1) differing evidentiary requirements for medical devices versus pharmaceuticals

2) the critical importance of patient-focused drug development

3) strategies for getting buy-in to invest in real-world evidence generation.

Chantal explains the historical divide between the evidentiary burdens for drugs versus devices is narrowing as innovative companies push the boundaries. The role of real-world evidence is becoming increasingly vital - not just for post-market surveillance, but to help define the problem that needs solving and guide the entire clinical development journey.

Chantal emphasizes that RWE data is critical not just for regulatory approvals, but for convincing payers and patients of a product's value in the real world. She shares insights on how leading companies are building the business case and narrative around building real-world evidence as this strategic imperative.

Overall, this conversation offers a nuanced, forward-looking perspective on the evolving evidence standards shaping the biotech and medtech industries. Chantal's expert insights and the relatable style make this a must-listen episode for anyone seeking to understand the changing landscape and stay ahead of the curve.

If you'd like to discuss how you might apply these learnings to your own context, contact us now.