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  • Over the next decade the combination of big data, analytics and the Internet of Things (IoT) will radically change healthcare
  • The social media revolution has raised peoples’ awareness of lifestyles and healthcare
  • The rise of smart watches and fitness sensors combined with IOT and Artificial Intelligence (AI) paves the way for preventative medicine becoming a key driver in the management of straining healthcare services and spending
  • Big data, analytics and the IoT is positioned to accelerate change away from output-orientated healthcare systems to value-based outcome-orientated systems
  • Patients and payers are increasingly aware of the opportunities and demanding change
  • The slowness for MedTech companies to change creates opportunities for newcomers to penetrate and grab share of healthcare markets
  • Regulation and requirements to undergo significant clinical studies to become standard of care will slow consumer and patient access to services
  
The IoT and healthcare
 
The Internet of Things (IoT) is positioned to radically transform healthcare. There are powerful social, demographic, technological, and economic drivers of this change. We describe some of these, and suggest that, within the next 10 years, there will be hundreds of millions of networked medical devices sharing data and knowhow, and this will drive a significant shift away from traditional healthcare systems focused on outputs to value-based systems dedicated to prevention and improving outcomes while lowering costs.
 

The IoT and its potential impact on healthcare
 
The IoT, which Cisco refers to as “the Internet of Everything” and GE as the “Industrial Internet” is also referred to as “machine-to-machine” (M2M) technologies, and as “smart sensors”. Whatever term is used, the IoT is an ever-expanding universe of devices embedded with microchips, sensors, and wireless communications capabilities, which enable them to collect, store, send and receive data. These smart devices and the data they collect are interconnected via the Internet, which significantly expands their potential uses and value. The IoT enables connectivity from anywhere to anywhere at any time, and facilitates the accumulation of big data and artificial intelligence (AI) to either complement or replace the human decision-maker. Over the next decade, anything that can be connected to the Internet probably will be. The Internet provides an almost ubiquitous, high-speed network, and cloud-based analytics, which, in nanoseconds, can read, analyse and act upon terabytes of aggregated medical data. Smart distributed services are positioned to become a powerful tool for health providers by optimizing medical results, preventing mistakes, relieving overburdened health professionals, improving patient outcomes, and lowering costs.
 
Two approaches to a common healthcare challenge

Let us illustrate the shift in healthcare referred to above by considering two different approaches to a shared healthcare challenge: that of providing people with personalized advice about maintaining and improving their wellbeing in order to ward-off lifestyle related illnesses, such as type 2 diabetes (T2DM). This is important because T2DM is a devastating lifestyle induced condition, which affects millions, costs billions, and in most cases can be prevented by lifestyle changes.
 
Approach 1

One approach is the world’s first nationwide diabetes prevention program, Healthier You, which was launched by NHS England, Public Health England and Diabetes UK in 2016. It is aimed at the 11m people in England thought to have pre-diabetes, which is where blood sugar levels are higher than normal, but not high enough for a diagnosis of T2DM. About 5-10% of people with pre-diabetes progress to "full-blown" T2DM in any given year. Healthier You is expected to be fully operational by 2020. Each year thereafter the program is expected to recruit 100,000 people at risk of T2DM. Personal lifestyle coaches will periodically monitor the blood sugar levels of these, and make recommendations about their diets and lifestyles. This is expected to prevent or slow the people with pre-diabetes progressing to full-blown T2DM.
 
Approach 2

The second approach is GymKit and Chatbox. The former is a new feature Apple is expected to add to its watch in late 2017, and the latter is a mobile app developed by Equinox, a New York-based health club chain, for its members.

Gymkit will enable the Apple watch to have seamless connectivity to the overwhelming majority of different kinds of cardiovascular equipment used in most fitness centres. Currently, there are a variety of smartphone apps, which allow gym users to connect to cardiovascular machines, but these are at best patchy. Gymkit is different, and will automatically adjust a user’s personalized needs to any cardiovascular machine without the user having to press a button. Itwill then wirelessly collect a range of data - if on a treadmill: speed, duration, incline, etc., - and combine these data with the user’s heart rate, age, gender, weight and body type to make health-related calculations and recommendations, and wirelessly transmit these to the user.

Chatbox does something similar. Ituses artificial intelligence (AI) to simulate the human voice, which talks to new health club members, encourages them to set personal goals, and sends them messages when they fall short. Further, Chatbox has sensors, which track users while they are in the gym, and suggests ways of improving and extending their personalized workouts. A survey, undertaken by Equinox of its members across 88 of its facilities reported that Chatbox users visited the fitness centres 40% more often than those without the app. This is significant because people who fail to form a habit of physical exercise tend to drop lifestyle goals.

The 2 approaches compared

Healthier You is unlikely to have more than a modest impact on the UK’s diabetes burden because the format it has adopted is like filling a swimming pool with a teaspoon. It would take over 100 years to recruit and counsel the 11m people with pre-diabetes, especially while the prevalence levels of pre-diabetes and T2DM in the UK are increasing.  Successfully changing the diets and lifestyles of large numbers of people requires an understanding of 21st century technologies. Ubiquitous healthcare technologies such as smartphone apps and wearable’s that support lifestyles abound, and have leveraged people's enhanced awareness of themselves and their health. Hence peoples’ large and rapidly growing demands for such devices to track their weight, blood pressure, daily exercise, diet etc. From apps to wearables, healthcare technology lets people feel in control of their health, while potentially providing health professionals with more patient data than ever before.  

The IoT and consumers

There are more than 165,000 healthcare apps currently on the market, there is a rapid growth in wearables, and smartphone penetration in the US and UK has surpassed 80% and 75% respectively. According to a 2017 US survey by Anthem Blue Cross, 70m people in the US use wearable health monitoring devices, 52% of smartphone users gather health information using mobile apps, and 93% of doctors believe mobile apps can improve health. 86% of doctors say wearables increase patient engagement with their own health, and 88% of doctors want patients to monitor their health. 51% of doctors use electronic access to clinical information from other doctors, and 91% of hospitals in the US have moved to electronic patient records (EPR).
 
Notwithstanding, these apps and wearables are rarely configured to aggregate, export and share the data they collect in order to improve outcomes and lower costs. This reduces their utility and value. However, the large and rapid growth of this market on the back of the social media revolution, and the impact it is having on shaping the attitudes and expectations of millions of consumers of healthcare, positions it well as a potential driver of significant change.

 A “minuscule fraction” of what is ultimately possible

According to Roger Kornberg, Professor of Structural Biology at Stanford University, the current capabilities of smart sensors like those used in Apple’sGymKit and Equinox’s Chatbox, “is only a minuscule fraction of what is ultimately possible . . . A sensor attached to a smartphone will enable it to answer any question that we may have about ourselves, and our environment,” says Kornberg. Smart sensors can provide you with a doctor in your pocket, which can be connected to a plethora of other devices that could collect, store, analyze and feedback terabytes of medical information in real time. Kornberg, who won the 2006 Nobel Prize for Chemistry, is excited about the disruptive effect, which smart sensors are having on traditional healthcare systems. This is because they can be connected to almost any medical device and human organ to, “monitor specimens . . . record in real time the health status of individuals,  . . . transmitelectronic signals wirelessly,  . . .  (and) provide responses to any treatment,” says Kornberg. 

Kornberg is engaged in developing sensors with the ability to detect and measure biological signals and data from humans, which can be wirelessly linked to smartphones to transmit the information for analysis, storage and further communication. Kornberg is convinced that, in the near term, we will be able to create a simple and affordable networked device that will, “detectan impending heart attack, in a precise and quantitative manner, before any symptoms”.
 


Potential of sensor technology



The excitement in the development of biosensors

 
Drivers of the IoT and market trends

Partly driving the IoT in healthcare and other industries are the: (i) general availability of affordable broadband Internet, (ii) almost ubiquitous smartphone penetration, (iii) increases in computer processing power, (iv) enhanced networking capabilities, (v) miniaturization, especially of computer chips and cameras, (vi) the digitalization of data, (vii) growth of big data repositories, and (viii) advances in AI and data mining.
 
Market trends suggest substantial growth in the total number of networked smart devices in use. By 2020, when the world’s population is expected to reach 7.6bn, it is projected that there will be between 19 and 50bn IoT-connected devices worldwide, more than 8bn broadband access points, more than 4m IoT jobs, and the number of installed IoT technologies will exceed that of personal computers by a factor of 10.
 
Crisis in primary care is a significant driver of change
 
In addition to these technological drivers, the simultaneous population aging and the shrinking pool of doctors also drives the IoT in healthcare. Increasing numbers of older people presenting with complex comorbidities significantly increases the large and rapidly growing demands on an over-stretched, shrinking population of doctors. This results in a crisis of care.
 
A 2015 Report from the Association of American Medical Colleges (AAMC) suggests that there is an 11 to 17% growth in total healthcare demand, of which a growing and aging population is a significant component. Further, the Report suggests that the US could lose 100,000 doctors by 2025, and that primary care physicians will account for 33% of that shortage.

There is a similar crisis in the UK, where trainee GPs are dwindling, young GPs are moving abroad, and experienced GPs are retiring early. According to data from the UK’s General Medical Council (GMC), between 2008 and 2014 an average of nearly 3,000 certificates were issued annually to enable British doctors to work abroad. Currently, there are hundreds of vacancies for GP trainees. Findings from a 2015 British Medical Association (BMA) poll of over 15,000 GPs, found that 34% of respondents plan to retire by 2020 because of high stress levels, unmanageable workloads, and too little time with patients.
 
Interestingly, Brexit is expected to compound the crisis of care in the UK. According to a 2017 General Medical Council survey of more than 2,000 doctors from the EU working in the UK, 60% said they were considering leaving the UK, and, of those, 91% said the UK’s decision to leave the EU was a factor in their considerations. 

 
Changing healthcare ecosystems

These trends help healthcare payers to employ IoT strategies in an attempt to replace traditional healthcare systems, which act when illnesses occur and report services rendered, with value-based healthcare systems focused on outcomes. US payers are leading this transformation. Some payers in the US have employed IoT strategies to convert a number of devices used in various therapeutic pathways into smart devices that collect, aggregate and process terabytes of healthcare data gathered from thousands of healthcare providers, and electronic patient records (EPRs) describing millions of treatments doctors have prescribed to people presenting similar symptoms and disease states. Cognitive computing systems analyse these data and instantaneously identify patterns that doctors cannot. Such systems, although proprietary, are positioned to help reduce the ongoing challenges of inaccurate, late, and delayed diagnoses, which each year cost the US economy some US$750bn and lead to between 40,000 and 80,000 patient deaths.
 
IBM Watson
 
IBM’s supercomputer, Watson is a well-known proprietary system that uses IoT strategies that include a network of smart sensors and databases to assist doctors in various aspects of diagnoses and treatment plans tailored to patients’ individual symptoms, genetics, and medical histories. Watson draws from 600,000 medical evidence reports, 1.5m EPRs, millions of clinical trials, and 2m pages of text from medical journals. A variant, IBM Watson for Oncology, has been designed specifically to help oncologists, and is currently in use at the Memorial Sloan-Kettering Cancer Center in New York. Also, it is being used in India where there is a shortage of oncologists. The Manipal Hospital Group, India’s third largest healthcare group, which manages about 5,000 beds, and provides comprehensive care to around 2m patients every year, is using Watson for Oncology to support diagnosis and treatment for more than 200,000 cancer patients each year across 16 of its hospitals.
 
In 2016 IBM, made a US$3bn investment designed to increase the alignment of its Watson super cognitive computing with the IoT, and allocated more than US$200m to its global Watson IoT headquarters in Munich. IBM will have over 1,000 Munich-based researchers, engineers, developers and business experts working closely with specific industries, including healthcare, to draw insights from billions of sensors embedded in medical devices, hospital beds, health clinics, wearables and apps in endeavors to develop IoT healthcare solutions.
 
Babylon
 
Using a similar IoT network of smart sensors and databases, Babylon, a UK-based subscription health service start-up, has launched a digital healthcare AI-based app, which offers patients video and text-based consultations with doctors, and is designed to improve medical diagnoses and treatments. Early in 2017, NHS England started a 6-month study to test the app’s efficacy by making it available to 1.2m London residents. The Babylon app is expected to be able to analyse, “hundreds of millions of combinations of symptoms” in real time, while taking into account individualized information of a patient’s genetics, environment, behavior, and biology. Current regulations do not allow the Babylon app to make formal diagnoses, so it is employed to assist doctors by recommending diagnoses and treatment options. Notwithstanding, Ali Parsa, Babylon’s founder and CEO says, "Our scientists have little doubt that our AI will soon diagnose and predict personal health better than doctors”.
 
Market forecasts

Market studies stress the vast and growing economic impact of the IoT on healthcare. Business Insider Intelligence (BII) suggested that the IoT has created nearly US$100bn additional revenue in medical devices alone. It forecasts that cost savings and productivity gains generated through the IoT and subsequent changes will create between US$1.1 and US$2.5trillion in value in the healthcare sector by 2025. In 2016, Grand View Research Inc. projected that the global IoT healthcare market will reach nearly US$410bn by 2022. A 2013 Report from the McKinsey Global Institute on Disruptive Technologies, suggests that the potential total economic impact of IoT will be between US$3 and US$6trillion per year by 2025, the largest of which will be felt in healthcare and manufacturing sectors. Although forecasts differ, there is general agreement that, over the next decade, the IoT is projected to provide substantial economic and healthcare benefits in the way of cost savings, improved outcomes, and efficiency improvements.
  
IoT and MedTech companies

We have briefly described the impact of the IoT on patients, healthcare payers and providers. But what about MedTech companies? They have the capabilities and knowhow to develop and integrate the IoT into their next generation devices. However, MedTech innovations tend to be small improvements to existing product offerings. Data, accumulated from numerous smart medical devices, are enhanced in value once they are merged, aggregated, analyzed and communicated. And herein lies the challenge of data security. Arguably the greater the connectivity between medical devices, the greater the security threat. In 2013 the FDA issued a safety communication regarding cyber security for medical devices and health providers, and recommended that MedTech companies determine appropriate safeguards to reduce the risk of device failure due to cyber-attacks. The cautious modus vivendi of most MedTech companies suggests that, in the near term, a significant proportion will not develop IoT strategies, and this creates a gap in the market.
 
The IoT and new and rising healthcare players

Taking advantage of this market gap is a relatively small group of data-orientated companies, which have started to employ IoT technologies to gain access to healthcare markets by developing specific product offerings, increasing collaborative R&D, and acquiring new data oriented start-ups. For instance, in addition to IBM and Apple mentioned above, Amazon is expected to enter the global pharmaceutical market, which is anticipated to reach over US$1 trillion by 2022. Microsoft has used IoT strategies to build its Microsoft Azure cloud platform to facilitate cloud-based delivery of multiple healthcare services. Google Genomics is using IoT strategies to assist the life science community organise the world’s genomic data and make it accessible by applying the same technologies that power Google Search to securely store petabytes of genomic information, which can be analysed, and shared by life science researchers throughout the world.

Takeaways
 
The powerful social, demographic, technological and economic drivers of healthcare change over the next decade suggest an increasing influence of IoT technologies in a sector not known for radical or innovative change. Research suggests that hundreds of millions of networked medical devices will proliferate globally within the next decade. The potential healthcare benefits to be derived from these are expected to be significant, especially through enhancing preventative and outcome-oriented healthcare while reducing costs. This has to be achieved in a highly regulated environment where concerns of data security are paramount. To reap the potential benefits of the IoT in healthcare, policymakers will have to reconcile the need for IoT regulation with the significant projected benefits of the IoT. Smart technologies require smart management and smart regulation.
 
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In January 2013 Andrew Marr, the 53-year-old BBC TV presenter and journalist, had a stroke after a bout of intensive exercise on a rowing machine in a gym.
 
What is a stroke?
A stroke is a serious medical emergency where the supply of blood to the brain is disrupted. In over 80% of cases, strokes usually happen because a blood clot blocks the blood supply to the brain. They can also happen when a weakened blood vessel that supplies the brain bursts and causes brain damage, known as a haemorrhagic stroke.
 
Andrew Marr's stroke prompted two questions: (i) Do younger healthy people have strokes? and (ii) Does physical exercise contribute to strokes?    
 
Are stroke victims getting younger?
Andrew Marr was one of 152,000 people in the UK who have strokes each year. Stroke is the third largest cause of death in the UK and the largest single cause of severe disability. There are approximately 1.1 million stroke survivors living in the UK and each year strokes cost the NHS £2.8 billion.
 
The picture is no better in the US, where every 40 seconds a person has a stroke, each year strokes kill 130,000 and cost the US $38.6.
 
Strokes are uncommon, but not rare in men in their fifties like Andrew Marr. Recent research suggests that strokes among the elderly are declining, while strokes among younger people are increasing.
 
Between 1998 and 1999 in the UK, 9,000 people under 55 were admitted to hospital due to stroke. By 2011 this figure had risen to more than 1,600.
 
It is not altogether clear why stroke is increasing among younger people, although experts note its correlation with type 2 diabetes.
 
The importance of specialist stroke units
Andrew Marr said that he believed what he read, that taking, "Very intensive exercise in short bursts is the way to health." Just before his stroke he said, "I went onto a rowing machine and gave it everything I had and had a strange feeling afterwards: a blinding headache and flashes of light". He took no notice and went home. The following morning he woke up lying on the floor unable to move.
 
The most important care for people with any form of stroke is prompt admission to a specialist stroke unit, but even with prompt treatment a stroke can often be fatal. 
 
Physical exercise and stroke
Marr, who is making a good recovery, said his advice would be to be wary of rowing machines, or at least of being too enthusiastic on them.
 
According to Dr Mike Loosemore, an expert in sports medicine at University College Hospital, London, "Intensive physical activity after work doesn't compensate for long periods sitting still in an office during the day (sedentary behavior). Lack of physical activity and sedentary behavior are two seperate risk factors. That's like saying drinking less alcohol can compensate for smoking and it can't".
 
In the first interview given after his stroke, Andrew Marr mentioned that he discovered that he had had a couple of mini strokes the previous year. A mini-stroke, or transient ischaemic attack (TIA), is similar to a stroke but the symptoms only last a few minutes. Due to the short duration of symptoms, many people are unaware they have had a stroke, as was the case with Marr. While not as serious as a stroke, a TIA is an important warning sign that you need to make substantial changes to your lifestyle or start taking medication and usually both.
 
Risk factors and prevention
The main risk factor for a haemorrhagic stroke is high blood pressure as the excess pressure can weaken the arteries in the brain and make them prone to splitting or rupturing. You cannot control some stroke risk factors, such as heredity, age, gender and ethnicity. Some medical conditions, such as high blood pressure, high cholesterol, heart disease, diabetes, overweight or obesity and previous stroke or TIA, can also raise your stroke risk. However, avoiding smoking and drinking too much alcohol, eating a balanced diet and increasing your activity are all choices you can make to reduce your risk of stroke.
 
According to Dr Loosemore, "The best way of preventing a stroke is to eat a healthy diet, engage in regular activity, avoid drinking too much alcohol and stop smoking. I'd stress activity rather than exercise because activity can be done anywhere at any time. Increasing your activity at work is probably better for you than intensive work-outs in a gym after work. For example, at work you can stand instead of sitting and take the stairs instead of the elevator.It's never too late to increase your activity, eat more healthily, stop smoking or cut down on alcohol".
 
Symptoms and aftercare
The symptoms of a stroke include, (i) sudden numbness or weakness of the face, arm, or leg-especially on one side of the body, (ii) sudden confusion, trouble speaking or understanding, (iii) sudden trouble seeing in one or both eyes, (iv) sudden trouble walking, dizziness, loss of balance or coordination and (v) sudden severe headache with no known cause.
 
Andrew Marr mentioned that the stroke had fortunately not impaired his voice or memory, but had affected, "the whole left hand side of my body, which is why I'm still not able to walk fluently". Stroke does not only cause physical damage, it also incurs psychological and emotional damage on survivors and their families. These effects, which include depression and aphasia (problems with language and speaking), are often profound, last a lifetime and are inadequately supported.
 
eHealth and managing stroke survivors
A stroke both debilitates and isolates a person. More than half of all stroke survivors are left dependent upon others for everyday activities. To give more control to patients medical professionals are increasingly using eHealth strategies to manage the aftercare of stroke patients.   
 
Standard behavioural therapies used to rehabilitate stroke patients, translate well into eHealth strategies and onto apps for smart phones and tablets. These include telemedicine, social media forums and apps to enhance impaired cognition and movement. Increasingly, stroke units throughout the country are using telemedicine, which enable doctors to check patients in their homes. This saves money and increases the quality of care. The introduction of eHealth devices means that stroke survivors can take greater control of their treatments from their homes and, as a consequence, feel more independent and less isolated.
 
Investment in research
Investment in stroke research is critical to the reduction and management of the disease. The majority of stroke research in the UK is supported by the Stroke Association, a charity. Each year the charity disburses about £30 million on research, which is small compared to the annual UK research expenditures on cancer and heart disease.
  
Does austerity promote health benefits?
According to an American public health organisation, 75% of healthcare costs are spent on treating sick people with preventable conditions, but only 3% on preventing people from getting sick in the first place.
 
To help reduce and manage the escalation of stroke, more  might be spent on preventive strategies.
 
Interestingly, following the Cuban Missile Crisis, the incidence of strokes, heart attacks and cancer fell significantly among Cuban citizens as their enforced isolation and austerity obliged them to adopt healthier diets and lifestyles. Could austerity trigger something similar in the UK?
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Patients want health information in ways that doctors are not providing.
 
Patients want reliable answers to simple questions about the presentation, diagnosis, treatment options, side effects, and aftercare of their conditions. They want answers at speed, and increasingly delivered to their smartphones in video formats.
 
With difficulties gaining face-time with doctors, patients turn to the Internet. Worldwide, some three billion health-related Internet searches are made each year.
 
Patients experience difficulty finding reliable answers to their basic questions among more than two billion health websites. According to research published by the American National Institute of Health, 33% of adults who search the Internet for health information become confused by what they find. This frustrates their therapeutic journeys and makes for fraught doctor-patient relations.
 
Things are changing, however, and now patients have a new free-and-easy-to-use online platform, www.healthpad.net. This provides patients with video answers to their FAQs that can be accessed at speed at anytime, from anywhere on any hand held device.
HealthPad
HealthPad was started by doctors and launched in June 2013. It has accrued a growing exclusive healthcare content library of over 4,000 videos that provide patients with premium, reliable answers to their FAQs across 32 therapeutic pathways. 

This unique health content library with embedded search facilities, has been contributed by leading health providers from premier North American, European and South Asian medical institutions. 
 
HealthPad does more than reformat print content into digital words and substitute a website for books and journals. The platform leverages the online communications potential, and is an interactive, multimedia utility, which meets the needs, health status and personal backgrounds of patients and patient groups.   
 
Enhanced communications
HealthPad serves the needs of patients by enabling doctors to capture, organize and distribute their medical knowledge more effectively. Doctors can drag-and-drop any type of content into a publishing template: scans, pdf files, ppt. presentations, videos, diagrams, photos, commentaries etc. These data are instantly and automatically re-formatted into attractive rich-media publications. By a click of a mouse, doctors then can choose how they wish to share their publications, ranging from private and secure to public and open.
 
In addition to publishing health knowledge, doctors can use HealthPad to create, develop and manage any number of bespoke online patient groups. 
 
What doctors say about HealthPad
"My HealthPad videos personalize medicine and have positive psycho-social effects. Because of HealthPad patients feel that they know me before we have even met and are less inclined to be swayed by discordant and often incorrect medical information they encounter on the internet that can create misperceptions and fear". Dr. Whitfield Growdon, Onco-surgeon, Harvard University Medical School and the Massachusetts General Hospital.
 
"My patients now don't always have to attend a hospital for reliable information to help them manage their conditions. HealthPad allows me to reduce valuable face-time with my patients while improving doctor-patient relationships and patient compliance by helping them understand their conditions and treatments better". Dr Sufyan Hussain, an endocrinologist specializing in diabetes at Imperial College, London.
 
Drivers of change
The overwhelming majority of UK doctors provide medical information in pamphlet form, while the overwhelming majority of their patients have smartphones and broadband connections and use online services to find jobs, receive their salaries, pay bills and taxes, learn, conduct business and interact socially.
 
Technological change combined with the escalation of chronic non-communicable diseases, especially among the over 55s, is expected to increase Internet searches for premium and reliable medical knowledge and this will force health providers to change the way they communicate with patients.  
According to a recent Deloitte's report, in 2014 UK citizens over 55 will experience the fastest year-on-year rises in smartphone penetration. By the end of 2014, UK smartphone ownership is expected to surpass 50%, and the difference in smartphone penetration by age will disappear.     
This mirrors the rest of the world.
 
Takeaways
If you're a health provider, HealthPad can significantly improve your online communications, enhance the quality of your services and save you money.
 
If you're a patient, HealthPad provides you with free and easy access to exclusive, premium and reliable healthcare knowledge in video formats you prefer, at anytime, anywhere, anyhow. 
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Africa is sick. Ninety per cent of the world’s cholera cases occur in Africa. Meningococcal meningitis is epidemic in most African countries. Yellow fever is endemic in 23 African countries. Africa has more than 28 million HIV/AIDS cases and 75% of the world’s AIDS population live in sub-Saharan Africa. Of the one million annual malaria deaths, 90% occur in the same region. Measles are common throughout Africa and result in high levels of morbidity and mortality. Lassa fever accounts for about 0.4 million deaths each year and avian influenza is endemic in many African countries.

This is not the whole story. In addition to being plagued with infectious diseases, Africa has a neglected epidemic of chronic non-communicable disease (NCDs). Over the next decade the continent is projected to experience the largest increase in mortality rates from cardiovascular disease, cancer, respiratory disease and diabetes.

Although, international health agencies and national governments are beginning to recognize and confront the significant global burden of NCDs, its awareness in Africa is still relatively low and political leaders there have not shown much interest in NCDs and this has been reflected in the allocation of health budgets. This neglect compounds Africa’s healthcare and development challenges, since the projected rise in NCDs throughout the continent is expected to occur on a compressed timeline compared to high income countries and Africa has restricted capacity to respond to the magnitude of its disease burden.

International organisations have flagged the magnitude and the urgency of the challenge. Healthcare advice from numerous non government agencies in the developed world on ways to deal with Africa’s escalating disease burden is forthcoming. This has been especially the case over the past decade when humanitarian aid budgets have peaked. Agency recommendations have been high on overall strategy and low on cost effective and scalable means of delivering such strategy. 

 

Most advice includes epidemiological surveillance, primary programmes that target healthy populations and secondary preventative programmes aimed at reducing complications in affected populations. All agencies agree that human resources are crucial to viable African health systems. Hitherto, human resources have been a neglected component of African healthcare. A common implementation strategy recommended and implemented by several non government agencies is to organise health workers from the developed world to spend time in African countries teaching the teachers. To assist such programmes, some agencies recommend that African governments build more roads to enable health workers to gain better access to rural areas where healthcare provision is poor or non-existent. Education is crucially important, but the key question is, how do you educate enough people to make a difference?

Africa has a population of over one billion; about 15% of global population,but only 2% of global GDP and its population is projected to double by 2050. Africa is exposed to multiple health risks combined with inadequate preventative healthcare and education. Projected trends of Africa’s disease burden and consequent rates of morbidity and mortality highlight the inadequacy of some popular traditional response to Africa’s healthcare challenge. In addition to the enormity of its disease burden, Africa, which has weak health systems, also has significant long standing structural, logistic, human and organisational barriers to the implementation of well intended traditionalhealthcare programmes many of which focus on teaching the teachers.

So, despite well intended traditional interventions, Africa’s disease burden continues to grow and its overall effect is likely to decrease productivity, lower competiveness, increase fiscal pressure, expand poverty and create greater inequity in most African countries. More scalable and effective solutions are required. These should build on Africa’s strength, which are her established and fast growing telecommunications networks and her relative absence of healthcare legacy systems. Current trends in disease prevalence and treatment costs will force African countries to make deliberate and innovative choices in order to address their disease burdens in sustainable and effective ways. Such choices are more likely to employ modern technology than to build more roads. In Africa, mobile penetration exceeds infrastructure development, including paved roads and access to electricity and the internet. According to the World Health Organization’s (WHO) Global Observatory for mHealth some 40 African countries are using mobile health services.

 

Africa is the fastest-growing mobile telephone market in the world and the biggest after Asia. Over the past five years the number of subscribers on the Continent has grown some 20% each year. By the end of 2012 it is projected that Africa will have 735 million mobile subscribers.The nature of Africa’s mobilemarket is also changing. Today, smart phone penetration rate in Africa is estimated to be about 18%: almost one in five and projected to reach 40% by 2015. While patchy, mobile penetration rates in Sub Saharan Africa, where the disease burden is greatest, are not low and the rate of smart phone penetration is estimated to be about 20%.

In 2007 Sarafaricom, a leading mobile phone network in Kenya, launched M-Pesa, a mobile phone‐based payment and money transfer service for people too poor to have a bank account. M-Pesa spread quickly and has become the most successful mobile phone‐based financial service in the developing world. Today there are some 17 million registered M-Pesa accounts in Kenya. It is only a small step to offer a mobile health information service for all M-Pesa account holders.

Africa’s new highways to carry healthcare information are virtual rather than physical. They already exist, they are extensive and, over the course of the next five years, are projected to rapidly expand and improve. With such an infrastructure one teacher can educate millions of people, which is significantly more cost effective and sustainable than traditional healthcare programmes.

Further, Africa will not be able to diagnose and treat its way out of its disease burden. Increasingly, healthcare programmes will need to emphasis prevention, alongside efforts to strengthen health systems to provide early diagnosis; targeted cost-effective and scalable treatments that are fiscally sustainable depending on countries’ epidemiological profile. Such solutions will need to fit complex, overstretched and under-resourced health systems; address the enormity of the escalating disease burden and bring about desired changes in specific African countries’ health systems. This cannot be achieved only by repeating traditional healthcare programmes delivered by non government agencies from developed countries.

According to the International Telecommunications Union there are some 5 billion wireless subscribers in the world today and over 70% of these reside in low and middle income countries. In 2011, Africa held its first mobile health summit in South Africa and firmly put mobile telephony at the centre of improving healthcare in poor countries. A 2011 WHO global survey of the use of mobile telephony in healthcare; mHealth, reported that commercial wireless signals cover over 85% of the world’s population. Eighty three per cent of the 122 countries surveyed in the Report used mobile phones for free emergency calls, text messaging and pill reminders.

Modern technologies have the scalability to provide the basis for Africa to develop country-congruent health policies that are locally applicable. Technological systems such as mobile telephony, the internet and biometric identification, which are appropriately implemented, have the capacity to empower individuals and encourage them to take care of their own health. Further, such technologies have the capacity to improve targeting, reduce fraud and increase access to healthcare. Technologically based healthcare strategies offer Africa an opportunity to leapfrog its ineffective traditional healthcare systems and begin to manage the enormity of its disease burden and, in turn, may benefit the whole world by demonstrating the benefits of patient centred healthcare.   

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  • Each year unhealthy diets are linked to 11m deaths worldwide a global study concludes
  • Red and processed meat not only cause disease and premature death from chronic non-communicable diseases (NCD) but also put the planet at unnecessary risk
  • Evidence suggests that the health benefits of a Mediterranean diet reduces the risk of NCDs and is better for the Planet

Eat like Greeks, live healthier lives and save our planet

 
Findings of an international research project about the relationship between diet and chronic diseases are reported in a paper entitled, “Health effects of dietary risks in 195 countries 1990-2017. A systematic analysis for the Global Burden of Disease Study 2017”, which is published in the April 2019 edition of The Lancet. The paper suggests that millions of people throughout the world consume an unhealthy diet comprised of  too much processed meat, sodium and sugar and too little plant-based foods, such as fruits and vegetables, whole grains and nuts. This results in a significant increase in the prevalence of chronic non-communicable diseases (NCD) such as coronary heart disease, cancer and diabetes and  each year causes some 11m avoidable deaths worldwide - 22% of all adult deaths: 10m from cardiovascular disease, 913,000 from cancer and some 339,000 from type-2 diabetes. According to the paper’s authors, “A suboptimal diet is responsible for more deaths than any other risks globally, including tobacco smoking, highlighting the urgent need for improving human diet across nations”.
 
In this Commentary
 
This Commentary reviews evidence of recent large-scale epidemiology studies, which suggest that “you are what you eat”.  Not only do unhealthy diets cause ill health and premature death for millions, they also harm the environment and push the Earth beyond its planetary boundaries. All the studies we describe conclude that we know the answer to this vast and escalating health problem: eat like Greeks or indeed the Japanese. Notwithstanding, changing the way populations collectively eat is a massive challenge facing governments, healthcare systems and individuals.
 
The Global Burden of Disease project
 
The Lancet paper’s findings described above are based on the Global Burden of Disease (GBD) enterprise, which is one of the world’s largest scientific collaborative research projects, which was started in the early 1990s by the World Bank to measure the impact of disability and death from hundreds of diseases worldwide. Over the past two decades its work has grown, and the endeavour has become institutionalized at the World Health Organization (WHO). Today, the GBD project is an international consortium of more than 3,600 researchers, its findings are updated annually and they influence health policy throughout the world.
 
Red meat and bowel cancer
 
Findings of a more narrowly focussed but nonetheless significant study, published in the April 2019 edition of the International Journal of Epidemiology warn that red-processed meat consumption is linked with bowel cancer.  According to Tim Key, the study’s co-author, Professor of Epidemiology and Deputy Director at Oxford University's Cancer Epidemiology Unit, “Results strongly suggest that people who eat red and processed meat four or five times a week have a higher risk of developing bowel cancer than those who eat red and processed meat less than twice a week . . . . There’s substantial evidence that red and processed meat are linked to bowel cancer and the World Health Organization classifies processed meat as ‘carcinogenic’ and red meat as ‘probably carcinogenic’”. Notwithstanding, Key warns that, “Diet studies are problematic because those who take part often either forget what they have eaten or fail to tell the truth”. Key also suggests that, “Most previous research [on diet and cancer] looked at people in the 1990s or earlier and diets have changed significantly since then”.
 
Chronic non-communicable diseases
 
Chronic non-communicable diseases (NCD) are largely caused by humans and are therefore preventable. Notwithstanding, they account for more than 70% of all deaths globally and emergent NCDs pose significant systemic challenges for both nation states and individuals. Forty percent of all adults in the world are overweight and 1.4bn suffer from hypertension: both critical risk factors of NCDs. In 2016, 18m people died from cardiovascular disease (CVD), representing 31% of all global deaths. In the US an estimated 92m adults are living with CVD. By 2030, 44% of the US adult population is projected to have some form of CVD. There are around 7m people living with heart and circulatory disease in the UK. Worldwide some 0.5bn people have diabetes and in 2018 there were 17m new cases of cancer worldwide. Although there are some encouraging signs associated with the slowing of the prevalence rates of NCDs globally, prevalence of NCDs is expected to rise because of population growth and aging, misaligned healthcare policies and institutional inertia.
 
The paradox of food insecurity and obesity
 
Paradoxically, food scarcity and obesity are both forms of malnutrition and represent a vast and escalating burden on the worlds limited and diminishing resources. This is because food insecurity can contribute to people being overweight and obese. Nutritious fresh foods often tend to be expensive, so when household resources for food become scarce, people choose less expensive foods that are often high in calories and low in nutrients. As a result, adult obesity rates continue to rise each year, from 11.7% in 2012 to 13.2% in 2016. In 2017 the World Health Organization estimated that more than one in eight adults, or more than 672m people in the world, were obese and 2bn were classified as overweight. A report from the Center for Strategic and International Studies, a think-tank based in Washington DC, US, suggests that worldwide each year, "Malnutrition costs US$3.5trn, with overweight- and obesity-related NCDs, such as cardiovascular disease and type 2 diabetes, adding US$2trn”.
 
The EAT-Lancet Commission on Food, Planet and Health
 
Not only do unhealthy diets result in NCDs and premature death, but they also harm the environment. The dual aspects of unhealthy diets causing disease and harming the planet are described in research conducted by the EAT-Lancet Commission on Food, Planet and Healthand reported in the January 2019 edition of  The Lancet.
EAT is an independent non-profit organisation based in Oslo, Norway, dedicated to food-system reform, which collaborated with The Lancet. The report took 3-years to complete and brought together 37 world-renowned scientists from 16 countries with expertise in health, nutrition, environmental sustainability, food systems, economics and political governance; and tasked them with reaching a consensus that defines a sustainable “healthy planetary diet”, which the authors suggest approximates a Mediterranean diet, see below.

The EAT-Lancet research, financed by the Wellcome Trust,analysed the diets of people in 195 countries using survey data, as well as sales data and household expenditure data to estimate the impact of unhealthy diets on the risk of death and morbidity from NCDs. The Commission’s authors provide a comprehensive picture of the consumption of 15 dietary factors across nations and quantify the potential impact of suboptimal intake of each dietary component on NCD mortality and morbidity among 195 countries. Also, researchers calculate mortality related to other risk factors,such as smoking and drug use, at the global level.

 

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Obesity: is processed food the new tobacco?
 

Criticism of the EAT-Lancet Commission
 
The EAT-Lancet Commission’s report has its critics. One is the UK’s National Farmers’ Union whose Vice President Stuart Roberts said, “Scientific communities agree that red meat plays a vital role in a healthy, balanced diet as a rich source of essential nutrients, minerals, amino acids and protein. It is overly simplistic to target one food group for a significant reduction in consumption, and it ignores its medically accepted role as a key part of a healthy, balanced diet   . . . It is clear that climate change is one of the greatest challenges of our time and British farmers are continuing to take action. A combination of policies and practises will be needed to enable farmers to meet their ambitions, but we must not forget the impact of a changing climate on food production”.
 
Benefits of red meat
 
Roberts is right to point out that red meat has health benefits. Heme iron, which is found in red meat (also in poultry, seafood and fish) is easily absorbed by your body and is a significant source of your dietary iron. Red meat also supplies you with vitamin B12 and zinc. The former is required for red blood cell formation, neurological function and DNA synthesis, and the latter helps stimulate the activity of at least 100 different enzymes and helps to keep your immune system working effectively. Further, red meat provides protein, which helps to build your bones and muscles. People have been eating meat for millennia and have developed digestive systems well equipped to handle it.

Notwithstanding, the overwhelming majority of red meat consumed in the developed world today is processed: raised in a factory environment, fed grain-based feed and given growth-promoting hormones and antibiotics and some animals, after being slaughtered, are further treated with nitrates, preservatives and various chemicals. The findings of all three studies described above demonstrate the harm of eating too much red and processed meat and stress the health and environmental benefits of a Mediterranean diet.

 
An urgent challenge
 
According to the EAT-Lancet Commission’s authors, “Providing healthy diets from sustainable food systems is an urgent and pressing challenge”. As the global population continues to grow - projected to reach 10bn by 2050 - and become wealthier, there is expected to be a concomitant increase in unhealthy diets comprised of red meat, processed food and sugar. To address this vast and escalating challenge, populations will need to combine significant dietary changes with enhanced food production and reduced food waste.
 
The impact of food waste
 
Before broaching some of the challenges associated with changing the way we eat collectively let us briefly describe the magnitude and effect of food wastage. According to the United Nation’s (UN) 1.3bn tonnes of food are wasted every year, which is about 33% of the total produced. The cost of global food losses and waste amounts to roughly US$990bn and yet some 800m people worldwide do not get enough to eat and 2bn people are overweight.
 
Further, food wastage is estimated to release the equivalent of 3.3bn tonnes of CO2 into the atmosphere each year. The total volume of water used annually to produce food that is lost or wasted (250km³) is equivalent to three times the volume of Lake Geneva. Similarly, 1.4bn hectares of land - 28% of the world's agricultural area - is used to produce food that is lost or wasted. And agriculture is responsible for a majority of threats to at-risk plant and animal species tracked by the International Union for Conservation of Nature. 
 
Changing what we eat and how we produce food will save lives and the planet
 
According to Alan Dangour, Professor in Food and Nutrition for Global Health at the London School of Hygiene & Tropical Medicine (LSHTM), “The EAT-Lancet Commission’s analysis demonstrates that shifts in our diets can have enormous beneficial effects on health and also substantially reduce our impacts on the environment.  This significant ‘win-win’ for health and the environment is not a new finding, but this analysis, which for the first time defines environmental boundaries for the food system, is the most advanced ever conducted”.
 
In a similar vein, Tara Garnett, a contributor to the EAT-Lancet Commission and a principal investigator of another research project on the future of food, also suggests that there’s nothing new in the Commission’s report but its fundamental message is that, “We’re not going to address our environmental problems unless we address the problems caused by the food system and we’re not going to address the problems caused by the food system unless we shift the way we eat collectively and globally”.

 
Rebalancing unhealthy diets is a significant challenge
 
Changing how we eat collectively, which Garnett and others suggest is necessary to reduce NCDs and enhance our environment, is not going to be easy. This is because it would involve cutting by half our consumption of red meat, processed food and sugar, and doubling our consumption of vegetables, fruit, pulses and nuts. For people living in the US and UK it would be even more challenging because the EAT-Lancet Commission ranks the US 43rd and the UK 23rd for their respective unhealthy diets out of the 195 nations in its study. It is suggested that in order to adopt a healthy diet Americans would need to eat 84% less red meat and six times more beans and lentils, and British people would have to eat 77% less red meat and 15 times more nuts and seeds.

Countries with the lowest rates of diet-related deaths are Israel, France, Spain and Japan. The highest rates are reported to be found in Uzbekistan, Afghanistan and the Marshall Islands. According to the Commission’s authors a Mediterranean-type-diet, “is what we should all be eating if we are concerned about our health and that of the planet”: it lowers the incidences of heart disease, diabetes and cancer, enables more environmentally helpful use of land and reduces carbon emissions.

 
The Mediterranean diet
 
The Mediterranean diet has been around for millennia and tends to be more of a lifestyle than a diet. It entails significantly lower amounts of beef, dairy products, sugar, soft drinks, pastries and processed foods; higher amounts of fish, fruit, nuts and salads, and no pasta, French fries and pastries. Unlike fashionable commercial diets associated with the weight management market, the Mediterranean diet does not have a set of specific rules that focus on losing weight, but instead emphasises eating fresh food over a lifetime. Also, the Mediterranean diet has been well studied. Research suggests that it is associated with a reduced risk of heart disease and cardiovascular mortality because of its significantly lower amounts of oxidized low-density lipoprotein (LDL) cholesterol, (the "bad" cholesterol) which is more likely to build up deposits in your arteries. Other benefits include reduced incidence of cancer, Parkinson's and Alzheimer's diseases. Further, women who follow a Mediterranean diet have a reduced risk of breast cancer.
 
The PREDIMED study
 
Findings of a landmark clinical trial, entitled “Primary Prevention of Cardiovascular Disease with a Mediterranean Diet”, was published in the June 2013 edition of the New England Journal of Medicine (NEJM). Popularly known as the PREDIMED study (Prevencion con Dieta Mediterranea), it tested the impact of two Mediterranean diets on cardiovascular risk. The first included a Mediterranean diet plus 30 grams of mixed nuts per day and the second was a Mediterranean diet plus at least four tablespoons a day of extra-virgin olive oil. The two diets were then compared to a low-fat diet, which is popularly advocated and pursued in the US and UK and among other developed nations and discourages the consumption of any high-fat items such as butter, cheese, oil, meats and pastries.
 
The low-fat diet
 
In the 1960s low-fat diets as opposed to high-fat, high-cholesterol diets were considered to promote heart health. By the late 1980s and early 1990s the low-fat diet was advocated by doctors, policy makers, the food industry and the media although there was no hard evidence to demonstrate it prevented heart disease and promoted weight loss. Notwithstanding, the low-fat-diet became an important part of the large and rapidly growing global weight management market, which is valued at some US$169bn and projected to grow at a CAGR of 2.4% and reach a value US$279bn by 2023. Interestingly, in the 80s and 90s, as the low-fat diet became an institution in the US and UK so the prevalence of overweight and obesity increased. Only recently has the low-fat diet been challenged as scientific evidence about fats increased.
 
A significant study with some methodological challenges
 
The PREDIMED study involved 7,447 people between 55 and 80 who were free from heart disease, came from 11 study centres across Spain and were randomly assigned to one of the three diets for five years. Findings suggested that the Mediterranean diet significantly reduced the risk of heart attack, stroke and cardio-vascular mortality compared to the low-fat diet. However, researchers discovered flaws with the study’s methodology and withdraw their findings. Most significantly, not all participants were randomly assigned to their diet and this could have influenced their findings.
 
Revised study of the Mediterranean diet
 
Researchers adjusted their methodology for its "irregularities in the randomization procedures" and published “new” findings in the June 2018 edition of the New England Journal of Medicine (NEJM), which confirmed the health benefits of a Mediterranean diet for adults at high risk for heart disease and found that the Mediterranean diet, plus olive oil or nuts, reduced risk for heart events by 30% compared to a low-fat diet. Lead author Miguel Ángel Martínez-González suggested that only about 10% of participants were affected in their earlier study reported in 2013, and their 2018 analysis made researchers, "More convinced than ever of the robustness of the protection by the Mediterranean diet against cardiovascular disease”. According to Jeffrey Drazen, editor-in-chief of the NEJM, "Medical professionals and their patients can use the republished information with confidence". While reaction to the study’s initial findings was disappointing, experts are encouraged by the adjusted findings, which confirm the heart-health benefits of a Mediterranean diet, particularly in adults at high risk for heart disease. Notwithstanding, experts emphasise the significance of sustaining a healthy diet over time.
  
The health benefits of the Japanese diet
 
The Mediterranean diet is not the only diet, which has proven to have significant health benefits. The Japanese diet, which is low in calories and saturated fat and high in nutrients, especially phytonutrients such as antioxidants and flavonoids, found in different coloured vegetables, also has considerable health benefits. Findings of two studies; one published in the April 2017 edition of PLOS.ONE, and another published in the March 2016 edition of the British Medical Journal demonstrate that, closer adherence to a Japanese diet resulted in a significantly lower risk of death from NCDs and in particular from cardiovascular disease or stroke. Japan has the highest life expectancy of any country: 90 years for women and 84 for men. Okinawa, in southernmost Japan, has the highest number of centenarians in the world as well as the lowest risk of age-related diseases such as cancer and heart disease. There are nearly 800 centenarians in Okinawa, which has a population of 1,368,000. The diet of the Okinawan people has been little influenced by the dietary changes influenced by western culture, which also have been seen in more urban Japan.
 
Takeaways
 
All the research findings we describe in this Commentary confirm the adage that, “You are what you eat”. Nutrients from the food you eat provide support for all the cells in your body, which have different “shelf lives”. For example, your skin cells live for about a month and your red blood cells for about four months. So, your body is constantly regenerating new cells to replace those that have “expired”. The health of your new cells is partly determined by how well you have been eating. A diet high on processed red meat and low on nutrients does not help in this regeneration process. But a nutrient rich, whole food diet can help to build your cells so that they work better to help you recover from common illnesses and the wear-and-tear of everyday life and make you less susceptible to disease.
 
Although our concern about healthy eating has intensified in recent years, the phrase, “you are what you eat” is not new. In 1826 Anthelme Brillat-Savarin wrote in Physiologie du Gout, ou Meditations de Gastronomie Transcendante, "Dis-moi ce que tu manges, je te dirai ce que tu es[Tell me what you eat, and I will tell you what you are]. However, the phrase did not emerge in English until the 1920s when nutritionist Victor Lindlahr, who believed that food controls health, developed the Catabolic Diet. According to Lindlahr, "Ninety per cent of the diseases known to man are caused by cheap foodstuffs. You are what you eat". And in 1942, he published a book entitled, “You Are What You Eat: how to win and keep health with diet”. Eat like the Greeks, live healthier lives and save our planet.
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  • Advanced wound care is a large and fast-growing global market currently dominated by North America and Europe  
  • In the next decade, Asia-Pacific, the Middle East and Africa and South America regions are expected to become significant wound care markets
  • Price sensitive Western MedTechs with wound care franchises might be challenged to penetrate these under-served rapidly growing emerging regional markets
  • Innovative technologies that currently contribute to advanced wound care include growth factors and cytokines, stem cells, tissue engineering, regenerative medicine approaches, and 3D bioprinting
  • Each has technical and clinical challenges likely to present obstacles for their future growth
  • 3D bioprinting however appears well positioned to eclipse competing technologies and disrupt the global advanced wound reconstruction market in the next decade
  
3D bioprinting and the advanced wound care market

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

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

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

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

 
In this Commentary

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

Complex wound reconstruction is a relatively new field that has emerged over the last few decades. Advances in medical devices and clinical techniques have allowed for the successful treatment of wounds that were previously considered untreatable. In the early 1990s, the concept of wound bed preparation was introduced, which emphasized the need to prepare a wound before applying any kind of dressing or treatment. This involved removing dead tissue, and controlling infection, to promote healthy tissue growth. In the late 1990s and early 2000s, tissue engineering and regenerative medicine emerged as promising fields for complex wound healing. These focused on using biological materials, such as stem cells and growth factors, to stimulate tissue growth and regeneration.
In 1996, the US Food and Drug Administration (FDA) approved the Integra Dermal Regeneration Template, a manufactured collagen matrix with a claim of regenerative dermal tissue designed as a skin replacement, and initially used in patients with extensive burns with insufficient donor tissue for coverage. In 1998, Apligraf became the first commercially available, FDA approved, product containing living cells, to treat venous ulcers that failed to respond to conventional treatments. It is a synthetic skin created from harvested infant foreskins and produced and marketed by Organogenesis, a US corporation based in Massachusetts. In 2000, the product obtained further approval for the treatment of diabetic foot ulcers. In the years since, other products containing living cells for wound healing have gained regulatory approval and are used to treat a range of complex wounds.

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In addition to advances in technology and treatment options, there has also been a growing recognition of the importance of a multidisciplinary approach to complex wound reconstruction. This involves teams of healthcare professionals, including wound care specialists, plastic surgeons, and rehabilitation professionals, working together to develop comprehensive personal treatment plans for individual patients.
 
Despite these advances, the clinical assessment and management of chronic wounds remain challenging owing to their long-term treatment regimens and complex wound healing mechanism. Various conventional approaches including cell therapy, gene therapy, growth factor delivery, wound dressings, and skin grafts are being utilized to promote healing in different types of wounds. However, such therapies are not satisfactory for all wound types, which creates a need to develop newer and innovative treatments. In recent years, innovative wound healing technologies have made progress and continue to evolve. These include stem cell therapies, bioengineered skin grafts, and 3D bioprinting, which all focus on skin regeneration with minimal side effects. According to a 2023 report by Tracxn, a MedTech research platform, globally there are ~580 companies producing wound care offerings.
 
A fast-growing global market

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

Advanced wound reconstruction markets vary in different regions of the world. Currently, North America is the largest, and expected to be valued at ~US$5bn by 2027, followed by Europe, which is currently valued >US$3bn with a projected 4.2% CAGR over the next four years. Here we draw attention to emerging markets of the Asia Pacific, Middle East and Africa (MEA) and South America regions.
 
The Asia-Pacific region has substantial growth potential particularly in India, China, and Southeast Asia. These regions have vast, aging populations, governments increasing healthcare expenditure, high incidence of chronic diseases, and a rising awareness of the importance of wound care among large and rapidly growing middle classes. In China (population >1.4bn), for instance, the wound reconstruction market is expected to grow significantly driven by: (i) an aging population - by 2040, ~402m people, (28% of the population) are expected to be >60 years, (ii) national efforts to improve healthcare infrastructure, (iii) increasing investment in medical research, and (iv) rising incidence of chronic diseases that require wound management. India (population ~1.4bn), is also a substantial potential market with a growing demand for advanced wound care solutions, increasing healthcare expenditure, and a rising number of government initiatives to improve healthcare services. Southeast Asia, which includes Indonesia (population ~280m), Malaysia (population >32m), Thailand (population >70m) and Vietnam(population ~100m), also represent significant growth potential for the wound reconstruction market. 
 
The Middle East and Africa (MEA) region is expected to have substantial growth potential for wound healing due to increasing medical management expenditure, improving healthcare infrastructure, and a rising number of government initiatives to improve wound care. Although this region is a diverse and complex healthcare market, there are several countries within it with significant growth potential for wound care. For instance, in the Middle East, the United Arab Emirates (population ~9.5m) is a wealthy market with a rapidly developing healthcare infrastructure, increasing demand for advanced wound healing solutions, and a high prevalence of diabetes-related wounds. Saudi Arabia too is a substantial potential market, driven by a large and growing population (~36m), increasing healthcare expenditure, and rising awareness of the importance of wound care management. In Africa, South Africa (population >61m) has a large and advanced healthcare system, increasing demand for complex wound care solutions, and a high prevalence of diabetes-related wounds.
 
South America is expected to experience significant growth in the wound reconstruction market, driven by increasing awareness of its importance, rising demand for advanced wound recovery solutions, and a growing number of government initiatives. Several countries in the region have substantial market growth potential, including: (i) Brazil, the largest economy in the region, with a population of ~217m and high incident rates of chronic wounds, (ii) Argentina (population >46m), which has a large healthcare sector and a growing demand for advanced wound care products and services, and (iii) Colombia, with a growing economy and a large population (>52m), is emerging as a key regional player in wound care solutions and services.
 
Leveraging opportunities in emerging markets
 
Many Western MedTechs are ill equipped to leverage the opportunities in emerging regions of the world with underserved, growing advanced wound care markets. North America and Europe account for ~55% of the global medical technology market and provide the largest share of MedTechs’ revenues. It is in these wealthy regions that most company executives have spent most of their professional careers and therefore have had little or no in-country experience of emerging economies. For decades, North American and European healthcare systems rewarded medical activity rather than patient outcomes and this drove high growth rates, significant profit margins, and industry expansion without much risk or in-depth strategic thinking. Such conditions, complemented by substantial periods of low interest rates and cheap money, encouraged the financialization of the medical technology industry: companies used mergers and acquisitions (M&A) to pursue scale and consequently became bigger but not necessarily better. Today, the ten largest medical device corporations account for >40% of the sales in a global market of ~US$490bn. The market has become an oligopoly, which emphasizes size and tends to blunt competition. Although such conditions are changing and having international experience, a global mindset, and R&D knowhow are increasingly valued, there is still a significant reliance on legacy products marketed predominantly in wealthy Western nations. Even now, relatively few company leaders have had in-depth experience of emerging regions of the world, where differences in language, competition, regulations, and culture create barriers to their ability to understand and navigate the nuances of these markets.
 
Wound healing technologies
 
The development of new wound healing technologies is an area of active R&D in the medical device industry, which aim to accelerate the healing process and improve outcomes for patients. Here we provide a flavour of these.
 
(i) Growth factors and cytokines
 
A promising area of research to stimulate wound healing is the use of growth factors and cytokines. These are naturally occurring proteins in the body that play a key role in the healing process. Researchers are exploring ways to use these proteins in wound care products to promote tissue regeneration and accelerate wound repair.
 
There are several MedTechs with offerings in this area. UK based Smith & Nephew markets a range of wound healing products, including biologic agents that contain growth factors and cytokines. The company’s REGRANEX Gel, which contains recombinant platelet-derived growth factors (PDGF), received FDA approval in 1997, and is used to treat diabetic neuropathic foot ulcers. Acelity, a Texas-based privately held company founded in 1976, manufactures and markets several advanced wound care products, including biologic agents that contain growth factors and cytokines. The company’s VAC VeraFlo Therapy with Prontosan, received CE Mark in 2017 and combines negative pressure wound therapy [a method of drawing out fluid and infection from a wound to help it heal] with a solution that contains cytokines and growth factors to help promote wound healing. Nasdaq traded Integra LifeSciences develops and markets wound healing products. The Integra Flowable Wound Matrix contains growth factors and is used to treat chronic wounds. Osiris Therapeutics, founded in 1993 and based in Maryland, USA, specializes in regenerative medicine and has a range of products to promote wound healing, including Grafix, a human placental membrane that contains growth factors and cytokines. NYSE traded MedTech, Stryker markets numerous advanced wound care products, including biologic agents that contain growth factors and cytokines. Its key product in this area is MIST Therapy, which is a painless, non-contact, low-frequency ultrasound treatment delivered through a saline mist containing cytokines and growth factors to promote wound healing.
 
Challenges
Growth factors and cytokines are proteins that are produced naturally by the body. Replicating their production in a laboratory setting can be challenging and result in high production costs and thereby limit their accessibility and affordability. Also, these molecules are quickly broken down and cleared from wound sites, which limits their effectiveness to promote healing. Developing methods to increase their stability and longevity is crucial to improving their efficacy.
 
While growth factors and cytokines have shown promise in preclinical studies, clinical trials have not always demonstrated consistent benefits in wound healing, and this raises some concerns about their potential for adverse effects such as allergic reactions or immune system activation. The success of these molecules in promoting wound healing depends on their ability to effectively interact with a complex network of cells in a precise and targeted manner, which can be challenging to achieve.
 
(ii) Stem Cells
 
In recent years, stem cell-based therapies for wound healing and skin regeneration have garnered much interest owing to their potential to morph into different types of cells that promote tissue regeneration and accelerate wound healing. Researchers are exploring the use of various types, such as mesenchymal stem cells (MSCs) [multipotent stem cells found in bone marrow]; adipose (body fat)-derived stem cells (ASCs), [a subset of MSCs, which can be obtained easily from adipose tissues and possess many of the same regenerative properties as other MSCs], and pluripotent stem cells (iPSCs) [cells that can develop into many different types of cells or tissues in the body]. These present the main sources of stem cells that are utilized for wound healing and skin regeneration.
 
While there are many products on the market, the leading MedTechs using stem cells for wound healing include Acelity, whose flagship offering is the RECELL Autologous Cell Harvesting Device, which uses patients’ skin cells to promote healing in chronic wounds and burn injuries. Organogenesis’s Apligraf, mentioned above, contains stem cells. Integra LifeSciences’s Dermal Regeneration Template, also mentioned above, is a matrix of bovine collagen and glycosaminoglycan molecules that contains autologous stem cells [stem cells removed from a person, stored, and later given back to the same person] to promote tissue regeneration. And Smith & Nephew’s PICO Single Use Negative Pressure Wound Therapy System, which uses a proprietary dressing with stem cells to promote healing in chronic wounds.
 

Challenges
Despite stem cell-based therapies being common and effective for the promotion of wound healing, there are challenges associated with their source, genetic instability, potential immunogenicity, risks of infection and carcinogenesis and high processing costs. Stem cells are a complex and heterogeneous population of cells that are sensitive to their environment, and replicating their production in a laboratory can be technically demanding and costly. They have the potential to differentiate into various cell types and promote tissue regeneration, but if not appropriately controlled, they can form tumours. Developing methods to ensure the safety and efficacy of stem cell-based therapies and minimising the risk of tumour formation are crucial to their future impact on the wound care market.
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(iii) Tissue engineering
 
Tissue engineering is another approach being explored for wound healing. This involves a combination of cells, engineering, materials, methods, and suitable biochemical and physicochemical factors to restore, maintain, improve, or replace different types of biological tissue. Researchers have developed tissue-engineered skin substitutes that can be used to promote wound healing and tissue regeneration in patients with chronic wounds. Leading MedTechs with advanced products in this area include Acelity, Organogenesis, Integra LifeSciences and Smith and Nephew.
Challenges
There are non-trivial challenges associated with the production and maintenance of functional and viable tissue engineered constructs in a laboratory setting. The technology requires the growth of cells on scaffolds or matrices that mimic the extracellular matrix of the target tissue. The process of creating these involves multiple steps, including cell isolation, seeding, differentiation, and integration with the host tissue. Ensuring the quality and functionality of these constructs is demanding, and replicating such processes in a large-scale production setting is time consuming and costly. Another technical challenge is the need for a vascular network to support the growth and survival of the engineered tissue. The lack of blood vessels can limit the delivery of oxygen and nutrients to the cells within the tissue construct, which can result in cell death and impaired tissue function. Developing methods to vascularize tissue constructs and integrate them with the host vascular system is crucial to the success of tissue engineering in wound reconstruction. Clinical success depends on offerings not being rejected by a patient’s immune system and being able to integrate with a complex network of cells in a precise and targeted manner, which can be difficult to achieve.
 
(iv) Regenerative medicine approaches
 
Regenerative medicine approaches such as platelet-rich plasma (PRP) and extracellular matrix (ECM) are being developed for their potential to promote wound healing. The former is an autologous biological product containing higher amounts of platelets [small cells that circulate within your blood and bind together when they recognize damaged blood vessels]. Compared to circulating blood, PRP contains an increased concentration of growth factors, which is a prerequisite for wound healing. The approach involves isolating platelets from a patient's blood, which, when introduced into a wound has the potential to stimulate and accelerate tissue healing. In recent years, PRP has attracted a lot of research attention.
 
ECM is an extensive three-dimensional scaffold made from natural or synthetic materials that provides structural integrity and can be used to promote tissue regeneration and accelerate wound healing. Because of the nature of chronic wounds, recovery is reduced by a lack of functional ECM in the dermal matrix, which is responsible for stimulating healing. The restoration of functional ECM in wounds contributes to their reconstruction and closure. Both PRP and ECM technologies show promise in promoting tissue regeneration.
 
MedTech leaders in this field include Osiris, Terumo, Stryker and Zimmer Biomet. Osiris Therapeutics specializes in regenerative medicine approaches for wound healing, including ECM products. Grafix, the company’s key offering, is a cryopreserved placental membrane product that is designed to promote tissue regeneration in chronic wounds. Terumo, a Japanese corporation founded in 1921, opened its first overseas office in the US in 1971 and subsequently became a global player. The company is now a leader in blood management technologies and offers a range of products specializing in wound healing, including PRP systems. Its main offering, the Terumo BCT COBE Spectra Apheresis System, is used to collect and process blood components, including platelets, for use in wound healing. Stryker’s flagship ECM product is the MatriStem UBM Wound Matrix, which is derived from porcine urinary bladder tissue and is designed to promote tissue regeneration in chronic wounds. Zimmer Biomet is a global leader in musculoskeletal healthcare and offers a range of products for wound healing, including PRP systems. Its principal product is the EBI Bone Healing System, which is used to promote healing in fractures and other musculoskeletal injuries.
 

Challenges
Regenerative medicine approaches for wound healing require an in-depth understanding of the underlying mechanisms of tissue regeneration, which is complex. A precise understanding of multiple signaling pathways, cell types, and extracellular matrix components are crucial, and how these interact is fundamental to the development of effective therapies. For regenerative medicine treatments to be successful they need appropriate delivery of cells, growth factors, and other biological molecules to the site of injury. Achieving this requires a careful consideration of the biological and physical factors at play, which can be challenging.
 
(v) Three dimensional (3D) bioprinting
 
In recent years, three dimensional (3D) bioprinting has emerged as a rapid and high throughput automated technology that significantly reduces the limitations of other wound healing and regenerative medicine technologies that depend on manual processes and are hindered by the time it takes for them to reconstruct large chronic wounds. 3D bioprinting is an automated process that allows for the creation of three-dimensional structures using living cells and biomaterials. It involves the layer-by-layer deposition of bio-inks, which contain living cells and other biological components, using a specialized printer. The resulting structures can then be implanted into the body to promote tissue regeneration and wound healing. Advances in the technology have led to the development of more complex tissue constructs, such as skin, bone, and cartilage. In the near to medium term, 3D bioprinting has the potential to eclipse established and evolving wound healing technologies and disrupt the advanced wound care market.

Centres of excellence
There are several scientists, institutions, and start-ups, which have made significant contributions to the field of complex wound reconstruction using bioprinting. Here we mention a few. A pioneer in the area is Anthony Atala, founding Director of the Wake Forest Institute for Regenerative Medicine, which is part of the Wake Forest School of Medicine in North Carolina, USA. The Institute is a world-renowned centre of excellence for research in 3D bioprinting and wound healing. Professor Atala, a bioengineer, urologist, and pediatric surgeon, is recognized for his work in the area. One of Atala’s most notable contributions is the development of the first 3D bio printed human bladder, which he created using a combination of patient cells and biomaterials and then successfully implanted the constructs into several patients with bladder disease. Atala’s pioneering work in 3D bioprinting has paved the way for new treatments and therapies for patients suffering from complex wounds and tissue damage.
 
The Advanced Regenerative Manufacturing Institute (ARMI) located in Manchester, New Hampshire, USA, is a public-private partnership with a specific focus on 3D bioprinting research and has developed innovative techniques to create living tissues and organs. ARMI collaborates with academic institutions, government agencies, and industry partners to accelerate the translation of 3D bioprinting research into clinical applications. Another leading institution is the Tissue Engineering and Regenerative Medicine International Society (TERMIS), which is a global organisation that aims to promote research, education, and clinical translation in the field of tissue engineering and regenerative medicine. It has >50 chapters worldwide and organises annual conferences to bring together experts in the field. TERMIS plays a significant role in advancing 3D bioprinting research by providing a platform for collaboration and knowledge exchange.
 
One example of a start-up specializing in advanced wound care that is using 3D bioprinting is Pandorum Technologies, founded in 2011 and based in Bengaluru, India. Its flagship offering CorneaGen, is a 3D-bioprinted cornea that can be used to replace damaged or diseased corneas in patients. The cornea is made up of a bio ink composed of corneal cells and hydrogels that mimic the natural extracellular matrix of the cornea. The company has also developed a bio printed skin that can be used for wound healing research and drug development. It is composed of layers of living cells that mimic the structure and function of human skin. Pandorum has R&D initiatives in India and in the US located in the Medical University of South Carolina (MUSC) at Charleston and MBC BioLabs, in the San Francisco Bay Area, USA.
 

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

Although it is difficult to predict the future of any technology with certainty, it seems reasonable to suggest that 3D bioprinting could become the dominant technology in the field of advanced wound reconstruction in the next decade. Bioprinting has several advantages over other technologies, briefly described in this Commentary, and currently used in wound reconstruction. Traditional methods such as skin grafting and tissue engineering using scaffolds, have limitations in terms of their ability to produce complex tissue structures and patient-specific treatments. 3D bioprinting, on the other hand, allows for precise control over the placement of cells and biomaterials, and can produce highly complex and customized tissue constructs. The technology is rapidly advancing, and new developments are being made at an unprecedented rate. Researchers are continuously developing new biomaterials, improving the resolution and speed of bioprinters, and exploring new applications. 3D bioprinting appears to have the potential to meet the large and growing demand for advanced wound reconstruction by allowing for the creation of customized tissue constructs tailored to the specific needs of individual patients. Further, it can reduce the need for multiple surgeries and treatments, improve patient outcomes and reduce healthcare costs.
 
Takeaways
 
Over the next decade, advanced wound care markets are expected to grow and change due to the increasing influence of the purchasing power in emerging regions of the world and advances in technology.  While wealthy North America and Europe, with ~14% of the global population, will continue to be commercially significant for the medical device industry, the Asia-Pacific, MEA, and South America regions, where >80% of the world’s population live, are likely to become important wound care markets because of the growing incident rates of chronic conditions and related wounds requiring treatment, expanding middle classes demanding improved care and governments’ commitment to enhancing their healthcare systems.
 
While it is unlikely that non-bioprinting technologies will disappear from the field of complex wound reconstruction, there are several reasons, which we have briefly described, why they are likely to have a reduced influence on the market as it evolves over the next decade. By contrast, the advantages offered by 3D bioprinting, combined with the rapid pace of its R&D, the growing demand for personalized affordable treatments in emerging economies, and the universal need to reduce healthcare costs, suggest that the technology is well positioned to disrupt the advanced wound care market in the next decade.
 
Will traditional MedTechs with wound care franchises be agile enough to benefit from these new market and technology opportunities?
 
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  • Cancer results when stem cells divide and mutate uncontrollably
  • Whether this is predominantly the result of intrinsic or extrinsic factors is unclear
  • Some experts say 65% of cancers result from intrinsic factors and are unavoidable
  • Other experts say most cancers result from extrinsic factors and are avoidable
  • Cancer strategy should not hide behind ‘bad luck’
  • Resources need to be allocated more smartly to prevent cancer

Is cancer the result of bad luck and unavoidable, or is it self-inflicted and prevented by simple lifestyles choices? Two 2015 studies arrive at strikingly different conclusions.
 
One, carried out by researchers from the John Hopkins Kimmel Cancer Centre and published in January 2015 in the journal Science, suggests that two thirds of cancers result from bad luck. Another, carried out by researchers from the Stony Brook Cancer Centre in New York and published in December 2015 in the journal Nature rebuts the findings of the Science paper, and suggests that 70 to 90% of cancer risk is self-inflicted and therefore can be avoided.

Which is right? And, why should this concern us?
 

Cancer


Cancer is a complex group of diseases characterised by the uncontrolled growth and spread of abnormal cells. If this is not checked it can cause death. Nearly 80% of all cancer diagnoses are in people aged 55 or older. Some facts about cancer In 2015 around 1.7m new cancer cases were diagnosed in the US, and about 330,000 in the UK. Each year, there are some 589,430 cancer deaths in the US, and some 162,000 in the UK. The annual treatment cost of cancer for the US is about $90bn and for the UK about £10bn. The causes of cancer include genetic, and lifestyle factors; certain types of infections; and environmental exposures to different types of chemicals and radiation.  Whitfield Growdon, Oncology Surgeon at Massachusetts General Hospital and professor at the Harvard University Medical School describes cancer and the causes of cancer.


         



         
           


 

The Science paper: cancer is unavoidable

The Science paper found that 65% of cancer cases are a result of bad luck: random DNA mutations in tissue cells during the ordinary process of stem cell division; regardless of lifestyle and hereditary factors. The remaining 35% of cancer cases, say the authors, are caused by a combination of similar mutations and some environmental and hereditary factors. One implication of these findings is that preventative strategies will not make a significant difference to the incidence rates of most adult cancers. So accordingly, the optimal way to reduce adult cancers is early detection when they are still curable by surgery.
 
Stem cell division is the normal process of cell renewal, but the extent to which random cell mutations contribute to cancer incidence, compared with hereditary or environmental factors, is not altogether clear. This is what the John Hopkins researchers sought to address with their study. Scientists examined 31 tissue types to discover whether the sheer number of cell divisions increases the number of DNA mutations, and therefore make a given tissue more prone to become cancerous.
 
Researchers developed a mathematical model, which suggested that it is incorrect to assume that cancer may be prevented with “good genes” even though we smoke, drink heavily, and carry excess weight. Their study found that, "the majority [of adult cancer risk] is due to bad luck, that is, random mutations arising during DNA replication in normal, noncancerous stem cells."  And, "this is important not only for understanding the disease, but also for designing strategies to limit the mortality it causes," say the researchers.
 
According to the Science paper bad luck mutations account for 22 of 31 adult cancer types, including ovarian, pancreatic, bone and testicular cancers. The remaining nine, including lung, skin and colorectal cancers, occurred more often than the random mutation rate predicted. This suggests that in these cancers, either inherited genes or environmental factors have a significant influence on cases.
 
Our study shows, in general, that a change in the number of stem cell divisions in a tissue type is highly correlated with a change in the incidence of cancer in that same tissue,” says Bert Vogelstein, Clayton Professor of Oncology at the John Hopkins University School of Medicine, and co-author of the study. One example, he says, is in colon tissue, which in humans, undergoes four times more stem cell divisions than small intestine tissue. Likewise, colon cancer is much more prevalent than small intestinal cancer.
 
In a BBC Radio 4 interview Cristian Tomasetti, co-author of the study said: “Let’s say my parents smoked all their lives, and they never got lung cancer. If I strongly believed cancer was only environment, or the genes that are inherited, then since my parents didn’t get cancer, I may think I must have good genes, and it would be OK to for me to smoke. On the contrary, our study says ‘no’, my parents were just extremely lucky, and played a very dangerous game.


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The Nature paper: cancer is avoidable

In a BBC interview, Yusuf Hannun, Director of the Stony Brook Cancer Center, Joel Strum Kenny Professor of Cancer Research and one of the authors of the Nature paper, challenged the findings of the ‘bad luck’ study. He suggests that hiding behind ‘bad luck’ is like playing Russian roulette with one bullet; one in six will get cancer. "What a smoker does is add two or three more bullets to the revolver and pulls the trigger. Although there is still an element of luck, because not every smoker gets cancer, they have stacked the odds against themselves. From a public health point of view, we want to remove as many bullets as possible from the revolver," says Hannun.
 
The Nature paper rebuts the John Hopkins ‘bad luck’ thesis. Its lead author, Song Wu, from the Department of Applied Mathematics and Statistics at Stony Brook University, notes that the Science paper had not conducted an alternative analysis to determine the extent to which external risk factors contribute to cancer development, and it assumes that the two variables: intrinsic stem-cell division rates, and extrinsic factors, are independent. “But what if environmental factors affect stem-cell division rates, as radiation is known to do?” asks Wu.
 
Wu and his colleagues provide an alternative analysis by applying four analytical approaches to the data that were used in the earlier Science paper and arrive at a radically different conclusion: that 70 to 90% of adult cancer cases result from environmental and lifestyle factors, such as smoking, drinking alcohol, sun exposure and air pollution. Wu admits that some rare cancers can result from genetic mutations, but suggest that incidence rates of cancers are far too high to be explained primarily by mutations in cell division.
 
According to the Nature paper, if intrinsic risk factors did play a key role in cancer development, the total number of divisions in tissue stem cells would correlate with lifetime cancer risk, and the incidence rates of the disease would be less than it actually is. Wu and his colleagues analyzed the same 31 cancer types as in the earlier Science paper, and evaluated the number of stem cell divisions in each. They then compared these rates with lifetime cancer incidence among the same cancer types. This allowed them to calculate the contribution of stem cell division to cancer risk.
 
Wu et al also pursued epidemiological evidence to further access the contribution of environmental factors to cancer risk. They analyzed previous cancer studies, which show how immigrants moving from regions of low cancer incidence to regions with high cancer incidence soon develop the same tumor rates, suggesting that the risks are environmental rather than biological or genetic.
 
The researchers’ findings suggest that mutations during cell division rarely accumulate to the point of producing cancer, even in tissues with relatively high rates of cell division. In almost all cases, the Nature paper found that some exposure to carcinogens or other environmental factors would be needed to trigger disease, which again suggested that the risks of the most prevalent adult cancers are due to environmental factors. For example, 75% of the risk of colorectal cancer is due to diet, 86% per cent of the risk of skin cancer is due to sun exposure, and 75% of the risk of developing head and neck cancers is due to tobacco and alcohol.
 
The Nature paper concludes that bad luck, or intrinsic factors, only explain 10 to 30% of cancer cases, while 70 to 90% of adult cancer cases result from environmental and lifestyle factors. "Irrespective of whether a subpopulation or all dividing cells contribute to cancer, these results indicate that intrinsic factors do not play a major causal role," say the authors. This suggests that many adult cancers may be more preventable than previously thought. 
 

Preventing cancer 

Even the Science study concedes that extrinsic factors play a role in 35% of the most common adult cancers, including lung, skin and colorectal cancers. This, together with the Nature study, and the rising incidence of avoidable cancers, should be a wake-up call because a substantial proportion of cancers can be prevented.
 
Hannun is right! Whatever the causes of cancer, we should not ‘hide behind bad luck’.  We should act on evidence, which suggests that it is within everyone’s capabilities to make simple lifestyle changes that can prevent common adult cancers.  Although maintaining a healthy lifestyle is no guarantee of not getting cancer, the Nature paper underlines the fact that a healthy lifestyle stacks the odds in your favor.  The paper supports preventative cancer strategies.
 
In 2015, tobacco smoking caused about 171,000 of the estimated 589,430 cancer deaths in the US. The Nature paper suggests that the overwhelming majority of these could have been prevented. In addition, the World Cancer Research Fund has estimated that up to 33% of the cancer cases that occur in developed countries are related to being overweight or to obesity, physical inactivity, and/or poor nutrition, and thus could also be prevented.
 
It seems reasonable to suggest that the risk of cancer can be significantly reduced by: (i) a cessation of smoking, (ii) drinking less alcohol, (iii) protecting your skin from the sun, (iv) eating healthily, (v) maintaining a healthy weight, and (vi) exercising regularly.
 

The UK Position

Everyone understands the enormity of the burden of cancer, and what to do to reduce its risk. In the UK, as in other wealthy countries, there is no lack of money, no lack of resources, and no lack of expertise for cancer care. The annual spend on cancer diagnosis and treatment alone in the UK is about £10 billion. The UK also has a government appointed Cancer Czar charged with producing a national cancer plan to bring Britain's cancer survival rates up to those of European levels. Despite our understanding and all these resources, a 2014 study published in the Lancet suggests that cancer survival rates in the UK still lag more than 20 years behind many other European countries, and that people are dying needlessly.  Why is this?
 

Fear of preventative medicine 

Writing in The Times in January 2016, Sir Liam Donaldson, a former UK Chief Medical Officer, suggested that although preventative healthcare strategies are vital “to provide safe, high quality care without running out of money”, governments avoid helping the public to mitigate the risks of modern living, which can cause cancer, because of  “two primal political forces: the mortal dread of being labeled a ‘nanny state’, and a fear of removing people’s perceived pleasures.
 
During Donaldson’s tenure between 1998 and 2010, the government rejected his recommendation for a minimum unit price for alcohol, and for the same reasons in 2014, the government rejected a tax on sugar recommended by Public Health England. Excess sugar increases the risk of cancer, heart disease and diabetes. According to Donaldson, without effective government action to lower the vast and escalating burden of cancer, and other chronic diseases, the NHS is unsustainable.
 
The missing link in preventative strategies is behavioral techniques that engage people who are at risk and help them change their behaviors. Such techniques have been demonstrated to be successful in both the UK and US. They explain how people behave, and encourage them to reduce unhelpful influences on their health, and change the way they think and act about important health-related issues such as diets, lifestyles, screenings and medication-management. See: Behavioral Science provides the key to reducing diabetes
 

Takeaway 

It is crucial that the UK government now embraces behavioral techniques to curb the curse of cancer.  Donaldson is right: if cancer, and other chronic diseases, which together consume the overwhelming percentage of healthcare expenditure, are not prevented the NHS will become unsustainable.

 
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  • China is seen as a significant growth frontier for MedTech
  • Over the past 2 decades Western companies have derived billions from China
  • But today companies seeking or extending their franchises in China will encounter significant barriers
  • China is successfully decreasing its dependence on Western medical devices and other high-tech products and replacing them with domestic offerings
  • The choice facing Western companies expecting to derive revenues from China is: either localize your value chain and help China achieve its goals to dominate key industries globally or be progressively squeezed out of markets
  • Some Western companies have localized and manufacture their offerings in China
  • Some MedTech companies concerned about China’s weak intellectual property (IP) protection and buoyed by 2 decades of growth and the current performance of the US stock market are turning away from China
  • Could adherence to history dent their futures?
  
China’s rising MedTech industry and the dilemma facing Western companies

 
This is the first of two Commentaries on China.
 
Increased cost pressures, maturing home markets, resource constraints, growing regulatory pressures and rapidly changing healthcare ecosystems are driving Western MedTech companies to seek or expand their franchises in large fast-growing emerging economies. For many, the country of choice is China. AdvaMed, the American MedTech trade association says, “China presents the most significant growth market for the medical device industry today and for the foreseeable future.”

Despite only accounting for 3% of the global MedTech market share, China’s attraction is a US$14trn economy growing at some 7% per annum, a population of 1.42bn with a large, ageing middleclass with disposable incomes, rising healthcare consumption and Beijing’s commitment to increase healthcare expenditure to provide care for all its citizens from “cradle-to-grave”. All these factors drive China’s MedTech market and the certainty of its increasing demand.

Despite this positive scenario, there are an increasing number of non-tariff barriers facing Western MedTech companies in China. This is because Beijing has launched extensive and aggressive initiatives to decrease China's dependence on Western medical devices and replace them with domestic offerings. Opportunities in China for Western players are shrinking and becoming tougher as Beijing’s new healthcare reforms kick-in and Chinese MedTech companies strengthen, increase their capacity, move up the value chain and take a bigger share of the domestic markets. To compete effectively in China, Western companies need to enhance their understanding of Beijing’s extensive healthcare reforms, increase their understanding of the complexities of China’s new procurement processes and be prepared to localize their value chains.
 
In this Commentary

This Commentary is divided it into 2 parts.
  • Part 1: China an ‘el Dorado’ for Western MedTech companies describes the significant commercial benefits derived by some Western companies who, for the past two decades, have supplied high-end medical devices to the Chinese market and benefitted from: (i) Beijing’s commitment to extend healthcare to all citizens, (ii) the country’s vast, rapidly growing and underserved middleclass and (iii) China’s large and aging population with escalating chronic lifetime diseases. These market drivers have profited Western companies because domestic Chinese MedTech enterprises had neither the capacity nor the knowhow to produce high-end medical devices. This gave rise to a bifurcated MedTech market with domestic Chinese companies producing low-end offerings and Western companies supplying high-end products.
  • Part 2: China the end of the ‘el Dorado’ for Western MedTech Companies suggests that commercial opportunities in China for Western MedTech companies have shrunk significantly and become much tougher as domestic manufacturers, incentivized by Beijing, move up the value chain and capture a bigger share of the domestic market. We describe Made in China 2025 (MIC2025), which is a well-resourced government initiative aimed at decreasing China’s dependence on Western MedTech suppliers by enhancing the capacity and scale of Chinese companies. This, together with China’s current 5-year economic plan aimed at a “healthier China” and its 2009 healthcare reforms are already significantly effecting some segments of MedTech markets previously dominated by Western companies.


PART 1
 
 China an el Dorado for Western MedTech companies
 
China’s healthcare market and the MedTech sector
The attraction of China’s healthcare market to Western investors over the past decade is easy to comprehend. In 2013 China surpassed Japan to become the world’s second-largest healthcare market outside the US and the fastest growing of all large emerging markets. Healthcare spending is projected to grow from US$854bn in 2016 to US$1trn in 2020. In 2016, China’s healthcare expenditure as a proportion of its GDP was 6.32%, up from 4.4% in 2006, and this is expected to rise to between 6.5 and 7% by 2020. Although this is a lower percentage than that of the US with 17%, Germany with 11%, Canada, Japan and the UK with about 10%; it suggests that China’s healthcare market has a substantial upside potential; especially as the country’s middleclass grows and becomes economically stronger and Beijing’s healthcare reforms kick-in.
 
The attraction of China’s MedTech market to Western investors also is easy to understand. It is one of the fastest growing market sectors, which has maintained double-digit growth for over a decade. In 2016 China’s MedTech market was valued at US$54bn, an increase of 20% compared to 2015; 72% of which was fuelled by hospital procurements. In 2017 China imported more than US$20bn worth of high-end medical devices the overwhelming majority of which was supplied by Western companies.
 
Drivers of China’s MedTech markets
 
Three China market variables making for highly valued Western MedTech businesses include: (i) the country’s vast, rapidly growing and underserved middleclass, (ii) China’s large and aging population with escalating chronic lifetime diseases and (iii) Beijing’s commitment to extend healthcare to all of its citizens.

 
  1. Rapidly growing and underserved middleclass
China’s past rapid economic growth lifted hundreds of millions of its citizens out of poverty and into the middleclass. As China’s middleclass has grown, its healthcare market has expanded and the opportunities for Western MedTech companies have increased. This partly offsets slower demand experienced by Western MedTech companies after 2009 when middleclass consumers in developed countries were challenged by the shocks to their living standards caused by the 2008 recession and subsequent lower global economic growth.
 
Since 2015, Chinese middleclass consumers have become a significant driver of the country’s economic activity and are projected to remain so through at least 2025. Since 2000, annual real GDP growth per capita has averaged 8.9% while real personal disposable income on average has risen 9.2%. According to Credit Suisse’s Global Wealth Report, in 2015 China overtook the US as the country with the biggest middleclass, which is comprised of some 109m adults compared with 92m in the US. Today, the Chinese middleclass is facing more lifestyle related diseases, whilst expecting more and better healthcare. By 2025, China’s middleclass is projected to reach 600m and have an annual disposable income between US$10,000 and US$35,000. Further, compared to the US and the UK, China’s middleclass has a low level of household debt. China’s household debt-to-GDP ratio is 40% compared with 87% for that of the US and UK. This suggests that consumer led growth in China still has a significant upside. However, there are cultural obstacles to Chinese citizens assuming more personal debt.

 
  1. Large aging population with escalating chronic lifetime diseases
China has a population of 1.42bn and each year Chinese citizens give birth to some 20m. In January 2016 China lifted its 40-year-old one-child policy, which is expected to increase the country’s birth rate and increase the demand for in-vitro fertilization among older parents. Notwithstanding, partly because of the country’s falling fertility rates and partly the increasing life expectancy of the elderly share of the country’s population (In 2017 total life expectancy was 76.5), the number of elderly Chinese citizens has been increasing. According to China’s Office of the National Working Commission on Aging, in 2017 the number of its citizens aged 60 or above had reached 241m, accounting for some 17% of the total population and this is expected to peak at 487m, or 35%, around 2050, when it is projected that China will have 100m citizens over 80.

This is significant because elderly people have a higher incidence of disease, demand more frequent, longer and more complicated treatment regimens and use medical services more often than their younger counterparts. For example, China’s ageing population is fuelling the rise in demand for orthopaedic devices. Projections suggest that over the next decade China could become the world’s largest orthopaedic device market. As the Chinese population continues to age, demand for healthcare services and medical devices are expected to increase substantially. Notwithstanding, a ‘dependent’ large growing and aging population has a significant economic downside.
 
Further, the 600m Chinese citizens of prime earning age tend to live in large urban centres. China has some 662 cities; 6 of which are mega cities with populations of about 10m. 160 Chinese cities have populations in excess of 1m. Increased urbanization, changing diets and lifestyles and increased air pollution and other environmental hazards are causing a substantial rise in the prevalence of chronic lifetime diseases. It is estimated that 330m Chinese citizens currently have chronic diseases. According to a 2018 study almost 100m adults (8.6%) have chronic obstructive pulmonary disease (COPD), about 110m have diabetes and more than 80m Chinese citizens are handicapped. Altogether this creates a vast and growing demand for various high-end medical devices.

 
  1. Beijing’s commitment to extend healthcare to all citizens
A 3rd driver of China’s expanding healthcare sector is Beijing’s healthcare reforms launched in 2009 and its current 5-year economic plan, which prioritizes a "Healthy China". According to a 2016 World Bank report, ”Since the launch of the 2009 health reforms, China has substantially increased investment to expand health infrastructure; strengthened the primary-care system; achieved near-universal health insurance coverage in a relatively short period; reduced the share of out-of-pocket expenses - a major cause of disease-induced poverty - in total health spending; continued to promote equal access to basic public health services; deepened public hospital reform; and improved the availability, equity and affordability of health services. It has also greatly reduced child and maternal mortality and rates of infectious diseases and improved the health and life expectancy of the Chinese people.”
 
The share of healthcare expenses covered by the government is expected to increase from 30% in 2010 to 40% in 2020, but current regional differences in access to and quality of healthcare are expected to remain in the near term. China’s current economic plan, which was approved in 2015 and adopted in 2016 is responsible for a number of well-funded and aggressive healthcare reform programs, and increased investment in healthcare infrastructure. The plan also encourages private capital investment to improve service quality and meet the public’s diverse, complex and escalating healthcare needs.
 
Bifurcated MedTech market

These three healthcare drivers have significantly benefitted Western MedTech companies who leveraged their pre-existing products and business models and served China’s fast growing and underserved high-end MedTech markets with sophisticated medical devices. Chinese domestic MedTech companies, which today are comprised of about 16,000 small-to-medium sized light manufacturing enterprises on China’s east coast, participated in the low end of the global value chain and mostly produced Class I and II cheap disposable medical devices, which required simple forms of manufacturing or assembly, but created large numbers of jobs and made a significant contribution to poverty reduction. This mutual dependence gave rise to a bifurcated market and reflected the type of foreign direct investment that China attracted at the time and the relative lack of capacity of the domestic labour force.
 
The foreign sourced market segment has been served historically by large, well-resourced Western MedTech companies such as Medtronic, General Electric (GE), PhilipsSiemens, Zimmer Biomet  and DePuy Synthes. Before 2009, such companies enjoyed a near monopoly supplying their pre-existing high-end medical devices to large Chinese hospitals (see below). US MedTech companies were the #1 foreign supplier of such offerings, followed by Germany and Japan. These 3 countries represented the overwhelming majority share of China’s imports of medical devices.


PART 2

China the end of the el Dorado for Western MedTech companies
 
Between 2003 and 2009 foreign direct investment in China’s MedTech sector was concentrated in low-value-added activities. This pattern reversed during 2010-2018 and enabled Chinese MedTech companies to move up the value chain and develop more sophisticated manufacturing processes, increase their R&D capacity, enhance their post-market services and begin to penetrate more segments of the higher-value-added Class lll MedTech markets. As this happened so the predominance of Western MedTech companies providing high-end product offerings was reduced. This shift suggests that late entrants to the China market may struggle.
 
A 2017 survey conducted by China’s New Center for Structural Economics, covering 640 Chinese export-oriented labour-intensive companies across four sectors between 2005 and 2015 suggests that upgrading low-tech industries is pervasive throughout China. “’Technology upgrading’ was the firms’ most common response to their challenges: 31% of firms ranking it top and 54% in their top three responses. Tighter cost control over inputs and in production was next (top for 27% of firms) and changing product lines or expanding markets was third most common (24%)”, says the report.
 
Taking share from Western companies

To-date domestic Chinese MedTech companies have captured about 10% of the technologically intensive segments of endoscopy and minimally invasive surgery as measured by value, and 50% of the market in patient monitoring devices and orthopaedic implants. Only 5 years ago Western companies such as Zimmer Biomet  and DePuy Synthes controlled 80% of the Chinese high-end orthopaedic market segments. Further, about 80% of China’s market of drug-eluting stents, (medical devices placed into narrowed, diseased peripheral or coronary arteries, which slowly release a drug to block cell proliferation), which is another relatively high-end therapeutic device segment, is controlled by Biosensors InternationalLepu Medical, and MicroPort. These three Chinese companies market drug-eluting stents, on average, for about 40% less than their Western counterparts. Just over a decade ago 90% of this market was controlled by Western MedTech companies. Similarly, Chinese companies have increased their domestic market share of digital X-ray technologies to 50%. In 2004 they had zero share of this market.
 
Made in China 2025
 
In May 2015, Beijing launched “Made in China 2025” (MIC2025), which is a national strategy to enhance China’s competitive advantage in manufacturing. Increasing competition from developing nations with similarly competitive costs, coupled with technology-driven efficiency gains in developed countries, means that China’s abundance of cheap labour and the competitive advantage of its infrastructure will soon be insufficient to drive sustainable economic growth. MIC25 is expected to redress this by comprehensively upgrading, consolidating and rebalancing China’s manufacturing industry, and turning China into a global manufacturing power able to influence global standards, supply chains and drive global innovation.
 
The strategy names 10 sectors, including medical devices, which qualify for special attention to help boost the country’s goal of accelerating innovation and improving the quality of products and services. The initiative incentivizes domestic Chinese companies, including SMEs, to increase their usage of artificial intelligence and digital technologies to move up the value chain and capture a greater market share from their Western counterparts. MIC2025 is explicit about China reducing its reliance on Western imports and includes subsidies, loans and bonds to support and encourage domestic companies to: (i) continue increasing their capacity, (ii) devise lean business models that emphasize “affordability”, (iii) increase their R&D, (iv) expand their franchises overseas, and (v) acquire foreign enterprises with cutting-edge technologies. The initiative  also addresses issues of quality, consistency of output, safety and environmental protection, which are all considered strategic challenges to China’s development.
 
Beijing expects MIC2025 to increase the market share of Chinese-produced medical devices in the country’s hospitals to 50% by 2020 and 70% by 2025, enable Chinese companies to compete with Western MedTech giants by 2035 and make China a world MedTech leader by “New China’s” 100th birthday in 2049. The initiative is expected to quickly spread beyond China’s borders as its leading manufacturers seek to develop global supply chains and to access new markets. MIC25 is important for the next stage of China’s emergence as an economic superpower and its ambition to design and make the products of the future required not only by the Chinese consumer, but consumers around the world.
 
US attempts to halt MIC25

While many Western countries are debating how to respond to MIC25 Washington sees the initiative as a well-defined, well-orchestrated strategy, which is “unfair and coercive” because it includes government subsidies and the “forced transfer” of technology and IP to enable the Chinese to “catch-up and surpass” American technological leadership in advanced industries.  An August 2018 US Council for Foreign Relations response says, “MIC25 relies on discriminatory treatment of foreign investment, forced technology transfers, intellectual property theft, and cyber espionage”. In June 2018 Washington sought to halt the policy by levying punitive tariffs on Chinese imports into the US and blocking Chinese-backed acquisitions of American technology companies.
 
The commercial effects of increased tariffs are unclear

It is not altogether clear how successful Washington’s punitive tariffs will be because they could unsettle the US medical supply industry given that a growing number of product offerings marketed in the US are made in China. MRIs, pacemakers, sonograms and other medical devices manufactured in China and imported into the US are all included in the list of items subject to the increased US tariffs. Some estimates suggest that the tariffs will cost the American medical device industry more than US$138m in 2018, and about US$1.5bn every year there after. According to AdvaMed, the US enjoys a trade surplus with China for medical products and rather than grow US productivity, the tariffs could result in less trade and a smaller surplus in medical devices. Whilst protectionist, the MIC25 initiative is permitted under World Trade Organization rules as China is not a signatory to the Agreement on Government Procurement, which covers state run hospitals. Further, historically healthcare products have been excluded from tariffs on humanitarian grounds and because they are seen as an asset to public health.
 
Western companies ‘encouraged’ to localize their value chains
 
Although Beijing is seeking to reduce its dependence on imported medical devices, it has not shut-out Western companies who are expected to continue to be significant high-tech market players in the short to medium term. This is because such international trade is crucial to facilitate China’s access to global knowhow and technology. But Beijing has amended its procurement and reimbursement policies to incentivise hospitals to purchase domestically manufactured medical devices and introduced tough conditions on companies seeking to do business in China. To qualify for inclusion in China’s new hospital procurement arrangements Western companies are obliged to localize their value chains and partner with domestic enterprises. Some companies have done so, while others have been reluctant to localize their value chains because of China’s weak record of IP protection. Beijing is aware of this and is streamlining and strengthening its IP prosecution system (see below).
 
Western importers seriously handicapped
 
Importers who choose not to localize their value chains face a number of significant non-tariff barriers. Unlike other Asian countries such as Japan, China has no national standard for tendering and bidding and there are significant differences between its 34 provincial administrations and 5 automatous regions. Further, China has a dearth of large ‘general’ distributors. Western MedTech companies importing product offerings into China are obliged to engage small-scale distributors dedicated to one sector, one imported brand and one type of product. Such distributors are ill-equipped to effectively navigate China’s vast hospital sector (see below) and its complex, rapidly changing and disaggregated procurement and reimbursement processes. A clash of sales cultures is a further disadvantage for Western MedTech companies’ whose marketing mindset is product-centric territory driven, while winning sales strategies in China and in other emerging markets are customer-centric key-account driven.
 
China’s vast hospital sector
 
One dimension of the challenges faced by Western MedTech companies who are obliged to engage small-scale distributors is the enormity of China’s hospital sector. China has about 30,000 hospitals, which have increased from about 18,700 in 2005, serving a population four and a half times that of the US across a similar land mass. By comparison, the US has some 15,500 hospitals and England 168 NHS hospitals. About 26,000 hospitals in China are public and some 4,000 are private. Although public hospitals in China provide the overwhelming majority of healthcare services, this is changing.  Recently, Beijing has loosened its regulations and private sector healthcare has witnessed an influx of private capital. Over the next decade, China’s private healthcare sector is expected to see new hospital chains, expansion of existing hospitals and improvements in a range of private healthcare services. Currently, Western participation in the Chinese private healthcare market is nascent but expected to grow over the next decade.
 
China’s hospitals provide about 5.3m beds, compared with about 890,000 in the US and 142,000 NHS beds in the UK. Chinese public hospitals, which are the biggest consumers of Western medical devices, are categorized into 3 tiers according to their size and capabilities. The largest are tier-3 hospitals of which there are about 7,000. These are 500-bed-plus national, provincial or big city hospitals, which provide comprehensive healthcare services for multiple regions as well as being centres of excellence for medical education and research. There are about 1,500 tier-2 hospitals, which are medium size city, county or district hospitals. Together teir-2 and 3 hospitals represent about 3.5m acute beds. Tier-1 hospitals are township-based and do not provide acute services. There is a range of specialist hospitals, which are also significant users of imported high-end medical devices. Further, Beijing is beginning to develop primary care facilities, which are normal in North America and Europe, but underdeveloped in China.
 
Mega private hospitals
 
Healthcare in China has traditionally been the monopoly of the central government. However, Beijing’s recent relaxation of the rules on private investment referred to above has triggered an explosion in the number of private healthcare facilities and the development of mega hospitals on a scale not seen elsewhere in the world. For example, Zhengzhou Hospital, which is nearly 700km south of Beijing and can be reached by bullet train in under 3 hours at a cost of about US$45, was officially opened in 2016 and was dubbed the “largest hospital in the universe”. Zhengzhou is a mega-city with a population of 10m and is the capital of east-central China's Henan province. The hospital has some 10,000 beds, facilities are spread across several buildings and over 28 floors and it has its own fire department and police station. In 2015, the hospital admitted some 350,000 inpatients and treated 4.8m people. In one day in February 2015 the hospital received 20,000 out-patients. 
Centralizing procurement
 
Most noticeable among the changes taking place in China’s procurement processes for domestically produced medical devices is the development of centralized e-commerce facilities, which are expected to increase efficiency and reduce spiralling hospital costs. The initiative is a partnership, announced in 2018, between IDS Medical Systems and Tencent’s digital healthcare subsidiary WeDoctor, to establish China’s first smart medical supply chain solutions and procurement company, which in the near term, is expected to dominate the Chinese market by becoming the “Amazon of healthcare”. Tencent is the world’s 6th largest social media and investment company and IDS Medical Systems is a Hong Kong based medical supply company with an extensive Asia-Pacific distribution network, which represents over 200 global medical brands in medical devices and consumables. 
 
WeDoctor, was founded in 2010 to provide online physician appointment bookings, which is an issue in China and patients often stand in-line for hours from 2 and 3 in the morning outside hospitals to get brief appointments with physicians. From this modest beginning WeDoctor has rapidly evolved into a US$5.5bn company, which employs big data, artificial intelligence and other digital tools to deliver cutting-edge healthcare solutions and support services to over 2,700 Chinese hospitals, 240,000 doctors, 15,000 pharmacies and 160m platform users; and these numbers are expected to increase significantly in the next few years.
 
Underpinning WeDoctor’s business model and differentiating it from Western endeavours such as Google’s DeepMind, is the freedom in China to collect and use patient data on a scale unparalleled in the West. WeDoctor is designed to leverage Tencent’s significant complementary strengths, innovative resources and networks in order to centralize device procurement by connecting domestic MedTech companies with China’s vast hospital network. WeDoctor’s ability to manage petabytes of patient data, its knowledge of and favoured position in China’s hospital procurement processes, its rapid and sophisticated distribution capacity and central government support, positions WeDoctor to have a significant impact on the procurement of medical devices in China and beyond in the next five years, and this is expected to provide domestic companies with a further competitive edge.
 
Localizing the value chain in China

Manufacturing in China has been an option only for larger Western MedTech companies with the necessary management knowhow, business networks and finance to bear the costs. Companies which have localized their value chains and support the MIC25 initiative include Medtronic and GE Healthcare.
 
Medtronic
Medtronic, the world’s largest MedTech company, has had a presence in China for the past 2 decades and has established local R&D facilities to design products specifically for the needs of the Chinese market and crafted partnerships with provincial governments to help educate patients about under-served therapeutic areas. In 2012 Medtronic acquired Kanghui Medical, for US$816m. In December 2017 the Chinese government approved sales of a new pacemaker, which is the product of a strategic partnership between Medtronic and Lifetech Scientific Corporation. In January 2012 Medtronic paid US$46.6m for a 19% stake in Lifetech and a further US$19.6m for a convertible loan note. The agreement called for LifeTech to develop a line of pacemakers and leads using its manufacturing plant in Shenzhen, (population 13m). Medtronic supplied “technology, training and support” and LifeTech provided local market expertise, brand recognition and growth potential within China. The alliance has made Lifetech the first Chinese domestic manufacturer with an implantable cardiac pacing system with world-class technology and features. In 2015 Medtronic entered into a partnership with the Chengdu’s (population 14.4m) municipal government in the south west of China to enable people with diabetes in Chengdu and the broader Sichuan province (population 87m) to access a new, locally produced next generation sensor augmented pump system with Medtronic’s SmartGuard technology and software displayed in the Chinese language. Medtronic’s 2017 revenues from its China operations amounted to US$1.6bn, 5% of total revenues, and US$3.4bn from other Asia-Pacific countries, 12% of total revenues.
 
GE Healthcare
GE Healthcare is the largest medical device manufacturer in China and China is a key manufacturing base for GE. GE started conducting business in China in 1906 and today has over 20,000 employees across 40 cities in the country. One third of GE's ultrasound probes, half of its MRIs and two thirds of its CT scanners, which are marketed globally are manufactured in the Chinese cities of Wuxi, Tianjin and Beijing respectively. These devices and others are now subject to a punitive US tariff levied in June 2018. “We remain concerned that these tariffs could make it harder for US manufacturers to compete in the global economy, and will shrink rather than expand US exports,” says Kelly Sousa, a GE Healthcare spokesperson.
 
Rachel Duan, president and CEO of GE China explains that, “GE China has been investing in people, processes and technologies throughout the value chain so that it can design, manufacture and service products closer to customers. This goes beyond market and sales localization, to product R&D, manufacturing and product services." GE has pinpointed localization, partnership, and digitization as the three key initiatives to drive its future development in China. In May 2017 GE opened an Advanced Manufacturing Technology Center in Tianjin, its first outside the US, and has partnered with over 30 Chinese engineering, procurement and construction (EPC) companies. "With a global footprint and depth of localized capabilities in China, we are partnering with customers and helping them win both in China and worldwide by connecting machines, software, and data analytics to unlock industrial productivity," says Duan. 

 
Changing IP environment
 
Medtronic and GE Healthcare provide object lessons of how best Western MedTech companies might leverage commercial opportunities in China. But many remain reluctant to manufacture in China because historically the country’s legal system has been weak in prosecuting IP infringements and more recently they have been further handicapped by Washington’s response to MIC25. For many years, when dealing with China, Western companies have faced a combination of IP challenges, which included litigation with low level damages, an inability to effectively enforce judgments, an inability to patent certain subject matter and a lack of transparency on legal issues. This amounts to substantial disincentives for Western companies to localize their value chain in China. However, the country’s IP environment is changing. In 2017 Beijing spent some US$29bn for the rights to use foreign technology, with the amount paid to US companies increased by 14% year-on-year. China’s IP legal system is maturing and has improved in the scope of allowable patent subject matter to enhancements of litigation options. However, Western reluctance to localize production in China is not only influenced by the country’s weak IP protection and recent trade tensions with the US, but also by ethical concerns and the perceived need for more predictable rules and institutions about environmental and regulatory issues.
 
All this, together with two decades of growth in developed nations and the continued performance of the US stock market might be enough for some MedTech companies to turn-away from China, but could such a reaction dent their futures?

 
Takeaways

This Commentary describes some of the near-term challenges facing Western MedTech companies looking to offset increasing challenges in their home markets by extending their franchises in China. We have suggested why operationalizing this strategy in the short term will be tougher than 5 years ago, especially if Western MedTech companies are reluctant to innovate and transform their strategies and business models. China presents a challenging dilemma for Western companies: either they manufacture in China and support that nation’s endeavours to become a world class manufacturing platform or they progressively get squeezed out of markets. Whatever Western companies decide, we can be sure that their near to medium term futures will be shaped by maturing developed world markets, encumbered by short termism and aging infrastructures and a rising Chinese economic power with state-of-the-art infrastructures and significantly enhanced capacities and capabilities. But how long can China sustain its rise?
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Cost-effective asset to relieve growing pressure on GPs

Can the escalating primary care crisis in England be helped with a new and innovative online dashboard, which automatically sends short videos contributed by clinicians to patients’ mobiles to address their FAQs?
 
Dr Seth Rankin, Managing Partner of the Wandsworth Medical Centre, and co-chair of Wandsworth CCG’s diabetes group, who has spearheaded the dashboard, thinks it can. Click on the photo below to view a short video that describes how health professionals can use the dashboard:
 
 
 
New and innovative dashboard
 
A 24/7 fully automated service that never wears out
We were motivated to do something about the increasing pressure on GPs, and the impact this has on the quality of our care. Patients may have to wait a couple of days for an appointment with a GP, but they can receive our videos within minutes of their request,” says Rankin. He continues: “A pilot study we carried out in two London primary care practices suggested that video is a patient’s preferred format if they can’t see a GP. Further, patients often don’t retain what you tell them in a 10-minute face-to-face consultation, and they tend not to read pamphlets, which also are expensive to produce. 53% of patients regularly search the Internet for healthcare information, but 81% can’t differentiate between good and bogus information. 72% prefer healthcare information from their GP, and like healthcare videos delivered directly to their mobiles. 70% want access to healthcare information at any time, from anywhere, on their mobiles.
 
“Unlike the Internet, our dashboard provides premium reliable information, which can be easily consumed and shared among family, friends and carers. Also, the videos can be viewed many times, from anywhere, and unlike pamphlets and doctors, they never get tired, never wear out, and are available 24/7, 365 days a year. The dashboard is fully automated [see figure below], relieves GPs of a lot of unnecessary work, and, importantly, reports on how our patients’ are using the different videos.”
 
Automated system that encourages engagement behaviours
 
Local experts
“We used local medical experts in our videos because we were keen to increase their connectivity with our patients. The videos provide 60 to 80 second talking-head answers to patients’ questions, and are designed to increase patients’ knowledge of their condition, propel them towards self-management, slow the onset of complications, and reduce face-time with GPs, while enhancing the quality of our care,” says Rankin.
 
Diabetes
He continues: “Although the dashboard easily can be used for any disease state, we started with T2DM as it represents our largest group of patients. Also, we know that: (i) T2DM is preventable with effective education that encourages diet and lifestyle changes, (ii) current diabetes education fails, and over the past decade, the incidence rate of the condition has increased by 65%, (iii) only 16% of the 120,000 people diagnosed each year with diabetes in England are offered structured educational courses, and (iv) only 2% of those offered courses actually enrol in them. So, we created our own bespoke dashboard and content library of about 120 videos, which we organised under 10 headings that we know interest our patients. Each heading has a cluster of ‘essential’ and ‘in-depth’ videos. We use the dashboard to relieve some of the pressure on our health professionals.”
 
Unprecedented crisis
 
Saturation point
A 2016 study published in The Lancet suggests that between 2007 and 2014 the workload in NHS general practice had increased by 16%, and that it is now reaching saturation point. According to Professor Richard Hobbs of Oxford University and lead author of the study, "For many years, doctors and nurses have reported increasing workloads, but for the first time, we are able to provide objective data that this is indeed the case . . . . . As currently delivered, the system [general practice in England] seems to be approaching saturation point . . . . . Current trends in population growth, low levels of recruitment and the demands of an ageing population with more complex needs will mean consultation rates will continue to rise.”
 
More than 1m patients visit GP every day
A 2014 Deloitte’s report commissioned by the Royal College of General Practitioners (RCGP) suggests that the GP crisis in England is the result of chronic under-funding and under-investment in primary care at a time when the demand for GP services is increasing as the population is ageing, and there is a higher prevalence of long term conditions and multi-morbidity.
 
According to the RCGP, over the past five years the number of annual GP consultations has increased by 60 million to around 370 million, while over the same period the number of GPs has grown by only 4.1%. More than one million patients a day visit their GP surgeries, with some GPs now routinely seeing between 40 to 60 patients daily.
 
GPs are extremely stressed
Deloitte’s findings are confirmed by a 2016 comparative study undertaken by the prestigious Washington DC-based Commonwealth Fund, which concludes that increasing workloads, bureaucracy and the shortest time with patients has led to 59% of NHS GPs finding their work either “extremely” or “very” stressful: significantly higher stress levels than in any other western nation. GP stress levels are likely to increase. In a speech made in June 2015, the UK’s Secretary of Health said, “Within 5 years we will be looking after a million more over-70s. The number of people with three or more long term conditions is set to increase by 50% to nearly three million by 2018. By 2020, nearly 100,000 more people will need to be cared for at home.” According to Dr Maureen Baker, chair of RCGP, “Rising patient demand, excessive bureaucracy, fewer resources, and a chronic shortage of GPs are resulting in worn-out doctors, some of whom are so fatigued that they can no longer guarantee to provide safe care to patients.”
 
Causes and consequences
 
GP exodus
Trainee GPs are dwindling and young GPs are moving abroad. According to data from the General Medical Council (GMC), between 2008 and 2014 an average of 2,852 certificates were issued annually to enable British doctors to work abroad. We now have a dangerous situation where there are hundreds of vacancies for GP trainees. Meanwhile, findings from a 2015 British Medical Association (BMA) poll of 15,560 GPs found that 34% of respondents plan to retire in the next five years because of high stress levels, unmanageable workloads, and too little time with patients.
 
Suggested solutions
 
5,000 more GPs by 2020
In the run up to the UK’s 2015 General Election the Secretary of Health pledged “to train and retain an extra 5,000 GPs by 2020” to ease the primary care crisis, but doctors’ leaders did not see this as a solution. Dr Maureen Baker said, "Even if we were to get an urgent influx of extra funding and more GPs, we could not turn around the situation [the GP crisis] overnight due to the length of time it takes to train a GP,” And Dr Chaand Nagpaul, chair of the BMA GPs’ committee, warned later that, “delivering 5,000 extra GPs in five years, when training a GP takes 10 years, was a practical impossibility that was never going to be achieved.” After the election the Health Secretary softened his promise and suggested that it would be ‘a maximum' of 5,000 by 2020.

In 2016, Pulse, a publication for GPs, suggested that the Health Secretary knows he cannot deliver his promise of 5,000 new doctors by 2020, and is negotiating with Apollo Hospitals, an Indian hospital chain, to bring 400 Indian GPs to England.
 
A more innovative approach

Better and smarter solutions needed
While searching for an immediate temporary solution to the GP crisis the Secretary of Health seems to understand that a more innovative approach is required for the medium to long term. In his June 2015 speech he said, “If we do not find better, smarter ways to help our growing elderly population remain healthy and independent, our hospitals will be overwhelmed – which is why we need effective, strong and expanding general practice more than ever before in the history of the NHS. Innovation in the workforce skill mix will be vital too in order to make sure GPs are supported in their work by other practitioners.”
 
Pharmacists in GP surgeries
In July 2015 the NHS launched a £15m pilot scheme, supported by the RCGP and the Royal Pharmaceutical Society (RPS), to fund, recruit and employ clinical pharmacists in GP surgeries to provide patients with additional support for managing medications and better access to health checks.
 
Dr Maureen Baker said, “GPs are struggling to cope with unprecedented workloads and patients in some parts of the country are having to wait weeks for a GP appointment yet we have a ‘hidden army’ of highly trained pharmacists who could provide a solution”. Dr David Branford, former Chair of the RPS said, “It’s a win-win situation . . . .  We will be doing everything we can to support the GPs and make sure this pilot is successful. In time, I hope pharmacists will be working in every GP practice in the country.” Ash Soni, president of the RPS suggests that it makes sense for pharmacists to help relieve the pressure on GPs, and says, “Around 18m GP consultations every year are for minor ailments. Research has shown that minor aliment services provided by pharmacists can provide the same treatment results for patients, but at lower cost than at a GP surgery.”
 
Progressive and helpful move
The efficacy for an enhanced role of pharmacists in primary care has already been established in the US, where retail giants such as CVS, Walgreens and Rite Aid have led the charge in providing convenient walk-in clinics staffed by pharmacists and nurse practitioners. Over time, Americans have grown to trust and value their relations with pharmacists, which has significantly increased adherence to medications, and provided GPs more time to devote to more complex cases. Non-adherence is costly, and can lead to increased visits to A&E, unnecessary complications, and sometimes death. According to a New England Healthcare Institute report, Thinking Beyond the Pillbox, failure to take medication correctly, costs the US healthcare system $300 billion annually, and results in 125,000 deaths every year. 
 
Takeaway
 
Introducing pharmacists into GP surgeries is a progressive and potentially helpful move forward, because, as Dr Maurine Baker suggests, “It is in everyone’s best interests to be seen by a GP who is not stressed or fraught and who can focus on giving their patients the time, attention and energy they need”. However, even more could be achieved if the dashboard described by Dr Seth Rankin were more widely introduced. “Videos play a similar role to practice-based pharmacists. Both deal with simple day-to-day patient questions, and relieve pressure on GPs, which allows them to focus their skills where they are most needed,” says Rankin.
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MedTechs Battle with AI for Sustainable Growth and Enhanced Value
 
Preface
 
The medical technology industry has experienced significant growth, consistently surpassing the S&P index by ~15 percentage points. This success is rooted in the early 1990s, a time when capital was costly, with interest rates ~10%. However, as we moved closer to 1998, interest rates began to recede, settling just below 7%. This early era of growth was not devoid of challenges. The US was still grappling with the aftermath of the oil embargo imposed in 1973 by the Organization of the Petroleum Exporting Countries (OPEC), which was a response to the American government's support for Israel during the Yom Kippur War and had lasting consequences. The oil crisis triggered hyperinflation, leading to a rapid escalation in the prices of goods and services. In response, the US Federal Reserve (Fed) raised interest rates to a historic high of 17% in 1981, which was aimed at curbing inflation but came at the price of increasing the cost of borrowing. As we entered the 1990s, the landscape shifted. The Fed’s monetary policies began to work, inflation started to decline, and interest rates fell to ~10%, eventually dipping below 7% in 1998. This created conditions for increased investments in research and development (R&D) and the American economy blossomed and benefitted from the internet becoming mainstream. It was during this period that many medical technology companies developed innovative medical devices, which were not only disruptive but also found a receptive global market characterized by significant unmet needs and substantial entry barriers. In the ensuing years, the industry thrived and matured. Fast-forward to the present (2023), and we find ourselves in a different scenario. Over the past five years, numerous large, diversified MedTechs have struggled to deliver value. One explanation for this is that growth of these enterprises over the past three decades, except for the early years, was primarily driven by mergers and acquisitions (M&A), often at the expense of prioritizing R&D. Consequently, many large MedTechs did not leverage evolving technologies to update and renew their offerings and are now heavily reliant on slow-growth markets and aging product portfolios. Navigating a successful path forward would be helped by a comprehensive embrace of artificial intelligence (AI) and machine learning (ML) strategies, since these technologies possess the potential to transform how MedTechs operate, innovate, and serve their stakeholders.
 
In this Commentary

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

Defining Artificial Intelligence (AI)

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


Part 2

Highlighting AI-Driven MedTech Success

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

Showcasing a Disruptive AI-Powered Medical Device

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

 
Part 4

The Potential Benefits of Full AI Integration for MedTechs

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

Potential Obstacles to the Adoption of AI by MedTechs

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

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

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

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

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

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

 
Takeaways
 
Hesitation among MedTechs to integrate AI technologies poses the threat of missed opportunities, diminished competitiveness, and sluggish growth. This reluctance hinders innovation and limits the potential for enhanced patient care. Embracing AI is not an option but a strategic imperative. Failure to do so means missing opportunities to address unmet medical needs, explore new markets, and access new revenue streams. The potential for efficiency gains, streamlined operations, and cost reductions across R&D, manufacturing and supply chains is significant. Companies fully embracing AI gain a competitive advantage, delivering innovative solutions and services that improve patient outcomes and cut healthcare costs. Conversely, those resisting AI risk losing market share to more agile rivals. AI’s impact on analysing vast amounts of complex medical data, accelerating discovery, and enhancing diagnostics is well established. MedTechs slow to leverage AI may endure prolonged R&D cycles, fewer breakthroughs, and suboptimal resource allocation, jeopardising competitiveness and branding them as ‘outdated’. In today’s environment, attracting top talent relies on being perceived as innovative, a quality lacking in AI-resistant MedTechs. As AI disrupts industries, start-ups and smaller agile players can overtake established corporations failing to adapt. A delayed embrace of AI impedes progress in patient care, diagnosis, treatment, and outcomes, preventing companies from realising their full potential in shaping healthcare. The time to embrace AI is now to avoid irreversible setbacks in a rapidly evolving MedTech ecosystem.
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