"In the past, FDA approval was 80% of the focus and reimbursement was 20%. I'd say those priorities are closer to equal today. The reimbursement piece of this has become more and more important and also more challenging. You really have two customers. You have FDA, and you have CMS, which has a different perspective. It truly goes hand in hand.”
Dr. Eric Fain is an MD with a passion for #medtech. His #medicaldevices career began when he joined Ventritex. Over the next 30 years, and through the company’s acquisition by St. Jude Medical, Eric has held a number of leadership roles and eventually became Group President through St. Jude’s exit to Abbott.
He’s now the CEO of Procyrion, Inc., a startup developing Aortix, an advanced percutaneous mechanical circulatory support device for patients with heart and renal failure.
In this Medsider interview, Eric and Scott Nelson discuss:
☕ Craft a compelling narrative for investors early on, focusing on your unique value proposition and growth strategy. Prioritize spending on essentials and consider outsourcing non-core functions to conserve resources to extend your runway.
💼 Put yourself in the acquirer’s shoes. Build robust clinical evidence and establish a strong quality management system to derisk your startup and enhance scalability and value.
🎯 Define your target market early to inform regulatory and reimbursement strategies. Address coverage challenges early on and engage CMS. Explore partnerships with private payers for both learning and clinical trial opportunities.
Check out the full interview link in the comments.
This Medsider episode was brought to you by FastWave Medical, a hot IVL startup in the cardiovascular space. Don’t miss out on their next fundraise (more details in the comments).
P.S. - We just launched Medsider Mentors Volume V, which is packed with insights and learnings from founders and CEOs of some of the most dynamic medical device and health technology startups in the world. Click the link in the comment section for this latest edition now available exclusively to our premium members.
Field Clinical Engineer- Clinical Trials Engineering Duty Officer US Navy - Reserves
3wGreat Job Dr Wu and team!!!