Medical devices and conflict of interest: Unique issues and an industry code to address them
Paul A. LaViolette, MBA
Chief Operating Officer, Boston Scientific Corporation, Natick, MA; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed
Correspondence: Paul A. LaViolette, Chief Operating Officer, Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760; email@example.com
Acknowledgment: The author is indebted to two individuals for their contributions to concepts discussed in this article: Donald S. Baim, MD, of Boston Scientific, and Christopher L. White of AdvaMed. Dr. Baim has coauthored a manuscript on this topic entitled “Medical Device Development: A Balanced Approach to Managing Conflicts of Interest Encountered by Physicians,” resulting in part from the 3rd Dartmouth Device Development Symposium (3D3), October 27 and 28, 2005.
Mr. LaViolette reported that he has no financial interests, relationships, or affiliations that pose a potential conflict of interest with this article apart from his employment with Boston Scientific Corp., from which he receives a salary and in which he holds ownership interest.
Development of medical devices requires interaction between physicians and industry that is considerably more intimate than that in pharmaceutical development. Progress in procedure-based medicine would be stalled if this collaboration were eliminated. This degree of interaction, however, creates conflicts of interest that must be managed to avoid compromising trust, credibility, and patient care. AdvaMed, a trade association for the medical device industry, has developed a code of ethics to manage many of these conflicts and to guide its members’ interactions with health care professionals. This article reviews the rationale for the AdvaMed code and provides a brief overview of the code itself.