About This Monograph
Prior to 2012, FDLI published the FDLI Monograph Series, which consisted of six monographs annually. We now publish 4 to 6 Primers each year.
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.
After reading this Monograph, you will be better able to:
- Understand challenges faced by medical device industry and the evolving investment strategies that are emerging to address such challenges.
- Develop a strategy to help navigate a product through FDA regulatory challenges to approval.
- Identify legal issues in the assignment of intellectual property rights in the medical device industry.
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