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  • Since 2000 healthcare has been transformed by genomics, AI, the internet, robotics, and data-driven solutions
  • Traditional providers, anchored in outdated technologies, struggle to keep pace with the evolving healthcare landscape
  • Over the next two decades anticipate another seismic shift, bringing further disruptions to medical technology and healthcare delivery
  • In the face of this imminent transformation, risk-averse leaders may cling to outdated portfolios, showing little interest in adapting to a 2040 healthcare ecosystem
  • Providers must decide; embrace change now and thrive in a transformed healthcare landscape, or stick to the status quo and risk losing value and competitiveness
 
Healthcare 2040
 
Abstract

By 2040, the landscape of healthcare will have undergone a seismic shift, discarding antiquated models in favour of cutting-edge AI-genomic-data-driven approaches that will radically change both medical technology and healthcare delivery. This transformation signifies a departure from the conventional one-size-fits-all system, ushering in an era of targeted therapies grounded in molecular-level insights that challenge entrenched healthcare paradigms. The evolving healthcare narrative emphasises prevention, wellbeing, personalised care, and heightened accessibility. This departure from the norm is not a trend but a significant reconfiguration, where the fusion of biomedical science, technology, and expansive datasets merge to facilitate early detection and proactive interventions. This not only deepens our comprehension of diseases but also elevates the efficacy of therapies. At the core of this transformation is the empowerment of individuals within a framework that champions choice and fosters virtual communities. Genetic advancements, far from just addressing hereditary conditions, play an important role in enhancing diagnostic accuracy, optimising patient outcomes, and fundamentally shifting the focus from reactive diagnosis and treatment to a proactive commitment to prevention and holistic wellbeing. The indispensable roles played by genomics and AI-driven care in reshaping healthcare are not isolated occurrences; they will catalyse the emergence of new data-intensive R&D enterprises, which are poised to redefine the healthcare landscape against a backdrop of multifaceted influencing factors. Successfully navigating this transformative period necessitates a distinct set of capabilities and strategic alignment with an envisioned 2040 healthcare environment.

Providers find themselves at a crossroads, confronted with a choice: adapt and thrive or risk losing value and competitiveness in a rapidly evolving landscape. Recognising potential resistance to change and the scarcity of pertinent capabilities, leaders of traditional enterprises must acknowledge that immediate strategic action is not just beneficial but a prerequisite for success in the redefined healthcare ecosystem of 2040. The urgency of this call to action cannot be overstated, as the window of opportunity for adaptation narrows with each passing moment.

 
In this Commentary

This Commentary aims to help healthcare professionals to strategically reposition their organizations for success in the next two decades. Leaders must evaluate their strengths and weaknesses in the context of an envisioned future and implement strategies to align their organisations with the demands of a rapidly changing health ecosystem. Failure to do so will dent enterprises’ competitiveness and threaten their survival. Leaders should anticipate and address resistance to change among executives with a preference for the status quo. The Commentary has two sections: Part 1, Looking Back 20 Years, describes the scale and pace of change since 2000 and emphasises how genomics, the internet, AI, digitalization, data-driven solutions, robotics, telehealth, outpatient services, personalised care, ubiquitous communications, and strategic responses to demographic shifts have transformed medical technology and healthcare delivery. Part 2, Looking Forward 20 Years, seeks to stimulate discussions about the future of healthcare. While we highlight a range of factors positioned to impact medical technology and healthcare deliver in the future, we emphasise the significance of genomics, varied and vast datasets, and AI. We suggest the emergence of specialised agile, AI-driven research boutiques with capabilities to leverage untapped genomic, personal, and medical data. The proliferation of such entities will oblige traditional healthcare enterprises to reduce their R&D activities and concentrate on manufacturing. Over the next 20 years, anticipate an accelerated shift towards patient-centric, cell-based prevention and wellbeing care modalities, large hospitals replaced with smaller hubs of medical excellence, the rapid growth of outpatient centres, and the acceleration of home care and care-enabled virtual communities. The future dynamic healthcare ecosystem necessitates stakeholders to change immediately if they are to survive and prosper. Takeaways posit a choice for healthcare leaders: either stick to the status quo and risk losing value and competitiveness or embrace change and stay relevant.
 
Part 1
 
Looking Back 20 Years

Reflecting on the past two decades shows the rapid evolution and interplay of factors shaping medical technology and healthcare delivery. Appreciating the speed and scale of change helps to envision the future. Factors such as genomics, the Internet, AI, robotics, digitalisation, data-driven health solutions, telehealth, outpatient services, home care, personalised wellbeing, ubiquitous personal telephony, and strategic responses to demographic shifts have all influenced medical technology and healthcare delivery and will continue to do so in the future. Here we describe a few of these factors.

The completion of the Human Genome Project in 2003 was a pivotal moment in the direction of medical advancement, laying the foundations for the emergence of genomics. Genomics, encapsulating the mapping, sequencing, and analysis of DNA, is a pivotal tool for unravelling molecular information, variations, and their implications in both traits and diseases. This achievement not only transformed biomedical research but also changed healthcare, shifting it from a generic one-size-fits-all approach to finely tuned care tailored to the unique genetic makeup of individuals.

Over the past two decades, the decoding of the human genetic blueprint has provided unprecedented insights into diseases at the molecular level, triggering a paradigm shift in medicine. This ushered in an era of personalised and precision approaches to diagnoses, treatments, and prevention. From the advent of targeted therapies to the implementation of genetic screening, genomic research has had a transformative influence and is positioned to continue its impact on healthcare.

Indeed, genomic testing has become a standard practice, and US Food and Drug Administration (FDA)-approved genomic care modalities have advanced medicine. For example, pharmacogenonics tailors drug treatments to individual patients by utilising genetic information, with FDA-approved tests for specific biomarkers that predict medication responses. Hereditary assessments evaluate an individual's cancer risk based on genetic makeup, such as identifying BRCA gene mutations linked to elevated risks of breast and ovarian cancers. Gene expression profiling analyses a patient's tumour genetics to guide targeted cancer therapies, with FDA-approved companion diagnostic tests for specific cancer treatments. Carrier testing identifies genetic mutations that could be passed on to children, which contribute to family planning and prenatal care. Pharmacodiagnostic tests help pinpoint patients that would benefit from specific drug treatments, predicting responses, especially in cancer therapies.

In 2012, the UK government inaugurated Genomics England, an initiative designed to spearhead the 100,000 Genomes Project, which aimed to sequence the genomes of 100,000 patients with infectious diseases and specific cancers. The project’s goals included the enhancement of our understanding of various genetic factors in diseases, the facilitation of targeted treatments and establishing a framework for the integration of genomics into everyday clinical practice. The successful completion of the project in 2018, provided a basis for genomic medicine and a deeper understanding of the genetic framework influencing health and disease.

In addition to genomic data, since 2000, there has been a significant increase in health-related data, driven by the proliferation of electronic health records (EHRs), developments in information management technologies, initiatives to improve healthcare efficiency, and enhanced communications among stakeholders. The growth in data has, in turn, created opportunities for the utilisation of AI and machine learning (ML) algorithms. Over the last two decades, AI has changed medical technology and healthcare delivery by enhancing diagnostics, personalising treatment plans, streamlining administrative tasks, and facilitating research through efficient data analysis, which has improved patient outcomes, and advanced the field. As of January 2023, the FDA has approved >520 AI and ML algorithms for medical use, which are primarily related to the analysis of medical images and videos. Indeed, the rise of algorithms has transformed healthcare, with many of them focusing on predictions using EHRs that do not require FDA approval.

In addition to EHRs there has been the evolution of wearable technologies like the Apple Watch and Fitbit, which have transformed personal health. Initially focusing on fitness tracking, these devices have expanded to monitor an array of health metrics. Over the years, they have amassed vast amounts of personalised data, ranging from activity levels to heart rate patterns. These data reservoirs are a goldmine for healthcare and wellbeing strategies, enabling individuals, healthcare professionals and providers to gain unprecedented insights into health trends, customised care routines, and the early detection of health issues. This combination of technology and health data has created opportunities for proactive healthcare management and personalised wellbeing interventions.

Targeted medicine not only benefitted from AI but also from personalised telephony, which experienced a significant boost in the early 2000s by the widespread internet access in households across the globe. The period was marked by the introduction of the iPad in 2001, closely followed by the launch of the iPhone. These innovations triggered widespread smartphone use and accessible internet connectivity, laying the foundations for the emergence of telehealth and telemedicine. In the early 2000s, global cell phone subscriptions numbered ~740m. Today, the figure is >8bn, surpassing the world's population. This increase was driven by the proliferation of broadband, the evolution of mobile technologies and the rise of social media, all contributing to the ubiquitous presence of the internet. By the 2010s, the internet had integrated into the daily lives of a substantial portion of the global population. Initially, in 2000, ~7% of the world’s population had access online. Contrastingly, today, >50% enjoy internet connectivity. In a similar vein, broadband access in American homes has surged from ~50% in 2000 to >90% in the present day. Personal telephony has evolved into an omnipresent force, and has become an integral part of billions of lives, actively enhancing health and wellbeing on a global scale. After 2010, patient-centric wellbeing evolved and later was helped by Covid-19 pandemic lockdowns, with telehealth and telemedicine offering remote consultations and treatments, empowering patients, and emphasising shared decision-making between healthcare providers and patients.

On a more prosaic level, consider how robotics has changed surgery over the past two decades by offering enhanced precision, reduced invasiveness, and improved recovery times. The use of robotic systems, like the da Vinci Surgical System, which gained FDA-approval in 2000, has allowed surgeons to perform complex procedures with greater accuracy. Between 2012 and 2022, the percentage of surgical procedures using robotic systems rose from 1.8% to 17%. Robotic surgery is becoming increasingly popular, with an annual growth rate of ~15%. In 2020, its global volume was 1.24m, with the US accounting for >70% of all robotic surgeries.

The shifting demographics over the past few decades, marked by decreasing birth rates, prolonged life expectancy, and immigration, has transformed prosperous industrial economies, resulting in a substantial rise in the proportion of the elderly population. For instance, in the US in 2000, there were ~35m citizens ≥65; today, this figure has risen to ~56m, ~17% of the population. Concurrently, there has been an increase of chronic lifetime illnesses such as heart disease, diabetes, cancer, and respiratory disorders. In 2000, ~125m Americans suffered from at least one chronic condition. Today, this figure has increased to ~133m - ~50% of the population. Simultaneously, there is a shrinking pool of health professionals. Research suggests that by 2030, there will be ~5m fewer physicians than society will require. This, together with ageing populations, the growing burden of chronic diseases and rising costs of healthcare globally are challenging governments, payers, regulators, and providers to innovate and transform medical technology and healthcare delivery.

 
Part 2
 
Looking Forward 20 Years

This section aims to encourage healthcare professionals to envision the future. Over the next two decades, medical technology and healthcare delivery are likely to be affected by numerous interconnected factors, which include: (i) continued progress in AI and ML, internet of things (IoT), robotics, nanotechnology, and biotechnology, (ii) advances in genomics, (iii) increasing availability of multi-modal data (genomics, economic, demographic, clinical and phenotypic) coupled with technology innovations, (iv) accelerated adoption of telemedicine and virtual monitoring technologies, (v) changes in healthcare regulations, (vi) an increase of patient-cantered care and greater patient involvement in decision-making, (vii) emerging infectious diseases, antimicrobial resistance, and other global health issues, (viii) Investments in healthcare infrastructure, both physical and digital, (ix) an evolving and shrinking healthcare workforce, including the further integration of AI technologies and changes in roles, (x) economic conditions and healthcare funding, (xi) the ethical use of technology, privacy concerns, and societal attitudes towards healthcare innovations, and (xii) environmental changes and their impact on health and wellbeing. Such factors and their interconnectivity are expected to drive significant healthcare transformation over the next two decades. Healthcare systems throughout the world are tasked with: (i) improving population health, (ii) enhancing patients’ therapeutic journeys and outcomes, (iii) strengthening caregivers’ experience and (iv) reducing the rising cost of care. There appears to be unanimous agreement among healthcare leaders that these goals will not be achieved by business as usual.
 
In November 2023, BTIG, a leading global financial services firm, organised its Digital Health Forum, bringing together >30 healthcare companies that offer a diverse range of products and services. During the event, executives discussed business models, reimbursement, and commercial strategies, and unanimously agreed that: "The market is primed for the mainstream integration of digital diagnostics and therapeutics."  Here we focus on the anticipated accelerated convergence of genomics and AI technologies, and foresee the emergence of agile, AI-driven R&D boutiques as key players in reshaping medical technology and healthcare delivery.
 
These dynamic research entities thrive on the power of data. Currently, ~79% of the hospital data generated annually goes untapped, and medical information is doubling every 73 days. This emphasises the vast latent potential within these repositories. Traditional enterprises and healthcare professionals, constrained by a dearth of data management capabilities, have struggled to unlock the full potential inherent in these vast stores of information. By contrast, the adept data processing capabilities of these new innovative enterprises position them strategically to harness untapped data sources, extracting valuable insights into disease states and refining treatment modalities. Moreover, they boast advanced technology stacks, seamless connections between semiconductors, software, and systems, and are well-prepared to leverage specialised generative AI applications as they emerge in the market. Armed with cutting-edge technology and extensive datasets, they stand ready to enhance diagnostic precision, streamline treatment approaches, and reduce overall healthcare costs. Private equity firms will be eager to invest in these disruptive AI start-ups, anticipating M&A activities focused on specific therapeutic areas that will make them appealing to public markets.

These innovative entities are set to expedite the introduction of disruptive solutions, improve patients' therapeutic journeys, and optimise outcomes while driving operational efficiencies. Anticipate them to overshadow their traditional counterparts, many of which have outdated legacy offerings and historically have treated R&D as small adjustments to existing portfolios. Given that many conventional healthcare enterprises have: (i) failed to keep pace with technological developments, (ii) a dearth of in-house data-handling capabilities, and (iii) no experience in data-heavy disruptive R&D, it seems reasonable to suggest that they will most likely retreat into their core manufacturing activities, relinquish their R&D roles and lose value.

In the forefront of seismic change, the integration of digitalisation, AI, and cutting-edge decision support tools propels the emerging agile, data-driven R&D enterprises into a pivotal role within the landscape of well-informed, personalised healthcare. Meticulously safeguarding sensitive information, these enterprises not only adhere to the highest standards of privacy but also elevate security measures through state-of-the-art encryption techniques and decentralised storage solutions. As staunch guardians of privacy, they go beyond conventional approaches, crafting data repositories that not only shield confidential information but also facilitate the seamless flow of critical insights crucial for advancing medical technology and elevating care delivery. The seamless synergy between vast genomic, economic, demographic, clinical, and phenotypic data repositories and advanced AI techniques is poised to radically change healthcare R&D, redirecting it away from refining traditional products towards disruptive endeavours. Moreover, these agile research entities are anticipated to encourage widespread industry cooperation, harnessing the power of diverse data sources to innovate health solutions and services that transcend boundaries, thereby playing an important role in shaping a borderless health and wellbeing ecosystem.

In the regulatory arena, a transformation is anticipated by 2040. Regulators are likely to evolve from enforcers to stewards of progress, collaborating with industry stakeholders to promote a consumer-centric healthcare. Advocating transparency, patients' rights, and ethical innovation, regulators will become influential drivers of progress, contributing to a shared and equitable healthcare future. This collaborative effort is expected to contribute to a data-driven healthcare ecosystem that prioritises individual wellbeing, innovation, and accessibility in equal measure.

By 2040, expect healthcare payers to have undergone a transformative change, fuelled by a seismic shift in medical technology and healthcare delivery. New payment models will prioritise individualised therapies and patient outcomes, leveraging real-time health data for customised coverage. AI will streamline administration, reduce costs, and enhance overall healthcare efficiency. Increased patient engagement and collaboration among payers, providers, and patients will drive a holistic, patient-centred approach, ultimately improving the quality and accessibility of healthcare services.


This section has emphasised the transformative forces of genomics and AI shaping a personalised healthcare ecosystem. While traditional medical technology and healthcare delivery may be predicated upon physical devices and a one-size-fits-all approach, the future lies in the fusion of data and smart software to accelerate targeted care, which marks a significant departure from the conventional.
 
Takeaways

The shift towards genomic-driven healthcare marks a transformation in the medical landscape expected by 2040. Moving away from outdated models, the trend towards personalised care, rooted in molecular insights, necessitates a revaluation from health professionals. This shift, facilitated by the fusion of biomedical science, advanced technologies, and vast amounts of varied data, foresees a future where prevention, individualised wellbeing, and improved accessibility become the new norm. The convergence of genomics and AI not only improves diagnostics and treatments but also points to prevention and overall wellness. This Commentary has highlighted the transformative impact of genomics and AI-driven healthcare at the cellular level, making way for data-intensive R&D enterprises that will shape the future of medical technology and healthcare delivery. The path to 2040 demands a departure from conventional norms of the past, requiring strategic realignment and specific capabilities. Traditional providers find themselves at a juncture: those that adapt to an envisioned care environment of 2040 are more likely to succeed, while those that resist risk becoming obsolete. By acknowledging potential obstacles to change and the scarcity of relevant capabilities, leaders are encouraged to recognise the urgency of strategic action as a prerequisite for success in the redefined healthcare landscape of 2040. The future is imminent, and the time for transformative readiness is now.
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MedTechs Battle with AI for Sustainable Growth and Enhanced Value
 
Preface
 
The medical technology industry has experienced significant growth, consistently surpassing the S&P index by ~15 percentage points. This success is rooted in the early 1990s, a time when capital was costly, with interest rates ~10%. However, as we moved closer to 1998, interest rates began to recede, settling just below 7%. This early era of growth was not devoid of challenges. The US was still grappling with the aftermath of the oil embargo imposed in 1973 by the Organization of the Petroleum Exporting Countries (OPEC), which was a response to the American government's support for Israel during the Yom Kippur War and had lasting consequences. The oil crisis triggered hyperinflation, leading to a rapid escalation in the prices of goods and services. In response, the US Federal Reserve (Fed) raised interest rates to a historic high of 17% in 1981, which was aimed at curbing inflation but came at the price of increasing the cost of borrowing. As we entered the 1990s, the landscape shifted. The Fed’s monetary policies began to work, inflation started to decline, and interest rates fell to ~10%, eventually dipping below 7% in 1998. This created conditions for increased investments in research and development (R&D) and the American economy blossomed and benefitted from the internet becoming mainstream. It was during this period that many medical technology companies developed innovative medical devices, which were not only disruptive but also found a receptive global market characterized by significant unmet needs and substantial entry barriers. In the ensuing years, the industry thrived and matured. Fast-forward to the present (2023), and we find ourselves in a different scenario. Over the past five years, numerous large, diversified MedTechs have struggled to deliver value. One explanation for this is that growth of these enterprises over the past three decades, except for the early years, was primarily driven by mergers and acquisitions (M&A), often at the expense of prioritizing R&D. Consequently, many large MedTechs did not leverage evolving technologies to update and renew their offerings and are now heavily reliant on slow-growth markets and aging product portfolios. Navigating a successful path forward would be helped by a comprehensive embrace of artificial intelligence (AI) and machine learning (ML) strategies, since these technologies possess the potential to transform how MedTechs operate, innovate, and serve their stakeholders.
 
In this Commentary

This Commentary explores the role of artificial intelligence (AI) in reshaping the future landscape of the MedTech industry in pursuit of sustainable growth and added value. We focus on the impact AI can have on transforming operational methodologies, fostering innovation, and enhancing stakeholder services. Our aim is to address five key areas: (i) Defining Artificial Intelligence (AI): Describes how AI differs from any other technology in history and sheds light on its relevance within the MedTech sector. (ii) Highlighting AI-Driven MedTech Success: In this section, we preview three leading corporations that have utilized AI to gain access to new revenue streams. (iii) Showcasing a Disruptive AI-Powered Medical Device: Here, we provide an overview of the IDx-DR system, an innovation that has brought disruptive change to the field of ophthalmology. (iv) The Potential Benefits of Full AI Integration for MedTechs: This section briefly describes 10 potential benefits that can be expected from a comprehensive embrace of AI by MedTechs. (v) Potential Obstacles to the Adoption of AI by MedTechs: Finally, we describe some obstacles that help to explain some MedTechs reluctance to embrace AI strategies. Despite the substantial advantages that AI offers, not many large, diversified enterprises have fully integrated these transformative technologies into their operations. Takeaways outline the options facing enterprises.
 
Part 1

Defining Artificial Intelligence (AI)

Artificial Intelligence (AI) is a ground-breaking concept that transcends the simulation of human intelligence. Unlike human cognition, AI operates devoid of consciousness, emotions, and feelings. Thus, it is indifferent to victory or defeat, tirelessly working without rest, sustenance, or encouragement. AI empowers machines to perform tasks once exclusive to human intelligence, including deciphering natural language, recognizing intricate patterns, making complex decisions, and iterating towards self-improvement. AI is significantly different to any technology that precedes it. It is the first instance of a tool with the unique capabilities of autonomous decision making and the generation of novel ideas. While all predecessor technologies augment human capabilities, AI takes power away from individuals.
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AI employs various techniques, including machine learning (ML), neural networks, natural language processing, and robotics, enabling computers to autonomously tackle increasingly complex tasks. ML, a subset of AI, develops algorithms that learn, adapt, and improve through experience, rather than explicit programming. The technology’s versatile applications span image and speech recognition, recommendation systems, and predictive analytics. In the quest to comprehend the intersection of artificial and human intelligence, we encounter Large Language Models (LLMs), like ChatGPT, which recently have gained prominence in corporate contexts. These advanced AI models grasp and generate human-like text by discerning patterns and context from extensive textual datasets. LLMs excel in language translation, content generation, and engaging in human-like conversations, effectively harnessing our linguistic abilities.


Part 2

Highlighting AI-Driven MedTech Success

This section briefly describes three examples of MedTechs that have successfully leveraged AI technologies to illustrate how AI’s growing influence drives improvements in accuracy, efficiency, patient outcomes and in the reduction of costs, which together, and in time, are positioned to transform healthcare.
 
Merative, formally Watson Health, a division of IBM that specialised in applying AI and data analytics to healthcare. In 2022, the company was acquired by Francisco Partners, an American  private equity firm, and rebranded Merative. The company leverages AI, ML, and LLMs to analyse extensive medical datasets that encompass patient records, clinical trials, medical literature, and genomic information. These technologies empower healthcare professionals by facilitating more informed decisions, identifying potential treatment options, and predicting disease outcomes. For instance, Merative employs ML to offer personalised treatment recommendations for cancer patients based on their medical histories and the latest research. Integrating LLMs enables natural language processing to extract insights from medical literature, helping healthcare providers stay current with scientific and medical advancements.
 
Google Health, a subsidiary of Alphabet Inc., focuses on using AI and data analysis to improve healthcare services and patient outcomes. It employs AI and ML to develop predictive models that can identify patterns and trends in medical data, which improve early disease detection and prevention. One notable application is in medical imaging, where the company's algorithms can assist radiologists to identify anomalies in X-rays, MRIs, and other images. LLMs are used to interpret and summarize medical documents, making it easier for healthcare professionals to access relevant information quickly. Google Health also works on projects related to drug discovery and genomics, leveraging ML to analyze molecular structures and predict potential drug candidates.
Medtronic is a global leader in medical technology, specializing in devices and therapies to treat various medical conditions. The company incorporates AI, ML, and LLMs into their devices and systems to enhance patient care. For instance, in the field of cardiology, Medtronic's pacemakers and defibrillators collect data on a patient's heart rhythms, which are then analyzed using AI algorithms to detect irregularities and adjust device settings accordingly. This real-time analysis helps to optimize patient treatment. Medtronic also employs AI in insulin pumps for diabetes management that can learn from a patient's blood sugar patterns and adjust insulin delivery accordingly. Additionally, LLMs are used to extract insights from electronic health records (EHR) and clinical notes, which help healthcare providers to make more personalized treatment decisions.
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Part 3

Showcasing a Disruptive AI-Powered Medical Device

AI has been applied to various medical imaging tasks, including interpreting radiological images like X-rays, CT scans, and MRIs and there are numerous AI-driven medical devices and systems that have emerged and evolved in recent years. As of January 2023, the US Federal Drug Administration (FDA) has approved >520 AI medical algorithms, the majority of which are related to medical imaging. Here we describe just one, the IDx-DR system, which was developed by Digital Diagnostics. In 2018, it became the first FDA-approved AI-based diagnostic system for detecting diabetic retinopathy. If left untreated, the condition can lead to blindness. Globally, the prevalence of the disease among people living with diabetes is ~27% and every year, >0.4m people go blind from the disorder. In 2021, globally there were ~529m people with diabetes, which is expected to double to ~1.31bn by 2050.
 
The IDx-DR device utilizes AI algorithms to analyze retinal images taken with a specialized camera and accurately detects the presence of retinopathy that occurs in individuals with diabetes when high blood sugar levels cause damage to blood vessels in the retina. Significantly, the device produces decisions without the need for retinal images to be interpreted by either radiologists or ophthalmologists, which allows the system to be used outside specialist centres, such as in primary care clinics. Advantages of the system include: (i) Early detection, which can improve outcomes and quality of life for individuals with diabetes. (ii) Efficiency. The system analyzes images quickly and accurately, providing results within minutes, which allows healthcare providers to screen a larger number of patients in a shorter amount of time. (iii) Reduced healthcare costs. By detecting retinopathy at an early stage, the system helps prevent costly interventions, such as surgeries and treatments for advanced stages of the disease, which can lead to significant cost savings for healthcare systems. (iv) Patient convenience. Patients undergo retinal imaging as part of their regular diabetes check-ups, reducing the need for separate appointments with eye specialists, which encourages enhanced compliance.

 
Part 4

The Potential Benefits of Full AI Integration for MedTechs

Large, diversified MedTechs stand to gain significant benefits by fully embracing AI technologies that extend across all aspects of their operations, innovation, and overall value propositions. In this section we briefly describe 10 such advantages, which include enhanced innovation, improved patient outcomes, increased operational efficiency, cost savings, and access to new revenue streams. Companies that harness the full potential of AI will be better positioned to thrive in the highly competitive and rapidly evolving healthcare industry.
 
1. Enhanced innovation and product development
AI technologies have the potential to enhance R&D endeavours. They accomplish this through the ability to dig deep into vast repositories of complex medical data, identifying patterns, and forecasting outcomes. This translates into a shorter timeline for the conception and creation of novel medical technologies, devices, and therapies. In essence, AI quickens the pace of innovation in healthcare. The capabilities of AI-driven simulations and modeling further amplifies its impact. These virtual tools enable comprehensive testing in a digital environment, obviating the need for protracted physical prototyping and iterative cycles, which can shorten the development phase and conserve resources, making the innovation process more cost-effective, and environmentally sustainable.
 
2. Improved patient outcomes
Beyond improving the research landscape, AI improves the quality of patient care by enhancing diagnostic precision through the analysis of medical images, patient data, and clinical histories. Early detection of diseases becomes more precise and reliable, leading to timelier intervention and improved patient outcomes. Additionally, AI facilitates the personalization of treatment recommendations, tailoring them to individual patient profiles and current medical research. This optimizes therapies and increases the chances of successful outcomes and improved patient wellbeing.
 
3. Efficient clinical trials
Increasingly AI algorithms are being used in clinical studies to identify suitable patient cohorts for participation in trials, effectively addressing recruitment challenges and streamlining participant selection. Further, predictive analytics play a role in enhancing the efficiency of trial design. By providing insights into trial protocols and patient outcomes, AI reduces both the time and costs associated with bringing novel medical technologies to market, which speeds up the availability of treatments and facilitates the accessibility of healthcare innovations to a broader population.
 
4. Operational efficiency
Operational efficiency is improved with the integration of AI technologies by refining operations. AI-driven supply chains and inventory management systems play a significant role in optimizing procurement processes. They analyze demand patterns, reduce wastage, and ensure the timely availability of critical supplies. By doing so, companies can maintain uninterrupted operations, enhancing their overall efficiency and responsiveness. Another component of operational efficiency lies in predictive maintenance, which can be improved by AI. Through continuous monitoring and data analysis, AI can predict equipment failures before they occur. Such a proactive approach minimizes downtime and ensures manufacturing facilities remain compliant and in optimal working condition. Consequently, healthcare providers experience improved operational efficiency, strengthened compliance, and a reduction in costly disruptions. The automation of routine tasks and processes via AI relieves healthcare professionals from repetitive duties and frees up resources that can be redirected towards more strategic and patient-centric initiatives. This reallocation reduces operational costs while enhancing the quality of care provided.
 
5. Cost savings
Beyond automation, AI-driven insights further uncover cost efficiencies within healthcare organizations. AI identifies areas where resource allocation and utilization can be optimized, which can result in cost reduction strategies that are both data-informed and effective. AI's potential extends to the generation of innovative revenue streams. Corporations can develop data-driven solutions and services that transcend traditional medical devices. For instance, offering AI-driven diagnostic services or remote patient monitoring solutions provides access to new revenue streams. Such services improve patient care and contribute to the financial sustainability of enterprises. Further, AI-enabled healthcare services lend themselves to subscription-based models, ensuring consistent and reliable revenue over time. Companies can offer subscription services that provide access to AI-powered diagnostics, personalized treatment recommendations, or remote monitoring, which have the capacity to diversify revenue streams and enhance longer-term financial stability.
 
6. New revenue streams
AI's ability to analyze vast datasets positions MedTechs to unravel the interplay of genetic, environmental, and lifestyle factors that shape individual health profiles. With such knowledge, personalized treatment plans and interventions can be developed, ensuring that medical care is tailored to each patient's unique needs and characteristics. This level of customization optimizes outcomes and minimizes potential side effects and complications. AI's ability to process vast amounts of patient data and detect patterns, anomalies, and correlations, equips healthcare professionals with the knowledge needed to make more informed decisions. Such insights extend beyond individual care, serving as the basis for effective population health management and proactive disease prevention strategies. In short, AI transforms data into actionable intelligence, creating a basis for more proactive and efficient healthcare practices.
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7. Regulatory compliance and safety
In an era of stringent healthcare regulations, AI is a reliable ally to ensure compliance and enhance safety standards. Through automation, AI streamlines documentation, data tracking, and quality control processes, reducing the risk of errors and oversights. Also, AI-powered systems excel in the early detection of anomalies and potential safety issues, which increase patient safety and the overall quality of healthcare solutions and services. This safeguards patient wellbeing and protects the reputation and credibility of companies.
8. Competitive advantage
MedTechs that are early adopters of AI stand to gain a distinct competitive advantage. They can offer AI-powered solutions and services that deliver superior clinical outcomes and improve overall patient experience. By harnessing the potential of AI, companies can position themselves as leaders in innovation and technological capabilities, likely drawing a loyal customer base, valuable partnerships, collaborations, and investments.
 
9. Talent attraction and retention
Embracing AI technologies also has an impact on talent attraction and retention. The allure of working on novel AI projects that improve lives attracts scarce tech-savvy professionals who seek to be part of dynamic, purposeful, and forward-thinking teams. Such talent contributes to a skilled workforce capable of extending the boundaries of AI innovation within MedTech companies. Further, fostering a culture of innovation through AI adoption encourages employee engagement and job satisfaction, leading to improved talent retention.
 
10. Long-term sustainability
The integration of AI goes beyond immediate advantages; it positions MedTechs for longer-term strategic growth and resilience. As the healthcare landscape continues to evolve, adaptability and innovation become more important. AI enables companies to adapt to changing market dynamics, navigate regulatory challenges, and remain relevant amidst industry transformations. By staying at the forefront of technological advancements, companies ensure their relevance and contribute to shaping the future healthcare landscape.
 
Part 5

Potential Obstacles to the Adoption of AI by MedTechs

The integration of AI technologies into numerous industries has demonstrated its potential to significantly enhance operations, improve R&D, and create new revenue streams. However, despite AI’s potential to contribute significant benefits for business enterprises, its adoption by many large, diversified medical technology companies has been limited and slow. This section describes some factors that help to explain the reluctance of senior MedTech executives to fully embrace AI technologies, which include an interplay of organizational, technical, and industry-specific issues. Without overcoming these obstacles, MedTechs risk losing the growth and value creation they once experienced in an earlier era.

Demographics of senior leadership teams
According to Korn Ferry, an international consultancy and search firm, the average age for a C-suite member is 56 and their average tenure is 4.9 years, although the numbers vary depending on the industry. The average age of a CEO across all industries is 59. If we assume that the MedTech industry mirrors this demographic, it seems reasonable to suggest that many corporations have executives approaching retirement who may be more risk averse and oppose the comprehensive introduction of AI technologies due to a fear of losing benefits they stand to receive upon retirement.

Organizational inertia and risk aversion
Large medical technology companies often have well-established structures, processes, and cultures that resist rapid change. In such an environment, executives might be hesitant to introduce AI technologies due to concerns about disrupting existing workflows, employee resistance to learning new skills, and the fear of failure. The risk-averse nature of the medical technology industry, where patient safety is critical, further amplifies executives' cautious approach to implementing unproven AI solutions.
 

Technical challenges and skill gaps
AI implementation requires technical expertise and resources. Many MedTech executives might lack a deep understanding of AI's technical capabilities, making it difficult for them to evaluate potential applications. Further, attracting and retaining AI talent is highly competitive, and the scarcity of professionals skilled in both medical technology and AI can hinder successful implementation.
Regulatory and ethical concerns
The medical field is heavily regulated to ensure patient safety and data privacy. Incorporating AI technologies introduces additional layers of complexity in terms of regulatory compliance and ethical considerations. Executives might hesitate to navigate these legal frameworks, fearing potential liabilities and negative consequences if AI systems are not properly controlled or if they lead to adverse patient outcomes.
Long development cycles and uncertain ROI
The R&D cycle in the medical technology industry is prolonged due to rigorous testing, clinical trials, and regulatory approvals. Although AI technologies have the capabilities to enhance R&D efficiency, they can introduce additional uncertainty and complexity, potentially extending development timelines. Executives could be apprehensive about the time and resources required to integrate AI into their R&D processes, especially if the return on investment (ROI) remains uncertain or delayed.
 

Industry-specific challenges
The medical technology industry has unique challenges compared to other sectors. Patient data privacy concerns, interoperability issues, and the need for rigorous clinical validation can pose barriers to AI adoption. Executives might view these complexities as additional hurdles that could hinder the successful implementation and deployment of AI solutions.
  

Existing Revenue Streams and Incremental Innovation
Many large, diversified MedTechs generate substantial revenue from their existing products and services. Executives might be reluctant to divert resources towards AI-based ventures, fearing that these investments could jeopardize their core revenue streams. Additionally, a culture of incremental innovation prevalent in the industry might discourage radical technological shifts like those associated with AI.

 
Takeaways
 
Hesitation among MedTechs to integrate AI technologies poses the threat of missed opportunities, diminished competitiveness, and sluggish growth. This reluctance hinders innovation and limits the potential for enhanced patient care. Embracing AI is not an option but a strategic imperative. Failure to do so means missing opportunities to address unmet medical needs, explore new markets, and access new revenue streams. The potential for efficiency gains, streamlined operations, and cost reductions across R&D, manufacturing and supply chains is significant. Companies fully embracing AI gain a competitive advantage, delivering innovative solutions and services that improve patient outcomes and cut healthcare costs. Conversely, those resisting AI risk losing market share to more agile rivals. AI’s impact on analysing vast amounts of complex medical data, accelerating discovery, and enhancing diagnostics is well established. MedTechs slow to leverage AI may endure prolonged R&D cycles, fewer breakthroughs, and suboptimal resource allocation, jeopardising competitiveness and branding them as ‘outdated’. In today’s environment, attracting top talent relies on being perceived as innovative, a quality lacking in AI-resistant MedTechs. As AI disrupts industries, start-ups and smaller agile players can overtake established corporations failing to adapt. A delayed embrace of AI impedes progress in patient care, diagnosis, treatment, and outcomes, preventing companies from realising their full potential in shaping healthcare. The time to embrace AI is now to avoid irreversible setbacks in a rapidly evolving MedTech ecosystem.
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  • Katalin Karikó and Drew Weissman were awarded the 2023 Nobel Prize for Physiology or Medicine for pioneering the use of messenger RNA (mRNA) as a therapeutic tool for vaccines
  • mRNA translates genetic instructions from DNA to cellular machinery, driving essential protein synthesis in cell biology
  • Karikó and Weissman’s innovations led to the development of the first mRNA vaccine to combat the Covid-19 virus
  • Katalin Karikó overcame significant professional and personal setbacks before becoming a world-renowned scientist
  • Her life changed after a chance meeting with Weissman, which resulted in their ground-breaking contribution to biomedical science and the Nobel Prize
 
A Nobel Journey: Triumph over Adversity, Serendipity, BioNTech’s Rise, and mRNA Marvels
 
On Monday 2nd October 2023, Katalin Karikó and Drew Weissman were awarded the Nobel Prize in Physiology or Medicine for their contributions to messenger RNA (mRNA) biology that led to the unprecedented rate of vaccine development during the Covid-19 pandemic.
 
In this Commentary

This Commentary has four sections. In Part 1, Triumph over adversity, we highlight the journey of Katalin Karikó, which is a testament to her indomitable spirit. Despite facing entrenched prejudices and significant setbacks, Karikó's brilliance eventually triumphed, earning her the respect she deserved. As her work gained prominence, she emerged as a passionate advocate for women in science. Part 2, Serendipity, briefly describes a chance encounter between Karikó and Drew Weissman, which triggered a collaboration that defied the odds, and resulted in a major contribution to biomedical science that safeguarded the health and wellbeing of billions throughout the world and gained them the Nobel Prize. Part 3, “BioNTech doesn’t even have a website”, outlines the role played by a German start-up founded in 2008 by a husband-and-wife team, which leveraged Karikó's expertise and developed the first mRNA vaccine for the Covid-19 virus - a significant feat with global ramifications. The concluding Part 4, mRNA marvels, explains the science and describes the early contribution of Roger Kornberg, which enhanced our understanding of the molecular machinery that underpins mRNA’s functions. Also, we focus on how Karikó and Weissman championed the practical implications of mRNA for its use as a therapeutic. The combined endeavours advanced the field of molecular biology and opened unprecedented frontiers in both basic research and transformative therapeutic innovations. Takeaways follow.
 
Part 1

Triumph over adversity

Born in 1955 in a small town in central Hungary, Katalin Karikó grew up in a household devoid of running water, a refrigerator, or a television. From a young age she became fascinated with science, which led to her developing a passion for biology.
 
In 1982, she obtained a PhD from the University of Szeged, Hungary. Her research explored how mRNA could be used to target viruses: an innovative endeavour as gene therapy was in its infancy. Recognizing the therapeutic potential of mRNA, Karikó secured a postdoctoral position at the Biological Research Centre (BRC) of the Hungarian Academy of Sciences, where she embarked on a journey to advance her research.
 
At this time, Hungary was under Communist rule as part of the Eastern Bloc. The prevailing socio-political environment presented challenges for Karikó, which included glass ceilings that were obstacles for her scientific ambitions. After two years of research, her funding abruptly ceased: an illustration of the volatile and uncertain conditions she faced during those early years.
 
Buoyed by a boom in mRNA research taking place in the US, Karikó turned her gaze towards America and landed a research position at Temple University in Philadelphia. She sold her car, converted the proceeds into 900 British pounds on the Black Market, and sewed the currency into her two-year-old daughter's teddy bear to facilitate taking them out of Hungary. In the US in the late 1980s, she entered a male-dominated scientific community and encountered the prevalent gender biases and stereotypes: unequal opportunities, limited representation in leadership roles, and both subtle and overt discrimination.
 
In 1988, Karikó accepted a position at Johns Hopkins University in Baltimore without notifying Temple University. This prompted her sponsor to report her to the US immigration authorities, accusing her of being "illegally" in the country. After successfully challenging the resulting extradition order, Karikó faced another setback as Johns Hopkins withdrew her job offer. However, she secured a research position at the Uniformed Services University of the Health Services in Bethesda, Maryland.
 
A year later, in 1989, the University of Pennsylvania recognized her talent and hired her. Karikó dedicated her research to exploring the therapeutic potential of mRNA, envisioning its use to stimulate protein production within the human body. Her research faced scepticism during a time when synthetic mRNA applications for therapeutics were met with doubt. During clinical studies, the injection of mRNA-based therapies into animals triggered a severe inflammatory response, resulting in the death of the subjects, thereby eliminating any possibility of human trials.
 
Consequently, the excitement around mRNA as a therapy faded, and securing funding for such research became impossible. Karikó received multiple rejections from funding agencies. Her inability to raise research monies led the university in 1995 to suggest that she was "not of faculty quality" and presented her with an ultimatum: "leave or be demoted". This was a devastating and demeaning blow for Karikó who was on a tenured career path to become a full professor. She decided to accept an untenured position with a reduced salary and persevered in her research.

Even in the face of demotion and funding rejections, Karikó showed resilience. Overcoming doubts and questions from the scientific community is no small feat. It demands an unusual form of persistence and a deep belief in the value of one's research. She had to reconcile staying true to her visionary ideas and adapting to the feedback around her. What makes Karikó’s story even more remarkable is the personal adversity she faced. Amidst her professional challenges, her husband encountered visa problems, which obliged him to return to Hungary for six months. During this period, she was diagnosed with cancer, underwent two operations while simultaneously caring for her daughter and maintaining her research.

 
Part 2

Serendipity

Serendipity played a significant role in Karikó's scientific journey, as her fascination with mRNA had to endure a time when its potential was largely doubted by the scientific community. A critical turning point for her was a chance encounter with Drew Weissman, a senior professor of immunology at the University of Pennsylvania, who was well-endowed with research funds.
 
In the late 1990s, Karikó and Weissman bumped into each other at a photocopier. At that time, scientists copied the latest research from journals. Their meeting led to a recognition of a shared vision and complementary skills, and together, they pushed the boundaries of what was deemed possible. Their collaboration addressed challenges associated with using synthetic mRNA as a therapeutic tool. Weissman's expertise in immunology, combined with Karikó's focus on mRNA and protein synthesis, led to breakthroughs in modifying mRNA to reduce its inflammatory response and increase its stability.
 
In retrospect, Karikó's journey, coupled with her collaboration with Weissman, not only showcased scientific acumen but also emphasised the transformative potential of collaborative efforts in advancing the boundaries of knowledge. Their partnership became a catalyst for ground-breaking discoveries, particularly in the development of modified mRNA.

 
Part 3

“BioNTech doesn’t even have a website”

BioNTech, a German start-up founded in 2008 by a dynamic husband-and-wife team, Uğur Şahin and Özlem Türeci, was launched without a website but had a mission to disrupt healthcare. In 2013, Karikó accepted an invitation to join the company as a senior vice-president. When she told her University colleagues they are reported to have laughed at her saying that the company does not even have a website. Later Karikó and Weissman licenced the mRNA technology they developed to BioNTech, which later partnered with Moderna and Pfizer. BioNTech’s partnership with Pfizer, a giant pharmaceutical company experienced in vaccine development and distribution, led to a global clinical trial of Karikó and Weissman’s mRNA tool as a therapy, which involved >43,000 individuals across six countries. The joint venture became a linchpin in the fight against the Covid-19 virus. Today, BioNTech is a Nasdaq traded company with a market cap of ~US$23bn, annual revenues of >US$18bn, >4,500 employees and research centres in San Diego and Cambridge, Massachusetts.
  
Unknown to Karikó and Weissman, in 2005, Derrick Rossi, while a postdoctoral researcher in molecular biology at Stanford University in California was impressed with a paper they published describing a modified form of mRNA that did not induce an immune response. In 2010, Rossi, together with colleagues from Harvard and MIT, founded Moderna, which, between 2011 and 2017, raised US$2bn in venture capital funding and later formed its partnership with BioNTech. In the throes of the global Covid-19 pandemic, BioNTech emerged as a pioneer, developing the first authorized mRNA vaccine by leveraging Karikó and Weissman's mRNA technology. This breakthrough had a competitive edge over traditional vaccines because it offered a faster and more efficacious solution. In April 2020, as the world clamoured for a solution to the Covid-19 virus, Moderna secured a significant boost, receiving US$483m from the US Biomedical Advanced Research and Development Authority to fast-track its Covid-19 programme. Today, Moderna, based in Cambridge, Massachusetts, is a Nasdaq traded company with a market cap >US$30bn, annual revenues of ~US$20bn, and a workforce of ~4,000.
 
From a humble start without a website to shaping the future of medicine, the stories of BioNTech and Moderna exemplify the transformative power of scientific innovation and unwavering determination.

 
Part 4

mRNA marvels
 
The molecular messenger: mRNA
mRNA functions act like a postal service of the genetic world, which takes instructions from the DNA in the cell’s nucleus and delivers them to the protein-producing machinery called ribosomes in the cell’s cytoplasm [a jelly-like substance that fills the cells and surrounds the nucleus]. Think of it as a template that guides the creation of proteins in a process known as translation. So, mRNA is the messenger that ensures the right genetic instructions reach the protein-making machinery, which helps cells produce specific proteins needed for different tasks.
 

Importance of mRNA in protein synthesis
mRNA plays a crucial role in protein synthesis, serving as the intermediary that carries genetic instructions from DNA to the ribosomes. This process is significant for several reasons: mRNA transfers the genetic code from DNA to the ribosomes in the cytoplasm, ensuring the accurate transmission of instructions for protein synthesis. Each mRNA molecule corresponds to a specific protein, providing the specificity needed for the synthesis of diverse proteins with distinct functions. The regulation of mRNA production allows cells to control when and how much of a particular protein is synthesized, contributing to the adaptation of cellular processes. Proteins are essential for the structure, function, and regulation of cells. The diversity and specificity of proteins determine the many functions that cells can perform. Thus, mRNA acts as a messenger, translating the genetic information stored in DNA into functional proteins, thereby influencing all cellular activities and maintaining the integrity and functionality of living organisms.
 

The transcription process and the role of RNA polymerase II
Transcription is the first step in the flow of genetic information, where a segment of DNA is used as a template to synthesize a complementary RNA molecule. RNA polymerase II plays an important role in this process, particularly in the transcription of protein-coding genes. Let us give a brief overview. Transcription begins with the binding of RNA polymerase II to a specific region of DNA called the promoter. This signals the start of the gene to be transcribed. Once bound to the promoter, RNA polymerase II unwinds the DNA double helix and starts synthesizing an RNA molecule complementary to one of the DNA strands. As it progresses along the DNA, RNA polymerase II adds nucleotides to the emerging RNA chain, always extending it in the 5’ to 3’ direction. Transcription continues until the RNA polymerase II encounters a termination signal in the DNA. This signals the end of transcription, and the RNA polymerase II detaches from the DNA template. The newly synthesized RNA molecule, called pre-mRNA, undergoes processing steps like capping, splicing, and polyadenylation to form mature mRNA. These modifications enhance stability, functionality, and transport of the mRNA. RNA polymerase II is responsible for transcribing protein-coding genes (mRNA). It recognizes the promoter sequences of these genes and catalyses the synthesis of the complementary mRNA strand. The precision and regulation of this process are vital for ensuring accurate gene expression and the production of functional proteins in cells.
Science made easy

Importance of mRNA in protein synthesis
Think of mRNA as a messenger in the protein-making factory of your cells. It is like the delivery person that carries important instructions from the cell's recipe book (DNA) to the protein-making machines (ribosomes). Here is why this messenger - mRNA - is important: (i) Accurate Delivery: mRNA ensures that the instructions from the recipe book (DNA) are accurately delivered to the protein-making machines (ribosomes) in the cell's kitchen (cytoplasm). (ii) Specific Recipes: Each mRNA molecule has a specific recipe for a particular protein. This specificity is important because it helps in making different proteins with different jobs in the cell. (iii) Controlled Production: Cells can control when and how much of a protein is made by managing the production of mRNA. It is like having control over how often and how many times a specific recipe is used in the kitchen. And (iv) Cellular Teamwork: Proteins are like the workers in the cell - they build structures, carry out functions, and regulate processes. mRNA, by delivering the right protein recipes, ensures that the cell's team is diverse and has the skills needed for various tasks. So, mRNA is the messenger that translates the genetic information stored in DNA into practical instructions for making proteins. This process is like the secret sauce that keeps the cell running smoothly and maintains the overall health and function of living organisms.

The transcription process and the role of RNA polymerase II
Imagine your DNA is like a cookbook, and you want to make a specific recipe from it. Transcription is the first step in this cooking process. RNA polymerase II is like the chef who reads the recipe and makes a copy of it.  The chef (RNA polymerase II) starts by finding the beginning of the recipe, which is called the promoter. Then, s/he reads the instructions in the recipe (DNA) and creates a matching copy in the form of RNA. This copy, known as pre-mRNA, undergoes some additional steps to become the final recipe (mature mRNA). The chef follows the recipe precisely from start to finish, and when s/he reaches the end of the instructions or sees a "stop" sign (termination signal), s/he finishes the job. The final recipe (mature mRNA) is then ready to be used in the kitchen (cell) to make a delicious dish (functional protein). This whole process is crucial to ensure that the right recipes are selected and copied accurately, leading to the creation of the correct proteins needed for the cell's functions.
Synthetic mRNA
Beyond its natural role, synthetic mRNA acts as a vaccine, directing cells to produce specific viral proteins, prompting an immune response without inducing illness. Initially, challenges arose with unwanted inflammation caused by early versions of these genetic instructions. Katalin Karikó and Drew Weissman addressed this issue by making adjustments, preventing inflammation, and enhancing target protein production. This breakthrough laid the groundwork for vaccine development.
 

mRNA, Roger Kornberg, Katalin Karikó and Drew Weissman
We have described how mRNA serves as a critical messenger, shuttling genetic instructions from the cell's nucleus to the protein-building ribosomes. Now, let us briefly describe the contribution to the field of Roger Kornberg, an American biochemist who, in 2006, was awarded the Nobel Prize in Chemistry for his research on RNA polymerase II, the enzyme central to transcribing DNA into mRNA. In the video below Kornberg explains his research interest in how biological information, encoded in the human genome, is accessed to inform all human activity.
 

Kornberg's research went beyond simply decoding genetic information; he illuminated the intricacies of transcription - the process translating DNA into RNA. Specifically, his work dissected the structure of RNA polymerase II uncovering the nuances of how RNA polymerase II interacts with DNA during transcription. This detailed molecular blueprint is central to understand how genetic instructions in DNA are accurately transcribed into mRNA, which, as we described above, is a crucial step in the cellular flow of genetic information.
 
Katalin Karikó and Drew Weissman built upon Kornberg’s insights and spearheaded the application of mRNA for therapeutic purposes. While they championed the practical implications of mRNA, Kornberg’s contributions enhanced our understanding of the molecular machinery that underpins mRNA’s functions. Their combined endeavours advanced the field of molecular biology and opened unprecedented frontiers in both basic research and transformative therapeutic innovations.
 
Takeaways
 
This Commentary tells a story of science, resilience, serendipity, and a ground-breaking achievement. We described the scientific intricacies of mRNA, flagging Roger Kornberg's pioneering contributions. A testament to the triumph of the human spirit, portrayed Katalin Karikó's journey: her brilliance, overcoming prejudice and blossoming into advocacy for women in science. The unexpected collaboration between Karikó and Weissman, which led to a biomedical breakthrough that transcended expectations, ultimately garnering the Nobel Prize. We introduced BioNTech, where a husband-and-wife team harnessed Karikó and Weissman’s innovative research to pioneer the development of the world's first mRNA vaccine to combat the Covid-19 virus. This not only marked a historic moment in biomedical science but also exemplified the power of collaboration, determination, and visionary leadership. As we reflect on this journey - from the molecular intricacies of mRNA to the global impact of a life-saving vaccine - it becomes clear that the convergence of scientific curiosity, individual tenacity, and collaboration can be a catalyst for transformative change. The 2023 Nobel Prize for Physiology or Medicine awarded to Katalin Karikó and Drew Weissman stands as recognition of their central role in reshaping the landscape of biomedical science and, more importantly, in safeguarding the health and wellbeing of billions throughout the world. In scientific discovery, their story serves as an inspiring chapter, encouraging us to embrace the boundless possibilities that arise when science and humanity join forces in the pursuit of a healthier, more resilient future.
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  • The MedTech industry has undergone a transformative journey marked by prolific mergers and acquisitions (M&A)
  • Between 2006 and 2016, the industry witnessed 2,680 acquisitions totaling US$607.8bn
  • In the pursuit of efficient integrations corporations often overlooked the significance of fostering a distinct organisational culture
  • In many cases this resulted in cultural dissonance, which is a silent but substantial obstacle to growth and value creation
  • Stories can overcome this obstacle and help to bridge gaps, align interests, and cultivate a shared sense of purpose among employees and stakeholders for long-term MedTech success
 
 The Silent Obstacle to MedTech Growth and Value Creation
 
The MedTech industry, marked by decades of prolific mergers and acquisitions (M&A), has undergone a transformative journey fuelled by factors like the pursuit of economies of scale, technological access, and navigating regulatory challenges. While strategic consolidations have yielded financial and organisational benefits, often they have inadvertently overlooked the softer facet of corporate identity - organisational culture.
 
Illustrating the magnitude of M&A within the industry, the decade from 2006 to 2016 witnessed 2,680 acquisitions with a value totaling US$607.8bn. Noteworthy is the consistency in the frequency of these acquisitions, juxtaposed against the variability in the consideration of individual deals.
                                                                                                                     
By 2023, a notable shift occurred within the MedTech M&A landscape. The deceleration of M&A activity led to a saturation in market segments with products and services, which intensified competition for market share and exerted pressure on pricing and profit margins. As the M&A market cooled, the accessibility to cutting-edge technologies became more elusive, putting companies at a disadvantage in terms of product development and maintaining competitiveness. Simultaneously, heightened geopolitical tensions and trade restrictions further complicated supply chains and distribution channels. The constrained M&A environment raised hurdles for expanding into emerging markets, which narrowed potential growth opportunities. Integrating talent from acquired companies, a common practice in M&A, also faced challenges amid the slowdown, which impacted the ability to sustain a competitive edge in expertise and innovation. Without the efficiency gains typically associated with M&A, numerous companies encountered escalating cost pressures, which encompassed R&D costs, manufacturing expenses, and other operational outlays that adversely affected overall profitability. The heighted expectations from shareholders for consistent growth, a hallmark for large diversified MedTechs, faced added difficulties due to the deceleration of M&A activity, potentially influencing stock prices and investor confidence.
 
Periods of integrating acquired enterprises tend to be dominated by the pursuit of efficiency, cost savings, and regulatory compliance, which often means relegating the significance of cultivating a distinct and cohesive organisational culture. In the current landscape, where M&A activity has decelerated and corporate values have plateaued, the ramifications of this neglect are becoming increasingly evident. Some enterprises are finding themselves with fragmented cultures, which have low levels of solidarity: employees disagree about organisational objectives, critical success factors, and performance standards. This can make organisations challenging to manage, and leaders unable to affect change. Organisational culture is not simply rhetoric; it is a critical element that molds how employees perceive their roles, comprehend their company's mission, and ultimately contribute to innovation and value creation. Further, a robust and distinctive culture plays a role in attracting and retaining top talent. In an industry driven by innovation, retaining the brightest minds is important for success. When employees sense a misalignment between their personal values and the organisational culture, it can result in disengagement, increased turnover rates, and a depletion of institutional knowledge - all of which undermine long-term growth.
 
Consider this scenario: A MedTech company with a clear and supportive culture is well equipped to navigate the intricacies of the industry. Such an environment fosters a shared sense of purpose and identity among employees, creating a collaborative space where diverse talents can thrive. This, in turn, augments a company's capacity to adapt to industry changes, respond to emerging healthcare needs, and drive sustainable value creation.
 
Culture embodies community; it is the essence of how individuals connect with each other. Flourishing communities arise from shared interests, mutual obligations, and a foundation of cooperation and camaraderie. A common oversight in certain management literature concerning corporate culture is the assumption that organisations are inherently homogeneous. However, just as one organisation differs from another, so do its internal units. Consider the contrasting nature of, for instance, the R&D function compared to manufacturing within a MedTech company. Moreover, hierarchical distinctions within an enterprise add layers of diversity; the cultural dynamics of senior leadership teams may differ markedly from those of middle managers and blue-collar workers.
 
In the MedTech industry, where financial and organisational factors maintain their importance, a strategy that develops a distinctive organisational culture is equally important. Overlooking cultural integration presents a nuanced yet potentially significant barrier to growth and value creation. This challenge manifests itself through indicators such as disengaged employees, talent attrition, and a lack of adaptability in meeting the evolving demands of the industry. Recognizing and addressing this cultural deficit extends beyond employee satisfaction; it emerges as a strategic imperative for long-term success in the dynamic landscape of MedTech.
 
Further, as corporations expand globally they encounter challenges to unite and motivate their constituencies. Internationalization means transcending geographical, linguistic, cultural, and religious boundaries. Multinational corporations operate in a world where employees are from various countries, speak different languages, and possess diverse cultural backgrounds, which emphasises the significance of establishing common ground and fostering a sense of belonging. Moreover, modern organisations are linked to an array of stakeholders, including governments, patients, insurance firms, advocacy groups, and a wide spectrum of customers. These often hold distinct interests and priorities, occasionally leading to conflicts with both each other, and the organisation's objectives.
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The power of stories

In this interconnected ecosystem, a cohesive and inspiring narrative emerges as a potential remedy for dissonance. A well-crafted story has the capacity to bridge divides, align interests, and instil a collective sense of purpose among both employees and stakeholders. This, in turn, contributes to a corporation's overall success.
The impact of a unifying narrative does not confine itself to an organisation's internal boundaries. It acts as a catalyst for collective action, motivating employees, and stakeholders alike toward shared objectives. This shared story becomes the driving force behind innovation, it bolsters problem-solving capabilities, and shapes the organisation into a responsive and adaptable entity. In a world where trust, differentiation, innovation, talent attraction, stakeholder engagement, and customer loyalty wield substantial influence, a captivating narrative emerges as a positive force for a diversified MedTech company. It adeptly communicates the company's mission, values, and impact, establishing trust, distinguishing the brand, fostering innovation, attracting top talent, engaging stakeholders, and cultivating customer loyalty. Ultimately, it solidifies a company's brand identity, nurtures relationships, and fuels long-term commercial success.
 
The potency of an inspiring company narrative lies in its ability to weave a common thread through the diverse interests of employees, creating unity and a shared company culture. A compelling story acts as a connective tissue, transcending departmental and hierarchical boundaries, resonating universally regardless of individual roles or backgrounds. Such narratives instill a collective sense of purpose and pride, fostering a shared identity embraced by every employee. When everyone is tethered to a common story, it encourages a cohesive culture where values and goals are not just communicated but lived and upheld by each member of the organisation. This shared narrative becomes a wellspring of motivation, aligning the workforce toward a singular vision and propelling the company forward as a unified and harmonious entity.
 
These claims may seem exaggerated when applied to a company narrative. However, to grasp the potential impact of storytelling, let us briefly examine the realms of religion, politics, finance, and the women’s movement. All these domains are predicated upon narratives that not only inspire and motivate diverse groups of individuals but also make them reshape their lives and dedicate their time and energy to the causes these narratives portray.
 
Religion

Religion plays an important part in the spiritual lives of billions of people around the world. Religious stories hold a significant influence over the beliefs and practices of faith communities, providing them with a sense of meaning and purpose. The potency of a narrative's impact is exemplified in the case of Jerusalem, a city that embodies the enduring power of stories.
 
For Jews, Jerusalem is a testament to the divine intervention of their narrative, where God commanded Abraham not to sacrifice his son Isaac. For Christians, Jerusalem holds multifaceted significance across various church factions, but it universally marks the hallowed ground where Jesus Christ delivered his teachings and shared the Last Supper with his disciples before his crucifixion. Similarly, for Muslims, Jerusalem bears importance as the place where the Prophet Mohammad started his mission and experienced a divine vision.
 
What is striking about these narratives is that they have endured through centuries, despite the absence of any scientific evidence, relying on the power of spiritual belief. This emphasises the influence of storytelling. People hold these stories dear to their hearts, embracing them with unwavering faith. Such narratives have the power to shape cultures, societies, and even geopolitical landscapes. The enduring power of religious narratives, like those surrounding Jerusalem, teaches us that stories are more than tales, but the scaffolding upon which belief systems are constructed, and they have the potential to move nations and shape destinies.
 
Politics

Consider politics. Political ideologies are founded upon stories that individuals hold so firmly that they are prepared to resolutely defend their convictions, even at the cost of armed conflict. These ideologies shape the governance, policies, and destinies of nations, and their power lies in the stories they tell.
 
Consider democracy, for instance. It is a powerful narrative that extols the virtues of power vested in the hands of the people or their elected representatives. Democracy's story emphasizes principles of equality, individual rights, and the regular exercise of those rights through elections. It speaks to the idea that citizens should actively participate in shaping their government and society through voting and civic engagement. This narrative has led people to fight for democratic values, even in the face of oppressive regimes, as they believe in the story of democracy's inherent worth.
 
Socialism is another political ideology grounded in a compelling narrative. It advocates for collective or state ownership and control of the means of production, distribution, and exchange. The story of socialism centres on reducing economic inequality and ensuring that resources and wealth are more equitably distributed among society's members. This narrative has inspired revolutions, social movements, and political changes across the world, as believers are motivated by the story of a fairer and more just society.
 
In contrast, authoritarian states are political systems characterised by centralised power and limited political freedoms. They too are predicated on stories. Such states often feature a single leader or a small group of individuals with substantial control over the government, little or no opposition, restricted civil liberties, and limited or no free elections. They prioritize order and control over individual rights and freedoms, often relying on censorship, propaganda, and coercion to maintain their authority. Despite its repressive nature, it has garnered fervent adherents who are willing to defend their vision of a disciplined and ordered society, sometimes at great human cost.
 
These political narratives are strong forces that shape the world we live in. They are stories that compel people to action, and at times, to support and engage in conflict. Understanding the power of these narratives is essential for comprehending the dynamics of political movements, governance, and global affairs. It emphasises that the stories we believe in are not just words; they are forces capable of reshaping societies and history itself.
 
Money

Money, in its essence, is a symbol devoid of inherent value. Take a $100 bill, for instance. It possesses no intrinsic worth; you cannot eat it, clothe yourself with it, or find shelter beneath its folds. In today's digital age, most monetary transactions occur virtually, further emphasizing that money is not a tangible commodity but a representation of value. What makes money intriguing is that its value is predicated upon a story, a narrative that commands the largest following worldwide, surpassing the collective adherents of all religions combined. Money, in essence, is a story with believers numbering billions.
 
This narrative begins with the idea that a particular piece of paper or digital entry holds value. It is a shared belief system, one upheld by individuals, corporations, and governments across the globe. This shared belief is what allows us to exchange money for goods, services, and even intangible assets like trust or promise. Consider the notion of a banknote. Its value exists because we believe in the authority and stability of the issuing government or institution. It is a mutual understanding that a piece of paper, despite its lack of intrinsic value, can be exchanged for something tangible or intangible in the real world.
 
This shared belief in money's value creates a complex web of economic interactions and relationships. It fuels trade, investment, and economic growth. It enables people to plan, save for retirement, and invest in education and healthcare. Money, as a story, is a unifying force in the modern world, transcending borders, cultures, and languages. Yet, like all narratives, money is not without its challenges and contradictions. Economic disparities, financial crises, and questions about the fairness of wealth distribution persist. But the fact remains that money, as a story, is a force of unparalleled influence, guiding the decisions and actions of individuals and nations alike. In a world where the value of money is woven into the fabric of society, it becomes clear that its true worth lies not in the physical notes or digital records but in the collective trust and beliefs that sustain this narrative. Money, in the end, is a story that shapes our lives, economies, and the world at large.
 
Women’s movement

The women's movement is a testament to the power and influence of a story about equality. Over decades, this movement has enhanced the status of women worldwide. What makes this narrative particularly interesting is that, unlike the stories underpinning religion, politics, and money, the pursuit of women's rights has largely been achieved through peaceful means, which is a testament to the millions of people around the world who embraced the story that activists told.
 
The narrative of the women's movement is simple: equality. It tells a story of a world where women and men stand on equal footings, where gender should not be a barrier to opportunities, rights, or dignity. This story resonated with countless individuals who recognized the inherent justice in this vision. The power of this story lies in its ability to inspire action. It mobilized women and men from all walks of life to come together and advocate for change. Grassroots activists, iconic leaders, and ordinary citizens joined forces, fuelled by the belief in the story's inherent truth. They organised rallies, signed petitions, and engaged in peaceful demonstrations, all with the goal of dismantling systemic inequalities and securing equal rights for women.
 
What sets the women's movement apart from many other stories that shape our world is its peaceful nature. While religious, political, and economic narratives have often been associated with conflict and violence, the women's movement has predominantly relied on peaceful activism and advocacy. This nonviolent approach has garnered widespread support and sympathy from people of diverse backgrounds, fostering a sense of unity and shared purpose.
 
The influence of this narrative has been significant. It has led to legal and societal changes, from suffrage and reproductive rights to workplace equality and gender representation in leadership roles. Women's rights have advanced on a global scale, improving the lives of millions. The women's movement is a powerful example of how a story can shape the world when embraced by a collective of individuals who believe in its message. It demonstrates that narratives grounded in principles of justice and equality can bring about transformative change, even without resorting to violence. The women's movement serves as a reminder that stories have the power to move societies and bend the arc of history toward progress and justice.
 
Takeaways

The MedTech industry's journey through decades of M&A activity has been a transformative one, marked by the pursuit of economies of scale, technological access, and regulatory mastery. The resulting financial and organisational benefits, however, have inadvertently overlooked a critical aspect: organisational culture. The magnitude of M&A activity, exemplified by 2,680 acquisitions totaling US$607.8bn between 2006 to 2016, showcases both consistency and variability in deal considerations. As we fast forward to 2023, global uncertainties prompted a recalibration of strategic initiatives, especially as MedTech companies aimed for operational scaling and global expansion. The challenges of uniting diverse constituencies in an internationalized context - spanning geographical, linguistic, cultural, and religious boundaries – emphasized the importance of establishing common ground and fostering a sense of belonging. The consequences of prioritizing efficiency and not cultivating a cohesive organisational culture during the integration of acquired enterprises has become increasingly apparent. Some companies find themselves with fragmented cultures, marked by low solidarity and disagreements about organisational objectives. This cultural deficit makes organisations challenging to manage, and leaders often feel powerless to effect change. In the MedTech sector, where collaboration and creativity are important for healthcare breakthroughs, cultural dissonance poses a significant risk. A robust and distinctive culture, however, is instrumental in attracting and retaining top talent, which is essential for success in an innovation-driven industry. A MedTech with a clear and supportive culture is better equipped to navigate industry intricacies, respond to emerging healthcare needs, and drive sustainable value creation.
 
This Commentary suggests that culture is community: a network of shared interests and obligations that thrive on cooperation and friendships. Acknowledging the heterogeneity within organisations is crucial, recognizing differences across departments and hierarchical levels. While financial and organisational considerations are critical, an approach encouraging a distinctive organisational culture is equally important. Neglecting cultural integration poses a silent yet substantial obstacle to growth and value creation - a challenge manifested through disengaged employees, talent attrition, and a lack of agility in meeting industry demands. Recognizing and redressing this cultural deficit transcends employee satisfaction; it emerges as a strategic imperative for long-term success in the dynamic landscape of MedTechs. As MedTech companies expand globally, the challenges to unite and motivate constituencies intensify. We have suggested that within this interconnected ecosystem, a unifying and motivating narrative emerges as a potential solution. A well-crafted story has the power to bridge gaps, align interests, and cultivate a shared sense of purpose among employees and stakeholders alike, contributing to a company’s success. The influence of a unifying narrative extends beyond an organisation's boundaries, serving as an inspiration for collective action. This shared story fuels innovation, enhances problem-solving, and transforms an organisation into a responsive and adaptable entity. In a world where trust, differentiation, innovation, talent attraction, stakeholder engagement, and customer loyalty are important, a captivating narrative becomes a positive contribution to the success of a diversified MedTech company. In the grand scheme of human endeavours, the power of stories seems undeniable. Whether in religion, politics, finance, or the women's movement, it is through stories that movements are built and legacies are shaped. Thus, for MedTechs to overcome the silent obstacle to growth and value creation, they might consider harnessing the power of narratives to fortify their brand identities, nurture relationships, and fuel long-term commercial success.
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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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  • 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.
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.
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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  • 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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  • 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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  • 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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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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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 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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