Medical Device Technology Forecast: Methodology
Fifteen experts from a broad range of backgrounds were enlisted to help identify the most significant trends in medical device technology over the next decade. Each participant provided responses to a questionnaire and participated in an in-depth individual interview. Twelve of the fifteen participated in a day-long group workshop.
The participants were selected to provide a range of perspectives. They included representatives from the clinical, engineering, manufacturing, research, futurist and healthcare policy communities. The participants are listed below, along with their organizational affiliations at the time they were enlisted for the study:
|Robert Abodeely, Ph.D||Pfizer - MTG|
|Harry Handelsman, D.O.||Agency for Health Care Policy and Research|
|James Allen, MD||American Medical Association|
|Peter Katona, Ph.D.||Whitaker Foundation|
|Clement Bezold, Ph.D.||Institute for Alternative Futures|
|Ian H. Leverton, M.D.||Kaiser Permanente|
|Maj. Stephen P. Bruttig, Ph.D.||U.S. Army Medical Research and Materiel Command|
|Barbara McNeil, M.D., Ph.D.||Harvard Medical School|
|Mr. Joseph F. Coates||Coates and Jarrett|
|Mr. Anthony J. Montagnolo||ECRI|
|Mr. Gilbert B. Devey||National Science Foundation|
|Robert M. Nerem, Ph.D.||Georgia Institute of Technology|
|Henry S. Eden, M.D., Ph.D.||National Institutes of Health|
|Charles H. Swanson, Ph.D.||Medtronic, Inc.|
|Don Giddens, Ph.D.||Georgia Institute of Technology and Emory University|
CDRH scientists drafted an initial list of generic technologies having potential significance for new medical devices over the next decade. This list was provided to the expert survey participants, who modified and augmented it. The final version of the questionnaire addressed 21 generic medical device technology areas. (Please see Appendix A).
The goal was to identify primary new or expanding areas in which FDA will need scientific expertise related to medical devices in the next decade. The technology list encompassed a wide range of topics that might influence the development of new medical devices, but there was no presumption that all of the technologies (or examples) covered by this survey will necessarily be regulated by the FDA.
In completing the questionnaire each participant identified significant examples of specific device groups for each generic technology. Expert participants scored the generic technologies and specific device examples with respect to several factors including (1) probability that substantial new developments would lead to new clinical products, (2) probable size of the affected patient population, (3) magnitude of expected benefits and risks, and (4) overall importance for causing significant changes in health care practice. Participants assigned numerical scores for each of these factors on a 5-point scale. Group scores were aggregated by simple averaging for both the generic technologies (Table 1), and for the specific device-groups (Table 2). The combined results were provided to participants before the next stage in the survey.
After the questionnaire results were compiled and distributed a one-hour interview was held with each participant either in person, by videoconference, or by telephone. During the interviews participants were invited to make changes to their original scores, if they wished. Clarifications were solicited regarding the specific examples they had personally provided, and they were queried on the underlying reasons for the scores they had assigned. In addition, they were asked to comment on the aggregated group scores for both the generic technologies and the specific examples. Finally, they were asked to identify and discuss whatever major 'trend-drivers' they expected to affect the development of new medical devices over the next decade. The results of these interviews were combined and provided to each participant before the final workshop stage in the process.
A workshop was held on November 24, 1997 to enable participants to expand and, if necessary, augment the suvey results. Twelve of the fifteen survey participants were present. Several senior CDRH scientific and regulatory managers participated in this workshop, as well.
In an interactive format survey participants reviewed and commented on the final scores resulting from the original questionnaire. They were also asked to discuss the impact that the 'trend drivers' they had collectively identified would have on future trends in medical device development. Discussions included both small group sessions and plenary gatherings. Finally, they were asked to brainstorm any developments that might alter or invalidate the trends they had projected.