Innovation and Invention in Medical Devices Workshop Summary (2001) / Chapter Skim
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6 Summary and Conclusions
6 Summary and Conclusions
Pages 69-70
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From page 69... ...
A myriad of changes are occurring in the device development and approval process, including the use of computers, e-mail, teleconferencing and the internet; high- throughput screening, rational drug design, bioengineering and miniaturization; more concern about special populations, including children, the elderly, and women; and greater access to products at their investigational stage. The medical device life cycle is not a simple, linear progression from basic to applied research, to development, to marketing.
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From page 70... ...
The device industry must be more proactive in approaching HCFA early on in the process. There are a number of ways in which the regulatory process for devices is improving, including the use of advisory groups, either in public forums or in private sessions; streamlining the process, particularly with respect to secondand third-generation devices; expedited reviews for breakthrough, highly beneficial innovations; early interactions and consultations on new, high-impact products; reducing burdens on companies with an excellent track record; increased access, particularly for smaller companies; facilitating access to and coordination with NIH and HCFA; and better coordination within FDA with respect to combination products.
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