Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the passage of MDUFA IV and the changes that are associated with it. Further, we discuss the potential impact this law will have on medical device innovation. In an era of politicians calling for greater healthcare technology and a reduction of healthcare costs, stagnating innovation in medtech seems to be counterintuitive to this demand; unfortunately, that’s exactly what MDUFA IV could do. This law could adversely impact the design and development of medical devices based on companies seeking to avoid the increased fees. Examples of companies changing their product submission strategy are also shared. Specifically, the following questions are addressed:This is the fourth version of MDUFA, which has been around for quite some time now. Why is this latest version significant?What are the significant changes in this version of MDUFA ?What about those companies who are currently in the submissi