Academic/industry challenges for medical device development

Science Translational Medicine

Volumn 2, Issue 63, 2010, Pages

  Linehan, John H ^a   Chaney, Ari ^b  

^a Northwestern University   (United States)

^b STANFORD UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOENGINEERING; BIOMEDICAL TECHNOLOGY ASSESSMENT; COMMERCIAL PHENOMENA; COMMUNICATION SKILL; CONFERENCE PAPER; CONSENSUS DEVELOPMENT; CULTURAL FACTOR; EDUCATION PROGRAM; FEASIBILITY STUDY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE NEED; INTERNET; MEDICAL INSTRUMENTATION; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; TRANSLATIONAL RESEARCH; APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; INDUSTRY;

EQUIPMENT AND SUPPLIES; INDUSTRY; TRANSLATIONAL RESEARCH;

EID: 78650630318     PISSN: 19466234     EISSN: 19466242     Source Type: Journal    
DOI: 10.1126/scitranslmed.3001631     Document Type: Conference Paper

References (12)

1. FDA Web site, http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHTransparency/ucm203018.htm
2. J. B. Pietzsch, L. A. Shluzas, M. E. Paté-Cornell, P. G. Yock, J. H. Linehan, Stage-gate process for the development of medical devices. J. Med. Devices 3, 021004-1-021004-15 (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).
6. University of California, San Diego's von Liebig Institute, http://www.vonliebig.ucsd.edu/
7. University of Kansas' Institute for Advancing Medical Innovation, http://www2.kumc.edu/iami/poc-rfp.html
8. Massachusetts Institute of Technology's Deshpande Center, http://web.mit.edu/deshpandecenter/
9. Northwestern University's Center for Translational Innovation, http://www.nucats.northwestern. edu/centers/cti/index.html
10. Stanford University's Biodesign Program, http://innovation.stanford.edu/ bdn/index.jsp
11. InnoCentive, http://www.innocentive.com
12. Acknowledgments: We would like to express our appreciation to D. J. McCloskey (NCRR) for her excellent service to the workshop as scribe and consultant to this paper.