May 17, 2026
Explore how real-world data and evidence can support decision-making across the medical device and diagnostics lifecycle.
Real-world data (RWD) and real-world evidence (RWE) are increasingly used to support regulatory, reimbursement, health technology assessment (HTA), and business decisions for medical devices and diagnostics (MDD). However, generating credible evidence for MDD presents unique challenges, including identifying devices in data sources, accounting for operator-related effects on outcomes, and addressing continuous device iterations. High-quality data and well-designed studies are essential to ensure the credibility and acceptance of RWD and RWE in this space.
Technical Topics Include:
Roles of RWD and RWE in regulatory, reimbursement, HTA, and market access decisions
Secondary data sources commonly used for MDD studies
Designing RWD studies across the medical device and diagnostics product lifecycle
Methods for descriptive analyses and comparative effectiveness research
Challenges unique to MDD, including device identification and operator effects
Strategies to support evidence acceptance and market access
This Course Includes Tools and Concepts That Can Be Immediately Applied, Including:
Best practices for designing and executing RWD studies for MDD
Practical approaches to generating high-quality, credible evidence
Case studies spanning new and follow-on device technologies
Real-world strategies to support evidence acceptance and market access expansion
Participants will gain practical insight into how RWD and RWE can be used to generate meaningful market insights and support evidence-based decision-making for medical devices and diagnostics.
LEVEL: Intermediate
TRACK: Real World Data & Information Systems
This short course is offered in-person at the ISPOR 2026 conference. Separate registration is required. Registration coming soon. Visit the ISPOR 2026 Program page to learn more.
FACULTY MEMBERS
Schedule:
LENGTH: 4 Hours | Course runs 1 day
Tuesday, 17 May 2026 | Course runs 1 Day
ISPOR short courses are designed to enhance knowledge and techniques in core health economics and outcomes research (HEOR) topics as well as emerging trends in the field. Short courses offer 4 or 8 hours of premium scientific education and an electronic course book. Active attendee participation combined with our expert faculty creates an immersive and impactful learning experience. Short courses are not recorded and are only available during the live course presentation.