Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a relatively new FDA regulatory review option—the Breakthrough Designation Program. Do you have questions about this program, how it impacts the device review process, what types of products are accepted, or other inquires? If so, this podcast is perfect as Mike explains a variety of factors that would impact a company’s decision as to whether the program is right for their product. Specifically, the following questions are addressed:What is the breakthrough designation program?How does a manufacturer apply for breakthrough designation?Why are nearly half of breakthrough designation applications rejected and what should be done to avoid that?What are the options for a company if its breakthrough designation application is rejected?Are there non-regulatory advantages of obtaining breakthrough designation, such as public relations, fund-raising, etc.?As mentioned during the podcast, further inf