Medtech is Dead. Long Live Medtech.

The old Chinese saying, “May you live in interesting times”, is often used as a curse (and likely originated as such), since interesting is oft synonymous with challenging, uncertain, stressful or otherwise difficult. Insult or blessing, we are entering interesting times.

The coming era of development in medical technology may be the most interesting in history. Let’s get to it.

Consider the near term:

Cost pressures, demands for improved outcomes, and need for better access to healthcare have been rising to the fore as forces overhauling markets for medical technologies.

Chronic disease has always represented a major cost challenge, given the expense of ongoing care, but as cost and quality become more demanding, while prevalence of type 2 diabetes, obesity, and associated co-morbidities increase (and compounded by higher prevalence of type 2 in an increasingly older population), driven by persistent sedentary lifestyles, diet, and other health choices, it becomes clear that chronic disease will command much attention, representing real opportunities in medtech.

Never before have so many technologies, alone or in combination, been poised to change the nature of intervention:

  • bioabsorbable, bioactive, & biocompatible devices
  • drug-device hybrids
  • surgical innovations: sutureless surgery, natural orfice surgery, intraoperative imaging and intraoperative pathology assessment, energy-based technologies;
  • information-intensive device, drug, and biotech product development
  • information-intensive medical devices
  • genetically-influenced drug development

In the medium term (next 5-10 years):

  • Type 1 diabetes gradually becomes less burdensome, with fewer complications, and improved quality of life for patients.
  • Type 2 diabetes continues to plague Western markets in particular, despite advances in diagnosis, treatment, and monitoring due to challenges in patient compliance.
  • Cancer five year survival rates will dramatically increase for many cancers. The number of hits on Google searches for “cure AND cancer” will reflect this.
  • Multifaceted approaches available for treatment of traumatic brain injury and spinal cord injury – encompassing exoskeletons to help retrain/rehabilitate and increase functional mobility, nerve grafting, cell/tissue therapy, and others.
  • Organ/device hybrids will proliferate and become viable alternatives to transplant, or bridge-to-transplant, for pulmonary assist, kidney, liver, heart, pancreas and other organ.
  • The use of stem cells for therapeutics is a radically different type of medicine, and while stem cells can be powerfully therapeutic, their use has also shown the potential to cause new cancer, graft-versus-host disease, organ damage, infection, and other direct and indirect complications. Nonetheless, the excitement around stem and other pluripotent cells creates a climate not far removed from the wild west – the potential of such open territory being up for grabs has drawn hordes of activity, not all in the best interests of patients or shareholders. The stem cell industry and others will continue to press the FDA to approve more therapies, with the pressure easing up only after a scarcity of patient deaths, complications, or just lackluster results.

Beyond 10 years, many things might happen, but which one actually happens (or the degree of its success) will be dictated by timing.

Will the big success in diabetes as we approach 2030 be cell-based — as in autogeneic pancreatic cells induced from stem cells — or will the state of the art at that time still be the “pump/meter closed loop artificial pancreas” (expected to be the case well before 2030?

Will tissue engineering allow us to preempt death?

The potential for us to preempt an enormous amount of disease is already before us, yet we studiously avoid it. At what point do we take advantage of this?

Consider what will be the case beyond 2026.

Research gaps will have narrowed drastically. The gap between basic science and clinical application will be very small. Our medical diagnostics will be extremely richly detailed, near-instantaneous, and widely accessible (e.g., there will be variants or embodiments of IBM Watson and similar intelligent diagnostic systems), which will of course optimize the potential for therapeutics. But the impact on research will be dramatic, because we will be able to much more rapidly and efficiently learn from an obvious integration of routine clinical data and research data via meta-analysis-esque (for lack of a less clumsy term) capacity to derive data from disparate local and remote systems.

Our nearly complete knowledge of the full spectrum of pathogenic factors (from environmental to genetic) and their correlation with specific patient populations will have pierced the veil that has concealed the etiologies of a large number of diseases, opening the door wide to the development of therapies.

We will understand, predict, and manage the development of genetic disease.

All political denial to the side, some of the most significant threats to our health in the future will ensue from our relentless campaign to ravage the planet’s resources – air, water, food – driven by overpopulation and happily capitalized upon by what we are seeing is a growing horde of lethal, many well evolved but otherwise persistent pathogens (from tuberculosis, MRSA, Ebola, Marburg, and many others as yet unidentified), already made more threatening due to antibiotic resistance we have knowingly facilitated.

However, fear not, my 2.3% excise tax refugees. The future is bright for you, if you care to recognize your place in it.

But first, here’s a blunt reality: Medical devices, at least as we know them, will simply become irrelevant. Medical devices, no matter how sophisticated, are clunky mechanical tools for amelioration of symptoms for diseases about which know too little to solve with near-zero cost permanent cures (think of the vaccine, an unbelievable idea in the mind of those fearing polio) but only when drugs or other interventions are not also possible.

Let there be no doubt — medical technology will thrive. Disease is persistent. Conditions are worsening for the human population. But, more importantly, at least from the sense of an industry with a big financial stake in the situation, nature does not give up her secrets easily and there remain many obstacles to overcome (not least of which is wanton and persistent human ignorance) before we are able to utterly avoid or cheaply cure all diseases.

 

 

The future (of medicine) is biology

It was once quite convenient for manufacturers of deluxe medical widgets to worry only about other manufacturers of deluxe medical widgets. Manufacturers must now widen their perspective to consider current and future competition (and opportunity) from whatever direction it may come. –> Just thought I might chime in and suggest that, if you do make such widgets, it might be a good idea to maybe throw at least an occasional sidelong glance at biotech. (Most of you are, great, but some of you think biotech is too far away to compete…)

Organ Bioengineering is years away and poses little challenge to medical devices …FALSE.  Urinary bladders have been engineered for pediatric applications. Bioengineered skin (the “integumentary” organ) is now routinely bioengineered for burns, chronic wounds, and other wound types. Across a wide range of tissue types (bone, cardiac, smooth muscle, dermal, etc.) scientists — clinicians — have rapidly developed technologies to direct the construction and reconstruction of these tissues and restore their structure and function.

Cell Biology. Of course cells are engineered into tissues as part of the science of tissue engineering, but combine this with advances in engineering not just between cells but between cells AND within cells and (…sound of my head exploding). With the sum of the understanding and capacity to control we have gained over cellular processes over the past few decades now rapidly accelerating, medical science is fast approaching the point at which it can dictate outcomes for cell, tissues, organs, organ systems, and humans (I am not frightened, but excited, with caution).  Our understanding and proficiency gained in manipulating processes from cell division to pluripotency to differentiation to senescence to death OR NOT has profound consequences for fatal, debilitating, incurable, devastating, costly, and nearly every other negative superlative you can conceive.

CRISPR*: This is a new, relatively simple, but extraordinary tool allowing researchers or, more importantly, physicians to potentially swap out defective genes with healthy ones. See Nature.
(* clustered regularly interspersed short palindromic repeats)

Biotech has, over its history, often succeeded in getting attention, but has had less success justifying it, leaving investors rudely awakened to its complexities.  It has continued, however, to achieve legitimately exciting medical therapeutic advances, if only as stepping stones in the right direction, like mapping the human genome, the development of polymerase chain reaction (“PCR”), and biotech-driven advances in molecular biology, immunology, gene therapy, and others, with applications ripe for exploitation in many clinical specialties, Sadly, the agonizing delay between advanced and “available now” has typically disappointed manufacturers, investors, clinicians and patients alike. CRISPR and other tools already available (see Genetic Engineering News and others) are poised to increase the expectations – and the pace toward commercialization – in biotechnology.

Vaccines and Infectious Disease: Anyone reading this who has been under a rock for lo these many years, blissfully ignorant of SARS, Ebola, Marburg, MRSA, and many other frightening acronyms besides HIV/AIDS (more than enough for us already) should emerge and witness the plethora of risks we face (and self-inflict through neglect), any one of which might ultimately overwhelm us if not medically then economically in their impacts. But capitalists (many altruistic) and others have come to the rescue with vaccines such as for malaria and dengue-fever and, even, one for HIV that is in clinicals.

Critical Mass, Synergies, and Info Tech. Biotechnology is succeeding in raising great gobs of capital (if someone has a recommended index/database on biotech funding, let me know?).  Investors appear to be forgetful increasingly confident (in the 1990s, I saw big layoffs in biotech because of ill-advised investments, but that was then…) that their money will result in approved products with protected intellectual property and adequate reimbursement and manageable costs in order to result in attractive financials. The advances in biological and medical science alone are not enough to account for this, but such advances are almost literally being catalyzed by information technologies that make important connections faster, yielding understanding and new opportunities. The net effect of individual medically-related disciplines (commercial or academic) advancing research more efficiently as a result of info tech and info sharing/synergies between disciplines is the expected burst of medical benefits ensuing from biotech. (Take a look also at Internet of DNA.)