(From October 2006 MedMarkets)
From time to time, when I am looking at current developments to gauge the future of medical technology markets, certain common threads seem to be seen suggesting a theme, if not a legitimate trend, encompassing them all. Each of the developments may be noteworthy on their own, but if part of an overall trend, the developments become supportive evidence.
Explosive New Technology
The emergence of evidence that drug-eluting stents correlate to some significant degree with increased risk of late-stage restenosis demonstrated that the technology that suddenly produced at $5 billion market for J&J, Boston Scientific and now others (see "Drug-Eluting Stents Vie for Market Share With Innovation, Acquisitions" in this issue, page 1) was not as perfect as cardiologists (or investors) would have hoped. One might be inclined to grant a little forgiveness on the part of both manufacturers and clinicians in their zeal for the new technology, given the incontrovertible data on the restenosis associated with bare metal stents and the overwhelmingly positive short term data that drug-eluting stents dramatically reduce restenosis. But the zeal did extend beyond the direct clinical benefit of anti-restenosis. It extended to the support for a huge medical device market—encompassing angioplasty and stents—that was arguably at risk of renewed competition by coronary artery bypass grafting, which has seen device market development of its own (beating heart bypass, percutaneous technologies, even robotics) to retake the market for treatment of coronary artery disease. Neither patients seeking better outcomes, nor clinicians seeking secured caseload, nor manufacturers seeking increased revenue had particular incentive to challenge the long-term outcomes of drug-eluting stents. Those who did raise such yellow flags were not well received.
Business Week Online (Science & Technology, October 9, 2006) noted the case of Dr. Renu Virmani of the cvpath Institute (Gaithersburg, MD) who, at a meeting in Paris in 2004, tried to inject a level of restraint in the enthusiasm for drug-eluting stents. She believed, based more on (what turned out to be valid) instinct than on a large body of hard clinical data, that the drugs used to prevent restenosis would in fact only delay restenosis or lead to other problems, such as clots. By all accounts, her message was not well received. Now, with the benefit of hindsight and hard clinical data, even clinicians and manufacturers are acknowledging the higher risk of blood clots associated with drug-eluting stents. However, one can't help but feel the implicit tendency among all stakeholders to minimize the significance of this increased risk while noting, of course, that more data needs to be collected.
We can go out on a relatively short limb here and assert that virtually every new technology will be overused in the short run. For medical technologies, the primary limiter is contraindication, and until a sufficient body of clinical data is produced to flesh out the contraindicated population, there will be little limitation in a new technology's growth. The alternative is untenable, that a new technology not be approved until such volume of data is produced by numbers of cases and long term follow up to fully elucidate all the risks. The FDA, of course, would be the remaining voice for restraint, but its voice is virtually drowned out by clinicians, manufacturers and patients who clamor for the new technology.
Radically New Technology
In a recent report issued by the Woodrow Wilson Center's Project on Emerging Nanotechnologies, Michael Taylor, former deputy commissioner for policy at the FDA and now a professor at the University of Maryland, notes that the FDA is severely constrained by budget limitations such that it is wholly ill-prepared to regulate nanotechnologies. Taylor notes that, with upwards of 320 products with nanomaterials already on the market, and with over 200 drugs and medical devices incorporating nanotechnology in the pipeline, the FDA needs to be authorized by Congress to collect more safety data and perform more post-marketing surveillance. Moreover, the agency simply needs more funding to hire staff and develop expertise that is as good or better than the nanotech industry that it will be expected to police.
Nanotechnology is a radically new technology or, rather, technologies. The definition of nanotechnology, framed as it is simply by the size the of products (or their components), lends itself to an incredibly diverse set of technologies (see past MedMarkets issues //Dona??//) that will exceed FDA’s abilities to address safety and efficacy. By some estimates, the U.S. government has already invested $1.3 billion in nanotechnology initiatives and private industry has added another $1.7 billion, as testament to the benefits that are expected to emerge. If, as was already noted, the FDA had limited ability to provide effective restraint in the growth of drug-eluting stents, a market for which it arguably already has adequate expertise, then what might one expect for nanotechnology?
The examples of drug-eluting stents and nanotechnologies centered on limitations with the FDA in constraining the emergence of technologies to protect patients, and while regulation of medical technologies by the FDA must certainly become more effective (read, more aggressive) to accompany the aggressive development of medical technologies, the best regulation of medical technologies cannot occur without the effective management of the downside of medical technologies by manufacturers themselves. The recent history of manufacturers not taking the long view of their products (e.g., Guidant, Merck) is evidence enough for products that aren’t characterized by rapidly growing or radically new technologies. The range, types and potential impact of new technologies poised to enter the marketplace (i.e., beyond nanotechnologies) is truly breathtaking and without some level of judicious restraint applied to the pace of their introduction, the past examples of repercussions from technologies too aggressively introduced will pale in comparison.
Tags: medtech, FDA, nanotechnology, stents
Wednesday, October 25, 2006
Thursday, October 05, 2006
Technologies and that Highlight Advances and Precipate Even More
September 2006
MedMarket Outlook: Technologies that Highlight Advances and Precipitate Even More
Product developments with the potential to dramatically alter the landscape of both patient care and manufacturer market shares are numerous. They take many forms, from pure device, biotech or pharmaceutical to endless combinations of them all. Device technologies also represent a unique platform for health care delivery beyond simple device, drug-coated or other device hybrids.
In any industry, there are many wildcard technologies --- innovations envisioned to enable radical solutions to problems, thereby turning current markets on their heads. The medical technology industry is not only no exception, but is as good an example of this as any. Here we consider examples for illustration:
Implantable Wireless Biosensors
The University of Rochester Medical Center and an associated startup (Physiologic Communications LLC) is working on producing implantable wireless biosensors that will be integrated with living cells in order to detect and report on localized physiologic and chemical changes. Moving beyond the idea of implantable miniature drug delivery chips (e.g., MicroCHIPS), these devices will be hybrids of devices and cells such that the cells remain viable as a component of a miniature electronic chip. Localized physiologic conditions can be monitored -- the presence of specific proteins, ion concentrations or changes -- or in the technology's more advanced potential therapeutics can be delivered directly or the biosensor can trigger delivery by other localized devices (e.g., a defibrillator or pacemaker). The devices also hold potential for in vitro drug testing in order to test new drug candidates prior to animal or human trials.
The ability to integrate devices with biologics and, indeed, viable cells has profound implications for technology development, particularly because the end result of doing so is to compensate for some of the inherent limitations of medical devices:
- Medical technology is eminently invasive. Just as laparoscopy was a radical improvement over traditional open surgery due to its ability to greatly reduce invasiveness, the advent of implantable technologies, which might ultimately be implanted via catheter, syringe or other relatively non-invasive techniques, if only for diagnostic or monitoring purposes, harbors the potential to similarly reduce the invasiveness of medical technologies.
- Medical technology, and devices in particular, is an arm's length proposition. Once a medical device is implanted, it is largely hidden. If the device can be revealed real-time by integrating sensors with cells as well as the device itself, then the resulting knowledge by the clinician (and the manufacturer) can enable multiple improvements in the device's performance. This would include optimizing placement of the device during implantation (e.g., to augment fluoroscopic guidance), alerting to changes in status of the device or the device's environment to alert the clinician to impending device failure, change in patient status requiring intervention or other local changes.
- Medical technology is symptom-oriented. Medical devices are innately crude -- this is not to detract from their sophistication of design, but metal, polymer or even more advanced material construction is frequently designed to, at best, minimize inflammation or other clinical sequellae. Understanding the nature of the device’s environment with which it actively or passively interacts is paramount to improving device performance.
The erosion of the differences between devices, drugs and biologics is furthered by advances of those described above. Wireless, living cell biosensors may soon have the capacity to be "aware of" and respond to local physiologic conditions by administering therapeutics or other intervention.
Non-invasiveness versus Minimal Invasiveness
Despite the best intentions of drugs, biotech and medical devices, it frequently becomes necessary to intervene with a surgical solution. Laparoscopy and thoracoscopy have already demonstrated that surgery can be made drastically less invasive. However, even the minimal invasiveness of "keyhole" surgery is still invasive and can therefore be improved upon.
Minos Medical (
Minos Medical's Appendoectomy is one of several procedures being developed in surgical endoscopy under the heading, "Natural Orifice Transluminal Endoscopic Surgery" or "NOTES". Minos is also developing procedures for cholecystectomy and hysterectomy, two other high volume surgeries.
Given the number of diseases in the gastrointestinal tract, NOTES represents a formidable potential for the continued evolution of surgery away from invasiveness.
Analogously, cardiovascular applications are similarly evolving away from invasive surgical procedures such as traditional coronary artery bypass graft (CABG) to percutaneous interventional procedures and even to percutaneous CABG (originally developed by TransVascular, Inc., acquired in 2003 by Medtronic).
The balance of care is shifting away from traditional surgery toward laparoscopic, endoscopic and percutaneous procedures, a trend driven by innovations that enable procedures to be done less invasively or non-invasively and with competitive outcomes. Healthcare is thereby shifting away from surgeons and toward gastroenterologists, interventional cardiologists and other non-surgical specialists, a fact enabled by and of great interest to manufacturers.
Ultimately, however, true non-invasiveness is an achievement that may well not be possible with any type of medical technology at all, but only with orally, nasally, topically or other non-syringe administered drugs.
Removing the veil
Gaining a more intimate picture of structures and processes at the cellular level and below is another advance that will augment the ability of health care to understand and intervene. In September, Nikon Corporation held its "Small World" international light microscopy photo competition, with this year’s winning image of the nuclei of a mouse colon cells, a picture taken by Dr. Paul Appleton, of the University of Dundee (UK). The picture was selected due to its originality, visual impact and, in particular, its informational content, which was that it was judged to help elucidate regulation of cellular changes and their involvement in the development of colon cancer.
The inability to directly see processes at the cellular and molecular levels has been, in some ways, the catalyst for truly innovative experiments that elucidate structure, function, dynamics, causality and other answers in medical science. But, with so many advances in imaging technology (X-ray, MRI, SPECT, etc.), combined with increased understanding (from other technologies) of the nature of cellular and molecular processes, a multitude of discoveries must be pending in medical science that will remove the veil from healthy and pathological processes and open the doors to treatments -- drug, biotech, device and others -- that we have not yet envisioned.
We have highlighted in past MMO columns that discoveries in medical sciences and advances in the development of more effective treatments are increasingly coming as a result of synergy gained between multiple scientific disciplines, as well as through the contribution of information technologies that can reveal what is significant, even when we are not looking for it. But it is the aggressive development of seemingly unrelated innovations that not only produces new treatments -- even cures -- but also furthers the trend toward more and greater advances.
URLs
Medtronic, Inc. -- Minneapolis, MN; http://medtronic.com
Minos Medical, Inc. -- Irvine, CA; http://minosmedical.com
Physiologic Communications, Inc. -- Rochester, NY; http://physiocomm.com (under construction)
Tags: medtech, medical technology
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