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 leveraged to support regulatory, reimbursement, health technology assessment (HTA), business, and market access decisions for medical devices and diagnostics (MDD). However, generating credible evidence for MDD presents distinct methodological and practical challenges. These include difficulties in identifying devices within secondary data sources, accounting for operator-related influences on outcomes, and addressing continuous device iterations throughout the product lifecycle. High-quality data and carefully designed studies are essential to increase the credibility, acceptance, and impact of RWD and RWE in this space.
This course provides a practical overview of best practices, processes, and methodological approaches to design and execute RWD studies for MDD. Participants will explore how secondary data sources can be used to generate market insights and high-quality evidence to meet the needs of multiple stakeholders across the product lifecycle.
Technical Topics Include:
- The role of RWD and RWE in regulatory, reimbursement, HTA, business, and market access decisions
- Common secondary data sources used in MDD research and their strengths and limitations
- Designing RWD studies across the MDD product lifecycle
- Methods for descriptive analyses and comparative effectiveness research
- Key challenges unique to MDD, including device identification, operator effects, and device iteration
- Strategies to enhance evidence credibility, stakeholder acceptance, and market access success
This Course Includes Tools and Concepts That Can Be Immediately Applied, Including:
- Best practices for designing and executing high-quality RWD studies for MDD
- Practical approaches to generating credible, decision-grade evidence
- Common research questions addressed with secondary data in the MDD space
- Case studies spanning new technologies and follower products
- Real-world strategies to support evidence acceptance and expand market access expansion
PREREQUISITES: Participants should be familiar with general HEOR methods and tools used in MDD, and the general concepts of real-world data and evidence, including the types of healthcare data that is generated as part of routine healthcare.
 | LEVEL: Intermediate |
This short course is offered in-person at the ISPOR 2026 conference. Separate registration is required. Visit the ISPOR 2026 Program page to learn more.
FACULTY MEMBERS
Schedule:
LENGTH: 4 Hours | Course runs 1 day
Sunday, 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.