultaneously, the assessment should uncover gaps and shortcomings. Identifying these informs targeted resource allocation for new technologies that support digital goals. Thus, a technology assessment allows organizations to strike a balance between leveraging existing capabilities and making targeted investments, in pursuit of their digital transformations.

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6. Effective digital solutions

An essential aspect of a digitalization strategy involves identifying effective solutions and services. This process entails exploring various facets of an organization to integrate innovations; from improving customer engagement to optimizing workflows. Equally crucial is deploying technologies that improve patient outcomes, diagnoses, treatments, and monitoring. This stage also identifies potential revenue streams derived from new digital solutions and services, like remote patient monitoring, telemedicine, data analytics, and AI diagnostics, which strengthen existing offerings.

7. Partnerships

Engaging in collaborations with technology companies, start-ups, and various stakeholders creates opportunities for synergistic growth. Such partnerships enable enterprises to tap into diverse expertise, gain fresh perspectives, and access specialized resources, all of which support the development and implementation of digital solutions and services. Collaboration facilitates knowledge and resource pooling, enhancing innovation cycles and ensuring a comprehensive transformation of healthcare services. Simultaneously, acquisitions can enhance in-house capabilities. Exploring the acquisition of companies possessing relevant digital competencies or disruptive technologies offers a potential competitive edge. Such moves can help with assimilating novel technologies and developing a culture of innovation. Acquisitions can assist companies to position themselves as key players, advancing their digital health agenda and solidifying their position in an evolving industry.

8. Data management and security

Enhancing data management entails developing and implementing robust protocols. This involves refining data collection procedures, enforcing privacy and security measures, and adhering to healthcare regulations like the US Health Insurance Portability and Accountability Act (HIPAA) and the EU General Data Protection Regulation (GDPR), which safeguard patient data from breaches or misuse. Such measures establish a foundation for data management and security and help to foster stakeholder trust. Compliance with regulations like HIPAA and GDPR should not simply be viewed a legal obligation, but also as a moral commitment when handling sensitive patient data. Such a proactive stance strengthens a company's reputation for data integrity and helps to avoid legal repercussions.

9. Technology roadmap

A technology roadmap is a blueprint charting a course toward enhanced efficiency, patient-centric care, and heightened competitiveness. Beyond action planning, it provides clarity and purpose in navigating technological advancements. It consolidates an enterprise's digitalization efforts by integrating initiatives with timelines and resources, thereby establishing a framework for goal setting and assessment. Such planning assists timely project execution and supports the rationale for digitalization with measurable benefits. With a well-structured roadmap, stakeholders can appreciate how digital initiatives improve operations, trigger innovation, and enhance patient outcomes.

10. Pilot programmes

Pilot programmes serve as incubators and evidence-based validators for innovations, offering a means to test and enhance digital solutions before they are fully implemented. Such initiatives provide tangible evidence to support an enterprise's commitment to a digitalization strategy. Pilots offer concrete proof of an enterprise’s commitment to its digitalization strategy. Each programme should concentrate on specific solutions and establish a controlled setting for gathering user feedback, which constitutes an on-going effort to refine functionality. Additionally, pilots demonstrate a commitment to user-centric offerings by proactively tackling challenges, thereby improving the chances of successful, large-scale digital deployments.

11. Scalability and integration
Establishing scalability and integration capabilities is important for MedTechs to realize their digital transformation. As healthcare technology landscapes evolve and organizational needs change, the ability of digital solutions to scale and integrate with existing structures increases in importance. Ensuring these attributes contributes to a digital transformation. Scalability emphasizes a company’s adaptability to evolving demands. A scalable digital solution that expands in scope without sacrificing functionality invokes confidence. Further, integrating novel solutions and services with existing systems signals operational intelligence, which adds credibility to the digital transition. When digital solutions merge with legacy structures, they reflect an alignment of traditional expertise and cutting-edge technology. Emphasising scalability and integration involves anticipating future requirements and aligning digital strategies with longer-term organizational objectives.

12. Change management
By supporting a mindset that views digital technologies as enablers rather than disruptors, companies demonstrate their commitment to progress and cultural change. Implementing change management acknowledges the importance of cultural shifts and affirms an intent to embrace digital technologies holistically and sustainably. It acts as the vehicle, which guides an enterprise through transformation, and ensures stakeholder support for technological evolution. Through communication, training, and engagement policies, enterprises lay the groundwork for digital adoption, and smooth technology integration. This strengthens the case for change and demonstrates an organization's commitment to fostering an innovation-receptive environment.

13. Training and skill development
Central to a successful digitalization strategy is an investment in training and skill development. This underlines an organization's commitment to harnessing and effectively utilizing the transformative potential of technology. By training, corporations equip their employees with capabilities required to support digital solutions and services. Training bridges the gap between skill shortages and technological advancements. Empowering employees with the capacity to navigate digital technologies positions an enterprise for a successful transition, by a process that reconciles change with employee growth. Training reinforces the notion that digitalization is not just an operational enhancement but also a means to cultivate a workforce with capabilities, which contribute to operational excellence and sustainable expansion.

14. Regulatory adherence
Regulatory compliance is an important feature of a digital shift, as it demonstrates a company's commitment to upholding the highest standards of patient care and industry excellence. It shows that transformation is about embracing the future with integrity by ensuring that an enterprise’s innovations are synchronized with the values underpinning medical practice. Adherence to regulatory standards is a declaration of an organization's commitment to patient safety and industry integrity. By ensuring all digital solutions and services adhere to rigorous medical regulations, corporations strengthen their case for digitalization within ethical and legal boundaries. Demonstrating adherence to medical regulations and industry benchmarks reinforces a new digital strategy as a responsible and trustworthy pursuit and showcases an organization's commitment to delivering technologies that both innovate and enhance patients' therapeutic journeys while respecting established medical protocols.

15. Market communication
Crafting a communication strategy is important as it underlines an organization’s commitment to transformation. Employing a variety of smart communication methods to describe the benefits of new digital offerings enables MedTechs to garner support from stakeholders and thereby strengthen their market position. By aiming at healthcare professionals, investors, payers, patients, providers and other stakeholders, these messages inform and persuade by highlighting the tangible benefits they bring to patient care, operational efficiency, and industry progress.

16. Feedback loop and iteration
Stakeholder feedback can be used to enhance digital solutions and services. By engaging users and patients, healthcare technologies can be tailored to cater to specific needs and preferences, fostering a user-centric design ethos. This collaborative approach identifies bottlenecks, deficiencies, and possible enhancements, which contribute to efficacious digital solutions and services. Moreover, stakeholder involvement helps to ensure a company's technological endeavours support broader healthcare goals, enhancing the overall quality of care. Iteration should be synonymous with evolution. Regularly integrating feedback to enhance the functionality of digital offerings enables an enterprise to adapt to market challenges and healthcare advancements.

17. Performance measurement

Effective evaluation of a company's digitalization strategy demands the use of key performance indicators (KPIs). These serve as a compass to assess the impact of digital solutions across patient outcomes, operational efficiency, and business expansion. By selecting relevant KPIs, MedTechs can show stakeholders the tangible effects of their digitalization strategy. These quantifiable metrics offer a lens to observe enhanced patient care, rectify operational inefficiencies, and decipher trends in business growth.

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18. Fostering a culture of continuous innovation

An effective digitalization strategy relies on fostering a culture of perpetual innovation, which is essential to maintain a market-leading position. Such an approach encourages the creation, implementation and refinement of smart technological solutions and services. It equips MedTechs with the agility to quickly embrace emerging trends, capitalize on novel prospects, and tackle unforeseen challenges. Further, a culture of continuous innovation encourages an executive mindset that perceives setbacks as opportunities and views technology as evolving tools to improve patient care and operational efficacy.

19. Adaptation to market changes

MedTechs must rapidly adjust their digital strategies to match prevailing technological trends, regulations, and market dynamics. These ever-changing elements emphasize the need for a proactive, flexible digitalization approach that can swiftly adapt. By staying ahead of shifting trends, businesses are better positioned to leverage emerging technologies and provide solutions for evolving market needs. Navigating regulatory changes is equally important. Balancing compliance with innovative solutions ensures the integration of digital offerings in a dynamic healthcare setting. Flexibility should extend to market fluctuations, aligning digitalization strategies with customer demands and competition. This not only helps a company to navigate volatile markets but also positions it as an agile player, primed for change and enduring growth.

20. Embracing longer-term sustainability

For MedTechs, it is important that their digital strategies align with their principal longer-term objectives. Instead of solely pursuing immediate gains, this strategy should support a company's core purpose and future aspirations, which are embedded within its day-to-day operations. Such an approach establishes an innovative, adaptable, and resilient framework and strengthens the potential for growth. When a digitalization strategy is aligned with a company’s longer-term goals, it assumes the role of a catalyst for growth by optimizing the utilization of resources, improving brand resilience, and securing a distinct competitive advantage. During constantly evolving technologies and markets, such an alignment provides the capacity for a company to effectively confront challenges and capitalize on emerging opportunities, thereby either moving into, or securing, a leadership position within the rapidly changing market landscape.

Takeaways

In the face of rapid technological evolution, the MedTech industry finds itself at a crucial juncture. While other sectors have embraced digitalization, many large diversified MedTechs have been hesitant in adopting these transformative tools. Yet, the imperative is clear: for sizable companies, the present demands recognition of digitalization's potential to drive growth and cultivate value. The fusion of conventional medical devices with digital innovations not only augments patient care but also streamlines operations and encourages innovation. The consequences of delaying this integration are significant. Without prompt action, corporations risk narrowing their competitive horizons and struggling to accelerate growth and enhance value. Failure to adapt may result in a substantial disadvantage in the rapidly changing arena of healthcare technology. It is important for MedTechs that have not already done so, to pivot towards digitalization and transform their challenges into opportunities, ensuring a dynamic and thriving future in an increasingly interconnected world.

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Redefining Leadership In The Evolving Landscape Of MedTech

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Medical Technology

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Many large diversified MedTechs are experiencing stagnate growth and aging products in slow growing markets
Initially, MedTech expansion leveraged disruptive technologies and underserved markets
As MedTechs’ evolved they shifted from innovation-led to financed-focused management taking advantage of low interest rates and cheap money
M&A substituted for innovation as a growth strategy
Today, MedTechs grapple with volatile politico-economic environments, stringent regulations, ethics, and increasing patient demands
The solution lies in visionary leaders driving R&D-focused growth, and more strategic M&A
This requires leaders able to blend finance, innovation and patient-centricity

Redefining Leadership in the Evolving Landscape of MedTech

Balancing Innovation, Profitability, and Patient Care

Preface

Over the past four decades the medical technology (MedTech) sector has experienced substantial transformation. Its initial rapid growth was driven by sophisticated devices, unmet clinical needs, entry barriers, and available funding. Later, expansion was primarily fueled by mergers and acquisitions (M&A), the integration of technology, market consolidation and financial undertakings. Decades of low interest rates, cheap money, and, the pursuit of top-line revenue growth, rather than profitability, led to an overemphasis on M&A, which enlarged the industry without equivalent enhancements in R&D. Over time, many large diversified MedTechs faced challenges associated with legacy products in slow-growth markets, and an overreliance on M&A. While the industry maintains ~6% compound annual growth rate (CAGR), much of this progress comes from smaller players. The industry’s maturity brings new challenges distinct from those of its early days. M&A, once effective for diversification, now struggles to sustain growth for larger companies. The industry’s financialization has shifted leaders’ focus from vision to short-term gains, creating a void in leadership. Amid current headwinds - political uncertainties, commercial pressures, stringent regulations, ethics, and patient empowerment - successful navigation requires visionary leaders committed to patient care over short-term gains. Emerging leaders must combine financial expertise with innovation. The next decade calls for a break from an overreliance on M&A-centred growth, embracing research-based, value-driven solutions and services, which enhance patient outcomes and reduce healthcare costs. This transformation demands leaders skilled in business strategy, R&D, and patient-centered approaches.

In this Commentary

This Commentary is comprised of four sections. Part 1 draws a distinction between leaders and managers and suggests that while both roles are necessary for a successful commercial enterprise, it is important for executives to balance the two roles. Part 2 describes the merits of M&A, the financialization of the MedTech industry, and its repercussions on leadership and innovation. Notably, financialization and M&A activities shifted executive focus away from innovation towards transactions. Part 3 explores the interplay between transactional proficiency and innovation and discusses the implications of M&A-focussed expansion on R&D and patient outcomes. Part 4 suggests a strategy for enterprises to reignite their stagnating values and slow growth rates, which entails less M&A-driven expansion and more innovation-centred growth. Achieving this involves developing leaders with a blend of financial and R&D acumen.

Part 1

Leaders and Managers

Leaders and managers play important roles in the success of commercial enterprises, each having distinctive yet interconnected functions. However, leadership and management differ, and this differentiation is important to understand their respective contributions to the medical technology industry.

Leadership, which has evolved over time, involves guiding, influencing, and motivating individuals and groups towards shared objectives. It includes envisioning a direction, making strategic choices, and inspiring growth within organizations. Leaders prioritize people, nurture relationships, and understand individual strengths, and motivations. This enables them to empower others to embrace change and achieve their potential. They adopt a forward-looking, longer-term strategic perspective, fostering innovation while being prepared to take calculated risks for growth. Effective leadership influences a company’s trajectory, culture, and efficacy. It fosters productivity, innovation, and a positive attitude to work. In an environment characterized by technological advancements, constant organizational change, and market shifts, leadership is crucial. Under such conditions, embracing change rather than resisting it not only brings stability but also reduces stress and prevents chaos. Leadership is essential for guiding enterprises and employees through uncertainty, fostering innovation, creative thinking, and stability. Leaders often possess a combination of leadership and managerial skills; and they know how to balance these and have the capacity to navigate dynamic environments which require adaptability, agility, and inspiring visions.

Conversely, management, revolves around organizing, planning, and efficiently controlling resources to attain specific goals. Managers address operational challenges, and focus on processes, structures, and day-to-day operations, ensuring tasks adhere to plans. Their strength lies in executing business plans, maintaining stability, control, and consistency in operations to ensure that organizations function smoothly. Managerial skills excel when supervising daily operations, allocating resources, and completing tasks efficaciously. Managers perform well in project-oriented environments, overseeing planning, execution, and monitoring to achieve objectives. They allocate budgets, personnel, and equipment optimally, managing risks and performance to ensure stability.

Part 2

The Rise of Financialization in MedTech

The financialization of the MedTech industry took root over several decades when interest rates were low and access to affordable capital was relatively easy. This encouraged corporate executives to lean away from developing innovative scientific devices for expansion and lean in on M&A to provide growth. One recent period during which central banks maintained low interest rates, and adopted accommodative monetary policies, is the aftermath of the global financial crisis of 2008. In response to the crisis, central banks, including the US Federal Reserve, (Fed) implemented measures to stimulate economic growth and stabilize financial markets. One of the primary tools used was reducing interest rates to near-zero. For instance, the Fed held its federal funds rate [the benchmark interest rate] at near-zero levels from December 2008 to December 2015. The purpose of this was to encourage borrowing and investment, which in turn was expected to stimulate economic activity, job creation, and consumer spending.

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Such extended periods of low interest rates encouraged MedTech executives to explore growth opportunities beyond conventional R&D investments. With significantly reduced financing expenses, and a large, underserved, fast growing sector, managers turned to M&A to bolster their resources and expansion efforts. This trend was further buoyed by investors seeking higher returns amid limited profitability in low-interest rate environments. Consequently, MedTechs gravitated toward M&A and financial activities, which promised near-term gains and broader market reach. This shift diverted executive focus away from innovation-centered expansion to transactional approaches for growth, ultimately reshaping the industry's trajectory toward financialization. M&A opportunities initially helped companies to strengthen their presence in underserved, rapidly expanding market segments. By merging with, or acquiring, near adjacent enterprises, MedTechs accessed new customer bases, technologies, and product portfolios, which allowed their executives to consolidate company resources, increase market share, and achieve economies of scale, which drove growth.

Perceived benefits of M&A

This shift towards M&A and financial optimization did not diminish the significance of scientific progress and innovation; but it did incentivize many MedTech executives to recalibrate their reliance on R&D. As the industry evolved, several factors encouraged executives to prioritize M&A and financial engineering as their principal drivers of growth. These included the increasingly stringent regulatory landscape for medical devices, which extended the time and costs associated with new product launches. Executives recognized the value of acquiring readily available innovations with existing regulatory approvals. Additionally, M&A offered the opportunity for MedTechs to streamline their operations, eliminate redundancies, cut costs, and enhance financial performance.

Over time, intensifying financial activities increased the industry’s global competition, and many MedTechs employed M&A to expand internationally and gain access to new markets. Simultaneously, acquisitions facilitated the diversification of product offerings, which lowered risks associated with relatively narrow product portfolios. Publicly traded corporations faced pressure from investors to deliver near-term financial results and shareholder value, which further steered executives to lean in on M&A for quick returns and access to a wider talent pool and complementary technologies.

Impact on leadership dynamics

The rise of M&A activities and the financialization of the MedTech industry reshaped leadership dynamics. While the sector was initially driven by innovation-focused leaders, the shift we describe has led to a gradual transition towards transaction-oriented managers taking control. Visionary figures like Willem Einthoven, a Dutch physiologist and Noble Laureate for Medicine, Thomas Fogarty, an American inventor, innovator, and cardiothoracic surgeon, Patricia Bath, an American ophthalmologist, and inventor and Robert Langer, an American engineer, scientist, and entrepreneur, are just four among many others who laid foundations for the industry's growth with their pioneering medical technologies. For instance, Einthoven's invention of the electrocardiogram (ECG) changed cardiology, Fogarty's embolectomy catheter, (balloon catheter), transformed vascular treatments, Bath’s Laserphaco Probe, disrupted cataract surgery, and Langer's work on biomaterials led to several breakthrough medical devices.

Notwithstanding, over time, M&A pursuits by companies altered resource allocation, diverting attention away from R&D towards activities like due diligence and integrations. This shift redirected budgets and talent away from innovation, affecting the creative and scientific progress of enterprises. Metrics tied to M&A outcomes gained precedence over those that encouraged internal innovative momentum. Further, the growing financial acumen of MedTech executives overshadowed R&D capabilities, emphasizing short-term gains over longer-term strategic innovative initiatives. After decades of successful M&A, changes in economic, financial, and technological landscapes prompted concerns about the industry’s sustained growth and innovation-centric leadership.

Consequences of M&A for innovation and R&D

Prioritizing financial transactions over R&D in a fast-paced industry can undermine innovation, sustainable growth, and competitive advantage. Companies favouring financial activities at the expense of R&D have tended to show diminished ability to create novel medical technologies, which results in fewer disruptive solutions and a weakened ability to address evolving healthcare challenges. The significance of R&D for longer-term sector growth cannot be overstated. A disproportionate focus on financial transactions leads to short-term mindsets, which tend to neglect opportunities for organic growth through innovation, and thereby disadvantaging companies by hindering their adaptation to economic trends and market dynamics.

Companies with robust R&D cultures attract scientific talent. Conversely, leaning away from innovation makes it difficult to attract and retain top researchers, engineers, and experts. An enterprise's reputation is tied to its innovation and scientific capabilities, while an overemphasis on financial transactions projects profit-centric motives, which can erode stakeholder trust and credibility. In the rapidly advancing technology landscape, neglecting R&D invites obsolescence. Companies not allocating sufficient resources to innovation run the risk of falling behind competitors as new breakthroughs emerge, jeopardizing their market share. Over emphasising M&A introduces dependence on external factors such as regulations, negotiations, and integration challenges, which can disrupt an enterprise’s growth predictability. While financial transactions may promise more immediate gains, they tend to divert resources away from longer-term strategies and R&D, which can compromise sustained growth and value added. This shift risks a company losing a core identity, which can undermine employee motivation and reduce stakeholder alignment. Further, prioritizing financial transactions can create discord within an organization between transaction-focused executives and innovation-aligned employees, which could impede strategy execution. Thus, leaning away from R&D for financial gains can jeopardize innovation, growth, and competitive edge, ultimately hampering a company's longer-term success.

Part 3

The Implications of M&A-Centric Growth

The implications of M&A-centric growth are multifaceted and extend beyond the immediate area of financial transactions. A trend that emerges within MedTechs as they prioritize M&A activities over R&D, is an innovation gap, which can introduce strains within leadership dynamics as resources are disproportionately allocated to financial pursuits rather than fostering technological advancements. Reallocating resources in this way can stifle the development of innovative technologies. Moreover, often the shift is accompanied by a transformation in executive skill sets, where financial acumen takes precedence over the ability to drive R&D. Consequently, there is a shift in the overall performance metrics of companies. Short-term gains resulting from transactional activities, often overshadow longer-term, research-driven achievements that are essential for innovation, growth, and competitive advantage.

The change in company culture is another potential consequence of this growing inclination toward financial activities. The once-pervasive values of creativity calculated risk-taking, and scientific exploration, which have historically fueled innovation, start to wane. This is further exemplified by a shift in talent attraction strategies. The attraction of financial expertise can eclipse the allure of nurturing disruptive innovation, thereby resulting in a dearth of fresh perspectives that could potentially drive growth and value.

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As decision-making processes prioritize short-term financial outcomes, there is a gradual sidelining of research-driven innovations that are needed for the sustained growth and relevance of MedTech companies. The ramifications of this choice are significant. Entities that opt for transactional expansion rather than innovative evolution may find themselves trailing behind competitors who continue to invest in R&D endeavours. This divergence in strategy could lead to a subsequent loss of market share and a gradual erosion of overall relevance. Innovation remains important to address the adaptive challenges that arise from evolving healthcare demands, increased patient voices, rapidly advancing technology, and increasingly stringent regulatory requirements. The transformation of MedTech companies into entities that prioritize financial outcomes run the risk of leaving them ill-equipped to effectively navigate these headwinds. A reduced focus on innovation tends to render companies vulnerable, impairing their capacity to anticipate and effectively respond to future industry and societal trends.

The importance of striking a balance between short-term financial goals and longer-term innovation objectives cannot be overstated. Companies that are unable to reconcile these contrasting perspectives risk compromising their ability to anticipate and adapt to the evolving healthcare landscape. In essence, the ramifications of an M&A-centric growth approach are not solely confined to fiscal aspects; they extend to the core of a company's competence to foresee, adapt to, and thrive within a rapidly evolving MedTech sector.

Reduced R&D resources impact on patient care and outcomes

The impact of diminished R&D resources on patient care and outcomes can be significant. At its core, a vibrant and forward-thinking MedTech industry is essential for the development and successful deployment of medical technologies, diagnostics, and treatments that increase the efficacy of healthcare and improve patient outcomes. The combination of innovation and healthcare can translate into tangible benefits for patients. For instance, personalized medicine therapies, which are outcomes of R&D, offer a transformative approach that enhances patients’ therapeutic journeys, and minimizes adverse effects.

Smart devices often mean swift and precise diagnoses, which pave the way for timely and effective interventions. Beyond this, innovation extends to healthcare accessibility. Remote monitoring and telehealth technologies reduce geographical barriers, bringing healthcare within reach of those in remote and underserved regions. This can reduce disparities in healthcare access, leveling the playing field for all individuals, regardless of their location, ethnicity, or socioeconomic status. Further, the shift toward minimally invasive technologies not only fosters quicker recovery times but also shortens hospital stays. The combination of improved healthcare protocols that promote better adherence and more efficient, cost-effective medical procedures helps to make quality healthcare accessible to more people.

Concern arises when MedTech innovation takes a back seat, which tends to perpetuate outdated medical devices that can result in suboptimal outcomes and the continuation of existing healthcare disparities. The neglect of innovative R&D endeavours delays the development of disruptive technologies, thus prolonging inequitable healthcare access and outcomes. In this context, companies that lean away from innovation could find themselves deepening divisions between different patient outcomes. The role of healthcare providers is associated with the availability of advanced technologies. Optimal care requires the integration of innovative technologies into medical practices, and the neglect of this can limit access to care, and potentially compromise patient outcomes. It is important to stress that the direction of the MedTech industry has an impact on the quality of healthcare that a society can provide. By placing innovation at the forefront of strategic priorities, companies are more likely to enhance treatments, patient experiences, and the overall efficiency of the healthcare ecosystem. Neglecting innovation, on the other hand, can result in stagnation that perpetuates inequalities, delays healthcare access, and slows the development of patient-centered care. The symmetry between financial considerations and the pursuit of innovation is important. The consequences of overlooking either aspect have effects, which can extend beyond company balance sheets into the health and wellbeing of patients who depend on the MedTech industry to provide leadership for a healthier and more equitable future.

Part 4

A Strategic Approach for MedTech Transformation

The phase of MedTech's growth driven by M&A has now matured, necessitating a fresh perspective and refined strategy. The transition from visionary leaders to financial managers has, in many medical technology companies, created a void in leadership, especially given the current headwinds faced by the industry. To improve patient outcomes and foster sustainable growth, a recalibration is required, which places innovative leadership and patient-centric care initiatives at the forefront. A synergy between financial and R&D strategies is important for success. Only by reconciling financial operations with innovation endeavours, can the potential for competitive advantage and improvements in patient care take place.

Strategic allocation of resources, particularly towards dedicated innovation efforts, drives research. Notwithstanding, the realization of this relies on company executives leaning in on the transformative potential of R&D endeavours. To counterbalance any undue focus on short-term gains, it is essential to develop and implement a balanced set of performance metrics that connect financial milestones with innovation breakthroughs. This provides the basis for a strategy, which fuses financial decision-making with the promotion of innovation-driven initiatives. Further, to help executives develop diverse and adaptable mindsets, enterprises might consider increasing collaborations with research institutions and start-ups, with the aim to gain access to talent and knowhow that complements internal capabilities.

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The establishment of structured innovation frameworks, closely tethered to fiscal objectives, should help to provide a consistency of purpose. Safeguarding innovations requires robust intellectual property (IP) strategies, and regular evaluations, attuned to prevailing market trends, and assisting with the ongoing alignment of a company’s strategy with exogenous trends. This nuanced approach hinges on executives being able to balance essential financial imperatives with innovations to create a balance, which, in turn, is expected to contribute to sustainable growth, heighten competitiveness, improved patient outcomes and reduced healthcare costs.

Cultivating leaders with balanced expertise

Successfully blending transactional expertise with R&D capabilities requires leaders with vision and purpose able to develop and implement strategies that harmonize with an enterprise’s goals and politico-economic trends, evolving stakeholders’ demands and changes in healthcare systems. Let us briefly suggest a roadmap to achieve this.

First, develop cross-functional leadership teams that unite financial and R&D experts, and are expected to help ensure that decisions become grounded in both fiscal considerations and innovative pursuits. Advocating for innovation within finance and R&D units, helps to foster alignment between financial choices and R&D priorities. Developing and implementing key performance indicators (KPIs) is crucial. These should measure both financial outcomes, and advancements in innovations. Consider incorporating into performance evaluations metrics such items as newly filed patents, and the delivery of product launches and impactful R&D projects on-time and within budget.

Establish a dedicated venture fund to drive and reward innovation. Facilitate collaborative workshops that bring together finance, R&D, marketing, and other functions to ideate transformative solutions and services. Such endeavours should aim to increase growth, enhance enterprise value, improve patient outcomes, and reduce the cost of care. Align financial objectives with innovation goals, linking bonuses to achievements in both financial performance and successful innovation. When contemplating M&A, give precedence to targets that enhance a company’s innovative capabilities by aligning with R&D expertise and novel product portfolios, thus amplifying innovation.

Create small cross-functional review groups to assess innovation projects for alignment with business goals and fiscal viability. Establish agile committees to oversee resource allocation and to ensure consistent R&D funding. Implement programmes to recognize and celebrate employees who contribute to innovative ventures to help cultivate a culture of inventiveness. Set up platforms to facilitate interdepartmental sharing of creative ideas. Actively involve financial specialists in innovation discussions. Cultivate external partnerships to infuse fresh perspectives into R&D initiatives. Foster communication channels between financial and R&D teams and encourage regular exchanges of insights and opportunities. Provide training to enhance financial experts' understanding of R&D processes and offer financial literacy training to R&D teams. By integrating transactional expertise and R&D acumen, MedTechs can more effectively balance financial growth and innovation, to help enhance competitiveness, adaptability, and industry-leading innovation.

Reviving visionary leadership

This Commentary started by describing differences between leaders and managers to highlight the prevalence of transactional management during a period of M&A-driven growth, which in turn diminished the demand for visionary leadership. As the industry has reached a mature phase, and facing significant headwinds, a juncture arises that calls for leaders capable of bridging the gap between financial success and technological advancement. This involves aligning financial strategies with a broader vision of innovation and patient-centric progress. In doing so, visionary leaders establish a framework that both augments a company's financial performance, and drives healthcare technology forward, ultimately enhancing patient outcomes. This strategic evolution depends on leaders embracing a forward-thinking mindset that extends beyond immediate gains and helps to steer enterprises towards sustained innovation and growth.

Central to this transformation is the synchronization of financial goals with a company's longer-term vision. This ensures that financial policies are conducive to fostering transformative technologies. Cultivating an innovative culture within an organization, leaders instill a spirit of expansive thinking, experimentation, and the pursuit of innovative technological solutions and services that address healthcare challenges. Acknowledging the need for strategic investments in R&D, these leaders allocate resources optimally to bolster novel solutions and services. Furthermore, they have an awareness of market trends, emerging technologies, and evolving patient needs. This equips them to anticipate shifts in both the market and technology landscapes, which enables them to strategically position their companies to take advantage of emerging opportunities. By balancing innovation and astute risk management, leaders blend calculated risk-taking with prudent financial decisions, thereby contributing to stability and improved competitiveness. With a focus on the longer-term impact of their actions, visionary leaders understand the interplay between present-day technological advances and a company's future standing.

In the dynamic ecosystems of contemporary medical technology, visionary leaders exhibit adaptability in navigating change, guiding companies forward by skilfully adopting new technologies and strategies. Their longer-term strategic outlook attracts top talent from both finance and technology. Inherently collaborative, these leaders forge alliances with other companies, start-ups, research institutions, and industry experts, which increase the potential for accelerating the pace of technological innovations from the bench to the bedside. Harnessing novel technologies to create distinctive solutions and services, they lead their organizations to prominence within a competitive market. Upholding ethical considerations, these leaders ensure that technological progress not only yields financial gains but also has benefits for patients and healthcare systems. Investors tend to gravitate towards enterprises with visionary leaders. The ability to articulate a compelling narrative that emphasises how innovation drives future growth and financial returns enhances their allure. Thus, visionary leaders orchestrate a successful synergy between financial acumen and technological ingenuity, encouraging an ecosystem where strategic foresight translates into substantial dividends.

Takeaways

The evolution of the medical technology sector over the past four decades has presented a dual-edged transformation that healthcare professionals must now grapple with. The shift from pioneering innovators to adept managers within the industry reflects the interplay between economic, technological, regulatory, and ethical factors. As these converge, healthcare companies face significant headwinds that demand leadership rather than management. The financialization of the industry, driven by prolonged periods of low interest rates and accessible capital, has had a significant influence on the industry’s ecosystem, accelerating growth while simultaneously steering priorities away from innovation towards financial pursuits. This shift opened a new era, characterized by an abundance of skilled managers but a deficit of visionary leaders. Today, the MedTech industry stands at a juncture, with the demand for strategic foresight and innovative thinking never more acute. The need to pivot towards sustained growth and enhanced enterprise value necessitates leaders who can balance the strategic imperatives of R&D and the financial acumen required for M&A. The future trajectory of the medical technology sector hinges on the ability of healthcare professionals to recalibrate leadership dynamics. By addressing the scarcity of visionary leaders, the industry can leverage its potential to overcome the headwinds it currently faces and pioneer transformative innovations that redefine the landscape. As healthcare professionals navigate the future, their collective efforts will determine whether the MedTech sector continues to evolve along its current trajectory or takes a bold new direction towards enhanced growth, innovation, and added value.

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Transforming Women's Health

HealthPad

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Medical Technology

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commentary

endometriosis

menopause

reproductive medicine

women's healthcare

Women's health needs are linked to their biological, physiological and psychosocial makeup, setting them apart from men and requiring specialized care
Women's health has been inadequately addressed
Gender inequalities continue and lead to uneven healthcare accessibility, resulting in postponed diagnosis and less than optimal treatment outcomes
Women play a pivotal role in families, communities, workforces and society
Investing in comprehensive lifetime care for women, rather than disparate, periodic interventions, is a human right, a social responsibility and an astute economic strategy

Transforming Women's Health
Pioneering a Comprehensive Lifelong Healthcare Paradigm

Preface

In a significant shift, gender issues pertaining to women’s health, are experiencing change driven by women’s growing refusal to accept secondary status. This change is accompanied by the substantial contributions women make to economic growth, stemming from their expanding presence in the workforce and their influential roles within families, communities, and society. While pharmaceutical and medical technology sectors have developed specialized treatments for certain women’s disorders, there remains a need for a proactive, lifelong approach to women’s healthcare. Although efforts to address conditions like menopause and breast cancer are commendable, they risk commodifying women’s health. To meet their diverse health needs and acknowledge the pivotal roles they play in both developed and developing economies, a comprehensive and sustainable healthcare model is necessary. This is more than episodic interventions and calls for an understanding of, and sensitivity towards the unique physiological and psychological challenges women encounter throughout their lives. A proactive paradigm prioritizing prevention, early detection, and treatment is mooted. Realizing this calls for collaboration among healthcare providers, institutions, advocacy groups, governments, and payers. While commercial enterprises may think that participating in a comprehensive lifelong strategy for women’s health is beyond their scope, the changing business environment, shaped by concerns related to Environmental, Social, and Governance (ESG) matters, highlights the ethical, social, and commercial importance of supporting a holistic approach to women’s healthcare.

In this Commentary

This Commentary is in three parts. It starts by briefly describing what constitutes women's health and suggests why women’s healthcare is important, which is followed by a short historical perspective and mention of gender disparities that still exist despite improvements. Part 2 describes a comprehensive lifetime healthcare strategy for women, to replace current disparate, episodic interventions, and contends that such a holistic approach has the potential to yield substantial health, wellbeing, and socio-economic benefits. The size of the global women’s healthcare market and some of the leading companies participating in it are described in Part 3. Takeaways follow and stress the significance of a comprehensive, lifetime healthcare model for women.

Part 1

Women’s health

Women's health is a critical and multifaceted area of healthcare that focuses on their specific biological, physiological, and psychosocial needs throughout their lifetime. It encompasses a wide range of conditions, from reproductive and gynecological health to hormonal changes, pregnancy, and menopause. Reproductive health includes family planning, contraception, and fertility management. Providing information about birth control and fertility treatments helps women to make informed decisions about their reproductive choices. Addressing issues related to sexual health, such as sexually transmitted infections (STIs) and sexual dysfunction, encourages women maintain a healthy intimate life. Gynecological health is another key component of women’s health, involving the prevention, diagnosis, and treatment of conditions affecting the female reproductive system. Routine screenings like Pap smears and mammograms help in early detection of cervical and breast cancers. Healthcare professionals should be adept at managing common gynecological conditions such as menstrual disorders, polycystic ovary syndrome (PCOS), endometriosis, and uterine fibroids. Throughout a woman's life, hormonal changes influence her physical and emotional wellbeing. Addressing concerns related to menstruation, hormonal imbalances, and menopause is important. Additionally, pregnancy and childbirth require prenatal care, delivery support, and postpartum care for both mother and baby. Sensitivity, empathy, and a patient-centered approach are essential. Only by recognizing and addressing the needs and challenges faced by women, can healthcare providers effectively contribute to female patients' overall wellbeing and quality of life.

The importance of women’s health

Historically, women’s health has predominantly revolved around reproductive aspects due to their perceived primary role. Despite enduring years of inadequate representation and underfunding in medical practice and research, the importance of prioritizing women’s health is a crucial step towards reducing gender disparities, optimizing outcomes, and fostering societal equity. Overlooking the holistic consideration of women’s distinctive lifelong attributes can lead to undetected or untreated disorders. Central to this is women’s reproductive and maternal wellbeing, which not only molds their own health but resonates across generations, influencing the wellbeing of their offspring. Thus, ensuring ample prenatal care, maternal nutrition, and birthing support is pivotal in securing favourable results for mother and infants.

Prioritizing women’s health leads to the reduction of preventable diseases. Comprehensive female health programmes encompassing screenings, vaccinations, and early detection of conditions such as breast and cervical cancers play a crucial role in disease prevention and prompt treatment, thereby amplifying overall health and longevity. Women’s wellbeing is a foundation for personal wellness, gender parity, and societal advancement. Optimal female health empowers women to confidently engage in decision-making, pursue education, seize economic opportunities and more. By concentrating on women’s health, we not only champion proactive care and lifestyle adjustments benefitting individuals and future generations, but also alleviate the large and rapidly growing burdens on healthcare systems.

Brief history

Over time, women's healthcare has experienced gradual advancements and improvements. In ancient times knowledge about women's health was passed down through oral traditions and informal practices. Women relied on natural remedies and herbal medicine for managing reproductive health, childbirth, and general wellbeing. During the medieval and Renaissance periods, women's healthcare was mainly in the hands of midwives and female healers. Their expertise in childbirth was valued, but formal medical education and knowledge were limited. As medical knowledge advanced during the 18th and 19th centuries, some progress was made in understanding women's anatomy and reproductive health. However, societal norms and prejudices often hindered women from either accessing formal medical education or seeking medical attention, which resulted in continued reliance on midwives and home remedies. The mid-19th century brought changes. In 1849 Elizabeth Blackwell, a British-American, became the first woman in US to earn a medical degree, and the first woman on the Medical Register of the General Medical Council for the UK. Florence Nightingale, best known for her pioneering work in nursing, played a significant role in the Crimean War (1853-1856), where she improved nursing care for wounded soldiers and established modern nursing practices, which have had a lasting impact on nursing and public health. Their achievements, and those of others, subsequently laid the foundations for the involvement of women in the field of medicine. However, societal attitudes still posed obstacles to women's healthcare advancements.

The 20th century saw progress in women's healthcare. With the suffrage movement and feminist activism, women's rights and health issues gained attention. In the early 1900s, the first birth control clinics were established, allowing greater control over reproductive choices. Further progress was made during the mid-20th century. In 1960, the US Food and Drug Administration (FDA) approved the first oral contraceptive pill, which changed family planning and reproductive rights. In the following decades, women’s movements advocated access to safe and legal abortion. Women's healthcare expanded further in the latter half of the 20th century, with increased research and understanding of women-specific health concerns. Breast cancer screenings, cervical cancer screenings (Pap smears), and other preventive measures became more widely available.

In the 21st century, women's healthcare continued to progress, with an emphasis on preventive care, and early diagnosis. Advances in medical technologies and research further improved women's health outcomes. Efforts were made to address disparities in healthcare access for different populations of women, including those based on ethnicity, socio-economic status, and geographical location. Initiatives to improve maternal health, reduce maternal mortality, and provide better support during childbirth gained momentum. Awareness campaigns focusing on issues, such as breast and cervical cancers, helped in early detection and treatment. Taboo and often misunderstood subjects like menopause are now widely discussed, primarily to educate people. Additionally, women's mental health received more attention, leading to increased resources and support. While challenges remain, the activities of healthcare professionals, researchers, advocates, policymakers, and commercial enterprises continue to help shape a healthier future for women.

Gender disparities in healthcare

Despite advances in women’s healthcare, gender disparities have been a persistent and concerning issue, with women often facing underrepresentation in medical research and practice. Such differences result in unequal access to healthcare services, delayed diagnosis, and suboptimal treatment outcomes. Women's health concerns have often been underrepresented in clinical trials, which results in a lack of evidence-based treatment options tailored to female physiology and health risks. This disparity can be pronounced in conditions such as heart disease, where symptoms and risk factors may differ between men and women. Women often face barriers in accessing comprehensive reproductive health services, including contraception, family planning, and safe abortion services. Some regions have limited availability of these services due to legal, cultural, or religious factors, which can impact women's control over their reproductive choices and health. In many parts of the world, maternal mortality rates are disproportionately high, particularly in low-income countries. Every two minutes, a woman dies from preventable causes related to pregnancy and childbirth. Lack of access to appropriate prenatal care, skilled birth professionals, and emergency obstetric care are contributory factors, reflecting a significant gender-based health inequity. Some chronic autoimmune diseases, such as lupus and psoriatic arthritis are more prevalent in women, yet diagnosis and treatment can be delayed or less effective due to gender biases in medical research and practice. Studies have shown that women's pain is often undertreated compared to men's, potentially due to biases in healthcare providers' perceptions of pain and discomfort. This can lead to inadequate pain relief and poorer health outcomes. While mental health problems affect both genders, women frequently encounter distinct challenges. These encompass conditions like postpartum depression and anxiety, which are primarily linked to hormonal imbalances, but also associated with factors such as insufficient sleep and inadequate support systems. Societal stigma around mental health, combined with gender norms, can discourage women from seeking help and support for their mental wellbeing.

In some societies, limited education and information about healthcare can lead to women having less knowledge about preventive measures, symptoms, and treatment options, which can result in delayed or inadequate care for certain conditions. Gender-based violence has health consequences, including physical injuries, mental health issues, and increased risk of sexually transmitted infections. Limited access to safe spaces, support services, and legal protection can hinder women's ability to escape such situations. Further, women tend to live longer than men, but they may also face difficulties accessing appropriate healthcare and support in their later years. Consequently, elderly women often experience greater social isolation, limited financial resources, and increased prevalence of certain health conditions.

Part 2

Comprehensive lifetime care

With increasing recognition of the contributions women make to economic growth and stability, their health has gained relevance. The emergence of women's economic influence and direct participation in the workforce has prompted a shift in our approach to women's health. The pharmaceutical and medical technology industries have made progress by developing medications and devices targeting specific health issues. Notwithstanding, it seems timely to move beyond such approaches and focus on a comprehensive care model that supports women throughout their lives.

Pharmaceutical and MedTech companies have tapped into the women’s healthcare market by focusing on high-volume areas, like mensuration, menopause, and breast cancer. While such efforts are improvements, women deserve better. In recognition of the significant contributions they make to society, and the changing perspectives of corporate social responsibility, it is time to pivot towards a new approach to women's health. Rather than focusing on reactive healthcare policies to address specific disorders, a comprehensive and proactive care model is required to address women's diverse healthcare needs. Women's health encompasses more than just the treatment of certain illnesses and diseases. It involves addressing the unique physiological and psychological aspects they experience throughout their entire lives. Thus, a shift towards providing lifetime care and support for women seems timely.

According to the World Health Organization (WHO), “Health is a state of complete physical, mental, and social wellbeing and not merely the absence of disease or infirmity”. Achieving this for women requires a collaborative effort from healthcare providers, institutions, organizations, governments, and payers. This should aim to break down barriers, improve access to quality care, and foster health equity for all women, regardless of their socioeconomic status or geographical location. Certain businesses may view participating in a comprehensive women’s health approach as beyond their commercial interests. However, with ESG concerns reshaping the landscape, collaborating in a women’s holistic healthcare strategy becomes ethically, socially, and commercially logical.

Benefits of a lifetime health programme

A proactive lifetime healthcare approach would result in long-term cost savings by identifying health concerns early and reducing expensive treatments, benefiting individuals, and trimming large and rapidly growing healthcare burdens. This allows resources to be reallocated for other needs. Moreover, enhanced women's health has a positive economic impact. Countries like the US and UK have relatively high female workforce participation rates: ~57% and ~72% respectively. A healthier workforce contributes to higher productivity, benefiting both businesses and economies.

Investing in women's lifetime healthcare also helps narrow gender pay gaps by providing access to consistent healthcare, promoting career advancement, financial security, and workplace parity. Prioritizing prevention and addressing women's health needs drives demand for innovative solutions and services, potentially leading to advancements in pharmaceuticals, medical technologies, and healthcare practices. Nation’s investing in holistic women's health can gain a competitive edge with an educated, committed female workforce, which supports stability, and innovation. Additionally, effective women's healthcare reduces reliance on public aid, channeling fiscal savings toward societal wellbeing.

The women's health market holds significant growth potential. Unique concerns provide opportunities for innovative solutions and services such as advanced fertility treatments and personalized therapies. Telemedicine and digital healthcare platforms expand access, especially in underserved regions. Amid competition from established players, newcomers can thrive by emphasizing innovation, patient-centered care, and technology integration. Adhering to safety standards and addressing cultural norms are crucial for building trust. Overcoming stigmas through education and targeted campaigns encourages women to prioritize their health. By collaborating in a comprehensive lifetime approach and strategic R&D, companies can gain a competitive edge.

Part 3

Women’s healthcare market

According to Grand View Research, in 2022, the global women’s health market was valued at ~US$41bn, and is expected to grow at a compound annual growth rate (CAGR) of ~5.4% over the next decade. Market growth is attributed to aging populations of women, and the increasing prevalence of women-centric diseases such as osteoporosis, menopause, and breast cancer. The World Health Organization (WHO) reports that breast cancer is the biggest killer of women, but only ~50% of them realize this. In 2020, there were 2.3m new cases of the disease globally and ~685,000 deaths.

There are many companies marketing products for women’s health. Pfizer, one of the world's largest pharmaceutical companies has a presence in women's health. They have developed and market contraceptives, hormone replacement therapies, and treatments for menopause-related symptoms. Merck & Co. is a global healthcare company that offers a range of products for women's healthcare, including fertility treatments, contraceptives, and medications for conditions like human papillomavirus (HPV) and osteoporosis. Johnson & Johnson, a diversified healthcare company, offers medicines for menopause, products for menstrual health, and contraceptives. Bayer, a multinational pharmaceutical company known for its contributions to women's healthcare, produce intrauterine devices (IUDs), and medications for various women's health conditions and wellbeing. AbbVie has offerings that include treatments for endometriosis and hormone replacement therapies. Hologic, a MedTech specializing in women's health, produces imaging systems, diagnostic tools, and surgical equipment for gynecological and breast health, including mammography and biopsy solutions. Medtronic, a global healthcare technology leader, provides medical devices for gynecological surgeries and treatments for urinary incontinence. CooperSurgical, a dedicated women's health company, offers a wide range of medical devices and products for gynecological procedures, fertility treatments, and obstetrics.

Takeaways

In a world where gender-specific health disparities persist, companies engaged in women’s health have the capacity to make an impact on women’s overall wellbeing. The growing recognition of distinct healthcare requirements for women emphasizes the significance of committing resources to women’s health, suggesting a choice that is both commercially astute and socially just. In addition to reactive interventions, businesses might consider partnering with stakeholders to support a comprehensive healthcare strategy tailored to women’s individual life journeys. This requires leadership, investing in R&D, and harnessing the potential of emerging technologies like digital health platforms, telemedicine, and AI-driven data analytics. Such an endeavour has the potential to change healthcare accessibility, amplify diagnostic precision, and refine disease management exclusively for the female demographic. By participating in such an approach, companies not only position themselves as leaders in an important market segment but also contribute to fostering a healthier, more equitable world for women throughout their entire lifespan.

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PPG technology: Unlocking the Potential of Healthcare

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traumatic brain injury

Photoplethysmography, commonly referred to as PPG, is a simple, non-invasive, and affordable technology used for monitoring heart rate, blood oxygen saturation, and other physiological parameters
PPG uses light to measure and analyze changes in blood volume, enabling the tracking of vital signs and assessment of cardiovascular health
With a growing interest in non-invasive physiological monitoring and a shift towards continuous and ubiquitous patient care, PPG has gained significant attention and provides alternatives to expensive, time-consuming, and invasive healthcare modalities
Many giant tech companies, including Apple, Google-Fitbit, and Samsung produce wearable products that incorporate PPG technology
PPG-driven devices are used by millions and have established a significant presence in healthcare and wellbeing
Despite its potential, PPG faces challenges that include signal variability, noise and artifact interference, which can distort the signal and hinder reliable information extraction
Overcoming these challenges will pave the way for pervasive adoption of PPG technology throughout healthcare

PPG technology: Unlocking the Potential of Healthcare
A Journey of Non-invasive Precision

This Commentary describes how photoplethysmography (PPG) has become a valuable tool in continuous vital sign monitoring, and exercise physiology, making it a promising avenue for improving patient care and empowering individuals to take better care of their health and wellbeing. PPG has the potential for many more non-invasive and affordable healthcare applications, providing alternatives to expensive, time consuming, and invasive methods. The technology benefits not only from the large and rapidly growing interest in non-invasive physiological tracking, but also from the paradigm shift in healthcare towards continuous and pervasive patient monitoring beyond traditional in-hospital care. This Commentary describes PPG, explores its applications in healthcare, highlights its advantages over traditional methods, and suggests that it has potential to disrupt the diagnosis and treatment of traumatic brain injury.

Photoplethysmography (PPG)

PPG is a non-invasive and straightforward measurement technology that utilizes a light source and a photodetector placed on the skin's surface to assess the variations in blood volume. Typically used for blood oxygen (SpO2) and heart rate monitoring, PPG sensors are commonly placed on the wrist or fingertip, where blood flow is close to the skin's surface. A light-emitting diode (LED) emits light into the tissue, and the photodetector captures the reflected or transmitted light, detecting changes in light absorption or reflection caused by fluctuations in blood volume. These fluctuations in light intensity are converted into electrical signals, which can be processed to determine SpO2 or heart rate levels.

The PPG signal, also known as the photoplethysmogram, is based on the principle that blood absorbs light, and this absorption changes as blood volume fluctuates with each heartbeat. When the heart pumps blood into the arteries during systole, the volume of blood in the arteries increases, leading to more light absorption. Conversely, during diastole when the heart relaxes, the blood volume in the arteries decreases, resulting in less light absorption. Analyzing these variations in transmitted or reflected light, the PPG signal provides information about pulsatile changes in blood flow and offers insights into peripheral vascular function, arterial stiffness, and other vascular characteristics.

PPG has several advantages, including its non-invasiveness, simplicity, and portability. Unlike other methods, it does not require needles or complex equipment, making it suitable for continuous monitoring in various settings. By providing physiological information about the cardiovascular system, PPG finds applications in vital sign monitoring, sleep apnea screening, exercise physiology, blood flow assessment, and continuous health tracking. The technology's convenience, affordability, and accessibility contribute to improved patient care and empower individuals to take a more proactive role in monitoring their health and wellbeing.

It is important to note that PPG provides only indirect measurements and does not offer detailed information about the underlying cardiovascular system. Its primary focus is on changes in blood volume. For accurate measurements in medical applications, calibration and validation against other gold standard techniques are necessary. Notwithstanding, PPG remains a healthcare technology with wide-ranging applications, serving as a valuable tool in enhancing healthcare monitoring and management.

Brief history

PPG has a history that spans several decades, with advancements and refinements in both the technique and its applications. Its foundations were laid in the 1930s when researchers began investigating the transmission and reflection of light through human tissues. The first PPG measurements were performed using mercury-filled plethysmographs and light sources like incandescent lamps. During this period, the technology was primarily used for studying changes in blood volume and its correlation with physiological events. In the 1950s, Karl Matthes invented the first practical PPG sensor, which utilized a red light-emitting diode (LED) and a phototransistor. Matthes's device was initially designed for measuring pulsations in the extremities and evaluating peripheral circulation. The technology gained further recognition in the 1970s with the introduction of pulse oximetry, when a combined PPG sensor and spectrophotometer were used to measure oxygen saturation (SpO2) non-invasively, providing a breakthrough in patient monitoring. Pulse oximetry enabled continuous SpO2 monitoring and changed the management of respiratory and cardiovascular conditions. In the 1980s and 1990s, the technology found applications beyond pulse oximetry, when its sensors were integrated into devices for measuring heart rate variability, blood pressure, and assessing autonomic nervous system functions. The use of PPG in wearable devices and ambulatory monitoring systems became more prevalent during this period. The 2000s saw miniaturization and the integration of PPG sensors into consumer electronics. Wearable fitness trackers, smartwatches, and pulse oximeters became popular, bringing PPG-based monitoring to the mainstream. The advent of smartphones further accelerated the adoption of PPG-based applications, with various health and wellness apps utilizing the technology for heart rate tracking and stress monitoring. Today, PPG continues to evolve with developments in sensor technology, signal processing algorithms, and expanding applications in healthcare, sports, and wellness monitoring. Ongoing research aims to enhance the accuracy and reliability of its measurements and explore its potential in areas such as vascular health assessment, sleep monitoring, early disease detection and the diagnosis and management of traumatic brain injury.

PPG applications

PPG applications include: (i) monitoring blood oxygen levels and heart rate in various healthcare settings, including hospitals, clinics, and homecare, to provide real-time information about a patient's cardiovascular status, allowing healthcare professionals to detect abnormalities or assess the effectiveness of treatments, (ii) sleep studies to detect respiratory events such as apnea [temporary cessation of breathing] and hypopnea [shallow breathing]. By monitoring changes in blood volume, the signals can identify disruptions in breathing patterns during sleep and help in diagnosing sleep-related disorders, (iii) fitness and sports settings to measure heart rate, assess the intensity of physical activity, and provide immediate feedback to individuals, helping them optimize their workout routines and monitor their cardiovascular response during exercise, (iv) assessing peripheral vascular functions to identify conditions like arterial stiffness or endothelial dysfunction, and (v) enabling continuous monitoring of heart rate and SpO2 levels, which facilitates early detection of potential health issues and encourages proactive healthcare management.

Over the past two decades, the increased adoption of PPG monitoring in medical technology has led to enhanced patient care, improved early detection of various health conditions, and facilitated remote patient monitoring, all contributing to more personalized and efficient healthcare delivery. This increased interest is underscored by the rise in research publications related to PPG over the past two decades. In 2000 the annual number of papers indexed in PubMed using the keywords "Photoplethysmography" or "Photoplethysmogram" was <50, but by 2022, had increased to ~500; an increase of ~900%.

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Leaning-in on digital and AI

PPG products

Most tech giants have developed and commercialized PPG products. For instance, Apple has incorporated PPG sensors into its Apple Watch, which allow users to monitor their heart rate and receive notifications for abnormal heart rhythms. The latest Apple smartwatch (Apple 7) includes a US Food and Drug Administration (FDA) approved electrocardiogram (ECG), which employs an electrical heart sensor capable of alerting its user to abnormal heart rhythms. In January 2021, Google acquired Fitbit for US$2.1bn, and integrated PPG technology into its wearable fitness trackers. In 2022, Fitbit received clearance from the FDA for a new PPG-driven algorithm to identify atrial fibrillation (AF). Huawei, a leading Chinese multinational, has also implemented PPG sensors in its smartwatches and fitness bands. The Massimo Corporation, a MedTech known for its development of innovative monitoring solutions, has created PPG sensors, which are used in hospitals and medical settings to measure SpO2, pulse rate, and perfusion index. Garmin, a company in the field of GPS navigation and fitness technology, has incorporated PPG sensors into its smartwatches and fitness trackers. Garmin's PPG products also offer sleep and stress monitoring. Samsung a global South Korean electronics company, has also integrated PPG technology into its wearable devices, including smartwatches like its Galaxy Watch series. The company’s offerings provide similar functionalities to the products described here, allowing users to track their heart rate, monitor stress levels, and receive alerts for abnormal heart rate patterns. All these companies have leveraged PPG technology, coupled with complimentary technologies, to create wearable devices that provide users with health and wellness insights and enable individuals to monitor their vital signs conveniently and track their overall wellbeing.

Advantages of PPG devices

Non-invasive PPG-driven devices offer painless monitoring without invasive procedures or body sensors. By simply placing optical sensors on the skin, patients experience minimal discomfort, reduced infection risks, and uninterrupted daily activities. Comfortable for extended wear, these devices enhance patient compliance and overall experience. Compared to invasive techniques, PPG-driven devices are cost-effective and eliminate the need for expensive disposable sensors or frequent laboratory tests. Portable and incorporated into wearable devices like smartwatches or fingertip pulse oximeters, they enable remote monitoring, reducing hospital visits and providing accessibility, especially for patients in remote areas.

The technology provides real-time data and rapid feedback for most conditions it currently monitors. It allows healthcare professionals to quickly detect abnormalities and make timely decisions, while patients receive immediate feedback, empowering them to manage their wellbeing proactively. PPG data can be seamlessly integrated into healthcare systems to enhance efficiency. For instance, data can be wirelessly transmitted to electronic health records (EHR) for convenient analysis. Integration with telemedicine platforms enables remote consultations and real-time communication. By combining PPG data with other diagnostics, such as ECG or sleep monitoring, it supports accurate diagnoses.

Additional information carried by the PPG signal

The PPG signal carries additional diagnostic information, which includes pulse rate and rhythm analysis, blood pressure estimation and peripheral vascular assessment, and assessment. Pulse rate and rhythm analysis involve analyzing the timing and intensity of pulsations in blood vessels to assess the regularity and irregularity of the heartbeat. Abnormalities in pulse rate and rhythm can indicate cardiac conditions, such as arrhythmias, tachycardia [rapid heart rate], or bradycardia [slow heart rate]. Utilizing the PPG signal, blood pressure estimation can be performed by analyzing changes in blood volume and arterial pulsations, which is helpful for monitoring and managing hypertension or hypotension without the need for complicated procedures. The PPG signal facilitates the assessment of peripheral vascular functions by examining the shape, amplitude, and timing of pulsations in peripheral blood vessels, which help to detect conditions like peripheral artery disease and other vascular abnormalities. Also, insights into the functioning of the autonomic nervous system can be obtained from the PPG signal.

Challenges for PPG adoption

Notwithstanding the advantages of PPG-driven devices, they face challenges, which include, limited standardization and variability in PPG signal acquisition, noise, and artifact interference, regulatory considerations, and validation and user acceptance. Let us briefly consider these.

The lack of standardization in signal acquisition and processing is an obstacle for the further adoption of PPG devices. Different manufacturers may use varying sensor technologies, placement locations, or algorithms that lead to inconsistencies in the PPG signal quality and measurements, and this can affect the accuracy and reliability of PPG data, making it challenging to compare results across different devices or settings. Standardization efforts and guidelines are needed to ensure consistent and reliable PPG signal acquisition and interpretation.

Further, PPG signals are susceptible to various forms of noise and artifact interference, which can distort the signal, posing challenges to obtain reliable and accurate information. Environmental factors, such as ambient light, motion artifacts, and poor sensor contact with the skin, can introduce noise into the PPG signal. Additionally, physiological factors like skin pigmentation, tattoos, vasoconstriction, or motion-induced variations can also impact the quality of the PPG signal. Techniques for noise reduction, artifact detection, and signal processing are essential to improve the reliability of PPG measurements.

PPG-driven devices intended for medical use need to comply with regulatory requirements and undergo validation to ensure their safety, accuracy, and effectiveness. Obtaining approvals can be a complex and time-consuming process, requiring clinical studies and proof against gold standard methods. Adhering to official standards is necessary to establish the credibility and trustworthiness of PPG-driven devices in healthcare settings.

The adoption of any new technology in healthcare relies on user acceptance and trust. Users, including patients, healthcare professionals, and caregivers, may have reservations regarding the accuracy, reliability, and privacy of PPG-devices. Educating users about the benefits, limitations, and evidence supporting PPG technology is important to build trust and acceptance. Ensuring data security, privacy, and addressing concerns about data misuse or unauthorized access are also factors in fostering user acceptance and adoption of PPG devices.

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Brain disorders and the changing nature of neurosurgery

PPG and traumatic brain injury

Given that these challenges can be effectively addressed, PPG technology is well positioned as a potential disruptive force in several fields of medical diagnostics and monitoring. For instance, PPG technology could transform the diagnosis and treatment of traumatic brain injury (TBI), a global public health concern. Each year, TBI impacts >50m individuals worldwide, creating a substantial economic burden, estimated at ~US$400bn annually. The US alone reports ~1.5m TBI survivors annually, with ~0.23m individuals enduring severe TBI resulting in hospitalizations, which each year costs ~US$32bn. The UK faces comparable challenges, with ~0.16m hospital admissions for TBI annually, costing the UK government ~£15bn (~US$19.3bn), accounting for ~0.8% of the nation's GDP.

A pivotal aspect in effectively managing TBI patients lies in the continuous monitoring of intracranial pressure (ICP), given its potential to cause complications. Despite the historical dominance of invasive modalities, such as monitoring ICP through a drilled hole in the patient's skull, progress in non-invasive alternatives has remained relatively stagnant over the past four decades. It seems reasonable to suggest that this is not solely due to technological limitations, but rather stems from insufficient investment in relevant R&D driven partly by the commercial interests of medical technology companies. Invasive techniques, although associated with drawbacks and risks, have maintained their market supremacy due to early development and commercialization.

Non-invasive measurement of ICP necessitates interdisciplinary collaboration, innovative approaches, and substantial research efforts. Inadequate R&D investment and support have hindered progress in this field, making it challenging to overcome inherent complexities and develop effective non-invasive methods. Governments bear a responsibility for public health and have a vested interest in discovering affordable and accessible methods for TBI diagnosis and treatment. By actively supporting PPG R&D, administrations can encourage innovation, stimulate healthy competition, and encourage patient-centric healthcare solutions. Non-invasive ICP measurement techniques offer several advantages for the management of TBI patients, which include minimized patient discomfort, reduced risk of infection, lower healthcare costs, and the capacity for continuous monitoring, enabling early detection of ICP fluctuations and timely interventions to prevent crises and further brain damage.

The recognition of these potential advantages underscores the necessity for increased R&D. Backing research into PPG technology aligns with broader objectives of promoting sustainable and cost-effective healthcare solutions. Non-invasive approaches, exemplified by PPG technology, have the capacity to reduce healthcare costs associated with invasive procedures, extended hospital stays, and post-operative care. Such potential advantages provide governments with an incentive to invest in PPG technology research, ultimately fostering enhanced quality of care for individuals affected by TBI while benefiting healthcare providers.

Takeaways

The benefits of PPG-driven technology in healthcare include non-invasiveness, patient comfort, and real-time data acquisition. Cost-effective and portable, PPG devices offer real-time feedback to patients and providers, improving healthcare efficiency and accessibility. Currently, PPG delivers advantages in various medical fields, such as cardiology, respiratory care, neurology, and fitness monitoring. In both inpatient and outpatient settings, the technology plays a role in diagnosing, monitoring, screening, and improving healthcare and wellbeing. It enables fast and accurate diagnoses of medical conditions, continuous monitoring of vital signs, and early detection of diseases like sleep apnea and hypertension. In addition, PPG supports fitness and wellness monitoring, providing real-time feedback for optimized workouts and overall wellbeing. Overcoming PPG’s challenges of standardization, noise interference, regulations, and user acceptance are crucial to unlocking its full potential.

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The Future Of Regenerative Medicine

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Medical Technology

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regenerative medicine

stem cell therapies

tissue engineering

The field of regenerative medicine is experiencing significant advancements and has the potential to transform healthcare by offering novel treatments, repairing damaged tissues and organs, and improving patients' quality of life
Key technologies shaping its future include stem cell research, tissue engineering, electro-stimulation, gene therapy, organ regeneration, 3D bioprinting, and nanotechnology
The progress of these technologies varies, raising the question of which will dominate the field in the next decade
Convergence of these technologies will play a pivotal role in transforming regenerative medicine
Advantages and challenges exist for each technology, and dominance will depend on scientific breakthroughs, clinical success, regulations, and patient acceptance
MedTech companies must intensify their R&D efforts in regenerative medicine to remain relevant
Collaboration between disciplines, institutions, and industry partners is crucial
Staying informed about emerging trends and breakthroughs is essential
Proactively identifying synergies and areas of collaboration can accelerate progress
MedTechs can actively shape the future of regenerative medicine by exploring and integrating evolving technologies

The Future of Regenerative Medicine
Navigating Evolving Technologies and the Imperative for MedTech Companies

In the rapidly evolving realm of modern medicine, regenerative medicine has emerged as a transformative and powerful force. With several innovative developments at its core, it has the potential to change our approach to healing and restoration. The long-awaited promise of personalized, curative, and transformative therapies appears to be within reach, giving hope to patients who have been waiting for breakthroughs.

Over the past decade, this broad field of medicine has witnessed significant developments, with various technologies emerging as promising avenues for medical innovation. Stem cell research, tissue engineering, electro-stimulation, gene therapy, organ regeneration, 3D bioprinting, and nanotechnology have all demonstrated their potential in addressing complex medical conditions. However, these technologies are progressing at different rates, and are often used complementarily, giving rise to a key strategic question for MedTechs investing in regenerative medicine research and development (R&D): Which technology or combination of regenerative medicine technologies will ultimately dominate the field in the next decade?

As this market segment gains momentum, it seems reasonable to suggest that many MedTechs have yet to fully grasp the magnitude and pace of these technological developments. To establish a presence or expand their footprint in this arena, companies must intensify their R&D efforts and monitor developments across the full range of these technologies to ensure they are not caught off guard. Time is of the essence, and those who fail to recognize this, risk being left behind.

Regenerative medicine

Regenerative medicine encompasses a broad range of approaches aimed at repairing, replacing, or regenerating damaged or diseased tissues and organs in the body. It draws upon principles from biology, engineering, and other scientific disciplines to restore both the structure and function of compromised tissues and organs. The concept underlying regenerative medicine involves utilizing the body's innate healing mechanisms to facilitate tissue repair and regeneration. This incorporates various techniques used either independently or together, and include stem cell therapy, tissue engineering, electro-stimulation, gene therapy, organ regeneration, 3D bioprinting, and nanotechnology, which either stimulate the body's natural regenerative processes or provide external support for tissue regeneration.

Brief history

Regenerative medicine has a rich history, driven by humanity's quest to heal and restore damaged tissues and organs. From ancient civilizations to modern times, medical science has continually evolved, seeking solutions to overcome the limitations of conventional treatments. This pursuit has given rise to the field of regenerative medicine. Early healers in ancient civilizations explored various remedies and techniques to promote tissue repair, ranging from herbal medicines to primitive surgical interventions. These practices laid the groundwork for our understanding of the body's inherent regenerative capacity.

In the 20th century, scientific advancements began unlocking new possibilities. The discovery of stem cells in the 1960s marked a breakthrough, revealing a versatile cell population capable of self-renewal and differentiation into specialized cell types. This discovery represented a paradigm shift in medical research and served as the foundation for modern regenerative medicine. The isolation and cultivation of human embryonic stem cells in the early 2000s was a significant milestone, offering potential for regenerative therapies. However, ethical concerns surrounding their use prompted scientists to search for alternative approaches. This led to the discovery of induced pluripotent stem cells (iPSCs) in 2006, which could be derived from adult cells and reprogrammed to resemble embryonic stem cells, thus bypassing the ethical concerns.

In recent years, regenerative medicine has experienced a surge of new and rapidly evolving medical technologies. Tissue engineering, biomaterials, gene editing techniques [a method for making specific changes to the DNA of a cell or organism], and advanced imaging modalities have impacted the field, enabling the creation of 3D tissue constructs, the bioengineering of organs, and direct tissue regeneration within the body. Regenerative medicine has expanded beyond traditional approaches, encompassing a wide range of therapeutic strategies, including cell-based therapies, gene therapies, electro-stimulation, and the utilization of growth factors and biomaterials. This multidisciplinary approach, leveraging the expertise of scientists, bioengineers, and clinicians, aims to develop transformative therapies for previously untreatable conditions.

In this Commentary

This Commentary explores the rapidly evolving technologies that have propelled regenerative medicine to the forefront of medical research and their potential implications for the future of healthcare. We describe the contributions to regenerative medicine of stem cell research, tissue engineering, electro-stimulation, gene therapy, organ regeneration, 3D bio printing, and nanotechnology. The Commentary discusses some of the challenges and ethical considerations facing the field and draws attention to governments actively pursuing regenerative medicine R&D. We stress that technologies, which contribute to this field are progressing at different rates and are often used complementarily. This raises a strategic question for MedTechs investing in regenerative medicine R&D: “Which technology or combination of regenerative technologies will ultimately dominate the field in the next decade?”. Answering this question should provide MedTechs, either contemplating entering this market segment or with established regenerative medicine franchises, with insights to guide their strategic decision-making and to assist in their long-term success in this rapidly evolving field.

Stem cell research

Stem cell research has changed regenerative medicine, opening new possibilities for tissue repair and disease treatment. One significant advancement is the development of Induced Pluripotent Stem Cells (iPSCs). These are created by reprogramming adult cells and can differentiate into any cell type, making them invaluable for personalized therapies. Unlike embryonic stem cells, iPSCs alleviate ethical concerns. However, ethical issues related to human cloning persist (see below). Nonetheless, iPSCs serve as a crucial tool, offering safer and more efficient techniques for studying diseases, screening drugs, and developing personalized therapies. They also enable the replacement of damaged cells and the creation of functional tissues and organs, providing opportunities for organ transplantation and personalized tissue replacement treatments. Researchers have also achieved success in transdifferentiation, rapidly generating desired cell types for regenerative and transplantation therapies. The gene-editing tool CRISPR-Cas9, (see below), further enhances stem cell research by allowing precise modifications for disease correction and improved traits. Clinical trials have demonstrated the potential of stem cell-based therapies in various areas, including spinal cord injuries, neurodegenerative disorders, heart disease, blood disorders, and diabetes. Advancements in bioengineering and microfluidics have further improved stem cell growth and differentiation, bringing us closer to fully harnessing the power of stem cell-based regenerative medicine.

Several companies and research institutions have made contributions to stem cell R&D. Mesoblast, an Australian biopharmaceutical company founded in 2004, focuses on developing cellular medicines based on mesenchymal lineage adult stem cells. They are actively involved in creating regenerative therapies for cardiovascular diseases, orthopedic disorders, and immune-mediated inflammatory diseases. Novartis, a Swiss pharmaceutical company, has made substantial investments in stem cell research and is dedicated to developing treatments for conditions such as macular degeneration and heart failure. Cellular Dynamics International (CDI), a biotech based in Japan and a subsidiary of Fujifilm, specializes in producing human iPSCs for use in drug discovery, toxicity testing, and disease modeling. Athersys, a biotech based in Cleveland, Ohio, US, focuses on developing innovative stem cell-based therapies. Their leading offering, MultiStem®, is a patented, adult-derived stem cell therapy platform designed to treat various disease states, including neurological disorders, cardiovascular diseases, and inflammatory conditions. Athersys has received Fast Track designations from the US Food and Drug Administration (FDA) for acute respiratory distress syndrome (ARDS), stroke, and transplant support. In 2022, Vertex Pharmaceuticals, based in Boston, US, acquired ViaCyte, a US biotech, for US$320m in cash. ViaCyte specializes in delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D). This acquisition provides Vertex with additional human stem cell lines, intellectual property related to stem cell differentiation, and manufacturing facilities for cell-based therapies, which can accelerate the company's T1D programmes. ReNeuron, a UK-based biotech focuses on developing cell-based therapies, for conditions like stroke disability, retinal diseases, and peripheral limb ischemia. Osiris Therapeutics, founded in 1993, developed Grafix®, a cryopreserved placental membrane used for wound healing and tissue repair. In 2019, the company was acquired by Smith & Nephew plc, a global medical technology business, for US$660m.

Tissue Engineering

Tissue engineering is a field that combines biology, engineering, and medicine to create functional tissues and organs. It has made advancements recently, such as the development of organoids used for studying diseases and personalized medicine. Biomaterials, like hydrogels, nanofibers, and 3D-printed scaffolds, play a role by providing support for cell growth. One challenge tissue engineering faces is creating blood vessels to ensure the tissues receive enough nutrients and oxygen. Researchers are using techniques like 3D bioprinting (see below), to create networks of tiny blood vessels within engineered tissues. 3D bioprinting allows for precise placement of cells and materials to create complex tissue structures. Decellularization, which removes cellular components from donor organs and replaces them with patient-specific cells, has also been successful in organ regeneration. Microfluidics and organs-on-a-chip platforms are used to mimic organ functions for studying diseases and testing drugs. Gene editing technologies like CRISPR-Cas9 (see below) show promise for modifying cells, enhancing tissue regeneration, and correcting genetic disorders.

Tissue engineering has achieved successes in various areas. Bladder tissues, tracheal replacements, skin substitutes, cartilage constructs, and liver models are some examples. In 1999, scientists successfully engineered and implanted bladder tissues in patients with bladder disease. In 2008, a tissue-engineered trachea was successfully implanted in a patient with a damaged airway. Tissue-engineered skin is commonly used for treating burn injuries, and advanced skin substitutes that closely resemble natural skin. Cartilage constructs show promise for repairing joints, and miniaturized liver models mimic liver function for drug testing. While these developments are promising, further research and clinical trials are needed to refine and expand the applications of tissue engineering in medical practice.

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Tissue Regenix, a UK-based company, that was spun out of the University of Leeds in 2006, employs decellularization and extracellular matrix technologies to create a range of products for wound care and orthopedic applications. Vericel, a Nasdaq traded US biotech based in Cambridge, Massachusetts, is focused on the development and commercialization of cell-based therapies. Its products include MACI [autologous cultured chondrocytes on porcine collagen membrane] for the repair of cartilage defects in the knee and Epicel [cultured epidermal autografts] for the treatment of severe burns. Medtronic, a giant American MedTech, has moved into regenerative medicine with the acquisition of MiroSurge AG, a Swiss company working on tissue engineering. Medtronic aims to develop regenerative therapies for the treatment of conditions like degenerative disc disease. Stryker, an American MedTech involved in orthopedics and tissue engineering, has a presence in the regenerative medicine through its subsidiary, Sage Products, which focuses on the development of advanced wound care and regenerative products.

Electro-stimulation

Electro-stimulation, also known as electrical stimulation or electrotherapy, offers a non-invasive and safe method to enhance tissue regeneration and repair. It involves the use of specialized devices that deliver controlled electrical impulses to specific areas of the body. While electro-stimulation has a range of applications in medicine, one area where it shows promise is in tissue regeneration and enhancing the body's ability to heal itself. A common application is for the stimulation of nerves and muscles. Applying electrical currents to these tissues can restore or improve their function. For instance, in patients with nerve damage or muscle weakness, the technology can help to reactivate the nerves or strengthen the muscles, leading to improved mobility and functionality. Electrotherapy also promotes tissue healing and regeneration by enhancing cellular activity. Electrical currents can stimulate the production of growth factors, which are substances that promote cell growth and tissue repair. Additionally, the therapy can increase blood flow to a treated area, bringing oxygen and nutrients that are essential for tissue healing. In some cases, electro-stimulation is used in combination with other regenerative therapies, such as stem cell treatments. Electrical currents can help guide and enhance the differentiation and integration of stem cells into damaged tissues thereby accelerating the healing process. While further research is still needed to fully understand its mechanisms and optimize its use, electro-stimulation holds potential for improving outcomes in regenerative medicine and helping patients recover from various injuries and conditions.

Several MedTechs are involved in electro-stimulation R&D for regenerative medicine. Medtronic has developed neurostimulation systems to manage chronic pain and improve neurological functions, which also can be used in regenerative medicine applications, such as nerve and muscle regeneration. Abbott Laboratories have made contributions to electro-stimulation devices for regenerative medicine. Their product portfolio includes implantable neurostimulation systems to manage chronic pain, movement disorders, and other neurological conditions and can aid in the regeneration of damaged nerves and muscles. Boston Scientific has developed a range of electrical stimulation systems for various applications, including chronic pain management, deep brain stimulation for movement disorders, and spinal cord stimulation, and can potentially contribute to regenerative medicine by stimulating tissue healing and facilitating the regeneration process. Nevro Corp specializes in the development of high-frequency spinal cord stimulation systems for chronic pain management. Their devices deliver electrical pulses to the spinal cord, modulating pain signals and providing relief to patients, and have the potential to aid in regenerative medicine by promoting tissue healing. Bioventus, established in 2012 and based Durham, North Carolina, US, is focused on ortho-biologic solutions for musculoskeletal healing. The company has developed a portable electro-stimulation device called the Exogen Ultrasound Bone Healing System, which has shown efficacy in promoting bone regeneration and is used in various clinical settings.

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Gene therapies

Gene Editing

Gene editing is a field of research that holds potential to change regenerative medicine. At its forefront is CRISPR-Cas9, a powerful tool that allows scientists to make precise modifications to our genetic material. By combining gene editing with gene therapy, new avenues for treating genetic disorders and diseases can be explored. CRISPR-Cas9, derived from bacteria, acts like molecular scissors, enabling researchers to modify specific genes efficiently and cost-effectively, which means they can introduce beneficial changes, remove, or replace faulty genes, and correct genetic mutations.

Gene therapy, a key component of regenerative medicine, involves introducing functional genes into a patient's cells to compensate for defective or absent genes that cause specific disorders. There are two primary approaches to gene therapy: in vivo, which delivers therapeutic genes directly into the patient's body, and ex vivo, which modifies the patient's cells outside the body before reintroducing them.

Gene therapy has shown success in treating Leber Congenital Amaurosis (LCA), a rare disorder causing vision loss in children. Luxturna, the first FDA approved gene therapy for LCA, delivers a functional copy of the RPE65 gene into retinal cells, restoring vision in patients. Another example is gene therapy for Severe Combined Immunodeficiency (SCID), also known as "bubble boy disease". By using a modified retrovirus, this treatment restores immune function in infants with SCID caused by a deficiency in the enzyme adenosine deaminase. Promising results have also been observed in the treatment of inherited blood disorders such as Beta-Thalassemia and sickle cell disease, both caused by mutations in the hemoglobin genes. Clinical trials are focused on editing patients' own hematopoietic stem cells to correct these genetic mutations. Despite successes, there are still challenges to overcome, which include improving delivery methods, ensuring long-term safety, managing immune responses, and increasing treatment accessibility.

Several companies are engaged in gene therapy R&D. Novartis developed Kymriah, the first FDA-approved gene therapy product. Kymriah utilizes the body's own T cells to fight certain types of leukemia. bluebird bio, another prominent company, focuses on developing gene therapies for severe genetic diseases and cancer. They obtained FDA approval for Zynteglo, a gene therapy used to treat transfusion-dependent beta-thalassemia patients. Spark Therapeutics, known for Luxturna, mentioned above, continues to operate as an independent subsidiary after being acquired by Hoffmann-La Roche. They are actively pursuing gene therapy treatments for inherited retinal diseases and other disorders. uniQure, a Dutch-based company, is a pioneer in gene therapy for rare genetic diseases and has developed Glybera, the first approved gene therapy in Europe. Pfizer, a global pharmaceutical company, has also made substantial investments in gene therapy, acquiring Bamboo Therapeutics, which is focussed on rare diseases related to neuromuscular conditions and the central nervous system. Sangamo Therapeutics, a biotech company based in California, US, specializes in gene editing and gene regulation technologies, with ongoing research in therapies for hemophilia and lysosomal storage disorders.

Organ Regeneration

Organ regeneration is a field in regenerative medicine that offers hope for patients in need of new organs. For instance, in the US, currently, there are ~114,000 people waiting for organ transplants, ~60% (70,000) will not receive the organ they need, and each day ~20 people die due to the lack of available organs. Through advancements in bioengineering and organ transplantation techniques, functional organs can now be developed to restore health and enhance quality of life. Stem cells and tissue engineering play a role in creating organs that mimic the structure and function of natural ones. Additionally, innovations in 3D printing and biomaterials have provided solutions for successful organ transplantation.

The liver has shown regenerative capabilities, and surgeons can transplant a portion of a healthy liver into a recipient, enabling regeneration and restoring the organ's function. Researchers have explored approaches to stimulate cardiac regeneration, such as using stem cells and biomaterial scaffolds to repair damaged heart tissue. While these techniques are still in development, they hold promise for treating heart diseases and reducing the burden of heart failure.

In the pursuit of overcoming the limitations of traditional organ transplantation, several companies are engaged in organ regeneration R&D. For instance, Miromatrix Medical utilizes decellularization techniques to create fully functional organs and tissues by removing cellular material from donor organs while preserving the extracellular matrix. United Therapeutics and its subsidiary Lung Biotechnology focus on bioengineering lungs using technologies like tissue engineering, stem cell therapy, and gene editing. CellSeed Inc., a Japanese biotech, has developed a technology called "cell sheet engineering" that uses patient-derived cells to promote tissue repair and regeneration.

3D Bioprinting

3D bioprinting is a technology in regenerative medicine that facilitates the creation of complex tissue structures with precision and customization. Significant progress in the filed has been made in the past decade, including the development of advanced bio-inks that consist of biocompatible materials and living cells. These bio-inks can be deposited layer by layer, resulting in 3D tissue constructs that closely resemble natural tissues in complexity and functionality. The resolution and speed of 3D printers have also improved, enabling the production of detailed structures at a faster pace. By integrating imaging technologies like MRI and CT scans, patient-specific models can be created, optimizing the design and production of customized implants and prosthetics. One of the key advantages of 3D bioprinting is its ability to recreate intricate tissue structures with vascular networks that ensure nutrient supply and waste removal, which are vital for the survival and functionality of larger constructs. This technology has created new possibilities in personalized medicine, particularly in the development of customized implants and prosthetics. By utilizing patient-specific data, such as medical images, 3D bioprinting can fabricate implants and prosthetics that perfectly fit an individual's anatomy, leading to improved comfort and functionality. Further, biologically active substances like growth factors can be incorporated into the printed structures, allowing for localized and controlled release. This targeted therapy promotes tissue regeneration at the site of implantation.

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Several companies have recognized the potential of 3D bioprinting and invested in R&D programmes to advance the field. Organovo, EnvisionTEC, the BICO Group, Aspect Biosystems, RegenHU, and Poietis are among enterprises driving innovation in 3D bioprinting. They all develop technologies and platforms to create functional human tissues, print biomaterials, offer standardized bio-inks, and provide advanced bio fabrication solutions. Their efforts aim to change regenerative medicine and contribute to the development of functional tissue constructs for therapeutic applications.

Nanotechnology

Nanotechnology has influenced regenerative medicine by enabling precise manipulation of matter at the nanoscale. This technology has led to breakthroughs in targeted drug delivery systems and the development of innovative nanomaterials for tissue regeneration and wound healing. Nanoparticles and nano-carriers, designed through nanotechnology, can encapsulate drugs, and deliver them directly to affected tissues or cells, improving treatment efficacy while minimizing side effects. These targeted drug delivery systems have reduced the required dosages, making treatments more effective and less toxic. The technology has also facilitated the development of advanced nanomaterials like nanostructured scaffolds, which mimic the natural extracellular matrix of tissues, and provide a supportive framework for cell growth and tissue regeneration. With high surface area-to-volume ratio and tunable mechanical properties, nanostructured scaffolds release bioactive compounds or growth factors in a controlled manner, promoting tissue regeneration in various areas like bone, cartilage, nerve, and skin. Additionally, nanotechnology has contributed to the creation of smart wound dressings that actively enhance the wound healing process by exhibiting antimicrobial properties, moisture management, and controlled release of therapeutics.

Several companies are involved in nanotechnology R&D for regenerative medicine. Nanobiotix focuses on nanoparticle-based solutions for cancer therapy, while Arrowhead Pharmaceuticals uses a nanoparticle-based delivery system to transport RNA interference (RNAi) therapeutics into target cells. Athersys [a biotech mentioned in the stem cell section above] incorporates nanotechnology-based methods in their allogeneic stem cell product, MultiStem. Capsulution Pharma AG offers customized nanoparticle-based solutions for targeted drug delivery, including applications in tissue engineering and wound healing. Capsulation’s nano capsules are invisible to the human eye. A pin head, which is ~1.5mm across, could contain ~3bn capsules. NanoMedical Systems specializes in implantable drug delivery systems with potential applications in regenerative medicine.

Challenges and ethical considerations

It is important to acknowledge the challenges and ethical issues, which accompany the field of regenerative medicine. One of its primary challenges is the complex and intricate nature of the human body. Developing therapies that can effectively repair and regenerate damaged tissues and organs is a daunting task that requires extensive scientific knowledge and technological expertise. The limited understanding of cellular behaviour, tissue interactions, and the intricacies of organ development present significant hurdles in translating regenerative medicine from the laboratory to clinical applications. In addition, regenerative medicine faces ethical considerations. One concern revolves around the use of embryonic stem cells, which are derived from human embryos. The destruction of embryos in the process raises ethical concerns, as it involves the termination of potential human life, which necessitates balancing the pursuit of medical advancements and respecting the moral value attributed to embryos. iPSCs have overcome ethical concerns associated with embryonic stem cells but raise ethical concerns of their own that are associated with their ability to clone humans, which we highlighted in the stem cell section above. Similarly, gene editing technologies like CRISPR-Cas9 have introduced new possibilities for manipulating genes and altering the genetic makeup of organisms, including humans. While gene editing presents significant opportunities for treating genetic diseases, it raises ethical questions about the modification of the germline, hereditary traits, and the potential for unintended consequences. International ethical frameworks need to be established to guide the responsible use of gene editing techniques and ensure that the potential benefits outweigh the associated risks.

Regulatory issues play a role in shaping the future of regenerative medicine. As the field progresses and new therapies emerge, regulatory bodies must establish clear guidelines and frameworks to evaluate the safety and efficacy of these treatments. Striking the right balance between fostering innovation and protecting patients' wellbeing is important for the development and implementation of regenerative medicine approaches. Public acceptance and understanding are paramount for the widespread adoption of these technologies. Educating the public about the science, potential benefits, and ethical considerations is essential to foster informed discussions and garner support. Building trust between the scientific community, regulatory agencies, and the public is essential to navigate the challenges and dilemmas inherent to regenerative medicine. Only with careful deliberation, collaboration, and responsible stewardship, will regenerative medicine contribute its full potential for solutions that improve health and wellbeing.

A role for governments

Government support for regenerative medicine is important for the development of innovative therapies for disabilities and diseases with limited treatment options. Administrations investing in R&D can result in therapies that address unmet medical needs and offer hope to patients. Many disabilities and diseases severely impact individuals' quality of life, hindering their daily activities and overall wellbeing. Governments have a public health obligation to foster the development of regenerative medicine, as it has the potential to restore or regenerate damaged tissues and organs, ultimately improving the lives of millions. In addition to the health benefits, regenerative medicine is a rapidly growing sector with significant economic potential. Appropriate support for R&D in this field can stimulate economic growth by creating high-skilled jobs and attracting investment from biotech and pharmaceutical companies. The successful development and commercialization of regenerative medicine therapies can also reduce healthcare costs, as they offer more effective treatments and alleviate the burden on healthcare systems.

Governments that prioritize R&D in regenerative medicine contribute to scientific advancements and potentially help to establish their countries as leaders in this emerging field. R&D facilitates collaboration between academia, industry, and healthcare institutions, driving innovation. This support aligns with principles of equity, access to healthcare, and the pursuit of scientific progress, demonstrating an administration's social and ethical responsibility to promote health and wellbeing among its citizens. Aging populations and increasing rates of chronic diseases and disabilities pose significant challenges to healthcare systems worldwide. Continuous treatments, hospitalizations, and long-term care result in substantial healthcare costs. By investing in R&D for regenerative medicine, governments can develop therapies that offer long-term solutions, reducing the need for costly and continuous interventions. This can lead to significant healthcare savings over time.

An international perspective

Countries worldwide are actively supporting R&D in regenerative medicine. The US is a leader in the area, with significant investment in R&D through organizations like the National Institutes of Health (NIH). Japan has established itself as a global leader with substantial funding, and supportive regulation with a streamlined approval process for regenerative medicine therapies. South Korea has also emerged as a prominent player, establishing dedicated centres and institutes to promote regenerative medicine and foster collaboration between academia and industry. The UK is committed to supporting R&D in the field and encouraging collaboration between various stakeholders. Germany invests in regenerative medicine R&D through research centres and institutes, while China has launched initiatives, established research centres, and has a rapidly growing regenerative medicine industry. These countries, and others, are actively engaged in advancing the field through funding, regulations, and collaboration, which aim to accelerate the development and commercialization of regenerative therapies.

Takeaways

We have presented a range of regenerative medicine technologies and described their advantages and challenges. We also mentioned that these technologies are developing at different rates and are often used together to create one therapy. So, what can MedTechs do to answer the question we posed at the beginning of this Commentary: Which technology or combination of regenerative medicine technologies will ultimately dominate in the next decade? While it is difficult to predict the future, it seems reasonable to suggest that the convergence of these evolving technologies will play a pivotal role in the transformation of regenerative medicine. Each technology brings both advantages and challenges, and their ultimate dominance will depend on several factors, including scientific breakthroughs, clinical success, regulatory considerations, and patient acceptance. To remain relevant and succeed in this arena, companies must recognize the urgency of intensifying their R&D efforts in regenerative medicine. This requires not only investing in cutting-edge technologies but also fostering collaboration between disciplines, institutions, and industry partners. By cultivating a comprehensive understanding of the evolving landscape, MedTechs can position themselves to either establish a significant presence or expand their footprints in regenerative medicine. It is important for them to closely monitor advancements across a range of relevant technologies. With the rapid pace of innovation, staying informed about emerging trends, breakthroughs, and disruptive technologies is essential to avoid being caught off guard. By proactively identifying potential synergies and areas of collaboration, enterprises can leverage their expertise and resources to accelerate progress.

Over the next decade, regenerative medicine has the potential to transform healthcare by offering novel treatments, repairing damaged tissues and organs, and improving patients' quality of life. MedTechs have an opportunity to help drive this transformation, but they must embrace the challenge of exploring and integrating various rapidly evolving and complex technologies. Will they be brave and agile enough to do this?

#stemcellresearch #tissueengineering #electro-stimulation #genetherapy #organregeneration #3Dbioprinting #nanotechnology

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Unleashing MedTech's Competitive Edge through Transformational Technologies

HealthPad

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Medical Technology

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Artificial Intelligence

transformational technologies

Digitalization, big data, and artificial intelligence (AI) are transformational technologies poised to shape the future of MedTech companies over the next decade
Fully embracing these technologies and integrating them in all aspects of a business will likely lead to growth, and competitive advantage while treating them as peripheral add-ons will likely result in stagnation and decline
MedTech executives’ analogue mindsets and resource constraints prevent them from fully embracing transformational technologies
There are also potential pushbacks from employees, patients, providers and investors
Notwithstanding, there are unstoppable structural trends forcing governments and payers throughout the world to oblige healthcare systems to leverage digitalization, big data, and AI to help reduce their vast and escalating healthcare burdens
Western MedTechs are responding to the rapidly evolving healthcare landscape by adopting transformational technologies and attempting to increase their presence in emerging markets, particularly China
To date, MedTech adoption and integration of digitalization, big data, and AI have been patchy
To remain relevant and enhance their value, Western MedTechs need to learn from China and embed transformational technologies in every aspect of their businesses

Unleashing MedTech's Competitive Edge through Transformational Technologies
Digitalization, Big Data, and AI as Catalysts for MedTech Competitiveness and Success

In the rapidly evolving landscape of medical technology, the integration of digitalization, big data, and artificial intelligence (AI) [referred to in this Commentary as transformational technologies] has emerged as a pivotal force shaping the future of MedTech companies. Such technologies are not mere add-ons or peripheral tools but will soon become the lifeblood that fuels competition and enhances the value of MedTechs. From research and development (R&D) to marketing, finance to internationalization, and regulation to patient outcomes, digitalization, big data, and AI must permeate every aspect of medical technology businesses if they are to deliver significant benefits for patients and investors. To thrive in this rapidly evolving high-tech ecosystem, companies will be obliged to adapt to this paradigm shift.

Gone are the days when traditional approaches would suffice in the face of escalating complexities and demands within the healthcare industry. The convergence of transformational technologies heralds a new era, where innovation and success are linked to the ability to harness the potential of digitalization, big data, and AI. MedTech companies that wish to maintain and enhance their competitiveness must recognize the imperative of integrating these technologies across all facets of their operations. From improving their R&D processes by utilizing advanced data analytics and predictive modeling, to optimizing internal processes through automation and machine learning algorithms. Embracing such technologies opens doors to enhanced marketing strategies, streamlined financial operations, efficacious legal and regulatory endeavours, seamless internationalization efforts, and the development of innovative offerings that cater to the evolving needs of patients, payers, and healthcare providers.

This Commentary aims to stimulate discussion among MedTech senior leadership teams as the industry's competitive landscape continues to rapidly evolve, and the fusion of digitalization, big data, and AI becomes not only a strategic advantage but a prerequisite for survival in an era defined by data-driven decision-making, personalized affordable healthcare, and a commitment to improving patient outcomes.

In this Commentary

This Commentary explores digitalization, big data, and AI in the MedTech industry. It presents two scenarios: one is to fully embrace these technologies and integrate them into all aspects of your business and the other is to perceive them as peripheral add-ons. The former will lead to growth and competitive advantage, while the latter will result in stagnation and decline. We explain why many MedTechs do not fully embrace transformational technologies and suggest this is partly due to executives’ mindsets, resource constraints and resistance from employees, patients, and investors. Despite these pushbacks, the global healthcare ecosystem is undergoing an unstoppable transformation, driven by aging populations and significant increases in the prevalence of costly to treat lifetime chronic conditions. Western MedTechs are responding to structural shifts by adopting transformational technologies and increasing their footprints in emerging markets, particularly China. To date, company acceptance of AI-driven strategies has been patchy. We suggest that MedTechs can learn from China and emphasize the need for organizational and cultural change to facilitate the comprehensive integration of transformational technologies. Integrating these technologies into all aspects of a business is no longer a choice but a necessity for companies to stay competitive in the future.

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Transformational technologies in MedTech

Digitalization in the MedTech industry involves adopting and integrating digital technologies to improve healthcare delivery, patient care, and operational efficiency. It transforms manual and paper-based processes into digital formats, enabling electronic health records, connected medical devices, telemedicine, and other digital tools. This allows for seamless data exchange and storage, improving clinical processes, decision-making, and patient empowerment. Big data in the MedTech industry refers to the vast amount of healthcare-related information collected from various sources. It includes structured and unstructured data such as patient demographics, clinical notes, diagnostic images, and treatment outcomes. Big data analysis identifies patterns, correlations, and trends that traditional methods may miss. They aid medical research, drug discovery, personalized medicine, clinical decision support, evidence-based care, population health management, and public health initiatives. Data privacy, security, and ethical use are crucial considerations. Artificial Intelligence (AI) in the MedTech industry uses computer algorithms to simulate human intelligence. AI analyzes medical data to identify patterns, make predictions, and improve diagnoses, treatment plans, and patient outcomes. It assists in medical imaging interpretation, personalized medicine, and patient engagement. In R&D, AI accelerates the development of devices and the discovery of new therapies and has the capacity to analyze scientific literature and molecular data. The technology serves as a tool to augment healthcare professionals' expertise and support decision-making.

With the proliferation of large language AI models (LLM) and to borrow from a recent essay by Marc Andreeseen - an American software engineer, co-author of Mosaic, [one of the first widely used web browsers] and founder of multiple $bn companies - everyone involved with medical technology, including R&D, finance, marketing, manufacturing, regulation, law, international etc., “will have an AI assistant/collaborator/partner that will greatly expand their scope and achievement. Anything that people do with their natural intelligence today can be done much better with AI, and we will be able to take on new challenges that have been impossible to tackle without AI, including curing all diseases.”

Two scenarios

We suggest there are only two scenarios for MedTechs: a company that fully embraces transformational technologies and one that does not. The former, will benefit from strengthened operational efficiencies, improved patient outcomes, and enhanced innovations, which will lead to increased market share and investor confidence. By leveraging digital technologies, such as remote monitoring devices, telemedicine platforms, LLMs, and machine learning, a company will be able to offer more personalized, effective and affordable healthcare services and solutions. An enterprise that integrates these technologies into their strategies and business models will, over time, experience improved growth prospects, increased revenues, and potentially higher profitability. These factors will contribute to a positive perception in the market, leading to an increase in company value. MedTechs that fail to fully embrace digitalization, big data, and AI will face challenges in adapting to the rapidly evolving healthcare landscape. They will struggle to remain competitive and relevant in a market that increasingly values transformational technologies and data-driven approaches. As a result, such companies will experience slower growth, lower market share, and limited investor interest, which will lead to a stagnation or decline in their value.

The analogue era's influence on MedTechs

If the choice is so stark, why are many MedTechs not grabbing the opportunities that transformational technologies offer? To answer this question let us briefly remind ourselves that the industry took shape in an analogue era, which had a significant effect on how MedTech companies evolved and established themselves. During the high growth decades of the 1980s, 1990s, and early 2000s, the medical technology industry operated with limited access to the technologies that have since radically changed healthcare. The 1980s marked a period of advancements, which included the widespread adoption of medical imaging such as computed tomography (CT) scans and magnetic resonance imaging (MRI). These modalities provided detailed visualizations of the human body, supporting more accurate diagnoses. Medical devices like pacemakers, defibrillators, and implantable cardioverter-defibrillators (ICDs) were developed and improved the treatment of heart conditions. The 1990s witnessed further advancements, with a focus on minimally invasive procedures. Laparoscopic surgeries gained popularity, allowing surgeons to perform operations through small incisions, resulting in reduced patient trauma and faster recovery times. The development of laser technologies enabled more precise surgical interventions. The decade also saw the rise of biotechnology, with the successful completion of the Human Genome Project and increased emphasis on genetic research. The early 2000s saw the emergence of digital transformation in some quarters of the medical technology industry. Electronic medical records (EMRs) began to replace paper-based systems, increase data accessibility and upgrade patient management. Telemedicine, although still in its nascent stages, started connecting healthcare providers and patients remotely, overcoming geographical barriers. Robotics and robotic-assisted surgeries gained traction, enabling more precise and less invasive procedures. During these formative decades, the medical technology industry focused on enhancing diagnostic capabilities, improving treatment methods, and streamlining healthcare processes. The industry had yet to witness the transformational impact of digitalization, big data and AI that would emerge in subsequent years, enabling more advanced analytics, personalized medicine, and interconnected healthcare systems.

From analogue to digital

During these formative analogue years, MedTechs experienced significant growth and expansion, where innovative medical technologies changed healthcare practices and improved patient outcomes. Companies thrived by leveraging their expertise in engineering, biology, and clinical research and developed medical devices, diagnostic tools, and life-saving treatments. For MedTechs to experience similar growth and expansion in a digital era, they must fully harness the potential of transformational technologies, and to achieve this, there must be a receptive mindset at the top of the organization.

According to a recent study by Korn Ferry, a global consulting and search firm, the average age of CEOs in the technology sector is 57, and the average age for a C-suite member is 56. Thus, as our brief history suggests, many MedTech executives advanced their careers in a predominantly analogue age, prior to the proliferation of technologies that are transforming the industry today. Thus, it seems reasonable to suggest that this disparity in experience and exposure colours the mindsets of many MedTech executives, which can lead to them underestimating and under preparing for the significant technological changes that are set to reshape the healthcare industry over the next decade. Senior leadership teams play a pivotal role in developing the strategic direction of companies and driving their success. Without a proactive mindset shift, these executives may struggle to fully comprehend the extent of the potential disruptions and opportunities that digitalization, big data, and AI bring.

By embracing such a mindset shift, senior leadership teams could foster a culture of innovation and agility. But they must recognize the urgency of preparing for a future fueled by significantly different technologies from those they might be more comfortable with. Such urgency is demonstrated by a March 2023 Statista report, which found that in 2021, the global AI in healthcare market was worth ~US$11bn, but forecasted to reach ~US$188bn by 2030, increasing at a compound annual growth rate (CAGR) of ~37%. As these and other facts (see below) suggest, the integration of digitalization, big data, and AI has already begun to redefine healthcare delivery, patient engagement, and operational efficiency and is positioned to accelerate in the next decade. To remain competitive and relevant in this rapidly evolving high-tech world, MedTechs must foster a culture of openness to change and innovation. Leaders should encourage collaboration, both internally and externally, and create cross-functional teams that bring together expertise from various domains, including AI and data analytics. This multidisciplinary approach facilitates the integration of transformational technologies into all aspects of the business, ensuring that the organization remains at the forefront of the evolving industry.

Implementation and utilization

Limited resources, such as budgets and IT infrastructure, can hinder the adoption and utilization of digitalization, big data, and AI, especially for smaller companies. Compliance with healthcare regulations like HIPAA and GDPR adds complexity and can slow down technology implementation. Resistance to change from employees, healthcare providers, and patients also poses challenges. Fragmented and unstandardized healthcare data limit the effectiveness of AI-driven strategies. The expertise gap can be bridged through collaboration with academic institutions and technology companies. Demonstrating the tangible benefits of digitalization, big data and AI is essential to address concerns about return on investments (ROI). Strategic planning, resource investment, collaboration, and cultural change are necessary for the successful implementation and utilization of transformational technologies in MedTech companies.

Organizational and cultural changes

MedTechs must embrace agility and innovation to harness the potential benefits from transformational technologies. This requires fostering a culture that encourages risk-taking and challenges conventional practices. Creating cross-functional teams and promoting collaboration nurtures creativity and innovative solutions. Transitioning to data-driven decision-making involves establishing governance frameworks, ensuring data quality, and leveraging analytics and insights from big data. Talent development and upskilling are crucial, necessitating training programmes to improve digital literacy and add analytics skills. Collaboration and partnerships with external stakeholders facilitate access to cutting-edge technologies. Enhancing patient experiences through user-friendly interfaces and personalized solutions is essential. Investing in agile technology infrastructure, including cloud computing and robust cybersecurity measures is necessary. MedTechs must navigate complex regulatory environments while upholding ethical considerations, transparency, and patient consent to gain credibility and support successful technology adoption.

Investors

A further potential inhibitor to change is MedTech investors who may harbour conservative expectations that tend to discourage companies from taking risks, such as fully embracing and integrating digitalization, big data, and AI across their entire businesses. This mindset also can be traced back to the formative analogue decades on the 1980s, 1990s, and early 2000s when investors became accustomed to growing company valuations. During that time, most MedTechs catered to an underserved, rapidly expanding market largely focussed on acute and essential clinical services in affluent regions like the US and Europe, where well-resourced healthcare systems and medical insurance compensated activity rather than patient outcomes. However, the landscape has since undergone a radical change. Aging populations with rising rates of chronic diseases have significantly increased the demands on over-stretched healthcare systems, which have turned to digitalization, big data, and AI in attempts to reduce their mounting burdens. These shifting dynamics now demand a more forward-thinking approach, but investor expectations often remain fixed on a past traditional model, which impedes the adoption and full integration of transformational technologies into MedTech enterprises.

To overcome investor conservatism and reluctance to embrace transformational technologies requires a concerted effort by MedTechs to demonstrate the tangible benefits of these technologies on the industry. Companies can focus on providing evidence of improved patient outcomes, increased efficiency, cost savings, and competitive advantages gained through the integration of digitalization, big data, and AI. Engaging in open and transparent communications with investors, showcasing successful case studies, and highlighting the long-term potential and sustainability of a technology-driven approach can help shift investor expectations and encourage a more receptive attitude towards risk-taking and innovation.

Global structural drivers of change

For decades, Western MedTechs have derived comfort from the fact that North America and Europe hold 68% of the global MedTech market share. These wealthy regions have well-resourced healthcare systems, which, as we have suggested, for decades rewarded clinical activity rather than patient outcomes, and MedTech’s benefitted by high profit margins on their devices, which contributed to rapid growth, and enhanced enterprise values. Today, the healthcare landscape is significantly different. North America and Europe are experiencing aging populations, and large and rapidly rising incidence rates of chronic diseases in older adults. Such trends are expected to continue for the next three decades and have forced governments and private payers to abandon compensating clinical activity and adopt systems that reward patient outcomes while reducing costs. This shift has put pressure on healthcare systems to adopt transformational technologies to help them cut costs, increase access, and improve patient journeys. MedTech companies operating in this ecosystem have no alternative but to adapt. Their ticket for increasing their growth and competitiveness is to adopt and integrate digitalization, big data, and AI into every aspect of their business, which will help them to become more efficient and remain relevant.

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Learn from the Chinese, but don’t misjudge Beijing

"When you fail to reach your goals don’t adjust your goals, adjust your actions"

Most developed economies are experiencing aging populations, which affect everything from economic and financial performance to the shape of cities and the nature of healthcare systems. Let us illustrate this with reference to the US. According to the US National Council on Aging, ~56m Americans are ≥65 and this cohort is projected to reach ~95m by 2060. On average, a person ≥65 is expected to live another 17 years. Older adult Americans are disproportionately affected by costly to treat lifetime chronic conditions such as cancer, heart disease, diabetes, respiratory disorders, and arthritis. ~95% of this older adult cohort have at least one chronic disease, and ~80% have two or more. Multiple chronic disorders account for ~66% of all US healthcare costs and ~93% of Medicare spending.

According to a May 2023, Statista report, the US spends more on healthcare than any other country. In 2021, annual health expenditures stood at US$4.2trn, ~18% of the nation’s Gross Domestic Product (GDP). The demographic trends we described in the US are mirrored in all the principal global MedTech markets. Many of which, particularly Japan, are also experiencing shrinking working age populations resulting from a decline in fertility rates, and curbs on immigration. This shrinkage further impacts a nation’s labour force, labour markets, and tax receipts; all critical for resourcing and paying for healthcare services.

MedTechs’ response to structural changes

Western MedTechs’ response to these structural challenges have been twofold: (i) the adoption of transformational technologies, which contribute to lowering healthcare costs, improving innovation, and developing affordable patient-centric services and solutions and (ii) targeting emerging markets as potential areas for growth and development. As we have discussed the first point, let us consider briefly the second. Decades ago, giant MedTechs like Johnson and Johnson (J&J), Abbott Laboratories and Medtronic established manufacturing and R&D centres in emerging economies like Brazil, China, and India, where markets were growing three-to-four times faster than in developed countries. Notwithstanding, many MedTechs, were content to continue serving wealthy developed regions - the US and Europe - and either did not enter, or were slow to enter, emerging markets. More recently, as a response to the trends we have described, many MedTechs are either just beginning or accelerating their international expansions. However, such initiatives might be too late to reap the potential commercial benefits they anticipate. Establishing or expanding a footprint in emerging economies is significantly more challenging today than it was two decades ago.

For instance, two decades ago, China lacked medical technology knowhow and experience and welcomed foreign companies’ participation in its economy. Today, the country has evolved, enhanced its technological capacity and capabilities, and is well positioned to become the world’s leading technology nation by 2030. No longer so dependent on foreign technology companies, the Chinese Communist Party (CCP) raised barriers to their entry. In 2017, government leaders announced the nation's intention to become a global leader in AI by putting political muscle behind growing investment by Chinese domestic technology companies, whose products, services and solutions were used to improve the country's healthcare systems. Over decades, the CCP committed significant resources to developing domestic STEM skills, and research to achieve “major technological breakthroughs” by 2025, and to make the nation a world leader in technology by 2030, overtaking its closest rival, the US. According to a 2023 AI Report from the Stanford Institute for Human-Centered Artificial Intelligence, in 2021, China produced ~33% of both AI journal research papers and AI citations worldwide. In economic investment, the country accounted for ~20% of global private investment funding in 2021, attracting US$17bn for AI start-ups. The nation’s AI in the healthcare market is fueled by the large and rising demand for healthcare services and solutions from its ~1.4bn population, a large and rapidly growing middle class, and a robust start-up and innovation ecosystem, which is projected to grow from ~US$0.5bn in 2022 to ~US$12bn by 2030, registering a CAGR of >46%.

>4 years ago, a HealthPad Commentary described how a Chinese internet healthcare start-up, WeDoctor, founded in 2010, bundles AI and big data driven medical services into smart devices to help unclog China’s fragmented and complex healthcare ecosystem and increase citizens’ access to affordable quality healthcare. The company has grown into a multi-functional platform offering medical services, online pharmacies, cloud-based enterprise software for hospitals and other services. Today, WeDoctor owns 27 internet hospitals, [a healthcare platform combining online and offline access for medical institutions to provide a variety of telehealth services directly to patients], has linked its appointment-making system to another 7,800 hospitals across China (including 95% of the top-tier public hospitals) and hosts >270,000 doctors and ~222m registered patients. It is also one of the few online healthcare providers qualified to accept payments from China's vast public health insurance system, which covers >95% of its population. WeDoctor, like other Chinese MedTechs, has expanded its franchise outside of China and has global ambitions to become the “Amazon of healthcare”. China’s investment in developing and increasing its domestic transformational technologies and upskilling its workforce has made the nation close to technological self-sufficiency and has significantly raised the entry bar for Western MedTechs wishing to establish or extend their presence in the country.

China's progress in AI and digital healthcare underscores the urgent need for Western MedTechs to adopt and implement these technologies. To remain relevant and survive in a rapidly changing global healthcare ecosystem, Western MedTechs might do well to learn from China's endeavours in leveraging AI, big data, and digitalization to drive innovation, enhance competitiveness, and ultimately contribute to the transformation of the global healthcare landscape. Notwithstanding, be minded of the ethical concerns Western nations have regarding China’s utilization of big data and AI in its healthcare system and its potential to compromise privacy and individual rights due to the CCP's extensive collection and analysis of personal health data.

Takeaways

Digitalization, big data, and AI are transformational technologies that have the power to influence the shape of MedTech companies over the coming decade, and their potential impact should not be underestimated. Fully embracing these technologies and integrating them into every aspect of a business is necessary for growth and competitive advantage. On the other hand, treating them as peripheral add-ons will likely lead to stagnation and decline. However, the path towards their full integration in companies is not without its challenges. MedTech executives, hindered by their analogue mindsets and resource constraints, often struggle to fully embrace the potential of digitalization, big data, and AI. Moreover, there may be pushbacks from various stakeholders including employees, patients, healthcare providers, and investors. These concerns and resistances can impede the progress of transformation within the industry. Nonetheless, governments and payers across the globe are being compelled by unstoppable structural trends to enforce the utilization of digitalization, big data, and AI within healthcare systems. The large and escalating healthcare burdens facing economies throughout the world leave them with little choice but to leverage these technologies to reduce costs, improve patient access and outcomes. In response to the rapidly evolving healthcare landscape, Western MedTechs are making efforts to adopt transformational technologies and expand their presence in emerging markets, particularly China. They recognize the need to stay ahead of the curve and adapt to the changing demands of the industry. However, the adoption and integration of digitalization, big data, and AI by companies thus far have been inconsistent and patchy. To remain relevant and enhance their value, Western MedTechs, while being mindful of ethical concerns about China’s use of AI-driven big data healthcare strategies, might take cues from their Chinese counterparts and embed these transformational technologies in every aspect of their businesses. The transformative impact of digitalization, big data, and AI on MedTech companies cannot be overstated. While challenges and resistance may arise, the inexorable drive towards leveraging these technologies is unstoppable. MedTech companies should shed their analogue mindsets and resource constraints and fully embrace the potential of these transformational technologies.

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Beyond the Battle: Illuminating Glioblastoma - Unmasking its challenges and promising horizons

HealthPad

Directory:

Cancer

Tags:

molecular targeted therapy

nanotechnology

novel therapies

tumor-treating fields

Glioblastoma (GBM) is an aggressive, challenging to treat, and not fully understood form of brain cancer that currently has no cure
Each year ~10,000 Americans and ~2,200 UK older citizens are diagnosed with the disease
The standard of care is surgery followed by radiation and chemotherapy
Prognosis is poor with median survival of ~15 months with treatment and ~3-4 months without treatment
Researchers and medical institutions throughout the world as well as multinational pharmaceutical companies, giant MedTechs and biotech start-ups are exploring novel therapies for the disease
The US leads the world in investment in biomedical research carried out in universities and research institutions, but China is catching up
Promising research avenues include immunotherapy, targeted therapies, gene therapy, nanotechnology, and tumour-treating fields but the current success of multiple clinical trials is not good
Diversified MedTechs might be reluctant to fund research and development (R&D) in GBM due to its complexities, rarity and smaller patient population
As GBM is a public health concern governments might consider increasing their investments and coordination of medical research to find efficacious therapies for the disorder
Agile smaller MedTechs and biotech start-ups with streamlined processes have a presence in GBM R&D, which might be due to the condition’s unique challenges and market dynamics

Beyond the Battle: Illuminating Glioblastoma
Unmasking its challenges and promising horizons

"In the battle against glioblastoma, a relentless and unforgiving adversary, we confront the fragility of our own existence, and the limits of our medical prowess. It is a disease that embodies the epitome of human suffering, where hope and despair dance an eternal waltz, and where the line between life and death blurs into an unsettling haze of uncertainty." Henry Marsh, Do No Harm

This Commentary explores the ever-evolving realm of glioblastoma (GBM) research and suggests that something promising is underway, which needs more support. As the landscape of research and development (R&D) takes shape, a compelling phenomenon emerges: the rising tide of university-based researchers and agile biotech start-ups daring to tackle the unique challenges of this brain cancer. With determination, they delve into niche areas, embarking on ground-breaking endeavours, fueled by scientific curiosity, patient advocacy, and the pursuit of disruptive innovation. Small companies’ streamlined decision-making processes and unwavering focus on GBM research give them a competitive edge, which they share with global pharmaceutical companies, while diversified MedTechs hesitate in the face of the relative rarity and complexities of the disease. GBM’s challenges, which extend from its elusive location to its resistance to conventional treatments pose substantial obstacles that require unconventional approaches. As the stakes rise, smaller MedTechs and start-ups, often fueled by innovative scientific breakthroughs from universities and supported by government research grants, prove their mettle, undeterred by failure or setbacks. Glioblastoma therapies appear to be a world where the underdogs rise, and cutting-edge treatments hold the key to rewriting the fate of the disease.

In this Commentary

This Commentary is in two parts. Part 1 entitled Glioblastoma: Advances and Challenges in Treatment provides an overview of glioblastoma, covering its characteristics, incidence, and standard treatment approaches. It delves into the global efforts of researchers who are exploring novel therapies for GBM, instilling a renewed sense of hope in the battle against this disease. The Commentary describes key innovative treatments such as immunotherapy, targeted therapies, gene therapy, nanotechnology, and tumor-treating fields, and briefly discusses the companies actively pursuing these therapies, highlighting that the current success of multiple clinical trials is lacking. Part 2, entitled Glioblastoma Research: Government Support and the Rise of Innovative Players, acknowledges the research conducted in universities and medical institutions worldwide. American universities and research institutes are particularly well-positioned due to the US’s leadership in biomedical research investment, although China is rapidly catching up. The Commentary suggests that governments should increase their support for novel therapies to treat glioblastoma, as relying solely on private entities to fund research for such a rare and complex disease seems unreasonable. We highlight the Chinese government's commitment to supporting biomedical research and addressing rare diseases like glioblastoma and draw attention to Parag Khanna’s thesis in Technocracy in America, suggesting Chinese state capitalism may have advantages over Western liberal democracies in developing high tech medical technologies. The Commentary ends by noting the significant presence of smaller companies in this field. Many that take risks in pursuing innovative solutions have streamlined decision-making processes and are driven by scientific curiosity, patient advocacy, and potentially disruptive innovation, which gives them a competitive edge.

Part 1

Glioblastoma: Advances and Challenges in Treatment

Glioblastoma (GMB) is an aggressive, common, and malignant form of brain cancer in adults, which is challenging to treat because the tumour is interconnected with healthy tissue, making it almost impossible to excise completely. Also, radiation has the potential to damage peripheral healthy tissue, and the brain’s natural barrier to chemotherapeutics makes GBM one of the most difficult and deadly diseases to deal with.

What are gliomas? - Mr Ranjeev Bhangoo

Your brain is made up of various types of cells, and GBM specifically affects glial cells, which have supportive roles, such as providing nourishment and protection to the neurons, which are the main cells responsible for transmitting signals in your brain. Glioblastoma develops when there is an abnormal growth of glial cells. However, its exact cause is not fully understood, but researchers believe that it may be influenced by a combination of genetic factors and environmental exposures. When someone is diagnosed with GBM, it means they have a tumour that typically starts in the brain but can spread to other parts of the central nervous system (CNS). The tumour grows rapidly, often infiltrating nearby healthy brain tissue, which makes it difficult to remove entirely through surgery. Because of its invasive nature, GBM can cause various symptoms depending on its location, including headaches, seizures, cognitive changes, weakness, and difficulties with speech or vision.

Incidence

Glioblastoma is relatively rare compared to other cancers and its global incidence rates vary by region. The disease is more common in older adults. While there have been no significant changes in its incidence over time, ongoing research aims to better understand the factors that influence its occurrence. The condition accounts for ~15% of all primary brain tumours and its annual incidence ranges from 0.59 to 3.69 cases per 100,000 people, and these numbers may vary based on factors such as age, genetics, and environmental factors. Each year, ~10,000 individuals in the US will present with the disease, and ~2,200 cases will be diagnosed in England. Advances in diagnostic techniques and increased awareness of the disease may have contributed to improved identification and reporting of cases. Age is a significant factor, with the highest incidence rates occurring in older adults; with the peak observed between 65 and 75, while being relatively uncommon in children and young adults. Researchers continue to study potential risk factors and factors that may influence its occurrence, but because the condition is complex and challenging to study, its causes and risks are still not fully understood. Notwithstanding, some factors that have been associated with GBM include, exposure to ionizing radiation, certain genetic syndromes, and a family history of glioblastoma, but most cases occur without any identifiable risk factors.

Standard of care

Treating glioblastoma is challenging because currently there are no curative therapies for the condition and treatment has remained almost unchanged for >20 years. The standard of care involves surgery, which aims to remove as much of the tumour as possible without causing damage to healthy brain tissue. However, due to the tumour's invasive nature, complete removal is rare. Thus, following surgery, the patient undergoes a combination of temozolomide, a type of chemotherapy medication that can enter the brain through the blood-brain barrier, and radiation therapy, followed by additional temozolomide treatment for six months. The effectiveness of these therapies is limited by high rates of tumour recurrence, treatment-related toxicity, emerging resistance to therapy and ongoing neurological deterioration. GBM has some of the worse outcomes of any cancer: a survival rate of ~15 months after diagnosis makes it a crucial public health issue. Only ~25% of patients survive more than one year, and only ~5% survive >5 years. Despite the first recorded reports of gliomas in British scientific reportswere in the early 19^th century and the first histomorphology was made in 1865, there only have been four drugs and one device approved by the FDA for the condition. Given the disease's poor survival rate with currently approved treatments, new therapeutic strategies for GBM are urgently needed.

Novel therapies

Various researchers, medical institutions, multinational pharmaceutical companies, giant MedTechs and biotech start-ups are exploring novel therapies for GBM, offering renewed hope in the battle against this devastating disease. Promising avenues have emerged and are chronicled here. Part 1 of this Commentary describes the current landscape of these therapies while acknowledging encountered challenges and failures. Despite setbacks in clinical trials, the unwavering commitment to combatting the disease and improving patient outcomes remains evident. Researchers throughout the world strive to unlock the full potential of these therapies, building upon successes and providing new hope for GBM patients, but this could benefit from more centralized support and coordination, which is addressed in Part 2.

Immunotherapy
Immunotherapy utilizes the body’s immune system to treat diseases, including cancer. By stimulating or enhancing the immune response, it strengthens the immune system’s ability to recognise and destroy harmful substances like viruses, bacteria, and cancer cells. For GBM, immunotherapy offers a promising alternative to traditional treatments.

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Immune checkpoint inhibitors (ICI) block checkpoints exploited by cancer cells, enabling the immune system to target cancer cells more effectively. Adoptive cell therapy modifies a patient’s own immune cells to specifically attack cancer cells. Immunotherapy for GBM is significant as it potentially improves patient outcomes, increases survival rates, minimizes damage to healthy tissues, and has shown promise in cases where other treatments have failed.

Companies conducting immunotherapy R&D
Ongoing clinical studies are actively assessing the effectiveness of immunotherapy in combating GBM. Global pharmaceutical companies such as Merck & Co. and Bristol Myers Squibb, are at the forefront of R&D efforts pioneering immunotherapies for the disease. Additionally, Roche has made investments in novel therapies for GBM and is actively involved in clinical trials evaluating the efficacy of their treatments. Bristol Myers Squibb’s clinical studies investigate the potential of immune checkpoint inhibitors (ICI), which as we explained, is a type of therapy that unleashes the immune system’s full potential by removing the brakes that hinder its ability to identify and eliminate cancer cells effectively. While ICI therapies have achieved substantial success in the broader field of oncology, their impact on GBM has been modest thus far.

Celldex Therapeutics, a clinical stage biotech based in New Jersey, US, is also committed to the development of immunotherapies for glioblastoma. Their research is focussed on innovative therapeutic vaccines and antibody-based treatments that stimulate the immune system’s response against glioblastoma cells. Despite the considerable R&D efforts dedicated to immunotherapy, its efficacy so far in GBM remains limited due to the complex challenges posed by the blood-brain barrier, incomplete understanding of the neuroimmune system, and the multifaceted immunosuppression that accompanies the disease. However, recent advances in treatment strategies offer renewed promise by combining immunotherapy with other complementary approaches.

Targeted therapies
Targeted therapies are a specialized form of treatment that focuses on specific molecules or pathways crucial for the growth and survival of cancer cells. Unlike conventional treatments like chemotherapy and radiation, which can harm healthy cells along with cancerous ones, targeted therapies aim to attack cancer cells while minimizing damage to healthy tissues. In the case of GBM, targeted therapies hold promise as they identify specific abnormalities or mutations driving the growth and survival of cancer cells. These abnormalities can be unique to cancer cells or occur more frequently in them compared to normal cells. Targeted therapies are designed to interfere with these specific abnormalities or mutations in various ways. Some treatments block or inhibit proteins or pathways that are overactive or abnormal in cancer cells, aiming to halt their growth, induce cell death, or hinder their ability to spread.

What are targeted therapies? - Dr. Whitfield Growdon

For instance, tyrosine kinase inhibitors, a group of drugs used in GBM, work by blocking the activity of tyrosine kinases - proteins involved in signaling pathways that promote cancer cell growth. By inhibiting these, the drugs slow down cancer cell growth and potentially shrink tumours. Another targeted therapy approach under investigation for GBM is angiogenesis inhibitors. Glioblastoma tumours, like all tumours, rely on a blood supply to grow and can stimulate the formation of new blood vessels (angio genesis) to sustain their growth. Angiogenesis inhibitors disrupt this process by targeting the molecules involved in blood vessel formation, depriving the tumour of essential nutrients and oxygen.

Targeted therapies are not universally effective, as their success depends on the specific abnormalities present in cancer cells and individual patient characteristics. Ongoing research and clinical trials focus on identifying the most effective targeted therapies and optimal ways to employ them in GBM and other cancer treatments. To enhance the effectiveness of targeted therapy for the condition, several strategies are being explored. These include utilizing nanoparticlesand monoclonal antibodies to transport anticancer drugs directly to the tumour, overcoming the brain's protective barriers. Additionally, introducing genetically modified bacteria into the tumour after surgical removal aims to selectively destroy cancer cells while sparing normal brain tissue. Also, tailoring treatments to individual patients and testing them through clinical trials are crucial steps in maximizing the potential of targeted therapies for GBM and other cancers.

Companies conducting targeted therapy R&D
Several prominent companies, such as Roche and Novartis, are engaged in R&D efforts for targeted therapies in GBM. Bristol Myers Squibb and AbbVie also have ongoing projects focused on targeted therapies for the disease. In January 2023, Cantex Therapeutics’ azeliragon, a targeted therapy developed for glioblastoma, received orphan drug designation from the FDA and commenced a phase II clinical trial. Cantex licensed the drug from vTv Therapeutics, a clinical-stage biotech, which intended the therapy to be for Alzheimer patients. Azeliragon, administered as a once-daily pill has excellent tolerability, and works by blocking the RAGE receptor involved in a specific biological process. By preventing certain substances from interacting with this receptor, the drug has the potential to enhance the effectiveness of GBM treatment. Despite progress in targeted therapy research, multiple phase III clinical studies have failed. This starkly highlights the gap between the urgent need for effective therapies, the expanding scientific understanding of the disease, and the lack of translation into novel treatments. This discrepancy can be attributed to various factors, including the inherent biological and clinical challenges posed by GBM, as previously mentioned.

A different type of targeted therapy for difficult to treat brain cancers is being developed by C ognos Therapeutics, a MedTech based in Inglewood, California, US. Its lead offering Sinnais, is a novel implantable drug delivery pump designed to overcome the blood-brain barrier (BBB), which is a significant challenge in modern medicine. Although we have mentioned the BBB several times in this Commentary, let us describe it more fully as it is central to Cognos’s Sinnais offering. The BBB protects the brain from potentially harmful substances in the bloodstream. While it serves a protective function, it also restricts the entry of many drugs, including those developed for brain and other central nervous system (CNS) diseases. Numerous medications have been developed by pharmaceutical companies for brain and CNS diseases but cannot be used or have limited efficacy due to their inability to cross the BBB. Sinnais is Cognos’s proposed solution. When implanted the device delivers therapeutics locally and metronomically (at precise intervals) to the desired area in the brain. By potentially providing patient- and tumour-specific targeted chemotherapeutics directly to the tumour site in microlitre resolutions, the device offers a more targeted and effective treatment option for brain cancers, including GBM. A commercial opportunity for the company is to partner with pharmaceutical companies that have developed drugs for brain cancers and other neurological disorders but cannot deliver them across the BBB. In January 2023, Cognos entered into a business combination agreement with Noctune Acquistion Corp, a special purpose acquisition company (SPAC), in a move to become publicly traded on Nasdaq. The deal is expected to help Cognos expedite its R&D of Sinnais, which has the potential to become the world’s first implantable device for local targeted and metronomic delivery of therapeutics for the treatment of neurological diseases.

Gene therapy
Gene therapy is a cutting-edge medical approach that aims to treat genetic disorders and certain diseases by targeting and modifying the genes within your cells. Genes are like the instruction manuals that tell your cells how to function properly. When there is a problem with a gene, it can lead to the development of various diseases.

In gene therapy, scientists use specialized techniques to introduce healthy genes into the cells of a person with a genetic disorder or disease. These healthy genes can replace the faulty ones or provide the cells with the necessary instructions to function correctly. The therapy’s goal is to fix the underlying genetic cause of the disease rather than just treating the symptoms.

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Gene Therapies

Because GBM is known to be aggressive and difficult to treat, gene therapy holds potential for its treatment. One reason is that GBM is believed to be often caused by specific genetic mutations that lead to the uncontrolled growth of brain cells. Gene therapy can target these mutations directly and correct them by introducing healthy genes or inhibiting the effects of the faulty ones. Another advantage is that it can deliver therapeutic genes directly to the tumour site in the brain. This may be achieved by using viral vectors or other delivery systems, with the capability to cross the blood-brain barrier. By doing so, gene therapy can precisely target cancer cells while minimizing damage to healthy brain tissue. The therapy has the potential to enhance the immune system's ability to recognize and attack cancer cells by modifying immune cells or by introducing genes that boost the immune response against the tumour. Gene therapy for GBM is still in its infancy but holds potential for treating the disorder by directly targeting the genetic abnormalities responsible for the tumour's growth. Its ability to deliver therapeutic genes precisely and enhance the immune response against cancer cells makes it a significant avenue to pursue for future treatment options.

Companies conducting gene therapy R&D
Several pharmaceutical and MedTech companies are actively engaged in gene therapy R&D programmes to treat glioblastoma. Novartis is currently conducting ongoing clinical trials, which involve the utilization of modified viruses to deliver therapeutic genes. Genprex, a small clinical-stage biotech traded on Nasdaq and based in Austin, Texas, is developing gene therapies for cancer, including GBM. One of their notable products is GPX1, that employs a non-viral nanoparticle delivery system to introduce a therapeutic gene into tumour cells, inhibiting their growth. Genprex has achieved some early success with advanced non-small cell lung cancer (NSCLC). Mustang Bio, another clinical-stage biotech specializing in gene therapy R&D is focused on developing CAR-T cell therapies. This involves modifying a patient's own immune cells to recognize and selectively attack cancer cells. In May 2019, the company obtained Orphan Drug status from the FDA for an oncolytic virus, licensed from the Nationwide Children’s Hospital, which effectively kills cancer cells and is used in the treatment of GBM.

In April 2019, the FDA granted Ziopharm Oncology Fast Track Designation for its treatment, Ad-RTS-hIL-12 plus veledimex, which targets GBM. The therapy involves delivering a gene that produces a protein to stimulate the immune system's response against the tumour. Initial studies produced promising results in a small number of GBM patients. However, following an activist attack by WaterMill Asset Management Corp, Ziopharm underwent a reorganization, appointed a new CEO, abandoned the clinical study, and rebranded itself as Alaunos Therapeutics, relinquishing its GBM asset.

Tocagen, a clinical-stage, gene therapy company based in San Diego, US, is dedicated to developing treatments for cancer, including GBM. The company developed two drugs, Toca 511 and Toca FC, that can cross the blood-brain barrier and target tumour cells. The drugs work together and involve delivering a therapeutic gene into tumour cells and then activating it with an oral medication to selectively kill the cancer cells. In April 2017 the company listed on Nasdaq and later that year, its lead product received FDA Breakthrough Therapy Designation and Priority Medicines (PRIME) designation from the European Medicines Agency for the treatment of high grade gliomas (HGG). However, in September 2019, Tocagen announced that its phase III randomized, multi-centre clinical trial consisting of 380 patients with recurrent HGG failed the primary endpoint of overall survival compared to standard of care treatment. To get so far in the process and not yield significant results for survival is a significant setback. Shares in the company fell ~80%, half of its employees were made redundant, and the company set about restructuring.

Nanotechnology
Nanotechnology involves working with tiny particles (nanoparticles), which are thousands of times smaller than the width of a human hair and can be engineered and manipulated to have special properties and functions. One area the technology is making significant contributions is in the field of medicine, particularly in the development of new therapies for challenging diseases like glioblastoma. Nanotechnology-based therapies for GBM work by utilizing nanoparticles that are designed to specifically target cancer cells in the brain. These can be loaded with drugs or other therapeutic agents to kill or slow down the growth of cancer cells. Scientists design nanoparticles in such a way that they can cross the blood-brain barrier and reach tumour cells more efficiently. Once the particles reach the tumour cells, they release therapeutic agents in a controlled and targeted manner. This precision helps to minimize the damage to healthy brain cells and reduces side effects compared to traditional therapies. Nanoparticles can be engineered to respond to specific signals or conditions within the tumour environment, allowing for even greater precision in drug release. The technology also allows for non-invasive imaging and diagnosis of GBM. Scientists have developed nanoparticles that can be used as contrast agents in imaging techniques such as magnetic resonance imaging (MRI), which can help visualize the tumour and monitor its response to treatment over time. While more R&D is needed, the use of nanotechnology holds promise for improving outcomes and quality of life for patients with GBM and other challenging cancers.

Companies conducting nanotechnology R&D
MagForce, a publicly traded German medical device company is among the early developers of novel nanotechnology-based cancer treatments. Its lead offering, the NanoTherm therapy system, is the first and only nanotechnology-based therapy to receive European regulatory approval (CE marking) for the treatment of brain tumours. The system utilizes magnetic nanoparticles to heat and destroy tumour cells. The process involves injecting magnetic iron oxide nanoparticles into the tumour. Then, MagForce’s therapeutic device, the NanoActivator, is used to treat the affected area with an alternating magnetic field, which generates heat, leading to localized tumour cell destruction. The company is now working on a strategy to market its NanoTherm therapy outside Germany aided by a €35m loan from the European Investment Bank under the European Fund for Strategic Investments.

Imunon previously, Celsion Corporation is a New Jersey, US-based clinical-stage oncology-focused company that has been working on a nanoparticle-based multi-modal drug delivery system called ThermoDox®. The system utilizes heat-activated liposomal nanoparticles to deliver chemotherapy drugs directly to tumour sites, including GBM. The nanoparticles release the drug when exposed to focused ultrasound or radiofrequency ablation, which selectively activates the drug within the tumour. In September 2022, Celsion changed its name to Imunon. “With this name change, we are underscoring our commitment to create a new category of medicines. With a strong balance sheet supporting current operations into 2025, we are well positioned to build a differentiated company to deliver the promise of our mission”, said Corinne Le Goff, president, and CEO. In February 2023, the company announced the commencement of patient enrolment of a clinical trial to evaluate a therapy for ovarian cancer, another “difficult to treat cancer”.

BIND Therapeutics was a biotech co-founded in 2007 by Robert Langer, a pioneer of many new technologies and widely regarded for his contributions to biotechnology. BIND engineered a nanomedicine platform developing Accurins®, a novel targeted and programmable class of therapeutics designed to target specific cells or tissues and concentrate a therapeutic payload at the site of disease. In 2013, the company raised a US$70m in an IPO, and had early success with a Phase I clinical trial comprised of 28 patients. The study established the safety and tolerability of BIND-014 in patients with advanced or metastatic solid tumour cancers, and in 2015, its findings were presented at the American Association for Cancer Research (AACR) Annual Meeting. Despite this success, in May 2016 BIND filed for voluntary Chapter 11 of the US bankruptcy code and its assets were acquired by Pfizer for US$40m. The novel therapy continued to be developed but not for GBM; findings of a phase II clinical study comprised of 42 patients with metastatic prostate cancer, was published in the July 2018 edition of JAMA Oncology, and reported the median radiographic progression-free survival to be 9.9 months.

Tumour-Treating Fields
Tumour-Treating Fields (TTFields) is an innovative treatment approach used for certain types of cancer, including GBM. It is a therapy that utilizes electromagnetic fields to disrupt the growth and division of cancer cells and involves the use of a device that generates low intensity alternating electric fields, which are designed to interfere with the process of cell division; a crucial step in the growth and spread of cancer cells. By applying electric fields to the tumour site, TTFields aim to disrupt cancer cells' ability to multiply and form new tumour masses. The significance of the technology for GBM lies in its potential to provide an additional treatment option that can complement existing therapies and can be used in combination with traditional treatments: surgery, radiation therapy and chemotherapy. One of its advantages is that it specifically targets cancer cells while sparing healthy tissues. The electric fields disrupt the division of actively dividing cells, which is a characteristic of cancer. Healthy cells, which typically have a slower rate of division, are less affected. This approach may lead to fewer side effects compared to other treatment modalities. Clinical studies have shown that TTFields can improve overall survival and progression-free survival in patients with glioblastoma when used in combination with standard treatments. The therapy has been approved by regulatory agencies, including the FDA, for the treatment of GBM and is being increasingly integrated into clinical practice.

Companies conducting TTFields R&D
Novocure is a pioneering MedTech oncology company that developed and commercialized the Optune®, a non-invasive portable device, which delivers TTFields therapy and has been approved by the FDA for the treatment of GBM. The company was founded in Haifa, Israel in 2000 by Yoran Palti, (Professor of Physiology and Biophysics at the Technion Israel Institute of Technology in Haifa). NovaCure grew to become a Nasdaq traded corporation with a market value of >US$7bn, >1,300 employees, annual revenues of ~US$0.54bn, and operations in the US, Europe, and Asia.

Palti hypothesized that alternating electric fields in the intermediate frequency range could disrupt cancer cell division and cause cancer cell death. He set up a home laboratory, where he demonstrated that, when applied at tumour cell-specific frequencies (200 kHz for GBM), alternating electric fields disrupt cell division, leading to cancer cell death but sparing healthy cells. The results motivated him to set up Novocure. The company’s second-generation Optune device has design improvements intended to enhance patients’ experience with TTFields treatment. The device consists of a set of adhesive patches or arrays that are placed directly on the patient's scalp over the area where the tumour is located. These are connected to a portable device that generates the electric fields. It weighs ~1.2 kg (~2.7 lbs) and is worn continuously while the patient carries on with their daily activities while receiving treatment.

On 6 June 2023, NovoCure’s shares crashed ~43% after the failure of a clinical trial of Optune on non-small cell lung cancer (NSCLC) patients. The company plans to file for US Premarket Approval (PMA) for TTFields in treating NSCLC later this year, and expects to announce results from three other late-stage studies of its device targeting other indications by the end of 2024.

QV Bioelectronics is a UK-based start-up founded in 2018 by a biomedical engineer and a neurosurgeon. The company’s lead offering, referred to as GRACE, (Glioma Resection Advanced Cavity Electric field therapy), employs electric field therapy like that of NovoCure, to slow the growth of GBM. Different to NovoCure’s Optune, GRACE is positioned to be implanted into patients already undergoing surgery. After surgery, it delivers therapy to the tumour resection margins where most of the glioblastoma recurrence takes place. The device is expected to operate without causing harm to healthy brain cells. To-date, QV has raised ~£3.5m, (~US$4.5m) and has received ~£2M (~US$2.5) in non-dilutive grants, including £860k (~US$1M) in March 2023 from Innovate UK, the UK’s national innovation agency. The company plans to use recent proceeds to expand its preclinical studies, finalise the initial design of GRACE, and develop a commercial strategy and regulatory pipeline as it prepares for clinical grade testing.

Part 2

Glioblastoma research: Government Support and the Rise of Innovative Players

Universities and research institutions engaged in GBM R&D

In addition to companies, which we described in Part 1 of this Commentary, universities and research institutions around the world are actively engaged in R&D efforts aimed at exploring novel therapies for glioblastoma. American universities and research institutes are particularly well placed as the US leads the world in investment in biomedical research. For instance, its National Institutes of Health (NIH) annually invests >US$40bn in medical research throughout the US. However, China is catching up (see below). One leading American institution that benefits from this US policy is the Massachusetts Institute of Technology (MIT), where researchers have been investigating innovative approaches such as nanotechnology-based drug delivery systems and targeted therapies to combat glioblastoma. In the UK, the University of Oxford has made significant strides in developing immunotherapies and personalized treatments for GBM. In Canada, the University of Toronto’s researchers are focussed on novel gene therapies and the development of targeted nanoparticles for improved drug delivery to GBM tumours. In Australia, the University of Sydney’s Brain and Mind Centre is actively involved in the exploration of stem cell-based therapies and advanced imaging techniques to better understand the tumour’s biology and improve treatment outcomes. These academic institutions, together with many others globally, are actively searching for breakthrough therapies for patients battling glioblastoma. University medical research groups can receive funding from medical research charities, as well as governments. However, a private company may licence a technology from a university or research institute and fund, or co-fund, clinical trials.

The Case for increased government funding for GBM R&D

In Part 1, we described how glioblastoma is characterized by its rapid progression, resistance to conventional treatments, and complex biological nature, which contribute to the difficulty in developing effective therapies. The intricate interplay between tumour cells and the brain, along with the blood-brain barrier, makes drug delivery and targeted treatment options particularly challenging. Given the multifaceted obstacles involved, it seems unreasonable to expect private entities to solely bear the burden of funding R&D for such a rare and complex disease. Glioblastoma affects a relatively small number of individuals, limiting the potential market for pharmaceutical companies and MedTechs. The high costs associated with R&D, clinical trials, and regulatory approval create a significant financial risk for private investors. The lack of substantial profitability prospects may discourage private entities from allocating resources to GBM research. In contrast, governments have a vested interest in public health and can allocate funding based on societal needs rather than immediate profitability.

Government-funded research can foster collaboration among scientists, clinicians, and institutions. By providing a platform for shared knowledge, data, and resources, governments are well positioned to facilitate scientific breakthroughs for complex conditions. GBM research would benefit from collective efforts, allowing scientists to efficaciously pool their expertise to accelerate progress. Government funding can enable the establishment of research consortia, collaborative networks, and specialized centres dedicated to glioblastoma R&D. Developing innovative therapies for the condition requires sustained long-term commitment. Private entities may be inclined to prioritize shorter-term projects with faster returns on investment. In contrast, governments have the capacity to pursue research with longer horizons and tolerate greater risks. By investing in long-term R&D, governments can support the exploration of unconventional ideas, disruptive technologies, and novel approaches that may yield significant advancements in glioblastoma treatment. Also, government involvement in funding R&D can prioritize the development of therapies that are accessible and affordable to all patients. Private entities may choose high-profit-margin treatments, potentially leading to a lack of affordability for many individuals. Government-funded R&D initiatives can ensure that breakthroughs in GBM treatment reach the wider population, reducing health disparities and ensuring equitable access to potentially life-saving interventions.

Chinese R&D in novel GBM therapies

In a thought-provoking book, Technocracy in America, Parag Khanna presents an argument that challenges the conventional wisdom surrounding economic systems and their impact on technological development. Khanna highlights the success of China’s blend of market economy and state-owned enterprises in fostering the growth of cutting-edge medical technologies. Drawing comparisons with Western liberal democracies, Khanna suggests that China’s technocratic approach, characterized by strategic direction and state-led initiatives, offers distinct advantages in driving advancements in the high-tech medical sector. Khanna prompts us to reassess our assumptions about the most effective pathways to progress in the realm of medical technology.

The development of a ‘Healthy China 2030’ is central to the Chinese Government’s agenda for health and development, and has the potential to reap benefits for the rest of the world. President Xi Jinping has put health at the centre of the country’s policy-making machinery, making the need to include health in all policies an official government policy. The Chinese government has expressed a commitment to supporting biomedical R&D, including efforts aimed at addressing rare diseases like glioblastoma. Specific initiatives may receive funding and support through programmes such as the National Natural Science Foundation of China (NSFC), China's National Key R&D Programmes (NKPs), and collaborations between domestic academic institutions, research centres, and pharmaceutical companies. In China, efforts are underway to develop innovative immunotherapeutic approaches, including immune checkpoint inhibitors, chimeric antigen receptor (CAR) T-cell therapy, and peptide-based vaccines. These approaches aim to enhance the immune system's ability to recognize and eliminate GBM cells. China is also exploring gene therapy approaches for GBM treatment. One notable example is the use of genetically modified viruses to deliver therapeutic genes directly into tumour cells. Researchers have conducted clinical trials, such as using oncolytic adenoviruses and retroviruses, to induce tumour cell death and stimulate the immune response against glioblastoma. Nanotechnology-based strategies are being explored to improve drug delivery and enhance the efficacy of GBM treatment. Scientists are developing nanoparticles and nanostructured systems capable of crossing the blood-brain barrier and delivering therapeutic agents directly to the tumour site, which aim to increase drug accumulation in tumours while minimizing systemic side effects. China is also involved in stem cell-based therapies that hold promise for glioblastoma treatment. Researchers are investigating the use of neural stem cells, mesenchymal stem cells, and induced pluripotent stem cells for targeted drug delivery, immune modulation, and regenerative purposes. These approaches aim to improve patient outcomes and overcome treatment resistance to GBM. Further, Chinese researchers are investigating the potential of traditional Chinese medicine (TCM) for glioblastoma treatment. Studies have focused on identifying bioactive compounds from medicinal plants and evaluating their anti-tumour effects, as well as exploring the synergistic effects of TCM in combination with conventional therapies.

Takeaways

This Commentary describes some of the ongoing developments of novel therapies for GBM mainly at the company level and suggests reasons why it is unreasonable for private companies to bear the main burden of finding therapies for glioblastoma. We also suggest that ongoing R&D initiatives at the company level should be approached with caution as their effectiveness and safety are still being investigated through clinical trials. Further, we mention that universities and research institutes worldwide are actively engaged in R&D programmes, involving multidisciplinary teams dedicated to various aspects of GBM. These efforts encompass understanding the underlying biology, exploring innovative treatment strategies, conducting clinical trials, and investigating novel therapeutic approaches. Further, we suggest that because GBM is a public health issue, governments might consider increasing their investments in, and their coordination of, GBM R&D. The Commentary draws attention the Parag Khanna’s book, Technocracy in America, which encourages us to re-examine our assumptions about the most effective policies to accelerate the development of medical technology and suggests that China’s model of state capitalism appears to have advantages over Western liberal democracies.

Regarding medical R&D landscape at the company level, it seems reasonable to suggest that the unique challenges and market dynamics associated with glioblastoma may lead to a more significant presence of smaller MedTechs and start-ups in this field. Such entities often possess the ability to focus on niche areas and take risks in pursuing innovative solutions. Their streamlined decision-making processes and flexibility in allocating resources specifically to GBM research, driven by scientific curiosity, patient advocacy, and potentially disruptive innovation, provide them with a competitive advantage. Conversely, many large diversified MedTechs may be less inclined to invest in GBM R&D compared to more prevalent cancers such as breast, lung, or colon cancer. This is primarily due to the relative rarity of GBM, resulting in a smaller patient population. From a business perspective, the smaller market size may be less financially attractive to established MedTechs seeking larger patient populations with higher profit potential. The highly complex and challenging nature of glioblastoma, including its location, infiltrative behaviour, and resistance to standard treatments, poses significant obsacles in developing effective therapies. The complexity and risks associated with GBM R&D present substantial challenges for many companies with more extensive resources and stakeholders to manage, as the potential for failure or setbacks is higher.

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The Financialization Dilemma of MedTechs

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MedTechs have experienced significant transformation through mergers and acquisition (M&A) to achieve steady growth, diverting resources from innovative research and development (R&D) initiatives
The industry’s M&A activities were fueled by a prolonged period of low interest rates and easy access to capital
Consequently, R&D efforts focussed on incremental improvements rather than breakthrough innovations
This financial-centric business model led to risk-averse bureaucracies among many MedTechs, resulting in a strategic deadlock with limited growth prospects
Adding to the challenges, the current era witness’s debt and asset prices surpassing productivity and economic output
For many MedTechs, these macro-economic conditions potentially pose funding constraints, reduced market demand, tightening regulatory challenges, cost pressures, and market volatility, further hindering their ability to overcome the deadlock
To address these issues and help MedTechs break free from their strategic deadlocks and create long-term value we propose seven strategic initiatives

The Financialization Dilemma of MedTechs

In the 1990s and 2000s, medical technology companies received praise for their rapid growth. However, they currently find themselves at a crucial juncture, facing challenges of low and stagnant growth rates. Additionally, an uncertain long-term outlook looms over them due to the expansion of global balance sheets surpassing GDP, as well as debt and asset prices outpacing productivity and economic output. This Commentary aims to shed light on how many MedTechs reached this strategic deadlock. It also proposes strategies that these companies can pursue to break free from this predicament, which have the potential to significantly enhance growth rates, improve balance sheet health, and foster value creation.

An era of low interest rates and cheap capital

The financialization of MedTechs has played a significant role in their current strategic deadlock, and the most viable solution lies in accelerating productivity. This financialization was facilitated by a prolonged period of low interest rates and easy access to inexpensive capital. Over the span of four decades, starting from the 1980s to the early 2020s, interest rates steadily declined across most industrialized nations. In the aftermath of the 2008-09 financial crisis, many countries adopted a low interest rate environment to stimulate economic recovery and restore liquidity in their banking systems. For example, the US Federal Reserve Board (Fed) lowered short-term interest rates from 4.25% in December 2007 to nearly zero by December 2008, registering the lowest rate in the Fed's history.

During the era of persistently low interest rates and readily available capital, MedTechs experienced a surge in merger and acquisition (M&A) activities, primarily targeting companies in near-adjacent sectors to capitalize on low-risk opportunities for incremental growth. This trend fostered a culture of consolidation, driven by the desire to access new technologies and broaden product portfolios. While M&A activities bolstered short-term profits and shareholder value, they often led to a neglect of research and development (R&D) initiatives. Acquisitions were perceived as a less risky and quicker avenues for expanding product lines, overshadowing investments in R&D. Consequently, many MedTechs adopted a risk-averse approach, channeling their R&D efforts towards incremental improvements of existing products rather than pursuing ground-breaking innovations that could significantly improve patient outcomes and disrupt the industry. Moreover, the increasingly stringent regulatory environment for medical devices, particularly in Europe, further discouraged companies from investing in R&D due to longer development timelines and escalated costs.

Over the years, these policies resulted in the consolidation of power and resources among a few large players, leading to the emergence of market oligopolies and the decline in industry diversity. This scenario posed challenges for smaller companies with innovative ideas, as they struggled to compete with established enterprises, thereby impeding both innovation and healthy competition. Moreover, established MedTechs benefited from the significant and rapidly growing healthcare demands in affluent Western markets, particularly North America and Europe, which account for ~65% of the global medical device market. In these markets, compensation was often tied to medical and surgical procedures rather than focussing on patient outcomes, further favouring the established industry players. While M&A can be an effective growth strategy, it is important for companies to strike a balance and prioritize innovation alongside their consolidation efforts to ensure sustainable success and drive meaningful advancements in the industry.

An era of surging prices and low productivity

We have now entered a distinct era that differs significantly from the previous era characterized by low interest rates, and easily accessible funds. Starting from March 2022, the Fed has implemented 10 consecutive rate hikes, bringing its benchmark rate to 5.25%. These increases, coupled with high leverage in the corporate sector, escalating geopolitical tensions and instability in the banking world triggered by the Silicon Valley Bank (SVB) collapse in March 2023, compounds the challenges faced by MedTechs. Furthermore, global balance sheets have expanded at a much faster pace than Gross Domestic Product (GDP). Debt and asset prices have surged far more rapidly than productivity and economic output. This trend is underscored by a report published in May 2023 by the McKinsey Global Institute, which reveals that the past two decades have resulted in the creation of US$160trn in paper wealth but have been marked by sluggish growth and the rise of inequality. According to the report, every US$1 invested has generated US$1.9 in debt.

Strategic initiatives to adapt and thrive

When global balance sheets expand at a faster rate than GDP and debt and asset prices outpace productivity, it becomes a concerning sign for MedTechs who find themselves trapped in a strategic deadlock characterized by sluggish growth and a fading belief in long term value creation. Under these conditions, companies should expect to encounter funding limitations, decreased market demand, stricter regulatory obstacles, cost pressures, and increased market volatility. In such a testing business environment, it is important for MedTechs to adopt bold adaptive strategies and navigate wisely to ensure continuous growth and enhanced value. We suggest seven such initiatives that are likely to help MedTechs break free from their strategic cul-de-sacs. By implementing these with vigour, companies can position themselves for success in an ever-changing and demanding economic and geopolitical landscape.

1. Revamp R&D

In recent times, costs associated with MedTech R&D have escalated. A study published in the September 2022 edition of the Journal of the American Medical Association (JAMA), and carried out by the US government’s Office of Science and Technology Policy, found that the development cost for a complex therapeutic medical device, from proof of concept through post approval stages, is US$522m. Significantly, the nonclinical development stage accounted for 85% of this cost, whereas the US Food and Drug Administration (FDA) submission, review and approval stage comprised 0.5%.

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Healthcare disrupters

Re-imagining healthcare

Thus, MedTechs have the potential to optimize their R&D processes, enabling them to develop more swiftly and economically ground-breaking devices that result in enhanced patient outcomes and expanded market share. To achieve this, companies may consider the following strategies to improve their R&D processes: (i) Integrating artificial intelligence (AI), machine learning, and big data techniques into their R&D endeavours and harnessing the power of these advanced technologies. (ii) Collaborating with academic institutions and start-ups to gain access to novel innovations and expertise. This collaboration can involve joint development and co-creation of innovative offerings. To tap into a diverse pool of expertise and resources, companies should consider a platform-based approach to R&D, which potentially improves the capacity to drive breakthrough advancements that improve patient care. (iii) Implementing agile methodologies to accelerate the R&D process, which involves breaking projects into smaller, more manageable segments and swiftly iterating based on stakeholder feedback. (iv) Engaging patients in the design process to ensure that newly developed offerings cater specifically to their needs, ultimately enhancing patient satisfaction.

2. Emphasize patient-centric care

Enhancing patient-centric care to improve outcomes is a crucial factor in the future of healthcare provision. There is a growing body of evidence indicating that patient choices will have an increased influence on the provision of healthcare over the next decade. With patients having more options and autonomy, MedTechs can leverage patient-centric strategies to better understand and address their needs, ultimately leading to improved market share. To achieve this, companies must prioritize effective communication, product education, and support services to build stronger relationships with patients. This requires increased utilization of electronic health records, advanced AI, data analytics capabilities, active engagement with patient communities, leveraging social media platforms, establishing patient advisory boards, and forging partnerships with payers and providers.

Further, embracing value-based care models is important for MedTechs. By prioritizing positive patient outcomes over quantity, companies can contribute to the development of sustainable care. As global healthcare systems transition toward value-based care, MedTech companies should align their offerings accordingly. Emphasizing solutions that enhance patient outcomes, reduce healthcare costs, and provide overall value positions, MedTechs become indispensable partners in the evolving healthcare landscape. This also may involve developing outcome-based pricing models, implementing remote monitoring solutions, and demonstrating real-world evidence of product effectiveness.

3. Revitalize organizational and operating models

Revitalizing organizational and operating models is essential for MedTechs to boost their growth rates and adapt to a rapidly evolving market. While companies experienced significant growth in the past, recent trends have shown a shift towards risk-averse bureaucracies, accepting modest annual growth rates as the "new normal". To overcome this stagnation and meet evolving customer demands, traditional MedTechs should consider embracing agile and flexible structures.

By flattening hierarchies and fostering cross-functional teams, organizations can facilitate faster decision-making processes. Implementing lean manufacturing and optimizing operational processes can reduce waste, enhance productivity, accelerate time to market, and lower costs. Leveraging AI-driven data analytics enables the extraction of valuable insights from vast datasets, empowering MedTechs to anticipate customer needs and market trends.

4. Harness the power of digital, AI and big data

Digital transformation has become a necessity rather than a choice. Although companies like Stryker and Siemens have championed digitalization, widespread implementation still remains a challenge. Indeed, Siemens’ suggests digitalization is “something that is often talked about but not fully implemented”. Previous Commentaries have shown how MedTechs can employ digital technologies to improve products, streamline operations, enhance customer experiences, and reduce costs. Streamlining operations and optimizing costs without compromising quality is crucial in the face of escalating economic pressures. This may involve re-evaluating supply chains, improving manufacturing processes, and adopting digital solutions.

In today's rapidly evolving digital age, investing in digital and analytics capabilities has become indispensable for companies as they shape their R&D, hone their processes and shift to a customer-centric stance. The seamless integration of digital and AI-driven techniques, along with data-driven decision processes, has emerged as a crucial factor in maintaining and improving competitiveness. For MedTechs, it is imperative to cultivate a culture of innovation that encourages and rewards experimentation and risk-taking. By doing so, organizations create an environment where employees are empowered to explore ideas, learn from failures, and ultimately drive meaningful innovations. Therefore, actively seeking external partnerships with technology companies, start-ups and academic institutions is a strategic move for MedTechs to access cutting-edge technologies and expertise in digital and analytics. By embracing these capabilities as core rather than adjunct components of their strategies, fostering an innovation-centric culture, and investing in talent development and retention, corporations position themselves optimally to leverage the transformative potential of digital and analytical technologies. This, in turn enables them to thrive in an increasingly interconnected and data-driven healthcare ecosystem.

5. Talent acquisition and retention

The rapidly changing landscape of globalization, the increasing influence of AI techniques, and the demands of a new generation of consumers seeking personalized experiences have compelled MedTechs to reassess their approach to talent acquisition and retention. To keep up with the pace of change, it is crucial for these companies to attract and retain highly skilled professionals with expertise in technology, healthcare, and business. A talented workforce plays a vital role in driving innovation, ensuring efficient and safe processes, navigating complex market dynamics, and effectively executing growth strategies. To achieve this, companies should invest in the development of their employees, foster a culture of innovation, and offer competitive compensation packages to attract and retain top performers.

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Out of the hospital into the home

According to a study published by the Harvard Business Review in January 2020, retaining top talent has become increasingly challenging for employers. The study revealed that in 2018, 25% of employed Americans left their jobs, with approximately 33% of this turnover attributed to unsupportive management and a lack of development opportunities. MedTech companies are not exempt from this trend, and to acquire and retain talent, they must strategically revamp their value propositions to align with the evolving needs and expectations of the modern workforce.

A crucial step in this direction is fostering a purpose-driven culture that highlights the significant impact medical technology companies have on improving people's lives. By instilling a sense of purpose, employees are more likely to develop a strong connection to the company's mission, inspiring them to consistently deliver their best work. Furthermore, providing ample career development opportunities is essential in empowering employees to enhance their skills and progress in their professional journeys. This can be achieved through training programmes, mentoring initiatives, and leadership development schemes.

Recognizing the importance of work-life balance is also critical. MedTechs can prioritize flexible working hours, a 4-day week, remote work options, generous vacation policies, allowing employees to effectively balance their personal and professional lives. By creating a supportive environment that promotes overall well-being and job satisfaction, companies can foster employee loyalty.

Competitive compensation and benefit packages are essential. Additionally, a commitment to diversity and inclusion is pivotal for MedTechs aspiring to become employers of choice. By emphasizing diversity in hiring practices and cultivating an inclusive work environment where every individual feels valued and respected, corporations can attract and retain a diverse array of talent. This, in turn, creates an environment conducive to enhanced innovation, creativity, and problem-solving.

Despite best efforts, there may be instances where companies are unable to attract and retain individuals with the necessary capabilities. In such cases, strategic partnerships, joint ventures, licensing agreements, and co-development initiatives allow MedTechs to tap into external expertise and resources, which can be employed to enhance product portfolios and gain access to new markets.

6. Realize global opportunities

MedTechs, traditionally reliant on most of their revenues from affluent US and European markets, now have the chance to expand their horizons and explore the untapped potential of the rapidly growing markets in Asia, Middle East and Africa, and Latin America. These regions boast transitioning demographics, with aging populations and a surge in chronic diseases. Additionally, their large and expanding middle-class populations demand advanced care, prompting governments to increase their healthcare expenditures significantly. By venturing into and expanding their footprints in these markets, Western MedTechs can diversify their revenue streams and leverage the growth opportunities stemming from the escalating demand for cutting-edge medical technologies and services.

Expanding into emerging markets not only provides a means to mitigate risks associated with economic volatility and changing regulatory environments but also necessitates acquiring new capabilities, fostering a change in executive mindsets, and embracing flexible pricing models. By adapting to the unique demands and challenges of these markets, MedTechs can position themselves strategically to tap into the vast potential they offer. This expansion serves as a catalyst for sustained growth and allows companies to seize opportunities that would otherwise remain untapped, thus bolstering their long-term success.

7. Align with rising ESG standards

To fully leverage their capabilities and resources and meet rising standards in ESG (Environmental, Social, and Governance), MedTechs might consider taking bold actions that: (i) embrace sustainable manufacturing practices to minimize their environmental impact, which entail reducing waste, water, and energy consumption, as well as transitioning to renewable energy sources. Such practices contribute to environmental conservation and mitigate a company’s carbon footprint, (ii) adopt circular economy principles, which involve designing products with a focus on reusability and recyclability. Additionally, establishing take-back programmes for end-of-life products, which ensure responsible disposal and encourage the reuse of valuable materials, thereby reducing waste and promoting sustainability, (iii) develop products that improve patient health, safety, and overall quality of life. This requires a patient-centric mindset, discussed above, that emphasizes the social impact and positive contributions MedTechs can make to society, (iv) produce offerings that are accessible and affordable to all segments of society. By addressing underserved communities and partnering with them to provide better healthcare solutions, companies can contribute to reducing healthcare disparities and promote equitable access to quality care, (v) enhance transparency and accountability, which includes setting clear targets, regularly measuring and reporting progress, and disclosing ESG performance, and (vi) engage with stakeholders, such as investors, customers, payers, employees, and patients, to better understand their expectations and concerns regarding ESG issues. Such a bold proactive approach to ESG issues contributes to a more sustainable and equitable world, strengthens a company’s reputation, and fosters its long-term success.

Takeaways

In today's rapidly evolving and technology-driven world, a successful pivot for MedTechs, which have been financialized and now find themselves in a strategic cul-de-sac, requires a simultaneous introduction of the suggested strategic initiatives, rather than a sequential approach. To regain high growth rates and create long-term value, MedTechs must:

Revamp R&D efforts to develop innovative solutions and services that address evolving market needs, prioritizing cost-effectiveness, and improved patient outcomes as primary drivers of value creation.
Prioritize patient-centric care by delivering solutions and services that significantly enhance outcomes, establishing a reputation for consistent value provision.
Revitalize outdated organizational and operating models through increased collaboration with industry stakeholders, enabling accelerated technology development and adoption. This ensures alignment with patient needs and facilitates swift market entry.
Harness the transformative power of digital technologies, AI, and big data to unlock new possibilities for innovation, efficiency, and personalized healthcare experiences.
Attract, retain, and develop talent equipped with 21st-century capabilities while fostering a purpose-driven culture that fuels innovation and drives organizational success.
Recognize and capitalize on the vast and rapidly expanding opportunities present in emerging markets, approaching them with a strategic mindset.
Align with ascending ESG standards, demonstrating a commitment to sustainability, ethical practices, and social responsibility, which reinforces the credibility and long-term viability of MedTechs.

By embracing these strategies simultaneously, corporations position themselves to navigate policy shifts, overcome global uncertainties, and take advantage of evolving technologies, which stand them in good stead to enhance their growth rates, and significantly improve their value.

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3D bioprinting and the advanced wound care market

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Advanced wound care is a large and fast-growing global market currently dominated by North America and Europe
In the next decade, Asia-Pacific, the Middle East and Africa and South America regions are expected to become significant wound care markets
Price sensitive Western MedTechs with wound care franchises might be challenged to penetrate these under-served rapidly growing emerging regional markets
Innovative technologies that currently contribute to advanced wound care include growth factors and cytokines, stem cells, tissue engineering, regenerative medicine approaches, and 3D bioprinting
Each has technical and clinical challenges likely to present obstacles for their future growth
3D bioprinting however appears well positioned to eclipse competing technologies and disrupt the global advanced wound reconstruction market in the next decade

3D bioprinting and the advanced wound care market

3D bioprinting is a relatively new and innovative medical technology. Although in its infancy, it has established a market presence of ~US$1.3bn, and, over the next four years, its market value is projected to increase at a compound annual growth rate (CAGR) of ~21% and reach >US$3bn by 2027. An earlier Commentary drew attention to the technology’s likelihood to impact several aspects of healthcare. Here we assess 3D bioprinting’s potential near-term influence on the advanced wound care market compared with competing technologies.

A silent epidemic

Chronic wounds have become a large and fast-growing silent epidemic. They are difficult to heal because of aggravated underlying causes such as diabetes, obesity, and an aging population. Such wounds increase morbidity and mortality and inflict substantial medical, economic, and social burdens on healthcare systems globally. For instance, the mortality rate of neuropathic foot ulcers, the commonest wound associated with diabetes, is comparable to that of cancer (~30%), and cost more to treat. In the US, ~10% of the population (~30m) have diabetes, and $1 out of every $4 in healthcare costs is spent on caring for people with the condition, and the total annual cost of diabetes ~US$327bn. Further, each year, ~2m people living with the condition develop a diabetic foot ulcer (DFU) or other difficult to heal wounds. The US National Institutes of Health (NIH) estimate the annual cost of treating DFUs to be between ~US$9bn and US$13bn, which is in addition to the cost of treating diabetes and excluding the huge costs associated with treating venous leg ulcers and pressure ulcers each year. The US government has increased its effort to introduce new and advanced products for chronic wounds, with the aim to offer effective and affordable treatment to a large and growing pool of elderly patients. By 2060, the nation’s geriatric population is projected to be >77m, suggesting an increase in the 2% of Americans currently suffering chronic wounds. Similarly in England, where >11m people, (~19% of the population) are ≥65 years. A 2017 study estimated that the annual cost of managing chronic wounds and associated comorbidities for seniors by the country's National Health Service (NHS) was £5.3bn.

Rapidly developing therapies

Without appropriate care chronic wounds may not heal properly, leading to pain, decreased mobility, other long-term complications, and death. Wound healing is a dynamic and complex process of repairing or replacing damaged or lost tissue and its goal is to restore the structure and function of an affected tissue as closely as possible to its pre-injury state. Over the past two decades there have been significant advances in technologies to treat chronic wounds, some of which are reviewed in this Commentary. Today, >3000 products have been developed to treat different types of wounds by targeting various aspects of the healing process. There are several approaches to wound repair, including the use of advanced wound dressings, skin substitutes, growth factors, and regenerative medicine techniques.

However, despite decades of R&D and advances in the management of chronic wounds, they remain an under-served, yet fast growing, therapeutic area. This is partly due to the lack of comprehensive assessment and diagnostic tools and the significant time and medical resources that their management consume. However, artificial intelligence (AI) techniques are beginning to be used to help medical professionals and institutions automate wound care assessment and thereby save valuable resources. For example, KroniKare, a start-up based in Singapore, has developed the KroniKare Wound Scanner, a handheld tool that employs multi-spectral scanning techniques that can assess a chronic wound in ~30 seconds, which enables quick and accurate treatment. The scanner has been clinically validated by the Singapore government’s Health Sciences Authority as a Class-B registered diagnostic AI device.

In this Commentary

This Commentary provides a brief history of the wound reconstruction market. North America and Europe represent the largest share of the advanced wound care market, which is currently valued at ~US$11bn, growing at a CAGR of ~5.7%, and projected to reach ~US$16bn by 2028. We draw attention to the fact that the market is changing with a growing presence of the Asia-Pacific, the Middle East, and Africa and South America regions: all with vast and rapidly growing populations, expanding middle-class segments demanding enhanced wound care and governments committed to increasing their expenditures on wound healing. Traditional US MedTechs, which currently dominate the wound care market, may struggle to increase their franchises in these emerging markets due to a range of factors including regulatory complexities, unique healthcare challenges, price sensitivity, and logistical challenges. The Commentary describes several innovative wound care products and the leading corporations developing and marketing them. These offerings include growth factors and cytokines, stem cells, tissue engineering, regenerative medicine approaches, and 3D bioprinting. For each we briefly describe the main technical and clinical obstacles they need to overcome to increase their impact on the chronic wound care market. The Commentary concludes by summarising the limitations of several advanced wound care offerings and suggests reasons why, in the next decade, 3D bioprinting is likely to eclipse competing technologies and disrupt the global wound reconstruction market.

Brief history

Complex wound reconstruction is a relatively new field that has emerged over the last few decades. Advances in medical devices and clinical techniques have allowed for the successful treatment of wounds that were previously considered untreatable. In the early 1990s, the concept of wound bed preparation was introduced, which emphasized the need to prepare a wound before applying any kind of dressing or treatment. This involved removing dead tissue, and controlling infection, to promote healthy tissue growth. In the late 1990s and early 2000s, tissue engineering and regenerative medicine emerged as promising fields for complex wound healing. These focused on using biological materials, such as stem cells and growth factors, to stimulate tissue growth and regeneration.

In 1996, the US Food and Drug Administration (FDA) approved the Integra Dermal Regeneration Template, a manufactured collagen matrix with a claim of regenerative dermal tissue designed as a skin replacement, and initially used in patients with extensive burns with insufficient donor tissue for coverage. In 1998, Apligraf became the first commercially available, FDA approved, product containing living cells, to treat venous ulcers that failed to respond to conventional treatments. It is a synthetic skin created from harvested infant foreskins and produced and marketed by Organogenesis, a US corporation based in Massachusetts. In 2000, the product obtained further approval for the treatment of diabetic foot ulcers. In the years since, other products containing living cells for wound healing have gained regulatory approval and are used to treat a range of complex wounds.

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In addition to advances in technology and treatment options, there has also been a growing recognition of the importance of a multidisciplinary approach to complex wound reconstruction. This involves teams of healthcare professionals, including wound care specialists, plastic surgeons, and rehabilitation professionals, working together to develop comprehensive personal treatment plans for individual patients.

Despite these advances, the clinical assessment and management of chronic wounds remain challenging owing to their long-term treatment regimens and complex wound healing mechanism. Various conventional approaches including cell therapy, gene therapy, growth factor delivery, wound dressings, and skin grafts are being utilized to promote healing in different types of wounds. However, such therapies are not satisfactory for all wound types, which creates a need to develop newer and innovative treatments. In recent years, innovative wound healing technologies have made progress and continue to evolve. These include stem cell therapies, bioengineered skin grafts, and 3D bioprinting, which all focus on skin regeneration with minimal side effects. According to a 2023 report by Tracxn, a MedTech research platform, globally there are ~580 companies producing wound care offerings.

A fast-growing global market

Wound reconstruction is a large and rapidly growing segment of the medical technology industry. According to a 2022 Fortune Business Insights report, the global advanced wound care market is projected to grow from ~US$11bn in 2021 to ~US$16bn in 2028 at a CAGR of ~5.7% in forecast period. Its expansion is driven by several factors, including: (i) an aging global population: ~10% of the world’s ~8bn people are ≥65 years and this age group is expected to increase to ~17% by 2050. Older adults are more prone to chronic wounds due to decreased skin elasticity, poor circulation, and other factors, (ii) increasing worldwide prevalence of chronic wounds such as diabetic foot ulcers, venous leg ulcers, and pressure ulcers, (iii) advances in wound care technologies, including growth factors, stem cell therapies, biomaterials, and regenerative medicine approaches, (iv) increasing healthcare spending: governments and healthcare systems throughout the world are investing more in advanced wound care, and (v) increased public awareness of the importance of wound healing.

Significant regional markets

Advanced wound reconstruction markets vary in different regions of the world. Currently, North America is the largest, and expected to be valued at ~US$5bn by 2027, followed by Europe, which is currently valued >US$3bn with a projected 4.2% CAGR over the next four years. Here we draw attention to emerging markets of the Asia Pacific, Middle East and Africa (MEA) and South America regions.

The Asia-Pacific region has substantial growth potential particularly in India, China, and Southeast Asia. These regions have vast, aging populations, governments increasing healthcare expenditure, high incidence of chronic diseases, and a rising awareness of the importance of wound care among large and rapidly growing middle classes. In China (population >1.4bn), for instance, the wound reconstruction market is expected to grow significantly driven by: (i) an aging population - by 2040, ~402m people, (28% of the population) are expected to be >60 years, (ii) national efforts to improve healthcare infrastructure, (iii) increasing investment in medical research, and (iv) rising incidence of chronic diseases that require wound management. India (population ~1.4bn), is also a substantial potential market with a growing demand for advanced wound care solutions, increasing healthcare expenditure, and a rising number of government initiatives to improve healthcare services. Southeast Asia, which includes Indonesia (population ~280m), Malaysia (population >32m), Thailand (population >70m) and Vietnam(population ~100m), also represent significant growth potential for the wound reconstruction market.

The Middle East and Africa (MEA) region is expected to have substantial growth potential for wound healing due to increasing medical management expenditure, improving healthcare infrastructure, and a rising number of government initiatives to improve wound care. Although this region is a diverse and complex healthcare market, there are several countries within it with significant growth potential for wound care. For instance, in the Middle East, the United Arab Emirates (population ~9.5m) is a wealthy market with a rapidly developing healthcare infrastructure, increasing demand for advanced wound healing solutions, and a high prevalence of diabetes-related wounds. Saudi Arabia too is a substantial potential market, driven by a large and growing population (~36m), increasing healthcare expenditure, and rising awareness of the importance of wound care management. In Africa, South Africa (population >61m) has a large and advanced healthcare system, increasing demand for complex wound care solutions, and a high prevalence of diabetes-related wounds.

South America is expected to experience significant growth in the wound reconstruction market, driven by increasing awareness of its importance, rising demand for advanced wound recovery solutions, and a growing number of government initiatives. Several countries in the region have substantial market growth potential, including: (i) Brazil, the largest economy in the region, with a population of ~217m and high incident rates of chronic wounds, (ii) Argentina (population >46m), which has a large healthcare sector and a growing demand for advanced wound care products and services, and (iii) Colombia, with a growing economy and a large population (>52m), is emerging as a key regional player in wound care solutions and services.

Leveraging opportunities in emerging markets

Many Western MedTechs are ill equipped to leverage the opportunities in emerging regions of the world with underserved, growing advanced wound care markets. North America and Europe account for ~55% of the global medical technology market and provide the largest share of MedTechs’ revenues. It is in these wealthy regions that most company executives have spent most of their professional careers and therefore have had little or no in-country experience of emerging economies. For decades, North American and European healthcare systems rewarded medical activity rather than patient outcomes and this drove high growth rates, significant profit margins, and industry expansion without much risk or in-depth strategic thinking. Such conditions, complemented by substantial periods of low interest rates and cheap money, encouraged the financialization of the medical technology industry: companies used mergers and acquisitions (M&A) to pursue scale and consequently became bigger but not necessarily better. Today, the ten largest medical device corporations account for >40% of the sales in a global market of ~US$490bn. The market has become an oligopoly, which emphasizes size and tends to blunt competition. Although such conditions are changing and having international experience, a global mindset, and R&D knowhow are increasingly valued, there is still a significant reliance on legacy products marketed predominantly in wealthy Western nations. Even now, relatively few company leaders have had in-depth experience of emerging regions of the world, where differences in language, competition, regulations, and culture create barriers to their ability to understand and navigate the nuances of these markets.

Wound healing technologies

The development of new wound healing technologies is an area of active R&D in the medical device industry, which aim to accelerate the healing process and improve outcomes for patients. Here we provide a flavour of these.

(i) Growth factors and cytokines

A promising area of research to stimulate wound healing is the use of growth factors and cytokines. These are naturally occurring proteins in the body that play a key role in the healing process. Researchers are exploring ways to use these proteins in wound care products to promote tissue regeneration and accelerate wound repair.

There are several MedTechs with offerings in this area. UK based Smith & Nephew markets a range of wound healing products, including biologic agents that contain growth factors and cytokines. The company’s REGRANEX Gel, which contains recombinant platelet-derived growth factor s (PDGF), received FDA approval in 1997, and is used to treat diabetic neuropathic foot ulcers. Acelity, a Texas-based privately held company founded in 1976, manufactures and markets several advanced wound care products, including biologic agents that contain growth factors and cytokines. The company’s VAC VeraFlo Therapy with Prontosan, received CE Mark in 2017 and combines negative pressure wound therapy [a method of drawing out fluid and infection from a wound to help it heal] with a solution that contains cytokines and growth factors to help promote wound healing. Nasdaq traded Integra LifeSciences develops and markets wound healing products. The Integra Flowable Wound Matrix contains growth factors and is used to treat chronic wounds. Osiris Therapeutics, founded in 1993 and based in Maryland, USA, specializes in regenerative medicine and has a range of products to promote wound healing, including Grafix, a human placental membrane that contains growth factors and cytokines. NYSE traded MedTech, Stryker markets numerous advanced wound care products, including biologic agents that contain growth factors and cytokines. Its key product in this area is MIST Therapy, which is a painless, non-contact, low-frequency ultrasound treatment delivered through a saline mist containing cytokines and growth factors to promote wound healing.

Challenges
Growth factors and cytokines are proteins that are produced naturally by the body. Replicating their production in a laboratory setting can be challenging and result in high production costs and thereby limit their accessibility and affordability. Also, these molecules are quickly broken down and cleared from wound sites, which limits their effectiveness to promote healing. Developing methods to increase their stability and longevity is crucial to improving their efficacy.

While growth factors and cytokines have shown promise in preclinical studies, clinical trials have not always demonstrated consistent benefits in wound healing, and this raises some concerns about their potential for adverse effects such as allergic reactions or immune system activation. The success of these molecules in promoting wound healing depends on their ability to effectively interact with a complex network of cells in a precise and targeted manner, which can be challenging to achieve.

(ii) Stem Cells

In recent years, stem cell-based therapies for wound healing and skin regeneration have garnered much interest owing to their potential to morph into different types of cells that promote tissue regeneration and accelerate wound healing. Researchers are exploring the use of various types, such as mesenchymal stem cells (MSCs) [multipotent stem cells found in bone marrow]; adipose (body fat)-derived stem cells (ASCs), [a subset of MSCs, which can be obtained easily from adipose tissues and possess many of the same regenerative properties as other MSCs], and pluripotent stem cells (iPSCs) [cells that can develop into many different types of cells or tissues in the body]. These present the main sources of stem cells that are utilized for wound healing and skin regeneration.

While there are many products on the market, the leading MedTechs using stem cells for wound healing include Acelity, whose flagship offering is the RECELL Autologous Cell Harvesting Device, which uses patients’ skin cells to promote healing in chronic wounds and burn injuries. Organogenesis’s Apligraf, mentioned above, contains stem cells. Integra LifeSciences’s Dermal Regeneration Template, also mentioned above, is a matrix of bovine collagen and glycosaminoglycan molecules that contains autologous stem cells [stem cells removed from a person, stored, and later given back to the same person] to promote tissue regeneration. And Smith & Nephew’s PICO Single Use Negative Pressure Wound Therapy System, which uses a proprietary dressing with stem cells to promote healing in chronic wounds.

Challenges
Despite stem cell-based therapies being common and effective for the promotion of wound healing, there are challenges associated with their source, genetic instability, potential immunogenicity, risks of infection and carcinogenesis and high processing costs. Stem cells are a complex and heterogeneous population of cells that are sensitive to their environment, and replicating their production in a laboratory can be technically demanding and costly. They have the potential to differentiate into various cell types and promote tissue regeneration, but if not appropriately controlled, they can form tumours. Developing methods to ensure the safety and efficacy of stem cell-based therapies and minimising the risk of tumour formation are crucial to their future impact on the wound care market.

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(iii) Tissue engineering

Tissue engineering is another approach being explored for wound healing. This involves a combination of cells, engineering, materials, methods, and suitable biochemical and physicochemical factors to restore, maintain, improve, or replace different types of biological tissue. Researchers have developed tissue-engineered skin substitutes that can be used to promote wound healing and tissue regeneration in patients with chronic wounds. Leading MedTechs with advanced products in this area include Acelity, Organogenesis, Integra LifeSciences and Smith and Nephew.

Challenges
There are non-trivial challenges associated with the production and maintenance of functional and viable tissue engineered constructs in a laboratory setting. The technology requires the growth of cells on scaffolds or matrices that mimic the extracellular matrix of the target tissue. The process of creating these involves multiple steps, including cell isolation, seeding, differentiation, and integration with the host tissue. Ensuring the quality and functionality of these constructs is demanding, and replicating such processes in a large-scale production setting is time consuming and costly. Another technical challenge is the need for a vascular network to support the growth and survival of the engineered tissue. The lack of blood vessels can limit the delivery of oxygen and nutrients to the cells within the tissue construct, which can result in cell death and impaired tissue function. Developing methods to vascularize tissue constructs and integrate them with the host vascular system is crucial to the success of tissue engineering in wound reconstruction. Clinical success depends on offerings not being rejected by a patient’s immune system and being able to integrate with a complex network of cells in a precise and targeted manner, which can be difficult to achieve.

(iv) Regenerative medicine approaches

Regenerative medicine approaches such as platelet-rich plasma (PRP) and extracellular matrix (ECM) are being developed for their potential to promote wound healing. The former is an autologous biological product containing higher amounts of platelets [small cells that circulate within your blood and bind together when they recognize damaged blood vessels]. Compared to circulating blood, PRP contains an increased concentration of growth factors, which is a prerequisite for wound healing. The approach involves isolating platelets from a patient's blood, which, when introduced into a wound has the potential to stimulate and accelerate tissue healing. In recent years, PRP has attracted a lot of research attention.

ECM is an extensive three-dimensional scaffold made from natural or synthetic materials that provides structural integrity and can be used to promote tissue regeneration and accelerate wound healing. Because of the nature of chronic wounds, recovery is reduced by a lack of functional ECM in the dermal matrix, which is responsible for stimulating healing. The restoration of functional ECM in wounds contributes to their reconstruction and closure. Both PRP and ECM technologies show promise in promoting tissue regeneration.

MedTech leaders in this field include Osiris, Terumo, Stryker and Zimmer Biomet. Osiris Therapeutics specializes in regenerative medicine approaches for wound healing, including ECM products. Grafix, the company’s key offering, is a cryopreserved placental membrane product that is designed to promote tissue regeneration in chronic wounds. Terumo, a Japanese corporation founded in 1921, opened its first overseas office in the US in 1971 and subsequently became a global player. The company is now a leader in blood management technologies and offers a range of products specializing in wound healing, including PRP systems. Its main offering, the Terumo BCT COBE Spectra Apheresis System, is used to collect and process blood components, including platelets, for use in wound healing. Stryker’s flagship ECM product is the MatriStem UBM Wound Matrix, which is derived from porcine urinary bladder tissue and is designed to promote tissue regeneration in chronic wounds. Zimmer Biomet is a global leader in musculoskeletal healthcare and offers a range of products for wound healing, including PRP systems. Its principal product is the EBI Bone Healing System, which is used to promote healing in fractures and other musculoskeletal injuries.

Challenges
Regenerative medicine approaches for wound healing require an in-depth understanding of the underlying mechanisms of tissue regeneration, which is complex. A precise understanding of multiple signaling pathways, cell types, and extracellular matrix components are crucial, and how these interact is fundamental to the development of effective therapies. For regenerative medicine treatments to be successful they need appropriate delivery of cells, growth factors, and other biological molecules to the site of injury. Achieving this requires a careful consideration of the biological and physical factors at play, which can be challenging.

(v) Three dimensional (3D) bioprinting

In recent years, three dimensional (3D) bioprinting has emerged as a rapid and high throughput automated technology that significantly reduces the limitations of other wound healing and regenerative medicine technologies that depend on manual processes and are hindered by the time it takes for them to reconstruct large chronic wounds. 3D bioprinting is an automated process that allows for the creation of three-dimensional structures using living cells and biomaterials. It involves the layer-by-layer deposition of bio-inks, which contain living cells and other biological components, using a specialized printer. The resulting structures can then be implanted into the body to promote tissue regeneration and wound healing. Advances in the technology have led to the development of more complex tissue constructs, such as skin, bone, and cartilage. In the near to medium term, 3D bioprinting has the potential to eclipse established and evolving wound healing technologies and disrupt the advanced wound care market.

Centres of excellence

There are several scientists, institutions, and start-ups, which have made significant contributions to the field of complex wound reconstruction using bioprinting. Here we mention a few. A pioneer in the area is Anthony Atala, founding Director of the Wake Forest Institute for Regenerative Medicine, which is part of the Wake Forest School of Medicine in North Carolina, USA. The Institute is a world-renowned centre of excellence for research in 3D bioprinting and wound healing. Professor Atala, a bioengineer, urologist, and pediatric surgeon, is recognized for his work in the area. One of Atala’s most notable contributions is the development of the first 3D bio printed human bladder, which he created using a combination of patient cells and biomaterials and then successfully implanted the constructs into several patients with bladder disease. Atala’s pioneering work in 3D bioprinting has paved the way for new treatments and therapies for patients suffering from complex wounds and tissue damage.

The Advanced Regenerative Manufacturing Institute (ARMI) located in Manchester, New Hampshire, USA, is a public-private partnership with a specific focus on 3D bioprinting research and has developed innovative techniques to create living tissues and organs. ARMI collaborates with academic institutions, government agencies, and industry partners to accelerate the translation of 3D bioprinting research into clinical applications. Another leading institution is the Tissue Engineering and Regenerative Medicine International Society (TERMIS), which is a global organisation that aims to promote research, education, and clinical translation in the field of tissue engineering and regenerative medicine. It has >50 chapters worldwide and organises annual conferences to bring together experts in the field. TERMIS plays a significant role in advancing 3D bioprinting research by providing a platform for collaboration and knowledge exchange.

One example of a start-up specializing in advanced wound care that is using 3D bioprinting is Pandorum Technologies, founded in 2011 and based in Bengaluru, India. Its flagship offering CorneaGen, is a 3D-bioprinted cornea that can be used to replace damaged or diseased corneas in patients. The cornea is made up of a bio ink composed of corneal cells and hydrogels that mimic the natural extracellular matrix of the cornea. The company has also developed a bio printed skin that can be used for wound healing research and drug development. It is composed of layers of living cells that mimic the structure and function of human skin. Pandorum has R&D initiatives in India and in the US located in the Medical University of South Carolina (MUSC) at Charleston and MBC BioLabs, in the San Francisco Bay Area, USA.

Challenges
The success of 3D bioprinting depends on its ability to create structures that can support the growth and differentiation of cells into functional tissue. Identifying and developing biomaterials that can mimic the extracellular matrix of the target tissue, while providing the necessary mechanical and biological cues to support cell growth is technically demanding. The process of 3D bioprinting involves the deposition of multiple layers of cells and biomaterials to create a three-dimensional structure. Achieving the desired geometry and spatial organisation of these layers can be challenging and requires precise control over the printing process. A challenge for the technology regarding wound healing is the time it takes to obtain autologous cells to fabricate skin constructs for patients with extensive burn wounds, which require rapid treatment.

Can 3D bioprinting disrupt the advanced wound care market?

Although it is difficult to predict the future of any technology with certainty, it seems reasonable to suggest that 3D bioprinting could become the dominant technology in the field of advanced wound reconstruction in the next decade. Bioprinting has several advantages over other technologies, briefly described in this Commentary, and currently used in wound reconstruction. Traditional methods such as skin grafting and tissue engineering using scaffolds, have limitations in terms of their ability to produce complex tissue structures and patient-specific treatments. 3D bioprinting, on the other hand, allows for precise control over the placement of cells and biomaterials, and can produce highly complex and customized tissue constructs. The technology is rapidly advancing, and new developments are being made at an unprecedented rate. Researchers are continuously developing new biomaterials, improving the resolution and speed of bioprinters, and exploring new applications. 3D bioprinting appears to have the potential to meet the large and growing demand for advanced wound reconstruction by allowing for the creation of customized tissue constructs tailored to the specific needs of individual patients. Further, it can reduce the need for multiple surgeries and treatments, improve patient outcomes and reduce healthcare costs.

Takeaways

Over the next decade, advanced wound care markets are expected to grow and change due to the increasing influence of the purchasing power in emerging regions of the world and advances in technology. While wealthy North America and Europe, with ~14% of the global population, will continue to be commercially significant for the medical device industry, the Asia-Pacific, MEA, and South America regions, where >80% of the world’s population live, are likely to become important wound care markets because of the growing incident rates of chronic conditions and related wounds requiring treatment, expanding middle classes demanding improved care and governments’ commitment to enhancing their healthcare systems.

While it is unlikely that non-bioprinting technologies will disappear from the field of complex wound reconstruction, there are several reasons, which we have briefly described, why they are likely to have a reduced influence on the market as it evolves over the next decade. By contrast, the advantages offered by 3D bioprinting, combined with the rapid pace of its R&D, the growing demand for personalized affordable treatments in emerging economies, and the universal need to reduce healthcare costs, suggest that the technology is well positioned to disrupt the advanced wound care market in the next decade.

Will traditional MedTechs with wound care franchises be agile enough to benefit from these new market and technology opportunities?

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