Medical technology defies definition

In a prior post, I sought to explore the shifting nature of the medical industry, from clearly defined categories of devices, drugs and diagnostics to a spectrum of products that defy categorization into any one category and instead frequently qualify as multiple.

…Competition in the medical product industry has long since changed from being defined as those products performing a similar, albeit narrowly-defined function, like when the angioplasty manufacturer could reasonably consider his/her competitors to be all other manufacturers of devices that produce catheter-based recanalization of the atherosclerotic lumen. It is a myopic angioplasty manufacturer who does not now also consider atherectomy, transmyocardial laser revascularization, bare metal stents, drug-eluting stents, and traditional/open, MIDCAB (and similar) or even percutaneous coronary artery bypass graft, as well as the classes of drugs and other non-device approaches to produce non-surgical reversal of atherosclerosis….

Gauging the state of technology development in the recent past and the present, the trend toward less demarcation between medical product categories continues unabated, not just for treatment of ischemic heart disease, but for other diseases and disorders. Advances in technology enable this, while the customer — healthcare systems, third party payers and, increasingly, patients — are demanding this.

There nonetheless remain certain aspects of select diseases and disorders that sustain preference if not dominance by one class of medical products.  The spine, playing as it does such a physical, structural, functional role, demands solutions that are device-intensive (e.g., discs, cages), however much bone growth factors, bone graft substitutes and other non-device products are moving in. Cancer treatment, aside from surgical intervention, remains largely a drug-intensive effort, although "drug" continues to be redefined to include moieties that are clearly biotech in nature.

I continue to think about ischemic disease in particular because it represents a sort of microcosm of medtech development. Physicians like to view treatment in terms of "gold standards" or the current state of the art, but as ischemic heart disease (and many other diseases) have shown, the goal line keeps changing as new technologies advance the quality of life, clinical outcome, cost of care and other criteria that determine value of innovations in the market.  Ischemia can be addressed from so many different perspectives that it has become a lightening rod for development efforts.  

Ultimately, I am thrilled at bearing witness to the evolution of technology development.  At the same time, however, I must empathize with. and work hard to come to the aid of, my medtech clients who must continually look to the bigger picture to ensure that their products and technologies remain relevant, lest the trend suddenly make them obsolete.

 

 

 

 

New medical technologies at recent startups

New medical technologies under development by recent startups:

  • Biomaterials for use in aesthetic surgery
     
  • New vascular devices for use on patients that undergo procedures with a high risk of blood vessel blockage
     
  • Treatments and diagnostics for orthopedics
     
  • Devices for cardiac surgery, including a device for performing structured sternal incisions
     
  • Handheld diagnostic device detecting cancer cells via fluorescing enzyme, performed following tumor removal to detect residual cancer
     
  • Ambulatory cardiac monitoring
     
  • Minimally invasive RF tissue welding technology for use in lung resection and biopsy
     
  • Innovative technologies to treat heart valve disease
     
  • Imaging capsule long-term monitoring of bladder cancer

 


These technologies are among those detailed in the Medtech Startups Database.

 

Top New Medical Technologies and/or Platforms

While this is separately a White Paper that I wrote and periodically re-write to reflect new stuff being developed (or progressing in that development), it is worthwhile to occasionally revisit the list of technologies that have real promise, especially if that promise is getting closer to reality, or only if the demand is simply getting greater.

  • Ablation and other high energy technologies.  What used to be handled by scalpel when my father did general surgery, is now increasingly being accomplished using energy-driven modalities that provide other tissue effects that a sharp metal blade alone could never do.  These technologies are therefore growing in both the penetration of traditional surgical procedures and the expansion to clinical applications.
     
  • Nanotech and microelectromechanical systems (MEMS).  It is actually a gross oversimplification to use a word like "nanotech" and imply that you are talking about one type of technology.  The only thing common to nanotech is size; every manner of material, construction, function and clinical benefit is part of this area.  The pace of development is striking.
     
  • Drug-device hybrids.  Just a few of the applications of combining drugs and devices in a single device include localized drug-delivery that avoids toxic, systemic dosages and vastly improved biocompatibility of existing devices. These two options alone represent multiple enormous markets.  Now, naked metal (or other) implants seem almost barbaric.
     
  • Bioresorbable materials.   Polymer and other materials technologies are enabling the development of implants and other devices that conveniently go away when they are no longer needed.  Already a significant market force in areas like bone growth in orthopedics, bioresorbable stents and other implants are proving their worth in cardiology and urology. 
     
  • Atherosclerotic plaque-reversing drugs.  When Pfizer divested itself of Esperion Therapeutics, it did not bode the end of this striking new drug approach to atherosclerosis, it simply illustrated the persistent challenge of drug development.  Here, it should be kept in mind that, the bigger the potential payout, based on huge clinical need (e.g., drug solution to the device intensive treatment of coronary artery disease), the more likely it is only a matter of time before the product reaches the market.  The jury is out on the "when" part, not the "if".
     
  • Rational therapeutics.  This is the holy grail thinking behind the development of many, many biotech products.  If one can develop a cure — a direct resolution of the underlying biological defect or deficiency in disease — and not just the symptoms, then one has changed the market in paradigm ways.  The hurdle and the payoffs are huge.
     
  • Tissue engineering technologies.  We have begun to be able to develop tissue engineered organs of increasing complexity — skin, bladders and rudimentary pancreases — and the benefits of these are huge.
     
  • RFID.  There is little, really, that is sophisticated about radiofrequency identification devices,  but their rapid integration into medical technologies of a wide range (tagging surgical instruments so they don’t get left behind, implants that enable external identification or even status, other types) will extend the utility and value of medical devices.
     
  • Noninvasive glucose monitoring.  Optimizing care for diabetes means, at a minimum, very frequent (5-10) checks per day of blood glucose.  This many finger pricks per year by the total number of diabetics globally (a rapidly growing number at that) who clearly would benefit from noninvasive monitoring reveals the value of this opportunity.  Capturing that opportunity means the combined success of both technology and cost.
     
  • Infection control.  This area is a top area, not for the sigificant technologies that have been developed, but the enormous demand for them.  Between rapidly emerging problems like methicillin-resistant staph aureus (MRSA), the resurgence of tuberculosis, the enormous costs of nosocomial infections and other infection-related challenges, infection control is an enormous, global opportunity.
     
  • Spine surgery.   The nature of the human spine, constructed of bone that needs to be both flexible and strong, demands device-intensive solutions.  The growing patient population of active, older adults is ratcheting the pressure on technologies to be less invasive, provide greater range of motion, last longer, cost less — all of which drives innovation in spine surgical technologies.
     
  • Obesity treatment technologies.  Technology solutions to the increasingly prevalant problem of obesity are imperfect, but still are frequently better solutions for the obese than an alternative that may ultimately also encompass heart disease, diabetes, stroke and other problems.  Diverse drug and device alternatives have been developed and the trend in obesity incidence will simply drive their continued development. 

Other forces are at work driving the above technologieis including, of course, cost containment, the integration of information technologies in both medical product and development process and the globalized economy.


The above topics are covered in various MedMarket Diligence reports.  See our list of titles.

European Ophthalmic Pharmaceuticals Market, by Segment, 2004-2012

(Excerpt from Report #G125, Products, Technologies, Markets and Opportunities in Ophthalmology Surgical, Device and Drug Markets Worldwide, 2007.)

Although there is a broad spectrum of medical technology innovations taking place in the ophthalmology sector, pharmaceuticals will continue to be a critical component of both elective and emergency ocular interventions. As a result, the dominant players in the pharmaceutical sector will realize strong growth, particularly in the areas of Dry Eye management (as a result of complications following refractive surgery), Glaucoma medications and treatments for wet AMD.

In addition, the generic drug sector will experience strong growth, particularly as expensive therapies for AMD reach the market and usurp scarce financial resources of markets with socialized healthcare systems.

Below is a forecast of the European ophthalmic pharmaceuticals market by segment.

The market in Europe for ophthalmic pharmaceuticals is dominated by Alcon, with Pfizer showing a distant second. 


The report #G125 on the worldwide ophthalmic products market is available for purchase and immediate download at link.


 

Cleveland Clinic’s Top 10 Medical Innovations

Below is Cleveland Clinic’s list of the top ten medical innnovations for their potential impact on patient care in the coming year. (I’ll add my two cents afterward.)

  1. Use of circulating tumor cell technology. Improves adjustments to cancer treatment, particularly for patients with repeat cancer
  2. Warm organ perfusion device. Increases from 4 to 12 hours the viability of donated hearts.
  3. Diaphragm pacing system. Improves breathing for paraplegics, making them considerably more mobile and reduces ventilator-induced pneumonia.
  4. Multi-spectral imaging systems. Enables multiple stained proteins to be visualized; speeds up diagnosis and dramatically improves directed therapy, especially for cancerous tumors.
  5. Percutaneous mitral valve regurgitation repair. One of innumerable advances yielding a minimally invasive procedure to be substituted for a highly invasive one.
  6. Strategies for creating avian flu vaccines of multiple types. Use of mock virus stimulates patient’s immune response, preempting need for variant-specific vaccines.
  7. LESS and NOTES. Use of single site laparoscopy (LESS) and natural orifice (NOTES) is making already minimally invasive endoscopy even less invasive. Faster healing and larger patient population.
  8. Integration of diffusion tensor imaging. Produces 2D and 3D color images to aid neurosurgeons in preserving functional pathways in the brain.
  9. Doppler-guided uterine artery occlusion. Possibly avoid hysterectomy and preserve childbearing ability for women with uterine fibroids.
  10. National health information exchange. Leveraging information technology to decrease costs and increase quality of medical care.

Let there be no doubt that ALL OF THESE technologies directly add to healthcare costs, even the ones, like number 10, which will reduce costs. Herein is precisely the challenge that was discussed in the prior post, Medical Technology Costs: Cause and Solution. These systems cost money to be put in place and, therefore, if assessed for their direct affect on healthare costs, the answer is that they do indeed increase costs (but, for #10, it is the indirect effect of eliminating old, inefficient systems that will lead to lowered costs). Systematically, as one reads through the list, we see the untapped demand of reducing trauma, expanding treatment to the untreated, improving diagnosis and treatment options and other benefits that increase the aggregate cost.

Let there also be no doubt that the compelling need to improve treatment so that it (1) serves more patients, (2) improves that quality of treatment, and, even, (3) lowers healthcare costs, inevitably involves at least an initial increase in costs. There is no magic bullet solution, as is occasionally suggested when the spotlight of cost focuses solely on medical technology. Increasing healthcare costs will demand solutions from many quarters, with a sanguine consideration of the actual benefits of medical technology.