A Practical Guide to Navigating the Medical Device Industry: Advice from Experts in Industry, Law, Intellectual Property and Academia

The Food and Drug Law Institute Monograph Series, Vol. 2, No. 4, 2011

95 Pages Posted: 3 Jun 2011

See all articles by Joanna Brougher

Joanna Brougher

Harvard University - T.H. Chan School of Public Health

Michael M. Gaba

Holland & Knight LLP

Mark E. Deem

The Foundry, LLC

Roseann B. Termini

Widener University Delaware Law School

Kalah Auchincloss

affiliation not provided to SSRN

Date Written: May 23, 2011

Abstract

The United States is a global leader in the development of innovative medical devices that improve patient care and reduce long term healthcare costs. The changing political and economic climate, however, presents challenges for the domestic medical device industry. These challenges include, for instance, the new healthcare reform bill and medical device tax, patent reform, potential changes to the premarket review process and an increased focus on post-market surveillance. As a result of these challenges, many technologies fail to reach the market as industry participants struggle to develop and commercialize their products.

This monograph will provide a comprehensive look at the various challenges faced by the medical device industry and will explore cutting-edge solutions that promote innovation from the legal, patent, regulatory, industrial and academic fields. After understanding the issues presented from the various fields, industry participants will be better prepared to develop and implement strategies for overcoming obstacles faced by medical devices in today's challenging political and economic climate.

Keywords: medical devices, regulation, healthare law, intellectual property, healthcare reform, patents

JEL Classification: K23, K32

Suggested Citation

Brougher, Joanna and Gaba, Michael M. and Deem, Mark E. and Termini, Roseann B. and Auchincloss, Kalah, A Practical Guide to Navigating the Medical Device Industry: Advice from Experts in Industry, Law, Intellectual Property and Academia (May 23, 2011). The Food and Drug Law Institute Monograph Series, Vol. 2, No. 4, 2011, Available at SSRN: https://ssrn.com/abstract=1850887

Joanna Brougher

Harvard University - T.H. Chan School of Public Health ( email )

677 Huntington Avenue
Boston, MA MA 02115
United States

Michael M. Gaba

Holland & Knight LLP ( email )

50 California Street
San Francisco, CA
United States

Mark E. Deem

The Foundry, LLC ( email )

199 Jefferson Drive
Menlo Park, CA 94025
United States

Roseann B. Termini (Contact Author)

Widener University Delaware Law School ( email )

4601 Concord Pike
Wilmington, DE 19803-0406
United States

Kalah Auchincloss

affiliation not provided to SSRN ( email )

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