Medical Devices: Lost in Regulation (Perspectives) (Company Overview)
The implanted medical device industry was founded in the United States and has been a major economic success and the source of numerous life-saving and life-improving technologies. In the 1950s and 1960s, technological innovations such as the cardiac pacemaker and prosthetic heart valve meant that thousands of suffering Americans had access to treatment options where none had existed before. And because so many breakthrough devices were developed in the United States, the nation’s citizens usually had timely access to the latest technological advances. In addition, U.S. physicians were at the forefront of new and improved treatments because they were working alongside industry in the highly dynamic innovation process. In fact, they rose to worldwide preeminence because of their pioneering work on a progression of breakthrough medical therapies. But that was then. Although the United States is still home to numerous medical device companies, these companies no longer bring cutting-edge innovations to U.S. patients first. And U.S. clinical researchers now often find themselves merely validating the pioneering work that is increasingly being done in Europe and elsewhere in the world. Worse still, seriously ill patients in the United States are now among the last in the world to receive medical innovations that have secured regulatory approval and clinical acceptance elsewhere in the developed world.