Members Forum: Building Better Device Evidence

As regulatory expectations continue to evolve, medical device organizations need evidence strategies that extend beyond traditional electronic health records. This session explores how integrated, longitudinal real-world data can support regulatory submissions, post-market commitments, clinical research, and label expansion while enabling stronger collaboration across regulatory, clinical, medical affairs, and HEOR teams.

Key Takeaways

• Move beyond single-source EHR data to integrated, longitudinal datasets that connect clinical context, device utilization, outcomes, and cost.
• Learn how regulatory-ready real-world evidence can support PMA/510(k) submissions, post-market commitments, clinical trials, and label expansions.
• Explore how integrated data can uncover meaningful insights while supporting a unified, lifecycle evidence strategy.

Presented by:

Myla Maloney, MBA, BCMAS Chief Growth Officer Premier Applied Sciences

Real-world evidence can support far more than post-market surveillance. This session examines how fit-for-purpose study design, high-quality data, and regulatory expectations can be leveraged to generate evidence across the entire medical device lifecycle—from pre-market planning and trial optimization to post-market studies and reimbursement. Practical case studies will demonstrate how organizations can maximize the value of their real-world evidence investments.

Key Takeaways

• Explore how real-world evidence supports pre-market, post-market, and reimbursement objectives across the product lifecycle.
• Understand FDA and EU expectations for generating valid, robust, and fit-for-purpose real-world evidence.
• Learn through practical case studies how a single evidence strategy can support multiple business and regulatory objectives.

Presented By:

Amelia Hufford, PhD Senior Vice President, Clinical and Regulatory Science Co-founder, 3Aware