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2 years, 12 months ago

Have diversified medical technology companies blown their competitive advantage?

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  • After decades of high growth and high valuations, large diversified medical technology companies (MedTechs) are faced with low growth and challenged to create long-term value
  • This is partly due to exogenous macroeconomic conditions and partly due to companies themselves eschewing broader strategic considerations and focussing on short-term performance
  • MedTechs’ past period of stellar performance benefited from company concentrations in large rapidly growing wealthy markets and benign fee-for-service business models that rewarded volume
  • During this time, large diversified MedTechs engaged in weak competition at a level of health plans, payers, and hospitals - an institutional level - and ignored competition at a patient level
  • Creating long-term future value for all stakeholders will require companies to compete at a patient level and accelerate the adoption of value-based care programmes that remunerate patient outcomes
  • To compete effectively at such a level requires vast amounts of patient data and sophisticated data handling and security capabilities, which many companies do not have
  • MedTechs that respond efficaciously to the rapidly evolving healthcare ecosystem and develop data and competences to compete at a patient level will have opportunities to create future long-term value  
  • Companies that continue with the status quo are likely to struggle to create long-term value and shall become acquisition targets
 
Have diversified medical technology companies blown their competitive advantage?
 
 
In the current fiscally constrained healthcare environment, creating long term value for medical technology companies (MedTechs) is challenging and many industry leaders have accepted ~5% annual revenue growth rate as the “new normal”. It has not always been like this. Between ~1990 and the late 2010s, medium and large diversified MedTechs were high growth, high value enterprises, which benefited from weak competition, large and rapidly growing underserved wealthy markets, barriers to entry, advancing medical technologies and benign fee-for-service business models that rewarded volume.
 
MedTechs’ recent decline in enterprise growth rates is partly due to worsening macroeconomic conditions, but a big part is due to companies themselves. Many became trapped in an outdated, narrow approach to creating value where a significant proportion of scarce corporate resources are focused on optimizing short-term financial performance. Albeit essential, this often meant that unmet market needs, and broader long-term strategic influences tended to be overlooked. We explore how this happened and what can be done about it.
 
In this Commentary

This Commentary describes how after ~3 decades of stellar growth many medium to large diversified medical technology companies (MedTechs) have become trapped in short-term performance-oriented cultures and struggle to create long-term value for all stakeholders. During their stellar years these companies operated at the level of payers, health plans and hospitals - an institutional level - where competition was, at best, weak, and patients’ therapeutic pathways largely ignored. Today, many diversified MedTechs struggle to create long-term value in the face of low growth rates, fiscal and regulatory constraints, vast and escalating healthcare costs, and increasing competition from giant tech companies and innovative start-ups. Further headwinds come from payers shifting away from benign fee-for-service payment models that reward volume to value-based care, which remunerates patient outcomes. To create long-term value MedTechs will need to radically change their strategies and business models. This will entail replacing legacy technology systems that hinder efficiency and innovation, tightening their security risks and improving their business process flows. If corporations do this efficaciously, they will be positioned to compete at a patient level where value is created and destroyed. However, competing at this level requires vast amounts of patient data and sophisticated data handling capabilities. Many companies neither have such data nor the capabilities to analyse and manage them. It seems reasonable to suggest therefore that, in the near- to medium-term, MedTechs that eschew retooling and competing at a patient level will struggle to create long-term value and likely become acquisition targets.
 
Structural challenges

As populations in wealthy economies age and shrink, due to increasing longevity and declining fertility, so healthcare headwinds increase and challenge MedTechs. Consider the US, which is an exemplar of most wealthy nations. Today, >56m Americans are ≥65, which accounts for ~17% of the nation's population. By 2030, when the last of the baby boomer generation ages into older adulthood, it is projected there will be >73m older adults, which means  >1 in 5 Americans will be of retirement age. As the American population ages a growing number of people present with age-related chronic conditions, which are costly to treat. Today, in the US, ~86% of people ≥65 is living with a chronic disease. This increases the risk of insuring the average US citizen, and the higher the risk, the higher the cost of annual health insurance premiums. According to the Centers for Medicare & Medicaid Services, in 2020, the US national health expenditure (NHE) grew ~10% to ~US$4trn, which equates to ~US$12,530 per person, and ~20% of the nation’s Gross Domestic Product (GDP). By 2030, US NHE is expected to reach ~US$7trn.
 
In 2020, Medicare spending rose by 3.5% to ~US$830bn or ~20% of total NHE. In the same year, Medicaid spending grew by 9% to ~US$671bn, or ~16% of total NHE. The largest shares of America’s total health spending are provided by the federal government (~36%) and households (~26%).  The private business share accounts for ~17%, local state governments account for ~14%, and other private revenues account for ~6.5%. According to the 2022 annual Kaiser Family Foundation (KFF) healthcare survey the average insurance premium for family healthcare coverage in the US increased 20% over the previous 5 years and 43% over the past decade. The average premiums for employer-sponsored health insurance are US$7,911 for single coverage and US$22,463 for family coverage.
 
Such changes are forcing the medical technology industry to adjust what products and services it develops and how value is created.
 
Stellar growth and short-term performance

During ~3 decades before ~2015, the medical device industry benefitted from unmet clinical needs, significant barriers to entry, technological advances, benign fee-for-service payment systems that reimbursed volume and industry concentrations. During this time MedTechs enjoyed stellar growth, and high valuations. Investors prioritized revenues over profit and cash flow, which encouraged enterprises to engage in portfolio moves: M&A, divestitures, and spin-offs. This had the advantage of helping companies to exit low-growth businesses and enter higher-growth segments, without engaging in years of uncertain and expensive R&D. It had the disadvantage of encouraging short-term performance rather than long-term value creation. During this period many senior leadership teams became weighed down with the demands of quarterly reporting and grew accustomed to using a variety of short-term accounting measures and ratios as their principal means to drive business and reward executives.
 
As a result, ‘successful’ medical technology companies had high growth rates but a deficit in ideas to unlock transformative new treatments for underserved patients and plans to seize opportunities presented by technological advances. The industry’s indifference to develop and leverage digitalization is indicative of corporations overlooking broader strategic influences and unmet market needs. Consequently, by ~2015, many large diversified MedTechs had fragmented technology systems that hindered efficiency and innovation and were overburdened by legacy products overexposed in slow growth markets. This made them ill-equipped to either respond quickly to innovative trends or compete with disrupters. According to a McKinsey & Company report published in June 2022, “84% of CEOs believe that innovation is critical to growth, but only 6% are satisfied with their company’s innovation performance”. To survive and stand a chance to create long-term value MedTech functions from R&D to sales will need to change.
Slow response to market changes

As MedTechs’ performance slowed and executives accepted ~5% growth as the “new normal”, markets continued to evolve: consumer-centred healthcare increased, clinical procedures moved out of hospitals into daycare centres and homes, regulation tightened, international markets expanded, medical technology continued to advance at pace, and tech giants and new entrants disrupted healthcare markets with innovative solutions and digital platforms that served patients rather than surgeons and hospitals. Because of MedTech companies’ lack of preparedness to respond positively to such changes, many doubled down on their traditional business models. This meant their M&A ecosystems were kept intact and active, and R&D continued with incremental additions to legacy products that mostly served the needs of surgeons and hospitals rather than patients.
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Should MedTechs follow surgeons or patients?


 
According to the Center for Studying Health System Change, the prominent trend of M&A in America’s healthcare industry increased consolidation and decreased competition, which is critical for lowering costs and improving productivity and innovation. With weak competition providers and insurers were able to drive up their prices unopposed. Findings of a study published in the American Journal of Managed Care found that hospitals in concentrated markets could charge considerably higher prices for the same procedures offered by hospitals in competitive markets. Although price increases often exceeded 20% when mergers occurred, studies suggest such increases neither improved healthcare quality nor patient outcomes.
 
With MedTechs focussed on consolidations and increasing the prices of their legacy offerings as a way of maintaining and increasing their revenue growth rates, many failed to keep current with the accelerating pace of technologies that were transforming healthcare. For example, over the three decades of stellar growth in the medical device industry, digitalization improved customer experience, connected devices, integrated, and leveraged external data sources and patients’ electronic health records, and connected with other stakeholders. This changed the way patients were diagnosed and treated, changed the way healthcare professionals communicated and collaborated, and changed how biomedical research was conducted. Notwithstanding, MedTechs were reluctant to digitize and continued to employ outdated labour-intensive business processes to market their product offerings. Today, providers, payers and patients are increasingly demanding digital solutions that are easier to use and more cost effective. This presents a challenge for traditional medical technology companies slow to adapt their business models to meet the needs of changing market conditions.  
 
The impact of Covid-19

The medical technology industry, along with many others, was adversely impacted by the Covid-19 crisis. In 2020, most medium to large MedTechs saw their revenues drop significantly. During lockdowns many experienced reductions in sales mobility, changed purchase demand profiles, supply chain disruptions, and increased risk aversion towards unnecessary spending. Such headwinds prompted some companies to re-evaluate their business models and set new directions for future success. This included digitally enhancing existing products, unlocking customers in new geographies, and monetizing data from existing devices to create new patient-centred solutions. Notwithstanding, today many MedTechs with reduced growth rates struggle to create long-term value for all their stakeholders.
 
There is no single answer to how value might be achieved as strategies will vary depending on specific industry segments and specific product offerings. However, some general suggestions include: (i) continue portfolio moves to divest low growth legacy products and reduce risk pathways to innovative offerings and growth. Target acquisitions with healthy growth prospects, well-stocked innovation pipelines and product offerings positioned to benefit from leveraging larger company infrastructures,  (ii) establish a pro-active venture function aimed at early-stage companies with disruptive offerings, (iii) invest in R&D to create new products and services that enhance patients’ therapeutic journeys, (iv) look beyond core devices and increase digital offerings and capabilities as software and digital solutions have become an essential part of patient journeys and clinical practice, (iv) shift away from volume-based care and accelerate value-based care to improve patient outcomes and reduce costs.
 
Value-based care

Healthcare experts have suggested that the fee-for-service healthcare payment model is wasteful, outmoded and partly responsible for US healthcare spending being significantly higher than other Western nations, but with patient outcomes no better and often worse. During the past two decades health plans, payers, employers, and patients have been requesting that healthcare systems deliver on value. The market responded to this with a shift towards value-based care, which instead of rewarding volume, pays providers based on patient-centric health outcomes. According to America’s Health Care Payment Learning & Action Network’s (LAN) annual survey; >60% of US healthcare payments in 2020 included some form of value component, which is up from ~53% in 2017 and ~11% in 2012. Similarly, 49% of primary care practices responding to the American Academy of Family Physicians (AAFP) 2022 Value-Based Care Survey said they are participating in some form of value-based payment, and 18% are developing the capabilities to do so.

Much of the energy for value-based care comes from America’s Affordable Care Act (ACA), (“Obamacare”), which is the most significant regulatory overhaul and expansion of healthcare coverage since the enactment of Medicare and Medicaid in 1965. The 2010 Act was originally developed to help reduce the rate of hospitalizations and readmissions by focussing on quality outcomes rather than quantity of patient visits. Value-based healthcare concepts have grown, and the ACA has created new incentives and penalties designed to encourage providers to deliver higher quality care at lower costs. These include the Hospital Value-Based Purchasing Program, which ties Medicare reimbursement to hospital performance on a set of quality measures, and the Medicare Shared Savings Program, which rewards provider groups for achieving cost savings while meeting agreed quality targets. The Centers for Medicare & Medicaid Services (CMS) supports value-based care as part of its “larger quality strategy to reform how health care is delivered and paid for”.
Omar Ishrak and value-based care
 
Omar Ishrak, CEO and chairperson of Medtronic plc  between 2011 and 2020, championed value-based care by incentivizing and leading discussions about how MedTechs should align value and price and how suppliers should get paid according to patient outcomes. He believed “[clinical] value has to be tied to economic value, otherwise people will not be able to afford the care we provide”. Before joining Medtronic, Omar Ishrak was the head of GE HealthCare and was well-versed in global politico-economic challenges associated with markets with a deep understanding of the human toll that comes from inadequate healthcare systems. “We live in a world where we get paid for our technology with a promise to improve outcomes, not a guarantee, a promise”, said Ishrak. While at Medtronic he extended value-based healthcare by insisting that efficacy is aligned with patient expectations and MedTechs get paid for medical outcomes rather than medical devices. He was convinced that value-based care incentivises MedTechs to develop and deploy products, services, and solutions, which improve patient outcomes per dollar spent, and measure value in terms of long-term patient outcomes rather than short-term transactions.

In 2016 Medtronic established a value-based care partnership with UnitedHealthcare, an American multinational managed healthcare and insurance company, which gave its customers living with diabetes access to Medtronic’s insulin pump and support services. After the first year, the partnership reported ~27% decline in the rate of preventable hospital admissions compared to patients using traditional daily insulin injections. Between 2015 and 2018, UnitedHealthcare's payments to physicians and hospitals tied to value-based care programmes were reported to be ~US$65bn and projected to grow to ~US$75bn within two years.

In February 2018, Medtronic signed a 5-year value-based care partnership with Lehigh Valley Health Network, (LVHN) based in Allentown, Pennsylvania. The two organizations established processes to treat more than 70 medical conditions using Medtronic devices to improve patient outcomes and cut costs. The endeavour reached ~0.5m patients in Northeast Pennsylvania and cut the cost of care by ~US$100m. Another benefit of the partnership was Medtronic obtained access to thousands of patient insights to their products, which the company used to establish baselines to monitor and improve outcomes. Another example of Medtronic linking a product directly to outcomes is its Tyrx Absorbable Antibacterial Envelope, a mesh used to hold pacemakers and implantable cardioverter defibrillators (ICD) in a stable environment and release antimicrobial agents over a period when the chance of infection related to surgery is high. These are just a few examples of devices that Ishrak linked to value-based payment schemes, there are many others. Cumulatively they “had a real differentiating value for Medtronic”, said Ishrak.

Although manufacturers of medical devices were slow to follow Ishrak’s example, the economic slowdown has led to a heightened cost-consciousness among healthcare providers and accelerated a shift towards value-based care and a growing influence of healthcare group purchasing organizations (GPOs). This, in turn, has incentivized MedTechs to increase their M&A activity to expand their portfolios and allow them to provide high-volume, discounted product bundles. Furthermore, value-based care has moved purchasing decisions away from physicians toward hospital administrators, who are more focused on costs than devices and their features. This has resulted in a downward pricing pressure across the MedTech landscape and rendered market entry more challenging for small companies, which provides large diversified MedTechs with further potential acquisition targets.
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Low Back Pain and the global spine industry

 
Spinal surgery and value-based care
 
A segment of the medical technology industry that looks ripe to benefit from value-based care is spinal surgery for low back pain (LBP), which is a common age-related health condition associated with degenerative spinal disorders. According to the World Health Organisation (WHO), LBP is one of the top ten global disease burdens and ~80% of all individuals will experience the condition at some point in their lifetime.
In the US, ~3 in 10 adults - ~72m - currently suffer from chronic LBP.  Each year, ~0.3m people present with LBP but only ~0.7-4.5% of these will have specific identifiable causes for their condition. This is because LBP is challenging to diagnose as there is no established protocol to evaluate the condition and it may be a symptom of many different causes. Notwithstanding, American third-party payers have tended to reimburse spine surgery for LBP more than non-invasive therapies, but this is changing.  America has the highest rate of spine surgeries in the world, and each year, clinicians perform ~1.6m spinal fusions in an attempt to cure LBP. Between 2004 and 2015, the volume of spinal fusions increased by 62% and aggregate hospital costs increased ~177%, exceeding US$10bn in 2015, and averaging >US$50,000 per admission. A 1994 international comparative study found that, “the rate of back surgery in the US was at least 40% higher than in any other country and was more than five times that in England. Back surgery rates increased almost linearly with the per capita supply of orthopaedic and neurosurgeons in the US”.
 
A significant percentage of patients with LBP continue to experience pain after surgery, which is referred to as ‘failed back syndrome’ (FBS) and is characterized by an inability to return to normal activities. A study reported in the American Journal of Medicine suggests that recurrent spine surgeries do not necessarily mean success. Notwithstanding, when a primary surgery fails to cure LBP, a significant percentage of patients have further surgeries. However, with each recurrent surgery the probability of a successful outcome drops: ~50% success rate after the first repeat surgery, ~30% after the second, ~15% after the third and ~5% after the fourth.
 
Research published in theBritish Journal of Pain, suggests that the overall failure rate of lumbar spine surgeries is between ~10 and 46%. A study reported in a 1992 edition ofSpine, followed 53 patients for an average of 20 months after a spinal fusion surgery and found that only 50% reported improved outcomes. Another study, published in the journal Trials, suggests that ~40% of lumbar fusion patients experience ongoing back pain and limited function two years after surgery; and research findings published in the Asian Spine Journalfound ~5 and 36% of people who undergo a discectomy for a lumbar herniated disc saw their leg and back pain return two years after surgery.
 
Such failure rates have prompted health insurers in the US to reassess their fee-for-service payment policies.According to a New York Times article,  reimbursements for spine surgeries are becoming tighter, and “financial disincentives accomplished something that scientific evidence alone didn’t”. The  article draws on research published in the journal Spine, which found that, “spinal fusion rates continued to soar in the US until 2012 and shortly afterwards Blue Cross of North Carolina said it would no longer pay for such surgeries”. It seems reasonable to assume that benign fee-for-service reimbursement policies are partly responsible for the increase in spine surgeries that fail to cure LBP. Following the Blue Cross decision other insurers followed, and US payers started to move away from fee-for-service models towards  reimbursing “value”. This transfers the costs of over-treatment, revision surgeries and adverse clinical outcomes from payers to providers and is expected to utilize resources more efficiently. Such shifts are beginning to happen in all the major medical technology markets. For example, in Europe fiscal pressure on healthcare systems has meant rationing and/or delaying elective spine surgeries, and in Japan more spine surgery costs are being shifted to employers and patients.
 
Given the changing ecosystem in the spine market, a potential opportunity for MedTechs might be to apply machine learning AI techniques to patient data in an endeavour to determine what products and procedures are most likely to produce optimal solutions for individuals contemplating spine surgery for LBP. Assuming enough relevant data are collected, and successful algorithms developed, this process might help to reduce the high failure rates of spine surgeries for LBP, improve patient outcomes and lower healthcare costs.
 
Weak competition at the wrong level

Value-based care has the potential to: (i) improve patient outcomes by incentivising providers to focus on the quality of care, (ii) create a more efficient healthcare system by eliminating wasteful spending, (iii) improve patient satisfaction by making the healthcare system more patient-centered, (iv) make it easier for enterprises to commercialize new products and services by providing a pathway to reimbursement, and (v) provide a platform for companies to partner with other healthcare stakeholders to improve care delivery and patient outcomes.
 
However, MedTechs are not well positioned to transition expeditiously to value-based care. This is because, for decades they have benefited from a benign fee-for-service business model and participated in weak competition at an institutional level: the level of health plans, providers, and hospital groups. Competition at this level is weak and neither creates value nor benefits patients. This is because the principal actors behave as if playing 'pass the parcel', i.e. shifting costs onto one another, restricting services, stifling innovation, and hoarding information.
 
In the medical technology industry value can only be created or destroyed by competition at a patient level, but this has been absent throughout the history of the industry. Because of this deficit company costs are high and rising, services are restricted, clinical procedures overused, standards of care often fail to adhere to clinical guidelines, diagnosis errors are common, quality and cost differences persist across providers and geographies, best practices are slow to spread, and innovation is resisted. In most other industries such outcomes are inconceivable.
 
The future for MedTechs must be at a patient level where costs and quality persist and where competition can drive improvements in efficiency and effectiveness, reduce clinical errors and incentivize innovation. Notwithstanding, competition at this level requires devising patient outcome measures for specific devices and procedures that are acceptable to all industry stakeholders. Data are essential to develop such measures and may be provided by surveys, electronic health records, personal devices and clinical studies or a combination of all four. However, the analysis and utility of such data require sophisticated data handling and security capabilities, which many MedTechs do not have. Companies that successfully re-tool and become eloquent at competing at a patient level will be well positioned to create long-term value for all stakeholders. Companies that fail in these endeavours will likely become targets for acquisitions.
 
Takeaways

MedTech companies have become trapped by their former commercial success and legacy structures and operating models that were neither set up to respond quickly to innovative trends nor to compete with disrupters. For ~3 decades high growth rates and valuations persisted in the medical technology industry despite companies ‘competing’ weakly at the wrong level and their cultures being defined by short-term financial performance. Such entrenched business models and the time and resources they consumed did not leave room for broader in-depth strategic considerations that could influence long term value creation. Today, MedTechs are at a crossroad: they can either change their strategies and business models and compete at a patient level or they can continue their weak competition at an institutional level. The former positions companies well to create long-term value for all stakeholders while the latter does not.
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3 years, 1 month ago

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

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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: 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. 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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3 years, 4 months ago

Learn from the Chinese, but don’t misjudge Beijing

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  • 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.
You might also like: 

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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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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3 years, 7 months ago

Leaning-in on digital and AI

HealthPad
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commentary
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wearables
  • 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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3 years, 12 months ago

Can elephants be taught to dance?

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MedTech
  • MedTechs have built proficiencies to successfully create and market physical devices predominantly for the US and Western European markets
  • To remain relevant in the rapidly changing healthcare ecosystem they will need to develop advanced digital and data capabilities and increase their penetration of Asian markets, which will present challenges for most of them
  • Will companies be forced to decide whether to remain hardware manufacturers or become software enterprises, or can they look both ways and prosper?
  • Given the rate of market changes, the next 5 years represent a window of opportunity for traditional MedTechs to pivot and transform their strategies and business models
 
Can elephants be taught to dance?
MedTech’s strategic challenges
 
MedTechs are at a crossroad of manufacturing physical devices and developing software solutions. Both aim to deliver value by enhancing patient outcomes while reducing costs. Can these two scenarios co-exist, or will industry leaders be forced to choose one or the other?
 
For decades, many companies have displayed a deep-rooted reluctance to transform their business models and adopt digitalization strategies and have used M&A activity to become bigger. This suggests that a significant proportion of MedTech leaders are likely to manage increased competition and changing healthcare ecosystems by accelerating M&A activities, which are familiar to them and require no significant change. However, such activities alone will not future-proof companies. Over the next five years, “informed” MedTechs will benefit by shifting away from their current business models that depend on developing and selling physical products predominantly to hospitals in the US and Western Europe and move toward providing patient-centric software solutions as partners in dynamic, connected international healthcare ecosystems.
 
M&A activity to enhance scale

For decades, M&A activities have helped MedTechs to acquire mature assets to tuck into their existing sales and distribution channels. More than anything, this has assisted them to increase their scale, while optimising their portfolios, reducing competition, and improving profits. Over the past decade, when Western markets became more uncertain, monetary policy tightened, technologies advanced, and global economic growth slowed, MedTechs responded by exploiting the fall in the cost of capital to increase their M&A activities with the main purpose of increasing their scale: bigger was generally perceived by industry leaders to be better.
 
Before the COVID-19 pandemic crisis, 2020 was expected to be a strong year for MedTech’s M&A. However, the disruptive impact of the coronavirus outbreak slowed the industry’s M&A performance, and between July 2019 and June 2020, M&A expenditures plunged by 60% compared to the previous 12-month period. Activity returned in Q3, 2020, and today, although high asset valuations and increasing cost of capital have impacted M&A transactions and re-focused attention on organic growth, there are signs that a M&A buyer’s market is developing, but with a difference.
 
The difference is a significant number of M&A transactions do not appear to be focussed entirely on acquiring scale. While there are still some advantages to increasing scale, there are disadvantages, which include having to integrate and service more customers, more employees, and more institutional investors, and this often contributes to strategic rigidities.
 
The demise of scale

The significance of scale was first elaborated in 1937 by Nobel economics laureate Ronald Coase in his seminal paper, The Nature of the Firm, and ~50 years later, repeated by Michael Porter in his book, Competitive Advantage. Both Coase and Porter suggested that scale gained from reducing the ratio of overhead to production would increase the power of firms in markets. In 2013, Rita McGrath challenged this thesis in, The End of Competitive Advantage, by suggesting that bigger was not necessarily better. According to McGrath, in an increasingly high-tech environment, more important than size, is whether enterprises have access to technical capabilities, which can drive top-line growth in dynamic market settings.


Recapitalized MedTech’s M&A firepower
 
According to a 2020 report on the state of the MedTech industry, published by EY, a consulting firm, between July 2019 and June 2020, MedTechs took advantage of low interest rates, and financing levels more than doubled to a record US$57.1bn compared to the previous 12 months; with >40% resulting from debt financing. Thus, as we emerge from restrictions imposed by the COVID-19 pandemic, there is a lot of liquidity in the market and larger MedTechs have significant M&A firepower. Will they use this to become bigger, or will they use their capital to make strategic investments in new technologies and to penetrate large rapidly growing Asian markets?
M&A driving a shift to digital health

In H1,2021, the MedTech sector recorded a total of 33 M&A deals, up from 25 in the whole of 2020. There is some evidence to suggest that some companies in the sector are using their renewed M&A firepower to acquire high growth digital and AI opportunities that can be integrated into their existing product offerings to provide access to new revenue streams and help companies pivot away from being solely dependent upon manufacturing physical devices. We briefly describe four such deals.
 
In January 2020, as the first COVID-19 case was reported in the US, Boston Scientific paid US$0.925bn for Preventice, a developer of mobile health solutions and remote monitoring services, which connect patients and caregivers. Its digitally enabled service has the potential to reduce healthcare costs and improve patient outcomes. In February 2020,  Medtronic, acquired, for an undisclosed sum, Digital Surgery, a London-based privately-held pioneer in surgical AI, data and analytics. The acquisition is expected to accelerate Medtronic’s plans to incorporate AI and data into its laparoscopic and robotic-assisted surgery platforms. In December 2020 Philips acquired BioTelemetry for US$2.8bn. BioTelemetry is a US-based provider of remote cardiac diagnostics and monitoring, with offerings in wearable heart monitors and AI-based data analytics and services. The deal provides Philips with the capability to expand its remote monitoring business outside of hospitals and into lower cost day-care settings and patients’ homes. One of the largest healthcare deals of 2020 was Teladoc’s US$18.5bn acquisition of Livongo, a remote patient monitoring company, founded in 2014, to build a cloud-based diabetes management programme, linking a person’s glucose monitor to personalized coaching to help control blood sugar levels. In 2019, just one year before Teladoc’s acquisition, Livongo IPO’d at a valuation of US$355m, and expanded its products and services to cover high blood pressure and behavioural health with an ultimate goal of leveraging digital medicine to address “the health of the whole person”. 
 
These four acquisitions are from market segments, which run parallel to traditional medical devices and are often perceived by some MedTech executives to be competitors destined to be controlled by giant tech companies such as Apple, Huawei, and Samsung. However, given the rate at which technology is developing, the speed at which MedTech and pharma are converging, and the renewed liquidity in the market, it might be more efficacious for MedTechs to view such specialised digital health companies as partners rather than competitors.
 
Technologies helping MedTechs to develop actionable solutions

Today, many new biomedical technologies are being developed and benefit from continuous miniaturization, enhanced battery life, cost reductions and increasing data storage capacity. One such technology is photoplethysmography (PPG), a non-invasive, uncomplicated, and inexpensive optical measurement method that employs a light source and a photodetector to calculate the volumetric variations of blood circulation. PPG is employed in smartphones and wearables that are used by billions of people worldwide. There is a large and growing global research endeavour to develop more effective and sophisticated PPG algorithms that could be attached to traditional, non-active medical devices and implants to provide accurate and reliable real time monitoring of a wide range of conditions.
 
Outside of specific health monitoring technologies, few MedTechs collect, store, and analyse data generated by their existing traditional devices and implants, and even fewer use such data to facilitate real time, monitoring of conditions. However, some companies are beginning to transform their dumb devices into intelligent ones to gain access to new revenue streams. For example Zimmer-Biomet’s “smart” knee, utilizes a biosensor [an analytical device that uses natural biological materials to detect and monitor virtually any activity or substance] to generate self-reports on patient activity, recovery, and treatment failures, without the need for physician intervention and dependence upon patient compliance. 
 
According to Roger Kornberg, Professor of Structural Biology at Stanford University and Nobel Laureate for Chemistry, “the excitement of biosensors pertains to their microscopic size and the ease with which they can transmit wirelessly in real time information about responses to treatment from an implantable device within the body”. [See video below].
 
A fast-growing field of AI is tiny machine learning (TinyML), which has the capability to perform on-device, real time, sensor data analytics at extremely low power, typically in the mW [one thousandth of a watt] range and below. The technology is expected to make always-on use-cases economically viable and accelerate the transformation of dumb devices and implants into smart ones.
 
 
Changing traditional R&D models
 
In their search for innovative healthcare solutions, MedTechs might consider increasing their R&D spend and reorganizing their R&D function. MedTech’s R&D spend, as a percentage of revenues, has slowed compared to levels the industry recorded prior to the 2007 financial crash. Overall, the industry tends to allocate more of its capital to share buybacks and investor dividends than to R&D. This strategy may please shareholders in the short term, but it suggests some uncertainty among industry leaders about how to invest for growth in the longer term and could have a medium- to long-term potential downside. 
 
Further, a significant percentage of R&D spend goes on tweaking existing products rather than creating new ones. Given that the future of the industry is dependent upon innovation, it seems reasonable to suggest that, as competition increases and markets tighten, MedTechs will need to consider increasing their R&D resources and capabilities to develop innovative technologies that provide improved actionable solutions across entire patient journeys.

Unlocking value from R&D innovations might require a different culture and new operating models to the ones that tend to prevail today. Instead of lengthy R&D cycles fixed on the launch of a physical product, it could be more beneficial to focus on developing minimum-viable patient-centric solutions, which research teams can deploy early, test, learn from and enhance. Moreover, R&D strategy sessions might benefit by including a mandatory question: “In the near- to medium-term, are there any evolving technologies likely to disrupt a specific market segment important to our company?”.
 
The potential of innovative technologies to disrupt markets
 
To illustrate the significance of this question, consider traumatic brain injury (TBI), which each year affects ~69m individuals worldwide. There is no cure for the condition, and the cornerstone of its management is to monitor intracranial pressure (ICP). [Pressures >15 millimetres of mercury (mm Hg) are considered abnormal, and ICP >20 mm Hg is deemed pathological]. An ICP monitor is expected to be easy to use, accurate, reliable, reproducible, inexpensive and should not be associated with either infection or haemorrhagic complications. Currently, the gold-standard is to drill a small burr hole in the skull, insert a catheter and place it in a cavity [ventricle] in the brain, which is filled with cerebrospinal fluid (CSF). Such an invasive intraventricular catheter system is accurate and reliable, but it is also a health-resource-intensive modality, which runs a risk of haemorrhage and infection. Recent advances in PPG and other technologies have accelerated research developing non-invasive techniques to continuously measure and monitor ICP, which in the medium-term, could replace the gold standard and avoid drilling a hole in a traumatised patient’s skull.   
  
Pros and cons of the COVID-19 crisis

One beneficial outcome for MedTechs of the COVID-19 crisis has been the change in regulatory norms, which favour innovation. In the US, the FDA reduced barriers to market entry for new devices by increasing its emergency use authorization (EUA), which fast-tracks the availability of medical devices. Also, at the onset of the pandemic, the EU deferred for one year the implementation of its Medical Device Regulation (MDR), which governs the production and distribution of medical devices in Europe. In mid 2021, when governments began removing the outstanding legal restrictions imposed to reduce the impact of the third wave of the COVID-19 pandemic, some MedTechs, which had invested in remote communication strategies, chose to build on the changes they had made and invest further in digitalization AI strategies, while many others reverted to their labour-intensive supply channels. According to a June 2021 Boston Consulting Group (BCG) study, “On average, MedTech companies are still spending two to three times more on selling, general, and administrative (SG&A) expenses (as a percent of the costs of goods sold) than the typical technology or industrial company”.
 
A potential disadvantage for MedTechs of the COVID-19 pandemic is that it can lead to an excessive focus on short-term challenges and put off addressing longer-term strategic threats.
 
MedTech executives have never had it so good

Why are some companies reluctant to transform their strategies and business models?

We suggest that a deep-rooted resistance to change results from MedTechs “never having it so good” over a long period. Indeed, for several decades before the global economic crisis in 2007 and 2008, the medical device market was buoyed by limited competition, benign reimbursement policies, aging populations, and a slower pace of technological change compared to today. These factors promoted double-digit growth rates, investor confidence, and solid valuations. This fostered a sense of security among C suites and encouraged “business as usual” agendas, which tended to focus on sharpening legacy products, legacy business models, legacy forms of market access and pricing and legacy capabilities.
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Who should lead MedTech?
The 2007-8 financial crisis only inflicted a short-lived blow to the industry and most companies bounced back relatively quickly. Throughout the decade that followed, MedTechs maintained solid financial performance, steady growth, investor confidence and robust valuations. Many enterprises across the industry ended 2019 in a strong position, with some trading at 52-week highs and the industry overall growing revenues at ~6%.
In 2020, the COVID-19 pandemic threw some segments of the industry off course by a substantial reduction in elective care. However, by 2H 2021, most MedTechs had recovered, albeit their annual growth in revenues did not recapture the heights of the early years of the 21st century.
 
MedTechs became like elephants

It seems reasonable to suggest that decades of commercial success shaped the mindsets of industry leaders and resulted in MedTechs becoming like elephants. In 1990, James Belasco published, Teaching the Elephant to Dance, in which he likened organizations to elephants. The book describes how trainers shackled young elephants to a stake securely embedded in the ground so that they could not move away despite their efforts. By the time the elephants became fully grown and had the strength to pull the stakes out of the ground, they were so conditioned they did not move and remained in position even though most were no longer tethered to the stakes. The author uses this analogy to warn how companies can become stuck in obsolete working practices, which are obstacles to their future commercial success.

In 1993, IBM, the world’s largest manufacturer of mainframe computers, had become “an elephant” continuing to produce hardware appliances when the industry was embracing software solutions. IBM, which had posted a US$8bn loss, appointed Lou Gerstner, an executive from outside the computer industry, to turn the company around. Nine years later, IBM had become one of the world's most admired companies. In a book published in 2002, entitled, Who Says Elephants Can't Dance?, Gerstner described how he successfully changed IBM from a maker of hardware to a service orientated company.
 
A 5-year window of opportunity
 
A doubt as to whether many traditional MedTechs can be taught to dance was sewn in a 2021 BCG study cited above, which suggested that enterprises “do not yet have the capabilities in place to develop and implement a next-generation, omnichannel commercial model”. Ten years from now, the MedTech market is projected to be significantly different to what it is today, and what it has been for the past four decades. However, it seems reasonable to assume that because of its size and growth rate, [~US$0.5tn, growing at a compound annual growth rate (CAGR) of ~6% and projected to reach US$0.75tn by 2030], many industry leaders will not feel any pressing need to transform their strategies and business models in the short-term.

However, with a rapidly changing healthcare ecosystem, it seems reasonable to suggests that, to remain relevant after 2030, MedTechs will need to use the next five years as a window of opportunity to prepare solutions that enable them to focus on entire patient treatment pathways, create best-in-class distributive services, and develop digital marketing and sales capabilities that help to expand their influence beyond selling hardware. This will require targeting the “right” market segments, developing the “right” solutions, funding in the “right” R&D, creating the “right” playbooks; and recruiting, retaining, and developing the “right” people with the “right” capabilities.
 
From restricted staged events to real time distribution

Companies are rich reservoirs of clinical data and expertise, but the data tend to be kept in silos and distributed intermittently to a limited number of clinicians and providers at “staged” events. Digital technologies can unlock these assets and facilitate real time, online marketing, self-service portals, and virtual engagements; all of which can provide physicians and providers with unprecedented access to knowhow that can help improve the quality of care and reduce costs. However, shifting to such a distributed care model to drive profitability requires developing a digital, remote, marketing and sales force, which is supported by data analytics, virtual demonstrations, automated call reporting, and AI-supported coaching tools.
 
The reduction of obstacles to data rich digital distributed care strategies

While distributed computing and communications systems have significantly enhanced a wide range of commercial organizations, they have yet to take root in MedTech settings, despite data sharing being critical in modern clinical practice and medical research. A challenge for MedTechs is to engage in data sharing that reconciles individual privacy and data utility. This will entail universally agreed AI and machine learning practices. Although there are sophisticated technologies that can help with this, MedTech’s management and information systems’ personnel may not be prepared to effectively reconcile these competing interests and push for universal data standards. According to a US National Institute of Health report, “The lack of technical understanding, the lack of direct experience with these new tools, the lack of confidence in their management, the lack of a peer group of successful adopters (except for a few academic medical organizations), and uncertainties about reasonable risks and expectations all leave conservative organizational managers hesitant to make decisions”. 
 
While the mindsets of some industry leaders appear to be obstacles to change, other obstacles to transformative business models have been reduced. For instance, privacy is now less of an obstacle for data-rich strategies than it once was. Increasingly, patients show a willingness for their clinical and personal data to be used anonymously in the interest of improving healthcare. Further, regulators’ attitudes towards data are changing.  In September 2021 the FDA published its AI enabled devices that are marketed in the US, which embrace the full scale of approvals from 510(k) de Novo authorizations to Premarket (PMA) approvals. The FDA’s initiative comes at a time of continued growth in AI enhanced digital offerings that contribute to a variety of clinical spheres, and the increasing number of companies seeking to enter this space. There are ~130 algorithms approved for clinical use in the US and Europe.
 
A recent report from Frost & Sullivan, a US market research company, suggests that although in the near-term, traditional medical devices will continue to make up the bulk of the market, after 2024, they are expected to grow at only a CAGR of ~2%. By contrast, digitally enhanced medical devices, and algorithms, which facilitate managing patients remotely and non-intrusively, are expected to grow at a CAGR >14% and reach US$172bn by 2024.
 
The shift to low-cost settings

Over the next five years, as technology advances, populations age, healthcare costs escalate, patient expectations continue to rise, and markets tighten, we can expect the shift away from hospitals to outpatient settings and other lower-cost venues to accelerate. This move to a distributed care model is a headwind for traditional MedTechs, whose principal focus is provider systems rather than patients, and a tailwind for new players entering the market unencumbered by legacy supply chains, costs, and infrastructures. According to an EY 2020 study, ~70% of start-ups in the diagnostics segment have products applicable to the point-of-care setting.
 
Corporate venture funds

To help traditional MedTechs dance leaders of medium sized, well capitalized enterprises might consider copying the world’s largest MedTechs and create corporate venture capital (CVC) funds to invest in tech-savvy start-ups. While 7 of the top 10 MedTechs by sales have venture arms, many company leaders shy away from investing in early-stage, unproven technologies. However, CVC funds offer traditional corporates access to innovations and scarce science, technology, engineering, and mathematics (STEM) skills, which are necessary to capture and analyse data, deliver enhanced care, and drive biomedical R&D with the potential to improve patient outcomes and lower costs.
 
The latest giant MedTech to launch a CVC fund is Intuitive Surgical. In Q4 2020, the company started disbursing capital from its initial US$100m venture fund to start-ups developing digital tools and precision diagnostics, with an emphasis on minimally invasive care. Intuitive is the world’s largest manufacturer of robotic surgical systems for minimally invasive surgery. Since its lead offering, the da Vinci Surgical System, received FDA approval in 2000, it has been used by surgeons in all 50 US states, ~67 countries worldwide and has performed >8.5m procedures.

In the first three quarters of 2020, CVCs participated in investment rounds worth US$1.2bn, which amounted to >25% of the total venture funding the sector raised. The lion’s share went to products and solutions that address digital therapies, telehealth, and treatments for low-cost settings. Such technologies are positioned to continue receiving significant funding in 2022 and beyond. A 2021 study by Deloitte, a consulting firm, suggests that MedTech start-ups, unencumbered by legacy products and practices have capabilities, which stretch beyond traditional devices that support episodic care, and focus on distributed solutions, which address the full patient journey: from diagnosis to rehabilitation. The study also maintains that technologies employed by these enterprises are getting smarter, with ~70% of them including digital AI capabilities.
 
Further, MedTechs with CVC arms might consider allowing their digital business functions to operate within a different organizational framework, giving them greater decision-making authority and enhanced freedoms.
 
Asia Pacific MedTech markets

Before closing let us briefly draw attention to the increasing significance of the emerging Asia Pacific MedTech markets. For the past 4 decades, industry leaders were not obliged to seriously consider penetrating markets outside the US and Western Europe because ~70% of global MedTech revenues came from the US and Western Europe. However, as Western markets tighten, and become increasingly competitive, attention is moving East towards Asia.

Over two decades ago, a handful of giant MedTechs began investing in Asia, but most companies in the sector preferred not to risk navigating such unfamiliar healthcare territories. An early investor in the region was Medtronic, which, since ~2000, has achieved significant growth from a multi-faceted strategy that included exporting innovative products from the US to China, establishing R&D facilities in China to design products specifically for the needs of the Chinese market, crafting partnerships with Beijing to educate patients in under-served therapeutic areas, and acquiring domestic Chinese MedTech companies.

Because of the current political stand-off between the two countries, such a China strategy is not so feasible as it has been over the past two decades. However, it is worth bearing in mind that Asia is comprised of 48 countries with a combined population of ~5bn, which is projected to reach 8.5bn by 2030, [~60% of the world’s population], with 1 in 4 people >60. In 2020, ~2bn Asians were members of the middle class, and by 2030, this demographic is projected to grow to ~3.5bn. Moreover, health insurance coverage in the region is expanding. By contrast, the middle classes in the US and Western Europe are smaller and growing at lower rates. According to the Pew Research Center in 2018, ~52% of the 258m US adults (>18 years) was considered middle class. The dynamics of the Asian middle class is driving a large and rapidly growing Asian MedTech market, which is on the cusp of eclipsing Europe to become the world’s second largest regional market, growing at a CAGR of ~9%.

Further, the region has become an important source of technological innovation. For example, in 2020, its digital health market was valued at ~US$20bn and projected to grow at a CAGR of ~21% until 2027, when its value is expected to be ~US$80bn. Despite its complexities and unfamiliarity, Asia represents a substantial opportunity for MedTechs. However, for Western enterprises to succeed in Asian markets they will require in depth local knowhow, long term commitments, agility, innovation, and robust strategies that can prosper under fiercely competitive conditions.  
 
Takeaways

MedTechs have built capabilities to develop, launch, market and sell physical devices. With some notable exceptions, few have the capabilities necessary to drive significant growth from digitalization and data strategies. Sharpening traditional commercial procedures and practices alone is unlikely to significantly increase growth, especially when competitors and new entrants have business models that are more effective, promote better patient outcomes and provide greater value to healthcare systems.  

MedTechs could play a significant role in the transformation of healthcare, but not without risks and some significant changes to the way they operate. Over the next five years, as competitive pressures increase, industry leaders have a window of opportunity to pivot. Here are six strategic questions that might help in this regard:
  1. Should we support significant investments in digitalization, and data analytics to improve our supply chains and R&D endeavours to convert dumb devices and implants into smart ones?
  2. What are the top three actionable innovations that we can develop in the near-term to provide access to new revenue streams?
  3. What are the top three technologies likely to disrupt our product offerings in the near- to medium-term and what should we do about them?
  4. Can we remain a hardware manufacturer while developing significant software solutions that embrace entire patient journeys or must we choose between manufacturing and software?
  5. How do we create valuable solutions that enhance patient journeys from data?
  6. How are global markets changing in ways that are not reflected in our company’s discussions?
The answers to these questions will help to shape a corporation’s strategy, and inform M&A and CVC activities, “must have” capabilities, desired partnerships, R&D spend and agendas, and the type of business models to pursue. All critical for teaching elephants to dance.
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6 years ago

For better or worse we all now live in CRISPR’s world

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Medical Technology
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CRISPR
CRISPR-Cas
gene editing
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prime editing
  • Prime editing devised by researchers at the Broad Institute led by David Liu is a significant advance of the original CRISPR gene editing tool discovered in 2012
  • CRISPR can cut and edit your DNA to correct defects inside your body’s cells to prevent and heal a range of incurable diseases and has revolutionized biomedicine
  • The original CRISPR is fraught with inaccuracies referred to as off target effects
  • Prime editing substantially reduces CRISPR’s off target effects and has the potential to correct up to 89% of known disease-causing genetic variations
  • CRISPR also has the capacity to edit genes in an embryo in such a way that the change is heritable
  • In 2018 Chinese researcher He Jiankui “created” the world’s first CRISPR babies
  • This triggered international criticism from scientists and bioethicists
  • A principal concern is that CRISPR is easy-to-use, cheap, regularly used in thousands of laboratories throughout the world and there is no internationally agreed and enforceable regulatory framework for its use
 
For better or worse we all now live in CRISPR’s world
 
In 2012 the world of biomedicine changed when a revolutionary gene editing technology known as CRISPR-Cas9 (an acronym for Clustered Regularly Interspaced Short Palindromic Repeats) was discovered. The technology harnesses your body’s naturally occurring immune system that bacteria use to fight-off viruses and has the potential to forever change the fundamental nature of humanity. Since its discovery CRISPR has been developing at lightning speed primarily because it is simple and affordable and today is used in thousands of laboratories throughout the world.
 
In this Commentary
 
In this Commentary we describe prime editing, which is the latest advance of the CRISPR's tool box, devised bya team of researchers, led by Andrew Anzalone, a Jane Coffin Childs postdoctoral fellow from the Broad Institute of MIT and Harvard and published in the October 2019 edition of Nature. Prime editing is significant because it provides a means to eliminate the unintentional consequences of CRISPR and therefore bring the technique closer for use in clinics. But this is still a long way off.
 
We also review a case where an ambitious scientist “created” the first CRISPR babies. This immediately triggered international criticism and a call for tighter regulatory control of the technology. Scientists and bioethicists are concerned that CRISPR can easily be used to create heritable DNA changes, which ultimately could lead to ‘designer babies’.
 
These two accounts of CRISPR might seem “opposites” and not sit well together in a single Commentary. Notwithstanding, what prompted putting them together was John Travis, the News Managing Editor of the well-known scientific journal Science, who soon after CRISPR’s discovery in 2012  said, “For better or worse we all now live in CRISPR’s world”. 
 
CRISPR and your DNA

CRISPR is different to traditional gene therapy, which uses viruses to insert new genes into cells to try and treat diseases and has caused some safety challenges. CRISPR, which avoids the use of viruses, was conceived in 2007 when a yogurt company identified an unexpected defence mechanism that its bacteria used to fight off viruses. Subsequent research made a surprising observation that bacteria could remember viruses. CRISPR has been likened to a pair of microscopic scissors that can cut and edit your DNA to correct defects inside your body’s cells to prevent and heal a range of intractable diseases. The standard picture of DNA is a double helix, which looks similar to a ladder that has been twisted. The steps in this twisted ladder are DNA base pairs. The fundamental building blocks of DNA are the four bases adenine (A), cytosine (C), guanine (G) and thymine (T). They are commonly known by their respective letters, A, C, G and T. Three billion of these letters form the complete manual for building and maintaining  your body, but tiny errors can cause disease.  For example, a mutation that turned one specific A into a T results in the most common form of sickle cell disease.
 
The original CRISPR
 
The original CRISPR tool, which is the first and most popular gene editing system, uses a guide RNA (principally a messenger carrying instructions from your DNA for controlling the synthesis of proteins) to locate a mutated gene plus an enzyme, like Cas9, to cut the double-stranded gene helix and create space for functioning genes to be inserted. However, a concern about CRISPR is that the editing could go awry and cause unintended changes in DNA that could trigger health problems. Findings of a study published in the July 2018 edition of  the journal Nature Biotechnology found that such inaccuracies, referred to as off-target effects, were substantially higher than originally reported and some were thought to silence genes that should be active and activate genes that should be silent. These off-target effects, such as random insertions, deletions, translocations, or other base-to-base conversions, pose significant challenges for developing policy associated with the technology.

Subsequently however, the paper was retracted, and an error correction was posted on a scientific website. Contrary to their original findings, the authors of the Nature Biotechnology paper restated that the CRISPR-Cas9 gene editing approach, "can precisely edit the genome at the organismal level and may not introduce numerous, unintended, off-target mutations".
 
Base editing

Notwithstanding, researchers remained concerned about CRISPR’s off target effects and several devised a technique, referred to as base editing, to reduce these. Base editing is described in three research papers published in 2017: one in the November edition of the journal ‘Protein and Cell’, another in the October edition of ‘Science’ the and a third by researchers from the Broad Institute, in the October edition of the journal ‘Nature’. Base editing takes the original CRISPR-Cas9 and fuses it to proteins that can make four precise DNA changes: it can change the letters C-to-T, T-to-C, A-to-G and G-to-A. The technique genetically transforms base pairs at a target position in the genome of living cells with more than 50% efficiency and virtually no detectable off-target effects. Despite its success, there remained  other types of point mutations that scientists wanted to target for diseases.

 

Prime editing
 
Prime editing is different to previous gene editing systems in that it uses RNA to direct the insertion of new DNA sequences in human cells. According to David Liu,  the senior author of the 2019 Nature paper and a world renowned authority on genetics and next-generation therapeutics, “a major aspiration in the molecular life sciences is the ability to precisely make any change to the genome in any location. We think prime editing brings us closer to that goal”.  Because prime editing provides a means to be more precise and more efficient in editing human cells in a versatile way, which eliminates many of CRISPR’s unintentional errors, it significantly expands the scope of gene editing for biological and therapeutic research.
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CRISPR-Cas9 genome editing a 2-edged sword
There are around 75,000 different mutations that can cause disease in people and prime editing has the potential to correct up to 89% of known disease-causing genetic variations. According to Liu, "Prime editing is the beginning, rather than the end, of a long-standing aspiration in the molecular life-sciences to be able to make any DNA change in any position of a living cell or organism, including potentially human patients with genetic diseases". Liu’s team at the Broad Institute intends to continue optimizing prime editing. In their October 2019 Nature paper researchers reported that they can precisely correct mutant genes, which cause sickle cell anaemia and Tay Sachs disease.
 
Sickle cell anaemia and Tay Sachs
 
Sickle cell anaemia is an inherited form of anaemia. This is when there are not enough healthy red blood cells  (haemoglobin) to carry adequate oxygen throughout your body. The condition is the most common inherited blood disorder in the US, affecting 70,000 to 80,000 and further it is estimated  each year some 300,000 babies are born with the disorder worldwide. Tay-Sachs disease is a rare and fatal nerve condition often caused by the addition of four extra letters of code.  Although anyone can be a carrier of  the disease it is much more common among people of Ashkenazi (Eastern European) Jewish descent. In the Ashkenazi Jewish population, the disease incidence is about 1 in every 3,500 new-borns and the carrier frequency is 1 in every 29 individuals.
 
Some moral and ethical implications of CRISPR
 
Being able to modify your DNA with CRISPR tools has transformed scientific research and is revolutionising medicine although it will be some time before the technology is regularly used in clinics. In addition to its potential benefits there are significant moral and ethical challenges associated with the technology, especially when it is used for germline engineering, which is the process by which your genome is edited in such a way that the change is heritable. Inappropriate use of germline editing could dent the progress of the CRISPR technology.
 
The first CRISPR babies
 
One well publicized  inappropriate use of CRISPR is a team in China, led by He Jiankui of the Southern University of Science and Technology in Shenzhen, which in November 2018 “created” the first gene edited twins, known by their pseudonyms Lulu and Nana. He edited the twins’ cells to be immune to HIV infection when they were embryos, therefore ensuring that every cell in their bodies were changed, including their reproductive ones, which means their edited genomes can be passed on to their children and grandchildren, despite the fact that scientists cannot be sure what the long term effects of such lasting modifications might be. The twins are the first CRISPR babies and the first humans to have every cell in their body genetically modified using the technology.
 
In 2015 Chinese researchers were the first to edit the genes of a human embryo in a laboratory dish. Although the embryos did not go to term, the experiment triggered an international outcry from bioethicists, who argued that CRISPR should not be used to make babies. Notwithstanding, He Jiankui did just this.
 
He  employed CRISPR to alter a gene in IVF embryos to disable the production of an immune cell surface protein, CCR5, which HIV uses to establish an infection before insemination. CCR5 is a well-studied genetic mutation, and there is scientific and medical value in understanding how CRISPR can be used to disable and prevent HIV/AIDS. He believed that the use of CRISPR technology was medically appropriate and expected his experiment, “to produce an IVF baby naturally immunized against AIDS”. But more contentiously, He created twins who could pass the protective mutation to future generations. It is CRISPR’s ability to easily and cheaply edit human embryos, eggs, or sperm in order to create irrevocable changes and the potential for designer babies, which raises concerns.  
 
He defended his work at a Hong Kong genomics conference in late November 2018, but there was immediate and significant international criticism about the scientific and ethical legitimacy of his experiments, which broached China’s guidelines as well as international ethical and regulatory norms. A Chinese government investigation found He to have violated state law in pursuit of “personal fame and fortune”.  His endeavours cost him his university position and the leadership of a biotech company he founded, which had successfully raised US$43m start-up capital and was advised by Craig Mello, professor  of the University of Massachusetts Medical School and Nobel Laureate for medicine in 2006 for his genetics research.
 
Opacity and scientific competition
 
Some scientists are reluctant to be critical of He and suggest his studies, which resulted in the first CRISPR babies,  simply signal the “next chapter in the technology’s story”. He Jiankui appears to be an ambitious scientist desperate to become the first to conduct the gene editing experiment on humans, but who made some significant errors of judgement by initiating his study prematurely and by withholding information from regulatory authorities and his university. A generous interpretation might suggest that He was motivated by science and humanity. Through a Beijing-based organization, which helps Chinese people with HIV, he recruited couples for his experiment where only the fathers were living with HIV infections, which they managed by antiviral drugs. Eight couples agreed to participate, although one subsequently withdrew.
 
Since He’s statement at the Hong Kong conference he has disappeared, but the background to his studies has been well documented. In late 2017, He, who specialized in sequencing DNA, began his efforts to produce human babies from gene edited embryos and before and during his study it is reported that he sought advice from international experts in the field and communicated openly with international colleagues about his plans. Notwithstanding, it is alleged that He faked a blood test for one of the fathers in the study, aware that in China the HIV status of the father would disqualify him from participating in fertility treatments. Also, He failed to appropriately inform the hospital where the twins were edited and implanted of the status of his experiments.

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Fierce competition among scientists is not uncommon and competition fuels opacity among scientists in their battle to become the first to make a discovery. Indeed, it is not uncommon for scientists to shield their ideas and research. This does not condone He’s actions, but it might help to explain them. Generally speaking, scientific opacity is not created by ambitious scientists alone, but it is partly created by scientific funding bodies and research institutions. Such opacity is a significant obstacle to open collaboration. In addition to wanting to be the first, He’s intentions might also have been an attempt to spare children of parents with HIV/AIDS  from inheriting the disease.
CRISPR is not yet safe
 
Be that as it may, many scientists agree that CRISPR is not yet safe and precise enough to be used in human embryos. In the March 2019 edition of Nature a group of 18 prominent CRISPR scientists and bioethicists from seven countries called for a global moratorium on heritable genome editing until the establishment of an international framework that would compel countries to establish both scientific safety and broad societal agreement before allowing the technology to progress.  "We call for a global moratorium on all clinical uses of human germline editing; that is, changing heritable DNA (in sperm, eggs or embryos) to make genetically modified children" , the scientists wrote.

Opposition to germline editing is mixed
 
However, opposition to germline editing is mixed. In February 2017 the US National Academies of Sciences, Engineering, and Medicine (NASEM) published a report, which did not call for an international ban of germline editing, but instead suggested that it "might be permitted" if strict criteria were met. In July 2018, the UK’s Nuffield Council of Bioethics published a report on heritable genome editing and suggested that under certain circumstances it could be morally permissible, even in cases of human enhancement. 

Given that CRISPR is cheap, easy-to-use and already an effective tool in thousands of laboratories throughout the world, it seems reasonable to assume that standards and laws are unlikely to prevent a determined scientist and desperate patients from using the technology prematurely. Indeed, science and medicine have a history of researchers attracting public criticism for undertaking experiments prematurely only to have those experiments become common medical practices: in-vitro fertilization  (IVF) is one such example. Although IVF has a chequered history today it accounts for millions of births worldwide and  1% to 3% of all births every year in the US and Europe.
 
Germline engineering and somatic genetic modification
 
Here we describe the difference between germline and somatic adjustments. The former uses CRISPR to modify DNA in such a way that the change is heritable. The latter uses CRISPR to modify the DNA of people with incurable diseases in a way that such modifications are limited to the people treated and not passed on to future generations. Broadly speaking, your body has two kinds of cells: somatic and germ cells. The vast majority are somatic. These cells make up your body and are responsible for forming all your familiar structures: such as your skin, blood, muscles and organs etc. Your somatic cells die when you die so there is no chance of them creating a new organism. However, germ cells are different. Early in your development your germ cells  are sequestered: they divide more slowly and under restricted circumstances. Germ cells cannot become a physical feature such as an ear or a finger, but they do make the only bits of you, which can form a new person: your eggs and your sperm. Every cell in your body holds your DNA in an unbroken lineage stretching back millions of years and thousands of generations, but only the germline has a chance to go forward. Human germline modification means deliberately changing the genes passed on to children and future generations and thereby creating genetically modified people. Somatic genetic modification is different. It adds, cuts, or changes the genes in some of your cells, typically to alleviate a medical condition. The use of human genome editing to make edits in somatic cells for purposes of treating genetically inherited diseases is already in clinical studies. If perfected, somatic gene editing (gene therapy) holds promise for helping people who are sick, affecting only an individual consenting patient. With the exception of He’s studies, human clinical studies with CRISPR have been limited to somatic cells. In effect, this renders CRISPR no more consequential than any other experimental drug or treatment. Any CRISPR-made somatic cell changes are a genetic dead-end and are not heritable. However, germline cells have the possibility of immortality, with the potential to affect thousands of people over the course of several generations. Tampering with germline cells is therefore a much more serious proposition.
 
Clinical studies of gene therapies
 
Gene therapy is primarily available in a research setting. The US Food and Drug Administration (FDA) has approved only a limited number of gene therapy products for sale in the US.According to the US National Institutes of Health, which serves as a clearinghouse for biomedical research worldwide, there are over 800 clinical studies currently underway to test gene therapy as a treatment for genetic conditions. The list includes a relatively small number of CRISPR studies as a treatment for cancers of the lung, bladder, cervix and prostate, the majority of which are in China where doctors appear to be leading the race to treat cancer by editing genes. For the past two decades China has been investing heavily in biomedicine. It is one way that China is able to compete with the West and demonstrate its technological prowess in the 21st century. Also, it is important for China to keep its vast population healthy in the 21st century. Given the somewhat ambiguous state of CRISPR technology it seems reasonable to assume that the first therapeutic applications of CRISPR will be in diseases where cells can be taken out of your body, edited, checked to ensure they are safe and then reintroduced. This suggests blood disorders such as sickle cell or thalassemia.
 
Takeaways
 
Bioethicist Henry T (Hank) Greely, professor at Stanford University, California, US, compares CRISPR to the Model T Ford, which was not the first automobile, but because of its simplicity of production, dependability and affordability it transformed society. CRISPR is not the first gene editing technology, but it is cheap and easy to use and is on the cusp of transforming biomedicine. A significant challenge is getting CRISPR tools, which are capable of performing gene edits, into the right place and to ensure they are safe. Prime editing is a smart, innovative and a substantial step forward in achieving this. Indeed, David Liu and his colleagues from the Broad Institute  have expanded the gene editing toolbox to facilitate ever-more precise editing ability and efficiency. Significantly, the overwhelming majority of human genetic disorders are due to the types of mutation that prime editing is able to correct, which stands the technique in good stead to be useful in therapies for intractable diseases. Notwithstanding, it is one thing to cut out sequences of DNA that cause genetic diseases and another to make genetic changes that are passed down to all later generations. Because CRISPR is cheap, easy-to-use, in the hands of scientists throughout the world, and already has been used to create babies with heritable traits, the technology provokes deep ethical and societal debate about what is, and what is not acceptable in efforts to prevent disease. Given that CRISPR has the potential to change the nature of humanity, it is incumbent on all citizens, not just scientists, bioethicists and regulators, to call for open and inclusive processes associated with all aspects of CRISPR.
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6 years, 4 months ago

Increasing MedTech’s future growth and value

HealthPad
Directory:
Medical Technology
Tags:
commentary
digitalization
global healthcare systems
healthcare expenditure
MedTech
  • Over the past decade MedTech valuations  have outperformed the market without changing its business model
  • The healthcare ecosystem is rapidly changing and MedTech is facing significant headwinds which require change
  • MedTech’s future growth and value will be derived from data and smart analytics rather than manufacturing
  • MedTech leaders will be required to leverage both physical and digital assets

 

Increasing MedTech’s future growth and value
 
 
Over the past decade, the medical device (MedTech) industry has enjoyed relatively high valuations and outperformed broader market indices without changing its manufacturing business model. Some MedTech leaders suggest that because the industry’s product offerings are essential, demand for them is increasing as populations grow and age, so unlike other industries, MedTech is immune to market swings and its asset value will continue to increase. As a consequence of this mindset, MedTech has been reluctant to change and slow to develop digitization strategies. Notwithstanding, digitization is an in-coming tide and positioned to impose a step-change on the industry. Future MedTech leaders will need to derive increased growth and value from digitization and emerging markets while improving the efficiency of their legacy manufacturing business and meeting quarterly earnings’ targets.

According to a 2018 report by the consulting firm Ernst & Young,“Stagnant R&D investment, low revenue growth and slow adoption of digital and data technologies suggest that entrenched MedTech companies are overly focused on short-term growth, even as the threat of large tech conglomerates entering the space grows larger, which, in addition to the changing global healthcare ecosystem, threatens future revenue growth".
 
In this Commentary
 
This Commentary suggests that to create future growth and value, MedTech will have to (i) leverage data generated by medical devices, patients, payers and healthcare providers to develop clinical insights and trend analysis, which are expected to significantly improve patient outcomes and reduce costs, and (ii) substantially increase its share of the large and rapidly growing emerging markets. We suggest that there is a significant relationship between MedTech’s digital capacity and competences and its ability to increase its share of emerging Asian markets. But first we briefly describe the MedTech industry and its traditional markets and draw attention to some concerns, which include the relative low rates of top-line growth, stagnant R&D and share buybacks, M&A slowdown, giant tech companies entering the healthcare market, and challenges to recruit and retain millennials with natural digital skills and abilities.
 
The medical device industry
 
The MedTech industry designs, manufactures and markets more than 0.5m different products to diagnose, monitor and treat patients. These include wearable devices such as insulin pumps and blood glucose monitors, implanted devices such as pacemakers and metal plates, and stationary devices that range from instruments to sophisticated scanning machines. Medical devices can be instrumental in helping healthcare providers achieve enhanced patient outcomes, reduced healthcare costs, improved efficiency and new ways of engaging and empowering patients. The principal business model employed by the industry is to manufacture innovative products relatively cheaply and sell them expensively in wealthy developed regions of the world; predominantly North America, Europe and Japan; which although representing only 13% of the world’s population account for 86% of the global MedTech market share. This premium pricing model is predicated upon doctors’ and health providers’ belief that MedTech products are of superior quality and safety. Notwithstanding, as eye-watering healthcare costs escalate, providers and regulators demand better evidence of clinical and economic value to justify the pricing and use of MedTech products.  Over the next five years, the global MedTech industry is expected to grow at a compound annual growth rate of between 4% and 5.6% and reach global sales of some US$595bn by 2024.
 
Concern # 1: Reduced growth rates
 
Since the worse post-war recession ended in 2009, MedTech asset valuations have outperformed the market. Notwithstanding, of increasing concern is the slowdown of the industry’s revenue growth rates to single digits. The industry's aggregate revenue grew to US$379bn in 2017, an annual average industry growth rate of 4%, which now appears to be the new normal, and is significantly lower than the average annual growth rate of 15%, which the industry enjoyed between 2000-2007. The reduction in top-line growth rates is largely attributed to the world’s growing and aging population and the consequent growth in the incidence rates of chronic conditions, which increases the burden on overstretched healthcare budgets and intensifies pressure on MedTech’s to reduce their prices.
 
Population growth and aging
 
The aging population is driven by improvements in life expectancy. People are living longer and reaching older ages as fertility decreases and quality healthcare increases. People are having fewer children later in life. Some 8.5% of the global population (617m) have ages 65 and over. This is projected to rise to nearly 17% by 2050 (1.6bn). The number of Americans aged 65 and older is projected to more than double from 46m today to over 98m by 2060 – from 15% to 24% of the total US population. Around 18% of the UK population were aged 65 years or over in 2017, compared with 16% in 2007. This is projected to grow to 21% by 2027.
 
 Concern # 2: Stagnate R&D spend and share buybacks
 
In addition to relatively low revenue growth rates, MedTech R&D spend has stagnated over the past decade despite the need for companies to develop new and innovative product offerings, which drive top-line sales. Over the same period, MedTech returned more cash to shareholders in the form of share buybacks and dividends (US$16.4bn) than it spent on R&D.

To the extent that share buybacks extract, rather than create value why are they popular? One suggestion is that because share incentive plans represent a significant portion of executive compensation, share buybacks make it easier for executives to meet earning-per-share (eps) targets by reducing the number of shares, in the 1970s, share buybacks were effectively banned in the US amid concerns that executives might use them to manipulate share prices. However, in 1982 the US Securities and Exchange Commission (SEC) lightened its definition of stock manipulation, and share buybacks became popular again.
 

 

Concern # 3: High asset values slow M&A activity

Over the past decade, as markets became more uncertain, monetary policy tightened, technologies advanced and global economic growth slowed MedTech’s, buoyed by the dramatic fall in the cost of capital, increased their mergers and acquisitions (M&A) activity. This optimised portfolios, increased scale, reduced competition and improved profits. Notwithstanding, MedTech’s current high asset valuations make M&A transactions challenging to underwrite, and so, M&A activity has slowed.
 

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Concern # 4: Giant techs entering market
 
Giant technology companies such as Apple, Amazon, Google and Microsoft, have entered the healthcare market by providing direct-to-customer innovative services, which leverage data, artificial intelligence (AI) and machine learning and define new points of value along the value chain, which is changing the traditional notion of “product vendor”. Such innovations and services result in raising the expectations of stakeholders who are beginning to insist that healthcare is as convenient and personalized as every other good or service they purchase. Notwithstanding, leveraging data generated by devices, patients, healthcare providers  and payers is challenging for traditional MedTech’s who tend to view IT as an isolated cost centre often constrained by legacy systems, aging infrastructures, complexity and skills’ shortages rather than as a key strategic asset.
 
It seems reasonable to assume that over the next five years MedTech’s will be forced to rethink their role as product manufactures and forced to find new and innovative ways to deliver value in a rapidly evolving healthcare ecosystem. Failure of MedTech’s to accelerate their digital agendas will benefit giant technology companies who have entered the market and well positioned to take advantage of the digital transformation of the 4th Industrial Revolution: characterized by the marriage of physical and digital technologies and an ability to change the nature of work to the extent where a significant proportion of future enterprise value will be predicated upon analytics, artificial intelligence and cognitive computing.
 
Concern # 5: The dearth of millennials
 
An obstacle for MedTech to develop digital strategies and keep up with the pace of innovation is its inability to recruit, develop and retain millennials. This is significant because millennials are “digital natives” and crucial to MedTech’s shift to increase their service offerings.  Millennials have been raised in a digital, media-saturated world and are well positioned to opine on and contribute to digital initiatives. Also, millennials have a natural ability to understand, adopt and implement new technologies, use digital platforms and analyse data, which enable them to make informed decisions.
 
Unlike most C-suite executives, millennials inhabit a world unconstrained by precedent, where processes are digitized, and tasks automated to create seamless offline-to-online experiences. It seems reasonable to assume that with a dearth of such capabilities MedTech will lag other industries in defining and developing positive online interactions. This is important because effective digital strategies involve significantly more than simply providing online customer services. They involve leveraging social media and evolving technologies to create memorable experiences from content to customer support.

Millennials have a distinct ethical orientation and “sense of purpose”, which makes them difficult for traditional MedTech’s to recruit and retain. According to a 2018 survey by Deloitte’s, millennials tend to be pessimistic about the prospects for political and social progress and have concerns about social equality, safety and environmental sustainability. While they believe that business should consider stakeholders’ interests as well as profits, millennials’ perception of employers tend to be that they prioritize the bottom line above workers, society and the environment. This leaves millennials with little sense of loyalty to traditional business enterprises and thereby difficult to recruit and retain. According to Larry Fink, CEO, Black Rock, “To prosper over time, every company must not only deliver financial performance, but also show how it makes a positive contribution to society. Companies must benefit all of their stakeholders, including shareholders, employees, customers and the communities in which they operate”.

Given MedTech’s dearth of expertise in digital skills, it might be obliged to develop dedicated teams and processes to source and execute value-added partnerships in a similar way big pharma has.
 
Smartphone penetration driving digitization strategies
 
Digital healthcare strategies are driven by the increased penetration of smartphones and the plummeting costs of wireless communications. Smartphones are powerful multipurpose devices capable of performing a number of tasks beyond their primary purpose of communication. These range from using the mobile’s SMS function to send alerts and reminders, to leveraging inbuilt mobile sensors or apps to capture and interpret clinical data.  Over the past decade, smartphones have fuelled the rapid uptake of internet access and transformed life for developed market consumers in terms of convenience and simplicity. In the US and UK smartphone penetration is about 84% and 80% respectively with the older age groups (55+) recording the highest growth. Smartphones have served an even more pivotal role for emerging market consumers by placing the internet into the hands of millions of consumers. In 2018, 98% of the global population had access to a mobile network with 75% having access to the fast 4th generation networks. Smartphones, together with other wireless technologies, (mHealth), are increasingly used in healthcare by patients, healthcare providers and payers, to improve health outcomes, increase efficiencies and reduce large and escalating healthcare costs. It is anticipated that by 2020, global smartphone subscriptions will be about 6bn and growing rapidly especially in emerging economies such as China, India, Egypt, Turkey, and the United Arab Emirates. In the past three years health apps have doubled and have reached over 140,000. The global mHealth market is expected to grow at a CAGR of 45% over the next six years and reach US$236bn by 2026.
 
 Concern # 6: Healthcare in emerging economies is predicated upon digital strategies
 
The relative high levels of healthcare demand and spending are expected to increase in emerging markets as populations grow, household spending rises and smartphone penetration increases. This is important to MedTech because emerging economies represent about 85% of the world’s population, 90% of which is under 30, and this cohort is expected to grow at three times the rate of the similar cohort in developed economies. Further, over the past decade, the number of high-income households have risen globally by about 30% to nearly 570m, with over 50% of this growth coming from emerging economies in Asia. Asia is comprised of 48 countries and represents roughly 60% of the global population, and its stake in world markets has grown dramatically in the last half-century. Today, Asian countries rank as some of the world’s top producers, which has brought them significant wealth.
 
According to Euromonitor International more than 50% of the world’s (3.6bn) internet users reside in Asia. Between 2013 and 2018, Asia accounted for 60% of new users coming online and the region has become an economic powerhouse, populated by young, digitally savvy consumers.  China is the largest mobile market in the world with close to 1.2bn subscribers. Significantly, in 2018, China’s rate of growth in mobile internet penetration reached 58% and the number of smartphone connections surpassed 1bn. Similarly, in India, the number of smartphone users is expected to double to 859m by 2022 from 468m in 2017; growing at a compound annual growth rate (CAGR) of 12.9% and expected to reach 859m by 2022.
 
Digitized services are replacing traditional distributors in China
 
Western MedTech operations in China have tended to replicate the Western commercial model, which relies heavily on distributor networks. But this is changing.
 
China has a land mass similar to that of the US and a population 1.4bn organised by 34 provincial administrative units, which are comprised of 23 provinces, four municipalities, five autonomous regions and two special administrative regions. Healthcare in China consists of both public and private medical institutions and insurance programs. About 95% of the population has at least basic health insurance coverage and is served by over 31,000 hospitals, primary care is patchy and there is a shortage of doctors.  Because of China’s large number of dispersed healthcare providers, traditional distribution models employed by western MedTech companies tend to be inefficient and costly.
 
In recent years, MedTech’s operating in China, supported by Beijing policy makers, have been gaining back control over customers from distributors. The reason for this is because, in the vast bureaucratic Chinese healthcare system, distributors evolved far beyond their core capabilities and controlled most commercial activities. For instance, the value Chinese distributors capture, as opposed to manufacturers, is disproportionately high and has led to restrictive policies. This has caught the attention of  policy makers who are seeking to correct these practices by promoting direct to customer digitized healthcare services. Beijing is minded that effective healthcare services for the nation’s vast and dispersed population cannot be achieved with traditional healthcare delivery models and has to be predicated upon appropriate digitized direct-to-customer operations. Similarly, this is true of other large emerging economies, particularly India.
 
The future is Asia and digitization
 
The reason we suggest that digitization is likely to help MedTech’s increase their market share in China is because digitization has become an essential part of everyday life in China including mobile payments, online-to-offline services, the sharing economy, smart retail, digital ID cards and healthcare services. WeDoctor and WeChat, are at the centre of this digitized society and only show signs of increasing their influence over Chinese healthcare and lifestyle.

WeDoctor is just one example of several Chinese start-ups that has leveraged data and digital strategies to re-engineer the nation’s healthcare system. Founded in 2010, the company has grown into a US$6bn enterprise and not only has increased access to healthcare, improved diagnoses, enhanced patient outcomes and lowered costs, but has disintermediated traditional distributors by simplifying and centralizing the procurement processes of medical devices.
 
It is sometimes hard for people based outside of China to grasp just how fully digitized Chinese society has become. WeChat, known in China as Weixin, is a multi-purpose messaging, social media and mobile payment app first released in 2011. By 2018 it had become one of the world's largest standalone mobile super-apps and controls life in modern China. For most Chinese citizens, especially those living in cities, it is possible to get through an entire day using WeChat for your every need. Millions of businesses have chosen to create mini-apps within WeChat instead of developing their own standalone apps. These allow businesses to send promotional messages directly to their customers via WeChat, as well as tap into the WeChat’s broader user base. With 1bn active monthly users, WeChat has reached the ceiling of its growth within China and its future will be about developing more services, which includes connecting people to businesses and products offerings.
 
Takeaways
 
Over the past decade, while the MedTech industry has increased its asset value, leaders focussed on, (i) short-term growth, (ii) portfolio optimization and (iii) returning cash to shareholders. Also, they allowed R&D to stagnate and were slow to appreciate the strategic significance of digitization. Data and smart analytics are positioned to play an increasing role in future MedTech growth and value creation. They are the key to creating new and innovative service offerings for healthcare providers, patients and payers and critical to MedTech increasing its share in large fast-growing emerging markets. Future  MedTech leaders will be required to leverage both physical and digital assets. Significantly, they will need to enhance the efficiency of legacy manufacturing systems while developing and marketing new innovative offerings derived from data and smart analytics.
 
Postscriptum
 
A concern not mentioned in the above discussion is ‘recession, which although mooted since the sharp fall in markets in December 2018 has not materialized. Indeed, the S&P 500 continues to rally, rising from 2,351 in 24th December 2018, to 3,026 in 26th July 2019. However, a reason for bullish US stock markets is low interest rates: the lower the interest rate, the higher the multiple the market applies to earnings. One indicator of recession is the J.P. Morgan Global Manufacturing Purchasing Managers’ Index (PMI), which has been declining since January 2018. In May 2019, it fell below 50, which is the number that suggests a recession has started. Another indicator of a recession is the yield curve, which is a chart showing the interest rate paid on bonds of different maturity. As a forecasting tool, the difference between long- and short-term interest rates has proved to be a reliable indicator of future recessions. Currently, the difference between the yield on the US 10-year bond and the US 3-month T-Bill is negative. This means the yield curve is inverted, which indicates recession. However, the yield curve is only an indicator of a recession and is neither definitive nor causal.
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6 years, 6 months ago

MedTech must digitize to remain relevant

HealthPad
Directory:
Medical Technology
Tags:
commentary
digitization
healthcare expenditure
healthcare services
MedTech
  • Two Boston Consulting Group studies say MedTech innovation productivity is in decline
  • A history of strong growth and healthy margins render MedTechs slow to change their outdated business model
  • The MedTech sector is rapidly shifting from production to solutions
  • The dynamics of MedTechs' customer supply chain is changing significantly and MedTech manufacturers are no longer in control
  • Consolidation among buyers - hospitals and group purchasing organisations (GPO) - adds downward pressure on prices
  • Independent distributors have assumed marketing, customer support and education roles
  • GPOs have raised their fees and are struggling to change their model based on aggregate volume
  • Digitally savvy new entrants are reinventing how healthcare providers and suppliers work together
  • Amazon’s B2B Health Services is positioned to disrupt MedTechs, GPOs and distributors 
  • MedTech manufacturers need to enhance their digitization strategies to remain relevant
 
MedTech must digitize to remain relevant
 
MedTech companies need to accelerate their digital strategies and integrate digital solutions into their principal business plans if they are to maintain and enhance their position in an increasingly solution orientated healthcare ecosystem. With growing focus on healthcare value and outcomes and continued cost pressures, MedTechs need to get the most from their current portfolios to drive profitability. An area where significant improvements might be made in the short term is in MedTechs' customer facing supply chains. To achieve this, manufacturing companies need to make digitization and advanced analytics a central plank of their strategies.
 
In this Commentary
 
This Commentary describes the necessity for MedTechs to enhance their digitization strategies, which are increasingly relevant, as MedTech companies shift from production to solution orientated entities. In a previous Commentary we argued that MedTechs history of strong growth and healthy margins make them slow to change and implement digital strategies. Here we suggest that the business model, which served to accelerate MedTechs' financial success over the past decade is becoming less effective and device manufacturers need not only to generate value from the sale of their product offerings, but also from data their devices produce so they can create high quality affordable healthcare solutions. This we argue will require MedTechs developing  innovative strategies associated with significantly increasing their use of digital technology to enhance go-to-market activities, strengthen value propositions of products and services and streamline internal processes.
 
MedTechs operate with an outdated commercial model
 
Our discussion of digitization draws on two international benchmarking studies undertaken by the Boston Consulting Group (BCG). The first,  published in July 2013 and entitled, “Fixing the MedTech Commercial  Model: Still Deploying ‘Milkmen’ in a Megastore World” suggests that the high gross margins that MedTech companies enjoy, particularly in the US, hide unsustainable high costs and underdeveloped commercial skills. According to BCG the average MedTech company’s selling, general and administrative (SG&A) expenses - measured as a percentage of the cost of goods sold -  is 3.5 times higher than the average comparable technology company. The study concludes that MedTechs' outdated business model, dubbed the “milkman”, will have to change for companies to survive. 
 
BCG’s follow-up 2017 study
 
In 2017 BCG published a follow-up study entitled, “Moving Beyond the ‘Milkman’ Model in MedTech”, which surveyed some 6,000 employees and benchmarked financial and organizational data from 100 MedTech companies worldwide, including nine of the 10 largest companies in the sector. The study suggested that although there continued to be downward pressure on device prices, changes in buying processes and shrinking gross margins, few MedTech companies “have taken the bold moves required to create a leaner commercial model”.
 
According to the BCG’s 2017 study, “Overall, innovation productivity [in the MedTech sector] is in decline. In some product categories, low-cost competitors - including those from emerging markets - have grown rapidly and taken market share from established competitors. At the same time, purchasers are becoming more insistent on real-world evidence that premium medical devices create value by improving patient outcomes and reducing the total costs of care”. The growth and spread of value-based healthcare has shifted the basis of competition beyond products, “toward more comprehensive value propositions and solutions that address the entire patient pathway”. In this environment, MedTechs have no choice but to use data to deliver improved outcomes and a better customer experience for patients, healthcare providers and payers.
 
MedTech distributors increasing their market power and influence
 
Although supply chain costs tend to be MedTechs' second-highest expense after labour, companies  have been reluctant to employ digital strategies to reduce expenses and increase efficiencies. As a consequence, their customer supply chains tend to be labour intensive relationship driven with little effective sharing of data between different territories and sales teams. Customer relations are disaggregated with only modest attention paid to patients and payors and insufficient emphasis on systematically collecting, storing and analysing  data to support value outcomes.   
As MedTech manufacturers have been slow to develop strong and effective data strategies, so MedTech distributors have increased their bargaining power through M&As and internationalisation. Some distributors have even assumed marketing, customer support and education roles, while others have launched their own brands. MedTechs' response to these changes has been to increase their direct sales representatives. However, consolidation among buyers - hospitals and GPOs -  and the extra downward pressure this puts on prices, is likely to make it increasingly costly for MedTechs to sustain large permanent sales forces. 

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Advantages of distributors but no way to accurately measure sales performance

Notwithstanding, the distributor model is still common with MedTechs and has been successful in many markets for a long time. Independent distributors are often used when producers have small product portfolios. In smaller markets, distributors are employed primarily to gain economies of scale as they can combine portfolios of multiple companies to create a critical mass opportunity and  obtain better and faster access to markets.
 
MedTechs have a history of investing in sales force effectiveness (SFE) typically to increase the productivity of sales representatives. Sales leaders have some indication that this pays-off through incremental revenue growth and profits, but they struggle to assess the true performance of such investments not least because SFE includes a broad range of activities and also it is almost impossible to obtain comparative competitor data.
 
Changing nature of GPOs
 
GPOs also have changed. Originally, they were designed in the early 20th century to bring value to hospitals and healthcare systems by aggregating demand and negotiating lower prices among suppliers. Recently however they have raised their fees, invested in data repositories and analytics and have been driving their models and market position beyond contracting to more holistic management of the supply chain dynamics. Notwithstanding, many GPOs are struggling to change their model based on aggregate volume and are losing purchasing volume amid increasing competition and shifting preferences.
 
New entrants
The changing nature of MedTechs' customer supply chain and purchasers increasingly becoming concerned about inflated GPOs' prices have provided an opportunity for data savvy new entrants such as OpenMarkets. The companyprovides healthcare supply chain software that stabilizes the equipment valuation and cost reduction and aims to reinvent how healthcare providers and suppliers work together to improve the way healthcare equipment is bought and sold. OpenMarkets’ enhanced data management systems allow providers to better understand what they need to buy and when. The company represents over 4,000 healthcare facilities and more that 125 equipment suppliers; and provides a platform for over 32,000 products, which on average sell for about 12% less than comparable offerings. In addition, OpenMarkets promotes cost efficiency and price transparency as well as stronger collaboration between providers and suppliers.
 
Amazon’s B2B Health Services
 
But potentially the biggest threat to MedTech manufacturers, GPOs and distributors  is Amazon’s B2B Health Services, which is putting even more pressure on MedTechs to rethink their traditional business models and to work differently with healthcare providers and consumers. With a supply chain in place, a history of disrupting established sectors from publishing to food and a US$966bn market cap, Amazon is well positioned to disrupt healthcare supply chain practices, including contracting. In its first year Amazon’s B2B purchasing venture generated more than US$1bn and introduced three business verticals: healthcare, education and government. Already, hundreds of thousands of medical products are available on Amazon Business, from hand sanitizers to biopsy forceps. According to Chris Holt, Amazon’s B2B Health Services program leader, “there is a needed shift from an old, inefficient supply chain model that runs on physical contracts with distributors and manufacturers to Amazon's marketplace model”.

“If you look at the way a hospital system or a medical device company cuts purchase orders, identifies suppliers, shops for products, or negotiates terms and conditions, much of that has been constrained by what their information systems can do. I think that has really boxed in the way that companies’ function. Modern business and the millennials coming into the workplace, can’t operate in the old way,” says Holt.

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Is the digital transformation of MedTech companies a choice or a necessity?
Millennials are used to going to Amazon and quickly finding anything they need; even the most obscure items. According to Holt, “A real example is somebody who wants to find peanut butter that is gluten-free, non-GMO, organic, crunchy and in a certain size. And they want to find it in three to five clicks. That’s the mentality of millennial buyers at home, and they want to be able to do the same things at work. . . . The shift from offline traditional methods to online purchasing is very significant. It is our belief that the online channel is going to be the primary marketplace for even the most premium of medical devices in the future. That trend is already proven by data. So, we’ve created a dedicated team within Amazon Business to enable medical product suppliers to be visible and participate in that channel.”
MedTechs fight back
 
According to the two BCG reports, MedTech companies can fight back by using digital technologies to strengthen and improve their go-to-market activities. This, according to BCG, would enhance MedTechs' connectivity with their customers and help them to learn more about their needs. Indeed, employing digitization to improve customer-facing activities could help standardise order, payment and after-sales service behaviour by defining and standardizing terms and conditions. This could provide the basis to help MedTechs increase their access to a range of customers - clinicians, institutions, insurers and patients - and assist them to tailor their engagements to the personal preferences of providers and purchasers. This could provide customers with access to product and service information at anytime, anywhere and could form the basis to implement broader digitalized distribution management improvements, which focus on value-based affordable healthcare in the face of escalating healthcare costs and variable patient outcomes.
 
Predictive models
 
Many companies use predictive-modelling tools to forecast demand and geo-analytics to speed delivery and reduce inventories. Online platforms provide customers with an easy way to order products and services, transparently follow their shipping status and return products when necessary. Barcodes and radio-frequency identification (RFID) chips, which use electromagnetic fields to automatically identify and track tags that contain electronically stored information attached to products, help customers track orders, request replenishments and manage consignment stock.
 
Back-office improvements
 
Further, the 2017 BCG study suggests that MedTechs only have made limited progress in improving their back-office operations. Many manufacturers  have more employees in their back offices than they do in their customer-facing functions and fail to leverage economies of scale. There is a significant opportunity for MedTechs to employ digital strategies to enhance the management of their back-office functions, including centralizing certain activities that are currently conducted in multiple individual countries.
 
Takeaway
 
For the past decade MedTech manufactures have been slow to transform their strategies and business models and still have been commercially successful. Some MedTech companies are incorporating digital capabilities into their products by connecting them to the Internet of Things (IoT), which potentially facilitate continuous disease monitoring and management. Notwithstanding, such efforts tend to be isolated endeavours - “one-offs” - and are not fully integrated into companies’ main strategies. This could run the risk of MedTech executives kidding themselves that they are embracing digitization while underinvesting in digital technologies. The two BCG studies represent a significant warning since digitization is positioned to bring a step-change to the MedTech sector, which potentially could wound successful manufacturers if they do not change.
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6 years, 11 months ago

Is the digital transformation of MedTech companies a choice or a necessity?

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Medical Technology
Tags:
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Medical Technology
MedTech

Is the digital transformation of MedTech companies a choice or a necessity?
 
Will 2019 see medical technology (MedTech) companies begin to digitally transform their strategies and business models to improve their commercial prospects?
 
We describe some of the changing market conditions that drive such transformations. We also briefly report the findings of two research papers on corporate digital transformations published in recent editions of the Harvard Business Review. These suggest that there are two “must haves” if company transformations are to be successful: leadership with the appropriate mindset and access to talented data scientists.
 
A bull market encouraging a business-as-usual mindset
 
MedTech is a large growing industrial sector (see below), which has benefitted significantly from the bull market in equities over the past decade but is one of the least equipped to prosper over the next decade in a radically changing healthcare ecosystem and a more uncertain global economy.

For the past decade equity markets have outperformed global economic growth and protected a conservative, production-orientated business-as-usual mindset in MedTech C-suites and boards of directors. This has made organizations either slow or reluctant to transform their strategies and business models, which define how they create and capture value. As we enter 2019 the protection that the MedTech industry enjoyed for years has been weakened by more uncertain markets, the tightening of monetary policy, slower global economic growth and disruptive technological change.

In this new and rapidly evolving environment MedTech markets are expected to continue growing but at a slower rate, operating margins are expected to decline as unit prices erode and companies will no longer be able to earn premium margins by business-as-usual strategies. Building a prosperous organization in a more uneven future is an important challenge facing MedTech leaders and will require a significant shift in their mindset and the talent they engage and develop.  
 
Medical technology

MedTech represents a significant sector of global healthcare, which has been relatively stable for decades. It has a market size of some US$430bn and has consistently experienced high margins and significant sales growth. For example, over the past decade the sector has grown at an annual compound growth rate of about 5%, with operating margins between 23% and 25%. The sector includes most medical devices, which prevent, diagnose and treat diseases. The most well-known include in vitro diagnostics, medical imaging equipment, dialysis machines, orthopaedic implants and pacemakers. The US and Western Europe are established centres for the sector, but trends suggest that China and India will grow in significance over the next decade. The sector is dominated by about 10 giant companies, which account for nearly 40% of the global market in sales revenues. All MedTech companies have significant R&D programs and the global spend on R&D is expected to grow from US$27bn in 2017 to US$34bn by 2022. An indication of how far developments in medical technology have come is robot-assisted surgery, which employs artificial intelligence (AI) for more precise and efficacious procedures. Robot-assisted surgery is expected to become a US$13bn global market by 2025. In the US the repeal of the medical device excise tax was not included in the recent tax reform. The industry believes the tax has a negative impact on innovation, and the rate of R&D spending by US MedTech companies is expected to fall by 0.5% over the next five years.
 
Resistance to change

For the past decade a substantial proportion of MedTech companies either have resisted or been slow to transform their strategies and business models despite increasing pressure from rapidly evolving technologies, changing reimbursement and regulatory environments and a chorus of Industry observers calling for MedTech companies to become less product-centric and more solutions orientated. This reluctance to change can be explained by a bull market in equities, which began in March 2009, outperformed economic growth, delivered some of the best risk-adjusted returns in modern market history and encouraged a conservative mindset among corporate leaders, who were reluctant to change and developed a “if it’s not broken why fix it” mindset.

Because the MedTech sector has been stable for years, established players have been able to compete successfully across the device spectrum, applying common business models and processes without much need for differentiation. MedTech’s strategy has been to market high priced sophisticated product offerings in a few wealthy regions of the world; mainly the US, Western Europe and Japan, which although representing only 13% of the world’s population account for more than 86% of the global MedTech market share (US: 42%, Europe: 33%, Japan: 11%). It seems reasonable to assume that in the future, as markets become more turbulent and uncertain, this undifferentiated strategy and business model will need to transform into ones that are far more distinctive and proprietary.
 
M&A has been MedTech’s principal response to market headwinds

MedTech’s principal adjustment to market headwinds over the past decade has been to increase its M&A activity rather than transform its strategies and business models. M&A’s increased companies scale and leverage, drove stronger financial performance, allowed companies to obtain a broader portfolio of product offerings and increased their international footprints. Some recent high-profile examples of M&A activity in the sector include Abbott’s acquisition of St. Jude’s Medical in January 2017, which led to Abbott holding some 20% of the US$40bn global cardiovascular market. Johnson & Johnson’s US$4bn buyout of Abbott Medical Optics Inc in February 2017, and the “mother of all M&A activity” was Becton Dickinson’s 2017 acquisition of C.R. Bard for US$24bn, which is expected to generate annual revenues of US$15bn.

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’s, and between 2006 and 2016, only 20% of 54 pure-play publicly traded MedTech companies, “mostly relied on organic growth”. 
As MedTech leaders return to their desks in early 2019 after the worst December in stock market recent memory, they might begin to reflect on their past all-consuming M&A activity, which resulted in bigger but not necessarily better companies. After such a prolonged period of M&A’s, there is likely to be a period of portfolio optimization. Divestitures and spin-outs allow companies to capture additional value by improving capital efficiency, reducing operational complexity and reallocating capital to higher-growth businesses as the industry invests more in R&D to develop innovative product offerings that demonstrate value in an increasing volatile era and increasing price pressures. But divestitures are not necessarily changing strategies and business models, so MedTech’s vulnerabilities remain.
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The IoT and healthcare


 
Black December 2018 for equities
 
It is too early to say whether “Black December 2018” represents the end of the longest equity market bull-run in recent history, but it is worth noting that on Friday 21st December the Nasdaq composite index closed at 6,332.99, which was a drop of 21.9% from an all-time high of 8,109.69 on August 29th. The generally accepted definition of a bear market is a drop of at least 20% from a recent peak. World markets followed Wall Street. Japan’s Topix Index fell to its lowest level for 18 months and the pan European Stoxx 600 Index hit a two-year low. However, seasoned market observers suggest that although the average bull market tends to last for about 10 years, it does not simply die of old age, and the December 2018 market behaviour is consistent with a “maturing cycle” in which there is still room for stocks to grow. This note of optimism could encourage a continuation of a “business-as-usual” mindset in MedTech C-suites and boards of directors.
 
Anaemic economic growth forecasted

The outlook for the global economy in 2019 does not bring any comfort. In October 2018 the International Monetary Fund lowered its forecast for global economic growth for 2019, from 3.9% to 3.7%; citing rising trade protectionism and instability in emerging markets. In September 2018 the Organisation for Economic Cooperation and Development (OEDC) suggested that economic expansion may have peaked and projected global growth in 2019 to settle at 3.7%, “marginally below pre-crisis norms with downside risks intensifying.” The OECD also warned that the recovery since the 2008 recession had been slow and only possible with an exceptional degree of stimulus from central banks. And such support is ceasing.
 
Tightening of monetary policy

Global monetary policy is tightening as central banks retreat from their long-standing market support. After four years of quantitative easing (QE) the European Central Bank (ECB) has ended both its money printing program and its €2.6trn bond purchasing program. The Bank has done this just as the Eurozone growth is cooling and Europe seems to be destined for a slow relative decline, which raises concerns about the sustainability of the single currency area. Notwithstanding, some observers suggests that for the next few years capital can be reasonably safely deployed in the beer-drinking nations of northern Europe, but not in the wine-drinking countries of southern Europe; especially France and Italy, two countries at the centre of the Eurozone’s current challenges. France’s budget deficit exceeds that permitted by the EU and in the latter part of 2018 the nation’s anti-government gilets jaunes demonstrators led to President Macron promising more welfare spending than the nation can afford. This could suggest that France is on the cusp of an Italian-style debt crisis. Although these economic trends have been telegraphed for some time, after nearly a decade of a bull market and low interest rates, there seems to be some complacency in the equity markets about the risks from higher rates and elevated corporate debt. But this sentiment is expected to change in 2019.
 
Transformation is no longer a choice

This more uncertain global economic outlook, heightened US-China tensions, tighter monetary policy and a maturing global business cycle together with significantly changed and evolving healthcare ecosystems suggest that transformation of MedTech strategies and business models is no longer a choice but a necessity if they are to maintain and increase their market positions over the next decade.
 
A challenge for many MedTech companies is that they still work on dated and inappropriate systems or hierarchical processes, and too few leaders and board members fully comprehend the speed and potential impact of advanced digital technologies. Those organization with some appreciation of this are already looking to adjacent sectors for talent and knowhow that could help them evolve their strategies and business models. But such partnerships might not be as efficacious as expected. We explain why below.
 
Digital transformations

Let us turn now to consider digital transformations. Data scientists and machine learning engineers are critical to any digital transformation. One significant challenge for companies contemplating such change is talent shortage, which disproportionately affects companies not use to dealing with such talent. Data scientists are aware of their scarcity value and they tend not to work in IT silos of traditional hierarchical organizations but prefer working for giant tech companies in devolved networked teams, focusing on projects that interest them.

Companies that fail to engage talented data scientists will be at a disadvantage in any digital transformation. Mindful of such challenges some MedTech companies are beginning to partner with start-ups and smaller digitally orientated companies. But this is not necessarily an answer because talent shortage also affects start-ups. The answer lies in understanding how giant tech companies recruit talented individuals. Companies like Google and Facebook are more interested in “tech savvy” individuals and less interested in formal qualifications. They tend to catch such talent with attractive internships when they are seniors in high school and juniors at university. These companies understand digital technology and have seen enough interns that they can correlate their performance on coding tests and technical interviews with their raw ability and potential rather than relying on formal qualifications as a proxy for skill.
 
A new and more dynamic leadership mindsets

Future MedTech leaders will not only need to have a deep knowledge of disruptive digital technologies and AI systems, but will need to have the mindset of an “inclusive networked architect” with an ability to create and develop learning organizations around diverse technologies with dispersed talent. Traditional hierarchical production mindsets, which have benefitted from business-as-usual for the past decade are unlikely to be as effective in an environment which is experiencing the impact of a significant and rapid shift in technological innovation. Sensors, big data analytics, AI, real-world evidence (RWE), robotic and cognitive automation are converging with MedTech and encouraging companies to pivot from being product developers to solution providers. This requires leaders with mindsets that reward value instead of volume and are agile enough to meet increasing customer expectations, whether those customers are payers, providers or patients.

Without leaders with informed, forward-thinking mindsets, enthused about new models of organizational structures, culture and rewards that provide greater autonomy to talented teams and individuals, MedTech companies could remain at a disadvantage in competing with other technology companies for similar talent and expertise. Future MedTech leaders must understand how work is being redefined and the implications of this for talented individuals and devolved networked teams. It seems reasonable to assume that future MedTech leaders will be generalists: executives with more than one specialism with an ability to breakdown silos and bridge knowledge gaps across organizations and develop new models of organizational structure, culture, and rewards.
 
Successes and failures of digital transformations

We have focused on digital transformation of traditional companies as a means for them to prosper in radically changing market conditions. Although there has been a number of successful corporate digital transformations there has also been a significant number of failures. Understanding why some succeed and some fail is important.
 
Successful digital transformations

One notable successful digital transformation is Honeywell, a Fortune 100 diversified technology and manufacturing company, which overcame threats from market changes and disruptive digital technologies by transforming its strategies and business models. In 2016, Honeywell’s Process Solutions Division, a pioneer in automated control systems and services for the  oil, gas, chemical and mining industries, set up a new digital transformation unit to assist its customers to harness advantages from the Internet of Things (IoT) by increasing their connectivity to an ever-growing number of devices, sensors and people in order to improve the safety, reliability and efficiency of their operations.

The Unit’s primary focus is on outcomes, such as reducing costs and enabling faster and smarter business decisions. Honeywell’s IoT platform called Sentience, is considered a toolkit to collect, store and process data from connected assets, offering services to analyse these data and generate insights from them to enable data-based, value-added services. Unlike similar platforms developed by Siemens and General Electric (GE), Honeywell does not sell their platform as an app, but markets data-based services predicated on its platform, which enable its customers to optimize the performance of their connected assets and improve overall production efficiency. Other corporations that have set up similar transformation units to harness the benefits of disruptive technologies include Hitachi, Hewlett-Packard, SAP and UPS.

Failed digital transformations

Perhaps the biggest digital transformational failure is General Electric (GE). In 2011, the then CEO Jeff Immelt became an advocate for the company’s digital transformation. GE created and developed a significant portfolio of digital capabilities including a new platform for the IoTs, which collected and processed data used to enhance sales processes and supplier relationships. Immelt suggested that GE had become a “digital industrial company”. The company’s new digital technology reported outcomes of a number of indices, which over time improved and attracted a significant amount of positive press. Notwithstanding, activist investors were not so enamoured, GE’s stock price languished, Immelt was replaced and the company’s digital ambitions came to a grinding halt. Other notable corporates, which tried and failed to harness the commercial benefits from disruptive technologies include Lego, Nike, Procter & Gamble and Burberry.  

Digitally transformed companies outperform those that resist change

Notwithstanding, research findings published in the January 2017 edition of the Harvard Business Review suggest that digitally transformed companies outperform those that lag behind. Findings were derived from 344 US public companies drawn from manufacturing, consumer packaging, financial services and retail industries with median revenues of some US$3.4bn. Conclusions suggest that digitally transformed companies reported better gross margins, enhanced earnings and increased net income compared to similar companies, which lagged behind in digital change. “Digital technology changes the way an organization can create value: digital value creation stems from new, network-centric ways your business connects with partners and customers offering new business combinations,” say the authors of the study. Critically, the mindset of leaders is significantly linked to successful digital transitions. According to the study’s authors, “Our research indicates that these leaders approach the digital opportunity with a different strategic mindset and execute on the opportunity with a different operating model.”

Reasons for failing to transform

According to a paper published in the March 2018 edition of the Harvard Business Review there are four reasons why digital transformations fail.
  • Leaders’ narrow understanding of “digital”, which is not just technology but a blend of talented people, organizational culture, appropriate machines and effective business processes
  • Poor economic conditions and depressed demand for product offerings
  • Bad timing. It is important that your market sector is prepared for the changes your company is proposing
  • Paying insufficient attention to legacy business. “The allure of digital can become all-consuming, causing executives to pay too much attention to the new and not enough to the old”. 
 
Takeaways
 
Business history has shown that large and established companies, which fail to respond to disruptive technologies in a timely and appropriate fashion can fail and disappear. Notable examples include America Online, Barnes & Noble, Borders, Compaq, HMV, Kodak, Netscape, Nokia, Pan Am, Polaroid, Radio Shack, Tower Records, Toys R Us and Xerox. MedTech leaders might be mindful of Charles Darwin’s hypothesis, which he describes in his book, On the Origin of Species published in 1859. Darwin suggests that “in the struggle for survival, the fittest win out at the expense of their rivals because they succeed in adapting themselves best to their environment”. Such a statement would not be out of place in a modern boardroom. It suggests that all industrial sectors need to develop to keep abreast of innovations and evolving trends. The main difference is that Darwin’s natural selection processes take millions of years, while significant changes that effect commercial businesses can take a matter of months.
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7 years, 2 months ago

Can Western companies engage with and benefit from China?

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Belts and Road Initiative
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Made in China 20
Medical Technology
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Pearl River Delta
  • China will not challenge the economic supremacy of the US in the near to medium term
  • But with a GDP of US$14trn growing at 6.9% a year China is a substantial economy and a significant trading partner of the US
  • China is replacing imported high-tech products with domestic ones and incentivizing Chinese companies to dominate high value global industries
  • China’s large and increasing supply of appropriately qualified human capital gives it a competitive edge
  • Beijing’s US$8trn-30-year Belt and Road (B&R) strategy aims to make China the centre of a new world order in which knowledge-based Chinese companies dominate high-value global markets
  • China is challenged by substantial debt and significant credit it has extended to economically weak nations
  • Notwithstanding, Western companies seeking growth outside their current wealthy markets need to develop constructive trading relationships with China
  • Lack of understanding and cultural differences are barriers to productive West-East trading relations
 
Can Western companies engage with and benefit from China?
 
Previously we described how Beijing had offered Western companies a ‘poisoned challis’: either localize your value chain and help China achieve its goals to dominate key industries globally or be progressively squeezed out of markets. Washington responded by levying punitive tariffs on products manufactured in China and marketed in the US in an attempt to force Beijing to change. China hit back, cross fire ensued, more US tariffs were levied, markets became nervous and a ‘flight for liquidity’ seems a possibility. This is when equity players become nervous about uncertainties in markets and move their investments into more liquid securities in order to increase their ability to sell their positions at a moment’s notice. To some observers the current trade conflict between the world’s two largest trading nations must seem like Stanley Kramer’s 1952 epic ‘High Noon” movie. The difference being the 2018 showdown could affect the lives of billions and threaten the global economy. The fact that the world can be brought to such a position in such a short time is partly due to a profound lack of understanding and cultural differences between Washington and Beijing and vice versa. The differences manifest themselves as: (i) competition versus harmony, (ii) short-termism versus long-termism, (iii) tactics versus strategy and (iv) nationalism versus globalism. These differences pervade organizations, institutions and mindsets in the respective regions.
 
In this Commentary

This Commentary is divided it into 3 parts.
  • Part 1: China’s penetration of emerging markets discusses the implications of China’s stated aim to become a major global high-end, knowledge-based economy and describes how, for the past three decades, the nation has been preparing for this by systematically upgrading its human capital. From a perceived position of strength Beijing suggested to Western companies seeking or increasing their franchises in China that unless they are prepared to localize their value chains, not only will they be squeezed out of the China market, but they will also encounter challenges in other large emerging markets as China’s presence and influence in these markets increase. This is significant because the world’s emerging economies are the growth frontiers of many high-tech industries. 
  • Part 2: China’s economic rise and its strategic objectives briefly describes China’s phenomenal transformation from a centrally managed economy to the world’s second largest economic power and a significant commercial partner of the US. We provide glimpses of some aspects of China’s recent history in order to convey the scale of its industrial reforms and its well-resourced, central government-backed long-term strategies to establish China as a world leader in knowledge-based high-value industries. We describe China’s planned slowdown of its economy and how Beijing is systematically upgrading its human capital. Indicative of China’s increasing trading prowess are its new technology companies. We describe three, which are likely to have a significant global impact in the next 5 years. We conclude part 2 with a description of the Pearl River Delta, China’s high tech production hub, in order to provide further insights into China’s achievements, the nature and scale of its projects to upgrade its economy and the thinking that drives China’s economic transformation. 
  • Part 3: China’s ‘Belts and Road’ (B&R) initiative. B&R is a bold ‘neo colonialist’ initiative to build a 21st century ‘Silk Road’ of infrastructure and trade-links between China and Eurasia. This is expected to stimulate trade, economic growth and domestic employment in some of the least developed regions of the world, which have suffered from post-colonial decline and are neglected by the West. Beijing expects that the B&R project will position China at the centre of a newly formed global trading network. We review some of the concerns raised by the R&D initiative including China's increasing exposure as a principal creditor to economically weak nations. This, together with China's mounting debt, presents Western companies with a dilemma: China is too big to be ignored but its structural weaknesses could be damaging.   
 

Part 1
 
 China’s penetration of emerging markets
 
 
Made in China 2025 (MIC25) incentivizes Chinese enterprises to develop their competences and capacities in order to respond to the pivotal needs of global customers to reduce costs while maintaining value by providing affordable quality product offerings.  It also encourages Chinese companies to become ‘global champions’ and help China establish itself as a dominant international force in knowledge-based technologies of the future. As a result, Chinese companies are successfully taking share of key segments in emerging markets. So, Beijing’s industrial strategies not only increase the challenges for Western companies in China, but also provide potential barriers for them to penetrate and increase their franchises in other large emerging markets such India and Brazil, which are the future growth frontiers.
 
China’s investment in human capital

Beijing’s well-resourced strategies to transition China from a manufacturing-based economy to a high-end, innovation-driven, knowledge-based economy could not be achieved without a significant supply of relevant human capital. It is instructive that for the past three decades China has been systematically upgrading its human capital, while Western nations have not been doing so at a similar pace.
 
According to the World Economic Forum, China has committed massive resources to education and training. In 2016 China was building the equivalent of one university a week and graduated 4.7m citizens, while in the US 568,000 students graduated. In 2017, there were 2,914 colleges and universities in China with over 20m students. The US had 4,140 with over 17m students enrolled. Significantly, between 2002 and 2014 the number of students graduating in science and engineering in China quadrupled. In 2013, 40% of all Chinese graduates completed a degree in science, technology, engineering or mathematics (STEM), whilst in the US only 20% of its graduates did so. In addition to China producing more STEM graduates than either the US or Europe, which are vital for high-tech knowledge-based industries of the future, the gap between the top Chinese and US and European graduates is widening. Projections suggest that by 2030 the number of 25 to 34-year-old graduates in China will increase by a further 300%, compared with an expected rise of around 30% in the US and Europe. This represents a substantial shift in the world's population of graduates, which was once dominated by the US, and gives China a potential competitive edge in high-tech growth industries of the future.
 
Further, US students struggle to afford university fees. Many American colleges and universities are struggling financially and as a consequence actively recruiting foreign students. In recent years, the number of Chinese students admitted to US universities has increased significantly. In 2017 for instance, some 350,000 Chinese students were recruited. Most graduates return to China with quality degrees. European countries have put a brake on expanding their universities by either not making public investments in them or restricting universities to raise money themselves.
 
Shanghai students are world’s best in maths, reading and science

Supporting this competitive edge is China’s world-beating performance of its 15 and 16-year-olds. According to an internationally recognised test, Shanghai school children are the best in the world at mathematics, reading and science. Every three years 0.5m students aged 15 and 16 from 72 countries representing 80% of the global economy sit a 2-hour examination to assess their comparative abilities in these three subjects. The examination, called the Program for International Student Assessment (PISA), is administered and published triennially by the Organisation for Economic Co-operation and Development (OECD). When the 2009 and 2012 PISA  scores were released they created a sensation, suggesting that students in Shanghai have significantly better mathematics, reading and science capabilities than comparable students in any other country.  Although these scores have been contested, and the most recent test scores suggest Shanghai students have slipped down the rankings, in the 2012 tests Shanghai students performed so well in mathematics that the report compared their scores to the equivalent of nearly three years of schooling above most countries.
 
Human capital strategies challenged by aging populations
Human capital strategies in China, the US and Western Europe are all challenged by aging populations. According to the United Nations, China’s population is ageing more rapidly than any country in recent history. America’s 65-and-over population is projected to nearly double over the next three decades, rising from 48m to 88m by 2050. The UK’s population also is getting older with 18% aged 65-and-over and 2.4% aged 85-and-over. In 2014, 20% of Western Europeans were 65 years or older and by 2030 25% will be that age demographic.
 
Taking share of high-value MedTech markets
 
Many Western MedTech companies are late-bloomers in emerging markets. This can partly be explained by the two decades of economic growth the industry experienced from developed markets and the continued buoyancy of the US stock market.  Thus, Western MedTech companies have felt little pressure to adjust their strategies and business models and venture into territories committed to “affordable (low priced) medical devices”. Beijing seems determined to take advantage of this and Chinese companies are increasing their share of large fast growing and underserved emerging markets by: (i) increasing their innovative go-to-market strategies and (ii) making sure they “localize” their product offerings. We briefly describe these two strategies.
 
Innovative go-to-market approaches

According to OEDC data, between 2000 and 2016 China doubled its R&D investment to 2% of GDP, which is more than the EU but less than America. In 2016, the US spent 2.7% of its GDP on R&D, which is more than any country. Individual Chinese domestic companies are also increasing their investments in R&D as part of their growth strategies. For instance, over the past decade, Mindray, China’s largest MedTech company has spent more than 10% of its annual revenues - currently US$1.7bn - on R&D. The company has a large R&D team of over 1,400 located in 2 centres: 1 in Mahwah, China and another in Seattle, USA. BGI, China’s largest manufacturer of next-generation gene-sequencing equipment, devotes more than 33% of its revenues to R&D, double that of its US competitor Illumina. In aggregate, however, Chinese companies are a long way behind their Western counterparts when it comes to R&D spending.
 
Supercomputers
High-tech companies require supercomputers to assist with their R&D and innovative strategies. These are powerful and sophisticated machines with enormous processing power, which can support medical and scientific R&D. According to an internationally recognised ranking, which has been conducted biannually by leading scientists since 1993, China leads the world with its installed-base of supercomputers. China has 206 and  America has 124. In 2000 China had none. The most recent rankings show that the US has regained the top performance position from China with an IBM-system-backed supercomputer now running at the US Department of Energy’s Oak Ridge National Laboratory. 
 
Increasing number of Chinese patents
Although the US maintains a lead in scientific breakthroughs and their industrial applications, innovation is increasing in China. The number of invention patent applications received by China in 2016 was 1.3m, which was more than the combined total from the US (605,571), Japan (318,381), South Korea (208,830), and the EU (159,358). Patents from these five countries accounted for 84% of the world total in 2016. 
 
Increasing share of high-tech markets
Emboldened by enhanced processing power, increased patents, greater R&D capacity and improved capabilities, Chinese MedTech companies are increasingly represented across a broad spectrum of high-end medical technologies and have made significant inroads into emerging markets. Some manufacture Class III product offerings such as orthopaedic implants and are beginning to compete in medium-level technology markets in Brazil, India, Japan and the UK. For instance, SHINVA markets its linear accelerators globally. Sinocare is #6 in the global market for blood glucose monitoring devices. In 2008 Mindray paid US$200m to acquire the patient monitoring business of US company Datascope, making it the third-largest player by sales in the global market for such devices. Also, Mindray has increased its share of the ultrasound imaging market to 10%, behind GE and Phillips. MicroPort broke onto the world stage in early 2014 when it acquired Wright Medical’s orthopaedic implant business for US$290m. In 2015 China overtook Germany to become Japan’s second largest supplier of MRI devices, behind the US, and Biosensors International is among the largest suppliers of drug-eluting stents in France, Germany, Italy, Spain and the UK.
 
Localized product offerings in India
 
Mindray, which positions itself as a world-class MedTech solutions company, has established a significant presence in India where it has built local operations, tailored its line of affordable high-quality patient monitoring, ultrasound and in vitro diagnostic devices to address India’s unmet needs, hired local engineers and operators and built a local marketing and sales team, which provides a 24-7 customer service. Mindray has understood that many of the factors, which drive China’s MedTech market growth are mirrored in India and other rapidly growing emerging markets that share a similarly high disease burden, aging demographics and a desire to reduce healthcare costs.
 
Mindray was one of China’s earliest MedTech companies to list in New York in 2006. However, the company felt its shares were undervalued and privatized in 2016 in a deal, which valued the company at US$3.3bn. A funding round shortly after its delisting valued Mindray at US$8.5bn. The company employs over 8,000 and its 2017 revenues were US$1.7bn.
 
India’s MedTech market
 
The attraction of India to MedTech companies is easy to understand. India’s MedTech market is the 5th largest in the world and could rival that of Japan and Germany in size by 2022 if it continues its 17% annual growth. Although India mainly has been an out-of-pocket healthcare market this is changing. In September 2018, the Indian government launched one of the world’s largest publicly funded health insurance schemes, which will provide some 0.5bn poor people with health cover of US$7,000 per year (a sizable sum in India) for free treatment of serious ailments. India’s medical device markets, like those of China’s, will benefit from this, but also from the country’s large and growing middle class with relatively high disposable incomes in an economy growing at around 7 to 7.5% annually.
 
In 2016 India’s middle class was estimated to be 267m - 83% of the total population of the US - and projected to increase to 547m by 2025. Further, India has a large and growing incidence of lifetime chronic diseases, which expands the need for medical devices. Between 2009 and 2016, China emerged as India’s 3rd largest supplier of medical devices (behind the US and Germany) and is currently India’s leading provider of CT scanners, representing 50% of the US$69m that India spent on imports of these high-tech devices during 2016. India’s orthopaedic devices market is estimated to be around US$375m and is projected to grow at about 20% each year for the next decade to reach US$2.5bn by 2030. In contrast the global orthopaedics industry is estimated to grow at 5% annually.

China is positioned to increase its share of MedTech markets in India and other emerging countries. This suggests that unless Western companies are prepared to transform their strategies and change their business models similar to what Medtronic and GE Healthcare have done, they will not only be squeezed out of the China market but shall encounter challenges to penetrate and increase their franchises in other large emerging MedTech markets. This is significant because the world’s emerging economies are the growth frontiers of the MedTech industry.


Part 2

China’s economic rise and strategic objectives: background

 
“How long can China sustain its rise?”. We broach this question in the next two parts of this Commentary. Here in Part 2, we describe some relevant aspects of China’s recent commercial history, its success in producing high tech global companies and we also provide a glimpse of its urban communities for creating and developing companies of the future.

It was not until the early 1980s, after the death of Mao Zedong in 1976, that China started to dismantle its centrally planned economy and began implementing its free market reforms and opened its economy to foreign trade and investment. Shortly afterwards China: (i) became the world’s fastest growing market-based economy with real annual GDP growth averaging 9.5% through 2017, (ii) lifted 800m citizens out of poverty and (iii) overtook Japan to become the world's second largest economy. By 2010 China had become a significant commercial partner of the US and is now America’s largest merchandise trading partner, its biggest source of imports and America’s third largest export market. Also, China holds US$1.7trn of US Treasury securities, which help fund the federal debt and keep US interest rates low. It is worth noting that China has a long history dating back more than 2,000 years BC. In more recent times, Adam Smith the father of modern capitalism, described China in The Wealth of Nations (1776) as a country which is, “one of the most fertile, best cultivated, most industrious, most prosperous and most urbanized countries in the world”.
 
Avoiding a middle-income trap
 
Over the past decade China’s economy has matured and Beijing has managed a planned slowdown of its growth rate to what it calls the “new-normal”. In 2017 China’s GDP was 6.9% and is projected to fall to 5.6% by 2022. The orchestrated slowdown is less based on fixed investment and exports and more on private consumption of China’s large and growing middle class, enhanced services and innovation. A previous Commentary described Beijing’s Made in China 2025 (MIC25) initiative and other policies, which prioritised innovation and the systematic upgrading of its domestic industries whilst decreasing its reliance on foreign technology. This is essential for China to avoid a ‘middle income trap’, which happens when nations achieve a certain level of economic growth, but then begin to experience diminishing returns because they are unable to restructure their economies to embrace new sources of growth.
 
Baidu, Alibaba and Tencent: BAT

An example of China’s ability to upgrade its economy and avoid a middle-income trap is its new technology companies, which are positioned to have significant global roles in the next five years. We briefly describe three: Baidu, Alibaba and Tencent: collectively referred to as BAT. Baidu, is a Chinese language Internet search provider incorporated in 2000, which has grown to  become the world’s 8th largest internet company by revenue. It has a market cap of US$80bn, annual revenues US$13bn and has the world’s largest Internet user population of about 800m. Alibaba, was founded in 2000 as a business-to-business (B2B) portal connecting Chinese manufacturers to overseas buyers. Today, the company is a multinational conglomerate with a market cap in excess of US$500bn and annual revenues of US$13bn. It is the world’s largest e-commerce company in terms of gross merchandise volume (GMV). For the fiscal year ended March 31, 2017, Alibaba had a GMV of US$0.43trn and 454m annual active buyers on its marketplaces. Alibaba’s long-term vision is to become a global company providing solutions to real world problems and using e-commerce to help globalization by making trade more inclusive. The company expects GMV to reach US$1trn by 2020, and to serve 2bn consumers(one-third of the world’s total population)and to support the profitable operation of 10m businesses on its platforms by 2036. Alibaba is sometimes referred to as the "Amazon of China," but the company’s founder Jack Ma suggests there are differences. "Amazon is more like an empire: everything they control themselves. Our philosophy is be an ecosystem”, says Ma. Tencent, founded in 1998, has become a multinational investment holding corporation with a market cap of US$556bn, annual revenues of US$22bn and specializes in various internet-related services, entertainment, AI and technology.  
 
The Pearl River Delta
 
Tencent has its HQs in Shenzhen, a megacity in the Pearl River Delta, which is China’s hub for high tech production. We briefly describe the delta to further show the progress China has made in transforming its economy. In the early 1980s the Pearl River Delta was primarily an agricultural area and Shenzhen was an unassuming town of about 30,000 (now 13m). The delta witnessed the most rapid urban expansion in human history to become the world’s largest urban area in both size and population by 2015, with more inhabitants than Argentina, Australia or Canada. Today the Pearl River Delta has a population of 120m and a GDP of US$1.5trn - growing at 12% per year - which is greater than that of Indonesia and equal to 9.1% of China’s output.
 
Land, sea and air infrastructure serving the delta is state of the art. For example, the delta has six airports; three of which are international air hubs. In 2016, the passenger traffic of Baiyun Airport in Guangzhou (population 15m) surpassed 60m and the volume of freight it handled was over 2m tonnes. In the same year passenger traffic at Shenzhen (population 13m) airport was in excess of 42m and the volume of freight it handled was over 1m tonnes.  This compares favourably with JFK and Newark Liberty airports. In 2017 both airports set records with more than 59m and 43m passengers respectively.

Part of the delta’s infrastructure is the new Hong Kong-Zhuhai-Macau Bridge, which spans 34 miles (55klm), crosses the waters of the Pearl River and connects Hong Kong with Macao. It is the longest sea-crossing bridge ever built and has a section that runs for seven kilometres in a submarine tunnel that passes four artificial islands. Its construction cost US$16bn, which is part of a US$30bn plan announced in 2009 to develop an infrastructure network to connect the nine cities in the delta so that collectively they would become the largest contiguous urban region in the world, which was achieved in 2015.  One of the infrastructure goals is to reduce travel time between the nine cities and Hong Kong and Macao to one hour from any which way.
 
The Pearl River Delta is the most southern of three major Chinese coastal growth areas. In the middle is the Yangtze River Delta region, which includes Shanghai with a population of 130m and a GDP of US$2trn. To the north is the Beijing-Tianjin-Bohai corridor, covering 10 cities and has a population of 100m and a GDP of US$1.3trn. These three urban clusters account for 21% of China’s population and about 40% of its GDP.


Part 3

 China’s Belt and Road initiative

 
It is not only important to understand the changes in China within the context of its recent history, MIC25 and Beijing’s restructuring of its healthcare sector, but also against the backdrop of China’s ambitious “Belt and Road” (B&R) initiative. Unveiled by President Xi Jinping in September 2013, it has become the centre of Beijing’s ambitions for a new world order predicated upon a modern-day Silk Road connecting China by land and sea to Southeast Asia, Central Asia, the Middle East, Europe and Africa. It is a bold model of economic development, which Xi has called, “the project of the century”. The initiative is supported by the new Asian Infrastructure Investment Bank (AIIB) and the Silk Road Fund. Some estimates suggest that Beijing has already invested US$900bn in the project. Overall, it is expected to cost US$8trn and take three decades to complete. At its core are 6 economic corridors, which connect 65 countries, about 65% of the world’s population, involve some 40% of global trade and 33% of global GDP.
 
Belt and Road’s 6 economic corridors
  1. The Eurasia-Land-Bridge economic corridor is developing rail transportation between China and Europe through Kazakhstan, Russia and Belarus
  2. The China-Mongolia-Russia economic corridor aims to develop trade between China and Mongolia by modernizing transport, telecommunication and energy networks to make Mongolia a hub between China and Russia
  3. The China-Central Asia-West Asia economic corridor connects the Chinese province of Xinjiang to the Mediterranean Sea, through Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan, Turkmenistan, Iran and Turkey 
  4. The China-Indochina-Peninsula economic corridor aims to strengthen cooperation among states of the Greater Mekong sub-region and support trade between China and the 10 nations of the Association of Southeast Asian Nations (ASEAN) that are already bound by a free trade agreement since 2010 to facilitate economic growth
  5. The China-Pakistan economic corridor connects Kashgar in the Chinese province of Xinjiang to the port of Gwadar in Pakistan and includes the construction of railways, highways, optical fibre networks, and the creation of an international airport in Gwadar as well as the establishment of special economic zones
  6. The Bangladesh-China-India-Myanmar economic corridor links Kunming to Kolkata (Calcutta) via Mandalay and Dhaka to strengthen connections between China and various economic centres of the Gulf of Bengal in order to increase interregional trade by reducing non-tariff barriers.
China’s neo-colonial strategy
 
China’s B&R initiative is based upon an interpretation of colonialism, which is significantly different to Western  interpretations. While Western nations struggle with a sense of guilt associated with their past colonial rule and feel responsible for the abject economic failure, widespread poverty and erosion of governance in post-colonial independent states, Beijing believes that there are lessons to be learned from colonialism, which are relevant today and necessary prerequisites to stimulate trade, economic growth and domestic employment. Beijing’s B&R initiative is best understood as a neo colonial strategy to strengthen China’s slowing economy, enhance its industrial capabilities and improve its geopolitical standing by driving economic growth in some of the least developed regions of the world, which are neglected by the West.
 
The lessons of Singapore
 
China’s neo-colonialist policies are influenced by Singapore, an island city-state located in Southeast Asia off southern Malaysia. The country gained independence from Malaysia in 1965 and has become a global financial centre with a multicultural population and a multi-party parliamentary representative democracy with a President as head of state and a Prime Minister as the head of government. Although China is 14,000-times bigger than Singapore, has 1bn more citizens and its GDP is US$14trn compared to Singapore’s US$300bn; China views Singapore as an object lesson of political stability and prosperity predicated upon aspects of its colonial legacy, which Beijing believes can be replicated in under-developed regions of the world. These include basic infrastructure, improved administration, widened employment opportunities, female rights, expanded education, improved public healthcare, taxation, access to capital, independent judiciary, and national identity. Such factors China views as benefits of colonialism and necessary prerequisites for trade, economic growth and prosperity. Singapore has a colonial history, but today is a rich country with a GDP per capita of US$55,235, (higher than that of the US: US$53,128) and where Asian culture is intact and Western knowhow is harnessed for economic growth and prosperity for its citizens and is where China would like to be in the future.
 
The AIIB comparable to other development banks
 
In 2013, when Xi Jinping first proposed creating the Asian Infrastructure Investment Bank (AIIB), Washington was against it and campaigned rigorously to persuade potential donor countries not to participate. The US expressed concerns that the AIIB would undermine the World Bank, and the Asian Development Bank (ADB), which operate in Asia and lend to China. Washington also believed that the AIIB would unfairly benefit Chinese companies and argued that China would not adhere to international banking standards of transparency and accountability. Today, the AIIB is up and running as a medium-sized regional development bank with capital of US$100bn and lending at around US$4bn. It is broadly comparable with other development banks and Washington’s concerns appear unfounded.
 
Systematically migrating low-tech manufacturing to low-cost locations
 
An important role of the AIIB is to assist the B&R initiative to open up and create new markets for Chinese goods and services, to stimulate exports and to provide low-wage locations, to which China can migrate its light manufacturing industries. Beijing no longer sees its country’s economy as competitive on the basis of low wages. China’s labour costs are rising faster than gains in productivity and cost estimates of outsourcing production to China will soon be equal to the cost of manufacturing in the US and Western Europe. China is adjusting to rising real wages in its domestic markets by systematically migrating its low-tech industries to less-common low-wage production operations in new locations in Africa such as Ethiopia.

A rationale for this strategy is provided in a 2017 paper from the Center for Global Development, which suggests that “Ethiopia could become the new China” as, “the cost of Ethiopian industrial labour is about 25% that of China today”. This suggests that migrating Chinese low-tech manufacturers might leap-frog middle and lower-middle income developing countries in favour of the poorest countries such as Ethiopia, which is included in China’s B&R initiative. African countries view B&R as a platform to promote global cooperation based on win-win strategies. Speaking at a conference in June 2018 in Addis Ababa, Tan Jian, the Chinese ambassador to Ethiopia said, "We are working closely with Ethiopia in advancing the Belt and Road Initiative. Ethiopia is a very important partner in this regard. We have been doing a lot of projects here in Ethiopia: infrastructure, policy dialogue, trade, financing and people-to-people exchanges.” At the same conference Afework Kassu, Ethiopia's Minister of Foreign Affairs, said, “the Belt and Road initiative is an advantage for African countries for infrastructure development and for economic growth”.
 
Concerns about China’s neo colonialism and debt management
 
Despite these good words, China's B&R initiative is not free of criticism mostly from Western nations and international institutions, which suggest Beijing’s motivation is a retrograde strategy that employs globalization to service its domestic economy, and many of the concerns are about China’s potential economic predominance.
 
A March 2018 Center for Global Development (CGD) paper suggests that because China’s record of international debt financing is not good, and the B&R initiative follows China’s past practices for infrastructure financing, which entail lending to sovereign borrowers, then the initiative runs the risk of creating debt distress in some borrower nations. The paper identifies 8 of the 68 B&R borrower countries as “particularly at risk of debt distress”. Pakistan is the largest country at high risk with the development of its Gwadar deep-sea port, which is part of the B&R China-Pakistan Economic Corridor. China is financing about 80% of this endeavour, which is estimated to cost US$62bn.  Other countries mentioned in the CGD paper to be at high-risk of debt distress from the R&D initiative include Djibouti, the Maldives, Laos, Mongolia, Montenegro, Tajikistan and Kyrgyzstan. The concern is that these at-risk nations could be left with significant debt ‘overhangs’, which could impede their ability to make essential future public investments and thereby challenge their economic growth more generally. Recently, public concerns from within China have been raised over the costs of the initiative. There is also concern that debt problems will create “an unfavourable degree of dependency” on China as a creditor. Several US Senators have expressed similar concerns and suggest that potential defaults could have a deleterious economic impact more generally. In addition to B&R loans, which have been questioned, it has been rumoured that Beijing has lent Venezuela US$60bn and also extended significant credit to Argentina. Venezuela is in economic meltdown and Argentina has applied to the IMF for a bailout. 
 
China’s mounting debt
 
China’s increasing exposure as a significant creditor to economically weak developing nations is compounded by its mounting debt and triggers concerns about China’s future stability. A popular Washington view, endorsed by President Trump’s chief economic adviser Larry Kudlow, is that China’s mounting debt and slowing growth mean that its “economy is going south”, and the recent imposition of tariffs on Chinese exports to the US will accelerate the nation’s demise. However, there is a view that Washington’s imposition of punitive tariffs is an over-reaction because the Chinese economy is nowhere as strong as that of the US economy. Notwithstanding, China is an important trading partner for the US and American companies should find a way to engage with China.
 
Since the 2008 financial crisis, China’s debt has been a concern in Beijing because it was a driver of the country’s economic growth. In 2016, Vice-Premier Liu He, President Xi’s top economic adviser, conscious of the potential national security risks of China’s mounting debt, took steps to de-risk the country’s financial sector. More recently, Liu has accelerated infrastructure investment and taken steps to avoid a banking crisis by ensuring that the renminbi does not fall too rapidly against the US dollar. Over the past 5 months the renminbi has weakened about 10% against the US$ and could weaken further if the currency becomes politicized. Despite Liu’s efforts to reign-in and control China’s debt, which some estimates put at about  260% of GDP, it is not altogether clear how successful these efforts will be especially if China’s debt challenges are considered in conjunction with its loose credit conditions.
 
Changing world economic order

Putting aside these concerns, it is instructive to note that a 2017 study by Price Waterhouse Coopers (PwC), suggests, ceteris paribus, that within the next decade China’s economy will be bigger than America’s and within the next three decades India’s economy will overtake that of the US. The study argues that the US will rank 3rd in the world and in 4th place could be Indonesia. The study suggests that China will have an economy of US$59trn, while India’s will be around US$44trn and America’s will total $34trn. Significantly, Japan (US$6.7trn), Germany (US$6.1trn), the UK ($5.3trn) and France (US$4.7trn), key markets for Western MedTech companies, are expected to fall respectively to 8th, 9th, 10th and 12th in the list. They are expected to be replaced by Indonesia (US$10.5trn), Brazil (US$7.5trn), Russia (US$7.1trn), and Mexico (US$6.8trn), which climb to 4th, 5th 6th and 7th positions respectively. This signals some significant economic shifts likely to take place over the next two to three decades and underlines the importance of emerging economies in the medium-term strategic plans of Western companies.
 
Takeaways
 
The world is on the cusp of some significant  economic changes and the two nations most likely to affect those changes are the US and China. Beijing’s policies and global aspirations are helping China to step into a leadership void created by Washington’s current rejection of multilateralism. However, it is still not altogether clear whether China will be able to sustain this new position, and the uncertainty this causes presents a significant strategic dilemma for Western companies seeking growth outside their current markets in the developed world. China is too big to be ignored by Western companies, but China’s conditions for engagement are onerous and its long-term stability remains in doubt.
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