Innovation for Safe and Effective Medical Devices: Contributions From Postmarket Surveillance.

Abstract

Recent years have seen great interest in finding new ways to develop innovative, safe, and effective medical devices. While there has been considerable research on the lead user and open innovation approach, relatively little attention has been given to postmarket surveillance as a valuable source of safety-related information on medical devices. An online questionnaire was sent to 118 postmarket surveillance experts throughout Germany to find out (1) what instruments medical device manufactures use to promote an internal transfer of postmarket surveillance knowledge and (2) to what extent this can lead to impulses for research and development meant to improve or develop new medical devices. Our results showed that technical and human resource-related instruments are of particularly high importance for the intraorganizational transfer of postmarket knowledge. The transfer of this postmarket-related device knowledge can have a positive impact on the improvement or development of (especially incremental) medical device innovations, thus contributing to a company's success and strengthening device-related patient safety at the same time.