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U.S. Department of Health and Human Services

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Medical Device Technology Forecast: Executive Summary

FDA's Center for Devices and Radiological Health conducted a survey of outside experts to identify major anticipated trends in medical device technologies over the next ten years. This analysis was undertaken to identify areas in which new or significantly increased product development activity is likely. The fifteen participants included physicians, engineers, healthcare policymakers and payers, manufacturers, futurists and technology analysts.

The process began with a questionnaire modelled on conventional Delphi techniques, in which participants assigned numerical scores to 21 medical technology areas reflecting their expectations regarding (A) probability of new product development, (B) likely patient population size, (C) potential benefits, (D) potential risks, and (E) overall importance of the technology area for medical device evolution over the decade. To complement the Delphi approach, each participant was later individually interviewed in a partially-structured format. Finally, participants were invited to an interactive one-day workshop to promote a synergistic interplay of viewpoints.

The questionnaire and interview results yielded a consensus that 18 of the technologies were expected to be important, and identified many specific examples of product types representing these technologies. Workshop discussions and subsequent CDRH analysis revealed that nearly all of the technologies and product types resulted from six major trends in (1) computer-related technologies, (2) molecular medicine, (3) home- and self-care, (4) minimally invasive procedures, (5) device/drug hybrid products, and (6) organ replacement/assist devices using hardware and tissue-engineered components.

In addition to the six major trends, participants noted a number of other patterns and issues having potential significance for medical device evolution including cost-containment pressures, technologically-tailored product customization, prevention-oriented health care, 'medicalization' of traditionally 'normal' conditions, interest in medical 'enhancement', special-interest patient advocacy groups, baby-boomers' activist patient attitudes and growing geriatric populations.

The workshop dialogue underscored the complex interactions between four groups who play critical roles in the emergence of new medical devices: investors and manufacturers, physicians and other direct health care providers, institutional payers and reimbursers, and patients and consumers.

A brainstorming session revealed four types of 'wild-card' developments which could induce major disruptions into the projected trends: radical scientific breakthroughs (e.g., in aging research); dramatic decreases in resources for health care research or delivery (e.g., from a global depression); major new public health problems (e.g., a substantial epidemic); and basic changes in societal values (e.g., eradication of health care disparities).