Keywords Medicaldevices .Regulatorybarriers .Regulatorycosts .Comparativeeffectiveness1 Introduction“How wonderful that we have met with a paradox.Now we have some hope of making progress.”—NielsBohr [1]The medical technology industry in the early twenty-firstcentury is marked by a puzzling paradox. The industry hascontributed to decades of life-saving innovations: the intro-duction of technologies like the implantable cardioverterdefibrillator, radiofrequency catheter ablation for cardiacarrhythmias, and cardiac resynchronization therapy, andwe have witnessed remarkable reductions in mortality andmorbidity due to cardiovascular disease [2, 3]. Nevertheless,we are simultaneously witnessing escalating concerns frompoliticians, the plaintiff’s bar, the general public, physicians,researchers, and patients over whether our technologiestruly are safe and effective [4–6]. Behind this paradox liesanother, more subtle paradox: a vigorously innovative med-ical technology industry requires strong and complex under-pinnings, but there is a growing sense that overlyburdensome and complex regulations threaten to choke offcontinued innovation. Our intent is to explore this paradox,by expressing the authors opinions based on their medicaldevice industry viewpoint, focusing on three areas of con-cern: the threat posed by a globally discordant patchwork ofdifferent regulatory approaches and standards, the threatposed by a particularly burdensome regulatory processwith-in the USA, and the implications of inappropriate use ofcomparative effectiveness with respect to medical devices.2 The global environment for innovation: regulatorydiscord or harmonyThe requirements to introduce new medical devices can varydramatically around the world. For example—consider thedifferences between the USA and the European Union. Inthe USA, the foundations of the regulatory requirements formedical products are defined statutorily in the Federal Food,Drug and Cosmetic Act and implemented in the Code ofFederalRegulations[7].Perthisconstruct,higherriskdevices(e.g., U.S. Class II and Class III) may only enter the USmarket after they have been demonstrated to provide a rea-sonable assurance of safety and effectiveness for the intendeduse in the labeled intended patient population. In contrast,under the European regulatory framework, manufacturersmust establish the safety and performance of the proposeddevice—a subtly different standard (Council Directive93/42/EEC) [8]. Furthermore, despite the similarity in thenomenclatures used for classification in the USA and theEU, the criteria used to classify, and thus identify those devi-ces which must meet higher premarket thresholds, are quitedifferent in these two regions. The net result of both thesefactors can be dramatically different requirements to placenew medical technologies into the market for use withpatients. There are two very different (and valid) perspectives