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(Circulation. 2004;109:3078-3080.)
© 2004 American Heart Association, Inc.

Mini-Review: Expert Opinions

Medical Technology Development and Approval

The Future Is Now

Dean J. Kereiakes, MD; James T. Willerson, MD

From the Lindner Center for Research and Education/Ohio Heart Health Center (D.J.K.), Cincinnati, Ohio, and St Luke’s Episcopal Hospital/Texas Heart Institute (J.T.W.), Houston, Tex.

Correspondence to Dean J. Kereiakes, MD, The Lindner Center for Research & Education, 2123 Auburn Ave, Suite 424, Cincinnati, OH 45219 (e-mail lindner@fuse.net) and James T. Willerson, MD, St Luke’s Episcopal Hospital/Texas Heart Institute, 6720 Bertner Ave, Room B524 (MCI-267), Houston, TX 77030–2697 (e-mail suzy.lanier@uth.tmc.edu).

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
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 . . . [Full Text of this Article]

This article has been cited by other articles:

				J. Somberg, W. Laskey, D. Morrison, J. Weinberger, D. J. Kereiakes, A. V. Kaplan, and R. Mehran Letter Regarding Articles by Kereiakes and Willerson, Mehran et al, and Kaplan et al, "Mini-Review: Expert Opinion" * Response Circulation, March 29, 2005; 111(12): e164 - e165. [Full Text] [PDF]