Academic/Industry Challenges for Medical Device Development

Author:

Linehan John H.1,Chaney Ari2

Affiliation:

1. Department of Biomedical Engineering, Northwestern University, Chicago, IL 60611, USA.

2. Biodesign Program, Stanford University, Stanford, CA 94305, USA.

Abstract

A session about the challenges that occur during medical device development was held at a 2010 NIH forum on promoting collaborations among academia, government, and industry.

Publisher

American Association for the Advancement of Science (AAAS)

Subject

General Medicine

Reference11 articles.

1. FDA Web site http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm203018.htm

2. Stage-gate process for the development of medical devices.;Pietzsch J. B.;J. Med. Devices,2009

3. R. Jaffe paper presented at the Transcatheter Cardiovascular Therapeutics Conference the Annual Symposium of the Cardiovascular Research Foundation San Francisco CA 21 to 25 September 2009.

4. FDA Web site http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/default.htm

5. S. Zenios J. Makower P. Yock T. J. Brinton U. N. Kumar L. Denend T. M. Krummel Biodesign: The Process of Innovating Medical Technologies (Cambridge University Press New York 2010).

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