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  • The convergence of MedTech and pharma can generate innovative combination devices that promise significant therapeutic and commercial benefits
  • Combination devices such as advanced drug delivery systems offer more precise, predictable and personalized healthcare
  • The global market for advanced drug delivery systems is US$196bn and growing
  • Biosensors play a role in convergence and innovative drug delivery systems
  • Roger Kornberg, Professor of Medicine at Stanford University and 2006 Nobel Prize winner for Chemistry describes the technological advances, which are shaping new medical therapies

    

The convergence of MedTech and pharma and the role of biosensors

MedTech and pharma companies are converging.
What role do biosensors play in such a convergence?
 
Traditionally, MedTech and big pharma have progressed along parallel paths. More recently, however, their paths have begun to converge in an attempt to gain a competitive edge in a radically changing healthcare landscape. Convergence leverages MedTech’s technical expertise and pharma’s medical and biological agents to develop combination devices. These are expected to significantly improve diagnosis, monitoring and treatment of 21st century chronic lifetime diseases, and thereby make a substantial contribution to an evolving healthcare ecosystem that demands enhanced patient outcomes, and effective cost-containment.
 

Conventional diagnostics & drug delivery

Conventional in vitro diagnostics for common diseases are costly, time-consuming, and require centralized laboratories, experienced personnel and bulky equipment. Standard processes include the collection and transportation of biological samples from the point of care to a centralized laboratory for processing by experienced personnel. After the results become available, which usually takes days, the laboratory notifies doctors, who in turn contact patients, and modify their treatments as required. Conventional modes of treatment have mainly consisted of simple, fast-acting pharmaceuticals dispensed orally or as injectables. Such limited means of drug delivery slows the progress of drug development since most drugs are formulated to accommodate the conventional oral or injection delivery routes. Concerns about the quantity and duration of a drug’s presence, and its potential toxic effect on proximal non-diseased tissue drives interest in alternative drug delivery systems and fuels the convergence of MedTech and pharma.



The end of in vitro diagnostics

Roger Kornberg, Professor of Medicine at Stanford University, reflects on the limitations of conventional in vitro diagnostics, and describes how technological advances facilitate rapid point-of-care diagnostics, which are easier and cheaper:

 
 
Converging interest
 
Illustrative of the MedTech-pharma convergence is Verily's (formerly Google Life Sciences) partnership with Novartis to develop smart contact lenses to correct presbyopia, (age-related farsightedness), and for monitoring diabetes by measuring glucose in tears. Otsuka’s, partnership with Proteus Digital Health is another example. This venture expects to develop an ingestible drug adherence device. Proteus already has a FDA-approved sensor, which measures medication adherence. Otsuka is embedding the Proteus’s sensor, which is the size of a sand particle, into its medication for severe mental illnesses in order to enhance drug adherence, which is a serious problem. 50% of prescribed medication in the US is not taken as directed, resulting in unnecessary escalation of conditions and therapies, higher costs to health systems, and a serious challenge for clinical studies.

Drivers of change

The principal drivers of MedTech-pharma convergence include scientific and technological advances, ageing populations, increased chronic lifestyle diseases, emerging-market expansion, and developments in therapies. All have played a role in changing healthcare demands and delivery landscapes. Responding to these changes, both MedTech and pharma have continued to emphasize growth, while attempting to enhance value for payers and patients. This has resulted in cost cutting, and a sharper focus on high-performing therapeutics. It has also fuelled MedTech-pharma convergence and the consequent development of combination devices. According to Deloitte’s 2016 Global Life Science Outlook, combination devices “will likely continue to rapidly increase in number and application”.

MedTech’s changing business model
 
Over the past two decades, MedTech has been challenged by tighter regulatory scrutiny, and continued pressure on healthcare budgets, but advantaged by technological progress, which it has embraced to create new business models. This has been rewarded by positive healthcare investment trends. Over a similar period, pharma has been challenged by the expiry of its patents, advances in molecular science, and changing demographics, but buoyed by increased healthcare spending trends, although the forces that increase health costs are being tempered by a demand for value.

As pharma has been increasingly challenged, so interest has increased in the potential of MedTech to address some of the more pressing healthcare demands in a radically changing healthcare ecosystem. Unlike pharma, MedTech has leveraged social, mobile, and cloud technologies to develop new business models and innovative devices for earlier diagnoses, faster and less invasive interventions, enhanced patient monitoring, and improved management of lifetime chronic conditions.
 
Such innovations are contributing to cheaper, faster, and more efficient patient care, and shifting MedTech’s strategic focus away from curative care, such as joint replacements, to improving the quality of life for patients with chronic long-term conditions. This re-focusing of its strategy has strengthened MedTech commercially, and is rapidly changing the way in which healthcare is delivered, the way health professionals treat patients, and the way patients’ experience healthcare.
 
Josh Shachar, founder of several successful US technology companies and author of a number of patents, describes the new healthcare ecosystem and some of the commercial opportunities it offers, which are predicated on the convergence of MedTech and pharma:
 
 
The decline of big pharma’s traditional business model
 
Pharma’s one-size-fits-all traditional business model, which has fuelled its commercial success over the past century, is based on broad population averages. This now is in decline as patents expire on major drugs, and product pipelines diminish. For example, over the past 30 years the expiry of pharma’s patents cost the industry some US$240bn.

Advances in genetics and molecular biology, which followed the complete sequencing of the human genome in 2003, revolutionized medicine and shifted its focus from inefficient one-size-fits-all drugs to personalized therapies that matched patients to drugs via diagnostic tests and biomarkers in order to improve outcomes, and reduce side effects. Already 40% of drugs in development are personalized medicines, and this is projected to increase to nearly 70% over the next five years.

Today, analysts transform individuals’ DNA information into practical data, which drives drug discovery and diagnostics, and tailors medicines to treat individual diseases. This personalized medicine aims to target the right therapy to the right patient at the right time, in order to improve outcomes and reduce costs, and is transforming how healthcare is delivered and diseases managed. 

 
Personalized medicine

Personalized medicine has significantly dented pharma’s one-size-fits-all strategies. In general, pharma has been slow to respond to external shocks, and slow to renew its internal processes of discovery and development. As a result, the majority of new pharma drugs only offer marginal benefits. Today, pharma finds itself trapped in a downward commercial spiral: its revenues have plummeted, it has shed thousands of jobs, it has a dearth of one-size-fits-all drugs, and its replacement drugs are difficult-to-find, and when they are, they are too expensive.

Illustrative of the advances in molecular science that helped to destroy pharma’s traditional commercial strategy is the work of Kornberg. Here he describes an aspect of his work that is related to how biological information encoded in the genome is accessed to inform the direction of all human activity and the construction of organisms for which Kornberg received the Nobel Prize in Chemistry 2006, and created the foundations of personalized medicine:

 

  
Advanced drug delivery systems
 
Over the past 20 years, as pharma has struggled commercially and MedTech has shifted its business model, drug delivery systems have advanced significantly. Evolving sensor technologies have played a role in facilitating some of these advances, and are positioned to play an increasingly important role in the future of advanced drug delivery. According to BCC Research, the global market for advanced drug delivery systems, which increase bioavailability, reduce side effects, and improve patient compliance, increased from US$134bn in 2008 to some US$196bn in 2014.
 
The growth drivers for innovative drug delivery systems include recent advances of biological drugs such as proteins and nucleic acids, which have broadened the scope of therapeutic targets for a number of diseases. There are however, challenges.

 

Proteins are important structural and functional biomolecules that are a major part of every cell in your body. There are two nucleic acids: DNA and RNA. DNA stores and transfers genetic information, while RNA delivers information from DNA to protein-builders in the cells.


For instance, RNA is inherently unstable, and potentially immunogenic, and therefore requires innovative, targeted delivery systems. Such systems have benefitted significantly from progress in biomedical engineering and sensor technologies, which have enhanced the value of discoveries of bioactive molecules and gene therapies, and contributed to a number of new, advanced and innovative combination drug delivery systems, which promise to be more efficacious than conventional ones. 
 
Biosensors
 
The use of biosensors in drug delivery system is not new. The insulin pump is one example. Introduced in its present form some 30 years ago, the insulin pump is a near-physiologic programmable method of insulin delivery that is flexible and lifestyle-friendly.

Biosensors are analytical tools, which convert biological responses into electrical signals. In healthcare, they provide analyses of chemical or physiological processes and transmit that physiologic data to an observer or to a monitoring device. Historically, data outputs generated from these devices were either analog in nature or aggregated in a fashion that was not conducive to secondary analysis. The latest biosensors are wearable and provide vital sign monitoring of patients, athletes, premature infants, children, psychiatric patients, people who need long-term care, elderly, and people in remote regions. 
 
Increased accuracy and speed
 
The success of biosensors is associated with their ability to achieve very high levels of precision in measuring disease specific biomarkers both in vitro and in vivo environments. They use a biological element, such as enzymes, antibodies, receptors, tissues and microorganisms capable of recognizing or signalling real time biochemical changes in different inflammatory diseases and tumors. A transducer is then used to convert the biochemical signal into a quantifiable signal that can be transmitted, detected and analysed, and thereby has the potential, among other things, for rapid, accurate diagnosis and disease management.
 
Recent technological advances have led to the development of biosensors capable of detecting the target molecule in very low quantities and are considered to have enhanced capacity for increased accuracy and speed of diagnosis, prognosis and disease management. Biosensors are robust, inexpensive, easy to use, and more importantly, they do not require any sample preparation since they are able to detect almost any biomarker  - protein, nucleic acid, small molecule, etc. - within a pool of other bimolecular substances. Recently, researchers have developed various innovative strategies to miniaturize biosensors so that they can be used as an active integral part of tissue engineering systems and implanted in vivo.

 
Market for biosensors
 
Over the past decade, the market in biosensors and bioinformatics has grown; driven by advances in artificial intelligence (AI), increased computer power, enhanced network connectivity, miniaturization, and large data storage capacity.

Today, biosensors represent a rapidly expanding field estimated to be growing at 60% per year, albeit from a low start. In addition to providing a critical analytical component for new drug delivery systems, biosensors are used for environmental and food analysis, and production monitoring. The estimated annual world analytical market is about US$12bn, of which 30% is in healthcare. There is a vast market expansion potential for biosensors because less than 0.1% of the analytical market is currently using them.

A significant impetus of this growth comes from the healthcare industry, where there is increasing demand for inexpensive and reliable sensors across many aspects of both primary and secondary healthcare. It is reasonable to assume that a major biosensor market will be where an immediate assay is required, and in the near-term patients will use biosensors to monitor and manage treatable lifetime conditions, such as diabetes cancer, and heart disease.

The integration of biosensors with drug delivery
 
The integration of biosensors with drug delivery systems supports improved disease management, and better patient compliance since all information in respect to a person’s medical condition may be monitored and maintained continuously. It also increases the potential for implantable pharmacies, which can operate as closed loop systems that facilitate continuous diagnosis, treatment and prognosis without vast data processing and specialist intervention. A number of diseases require continuous monitoring for effective management. For example, frequent measurement of blood flow changes could improve the ability of health care providers to diagnose and treat patients with vascular conditions, such as those associated with diabetes and high blood pressure. Further, physicochemical changes in the body can indicate the progression of a disease before it manifests itself, and early detection of illness and its progression can increase the efficacy of therapeutics.
 
Takeaways

Combination devices, which are triggered by the convergence of MedTech and pharma, offer substantial therapeutic and commercial opportunities. There is significant potential for biosensors in this convergence. The importance of biosensors is associated with their operational simplicity, higher sensitivity, ability to perform multiplex analysis, and capability to be integrated into different functions using the same chip. However, there remain non-trivial challenges to reconcile the demands of performance and yield to simplicity and affordability.
 
 
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  • Healthcare systems throughout the world are in constant crisis
  • Attempts to introduce digital infrastructure to improve the quality of care, efficiency, and patient outcomes have failed
  • Modern healthcare systems were built on the idea that doctors provide healthcare with meaning and power, but this is changing
  • Advances in genetics and molecular science are rapidly eating away at doctors’ discretion and power
  • People are loosing their free will and increasingly being driven by big data strategies
  • An important new book suggests that a biotech-savvy elite will edit people's genomes and control health and healthcare with powerful algorithms, and that people will merge with computers
  • Homo sapiens will evolve into Homo Deus
 
Future healthcare shock
 
This book should be compulsory reading for everyone interested in health and healthcare, especially those grappling with strategic challenges. Homo Deus: A brief history of tomorrow, by Yuval Harari, a world bestselling author, published in 2016 is not for tacticians responding to their in-trays, but for healthcare strategists planning for the future.

The book is published a year after an OECD report concluded that NHS England is one of the worst healthcare systems in the developed world; hospitals are so short-staffed and under-equipped that people are dying needlessly. The quality of care across key health areas is “poor to mediocre”, obesity levels are “dire”, and the NHS struggles to get even the “basics” right. The UK came 21st out of 23 countries on cervical cancer survival, 20th on breast and bowel cancer survival and 19th on stroke.


Harari pulls together history, philosophy, theology, computer science and biology to produce an important and thought provoking thesis, which has significant implications for the future of health and healthcare. Homo Deus, more than the 2015 OECD Report will make you think.
 
Healthcare’s legacy systems an obstacle for change

While a large and growing universe of consumers regularly use smartphones, cloud computing, and global connectivity to provide them with efficient, high quality, 24-hour banking, education, entertainment, shopping, and dating, healthcare systems have failed to introduce digital support strategies to enhance the quality of care, increase efficiency, and improve patient outcomes.

Why?

The answer is partly due to entrenched legacy systems, and partly because digital support infrastructure is typically beyond the core mission of most healthcare systems. Devi Shetty, cardiac surgeon, founder and CEO of Narayana Health, and philanthropist, laments how digital technologies have, “penetrated every industry in the world except healthcare”, and suggests doctors and the medical community are the biggest obstaclesto change.
 
 
Doctors’ traditional raison d'être is being replaced by algorithms

Notwithstanding, modern medicine has conquered killer infectious diseases, and has successfully transformed them, “from an incomprehensible force of nature into a manageable challenge . . . For the first time in history, more people die today from old age than from infectious diseases,” says Harari.
 
Further, modern healthcare systems were built on the assumption that individual doctors provided healthcare systems with meaning and power. Doctors are free to use their superior knowledge and experience to diagnose and treat patients; their decisions can mean life or death. This endowed doctors and healthcare systems with their monopoly of power and their raison d'être. But such power and influence is receding, and rapidly being replaced by biotechnology and algorithms.

 
Healthcare systems in crisis

This radical change adds to the crisis of healthcare systems, which lack cash, and have a shrinking pool of doctors treating a large and growing number of patients, an increasing proportion of whom are presenting with complicated co-morbidities. Aging equipment in healthcare systems is neither being replaced nor updated, and additionally, there is a dearth of digital infrastructure to support patient care.
  
A symptom of this crisis is the large and increasing rates of misdiagnosis: 15% of all medical cases in developed countries are misdiagnosed, and according to The Journal of Clinical Oncology, a staggering 44% of some types of cancers are misdiagnosed, resulting in millions of people suffering unnecessarily, thousands dying needlessly, and billions of dollars being wasted. Doing more of the same will not dent this crisis.
 
Computers replacing doctors
 
As the demand for healthcare increases, healthcare costs escalate, and the supply of doctor’s decrease, so big data strategies and complex algorithms, which in seconds are capable of analysing and transforming terabytes of electronic healthcare data into clinically relevant medical opinions, are being introduced.
 
Such digital infrastructure erodes the status of doctors who no longer are expected solely to rely on their individual knowledge and experience to diagnose and treat patients. Today, doctors have access to powerful cognitive computing systems that understand, reason, learn, and do more than we ever thought possible. Such computers provide doctors almost instantaneous clinical recommendations deduced from the collective knowledge gathered from thousands of healthcare systems, billions of patient records, and millions of treatments other doctors have prescribed to people presenting similar symptoms and disease states. Unlike doctors, these computers never wear out, and can work 24-7, 365 days a year.
 
The train has left the station

One example is IBM’s Watson, which is able to read 40 million medical documents in 15 seconds, understand complex medical questions, and identify and present evidence based solutions and treatment options. Despite the resistance of doctors and the medical establishment the substitution of biotechnology and algorithms for doctors is occurring in healthcare systems throughout the world, and cannot be stopped. “The train is again pulling out of the station . . . . Those who miss it will never get a second chance”. For healthcare systems to survive and prosper in the 21st century is to understand and embrace “the powers of biotechnology and algorithms”. People and organizations that fail to do this will not survive, says Harari.
 
The impact of evolutionary science on healthcare systems

Roger Kornberg, Professor of Medicine at Stanford University who won the 2006 Nobel Prize in chemistry, "for his studies of the molecular basis of eukaryotic transcription", describes how human genome sequencing and genomics have fundamentally changed the way healthcare is organized and delivered. “Genomic sequencing enables us to identify every component of the body responsible for all life processes. In particular, it enables the identification of components, which are either defective or whose activity we may wish to edit in order to improve a medical condition,” says Kornberg.



 
The new world of ‘dataism’

Harari’s “new world” describes some of the implications of Kornberg’s discoveries, and suggests that evolutionary science is rapidly eroding doctors’ discretion and freewill, which are the foundation stones of modern healthcare systems and central to a doctors’ modus vivendi. Because evolutionary science has been programmed by millennia of development, our actions tend to be either predetermined or random. This results in the uncoupling of intelligence from consciousness and the “new world” as data-driven transformation, which Harari suggests is just beginning, and there is little chance of stopping it.
 
Over the past 50 years scientific successes have built complex networks that increasingly treat human beings as units of information, rather than individuals with free will. We have built big-data processing networks, which know our feelings better than we know them ourselves. Evolutionary science teaches us that, in one sense, we do not have the degree of free will we once thought. In fact, we are better understood as data-processing machines: algorithms. By manipulating data, scientists such as Kornberg, have demonstrated that we can exercise mastery over creation and destruction. The challenge is that other algorithms we have built and embedded in big data networks owned by organizations can manipulate data far more efficiently than we can as individuals. This is what Harari means by the “uncoupling” of intelligence and consciousness.
 
We are giving away our most valuable assets for nothing

Harari is not a technological determinist: he describes possibilities rather than make predictions. His thesis suggests that because of the dearth of leadership in the modern world, and the fact that our individual free-will is being replaced by data processors, we become dough for the Silicon Valley “Gods” to shape.
 
Just as African chiefs in the 19th Century gave away vast swathes of valuable land, rich in minerals, to imperialist businessmen such as Cecil Rhodes, for a handful of beads; so today, we are giving away our most valuable possessions  - vast amounts of personal data - to the new “Gods” of Silicon Valley: Amazon, Facebook, and Google for free. Amazon uses these data to tell us what books we like, and Facebook and Google use them to tell us which partner is best suited for us. Increasingly, big-data and powerful computers, rather than the individual opinion of doctors, drive the most important decisions we take about our health and wellbeing. Healthcare systems will cede jobs and decisions to machines and algorithms, says Harari.
 
Takeaways

For the time being, because of the entrenched legacy systems, health providers will continue to pay homage to our individuality and unique needs. However, in order to treat people effectively healthcare systems will need to “break us up into biochemical subsystems”, and permanently monitor each subgroup with powerful algorithms. Healthcare systems that do not understand and embrace this new world will perish. Only a relatively few early adopters will reap the rewards of the new technologies. The new elite will commandeer evolution with ‘intelligent’ design, edit peoples’ genomes, and eventually merge individuals with machines. Thus, according to Harari, a new elite caste of Homo sapiens will evolve into Homo Deus. In this brave new world, only the new “Gods”, with access to the ultimate source of health and wellbeing will survive, while the rest of mankind will be left behind.

Harari does not believe this new health world is inevitable, but implies that, in the absence of effective leadership, it is most likely to happen.

 
 
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The next ‘big thing’ in healthcare . . . . is IT, which will dramatically change the way health professionals interact with patients. Every step of a patient’s care will be determined by protocols on a hand-held device. This will make healthcare safer and shift many hospital activities into the home,” says Dr Devi Shetty, world-renowned heart surgeon, founder and chairman of Narayana Health, India’s largest multi-purpose hospital group and the person said to have, “the biggest impact on healthcare on the 21st century”.

Shetty also warns that, “Despite the advantages of such technologies, the medical community is reluctant to accept them.

Although doctors and patients have iPads and smartphones and use social networks, the healthcare community, “fights like mad to resist change”, and fails to embrace life-saving technologies, which would improve patient care and reduce costs.

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Diabetes is a complex, chronic illness, which requires continuous medical care and risk reduction strategies over and above glycemic control. Education and on-going patient self-management and support are critical to preventing complications and reducing the risk of long-term acute complications.

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