Medical device development: Managing conflicts of interest encountered by physicians

Abstract

New technologies introduced over the past three decades have transformed medical diagnosis and treatment, and significantly improved patient outcomes. These changes have been mediated by the introduction of new medical devices, particularly for the treatment of cardiovascular, orthopedic, and ophthalmic disorders. These devices, in turn, have created large markets and spawned a burgeoning medical device industry, including six Fortune 500 companies whose combined market capitalization now exceeds 400 billion dollars. This success story, which has unquestionably benefited patients and society alike, has been dependent upon an intense collaboration among industry, clinicians, and regulatory authorities. However, when physicians actively involved in patient care participate in such collaborations, they are increasingly vulnerable to creating potential conflicts between these two (clinical and device development) roles. Such conflicts, which may ultimately erode public trust, have important consequences not only for the individual physicians, but also for their parent institutions, their patients, sponsoring companies, and the entire clinical research enterprise that makes the development and introduction of new devices possible. The third Dartmouth Device Development Symposium held in October 2005 brought together thought leaders within the medical device community, including academicians, clinical investigators, regulators from the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS), large and small device manufacturers and the financial (venture capital and investment banks) community. The Symposium examined the conflicts of interest encountered during the early development and commercialization of a medical device. The goal of these discussions was to (1) identify and characterize the conflicts that arise and (2) provide strategies to address these conflicts. This manuscript was prepared by a writing committee to provide a summary report of those discussions.