Technology platforms and clinical applications overlap

Diverse technologies have a surprising number of common threads, whether in the technologies themselves or in the clinical applications.  For this reason, manufacturers need to consider that:

1. A technology platform can be the launchpad for products in clinically diverse areas. Case in point, cell therapy, which as a fundamental scientific discipline can have uses as far afield as wound management, bone repair, treatment of myocardial ischemia and others.

2. A disease state can sometimes be targeted by many very different technologies.  Examples include that wound management can be accomplished by tissue engineering, sutures, fibrin-based surgical glues, cyanoacrylate-based surgical glues, dressings and others.

The driver behind technologies having multiple clinical applications is, of course, that companies wish to maximize their ROI.  

The driver behind single disease states being the target of multiple alternative technologies is cost — healthcare systems (in principle, anyway) seek the most competitive options for treating specific patient populations, and this driver has been gaining momentum over the past ten years due to “managed care” efforts as well as aggressive, cost-focus innovators creating technologies that displace market share with convincingly better patient outcomes compared to alternative technologies.


MedMarket Diligence publishes medical technology market reports on a wide range of clinical and technology subjects (of course, sometimes overlapping). See list.


(This post was done via the Palm Pre WebOS app Po’ster by Gabriele Nizzoli.) 

Nature and medical technology trends

If one is in the position of needing to look to the future of medical technology (and who in this industry is not?)—to identify opportunities or predict challenges in the market—then it is hard to not factor into it two very different current trends and play them out toward the resulting future market impact. One trend is the biotech-driven trend of elucidating natural processes of health, disease and healing in order to exploit understanding of the natural sciences to solve medical problems. The other trend is the technology-centric trend of developing hardware, largely surgical or at least interventional technology, that may dramatically achieve better surgical/interventional endpoints. To (over)simplify, one could say this is the biotech versus device polemic, but that really does simplify the dynamics too far, suggesting there is ultimately an either/or conclusion, which is false.

A group at Harvard-MIT in early 2008 reported in the Proceedings of the National Academy of Sciences on a flexible, waterproof and even biodegradable bandage based on the sticky feet of the gecko. The lesson of the gecko is that the gecko’s stickiness comes from nanoscale fibers or "pillars" that increase the surface adhesion, which the Harvard-MIT team mimicked in the construction of the tape with nanostructures in the surface. Now, while this does not really represent a biological solution (such as the protein-based glue used by mussels to attach to surfaces), the study of natural processes revealed a solution that could be modeled in medical technology. This points up the huge number of opportunities that reside in nature directly (e.g., mussel glue) or indirectly (nanostructured adhesive based on the gecko). After millions and millions of years of evolution that has produced survival advantage for the natural world, it would almost be viewed as foolish to pursue solutions to medical problems without considering that those problems already have been solved, somewhere, in nature. Some scientists are convinced, for example, that the biological diversity resident in the Amazon rain forest holds cures for cancer and many other diseases.

At the other end of the spectrum is technology like the da Vinci (Intuitive Surgical), a four-arm, flexible wrist robot on which are mounted miniaturized tools and cameras controlled by a surgeon, at a cost of $1.4 million, not including the cost of parts, maintenance and training. The system enhances the precision of surgeons performing prostate surgery and is also being adapted to the performance of hysterectomies, fibroid removal (and other gyn procedures), heart valve replacement and kidney surgery. The system enables a level of control that is simply not possible by the freehand surgeon, which enables much more challenging procedures, ones that may heretofore have been inoperable or simply not possible without causing unacceptably high complications. Intuitive’s da Vinci is not alone in this trend. Accuray has developed its CyberKnife for its ability to precisely attack tumors without surgery. There are also complex systems under development by Hansen Medical and Stereotaxis.

Certainly, the emergence of medical/surgical robotics can be viewed analogously, albeit simplistically, to the advent of laparoscopy, with its technology-intensive approach that minimizes trauma to the patient. But, the several-thousand dollar investment of laparoscopy hardly compares to $1.4 million (plus) for da Vinci. Nonetheless, the facts of da Vinci’s market success to date have been clear, since Intuitive has been exceeding Wall Street’s expectations for sales, revenues, etc., all of which is nothing less than remarkable in this era of cost containment.

What do these trends say for future market opportunities? The "biotech" trend tells us that there are many opportunities yet to be discovered based on the amount of disease (and even trauma) in the world and the lack of cures for them that are not "perfect"—reversing the disease condition and restoring health without the smallest complication. Of course, there also remain a huge number of "nearly perfect" solutions, or even less perfect ones that hold potential due to the fact that they provide even the most marginal advantage over existing therapies, if such exist at all for the treatment of specific diseases.

The "technology-intensive" trend suggests that the limitation of what we can achieve is not dictated by our knowledge of natural systems but is determined only by the apparent limits of our imagination and technology development well outside of health care (e.g., robotics are not inherently medical), which will include materials sciences, information technology and the stunning array of technology hybrids that can be constructed to achieve specific outcomes (RFID-embedded surgical instruments, ingestible pillcams, etc.).

The two schools of thought are not mutually exclusive, by any stretch of the imagination. In fact, there are enormous opportunities in the marriage of the two. The mandate for medtech manufacturers seems to be then that they should, on the one hand, come to as thorough an understanding possible of the natural biological processes associated with the disease or disorder of interest and, on the other hand, imagine and apply any and all technology, regardless of scientific discipline, that will result in an improved outcome for the patient. With the rapid growth in our understanding of the complex etiologies of disease and with the spectrum of technologies that can be constructed to serve specific functions, the only limitations appear to be imagination and reimbursement, and with Intuitive Surgical’s market success, one would wonder if the latter is even a problem.


Links:
Accuray (Sunnyvale, CA; http://accuray.com
Hansen Medical (Mountain View, CA; http://www.hansenmedical.com
Intuitive Surgical (Sunnyvale, CA; http://intuitivesurgical.com
Stereotaxis (St. Louis, MO; http://stereotaxis.com)

Trends and drivers in medical technology

Through the course of researching advanced medical technologies and the markets and opportunities for them, I see some real trends and drivers in the market:

  1. The drive for minimal invasiveness.  NOTES (natural orifice surgery), single port laparoscopic procedures, percutaneous procedures — anything that causes less pain and collateral damage, shortens recovery and (but not necessarily) reduces cost
     
  2. The development of hybrid devices that combine multiple product forms to achieve new clinical goals:  the integration of drugs with devices with drugs to enhance device performance, implanted devices to deliver drugs
     
  3. Advanced materials development:  devices that dissolve, resorb, stimulate tissue ingrowth, prevent infection, prevent inflammatory response
     
  4. Information technology: radiofrequency identification devices (RFID), computer-aided drug design, surgical simulation preoperative/planning systems, electronic medical records
     
  5. Drive for healthcare reform:  this is the most nebulous and significant of trends given its pervasive discussion in economic, political and business forums.  For medtech, it means anything related to better outcomes at existing or lower cost, which underlies almost all other trends
     
  6. Economy:  Never before has the impact of a declining or stagnant economy had as much impact on the medical technology industry.  Elective procedures (cosmetic/aesthetic and others) will take the hardest direct hit, but restrictive credit markets are forcing investment — in startups as well as later stage — from alternative sources.  Capital equipment expenditures are also on the chopping block.

Then there the clinical and technology areas where there is just a hotbed of activity:

  1. anything related to the spine:  pain relief, dynamic stabilization, all tapping into aging population
  2. any kind of drug-eluting stent:  Boston Scientific and J&J have hoarded the pie too long
  3. obesity drugs, devices:  the burgeoning population is driving just as much activity
  4. neuromodulation:  a true growth market, the true potential for which is untested but still a big opportunity
  5. glucose monitoring: the non-invasive test is a holy grail 

These are just some of the drivers, trends and hot areas that I see.  I would love to see your comments!

Comments welcome!