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Medical Devices Technology Forecast: Appendix B Trend Drivers

During the individual interviews, fourteen 'trend drivers' were independently identified by multiple participants. Comments are summarized below:

1. Changing U.S. health care system, cost containment pressures, and 'outcomes' research

Five participants directly cited ongoing changes in the U.S. health care system; several more alluded to this issue indirectly. Most noted the unresolved and relatively unpredictable outcome of this unfolding issue. Several participants felt that the quality of health care may deteriorate during the process and that the current system is substantially flawed. The impact on medical device technology will be determined by what devices and procedures are funded by both government and private insurers.

Six participants identified cost-reduction as a primary 'trend-driver'. Respondents identified several consequences that may impact medical device development. Participants expected intensified interest in self-care, preventive monitoring, early detection techniques, transfering care to non-hospital settings, use of minimally-invasive procedures, and replacement of medical devices by less-expensive pharmaceuticals. Some participants anticipated fewer future innovations involving large expensive devices (e.g., MRI) and more commodity-like mass-produced devices (e.g., a lab-on-a chip). Some participants predicted greater patient loads for health-care professionals who will have to leverage their efforts technologically.

Four experts described outcomes research as a primary large-scale influence, motivated by cost-reduction pressures. They believed that morbidity, mortality, and length of hospital stays will substantially influence medical device technology development, as well as continuation of reimbursement for present procedures and devices. Several interviewees commented on the relationship between the development of 'outcomes' data and the emergence of computerized patient information systems described below.

2. Computerization

Nine participants described this area as one of major importance. Several experts specifically described the integrated patient medical information system as being clearly the most important specific device group identified by the survey. Some described it as transformational in its probable impact. A variety of reasons were cited for these assessments including improvements in physicians' access to comprehensive patient information, business and sales data management, facilitation of outcomes research, potential for computer-aided diagnosis and patient modelling, and the potential need to manage large volumes of information that may result from advances in genetics and biomolecular medicine. However, numerous participants described potential problems related to accuracy and completeness of stored patient records, data privacy and security, reliability of diagnostic algorithms, and legal ownership of medical data. A number of participants described patient 'smart-cards' as part of the overall computerized medical information system. Several envisioned future medical devices as being designed for integration into such systems.

3. Device Customization

In workshop discussions some participants noted that programmable microprocessor-based products with sophisticated biosensors could increase the ability to individualize device performance characteristics. The possibility was raised that such technology might enable the tailoring of therapies to clinically-relevant patient genotype- and phenotype-groups. Other participants, however, felt that significant areas of medicine have not yet achieved even rudimentary standardization, and that customization would or should come later.

4. Molecular Medicine

Six experts cited improvements in molecular understanding of disease as primary 'trend-drivers'. One of the most frequently mentioned factors was the advancement of human genetics, though several participants noted improvements in the state of knowledge of cellular and molecular biology in general. Several manifestations were mentioned that may be relevant to medical devices including functional medical imaging, biosensors, diagnostic devices, and tissue-engineered organs.

5. Home- and Self-Care

Strictly speaking this issue was identified as a 'trend-driver' by only one participant, but five others strongly recommended that home/self care devices belong near the top of the scored priorities. Almost all of these participants emphasized the economic motivation for such devices -- especially in view of the sizable patient population, the potentially large market, and the cost containment pressures mentioned above. Some commenters noted that many of these products might be relatively low technology devices. A few participants said that this area could have a revolutionary impact on health care. Some also expressed concern that difficulties would develop in the home setting that require professional attention, and that treatment quality may be compromised.

6. Prevention

Three interviewees explicitly identified this area as a major influence, but several more referred to it indirectly. Participants cited both cost reduction and improved outcomes as motivators. Examples of the impact on medical devices included products related to monitoring and diagnosis, especially in the context of increasing home/self care (see above). Respondents also mentioned the importance of managing patients with chronic conditions to forestall serious (and expensive) deteriorations.

7. Reductions in Invasiveness

Six experts cited reductions in invasiveness as a primary 'trend-driver'. Respondents detailed the continuing tendency toward precisely-targetted surgical intervention and away from invasive exploratory procedures. Some participants noted that, despite obvious trauma-reduction benefits, minimally-invasive procedures often pose nontrivial risks. Even after experience matures along the inevitable "learning-curve" with these new techniques, they are frequently more difficult to perform properly than conventional techniques. Frequently-mentioned applications relevant to medical device technology included cardiovascular surgery, neurosurgery, laser techniques, noninvasive diagnostics, and advanced medical-imaging applications such as image-guided procedures.

8. Miniaturization

Four respondents identified advances in micro- and nano-fabrication technology as a likely major influence over the next decade. Some others agreed that nanotechnology might eventually be a profound influence, but doubted that this would happen in the next decade. On the micro-technology scale participants envisioned electronic, mechanical, and chemical functions on a single structure. Participants described several potential medical-device applications of miniaturization techniques including DNA and protein diagnostic chips, miniaturized robotic surgical aids, blood chemistry biosensors, and implantable neural stimulators.

9. Tissue Engineering

Two participants mentioned a growing tendency toward the use of tissue-engineered or hybrid parts and organ replacements instead of nonbiological devices. These respondents stressed the relatively simplistic design and performance features of many nonbiological devices. It may be noteworthy that the examples cited in Table 2 include at least nine device groups that may exemplify the general topic of tissue engineering.

10. Pharmaceutical Developments

Two respondents specifically mentioned the potential relationship between new pharmaceutical developments and medical devices. Several others referred indirectly to this issue. One issue mentioned by several experts was the potential for new drugs to serve as cheaper and more convenient replacements for some types of medical devices. One respondent noted the market opportunity that improved genetic diagnosis may provide for drug development -- patients diagnosed with incurable genetic diseases are likely to be eager for new interim drug treatments, at least until genetic therapy techniques advance substantially. The high priorities that participants assigned to hybrid drug-device products and implanted drug delivery devices are also noteworthy.

11. Neuroscience Advances

Three participants described this area as one having great potential significance over the next decade. These comments focussed on advances in understanding and treatment of issues related to brain function. The potential importance of developments in nerve regeneration was also noted by several respondents.

12. Cancer Therapy Advances

Two interviewees expressed the belief that there will be substantial progress in this field within the next decade having important large-scale ramifications. This view was underpinned in part by improving knowledge of tumor pathophysiology, new drugs, and less invasive technologies.

13. Social Factors

During the interviews, five experts described an expanding group of active health care consumers who insist on active participation in the medical decisionmaking process. Factors cited as contributing to this development included the aging baby-boomer population, the availability of information (of uneven reliability) on the internet, and the emergence of special-interest patient advocacy groups. Some respondents expect these groups to exert considerable influence on the availability of medical treatments and devices, and to play a significant role in the evolution of home/self care devices and telemedicine.

Workshop discussions noted a considerable range of other social factors relevant to medical device development, including the growing U.S. geriatric population, the aging of the "baby-boom" population, and the profound effect of behavior on health care expenditures.