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  • For the past three decades care has been moving out of hospitals into peoples’ homes
  • This is a significant and rapidly growing shift positioned to accelerate over the next decade
  • Driving this change are significant structural, organizational, and social factors
  • An early wave of new entrant digital ‘pure plays’ started to take advantage of this move ~3 decades ago and developed innovative software health solutions and services for people to consume in their homes
  • Later, there followed a second wave, comprised of several giant diversified healthcare companies that created and marketed digital home health offerings
  • The majority of traditional MedTechs have not responded to this shift and continue to produce physical devices for episodic surgical interventions in hospital operating rooms
  • Could their failure to develop software solutions for care in the home be an obstacle to their future growth and competitive advantage?
  
Out of the hospital into the home
A bridge too far or one that traditional MedTechs must cross?
 
On 30th January 2023, England's state funded National Health Service (NHS) announced a two-year recovery plan to help restore emergency care and frontline services. The plan, backed by a £1bn (US$1.2bn) fund, will increase virtual hospitals where patients receive high-tech care in their homes. It also includes 5,000 new hospital beds that will boost capacity by 5%, and 800 new ambulances, which will increase the fleet by 10%. Currently, England has ~7,000 virtual ward beds in the community. By 2024, ~50,000 patients a month are expected to benefit from these, which shall provide care mostly for elderly patients with chronic lifetime conditions. NHS virtual hospitals will be supported by a range of wearables and medical devices to diagnose and monitor patients’ conditions and share the data with their physicians in real time. This is not a new phenomenon; in 2006, China responded to its shortage of health professionals by developing virtual (internet) hospitals, and by mid-2021 there were >1,600 of them providing convenient and efficient medical services to millions of patients in their homes.

The UK government’s NHS recovery plan is a response to a series of strikes by health workers, protesting about staff shortages and deteriorating hospital conditions. Currently, there are >130,000 vacancies in the NHS; a vacancy rate of ~10%. Last December (2022), 54,000 people in England waited >12 hours for an emergency hospital admission. The figure was virtually zero before the pandemic. The average wait time for an ambulance to attend a stroke or heart attack in December 2022 was >1.5hrs, while the target is 18 minutes. In September 2022, >7m people in England were waiting to start NHS hospital treatments, which is the highest number since records began in August 2007. Surgeons were reported to being frustrated because operating rooms were not being used due to a lack of beds and staff.

This is not simply a UK problem. Since December 2022, health workers in the US, and France have engaged in similar strikes to protest about deteriorating hospital conditions. According to the World Health Organization (WHO), such protests are manifestations of a global shortage of medical staff. “All countries face challenges in training, recruitment, and the distribution of health professionals”, says the WHO, and suggests that by 2030, the global shortage of medical staff will mount to ~15m.  To the extent that a significant element of the challenges facing healthcare systems is staff shortages, it is not altogether clear how the British government’s recovery plan to increase NHS hospital beds and services will work if there is a dearth of health professionals.

 

In this Commentary

This Commentary suggests that the movement of care out of hospitals to peoples’ homes is not just a passing political response to a temporary crisis. The shift is driven by significant structural, organizational, and social factors, which we describe.  Since the late 1980s these factors have been gaining momentum and are positioned to have a defining influence over the next decade. Two distinct ‘waves’ of medical technology companies have taken advantage of this shift. The first wave started ~3 decades ago with several digital ‘pure play’ new entrants, which included ResMed, Propeller Health, Teladoc Health, Livongo Health, and Masimo. These companies all developed and marketed software health solutions to be consumed by patients in their homes. Later, there followed a second wave, comprised of a few giant diversified healthcare companies that included Philips,Medtronic, and Johnson & Johnson, which successfully entered the digital home care market. Notwithstanding, the overwhelming majority of traditional MedTechs have not developed digital solutions and services for patients to consume in their homes. Is this “a bridge too far” for them, or a bridge they must cross if they want to increase their growth rates and competitiveness?
1st wave: digital pure plays
 
ResMed
An early pure play that developed digital health solutions and services to be consumed by patients in their homes is ResMed, (an abbreviation of ‘respiratory medicine’), which started life in the late 1980s in Australia. In 1981, Colin Sullivan, a Professor of Medicine at the University of Sydney, developed and patented a continuous positive airway pressure (CPAP) device, which was the first successful non-invasive treatment for obstructive sleep apnea (OSA). Before Sullivan’s invention, the treatment for chronic OSA was a tracheostomy, where a hole is made through the neck into the trachea so breathing can bypass the nose and mouth. Initially, Sullivan partnered with Baxter, a US multinational medical technology company, to help commercialize his technology. In 1989, Baxter decided not to enter the sleep apnea market, and Peter Farrell, a Baxter executive, led a management buyout to acquire the technology and established ResMed in Australia. In 1990, the company relocated to San Diego, USA, and today, is a world leading software-driven, medical device enterprise, traded on the New York Stock Exchange (NYSE), with a market cap ~US$32.5bn, annual revenues ~US$3.6bn, >8,000 employees and a presence in >140 countries. Its main product offering, the AirView™ telehealth platform, is a secure, cloud-based system, which enables patients with sleep-disordered breathing and respiratory insufficiencies to be treated in the comfort of their own homes. The device provides real-time patient data, personalized insights, and proactive alerts that allow physicians to remotely monitor and connect to their patients. ResMed has >10m, cloud enabled, home care devices in the market and has accrued ~5bn nights of medical sleep and respiratory care data.
 
Propeller Health
In 2019, ResMed acquired Propeller Health for US$225m, but the company continued to operate as a standalone business. Founded in 2007, Propeller developed a mobile platform that offers sensors, mobile apps, analytics, and services to support respiratory health management. It is now a world leader in providing digital health solutions that keep patients with chronic obstructive pulmonary disease (COPD) and asthma out of hospital. The company’s sensors attach to patients’ inhalers and through its app, users can track their medication use, record their symptoms, receive environmental forecasts, which could affect their conditions, and download progress reports to share with their physicians. The app allows health providers to monitor their patients’ progress remotely, adjust treatment plans based on objective data and intervene when necessary. Propeller’s clinically validated solutions have found favour with US health insurers because they have demonstrated ~58% improvement in medication adherence, ~48% increase in symptom-free days, ~53% reduction in hospital visits and lowered costs of treating COPD, a condition that affects ~24m American adults and costs ~US$50bn to treat each year. In 2017, Fast Company named Propeller as one of the “most innovative companies”. In January 2019, the company launched ‘My Pharmacy’ with Walgreens as an in-app feature that allows users to manage their prescription refills for COPD and asthma and to locate a nearby pharmacy. The company quickly expanded this feature to CVS, Kroger, Rite-Aid and Walmartfive of the seven largest pharmaceutical providers in the US.
 

Teladoc Health
Another early digital pure play is Teladoc Health, an American enterprise founded 21 years ago to provide convenient home healthcare for those who have difficulty accessing traditional healthcare services. Initially, it provided telephone-based physician consultations and medical advice. In 2006, the company added a proprietary digital platform, which enabled patients to securely upload medical records, images, and notes and share them with their doctors. This allowed physicians to assess a patient’s medical information and provide appropriate treatment plans quickly and easily. Teladoc continued to expand its services, including the introduction of remote medical consultations and a suite of digital health tools. Today, the company is a multinational telemedicine and virtual healthcare corporation. Its offerings include virtual care services and digital health solutions, medical opinions, artificial intelligence (AI) and machine learning (ML) driven analytics, telehealth devices and licensable platform services. Its primary services, which have expansive clinical depth and breadth across >450 medical subspecialties, are available in 40 languages and 175 countries.
 

Livongo Health
In 2020, Teladoc acquired Livongo Health, another pure play, in a deal valued at US$18.5bn, which is the largest digital health transaction in history, and created a combined entity valued at ~US$38bn. Livongo was founded in 2008, with a mission “to make virtual care the first step on any healthcare journey”. In July 2019, the company successfully IPO’d and raised US$335m. Until its merger with Teladoc, Livongo traded on Nasdaq and reached a market cap of ~US$14bn. The company’s principal offering is a digital platform that collects data from connected devices, wearables, and mobile apps to provide users with personalized care plans, coaching, and support to help them accomplish their medical goals from the comfort of their homes. A joint statement from the two companies at the time of the merger said that the combination is expected, “to create substantial value across the healthcare ecosystem, enabling clients everywhere to offer high quality, personalized, technology-enabled longitudinal care that improves outcomes and lowers costs across the full spectrum of health".
Masimo
Masimo is a digital pure play founded in 1989 by Joe Kiani, an Iranian American with the mission to create innovative digital patient centric medical solutions that improve outcomes and lower health costs. Over the past three decades Masimo has helped to make in-home medical care more accessible and affordable. Its digital offerings help to automate processes, reduce costs, and streamline communications between providers and patients. The company’s first product was a digital stethoscope, a device, which enables doctors to monitor a patient’s heart sounds remotely.
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Kaini, an electrical engineer by training, has >500 patents or patent applications for advanced signal processing, optical sensors, and wearable technologies, and is the company’s current chair and CEO. Masimo became a Nasdaq traded company in 2007, and today is a global player with a market cap of ~US$9bn, annual revenues ~US$1.25bn and >5,300 employees. The company has grown to become a leader in the digital healthcare space by developing and marketing a range of offerings, including a clinical decision support and monitoring platform, which helps to provide convenient and cost-effective care in patients’ homes.  Its core offering, a pulse oximeter, is a non-invasive, medical device that can easily be clipped onto a finger or toe to provide accurate readings in just seconds and is used to diagnose and monitor the amount of oxygen in the blood of people with respiratory conditions, such as COPD and asthma. Previously, blood oxygen levels could only be determined in a laboratory on a drawn blood sample. The pulse oximeter is also used for monitoring newborns, the elderly, and athletes, and each year monitors >200m patients.
 
In 2020, in response to the COVID-19 pandemic, the company introduced the Masimo SafetyNet for smartphones. In addition to helping combat COVID-19, the device can also be configured to help physicians create, relay, and manage treatment plans for >150 other health needs. In 2022, the company launched its W1 Health Watch, which is a water-resistant and dust-proof consumer-oriented health monitoring device equipped with a range of sensors and sensor-based algorithms that are designed to give users a comprehensive overview of their health. The watch also has an emergency feature that can detect and alert specified contacts if the wearer is in distress.
 
Factors driving care out of hospitals into homes
 
Since this first wave of digital health pure plays, there have been several significant structural, organizational, and social factors that have gained momentum and together helped to drive care out of hospitals into homes. We briefly describe these.

(i) Demographics: aging populations and escalating chronic lifetime disorders
United Nation’s data on global population trends suggest that by 2050, one in six people will be ≥65, (16%), up from one in 11 in 2019 (9%). According to the US Census Bureau, in 2022, there were ~56m Americans ≥65, which is ~17% of the population. This figure is projected to reach >73m by 2030 and ~86m by 2050: ~22% of the population. In the US, ~60% of adults have chronic diseases. According to the Centers for Disease Control and Prevention (CDCP), 90% of America’s ~US$4trn annual healthcare costs is attributed to people with chronic lifetime diseases and mental health conditions.

Since 2000, in the US, 18% of healthcare professionals have quit their jobs. According to data published in June 2021 by the Association of American Medical Colleges (AAMC), the US could see a shortfall between ~37,800 and ~124,000 physicians by 2034, with the largest disparities being in specialty doctors. These data suggest that, over the next decade, there will be fewer hospital resources available to care for a growing aging population with complex healthcare needs.


(ii) Technological advances
Technological advances are changing how clinicians practice medicine, how consumers manage their own health, and how patients and providers interact.

Remote patient monitoring, video conferencing, telemedicine, and mobile health applications have enabled care to move out of hospitals and into peoples' homes. Remote patient monitoring allows healthcare professionals to monitor a patient's vital signs and other health data remotely. Video conferencing provides patients with the ability to have real-time consultations with their physicians. Telemedicine allows a patient’s medical information to be securely shared with a range of healthcare providers, which increases access to care, and enhances its coordination. Mobile health applications allow patients to track their health data and receive reminders for taking medications, scheduling appointments, and other health-related tasks. These technological advances have enabled healthcare workers to deliver care to patients in their own homes, reducing the need for in-person visits to a hospital. AI and ML big data advances have facilitated remote diagnosis and monitoring and improved communications between healthcare providers and patients. Further, AI-powered chatbots help patients navigate healthcare systems, make appointments, and answer medical questions more quickly and accurately than traditional methods.
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(iii) Regulations
The US Food and Drug Administration (FDA) has revised its healthcare regulations to include the acceptance of algorithms for use in the healthcare industry. Since 1995, the FDA has authorized >500 AI-enabled medical devices. By providing for the use of algorithms, the FDA is helping to move care out of hospitals into homes. Recently, the agency set up the Digital Health Center of Excellence (DHCoE) to “empower stakeholders to advance healthcare by fostering responsible and high-quality digital health innovation”.
(iv) Payors’ policies
In most nations, governments increasingly offer coverage for in-home health care services. We have mentioned government backed virtual hospitals in the UK and China. In the US, Medicare, and Medicaid [federal and state healthcare insurance programmes] have expanded their benefits to support home health care. The agencies' reimbursement policies are becoming more favourable in providing value-based healthcare for improved patient outcomes at lower costs. As a consequence, in-home care has become a modality of choice for treatment. Medicare now covers a variety of telehealth services, including remote patient monitoring, and the Medicare Advantage plans [Medicare-approved plans from private insurance companies] are now required to cover certain home health services, including skilled nursing, as well as medical equipment and supplies. Additionally, Medicaid programmes have implemented waivers that allow for some long-term health services to be provided in peoples’ homes. According to the US Centers for Medicare & Medicaid Services, spending on home healthcare services in America rose from ~$37bn in 2000 to >$97bn in 2018; an overall increase of ~161%.
 
Over the past decade, an increasing number of American private insurance plans have extended their cover for home health services. Research published in March 2022 by Deloitte, a consulting firm, suggests that over the next decade, as digital pure plays continue to grow and increase their capabilities, major health plans (government and commercial) will increase their partnerships with them. Deloitte suggests that by 2030, “>25% of health plans’ net profits will shift to digital health entrants”. According to a recent market analysis by GrandViewResearch, the global home healthcare market was valued at ~US$336bn in 2021 and is expected to expand at a compound annual growth rate (CAGR) of ~8% from 2022 to 2030.

 
(v) The rise of consumer power in healthcare
The rise of consumerism in healthcare has increased the emphasis on patient empowerment, convenience, cost-effectiveness, and home care. In 2018, Gordon Moore et al provided a compelling rationale of the significant rise of consumerism in healthcare in a book entitled ‘Choice Matters. Moore, Professor of Population Medicine at Harvard University Medical School, identified the growing influence of patients, which previously had been largely overlooked. Over the past three decades patients have become more knowledgeable about health and this has empowered them to take added charge of their own health and seek out the best possible care for their individual needs. This has helped to drive care out of hospitals and into the home, where patients can receive personalized treatment in a comfortable, familiar setting. Moore argues that patients have more choices than ever before and increasingly demonstrate an ability to make informed decisions about their health. Choice Matters stresses the importance to understand both the medical and financial implications of patients’ decisions and how they help to shape technology, inform public policy, and trigger healthcare initiatives. Moore’s thesis discusses the growing implications of consumer-driven healthcare and explores how the marketplace is evolving in response to the changing needs of patients. The book outlines a variety of arguments that support the idea of healthcare decentralization, such as the need for care to be tailored to an individual's unique needs and preferences, the advantages of providing care in the home, and the potential cost savings associated with these changes. Moore also highlights the value of integrating technology into the home-based care model and the potential of this delivering increased efficiency and improved outcomes for patients. Today, consumerism in healthcare is challenging the traditional medical modality of diagnosis and treatment by putting a greater emphasis on lifestyles and prevention.
 
2nd wave: giant healthcare companies
 
The commercial success of the first wave of digital health pure plays, together with the factors we outlined above, made some giant diversified healthcare companies rethink their business models and employ AI and ML big data strategies to develop and market health solutions and services for people to consume in their homes. These companies include Philips, Medtronic, and Johnson & Johnson; together they represent a second wave of healthcare companies that have successfully gained access to new revenue streams by serving the large and growing home care market. Here we briefly describe some of their digital offerings.
 
The Philips HealthSuite digital platform is designed to help healthcare providers deliver patient-centric  care, reduce costs, and improve outcomes. The platform is powered by the cloud and includes a suite of AI big data analytic tools, which support the monitoring of patients in their homes, and allows physicians to access real-time health information and respond quickly to any changes in a patient’s condition. Similarly, Medtronic’s CareLink™ remote monitoring platform supports home care by facilitating patients to monitor and manage their health information remotely. The device allows healthcare providers to access a variety of patient data, including vital signs, weight, diet, sleep, activity, and medication adherence. It also provides two-way communication between healthcare providers and patients, allowing for more personalized care. Johnson & Johnson has built on its consumer health business that “helps >1.2bn people” and, in August 2019, launched its CarePath Solutions platform to provide patients with personalized health plans and support in their homes. It also helps healthcare providers to make informed clinical decisions, reduce costs, and improve patient outcomes.
 
Takeaways
 
The commercial success that digital pure plays and giant healthcare corporations have gained by providing solutions and services for patients in their homes should raise alarm bells for traditional MedTechs that continue to focus on providing legacy physical devices for episodic surgical interventions in hospitals. Patient centric health, emphasizing convenience and accessibility, shifts the focus of healthcare from the hospital to the home, from physical devices to digital solutions and services. To take advantage of this shift companies will need to invest in developing new digital health innovations. Patient centric healthcare also emphasizes the need for data-driven decision making, which requires the use of more advanced analytics and AI, ML big data strategies. Traditional MedTechs producing physical devices may not be able to keep up with the rapid pace of software developments in healthcare. Pivoting to develop and market software health solutions and services for patients to use in their homes might be a “bridge too far” for these companies. However, can traditional MedTechs afford not to cross this bridge?
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"When you fail to reach your goals don’t adjust your goals, adjust your actions"
 
On Saturday 20th October 2022, the Chinese Communist Party (CCP) ended its twice-a-decade Congress. It amended its charter and elected Xi Jinping for a historic third 5-year term, making him China's most powerful ruler since Mao Zedong, the founding leader of the People's Republic. Given these outcomes, followers of HealthPad suggested we re-publish the Commentary, ‘Learn from the Chinese, but don’t misjudge Beijing’, which we do below. The Commentary describes the tightening of China’s regulatory and competitive environments and suggests that Western corporations, with interests in China or thinking of entering the Chinese market, should not underestimate: (i) the large and growing differences between China and the US, and (ii) the CCP’s uncompromising ambition to become economically self-reliant, a world superpower and a global high-tech leader.

Deteriorating East-West relationships
Xi Jinping used the Congress to tighten his hold over the CCP by evicting all remnants of factional opposition, placing political allies in key positions and establishing complete control over the Party and the country. Xi re-emphasized the significance of making science and technology cornerstones of China’s strategy for national economic and military “self-reliance”. He also hinted that China will further decouple its economic links with the US and Europe and increase market restrictions on Western companies trading in China. With Xi’s increased authority and China’s increased global power and influence, it seems reasonable to assume that, in the near-term, China is likely to develop a more aggressive foreign policy, and the US and its Western allies will doubtless respond with a more confrontational approach to China. This significantly raises the possibility that East-West geopolitical relationships will deteriorate further.
 

Guanxi
China and the Chinese are different to the West and Westerners. Whereas most Western nations, have a deep sense of individualism based on democracy with social and political freedoms, China and the Chinese are rooted in Confucian collectivist principles with a top-down hierarchical structure that views individuals as part of a community with ordered and friendly relationships. This is perhaps best understood by the Chinese term, ‘Guanxi’ (关系), which refers to tacit mutual commitments, reciprocity, and trust, and is central to all personal, business, and politico-economic relationships.

China’s ambition
None of China’s renewed global posturing should surprise Western corporate leaders with their fingers on the pulse of their international strategies. For decades China has been increasing its power and influence in the world. In his 2017 report to the 19th Party Congress, Xi Jinping stressed the decline of America’s  international authority and the “substantial and rapidly growing” global power and influence of China. He predicted that, by the mid-21st century, China will have become “a global leader in terms of comprehensive national power and international influence,” and will be a development model for the world.

The past 5-years
Also in 2017, Xi advocated a more aggressive and activist Chinese foreign policy, and over the ensuring 5 years, Beijing has: (i) weakened foreign enterprises trading in China and raised the bar for new entrants, (ii) strengthened Chinese domestic companies and incentivized them to trade internationally, (iii) ratcheted-up pressure on Taiwan, (iv) exerted greater control over Hong Kong, and (v) increased China’s rhetoric and tactics in defence of its interests.
 

Business-as-usual versus strategically active
Over the past 3 decades, China has strategically invested in innovation-driven development, which has helped the nation improve its core competitiveness, and significantly shape its international leadership role. During this time, many Western companies with interests in China have been strategically passive and pursued ‘business-as-usual’ policies, which often meant they: (i) continued to invest in products and services that had been overtaken by technology and were losing market share, (ii) were relatively slow to invest in emerging technologies and develop new offerings, (ii) tended to fixate on their initial success and failed to quickly recognise that something new was replacing it, and (iii) focused scarce resources on short-term performance rather than long-term value. For many corporates, such policies resulted in missed commercial opportunities and weakened global competitiveness.
 

Reducing the healthcare gap
Over the past decades while many Western companies have been strategically passive, China, by contrast, has been strategically active, aggressively developing innovative and technologically advanced solutions to narrow its healthcare gaps caused by increased healthcare demand and shrinking numbers of healthcare professionals. Witness Chinese start-ups that rapidly grew to become significant companies by leveraging data and artificial intelligence (AI) to develop digital healthcare solutions that enhanced patient outcomes and reduced costs. Examples include: WeDoctorAlibaba HealthJD Health, DXY.cn. and Ping An Good Doctor. These, and other digital innovations, provide a range of health services including, online consultations, hospital referrals and appointments, health management, medication regimens, medical insurance, and wellness and prevention programmes. Such initiatives have provided vast numbers of Chinese citizens with easier access to healthcare and enhanced patients’ therapeutic journeys while reducing vast and escalating healthcare costs and shifted many healthcare services out hospitals into peoples’ homes.

Hospital services shifting to the home
This shift is nothing new and not exclusively Chinese. Twelve years ago, Devi Shetty, a world-renowned heart surgeon, was emphasising the impact that digitalization would have on traditional hospital based services. In just 2 decades, Shetty built Narayana Health (NH), India’s 2nd largest hospital group. In 2019, Narayana was recognised by  Fortune Magazine as, “one of the world’s most innovative healthcare providers”. In 2000, Shetty, like his Chinese counterparts, was emphasising that the “next big thing in healthcare is not going to be a magic pill, or a faster scanner, or a new operation. The next big thing in healthcare is going to be IT, which will change the way a health professional will interact with the patient. Every step of patient care will be dictated by a protocol stored on a handheld device. That will make healthcare safer for the patient and shift most hospital activities to the home. The doctor and patient can interact regardless of time and place”. See video.
 
 
Two types of capitalism
The difference between Western and Chinese corporates reflects two different types of capitalist systems: liberal meritocratic capitalism in the West, and state-led authoritarian capitalism in China. In the former, the emphasise on quarterly reporting and the time, effort and costs associated with it tends to encourage short-term performance while the latter creates more opportunities for generating long-term value. There is plenty of evidence to suggest that when executives consistently invest in long-term strategic objectives their companies’ productivity increases, they generate more shareholder value, create more jobs, and contribute to higher levels of economic growth than do comparable companies that focus on the short-term performance. Data also suggest companies that implement effective environmental, social and governance (ESG) strategies, which address the interests of all stakeholders, achieve better long-term value.

Fink criticizes business executives
In 2014, Laurence Fink, chairman of Black Rock, the world’s largest asset manager, criticized Fortune 500 CEOs for their focus on short term corporate behaviour. While recognising the market pressures on company executives, Fink said, “It concerns us that many companies have shied away from investing in the future growth of their companies” and increasingly engaged in actions that “deliver immediate returns to shareholders, such as buybacks or dividend increases, while underinvesting in innovation, skilled workforces, or essential capital expenditures necessary to sustain long-term growth”.

Takeaways
Western corporate leaders are challenged to devise ethical strategies that create long-term value rather than just short-term performance. Following Fink’s suggestions policies to create long-term value might include: (i) developing a suite of strategic initiatives expected to deliver returns that exceed the cost of capital (ii) allocating resources to initiatives that create most value, (ii) focusing on generating value not only for shareholders but for all stakeholders, and (iii) resisting actions that only boost short term profits.
 
  • China is the world’s second largest economy after the US
  • Its MedTech sector is the world’s second largest after the US and accounts for 20% of the global market
  • The size of China’s market is attractive to Western MedTechs but its regulatory and competitive environments are changing, which makes it more challenging for foreign corporations to enter or grow their franchises in China
  • China’s healthcare system has similar structural challenges as those of the US and other wealthy nations: the demand for care is increasing and overwhelming health professionals, which creates care gaps
  • China is ahead of the US and other nations in attempting to reduce such gaps with patient-centric innovative digital therapeutic solutions, which is supported by a deep bench of capabilities
  • Western MedTechs have a lot to learn from Chinese digital health innovations
  • However, Beijing is engaged in an unprecedented mission to become a self-reliant, high-tech economy and a world superpower within the not-too-distant future
  • Misjudging Beijing can have significant commercial consequences
 
Learn from the Chinese, but don’t misjudge Beijing


An earlier Commentary ended by posing the question whether Western MedTechs can compete with China’s large and rapidly growing domestic medical device industry, which benefits from China being the second largest MedTech market in the world behind the US, with annual sales revenues of ~US$84bn in 2020. China now accounts for ~20% of the global medical device market, which is expected to continue an upward trajectory, supported by the nation’s quickly aging population, rising incomes, and the continued enhancement of health services.
 
With this foundation, Beijing is incentivising its domestic MedTech companies to expand internationally. Beijing’s 14th Medical Equipment 5-Year Plan (2021–25) sets a goal to have >6 Chinese MedTechs among the top 50 global industry corporations by 2025. The policy complements Made in China 2025, which is a macroeconomic strategy to reduce China’s reliance on imported foreign products including medical devices. So, while China’s domestic market is becoming more challenging for foreign MedTechs, Beijing is supporting the growth and expansion internationally of its local medical device companies to compete with their Western counterparts. For example, Mindray Medical International, China’s biggest medical device corporation by sales revenue, is the #4 ultrasound vendor in the world and over the next 5 years, expects to increase its overseas sales revenues from <50% today to ~70%.
 
Despite Beijing’s ‘for China’ policies, many Western MedTech leaders view China as a significant commercial opportunity, recall foreign corporations that have prospered in the nation over the past two decades and suggest that it is important to do business there if one of your company’s objectives is to grow its international franchise. But China has changed, and its regulatory and competitive ecosystems are tightening, which present headwinds for Western MedTechs that were not present a decade ago. Further, China has an ambition to become a self-reliant, world leading high tech nation in the not-too-distant future, which could have consequences for foreign companies participating in the Chinese market.
 
With ~400m chronic disease patients, a fast-aging society, vast and rapidly rising healthcare costs, and an economy that has slowed, China is resolute in developing a new model of digitally enabled, patient-centred integrated healthcare. This ambition is supported by significant resources and a deep-bench of capabilities positioned to enable China to achieve its goals, which include transforming its medical devices sector by supporting the development of world class, high tech, patient-centric, digital enterprises.
 
All these factors suggests a dilemma for Western MedTech leaders: China is too big to ignore, but Beijing is too powerful and unrelenting to misjudge.

 
In this Commentary

This Commentary has 3 sections. The first, entitled ‘Reducing care gaps with digital therapeutic innovations’, suggests that China, the US, and other developed nations share a common challenge of care gaps created-by a limited supply of health professionals and a large and increasing demand for care. China’s attempts to resolve these gaps differ from other nations in their scale and nature. They are nationwide innovations predicated upon digital AI strategies, which manifest themselves in digital platforms that directly address patients’ healthcare needs. We briefly describe a few examples of these and suggest that they are advantaged by China’s data policies and AI competencies. Section 2, entitled ‘Capabilities’, describes Beijing’s plans for China to become the world’s leader in AI technologies within the next decade and suggests that China has the capabilities to achieve this goal in the proposed timeframe. The final section entitled, ‘Understanding Beijing’, briefly describes the tightened regulatory and competitive environments and suggests how this impacts the business models of Western corporations seeking to enter the Chinese market or increasing their existing franchises. We posit that China and the Chinese are significantly different to Western democracies and Westerners and emphasize the Chinese Communist Party’s uncompromising ambition to become economically self-reliant, a world superpower and a global high-tech leader. Misjudging Beijing could be commercially damaging for foreign corporations.
 
 
1: Reducing care gaps with digital therapeutic innovations
 
China has similar structural healthcare challenges to the US and other developed economies, which manifest themselves in care gaps caused by a limited supply of overworked healthcare professionals and a vast and rapidly growing demand for care from aging populations. The Chinese population ≥65 years is ~140m, and this cohort is expected to grow to ~230m by 2030. By that time, the nation’s aging middle class will have grown from today’s ~0.3bn to ~0.7bn. High-risk behaviours like smoking, sedentary lifestyles, and alcohol consumption as well as environmental factors such as air pollution take a huge toll on health and increase the demand for care. According to Statista, a large portion of the Chinese population suffer from chronic lifestyle diseases, which account for >80% of the nation’s ~10m deaths each year; >0.5bn people are overweight or obese, while high blood pressure is a common illness among >0.4bn people. China’s healthcare expenditure is growing at >8% a year, and without reform, the nation’s health spending could increase to >US$2trn by 2030. Such factors, together with the nation’s economic slowdown motivate Beijing to prioritize the transformation of its healthcare system.
Significant differences in tackling care gaps

A significant difference between China and the US and other wealthy nations, whose healthcare systems are all in need of reform, is that China has been quicker to develop digital therapeutic technologies to reduce care gaps and relieve its large and rapidly growing burden on hospitals, care systems and families caring for the sick and elderly.
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Should MedTechs follow surgeons or patients?

In any healthcare system, people should be the priority, but because of a dearth of health professionals, overburdened hospitals, soaring health costs and overworked physicians, patients’ needs are often not prioritized. China has been no exception but expects to reverse this trend with the help of artificial intelligence (AI) enabled digital therapeutic solutions that put patients first. Examples include: WeDoctor, Alibaba Health, JD Health, DXY.cn. and Ping An Good Doctor. These, and other digital innovations, provide a range of health services including, online consultations, hospital referrals and appointments, health management, medication regimens, medical insurance, and wellness and prevention programmes. China’s early adoption of AI medical solutions has benefitted from Beijing’s “Healthy China 2030” policy, which, since its launch in 2016, has directed substantial funds to Chinese AI start-ups developing technological innovations to ease the burden of care gaps. According to Tracxn, one of the world’s largest tracking platforms, there are ~227 AI driven healthcare start-ups in China. Let us briefly describe three established ones: WeDoctor, DXY.cn and Ping An Good Doctor.
 
WeDoctor

Tencent-backed WeDoctor, founded in 2010 to provide people with physician appointments, is based in Hangzhou, a city of ~11m and the capital of China’s Zhejiang province. Since its inception, the company has grown into a multi-functional platform offering a range of medical services predicated upon a database of >2,000 Western treatment plans, online pharmacies, health insurance, cloud-based enterprise software for hospitals and other services. Today, WeDoctor hosts >270,000 doctors and ~222m registered patients. It has an impact on reducing care gaps and is one of the few online healthcare providers qualified to accept payments from China's public health insurance system, which covers >95% of the population. WeDoctor's services are especially valued in rural areas, where there are fewer physicians than the national average of 1.5 per 1,000 people.

In response to the COVID-19 crisis the company launched the WeDoctor Global Consultation and Prevention Center (GCPC),  which provided a free 24/7 global online health enquiry service, psychological support, prevention guidelines and real-time pandemic reports. Just before the pandemic, WeDoctor planned to float its medical and health service function on the Hong Kong stock exchange at a valuation ~US$7bn. However, it was pulled because of the Beijing-Hong Kong tensions. WeDoctor’s. other business functions, which include health insurance and health data services, were not included in its proposed flotation, and are likely to stay private to appease Chinese regulators.
 
DXY.cn
 
DXY.cn is an online healthcare community for doctors, patients, and healthcare organizations. It was founded in 2000 and is also based in Hangzhou. Over the past 2 decades it has evolved into the world’s largest community of physicians who use the platform to gain insights from colleagues, discuss new medical research, and report unusual clinical events. More recently, DXY has added a consumer-facing service that brings wellbeing advice and medical consultations to the public. DXY generates revenues from public-facing medical advertising and job recruitment for its life science clients, as well as clinics where patients can receive in-person medical care. According to TechCrunch, in 2021, DXY reached ~130m consumers, >9,000 medical organizations, and had a registered user base of ~20m.
 
Ping An Good Doctor

Ping An Insurance (Group), is one of the world’s largest financial services companies with >210m retail customers and ~560m internet users and is headquartered in Shenzhen, southeastern China. In 2014, it launched Ping An Good Doctor to provide end-to-end, AI-powered health services directly to patients. These include 24/7 online consultations, diagnoses, treatment planning, second opinions, and prescription management solutions. Today, Good Doctor has ~400m registered users and drives synergies across China’s healthcare ecosystem. The platform collaborates with >3,700 hospitals and is supported by an off-line healthcare network of >2,200 in-house medical staff and ~21,000 contracted experts to ensure quality and accuracy of its medical services. The company provides insurance coverage for both users and physicians, which helps to ease China’s healthcare payment pressures. Ping An Good Doctor’s technology also assists patients to manage their personal health records, treatment plans, and medical histories.
 
In 2019, the company launched the world's first AI-powered, un-manned healthcare service: the One-minute Clinic. This is a 3m2 booth, which patients walk into, enter their digitized medical history from their mobile phones, and add their symptoms. The clinic’s algorithms, which have been trained on data from >300m medical records, then make a diagnosis, prescribe drugs, and provide a treatment plan. Medications are purchased from an adjacent vending machine. Within a year of the start of the first clinic, Good Doctor rolled out ~1,000 units in shopping malls, airports and other public spaces throughout China providing onsite medical and pharmaceutical services 24/7. Today, the clinics provide accessible and affordable medical and health services to >3m users. Good Doctor believes that its AI-driven, un-manned clinics have a promising future helping to reduce China’s care gaps and has plans to expand its services into Southeast Asia. In December 2019, the company signed a strategic collaboration with Merck, an American pharmaceutical multinational to advance further intelligent healthcare in China.

 
Internet hospitals

Digital initiatives like those described above have led to the development and spread of internet hospitals, which are online medical platforms associated with offline access to traditional hospitals that provide a variety of services directly to patients. Today, internet hospitals are booming in China, driven jointly by government and market initiatives.
 
The first internet hospital was established in China’s Guangdong province in October 2014. It consisted of four clinics operated by doctors from the Second People's Hospital, an online platform operated by a medical technology company, and a network of medical consulting facilities based in rural villages, community health centres, and large pharmacy chain stores. Initially webcams were used for patients to communicate with physicians and share medical images of their conditions. A patient's vital signs were taken by on-site machines and uploaded onto the system. With all this information, physicians made a diagnosis and prescribed medications, which patients obtained from nearby pharmacies. According to the Lancet, two months after its launch, China’s first internet hospital “was dealing with ~200 patients and issuing ~120 prescriptions every day”. After six months, the number of patients had increased to >500 a day, ~60% of whom needed prescriptions. Soon afterwards, a network of consultation sites expanded to >1,000 facilities in 21 of Guangdong’s municipalities. In 2018, Beijing gave the legislative green light for internet hospitals, which prompted many Chinese digital health companies to start using internet-based AI solutions to meet the country’s medical and healthcare needs and contribute to the reduction of care gaps. By August 2021, >1,600 internet hospitals had been established in China. The public and physician acceptance of these and Beijing’s support for them suggests a new era in digital healthcare.

 
Internet + Healthcare” initiatives

Since 2018, a range of Internet + Healthcare” initiatives have consolidated and enhanced the position of digital healthcare innovations. The success and continual improvement of China’s digital health service platforms all benefit from Beijing’s policies to facilitate medical practice supported by digital tools. Laws and policies have been issued to support this digital transformation, including health data digitalization, data sharing, and interoperability across the whole of China’s healthcare ecosystem. After the outbreak of the COVID-19 pandemic, the government increased its “Internet + Healthcare” efforts to include telemedicine in state medical insurance coverage, and to lift barriers for prescribed drugs sold online.
 
Data advantage

Compared to the US and other Western democracies, China has significant data advantages to drive its digital healthcare initiatives. Eric Topol, a cardiologist, director of the Scripps Research Translational Institute, and author of Deep Medicine: How AI can make healthcare human again, argues that “China has a massive data advantage when it comes to medical AI research”. To put this in perspective, consider that Chinese patient healthcare data are drawn from the nation’s provinces, many of which have populations of >50m. By contrast, US AI research tends to be based on patient data often drawn from one hospital. China’s big data advantage allows machine learning algorithms to be more effectively trained to perform key functions in a range of clinical settings. Another comparative advantage of China is its large workforce of AI specialist, data scientists, and IT engineers, which can work on healthcare projects at comparatively low costs. This is partly the result of China’s emphasis over the past four decades to encourage science, technology, engineering, and mathematics (STEM subjects) in their schools and universities to fuel Beijing’s technological ambitions.

Not known for good data governance practices, but with intensions to expand internationally, China is now tightening its data protection regulations. For example, in November 2021 Beijing introduced the Personal Information Protection Law (PIPL), which is designed to prevent data hacks and other nefarious uses of sensitive personal information. Much like the EU’s General Data Protection Regulation (GDPR), the PIPL stipulates that an individual’s explicit consent must be obtained before their medical health data are collected, and it places the burden on medical AI companies to ensure that these data are secure.
 
2: Capabilities
 
Healthy China 2030

In October 2016, President Xi Jinping announced the nation’s Healthy China 2030 (HC 2030) blueprint, which put patient-centred healthcare at the core of Beijing’s healthcare plans, recognizing its ability to influence both social and economic development. The policy sets out China’s long-term approach to healthcare and shows the nation’s commitment to participate in global health governance, which Beijing recognises as necessary as it seeks to extend its international reach. By 2030, Beijing aims to reach health equity by embracing the United Nations’ Social Development Goal 3.8, which seeks to “Achieve universal health coverage, including financial risk protection, access to quality essential healthcare services and access to safe, effective, quality and affordable essential medicines and vaccines for all”. In 2019, Beijing announced an action plan to accelerate the delivery of Healthy China 2030. This puts patients first in an endeavour to build a healthy society by leveraging AI technologies to reduce the prevalence of lifestyle induced chronic disorders and subsequent care gaps. The World Health Organization (WHO) believes the policy “has the potential to reap huge benefits for the rest of the world”.
 
AI capabilities
 
As China’s economy has matured, its real GDP growth has slowed, from ~14% in 2007 to ~7% in 2018, and the International Monetary Fund (IMF) projects that growth will fall to ~5.5% by 2024. Beijing refers to the nation’s slower growth as the “new normal” and acknowledges the need to embrace a new economic model, which relies less on fixed investment and exporting, and more on private consumption, services, and innovation to drive economic growth. Such reforms are needed for China to avoid hitting what economists refer to as the “middle-income trap”. This is something many Western economies (and corporations) face: it is when countries achieve a certain economic level but then begin to experience diminishing economic growth rates because they are unable to effectively upgrade their economies with more advanced technologies. To avoid this scenario, for the past three decades, China has been investing in AI and systematically upgrading its economy.


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Leaning-in on digital and AI


 
Today, China has a significant supply of innovative AI talent to deliver a Healthy China by 2030. Some of the world’s largest technology companies are Chinese and all are developing different aspects of AI applications. For example, Alibaba’s cloud division concentrates on using AI in healthcare and Baidu, which has numerous AI research laboratories in the US, is focussed on a range of AI innovations, which include “deep learning”, and “big data”. More recently, Baidu added a Business Intelligence Lab, which develops data analytics for emerging data-intensive applications, and a Robotics and Autonomous Driving Lab, which specializes in computer vision.
In 2017 China's State Council launched a 3-step plan to become a world leader in AI technologies by 2030, with a domestic AI industry valued ~US$150bn. Beijing completed step 1 in 2020 by establishing a “new generation” of AI technologies and technocrats and developing national standards, policies, and ethics for its emerging industry. Step 2 is anticipated to be completed by 2025, by which time China expects to achieve “major breakthroughs” in AI applications that will help the completion of upgrading the nation’s industrial sector and thereby avoiding the middle-income trap. The final step is anticipated to take place between 2025 and 2030, which, among other things, will project China internationally as the world leader in AI technologies.
 
3: Understanding Beijing
 
Regulatory changes

A decade ago, foreign MedTechs operated in China with relative ease. Chinese regulations were lighter than they are today, and companies were supported by a multi-layered network of small scale and localised sub-distributors. This fragmented structure resulted in higher prices and tended to encourage corruption, but the relatively high margins obtained from foreign products allowed medical device corporations to compensate the multiple distribution levels and still make a profit. In return, domestic Chinese distributors managed the market and foreign MedTechs did not engage directly with hospitals and physicians.
 
Volume-based procurement

Recent regulatory changes have disrupted this modus operandi for foreign MedTechs. One change positioned to have a significant impact on MedTech profits is volume-based procurement (VBP). This is aimed at lowering the price of medical consumables by tendering the market volume of cities, provinces, or the country to manufacturers with the lowest price. Following a successful pilot with pharmaceuticals, VBP was extended to medical devices in 2019, and since then it has had a significant effect on certain products. For example, the price of cardio stents and hip and knee implants have been reduced by ~70% to ~90%. China’s message is clear: Medtechs are either ‘in’ with significantly lower prices, or ‘out’. This suggests that companies wishing to enter or grow their franchise in the Chinese market will have to adapt their business models by accelerating their pre-launch registrations and post-launch commercialization strategies for new products as margins on legacy offerings are expected to be substantially reduced. However, review processes for new offerings have become longer, more bureaucratic, and more expensive than they were five years ago. For example, if a Class 2 device without clinical studies took ~9 months to register five years ago, today expect ~2 years. VBP has forced foreign MedTechs to consolidate their multi-layered distribution channels to improve economies of scale. 
 
More recently Beijing has introduced a two-invoice policy for the medical devices industry: (i) MedTech to a distributor, and (ii) distributor to a hospital. This will push small and less competitive distributors out of the market and shorten and consolidate supply chains. The likely effect of this is for Chinese distributors to concentrate more on logistics to “deliver product”, rather than managing the market. To the extent that this is the case, a larger share of customer engagement will become the responsibility of MedTechs.
 
This will mean that foreign corporations trading in China will need to reassess their capabilities and adjust their business models. Further, MedTechs operating in China should expect VBP to increase the significance of “value”. This is because the policy is likely to enhance the purchasing power of hospital administrators and reduce that of physicians.  As a result, companies might expect procurement conversations to focus less on clinical outcomes and more on the overall value of products and their potential to minimize costs. Many readjustments companies will be obliged to make to their business models may be achieved by having someone local on the product management team rather than engaging high-margin agencies to resolve critical, but relatively simple domestic challenges.
 
A narrow window of opportunity for foreign MedTechs

Beijing’s “in China for China” policy makes it a condition that foreign companies entering the Chinese market must share their technology and intellectual property (IP) with a domestic “partner”. Beijing has been using this condition to acquire valuable scientific knowhow, which has helped the country to develop a large domestic medical device industry. According to a 2021 research report from Deloitte, a consulting firm, “China now boasts over 26,000 medical device manufacturers”. Beijing’s policies render China a substantially more challenging market to enter and to grow in than it was five years ago. China’s market opportunities for foreign corporations are not only getting tighter; they are getting shorter, and their orientation is changing away from surgeons towards patients. Further, Beijing is on a relentless drive towards self-reliance and tolerates the presence of Western companies in its domestic markets only for as long as they contribute offerings that are useful to the Chinese Communist Party. If China is successful in delivering on its healthcare and high-tech development plans, the window of opportunity for many foreign MedTechs could be only ~10 years.
 
China’s different

China and the Chinese are unlike the West and Westerners. When Deng Xiaoping’s started China’s reforms in 1978 and opened the nation to the world’s trading economies, he created a socialist market economy, in which private capitalists and entrepreneurs co-existed with public and collective enterprise. This formed the foundations for China’s phenomenal economic growth, prosperity, reduction of poverty, massive infrastructure investment, and development as a world-class technology innovator. As a result, many Western business leaders and politicians believed that China had abandoned ideology in a similar way that former communist regimes of Eastern Europe did in the early 1990s after the fall of the Soviet Union. However, such a transformation did not happen in China, which remains a one-party authoritarian state, tightly governed by the Chinese Communist Party (CCP), whose constitution states that China is a “people’s democratic dictatorship”. The CCP has a mission to become the world’s leading technology economy by 2030. This is backed by substantial sovereign wealth and a supply of relevant high tech human capital and an impressive history of national achievements.
 
Scale and speed of transformation

The phenomenal politico-economic progress China has made in a relatively short time is an indication of the nation’s determination, and its ability to affect change, and contextualizes Beijing’s policies to make China a self-reliant economy in the not-too-distant future. A 2022 report jointly released by China’s Development Research Center and the World Bank highlights the nation’s transformation in just four decades, from a struggling agrarian society to a global superpower. The nation’s achievements include increased health insurance coverage to >95% of its 1.4bn population, lifting ~0.8bn people out of poverty, which accounts for ~75% of global poverty reduction in the same period, a burgeoning middle class, which by 2030, will have grown from today’s ~0.3bn to ~0.7bn. In 2010, China overtook Japan to become the world's second largest economic power after the US when measured by nominal GDP. According to the World Bank, in 1960, China's GDP was ~11% of the US, and in 2019, ~67%. Not only is China the world's second-largest economy it has a permanent seat at the United Nations Security Council, modernised armed forces, and an ambitious space programme. China’s growing international clout and economic leadership positions it well to replace the US as the greatest superpower.

Such factors provide a context for Western corporation with global pretentions wishing to engage with and learn from China. At the 13th Annual National People’s Congress in March 2022, Premier Li Keqiang called for “faster breakthroughs” in key technologies, and said the government would increase the tax rebate for small and medium-sized science and technology firms from 75% to 100% and grant tax breaks for basic research to encourage innovation. Significantly, the Congress also underscored self-reliance in China’s economic priorities amid warnings of trade headwinds and geopolitical complexities.

 
Takeaways
 
China is too big a commercial opportunity to ignore. In 2021, China accounted for >18% of the global economy, rising from ~11% in 2012, its GDP was ~US$18trn, and per capita GDP reached US$12,500, which is close to the threshold for high income economies. In recent times, the contribution of China's economic growth to the world economy has been ~30%, which makes China the largest growth engine for the global economy. However, the relationship between China and the rest of the world is changing. As China becomes more self-reliant, its exposure to the world has decreased. Add to this (i) international trade disputes, (ii) increasing geopolitical tensions between the US and China, (iii) the nation’s evolving new rules to evaluate technology flows, (iv) increase of protectionism and (v) its healthcare mission to pivot towards patients, and you have significantly changed trading conditions than a decade ago. Misjudging Beijing’s rapidly evolving commercial ecosystem could be costly for Western MedTechs.
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  • Digital therapeutics and artificial intelligence (AI) techniques are increasing their influence on the medical devices industry and fuelling a shift of healthcare away from hospitals into peoples’ homes
  • This poses a challenge to traditional medical device companies (MedTechs) that solely focus on manufacturing physical devices for hospital-based episodic interventions
  • Some MedTechs are changing their business models and strategies, diverting their focus to patients, and adding digital therapeutic applications to their legacy offerings
  • Zimmer-Biomet and Stryker are MedTechs that have embraced digital therapeutics and AI
  • Stryker’s CEO advises other MedTechs to ‘lean-in on AI and don’t be sceptical’
 
Leaning-in on digital and AI
 
Rapidly growing digital therapeutic technologies are disrupting hospital-based healthcare and posing a challenge to those medical device companies that are slow to complement their legacy physical product offerings with patient centric digital solutions. Such technologies have the potential to enhance patient outcomes, reduce healthcare costs, and give providers access to new revenue streams. Today, digital solutions increasingly contribute to the prevention, management, and treatment of a wide range of diseases and health conditions. Their rapid growth is driven by advances in the behavioural sciences, artificial intelligence (AI) techniques and the increase in the consumer health wearables market, which is converging with the regulated medical devices market. This convergence facilitates care to move away from hospitals and into peoples’ homes.
 
In this Commentary
 
This Commentary describes how two decades ago a world-renowned surgeon and CEO of a large hospital group warned that digital therapeutics would disrupt healthcare and push a lot of hospital-based care to peoples’ homes. For years the medical devices industry did not pay too much attention to such warnings and continued to focus on manufacturing physical products for surgeons in hospitals. The Commentary describes two leading MedTechs - Zimmer-Biomet and Stryker – which have recently begun to reinvent themselves and embrace digital therapeutics and AI techniques expected to improve patient outcomes and reduce surgical inconsistencies. We briefly develop this thought process by suggesting how machine learning AI techniques might be employed to reduce the high failure rates of spinal surgeries. The Commentary describes the large and growing global market for digital therapeutics and prescription digital therapeutics, a large proportion of which are enabled by wearables and telehealth. The market for digital therapeutics is large enough and growing fast enough to pose a threat to traditional medical device companies that solely manufacture physical offerings and fail to develop digital solutions to improve patient journeys. Although some MedTechs neither have the resources nor the mindsets to develop digital solutions, it seems reasonable to suggest that, in the medium term, they will be obliged to acquire or develop such assets to remain competitive. However, achieving this will be challenging.
  
Early warnings of change

Over a decade ago, Devi Shetty, warned health professionals to prepare for care to become heavily influenced by digital therapeutics, which he argued would move a significant portion of care away from hospitals and into peoples’ homes. This warning had resonance because Shetty is a surgeon as well as being the founder and executive director of Narayana Health, one of India’s largest hospital groups. In an interview with HealthPad in 2012 he suggested that hospitals were becoming less relevant in a new, and rapidly growing digitally driven healthcare ecosystem. “Healthcare of the future will be dramatically different to that of the past. The future is not an extension of the past. In the future, chronic illnesses will be treated at home”, said Shetty and continued,The next big thing in healthcare is not going to be a magic pill, a faster scanner, or a new operation. It’s going to be digital therapeutics, which will dramatically change the way health professionals interact with patients. Every step of a patient’s care journey will be informed by software. This will make healthcare safer for the patient and shift most of hospital activities to the home. If a physician doesn’t have to operate on a patient, the patient can be anywhere, distance doesn’t matter”. Shetty repeated this argument at a 2022 Microsoft ‘Future Ready’ conference suggesting that, “95% of people who are unwell, don’t need an operation. All they need is medical intervention, which can be enabled by digital technology and telehealth and treated in the home”.
 
Leading MedTech companies reinventing themselves
 
Two decades after Shetty’s warning, the CEOs of Zimmer-Biomet and Stryker, respectively Bryan Hanson, and Kevin Lobo, have made substantial commitments to digital therapeutic solutions that improve patient outcomes, reduce surgical inconsistencies and extend treatment and monitoring to the entirety of patients’ journeys, much of which takes place in patients' homes. Medical device companies that fail to develop software solutions or link-up with providers of such technologies could risk losing market share to emerging competitors.

 
Zimmer-Biomet and digital therapeutics

Zimmer is a player in total knee arthroplasties, which involve replacing the knee joint with a prosthetic device that carries out similar functions as a person’s own knee. The surgery has become routine. In 2020, US physicians carried out ~1m total knee arthroplasties, and by 2030, ~2m such procedures are expected to be carried out annually in the US. In 2020, the global total knee replacement market was valued at ~US$7.8bn, expected to grow at a CAGR of >6%, and reach ~US$12.5bn by 2027.

In 2021, Zimmer and Canary Medical, a software company, which had developed an implantable digital therapeutic application, received approval from the US Food and Drug Administration (FDA) to market Persona IQ: the world’s first ‘intelligent’ total knee replacement. Zimmer’s traditional knee prosthesis is embedded with Canary’s technology to provide a range of automatic, reliable, and accurate data and analyses that facilitates remote monitoring and tracking of patients' post-operative progress long after they have left hospital.  Following this success, Hanson is directing a substantial percentage of Zimmer’s R&D spend on the development of digital therapeutic solutions, and Persona IQ is expected to be the first in a pipeline of intelligent joint prostheses.

 
Stryker and digital therapeutics

In a March 2022 interview, Stryker’s CEO, Kevin Lobo, stressed his ongoing commitment to increase his company’s digital therapeutic and AI capabilities. In 2021 Stryker acquired Gauss Surgical, which had developed Triton™, an AI-enabled app for real-time monitoring of blood loss during surgery. “After a mother gives birth”, says Lobo “it’s important to calculate how much blood she’s lost. Today, this quantification is very crude and rudimentary. Triton™ allows you to use your smartphone to accurately measure the amount of blood that is in sponges as well as cannisters. It can distinguish between different liquids and measure only the haemoglobin. This is critical to determining whether a mother needs a transfusion or not. You would be shocked, even here in the US, how often a mother doesn’t get a transfusion she needs or gets one she doesn’t need”.

In January 2022, Stryker acquired Vocera Communications for ~US$3bn. Vocera is a US Nasdaq traded company founded in 2000 that makes wireless communications systems for healthcare and has developed a digital platform, which helps connect caregivers and "disparate data-generating medical devices". The platform is used by >2,300 facilities throughout the world, including ~1,900 hospitals. Interoperability between the platform and >150 clinical and operational systems reduce health risks and enhance the consistency of surgical procedures, speeds up staff response times; and improves patient outcomes, safety, and affordability. According to Lobo, "Vocera will help Stryker significantly accelerate our digital therapeutic aspirations to improve the lives of caregivers and patients".

Lobo has made AI a shared service. Stryker employs ~200 software engineers that are using AI. “This we never had before at Stryker. AI is going to be a central core competence for our company. I can see that all our business units are going to be using AI within the next two to three years”, says Lobo, who expects AI inspired digital therapeutic applications to “lead to more consistent outcomes for our procedures”. According to Lobo this is “a big deal because today there are a lot of variations in surgical outcomes”.

AI and its potential impact on spinal surgery

Spinal surgery is a good example of significant inconsistencies in outcomes. Each year, ~7.6m spinal surgeries are performed globally, and ~1.2m in the US, where spinal fusions account for ~60% of all procedures. Although ~50% of primary spinal surgeries are successful,  ~30%, ~15%, and ~5% of patients only experience a successful outcome after the second, third, and fourth surgeries, respectively. Machine learning AI techniques applied to patients’ electronic medical records (EMR) and clinical data could potentially reduce this high failure rate by predicting what product and surgical procedure could produce an optimal solution for individual patients.
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Robotic surgical spine systems, China, and machine learning
Let us briefly explain. Machine learning, a subfield of AI, is the capability of a machine to imitate intelligent human behaviour. It is the process of using mathematical models of data to help a computer to learn and adapt without following explicit human instructions. Machine learning employs algorithms (a set of instructions for solving a problem) to identify patterns in large data sets, potentially comprised of multiple sources, and then uses these patterns to create a predictive model. With increased training on more data, the results of a machine learning algorithm may become more accurate, much like how humans improve with practice. Once this point is reached, regulatory approval for the algorithm can be applied for under the FDA’s category of “software as a medical device”. Once approved, the algorithm may be used to help reduce the high failure rates of spinal surgery.
 
The digitalization of healthcare
 
MedTech leaders should be mindful of the impact that digital therapeutics is having on their industry, which goes far beyond embedding legacy physical offerings with sensors. Digital therapeutics is a rapidly growing healthcare modality, predicated upon scientific advances in the behavioural sciences and AI techniques, that help individuals to form habits, which improve their health, reduce healthcare costs and boosts productivity. Such software tools increasingly are used for the management and prevention of a range of debilitating and costly chronic conditions, including mental health challenges, substance abuse disorders, opioid-induced conditions, cancer, cardiovascular diseases, metabolic disorders, respiratory conditions, and inflammatory diseases. Chronic disease is a public health emergency. In the US, six in ten citizens are living with at least one chronic disorder. Not only are such conditions the leading cause of hospitalizations, disability, and death, but their total annual cost to the US exchequer, which includes lost economic productivity, is ~US$3.7trn.
 
The market for digital therapeutics is driven by a combination of different factors, including: technological advances, particularly consumer wearables (such as the Apple Watch and Fitbit apps, see below), the high penetration levels of mobile telephony, the growth of telehealth, the increasing demand from consumers to take more control of their health, aging populations, the large and escalating incidence of preventable chronic diseases, the need to control healthcare costs, and rising investments in digital therapeutics. According to Statista, a business data platform, in 2021 the number of people globally using digital therapeutic applications reached ~44m. Almost double the number of 2020. By 2025 the number of users is expected to reach >362m, and this only includes devices that have sought validation in clinical trials. The global digital therapeutics market is growing at a CAGR of ~31% and is projected to reach ~US$13bn by 2026, up from ~US$3.4bn in 2021.
 
An advantage of digital health modalities is their ability to deliver continuous personalized care and bridge large care gaps created by shortages of specialized health professionals. In the US, for instance, there are ~6,500 specialist physicians in full-time clinical practice to treat diabetes (endocrinologists), but there are ~27m Americans living with the condition. Similar health gaps occur in other common disease states. In developing economies, care gaps are even wider. For example, India has a chronic shortage of doctors and nurses and has ~77m people living with diabetes and ~55m people living with cardiovascular disease. The latter kills ~5m Indian citizens each year. India, like many other Asian countries, has chosen to deal with care gaps by establishing itself as a major presence in the digital health economy. By several key metrices, from internet connections to app downloads, both the volume and the growth of India’s digital economy now exceeds those of most other countries. Expect this shift to increasingly influence corporations looking to enter and extend their franchises in large and rapidly growing medical devices markets in developing economies. 

 
Cybersecurity challenges

Headwinds for digital therapeutic applications, particularly in Western democracies, include challenges of informed consent to use, safety and transparency, algorithmic fairness and biases, and data privacy. Digital therapeutic applications tend to be more vulnerable to cyberattacks than traditional medical devices, which are manufactured according to strict protocols by a handful of regulated manufacturing partners. By contrast, digital applications often rely on third-party software, which may be less rigorous than the usual medical device standards. Cybersecurity threats to digital therapeutics include data theft, identity disclosure, illegally accessing data, corruption of data, loss of data, and violation of data protection. These risks are accentuated by the fact that the modality is predicated upon the continuous monitoring of patients’ vital signs and increased connectivity between physicians, providers, payers, and patients and breaches can occur at various points along the path of data movement. Risk mitigation includes encryption protocols and the ability to control data access and data integrity. An indication of how quickly the US policy environment around cybersecurity is changing is in March 2022, the US Senate unanimously passed legislation, which would usher in sweeping changes to the federal legal landscape relating to cybersecurity and mandate companies to report damaging hacks and ransomware payments to the government.
 
Prescription digital therapeutics

Another indication of the growing significance of digital therapeutics is a recent US policy push to establish an equivalence between some wearable healthcare solutions and prescription drugs and medical devices. On 10 March 2022, two US senators, Catherine Cortez Masto, D-Nevada, and Todd Young, R-Indiana, introduced legislation to expand Medicare and Medicaid coverage to include prescription digital therapeutics. Medicare is a federally run US medical insurance programme covering ~64m citizens >65 and younger disabled people. Medicaid is a government assistance programme, funded by both federal and state governments, but run by individual states and covers the medical expenses of ~75m Americans on low incomes and with limited resources. This is significant because of the vast number of individuals covered by these health insurances and the fact that the US regulatory hurdle is one of the toughest in the world. Prescription digital therapeutics fall under the FDA category of “software as a medical device” and are subject to the same stringent requirements as drugs and medical devices, and must demonstrate evidence of clinical effectiveness, safety, and quality. After that they require a prescription for use, following a consultation with a doctor.
 
The bill would standardize US reimbursement codings for prescription digital therapeutics, which is expected to incentivize American doctors to increase prescribing them. This would not only facilitate greater access to a wide range of digital therapies for >44% of Americans receiving state healthcare support but potentially create a precedent for US private health insurance companies to increase their coverage of prescription digital therapeutics. This would significantly help to propel the modality into mainstream healthcare.



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The future of health wearables

In June 2020, as the COVID-19 crisis escalated, the FDA expanded its guidance for non-invasive patient-monitoring technologies, including the Apple Watch’s ECG function. In 2021, ~34m Apple Watches were sold worldwide; up from ~22.5m in 2018. In addition to smartwatches, there is a wide range of intelligent wearables that monitor your vital signs in real time, promote self-management of chronic conditions, help people to engage with their own health and incentivize them to change their behaviour to improve their health and lifestyles. Thus, digital therapeutic applications have the potential, among other things, to slow the development of chronic disorders and reduce hospital visits and readmissions. The size and growth rate of the wearable health technology market influences the decisions of insurers, employers, health providers and producers. For example, insurers use data from wearables to adjust their premiums,  corporates derive benefits from their employees using wearables, which include healthier company cultures, a reduction in employee turnover, an increase in workplace safety and enhanced efficiency.  
In the US, consumers' use of wearables increased from 9% to 33% in four years as of 2021. The use of wearables is likely to increase as they become more conventional, connectivity expands, and more accurate sensors are developed. Such developments are likely to provide further incentives for insurers and employers to use wearables to develop healthier lifestyles to boost profitability and cut costs. According to Gartner, a technological research and consulting firm, in 2021 worldwide user spending on wearable devices was ~ US$82bn, ~18% increase from the previous year. This seems reflective of consumers, encouraged by the COVID-19 pandemic, becoming more conscious about their health, wellbeing, and changes to their lifestyles. According to a 2021 Deloitte’s survey, ~58% of US households own a smartwatch or fitness tracker, and ~39% of Americans personally own a smartwatch or fitness tracker. ~14% of consumers have bought their fitness devices since the start of the COVID pandemic in 2020, and activities such as counting steps, workout performance, heart health, and sleep quality monitoring are amongst the most popular activities.
 
Telehealth

Another factor driving the shift of care away from hospitals to peoples’ homes is the development of telehealth. The COVID-19 pandemic caused telehealth usage to surge as consumers and providers sought ways to safely access and deliver healthcare. According to the US Centers for Disease Control and Prevention (CDC), by late March 2020, telehealth had increased >154% compared to the same period in 2019.  Since the peak of the COVID-19 pandemic, telehealth has become a permanent part in the delivery of healthcare. The telehealth market is expected to rise to >US$397bn by 2027 from US$42bn in 2019. According to Devi Shetty the history of healthcare will be written in two sections, BC, and AC: before COVID and after COVID.COVID-19 disrupted and transformed healthcare and forced inward looking healthcare professionals to rapidly change and adopt digital therapeutic technologies”, says Shetty.
 
The legacy of the COVID-19 related surge in digital therapeutics is an opportunity to make permanent hybrid care modalities created during the pandemic. The foundations for the opportunity are described in a 2021 McKinsey research report, which suggests that the pandemic, (i) accelerated the growth and acceptance of telehealth, which “stabilized at ~38X higher than before the crisis”, (ii) improved the attitudes of consumers and providers towards telehealth, (iii) made permanent some regulatory changes put in place during the pandemic (for example, Medicare and Medicaid’s expansion of reimbursable telehealth codes introduced in 2021 for US physician fee schedules, which have been made permanent), (iv) fuelled venture capital’s digital health investments, and (v) drove the adoption of digital therapeutics across a wide range of disease states. 
Shift in mindset

In the changing healthcare ecosystem, a primary strategic objective for MedTech leaders is to define relevant planning cycles and efficaciously manage from one cycle to the next. The current planning cycle in the medical devices industry is influenced by data, AI techniques, and patient centric digital therapeutic solutions. To effectively manage this cycle, MedTechs might consider copying Zimmer and Stryker and acquire complementary digital therapeutic assets and capabilities. Adapting M&A knowhow and experience to make such acquisitions is an option but not without risk.
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MedTech must digitize to remain relevant
This is because enterprises with digital assets and capabilities have different cultures, development practices, reimbursement policies and data management policies and practices compared to traditional medical device companies. It seems reasonable to suggest that poorly managed acquisitions could result in MedTechs ending up with a graveyard of unfulfilled digital technologies. To reduce this risk industry leaders might consider following Stryker’s example and recruit experienced digital and AI specialists, and make them a core competence.
 
Takeaways

In the near-term, disruptive digital technologies present both challenges and opportunities for medical device companies. Zimmer and Stryker have started to reinvent themselves through parallel efforts to digitize their legacy businesses, acquire complementary digital assets, and make AI a core competence. However, many MedTechs have not changed their business models and still focus R&D on making small improvements to existing product offerings. Corporate leaders considering changing their business models and strategies should be mindful that digital and AI assets and capabilities with the potential to create disruptive growth need to be protected from unnecessary bureaucratic burdens common in many traditional companies. To survive and prosper, managers might consider rethinking their operating models for innovation-led growth. The most effective models appear to combine a strategic process with multiple mechanisms for driving innovation development and scale-up. Stryker’s shared service of AI expertise is one example of a contrived core “capability” expected to transform legacy devices into growth engines that could help secure the company’s long-term survival. MedTech CEOs might do well to follow Lobo’s advice and, “lean-in on AI and do not be sceptical.”.
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International Fertility Centre is widely recognized as the most advanced and leading network of fertility and IVF clinics in India. Since its inception, the center has maintained its reputation in performing the most successful IVF and ICSI treatments. The center is known for its new-age technologies in Assisted Reproduction and has changed the lives of a great number of hopeful parents, IFC plans to extend only the best of services. Dr. Rita Bakshi, a leading IVF specialist in the country. Well, emphasize greatly providing quality fertility treatment at affordable prices. Based in the capital, New Delhi, International Fertility Centre prides itself on having an international reputation on being able to provide a full range of fertility treatments, including IVF, IUI, ICSI, egg donation, and surrogacy, to thousands of patients wanting to have a baby. With having 30 years of experience in assisted reproduction, they understand the physical and emotional challenges faced by people with fertility problems.


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  • The MedTech industry is undergoing an era of unprecedented change
  • Pressure on revenues and margins have forced leaders to cling tightly to business as usual
  • In the next decade business as usual will come with significant commercial risks
  • For commercial success future MedTech leaders will need to be different to past leaders
 
Who should lead MedTech?
 
Questions about who should lead medical device (MedTech) companies in the future and what strategies and business models they should pursue are critical. Over the next decade MedTech faces an era of unprecedented change, when it will be necessary to develop new strategies, new business models, new markets, new capabilities and new technologies, while keeping the legacy business running. Future MedTech leaders will be tasked with bridging the gap between traditional manufacturing and sophisticated, digitally driven services while managing unprecedented change and significant competition. For the past 20 years MedTech leaders have been drawn from a relatively narrow set of people with a relatively narrow set of skills. Although this has served the industry well, it might not be the most appropriate policy to ensure commercial success over the next decade.
 
In this Commentary

In this Commentary we: (i) describe the traditional MedTech market, indicate the structure parameters of the industry and note that there is a rapidly evolving parallel digital healthcare technology market: one that is growing more than twice as fast and soon will be comparable in size to the traditional manufacturing-based market, (ii) suggest that MedTech leaders tend to be men in their 50s with limited understanding of this parallel digital healthcare universe, which is positioned to play a significant role in  shaping MedTech companies of the future, (iii) suggest that because MedTech leaders have performed relatively well over the past two decades, they have tended to become prisoners of their own traditions and felt little or no need to evolve their strategies and business models, (iv) contend that MedTech leaders’ principal response to market changes to-date has been increased M&A activity, which has made companies bigger but not better, (v) suggest that the industry is undergoing a significant market shift from manufacturing to solutions and services driven by the 4th industrial revolution, which is characterized by a fusion of technologies, and (vi) conclude that future MedTech leaders will require a deep knowledge and understanding of the 4th industrial revolution if they are to successfully transform traditional strategies and business models in order to deliver superior healthcare solutions at lower prices.
 
MedTech market and the structure of the industry

MedTech is a conservative manufacturing industry, which produces and markets a diverse group of product offerings predominantly in a few developed wealthy markets. Over the next decade the MedTech market is expected to change significantly. For the past two decades the industry has fallen into three broad segments: (i) diagnostic products, which include imaging devices, with a global market of some US$100bn, (ii) medical aids including consumer durables, such as hearing aids and bandages with a worldwide market of about US$150bn, and (iii) surgical products that include equipment and instruments used in the operating room, which has a global market of some US$140bn.
 
A 2017
EvaluateMedTech report suggests the global MedTech market is projected to eclipse US$500bn in sales by 2021, over 33% of which is expected to be derived from the US. The worldwide market is projected to continue growing at a compound annual growth rate (CAGR) of 5%. Ranked by 2017 revenues, seven of the world’s largest MedTech companies are American and a significant proportion of the world’s MedTech companies trade on Nasdaq. This includes 13 large companies with a market cap in excess of US$10bn, some of which are divisions of even larger corporations such as Johnson & Johnson Medical Devices and Diagnostics, with estimated global sales of US$38bn for 2018; this equates to approximately 7.6% of the worldwide MedTech market. Medtronic, which is the world's largest stand-alone MedTech company, has a market cap of US$117bn and in 2017 recorded revenues of US$29.7bn; 26% of which was generated in the US. Nasdaq has about 24 mid-cap MedTech companies ranging in value from US$2bn to US$10bn. The majority of these are American and tend to be regionally based with relatively small markets outside the US, Europe and Japan. There are some 27 small-cap companies with market caps between US$300m and US$2bn, 46 micro-cap companies ranging from US$50m to US$300m and finally some 28 nano-cap MedTech companies with market caps less than US$50m.
 
In recent years, a digital healthcare technology industry, where medical devices meet innovative software, has grown substantially, but mostly in parallel to the traditional manufacturing-based MedTech industry. According to
Transparency Market Research, in 2016 this industry, which is based on healthcare information systems and wearable devices, had annual sales of US$180bn, and is projected to grow at a CAGR of 13.4% between 2017 and 2025, reaching US$537bn in annual sales by the end of 2025.

 
MedTech executive leadership
 
There is a relative dearth of data specifically on MedTech leaders and the demographics of MedTech C-suites (senior executives which tend to start with the letter C). Notwithstanding, there are data on Fortune 500 and S&P 500 company leaders from regular surveys undertaken by executive search firms Korn Ferry, and Spencer Stuart. Some of the larger MedTech companies, such as Abbot Laboratories, Baxter International, Stryker and Boston Scientific, are listed in the Fortune 500 and S&P 500. If we assume a significant similarity between the demographics of Fortune 500, S&P 500 and MedTech company executives, then MedTech leaders will tend to be white males in their 50s, predominantly drawn from similar sector company C-suites and will have an average tenure of about eight years.
  
Middle-aged men
 
Over the past 20 years MedTech leaders have benefitted from the industry’s commercial success, albeit in recent years at a slower pace than before 2007. Most leaders are constrained by quarterly earnings targets, shareholder expectations, regulations and the high risk and cost associated with changing manufacturing systems. MedTech CEOs received their formative education before the widescale uptake of the Internet and email. Many had just started their careers in large corporations when giant technology companies such as Amazon (launched 1994) and Google (1998) in the US and their Chinese equivalents - Alibaba (1999) and Baidu (2000) - were start-ups, and the Chinese and Indian economies were still somewhat underdeveloped and inchoate. Consequently, most MedTech leaders were entering middle-age when US social media giants such as Facebook (2004), YouTube (2005), WhatsApp (2009) and Instagram (2010) and their Chinese counterparts such as WeChat (2011), RenRen (2005), Weibo (2009) and Youku (2005), were just taking off.
 
This might partly explain why some MedTech leaders appear to be challenged by the rapidly evolving new digital technologies and the industry’s shift from manufacturing to solutions and services. Such is the pace of change, it will require a shift of mindset among incumbent MedTech leaders if they are to fully grasp this new and significant opportunity set.
 
Similarly, with emerging markets. Most CEOs have knowledge of the wealthy MedTech markets, in particular the US and Europe. Few, however, have in-depth knowledge or first-hand experience of the large and fast-growing emerging economies such as Brazil, Russia, India and China (BRIC). The BRIC countries are at a similar stage of their economic development, and have a combined population of more than 3bn, which equates to about 40% of the global population. BRIC countries are differentiated from other promising emerging markets by their demographic and economic potential to rank among the world’s largest and most influential economies in the 21st century, and by having a reasonable chance of realizing this potential.
 
A future HealthPad Commentary will examine the opportunities for Western MedTech companies seeking or expanding their franchise in China and will suggest that they might not find it as easy as it would have been 5 years ago. Opportunities in China for global MedTech players are becoming tougher as the Chinese economy slows and restructures; Beijing’s healthcare reforms kick-in and local MedTech producers, buoyed by legislation, revenue growth and increased capacity, become commercially stronger, more technically sophisticated and take a bigger share of both the Chinese domestic and international emerging MedTech markets.
 
Underrepresentation of women
 
Not a single woman serves as CEO of a large MedTech company. Only 22% of their board members are women, which is about the same proportion as the Fortune 500 overall (20%), and about 22% of MedTech C-suites are women. In 2017, nearly 50% of the US labour force were women and 40% of these worked in management, professional and related occupations.  Although women are underrepresented in MedTech leadership positions they are key stakeholders in healthcare. About 35% of active US physicians are women. According to the Association of American Medical Colleges, (AAMC), 46% of all physicians in training and almost 50% of all medical students in the US are women.  60% of pharmacists in America are women.

It should not be forgotten that women have played significant roles in medicine and healthcare. For example, Marie Curie, the only person to win a Nobel Prize in two different sciences, pioneered research on radioactivity. Curie made a significant contribution to the fight against cancer and is credited with having created mobile radiography units to provide X-ray services to field-hospitals during World War I. Sussman Yalow, was awarded the Nobel prize in Physiology or Medicine in 1977 for the development of the radioimmunoassay technique, and Gertrude Elion won a Nobel Prize in Physiology or Medicine in 1988 for her work in helping to develop drugs to treat leukaemia and AIDS. More recently, Jennifer Doudna, and Emmanuelle Charpentier, were credited with the discovery of the ground-breaking CRISPR-Cas9 gene-editing technology, which effectively changes genes within organisms and is positioned to radically change healthcare and MedTech in the 21st century.

In addition to under-representation, which suggests that the pipeline of women candidates for top jobs in MedTech is weak, there is some evidence to suggest that the MedTech industry does not have a positive attitude towards women. Findings of a 2015 survey conducted by AvaMed, the industry’s principal trade association, suggest that women in the industry feel discriminated against. Some 42% of women respondents of the survey said they, “felt held back from senior leadership positions” and 37% felt “overtly discriminated against”. "The world cannot afford the loss of the talents of half its people if we are to solve the many problems which beset us,” said Yalow in her 1977 Nobel Prize acceptance speech.
 
MedTech’s business model
 
Over the past two decades MedTech leaders have drawn comfort from the fact that the global MedTech market is highly centralized. The US, Western Europe and Japan, which represent only about 13% of the world’s population, account for more than 86% of the global MedTech market share (US: 42%, Europe: 33%, Japan: 11%). Conversely, the BRIC countries, which represent about 40% of the world’s population, currently only account for about 5% of the global MedTech market. This has enabled MedTech leaders to market their product offerings to healthcare providers principally in a few wealthy developed regions of the world via well-compensated sales representatives with deep product knowledge and expertise. The industry’s predominant business model has been to raise prices on existing products and market new offerings at higher prices than the products they are meant to replace. This worked very well before 2007 during a period of sustained global economic growth, predominantly fees-for-service healthcare systems and relatively benign reimbursement policies; all of which contributed to high margins and significant sales growth.
 
Market changes not perceived as acute enough to trigger transformation
 
Since the 2008 recession the MedTech market has changed. The global economy has weakened, debt (sovereign, corporate and personal) has escalated, populations have continued to grow, and the prevalence of chronic lifetime diseases and multi-morbidities have increased. Over that period, healthcare systems have become fiscally squeezed, costs have become pivotal and impacted all stakeholders. This has led to: (i) a shift in healthcare systems from fees-for-service to fees-for-value (ii) increased consolidation, convergence, and connectivity of stakeholders and a consequent change in purchasing decisions from individual (fragmented) hospitals and clinicians to centralized procurement bodies, which can leverage economies of scale and negotiate for larger purchases at volume discounts, (iii) the decline of MedTech R&D productivity, and (iv) increased competition from new market entrants, often from different industries. MedTech’s gross margins have been squeezed and annual growth rates have slowed to a CAGR of between 4 and 5%. Notwithstanding, MedTech leaders, buoyed by continued but slower revenue growth, and doubtless comforted by a prolonged surge in US equity markets, have not perceived these market changes as being with sufficient acuity to transform their strategies or business models.  Their principal response has been to increase M&A. 
 
M&A main strategic response to market changes
 
Over the past decade M&A has provided MedTech leaders with a means to: (i) increase scale and leverage, (ii) drive stronger financial performance, (iii) obtain a broader portfolio of product offerings, (iv) enhance therapeutic solutions and (v) increase international expansion; without changing their companies’ fundamental manufacturing structures and strategies. According to a January 2018 McKinsey report, between 2011 and 2016, 60% of the growth of the 30 largest MedTech companies was due to M&A. The report also suggests that between 2006 and 2016, only 20% of 54 pure-play publicly traded MedTech companies, “mostly relied on organic growth”.  M&A activity has resulted in bigger MedTech companies but not necessarily better ones. This is because M&A and collaborative relationships have not encouraged healthcare providers to change their strategies and business models and develop powerful data-sharing networks, which help drive integration across the continuum of healthcare.
 
Need for portfolio transformation
 
Encouragingly, the 2018 McKinsey report also suggests that some MedTech companies are beginning to use M&A to acquire “non-traditional” assets, such as software and service companies, to assist them in transforming their portfolios. Notwithstanding, portfolio change in a rapidly evolving and increasingly competitive healthcare ecosystem requires a sound strategic understanding of the potential role that the 4th industrial revolution can provide for MedTech. Given our discussion so far, it seems reasonable to assume that many current MedTech leaders and C-suite executives might not have fully grasped the commercial implications of this revolution for their industry. Portfolio change in the MedTech industry is arguably more likely to be led by executives from, or with an intimate knowledge of, adjacent, service-based companies; those who have successfully employed sophisticated digital technologies and big data strategies to transform their business models and who are now looking to do something similar in MedTech and healthcare markets.
 
The relative slowness of the MedTech industry to transform its strategies and business models is perceived as an opportunity by giant technology corporations. They sense the disruptive potential, just as they do in financial markets due to Wall Street’s inertia to digital change.  For example, in early 2018, Amazon, Apple, Google, and Uber announced their intentions to enter and disrupt the healthcare market by leveraging digital technologies to provide quality healthcare solutions and services at lower costs.
 
Rather than marketing products, MedTech companies are now increasingly being tasked with marketing solutions that can deliver better care at lower prices. The 4th Industrial Revolution is a primary enabler for achieving this. However, given the demographics and the conservatism of the MedTech industry, it seems reasonable to suggest that companies in the sector, which do not adapt, run the risk of becoming simple commodity producers stuck in the middle of a new and rapidly evolving value chain.

 
The 4th Industrial Revolution

The 1st industrial revolution used water and steam to mechanize production, the 2nd used electric energy to create mass production, the 3rd used electronics and information technology to automate production. The 4th industrial revolution, also known as ‘industry 4.0’, is characterized by a fusion of technologies, which is blurring the boundaries between medical devices, drugs, software and patient data and redefining relationships between the physical, biological and digital worlds. These exogenous shifts are likely to demand different strategies, different business models and different leaders for the MedTech industry.
 
Industry 4.0 provides MedTech with an opportunity for portfolio transformation by developing sophisticated data and digitization strategies to enhance company operational and financial performance. Industry 4.0 is driven by greater connectivity via the Internet and computing devices embedded in physical objects and advanced digital technologies, which enable them to send and receive data to help integrate producers, suppliers, business partners and customers; at the same time providing opportunities for MedTech companies to become smarter, more efficient and fully-networked organizations.
 
Key for superior shareholder returns
 
To date, MedTech leaders have been relatively slow to integrate new and evolving digital technologies into their core business operations, although there are encouraging signs that some companies are beginning to do so. Findings of a 2017 report by the Boston Consulting Group, (BCG) suggest MedTech companies are, “masking unsustainably high costs and underdeveloped commercial skills” and relying, “on an outdated commercial model”.  The BCG findings are based on a survey of some 6,000 MedTech employees in commercial functions, more than 100 interviews with MedTech leaders and benchmarking financial and organizational data across 100 MedTech businesses (including nine of the 10 largest companies) worldwide. According to BCG, although the industry overall has made little progress to change its business model and upgrade its skill levels, the companies, which have done so, are winning in the market and generating superior shareholder returns.

MedTech leaders should not mistakenly think that because their companies hold plenty of enterprise data they are implementing industry 4.0 strategies. Often, enterprise data do not provide any competitive advantage whatsoever but are simply a legacy cost of doing business. New sources of data, and the ability to use data’s power, are essential to enhance a company’s competitive advantage. A next-generation enterprise resource planning (ERP) platform, launched by SAP in 2017, is already being used by service companies to provide them with a digital core, which helps to create real-time matrixed data produced by social media, third party information, genetics, the Internet of Things, points of sale, etc.

 
Shift from selling products to selling solutions

To remain competitive in the next decade MedTech leaders will need to employ artificial intelligence (Al), augmented reality, robotics, advanced sensors, the Internet of Things (IoT), blockchain, nanotechnology, 3D printing, petabytes of data, enhanced processing power and storage capacity to help them transform their strategies and business models and enable their companies to evolve from being product-centric to customer-centric, with an emphasis on digitization and the capture and communication of data. Industry 4.0 and the convergence of the physical, biological and digital worlds will fundamentally change MedTech strategies and business models, as decision-making powers continue to shift from manufacturers to other healthcare stakeholders. Critical to this transformation will be those MedTech leaders who are well positioned to ensure that companies remain competitive in their core markets while establishing new markets underpinned by 4.0 technologies.
 
"Out-of-touch leaders" the main cause of company failure

A book published in 2016 entitled Lead and Disrupt suggests that company transformations fail because of out-of-touch leaders rather than competition. According to Michael Tushman, co-author of Lead and Disrupt, “The things that help organizations execute their current strategy - the cultures they build, the structures they forge, the processes that work so well to get today’s strategy executed - actually collude to hold the organization hostage to that soon-to-be-obsolete strategy. The more firms engage in getting today’s work done, it actually reduces the probability of making shifts in innovation and strategy. That is what is so strikingly paradoxical to leaders: The very recipes that work so well for today often get in the way of the future. It’s a challenge to incrementally improve what you’re doing as you’re trying to complement it with something different. The dual strategies are inconsistent.”
 
Takeaways

Over the past two decades MedTech companies have helped to shape healthcare systems in wealthy advanced industrial societies and have been rewarded with commercial success. But just as the fund investment axiom tells us, past performance is no guarantee of future success.

Crucial to the future success of MedTech companies will be their leaders. We have suggested that employing recruiting criteria, which have worked in the past might not guarantee future success. The next 10 years will be an era of unprecedented technological change for MedTech companies when the boundaries between medical devices, drugs, software and patient data become blurred.

Business as usual, which has served the industry well in the past, is unlikely to bring continued commercial success in this new healthcare ecosystem. In recent years, investment in digital healthcare has soared and the momentum towards a digital future has gathered pace. Future successful MedTech leaders will be those who combine a deep understanding of the 4th industrial revolution to leverage sophisticated digital technologies and data to assist them in creating and delivering enhanced healthcare solutions at lower costs, with an ability to keep the legacy manufacturing business running.  

MedTech companies face a stark choice: either appoint leaders similar to those of the past and become challenged or appoint leaders able to integrate new and evolving technologies into the core of the business to create and market cost effective quality healthcare solutions and remain profitable. MedTech leaders might consider adopting the motto: tempora mutantur et nos mutamur in illis.
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