Medtech Matters

In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the impact of personalized medicine on the medical device sector. Specifically, we address a number of questions, including:As far as we’re concerned with regard to the medical device industry, what is personalized medicine?For the few devices that have been “personalized” for an individual, how has the FDA handled their approval process?What are the challenges to pursuing personalized medicine given the current regulatory environment as it relates to finished devices?What are the most significant changes that would need to occur within the regulatory environment to enable the review and approval of personalized medicine technologies?What is the impact on the manufacturing side with regard to regulating protocols involved with the development of personalized medicine technologies (for example, additive manufacturing and 3D printing)?There was also reference made to a previous podcast on the topic of regulating the p