On the Global Trial Accelerators podcast, Deborah Morley, co-leader of the RQM+ Cardiovascular Center of Excellence, explains why Class III cardiovascular programs succeed or stall long before a submission. Her case for building evidence around adoption and reimbursement from day one demonstrates the same thinking this webinar applies to biocompatibility and clinical evidence.
What You’ll Learn
- Why Class III cardiovascular programs usually break down before the pivotal trial
- How to design studies that satisfy FDA and CMS evidence requirements together from the start
- When a U.S. early feasibility study (EFS) makes more sense than running first-in-human abroad
- How the EU MDR has changed where cardiovascular first-in-human studies happen
