Innovation in medical devices and medical electronics: Are European regulations and practices shifting innovation to europe?

Abstract

A key issue in innovation research is to understand the effects of changes in regulatory practices and incentive systems on how much innovation takes place and where those inventive activities will occur. There is anecdotal evidence, and some empirical evidence, that changes in medical device regulation in Europe may be shifting new product development research, clinical trials and experimentation from North America to Europe. Results from this study indicate that in the field of medical equipment, patents granted to European inventors have increased at a faster rate from 1996 through 2000 than for North American inventors. This reverses the trend found from 1991 through 1995. Organizational learning theory implies that if this trend in growth continues there may be serious consequences in North America for the future of medical device innovation, healthcare implications for patients in need of access to clinical trials of new technology and the loss of the potential benefits for the training of future researchers and physicians in the U.S.

Citation

Robinson, D.F. (2002), "Innovation in medical devices and medical electronics: Are European regulations and practices shifting innovation to europe?", Advances in Health Care Management (Advances in Health Care Management, Vol. 3), Emerald Group Publishing Limited, Leeds, pp. 195-230. https://doi.org/10.1016/S1474-8231(02)03010-0