• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

Medical Device Technology Forecast: Results


The specific survey questions, technology definitions, and scoring parameters appear in Appendix A of this report. In general, each expert participant identified significant product-types exemplifying twenty-one generic medical-device technology areas. Individual participants assigned numerical scores from 1 (low) to 5 (high) to several parameters describing the examples and the generic technology areas. The parameters included probability of new product development, patient population size, expected benefits, potential risks, and overall importance. The participants' final aggregated scores are shown in Tables 1 and 2.

Table 1 represents the average scores for each of the twenty-one medical-device technology areas addressed by the questionnaire. Scores for a technology are the averaged scores for the examples participants identified in that technology. These technologies are listed in order of overall importance, as reflected in participants scores.

Table 2 provides the average scores for 36 specific examples provided by participants (irrespective of the technology category they represented). Since these examples were generated independently by each individual, there was considerable variation in the examples from one participant to another. Consequently, the average scores for any particular example in Table 2 reflect input from only a subset of the entire panel, although considerable overlap was evident among participants. Table 2 includes all examples addressed by more than 25% of the participants (in the questionnaires and the interviews). Examples are listed in order of overall importance, as reflected in participants scores.


The Tables reflect minor adjustments that two participants made in their initial scores during the interview phase. These changes did not alter the original order of the Table entries. In the interviews most participants specifically stated that almost all technologies and examples in both Tables would probably be significant over the next decade. Important caveats emerged, however, about two technology areas in Table 1. First, all commentors expected "virtual reality" (the coupling of technologically synthesized environments to the human senses) to be limited primarily to educational use over the next decade. Second, varying interpretations of the "infection control devices" category led to such varied examples that the aggregated scores for this topic were not deemed meaningful. Comments on individual examples from Table 2 are examined in the "Discussion" section.

During the interviews participants identified evolving large-scale issues they expected to influence the evolution of medical devices over the next ten years. Again, there was considerable overlap in participants' views of these 'trend-drivers'. After group discussions at the subsequent workshop, thirteen such issues emerged:

  • Changing U.S. health care system, cost containment pressures, and 'outcomes' research
  • Computerization
  • Device customization
  • Molecular medicine
  • Home/self care
  • Prevention
  • Reducing invasiveness
  • Miniaturization
  • Tissue engineering
  • Pharmaceutical developments
  • Neuroscience advances
  • Cancer therapy advances
  • Social factors (e.g., activist patients and consumers, aging patient population, etc.)

Each of these 'trend-drivers' is elaborated in Appendix B.


At the workshop, survey participants reviewed the questionnaire results, analyzed the impact of the 'trend drivers', and explored potential 'wild cards' that might alter their expectations.

Questionnaire results
An interactive review of the questionnaire data elicited a number of interpretive comments (see "Discussion" section) but revealed no significant misgivings about the overall picture presented in Tables 1 and 2. Except for the caveats above regarding "virtual reality" and "infection control devices", participants noted again that basically all technologies in Table 1 were likely to be signficant over the next decade. Comments on individual examples are described in the "Discussion" section below.

Impact of 'Trend-drivers'
In both small groups and plenary discussions, survey participants debated the probable impact on medical device development of the "trend-drivers" previously identified in the interviews.

The workshop generated spirited discussion of the real decisionmaking processes that determine which new medical devices will be developed and introduced. Many survey participants expected a growing competition between differing societal expectations for allocating finite health care resources. For example, participants cited increased societal expectations for medical 'enhancement', accompanied by the 'medicalization' of previously 'accepted' conditions such as myopia and infertility. Increasing expectations within this paradigm would certainly compete with some more conventional expectations, and would probably result in different product development patterns.

The workshop dialogue underscored the complex interactions among four groups that play critical roles in these determinations:

  • investors and manufacturers
  • physicians and other direct health care providers
  • institutional payers and reimbursers
  • patients and consumers

Each of these groups both influences and is influenced by each of the others. Participants made it clear that a dynamic interplay among these groups profoundly influences the emergence of new products, notwithstanding the significance of scientific and clinical breakthroughs. New devices will be developed when coherence emerges among these key decisionmakers. Workshop participants believed that such coherence is developing in several areas.

(Incidentally, few participants believed that 'outcomes research' plays a major role in this process. Several participants suggested that products have often reached mature stages of their commercial lifetimes by the time 'outcomes' information becomes available. By that stage, developers are often already actively preparing a new generation of products.)

One area that participants emphasized was home- and self-care including certain basic versions of telemedicine. A variety of factors motivated this expectation, including (1) pressures for efficiency in health care delivery, (2) existence of a substantial business opportunity based on market size, (3) compatibility of emerging noninvasive sensor technologies with patient comfort, (4) a global trend toward individual- and community-centered health care, and (5) a quality-of-life motivation for aging patients to avoid institutionalization.

Potential cost-savings were also a factor in several other areas emphasized by participants. An increase in medical (vs. surgical) management suggested new device/drug combination products. The potential impact of earlier diagnosis motivated participants' expectations for new diagnostic products (e.g., new biosensor arrays and advanced medical imaging techniques), and for increasing use of sophisticated information data bases in new hospital computer systems and smart devices.

Further, cost savings were viewed as important in the expected growth of minimally-invasive techniques and devices. Indeed, some participants expected such savings to play a larger motivating role than trauma-reduction for the development of new minimally-invasive techniques. Participants who expressed that view noted that many new minimally-invasive techniques are more challenging to perform than conventional methods, and may merely redistribute risk rather than reducing it.

Developing momentum in scientific and clinical research accounts for three other areas that received emphasis in the workshop: potential new products related to tissue engineering; cancer therapy; and neurosciences.

Finally, discussions of the impact of 'trend-drivers' led several participants to point out the importance of a fundamental core of scientific disciplines that underlie the anticipated technological developments. Participants underscored the importance of integrating engineering and physical sciences on the one hand with biology on the other.

During the workshop, participants also addressed the kinds of developments that could fundamentally alter the trends they were anticipating. They brainstormed a range of possibilities, which ultimately fell into four groups:

  • major technical or scientific breakthroughs
  • substantial decreases in resources for health care research or delivery
  • emergence of dramatic new public health problems
  • significant changes in societal medical values