The Annals of Thoracic Surgery, Vol 29, 331-335, Copyright © 1980 by The Society of Thoracic Surgeons
Medical device development: innovation versus regulation
AL Kaganov
Innovation in the development of medical devices has been an important
factor in the practive of health care in the United States. However, in a
climate of increasing federal regulation, concern is expressed that such
regulation can inhibit scientific creativity in the medical device
industry. Several examples of the impact of increasing regulation in the
discovery and development of new drugs are presented. Increasing regulation
will divert research dollars from discovery efforts to regulatory
maintenance. Surgeons can participate in the regulatory process by
informing the public and the government on issues regarding safety and
effectiveness of medical devices.