Turning Real-World Evidence into Real-World Impact for MedTech Innovators

Join representatives from the FDA and the MedTech industry as they discuss why RWE may no longer be optional and what you need to know to move forward.

As regulatory expectations evolve and market access grows more competitive, leveraging RWE may no longer be optional - it's essential.

Learn how MedTech companies can use RWE to improve product development, regulatory submissions, and post-market strategy.

Whether you're navigating early-stage development or scaling an existing device, you'll walk away with actionable insights on how to integrate RWE into your innovation strategy.

Reserve your spot today and turn real-world data into real-world results.

🎤 Featured Speakers

Julia Ward, Ph.D., M.P.H., Chief Epidemiologist, Office of Clinical Evidence and Analysis, FDA

Rebecca Torguson, M.P.H., Associate Director for Evidence Generation, FDA

Heather Colvin, M.P.H., Senior Director, J&J MedTech

Dawn Heimer, Ph.D., VP of Clinical Research, Corvivo Cardiovascular

Stephan Ogenstad, Ph.D., Biostatistician

Manvi Sharma, Ph.D., R.Ph., M.B.A., M.S., Director, Real-World Evidence at CHEORS powered by BioBridges

✅ Key Takeaways

This panel will offer a comprehensive and practical understanding of how RWD and RWE are evolving and being used across the medical device lifecycle—from development through regulatory decision-making. Participants will gain insights into how industry leaders and FDA experts approach data quality, study design, regulatory fit, and real-world applications. Attendees will leave with actionable strategies to improve FDA engagement, avoid common pitfalls in submissions, and effectively leverage RWE to support innovation and expanded indications.

👥 Who Should Attend

• Regulatory Affairs Professionals
• Clinical and Medical Affairs Teams
• Biostatisticians and Data Scientists
• R&D Leaders and Product Strategists
• Health Economics and Outcomes Research (HEOR) Teams
• Quality and Compliance Professionals
• Startups and Innovators
• Anyone preparing for Breakthrough, STeP, De Novo, or PMA submissions
• Anyone with an interest in RWE in MedTech