A new vision has emerged in the field of medical implants-that of being able to design whole organs based on a comprehensive scientific understanding of materials and their interactions with the body. Progress in advanced materials characterization and rational synthesis, combined with molecular advances in understanding biological responses, has set the stage for an ultrastructural basis for biomaterials and implant design.
An estimated 11 million people in the United States have medical implants, attesting to the importance and value of implants in both saving and improving the quality of lives. In the great majority of cases, implants have been successful in achieving the performance for which they were designed.
Despite this success, the nation is on the brink of losing its leadership position in the biomaterials field and in the associated $40-50 billion per year medical device industry. Progress toward reaching our vision is threatened by the current fragmented approach to funding research in this area, and the resulting absence of integration of efforts among the biological, health, and material sciences. In order to counteract liability issues, the whole enterprise must be more firmly based in science and technology. This can be accomplished by determining realistic risk-benefit as- sessments of individual implants as well as realistic expectations for the performance and safety of medical devices.
Responding to the scientific opportunities and public concerns in this area, the National Institutes of Health (NIH) convened a 2-day workshop October 16 and 17,1995, bringing together more than 100 univer-*Editor's Note: This report is an edited version of the full report. Copies of the full report and reprints of the edited report may be obtained from John T.