Bridging the Real-World Evidence Gap in MedTech A practitioner’s guide to applying real-world data in regulatory strategy.
Why Real-World Evidence Matters Regulators are increasingly open to real-world evidence (RWE) as a foundation for market entry, indication expansion, and post-market surveillance. Both the FDA and EU regulators recognize that randomized controlled trials alone can be overly burdensome and alone capture the realities of device use in everyday clinical practice. Real-world evidence offers manu-facturers a path to demonstrate ongoing safety, performance, and value without defaulting to costly or impractical studies. The opportunity is clear but leveraging real-world evidence effectively requires a strong grasp of the data sources, their strengths, and their limitations.
Defining the Basics: RWD vs. RWE Real-world data (RWD) is information on patient health or healthcare delivery that is routinely collected in clinical practice. This includes data from medical records, claims, registries, surveys, and digitally connected devices. Real-world evidence (RWE) is what happens when this data is systematically analyzed to evaluate safety, performance, and other outcomes of interest. The distinction is subtle yet important. Data alone is not sufficient—its transformation into evidence is what regulators use to support decisions.
Where RWE Fits in Regulatory Strategy RWE is most commonly applied to confirm safety and performance in the post-market phase as it is being used in standard care. Its potential, however, extends much further. It can support the expansion of indications when physicians pioneer new uses in practice, provided manufacturers are prepared to capture and analyze that data. It can also be applied to initial submissions in new regions, as long as differences in demographics, clinical practice, and standards of care are recognized and justified. In addition, RWE drawn from equivalent or similar devices can be used to benchmark performance or strengthen the design of a clinical investigation. The value is clear: RWE creates regulatory flexibility when applied strategically.
by Bethany Chung Ph.D. RAC Principal, Clinical and Post-Market Practice, RQM+
bchung@rqmplus.com
Methods Use of RWE is not new to regulatory submissions. Historically, this evidence has been captured by retrospective chart reviews, registries and claims data. Traditional retrospective chart reviews generate patient-level data but are limited to what is recorded during routine care, registries provide long-standing, regulator-accepted evidence but often lack device-specific linkage or complete follow-up, and claims data offers large, structured datasets but rarely captures outcomes. More innovative approaches, such as survey-based chart reviews, allow healthcare providers to supply patient-level insights alongside reports of their own experience with the device. Comprehensive electronic health record datasets allow sponsors to see longitudinal outcomes across integrated systems, though linkage and access to unstructured notes remain challenges. Finally, the growing presence of wearables and connected devices allows for the creation of continuous streams of information, including patient-reported outcomes, that manufacturers can leverage with the proper consent.
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