Where will medicine be in 2035?

An important determinant of “where medicine will be” in 2035 is the set of dynamics and forces behind healthcare delivery systems, including primarily the payment method, especially regarding reimbursement. It is clear that some form of reform in healthcare will result in a consolidation of the infrastructure paying for and managing patient populations. The infrastructure is bloated and expensive, unnecessarily adding to costs that neither the federal government nor individuals can sustain. This is not to say that I predict movement to a single payer system — that is just one perceived solution to the problem. There are far too many costs in healthcare that offer no benefits in terms of quality; indeed, such costs are a true impediment to quality. Funds that go to infrastructure (insurance companies and other intermediaries) and the demands they put on healthcare delivery work directly against quality of care. So, in the U.S., whether Obamacare persists (most likely) or is replaced with a single payer system, state administered healthcare (exchanges) or some other as-yet-unidentified form, there will be change in how healthcare is delivered from a cost/management perspective. 

From the clinical practice and technology side, there will be enormous changes to healthcare. Here are examples of what I see from tracking trends in clinical practice and medical technology development:

  • Cancer 5 year survival rates will, for many cancers, be well over 90%. Cancer will largely be transformed in most cases to chronic disease that can be effectively managed by surgery, immunology, chemotherapy and other interventions. Cancer and genomics, in particular, has been a lucrative study (see The Cancer Genome Atlas). Immunotherapy developments are also expected to be part of many oncology solutions. Cancer has been a tenacious foe, and remains one we will be fighting for a long time, but the fight will have changed from virtually incapacitating the patient to following protocols that keep cancer in check, if not cure/prevent it. 
  • Diabetes Type 1 (juvenile onset) will be managed in most patients by an “artificial pancreas”, a closed loop glucometer and insulin pump that will self-regulate blood glucose levels. OR, stem cell or other cell therapies may well achieve success in restoring normal insulin production and glucose metabolism in Type 1 patients. The odds are better that a practical, affordable artificial pancreas will developed than stem or other cell therapy, but both technologies are moving aggressively and will gain dramatic successes within 20 years.

Developments in the field of the “artificial pancreas” have recently gathered considerable pace, such that, by 2035, type 1 blood glucose management may be no more onerous than a house thermostat due to the sophistication and ease-of-use made possible with the closed loop, biofeedback capabilities of the integrated glucometer, insulin pump and the algorithms that drive it, but that will not be the end of the development of better options for type 1 diabetics. Cell therapy for type 1 diabetes, which may be readily achieved by one or more of a wide variety of cellular approaches and product forms (including cell/device hybrids) may well have progressed by 2035 to become another viable alternative for type 1 diabetics.

  • Diabetes Type 2 (adult onset) will be a significant problem governed by different dynamics than Type 1. A large body of evidence will exist that shows dramatically reduced incidence of Type 2 associated with obesity management (gastric bypass, satiety drugs, etc.) that will mitigate the growing prevalence of Type 2, but research into pharmacologic or other therapies may at best achieve only modest advances. The problem will reside in the complexity of different Type 2 manifestation, the late onset of the condition in patients who are resistant to the necessary changes in lifestyle and the global epidemic that will challenge dissemination of new technologies and clinical practices to third world populations.

Despite increasing levels of attention being raised to the burden of type 2 worldwide, including all its sequellae (vascular, retinal, kidney and other diseases), the pace of growth globally in type 2 is still such that it will represent a problem and target for pharma, biotech, medical device, and other disciplines.

  • Cell therapy and tissue engineering will offer an enormous number of solutions for conditions currently treated inadequately, if at all. Below is an illustration of the range of applications currently available or in development, a list that will expand (along with successes in each) over the next 20 years.

    Cell therapy will have deeply penetrated virtually every medical specialty by 2035. Most advanced will be those that target less complex tissues: bone, muscle, skin, and select internal organ tissues (e.g., bioengineered bladder, others). However, development will have also followed the money. Currently, development and use of conventional technologies in areas like cardiology, vascular, and neurology entails high expenditure that creates enormous investment incentive that will drive steady development of cell therapy and tissue engineering over the next 20 years, with the goal of better, long-term and/or less costly solutions.
  • Gene therapy will be an option for a majority of genetically-based diseases (especially inherited diseases) and will offer clinical options for non-inherited conditions. Advances in the analysis of inheritance and expression of genes will also enable advanced interventions to either ameliorate or actually preempt the onset of genetic disease.

    As the human genome is the engineering plans for the human body, it is a potential mother lode for the future of medicine, but it remains a complex set of plans to elucidate and exploit for the development of therapies. While genetically-based diseases may readily be addressed by gene therapies in 2035, the host of other diseases that do not have obvious genetic components will resist giving up easy gene therapy solutions. Then again, within 20 years a number of reasonable advances in understanding and intervention could open the gate to widespread “gene therapy” (in some sense) for a breadth of diseases and conditions –> Case in point, the recent emergence of the gene-editing technology, CRISPR, has set the stage for practical applications to correct genetically-based conditions.
  • Drug development will be dramatically more sophisticated, reducing the development time and cost while resulting in drugs that are far more clinically effective (and less prone to side effects). This arises from drug candidates being evaluated via distributed processing systems (or quantum computer systems) that can predict efficacy and side effect without need of expensive and exhaustive animal or human testing.The development of effective drugs will have been accelerated by both modeling systems and increases in our understanding of disease and trauma, including pharmacogenomics to predict drug response. It may not as readily follow that the costs will be reduced, something that may only happen as a result of policy decisions.
  • Most surgical procedures will achieve the ability to be virtually non-invasive. Natural orifice transluminal endoscopic surgery (NOTES) will enable highly sophisticated surgery without ever making an abdominal or other (external) incision. Technologies like “gamma knife” and similar will have the ability to destroy tumors or ablate pathological tissue via completely external, energy-based systems.

    By 2035, technologies such as these will measurably reduce inpatient stays, on a per capita basis, since a significant reason for overnight stays is the trauma requiring recovery, and eliminating trauma is a major goal and advantage of minimally invasive technologies (e.g., especially the NOTES technology platform). A wide range of other technologies (e.g., gamma knife, minimally invasive surgery/intervention, etc.) across multiple categories (device, biotech, pharma) will also have emerged and succeeded in the market by producing therapeutic benefit while minimizing or eliminating collateral damage.

Information technology will radically improve patient management. Very sophisticated electronic patient records will dramatically improve patient care via reduction of contraindications, predictive systems to proactively manage disease and disease risk, and greatly improve the decision-making of physicians tasked with diagnosing and treating patients.There are few technical hurdles to the advancement of information technology in medicine, but even in 2035, infotech is very likely to still be facing real hurdles in its use as a result of the reluctance in healthcare to give up legacy systems and the inertia against change, despite the benefits.

  • Personalized medicine. Perfect matches between a condition and its treatment are the goal of personalized medicine, since patient-to-patient variation can reduce the efficacy of off-the-shelf treatment. The thinking behind gender-specific joint replacement has led to custom-printed 3D implants. The use of personalized medicine will also be manifested by testing to reveal potential emerging diseases or conditions, whose symptoms may be ameliorated or prevented by intervention before onset.
  • Systems biology will underlie the biology of most future medical advances in the next 20 years. Systems biology is a discipline focused on an integrated understanding of cell biology, physiology, genetics, chemistry, and a wide range of other individual medical and scientific disciplines. It represents an implicit recognition of an organism as an embodiment of multiple, interdependent organ systems and its processes, such that both pathology and wellness are understood from the perspective of the sum total of both the problem and the impact of possible solutions.This orientation will be intrinsic to the development of medical technologies, and will increasingly be represented by clinical trials that throw a much wider and longer-term net around relevant data, staff expertise encompassing more medical/scientific disciplines, and unforeseen solutions that present themselves as a result of this approach.Other technologies being developed aggressively now will have an impact over the next twenty years, including medical/surgical robots (or even biobots), neurotechnologies to diagnose, monitor, and treat a wide range of conditions (e.g., spinal cord injury, Alzheimer’s, Parkinson’s etc.).

The breadth and depth of advances in medicine over the next 20 years will be extraordinary, since many doors have been recently opened as a result of advances in genetics, cell biology, materials science, systems biology and others — with the collective advances further stimulating both learning and new product development. 


See the 2016 report #290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.”

The future of medtech demands more and better imagination

I frequently see conclusions about the the future of medtech derived by analysts who are walking backward looking at their feet — living by the tenet of “past is prologue”. This type of “foresight” presumes an unchanging set of forces, leading (at best) to a conclusion that the future will hold more of the same.

Yet, the future of medtech is dictated far more significantly not by what has already happened, or as a result of past trends continuing as future trends, but by what has not happened yet. The major thrust of any significant growth (and isn’t growth what interests us?) comes primarily from events that do not as clearly follow from past events:

  • Surgical device sales forecasts are uprooted by introduction of laparoscopy
  • Tissue engineering preempts conventional treatments in wound, orthopedics, cardiology…
  • Success in type 1 diabetes treatment will be determined by device advances as well as cell therapy advances
  • Systems biology reveals risks and opportunities previously unseen

If you view your markets myopically, then you consider your competitors to be limited to those whose products most resemble your own. If you have a long view, you consider what might be possible based on available/emerging technology to tap into untapped demand or simply create latent demand that no company has yet been sufficiently visionary or innovative to seize. What patient populations, clinical practice patterns and their trends are the pulse that you monitor (or are you even monitoring these)?  There is a gap between what is available and a whole set of patients virtually untreated, physicians unsatisfied, and third party payers struggling.  Are you an angioplasty catheter manufacturer — or a coronary artery disease solution?  Do you make devices — or outcomes?

Source: Yann Girard https://www.linkedin.com/pulse/life-explained-through-technology-yann-girard

Look at staid “device” companies like Baxter International and see that they have “biosurgery” divisions.  Look at Medtronic and appreciate that they are as sensitive to developments in glucose monitoring and insulin pump technologies as they are to the litany of cell therapy approaches under pursuit. (These companies are fundamentally aware of technology “S-curves” — see graphic at right.)

Virtually every area of current clinical practice is subject to change when considering drug/device hybrids, biomaterials, nanotechnology/MEMs devices and coatings, biotechnology, pharmaceutical (and its growing sophistication in drug development), western medicine and eastern medicine, healthcare reform, cost containment, RFIDs, 3D printing, information technology  — it is imperative to see the upside and downside of these.

These are some of the forces that less characteristic of the past that are leading to startling new success in medtech developments:

  • Materials technologies are redefining the nature and functional limits of medical devices
  • Technologies more closely aligned with cure than symptomatic treatment gain rapid acceptance
  • The practice of considering outcomes measures of highly diverse technology solutions to disease has ascended to prominence in the mindsets of healthcare systems and payers
  • The use of information technologies and cross-medical discipline initiatives enables rapid determination of likely success and failures in whole new ways

Aside from the demands for operational efficiency and managing cash flows, the success or failure of medical technology companies has become a reflection of how well these companies position themselves now and in the future with an imaginative long view. Companies must consider the revenue streams in Year 1, Year 5 and Year 10.

 

Medtech succeeds by responding to multiple demands

Medtech is resilient, adapting to the changing demands of patients, payers, regulators, and the economy, but only in the hands of the innovators who keep a finger in the wind on these demands.

  1. Comprehensive outcomes versus symptomatic intervention. Competition in medtech, heightened by cost pressures in particular, is characterized by the demand for comprehensive solutions to disease/trauma rather than technologies that simply ameliorate symptoms. Manufacturers are focusing on longer term solutions, competing against the full spectrum of therapeutic alternatives rather than incremental improvements in their widgets.
  2. Whatever the cost, make it lower. Cost is poorly understood in healthcare (hence the problem!), but it is recognized as important simply by the rate at which premiums increase, the percentage of GDP adding to healthcare spending, the cost of Medicare and other similar benchmarks. Cost is difficult to assess in medical technologies, because there are long term, unforeseen implications of nearly every medtech development. Nonetheless, the manufacturer who does not only bow down in homage to cost but also makes cost at least an implicit part of its value proposition will be quickly put out of business.
  3. The life spans of “gold standards” of treatment are getting shorter and shorter. Technology solutions are being developed, from different scientific disciplines, at such a pace as to quickly establish themselves, in a broad enough consensus, as new gold standards. Physicians are increasingly compelled to accept these new new standards or find their caseload shifting to those who do.
  4. Many manufacturers strive for being able to claim their products are “disruptive” — overturning existing paradigms. However, few medtech manufacturers really ever achieve anything more than marginal improvements. Note the relative amount of 510Ks versus PMAs in regulatory approvals (not that a PMA denotes a “disruptive” development).
  5. Materials technologies are defining what is a “device” as well as what they can accomplish. Competitive manufacturers are aggressively gaining a broad understanding of materials technologies to encompass traditional device, pharma, biopharma, biotech, cell biology and others, ensuring their success from a broadly competitive position.
  6. Interest in startup innovations by VCs and large-cap medtech companies has never been more intense, but funding still demands concrete milestones. Proof-of-concept gets entrepreneurs excited, but 510(K) or better is what gets the money flowing. This is not the credit-crunch of 2008, when the sour economy caused funding to largely dry up. Money is indeed flowing into medtech now, as evidenced by the IPO market and the volume of early stage funding, but potential investments — especially at very early stages — are no less intensively vetted. Startups must therefore carry the risk well into the development timeline, when the prospect of their products reaching the market has been demonstrated far more effectively.
  7. Medtech markets are influenced by many forces, but none more strongly than the drive of companies to succeed. Reimbursement. Regulatory hurdles. Healthcare reform. Cost reduction, even a 2.3% medical device excise tax, et cetera, et cetera. None of these hold sway over innovation and entrepreneurship. And the rate of innovation is accelerating, further insulating medtech against adverse policy decisions. Moreover, that innovation is reaching a sort of critical mass in which the convergence of different scientific disciplines — materials technology, cell biology, biotech, pharma and others — is leading to solutions that stand as formidable buttresses against market limiters.
  8. Information technology is having, and will have, profound effects on medical technology development. The manufacturers who “get” this will always gain an advantage. This happens in ways too numerous to mention in full, but worth noting are: drug and device modeling/testing systems, meta-analysis of clinical research, information technology embedded in implants (“smart” devices), and microprocessor-controlled biofeedback systems (e.g., glucose monitoring and insulin delivery). The information dimension of virtually every medtech innovation must be considered by manufacturers, given its potential to affect the cost/value of those innovations.

This is not a comprehensive list of drivers/limiters in medtech, but these stand behind the success or failure of many, many companies.

Patrick Driscoll is an industry analyst and publisher of content on advanced medtech markets through MedMarket Diligence.

When Medical Devices are “Finished”

In last week’s Wall Street Journal, Stephen Oesterle, the vice president for medicine and technology at Medtronic was paraphrased for his startling conclusion that medical devices are “finished”. His point, “You can’t keep stuffing gizmos into people to treat end-stage disease… When biotechnology gets right, we’re finished. Because it’s restorative, not palliative as devices are.”

While subsequent to his statement other Medtronic representatives tried to put this in the context of something other than foretelling the death knell of Medtronic itself, his point is, IMHO, right on target.

Setting aside pharmaceuticals in its own category and addressing biotech and medical devices, there is a fundamental distinction between these two approaches to healthcare that defines the status quo and an inevitable future for both. Succinctly put though Dr. Oesterle’s comments are, I can endeavor to put it in other words: medical devices treat symptoms while biotech — if not now, then ultimately, treats underlying disease.

Therein lies a distinction that has turned the medical device industry into a major market worldwide, while the biotech industry has yet to reach a fraction of its commercial potential.  With a focus on symptoms, arguably a much lower technololgy hurdle than the myriad challenges faced by biotech as it seeks to effectively eliminate disease(s) at their source, the medical device industry produces limited, though very specific clinical endpoints that are arguably very incomplete, yet highly valuable.  (The coronary stent does not cure the patient of his/her atherosclerosis; it just maintains the crucial patency of coronary arteries to keep the patient alive.)

This is a topic i have addressed in the past, sometimes hammering the point endlessly to anyone who would listen.  Biotech is ideal. Devices are now. However, lest one think that there is a point at which we simply switch from devices to biotech (when Medtronic folds!), the reality is that devices, imperfect as the are, will continue to evolve. To this point, below please find the August 2006 edition of “MedMarket Outlook” from our discontinued “MedMarkets” publication. 

 


(August 2006)  MedMarket Outlook: Medical Devices in a Future Scenario

 

 

The future of medtech is proceeding along paths determined by technologies already developed, but also guided by the need to provide less invasive treatment of disease with better long-term outcomes. If these paths are followed to their logical endpoint, medical technologies of the future can be predicted. Concurrently, paths toward the development of treatments via biotechnology have their own logical endpoints. Many biotechnologies have the potential to preempt medical technologies, due to their intrinsic design as “rational therapeutics” — treatments of the root cause of disease rather than only its symptoms.

Here we consider the development in medical technology to have largely achieved its potential and we describe the devices and their characteristics as they would exist in such a future. We make no assertion that each and every technological hurdle that needs to be crossed can indeed be crossed (we imply the possibility); we simply give the benefit of doubt to the technologies that may be developed in order to consider what benefits may ensue.

In short, the future of medtech will be such that two general categories of technologies exist; those that are focused on treating specific pathologies and symptoms and those that represent organs or organ systems. Lastly, it should be noted that we envision this “future scenario” not as one happening 25 years (or more) hence, but in some cases less than a decade.

Disease- and Trauma-Specific Device Solutions
In the idealized future medtech industry, medical devices will have been optimized to facilitate the body’s own capacity to heal. Devices will be constructed to provide the function — e.g., maintaining the patency of a vessel lumen (stents), serving as a temporary or permanent lumen (AAA graft), be a fully functioning hip replacement, etc. — as long as (and no longer than) necessary for the body to complete all of the repairs of its own that are possible. In this sense, devices will be developed to help the body help itself, then get out of the way to not impede further healing. In particular, bioresorption will have become highly sensitive to timing (stents will dissolve or deconstruct to be excreted at the precise time needed). This will include extracellular matrices used for the regeneration of tissues of all types of tissue (muscle, bone, even nerve) with the matrix facilitating tissue ingrowth before being resorbed. Similarly, biocompatibility will become a more active feature of implanted devices such that they will go well beyond simply being inert or inducing no immunological or other response and will at a maximum, will elute drugs, proteins or other agents that will actively stimulate or facilitate the body’s normal healing process.

Devices will be highly intelligent, sensing the conditions in their environment and responding as necessary. Responses will include bioresorption, release of drugs, change in shape or other responses

Devices will be tracked wirelessly for status, providing patient and clinician with information about the status of healing, alerting each to changes requiring intervention long before adverse symptoms appear. This tracking will also include tracking of the device itself, revealing data on device integrity and alerting the patient/clinician to any change.

Increasingly complex devices will be implanted percutaneously, endoscopically or by other means to minimize any trauma. During implantation, the devices will have very low profiles to enable them to traverse to the target site through very small and/or sensitive (e.g., enervated) tissues.

Cost will have played a critical role in determining the effectiveness of device development, but not simply considering the device cost itself, which may be significant. The true cost of these devices will be determined thoroughly as a measure of their ability to achieve specific outcomes compared to the costs of any and all technologies or approaches that compete for similar outcomes.

These device technologies are based on the premise of technologies under development now. Advances in materials technologies, drug/device innovations and many others may produce opportunities for devices with benefits largely unforeseen at this time.

Biohybrid, artificial organs
In light of medtech’s general inability to compete directly with the premise of biotech — treatment of root disease rather than symptoms, medtech will have the potential nonetheless to provide solutions to disease and trauma, with the solutions being ones in which medtech devices or systems so thoroughly address the symptoms of diseases as to emulate cures of them.

In the future world we are envisioning, many organs and organ systems will be available to replace or augment the functions of organs that have been removed or are dysfunctional as a result of disease or trauma. The organs will be comprised of mechanical and biological components that will variously house reservoirs of therapeutics that will periodically and painlessly be replenished, contain bioreactors that will express patient-specific proteins, hormones and other naturally occurring substance, or provide other therapeutic intervention (as with defibrillators, pacemakers, etc.). Mechanical components will be made of materials producing no inflammatory response, inducing no clot formation or other effect and will otherwise be completely neutral to the body.

These organ systems, like the devices described above, will be intelligent, sensing multiple parameters and responding in real-time basis to maintain ideal homeostatic control specific to the patient’s dynamic needs (sleep, stress, exercise, metabolism, etc.). The “intelligence” of the systems will be represented in ways from the simple, including elution based on the concentration of substances (platelets, specific proteins, etc.) in the environment (such as to prevent restenosis), to the complex, including microprocessor-calculated basal or bolus infusion of drug or other substance based on biofeedback-mediated function (e.g., insulin pump and glucose monitor).

The status of the biohybrid organ/system will be monitored remotely by the patient and, in turn, by the physician through wireless communication to display current patient condition, trended functions and other status. Eventually, such external monitoring will become unnecessary other than for unusual events, such as extreme changes in patient condition that, even though the organ/system may be well prepared to respond to, warrants attention by the patient and/or clinician.

The biohybrid organ/system status will also be communicated wirelessly, displaying data on its sensor functions, reservoir levels or other parameters of its function, as well as the system’s integrity. As with monitoring the organ/system’s environment (noted in previous paragraph), the monitoring of the organ/system itself will eventually be silent other than for unusual or adverse events signalling a problem with the system itself.

The power sources employed by these systems will have evolved from being extremely long-term batteries that only infrequently require recharging (done remotely) to motion-activated power (or similar alternative energy sources) to potentially biological sources deriving power from the patient, such as (in a very advanced scenario) through exploitation of energy from adenosine triphosphate (ATP).

Examples of the organs or organ systems that may ultimately be developed (and are in process) include the following:

  • Pancreas – Glycemic control will be ensured through basal infusion of insulin and periodic bolus matching fluctuating needs.
     
  • Heart – Effective replacement of normal heart function will be achieved through designs and construction that will produce no hemolysis, and produce cardiac output precisely matching circulatory need.
     
  • Lung – An artificial lung will largely be achieved through the development of highly effective materials that virtually mimic alveolar epithelium at the interface between lung and blood vessels, enabling efficient gaseous exchange.
     
  • Liver – The myriad functions of the liver will have made it one of the most difficult organs to replace, in effect demanding the development of a master organ with multiple separate organ components addressing the needs of homeostasis (proteins, fat/cholesterol, hormones, vitamins, glucose, etc.), synthesis (proteins, bile acids, cholesterol), storage, excretion, filtering and defensive barrier against bacteria in the gut. The development of biofeedback and control across such multiple areas will be a herculean accomplishment.
     
  • Kidney – Filtration and regulation of water and inorganic electrolytes in the artifical kidney, by comparison to the development of the artificial liver, will be considerably less challenging.
     
  • Skin/integumentary – As an organ system, the integumentary serves an extremely important one in its defense against infection. Artificial integumentary systems may well be developed, although tissue engineering technologies are likely to soon eclipse any artificial technologies.
     
  • Limbs – The necessary development of biomechanics and systems to enable autonomic and conscious neural control of limbs may ultimately only be limitated by the strength the patient’s healthy anatomy to which it is joined. Fine-motor skills will likely be indistinguishable from biological limbs. Sensitivity to heat and pressure may even be regulated to maximize tolerance of the environment such that performance will exceed that of normal limbs. Overall appearance and in detail will be indistinguishible from normal limbs.

In varying degrees, these developments are already on their way toward completion. And while, indeed, many hurdles remain before some of these scenarios will be possible, one must consider these hurdles in comparison to the hurdles faced by the biotechnology industry as it pursues solutions a variety of diseases and disorders. The “rational therapeutic” holy grail is one that has for biotech been a source of endless promise and endless solicitation of additional venture capital. But as “imperfect” as some of
the medtech solutions above may be, their potential as self-contained, cure-like solutions for disease make them eminently more promising for their near-term potential than do “perfect” biotech solutions.