Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the use (or lack of use) of real world evidence. This discussion is a sort of update on the first Mike on Medtech podcast, which offered an introduction to real world evidence. Specifically, we address a number of questions, including:Can you please provide a quick refresher on what real world evidence (RWE) is within the context of the FDA’s world?How was the agency viewing the use of real world evidence for a medical device’s regulatory pathway at the time?What does the actual use of real world evidence look like today?Why hasn’t real world evidence seen the implementation the agency was expecting or hoping to see? What are the challenges?Should medical device manufacturers be using RWE?What are the most important takeaways device manufacturers need to keep in mind with regard to the use of RWE?You can click here to listen to the aforementioned first podcast about real world evidence from 2