Technology transfer of neuroprosthetic devices.
Despite long development periods for neuroprosthetic devices, the numbers in clinical use or clinical trials are rising, with an estimated 3,000 systems in use today. As they gain experience with the regulatory approval process, developers are learning to conduct research to best prepare for transfer of technology to industry. The track record of the first motor prosthesis to be approved by the United States Food and Drug Administration contains important lessons for a company planning to undergo the regulatory process. Throughout the development of a neuroprosthesis, the capabilities and preferences of the customers who will use it (physicians, surgeons, therapists, and end-users) should be sought out and used in device design. When a device has reached clinical application, particular attention is needed to maximize both the population who will use it and each individual's degree of use (optimal, partial, reluctant). Identification of person-technology mismatches can help to select training strategies and other interventions that can be applied to ensure a good rehabilitation outcome.
Peckham
P H
PH
VA Cleveland FES Center, Cleveland VA Medical Center, OH 44106-3052, USA.
Thrope
G
G
Woloszko
J
J
Habasevich
R
R
Scherer
M
M
Kantor
C
C
D002986:Clinical Trials as Topic; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004599:Electric Stimulation Therapy / Q000295:instrumentation*; D004869:Equipment Safety; D017408:Guidelines as Topic; D006801:Humans; D013677:Medical Laboratory Science / Q000331:legislation & jurisprudence*; D019736:Prostheses and Implants; D014481:United States; D014486:United States Food and Drug Administration