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The Role of Physicians in Device Innovation: Critical Success Factor or Conflict of Interest?

The Role of Physicians in Device Innovation: Critical Success Factor or Conflict of Interest?

By
Lawton Burns, Lyn Denend, Stefanos Zenios
2011| Case No. OIT105

As of 2012, the Physician Payments Sunshine Act of 2009 requires medical device manufacturers to track any payments or gifts they make to physicians that are worth more than $10 and then starting in 2013 to report those that exceed a total of $100 per year to any given doctor. While a majority of doctors, academic medical centers, and pharmaceutical and device companies generally support the principle of greater transparency when it comes to physician-industry collaborations, many have raised concerns that over regulating potential conflicts of interest could be detrimental to the development and commercialization of new treatments. Particularly in the medical device industry, physicians play a host of essential roles that span commercialization and, more importantly, product development. Any requirements that negatively affect the willingness or ability of physicians to partner with industry have the potential to hinder medical device innovation because, by its very nature, it is incremental and doctor-dependent.
This note provides a taxonomy of the different roles physicians play in device innovation and identifies which ones are most susceptible to conflicts of interest that may not be well managed by today’s institutions. It also makes recommendations on how to better manage conflicts without jeopardizing the ability of physicians and companies to collaborate for the betterment of patient care.

Keywords
medtech, laws and regulations, innovation, medical devices, conflicts of interest
PDF restricted to the Stanford GSB community.
Faculty Authors
Stefanos   Zenios
Professor, Operations, Information & Technology