title: Navigating conflicts of interest for the medical device entrepreneur.
abstract: The past fifty years has witnessed dramatic progress in the understanding and treatment of patients suffering from cardiovascular disease leading to symptomatic relief and impressive increases in longevity. These advances have been due in large part to the development, study and implementation of new technology. Within interventional cardiology in particular, these advances have been driven by the availability of new technology in the form of medical devices. Successful device development efforts require close collaboration among basic scientist, clinician-inventors/entrepreneurs, clinician-investigators and corporations. Though the role of the clinician is central to this process, these activities present important conflicts-of-interest (COIs). The purpose of this paper is to 1) characterize these conflicts, 2) provide a context from which to approach their management and 3) recommend management strategies.
authors.affiliation: Ethics Institute, Dartmouth College (AD) and Cardiology Section Dartmouth Hitchcock Medical Center and the Geisel School of Medicine at Dartmouth (AVK), Lebanon, NH 03756-0001, USA.
authors.forename: Aine
authors.initials: A
authors.lastname: Donovan
authors.forename: Aaron V
authors.initials: AV
authors.lastname: Kaplan
mesh_terms: D016265:Conflict of Interest / Q000331:legislation & jurisprudence*; D030881:Disclosure / Q000941:ethics*; D004864:Equipment and Supplies / Q000592:standards*; D004992:Ethics, Medical; D033161:Government Regulation; D006801:Humans; D016134:Organizational Policy; D010820:Physicians / Q000941:ethics*