MedMarket Outlook:

Information Influence in the Medtech Industry

The medtech industry is at the forefront of merging scientific disciplines that will impact how pathology is understood and the available tools for intervening. Physiology, biochemistry, genetics, cell biology, immunology and other disciplines are increasingly part of a more complete understanding of an organ system in its healthy and pathological context, and with the concomitant use of other disciplines/sciences (e.g., materials technology, nanotechnology, etc.), the options for intervention are proliferating. But the most significant impact on the medtech industry may well ensue from its merger with information and information technology.

Information Technology as an Integral Component

Here we make an important distinction between information and information technology—information is an input to the process of developing medical products while information technology can not only expedite the application or usefulness of information in the development process but is also increasingly an inherent part of medical technologies themselves. The use of information technology as a component of the medical product or as part of the development process has several salient examples:

• Patient monitoring systems, already sophisticated at simultaneously monitoring multiple parameters, assessing patient condition and delivering/displaying/reporting results, are becoming more facile, smaller, lower cost, adapted to more sites (point-of-care)

• Smart bandages are able to report on wound status, including infection

• Smart shirts collect and report on various vital signs data

• Radiofrequency identification (RFID) has as a most direct impact the ability to track devices for inventory management system. On a more complex level, coupled with implants, RFID can provide the function of patient records purposes (e.g., VeriChip), reducing the risk of wrong-site surgeries, tracking surgical instruments in the OR and other purposes

• Drug candidates are evaluated on supercomputer-like distributed processing networks, screening thousands of moieties for their potential simply by evaluating known interactions and other factors that will exclude candidates and thereby preempt need for in vitro or in vivo study

• Medical devices are designed on CAD (computer-aided design) systems to investigate alternative designs for better performance, to anticipate design flaws, and to determine manufacturing requirements. Prototype models are also being produced by three-dimensional printing

The Dissemination of Information

The use of information and its changing influence on the medtech industry is an issue that also extends to a macro level, considering the potential benefits of better dissemination of information in health care, the ease with which information can be communicated and the lack of remaining, legitimate obstacles to doing so.

Senate Bill Makes Federal Grant Study Info Available Online Publicly
A Senate bill introduced in May would mandate that recipients of federal grant money post their research findings on the Internet within six months of publication in a journal. With study results made more widely available in this manner, so the argument goes, more researchers will be made aware of findings that can influence their own research, enabling them to direct their efforts away from areas where other researchers have run into problems (or found dead ends) and toward those areas where research will be more effective in solving problems or at least generating more useful research findings.

It is an intuitive argument that more freely available information will facilitate the research process. At the same time, there is a well-established incentive on the part of researchers to withhold information, since their professional success is based on being first to publish on their findings. Indeed, as reported in the Washington Post (May 3, 2006), the NIH in 2005 recommended grant recipients post their findings on the Internet within one year of publication, but after six months, only 4% had done so. Nonetheless, the Senate bill deferred to physicians, proposing that the requirement be for making the data available six months after publication, a requirement that also mitigates the likely subscriber hit that publishers will experience.

The posting of research findings and their access for free on the Internet will also add to the growing body of health care information available to patients, serving to increase their awareness of the leading edge of medical research just enough to (at least initially) antagonize their primary care physicians with questions about theoretical treatments that more often than not won’t apply to them. But, as patients eventually will truly understand more of the science behind medicine, their questions will be more pointed, more accurate and more inclined to sway physicians to modify treatment.

As a result of the increased awareness, medical publishers will see subscriptions decline and physicians will lose some of the exclusivity of their knowledge, which will lower them on the pedestal from whence they previously could peer at patients condescendingly. In short, patients will gain more control over their health care decisions.

Opening Up the Black Box
While asserting that there were far more problems with the peer-review system than were defensible, a recent New York Times article (“The Doctor’s World: For Science’s Gatekeepers, A Credibility Gap,” May 2, 2006) was correct in pointing out that peer-review is the subject of at least some increased scrutiny. The “landmark” stem cell paper in Science by the now-discredited researcher, Hwang Woo-suk, is the symbol of the need for better validation of clinical data. Another example is the assertion that Merck understated the risk of heart attack from use of its painkiller, Vioxx. These two examples have added considerable heft to arguments calling for greater scrutiny of clinical research.

However, exposing fraud, whether motivated by professional hubris or corporate greed, is not the only impetus for opening up the black box of clinical research. In a late 2005 issue of CANCER (Luis Camacho, et al., 104(7): 1497–1504, October 1, 2005), from the American Cancer Society, researchers from the University of Texas M.D. Anderson Cancer Center in Houston found that fully one-third of studies of Phase 1 cancer drugs presented at a major cancer meeting were not published due to lack of time or other constraints upon researchers. Such underreporting of cancer drug trial data, according to the study authors, has the potential to delay progress and may ultimately have an adverse effect on patient care.

Although it was corporate accounting scandals at Enron, Global Crossing, MCI/Worldcom and others that raised the alarm about the need for better access to financial data at public companies, the peer-review system is likely to undergo a similar transition, albeit on a smaller scale. One can expect to see increased pressure placed on physicians and manufacturers to reveal all of the results of trials, not just the results in support of the desired conclusion, but also the raw data.

The need for more credibility in peer-reviewed data has arisen at a time when it has never been easier to disseminate information. Therefore, unless a strong countervailing argument arises, the trend toward greater openness in such data will certainly persist.

Medtech Catching Up with the Information Age
Ironically, despite the fact that the U.S. medical product industry has had an almost addictive relationship with advanced technologies, the industry has been a follower when it comes to the use of information technologies, whether integrated with medical products or as a common business tool. However, information technologies have advanced in their ease of use, potential for integration with medical products and the ability to generally lend themselves toward providing competitive advantage. As such, the medical product industry is becoming a considerably more eager adopter of information and information technologies. The coincident development of advanced information technologies and increased competition in the medical product industry has forced the industry into the information age.