APPLIED SCIENCE & ENGINEERING LABORATORIES
duPont Hospital for Children and the University of Delaware
Vol. 2, No. 1 -- Fall 1996
This section features plain-language summaries of technical articles to help bring research into better focus as well as highlight work that concerns consumers directly. This issue we feature "Technology transfer of neuroprosthetic devices" by P. Hunter Peckham, Ph.D.; Geoffrey Thrope, B.S.; Jean Woloszko, M.D., Ph.D.; Robert Habasevich, M.S., P.T.; Marcia Scherer, Ph.D. Carole Kantor, M.S., Journal of Rehabilitation Research and Development, April 1996, Vol 33, No 2, pp 173-183 (13 references)
This article describes the steps required to bring a medical device to market. The authors enumerate five players in this process; researchers, manufacturers, providers, end users and regulators.
The article discusses how each of the players view the process and how each must deal with the other players in order to successfully transfer a technology into general use. It provides some interesting insights into the process.
The manufacturer has the largest role to play in the process and similarly has the most to lose. (Studies have shown that bringing a new spinal or brain drug to market takes, on average, over ten years and cost just under $100 million.)
Manufacturers are therefore often most interested in evolutionary rather than revolutionary technologies. Researchers must also be aware of a corporationís interests and "corporate culture" in order to facilitate the transfer of their technologies.
Regulators are concerned with safe-guarding the public which includes insuring that a device is effective as well as insuring that it is safe to use. Here again an evolutionary device will be more readily accepted. Historical data from similar technologies will make regulators more comfortable when evaluating the potential problems and benefits of a new device and may help the manufacturer avoid excessively long and costly clinical trials.
The device must also gain acceptance in the market place. The end users are obviously consumers, but the authors point out that the doctors, therapists and care providers who will apply the technology should also be viewed as consumers. Their needs and concerns should be addressed in order to make them both willing and able to apply the new device and to help it gain general acceptance.
It is estimated that a third of all assistive technology devices are abandoned. Factors that can contribute to this abandonment vary from inadequate service to better or cheaper alternatives to social stigmas and discomfort with technology. Ultimately, each individual end user applies a subjective assessment as to whether or not a device improves his or her quality of life. The outcomes expressed in this article support that consumer involvement in the design, testing and evaluation is important.
-Reviewed by Arthur W. Joyce, III, Ph.D., Applied Science & Engineering Laboratories