Two Important Customers — FDA and CMS: Interview with Procyrion CEO Dr. Eric Fain

This podcast episode explores the challenges and importance of reimbursement in the medical device industry. It emphasizes the need for startups to develop a compelling story and strong relationships with investors. The significance of robust clinical evidence, a well-developed quality management system, and addressing coverage challenges early on are also highlighted. The episode features an interview with Dr. Eric Fain, CEO of Procyrion, discussing the development of a percutaneous mechanical circulatory support pump technology for the treatment of acute decompensated heart failure. The conversation covers engineering challenges, fundraising, and navigating the regulatory landscape. The importance of clinical data, reimbursement, and the Medicare patient population are also discussed. Overall, the episode provides insights into the challenges and strategies involved in bringing innovative medical technologies to market.