Medical technology development and approval: the future is now.

Alvin Toffler, a 20th century philosopher and author of the novel Future Shock once said, “As we move into the 21st century, not only will technology advance, but the rate at which technology advances will increase exponentially.”1 Perhaps those technological advances with greatest relevance to the health and welfare of society involve science and healthcare. Indeed, societal demands for new drug and device design and development have never been greater. Because of advances in medical care, the mortality from cardiovascular diseases has progressively declined over the past 2 decades. We currently stand on the threshold of “cures” for several of mankind’s greatest afflictions, including cancer, atherosclerotic cardiovascular disease, and human immunodeficiency disease.2 Obviously, the time efficiency of providing potentially live saving technologies to society is crucial—lives literally depend on this process. Ideally, benchmarks for safety and efficacy of technology should be satisfied before drug/device availability to assure net clinical benefit. The “gatekeeper” for medical technology is the United States Food and Drug Administration (USFDA), whose charge it is to promote and protect the public health by making safe and effective medical technologies available in a timely manner. Furthermore, in the current era of escalating costs for medical technology, the time required for the development–FDA approval–release process (“time to market”) translates directly into drug/device pricing. In recent years, as cardiovascular specialists, we have been fortunate to be provided with both primary preventative therapies (aspirin, statins, angiotensin-converting enzyme inhibitors, etc) that reduce the prevalence of cardiovascular disease, in addition to exciting new technologies (implantable cardiac defibrillators, cardiac resynchronization therapy, drug-eluting stents, etc) that substantially reduce the morbidity and mortality for those in whom this disease is established. As clinical investigators for new technologies, we are acutely aware of a widening time gap between the availability of US industry-developed technologies in Europe or other countries outside the US and the United States itself. Concern exists that a bureaucratic process should not disadvantage the US public by stifling timely access to new or improved medical technology. Probably no other single topic more effectively aligns the incentives of all interested parties, including the US public, physician investigators, industry, and the USFDA. Close collaboration between physician investigators, industry, and the USFDA is essential to effect enhanced efficiency in the process of device development, USFDA approval, and release, while still maintaining a premium on public safety. Such a collaborative effort is made evident in the current issue of Circulation by Aaron Kaplan, MD, et al,3 who describe in detail the current process by which new medical devices are developed, undergo clinical testing, and are evaluated by the USFDA. In addition, a consensus proposal for improving our current system is provided in the accompanying work by Mehran et al.4