The Ethics of Innovation in the Medical Device Industry: A Complex Interaction between Multiple Actors and a Search for a Novel Approach

Abstract

Ethics are inexorably linked to innovation and the release of new technology in the medical device industry. This thesis explores the ethical responsibilities of the actors within the industry, and questions the effectiveness of Premarket Notification [510(k)] regulation to adequately and ethically regulate the release of medical devices. Revision or redefinition of 510(k) policy is strongly suggested to properly address concerns of safety and efficacy in the ethical release of innovation to the public.