Health care policy and regulatory implications on medical device innovations: a cardiac rhythm medical device industry perspective.

摘要

"How wonderful that we have met with a paradox. Now we have some hope of making progress."—Niels Bohr [1]The medical technology industry in the early twenty-first century is marked by a puzzling paradox. The industry has contributed to decades of life-saving innovations: the introduction of technologies like the implantable cardioverter defibrillator, radiofrequency catheter ablation for cardiac arrhythmias, and cardiac resynchronization therapy, and we have witnessed remarkable reductions in mortality and morbidity due to cardiovascular disease [2, 3]. Nevertheless, we are simultaneously witnessing escalating concerns from politicians, the plaintiff's bar, the general public, physicians, researchers, and patients over whether our technologies truly are safe and effective [4-6], Behind this paradox lies another, more subtle paradox: a vigorously innovative medical technology industry requires strong and complex underpinnings, but there is a growing sense that overly burdensome and complex regulations threaten to choke off continued innovation.