Improvisation in implantable medical devices: A gordian knot

0 ver the past two decades, the practice of medicine has been revolutionized by the introduction of a whole variety of diagnostic and therapeutic devices. The rapid pace of these technologic advances, however, has ,placed a burden on government agencies charged with evaluating the safety and efficacy of these products before their approval for commercial use. So severe have bureaucratic delays become that physicians now lind themselves caught in an ever-worsening regulatory gridlock that severely limits their access to cutting-edge medical technology. lj2 In the current issue of the Journal, the report by Ip et al3 serves as a case study of the kind of improvisations some physicians are pursuing in order to provide