Grace Gahlon

Medical devices and diagnostics often enter the market with less clinical evidence than pharmaceuticals because regulatory pathways place greater emphasis on technical and analytical performance than on patient outcomes. As a result, a well-recognized evidence gap exists at launch, particularly for payer decision-making, in which demonstration of clinical utility—that is, evidence that a test or device meaningfully alters care pathways or improves patient outcomes—is increasingly required. At the ISPOR 2026 Annual Meeting, a workshop explored how real-world evidence (RWE) can help address this gap when randomized clinical trials are impractical, with a focus on scalable and credible approaches for health technology assessment and reimbursement decision-making.

From a diagnostics perspective, speakers emphasized the importance of evaluating clinical and operational impact within real-world care pathways. Structured collaborations among hospitals, laboratories, and research institutions can facilitate timely evidence generation on how diagnostics influence referral patterns, treatment decisions, and downstream outcomes. For medical devices, methodological innovation using secondary data sources was a central theme. Examples included linking device registration data with claims or electronic health records, integrating registry and clinical trial data with outcomes databases, and using hospital chargemaster data to identify specific products. These approaches can support comparative effectiveness and safety analyses even when device identifiers are incomplete or unavailable.

The discussion of national registries further illustrated how robust data infrastructure can bridge the gap between clinical research and policy decision-making. Registry systems enable continuous, population-level monitoring of utilization, outcomes, and device performance at relatively low cost, supporting high-impact studies without the need for traditional clinical trials.

Overall, the workshop underscored the importance of early, intentional evidence planning and the integration of diverse real-world data sources to generate decision-grade evidence. These strategies have the potential to accelerate patient access to innovative technologies while maintaining methodological rigor and supporting informed reimbursement and policy decisions.

Reference
Boltyenkov AT, Longacre CF, Kyhlstedt M. Closing the Clinical Impact Evidence Gap: Practical RWE Strategies for Medical Devices and Diagnostics Using Registries, Research Partners, and Regulatory Data. Presented at: ISPOR 2026 Annual Meeting; May 17-20, 2026; Philadelphia, PA.