In the medical technology arena, there are numerous forces and trends that persist year to year, only occasionally tempered by current economic or other events. The trends listed below are persistent, their influence rarely declining and always giving weight to the opportunities and challenges for specific medical technologies.
- Outcomes drive more, but not all, development than do episodic success (meaning treatment of symptoms versus treatment of underlying disease). Manufacturers are focusing on longer term solutions, competing against the full spectrum of therapeutic alternatives rather than incremental improvements in their widgets.
- The recessionary economy demands, rightly or not, that homage be paid to cost. 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.
- 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.
- 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).
- 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 broady competitive position.
- VCs are less interested in medtech than are large-cap medtech companies. The recessionary economy of the past several years has caused a shift in financing from those with a short(er) term focus on innovation — venture capitalists and angels — to those with a vested stake in medical technology’s success in the long haul — the mid-cap and large-cap medical technology companies. Established medtech companies intend to stay in the medtech business, regardless of current economic variables, and therefore need strong innovation pipelines. VCs are in the business of “returns” rather than “healthcare”, which may be an entirely different set of incentives.
- Economic downturns, especially ones of the depth and length of the one affecting global markets since 2008, serve to hasten the impact of business evolution. Those companies that could not complete development of clinically proven, regulatory approved products during the days of free-flowing capital (as harsh as it may sound) simply don’t belong in the business. With scarce capital, it is inevitable that marginal innovations will be shaken out of a healthcare system that can ill afford them.
- Healthcare reform, or its repeal, will have little negative impact on medical technology development. I am convinced of the convergence of different scientific disciplines — materials technology, cell biology, biotech, pharma and others — being capable of producing therapeutics matching the cost du jour demands of the healthcare marketplace.
- Information technology is having, and will have, profound effects on medical technology development and 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 virtually untapped frontier of medical technology applications in neurology. The collective scientific understanding of the functional roles of the brain and nervous system has reached a near critical mass at which point the equally advanced capabilities of medical technology are rapidly accelerating in their ability to modulate those functional roles for intervention in neural disease and trauma.
- Convergence of multiple scientific disciplines. The “systems biology” view of complex organic systems has achieved an understanding and ability to recognize and account for the interplay of multiple different cellular, biological, biochemical and other processes associated with disease, trauma and healing, which has been especially helpful in advancing the capabilities of medical devices previously designed as inert implants. Understanding such as this has led to the development of technologies like drug-eluting stents, drug delivery technologies, bioabsorbables and other biomaterials, extracellular matrices for cell/tissue regeneration and other novel medical products.
- The medical device excise tax component of the Patient Protection and Affordable Care Act as part of the Obama administration’s effort to reform healthcare will NOT stifle innovation or cause loss of jobs (see link or link or link, etc.). The wholesale expansion of the patient population to an additional 33 million otherwise uninsured Americans is most often trivialized, minimized or just blithely ignored in lobbyists’ and Republicans’ arguments against an excise tax that was scaled back and ultimately endorsed by the medical device industry.
This is by no means an exhaustive list and in any event is not a static list. Continued evolution of technologies, regulatory/tax/reimbursement and other forces will inevitably alter the impact of these and other forces on the global medical device market.