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
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: Suggested Citation