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The Cost of Innovation Roles of Industry, Regulatory Agencies, and the Clinician

Friedlaender, Gary E., MD

doi: 10.1097/BTO.0000000000000287

New knowledge and innovative technology have provided exciting potential improvement in clinical outcomes, but come with increasing costs, challenges in assessing their safety and efficacy as well as the need to carefully define guidelines for their successful applications. Industry plays a major role, along with individual scientists and clinicians, in providing the research and product development required to bring new products to the market. The Federal government, specifically, the Food and Drug Administration in the United States, must carefully evaluate these products in a manner that protects the public from harm while, simultaneously, providing a pathway for the timely availability of potentially beneficial health care products. Clinicians partner with industry and the regulatory authorities to innovate and evaluate new opportunities in health care, and they must also be strong conflict-free advocates for their patients in the proper selection and skillful application of these new and, often, costly technologies.

Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, New Haven, CT

The author declares that there is nothing to disclose relevant to this manuscript or its preparation, including financial support from any source, consultant arrangements, or any board or institutional positions.

For reprint requests, or additional information and guidance on the techniques described in the article, please contact Gary E. Friedlaender, MD, at or by mail at Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, P.O. Box 208071, New Haven, CT 06520-8071. You may inquire whether the author will agree to phone conferences and/or visits regarding these techniques.

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