MTI Viewpoints

Insights shared by industry relative to healthcare and the advancement of medical technology.

Simon Mason is president of NEST

The path to bringing medical devices to market is evolving, with real-world evidence (RWE) paving new avenues for more efficient approvals. By utilizing data generated in everyday healthcare settings—such as electronic health records, patient registries, and remote monitoring—RWE is providing a fuller picture of device performance, one that goes beyond traditional clinical trials.

To address the need for integrating real-world evidence (RWE) into medical device evaluation, the FDA and industry stakeholders collaborated to establish the National Evaluation System for health Technology (NEST), creating a framework to enhance regulatory decision-making across the total product life cycle. Our mission is to catalyze the use of RWE to enable life-saving devices to reach approval more quickly and get into the hands of physicians, ultimately benefiting patients. Through frameworks and quality standards, NEST ensures that real-world data (RWD) is robust enough to complement traditional clinical data, creating a more efficient pathway to demonstrate safety and efficacy in real-world settings.

Real-World Evidence: Expanding Possibilities for Approval

Real-world evidence offers unique advantages by broadening the scope of how device performance and safety are assessed. RWD provide insights from diverse, real-life patient scenarios, offering perspectives that traditional trials alone might not capture. By leveraging existing data from healthcare systems, RWE can sometimes reduce the need for additional trials, providing timely, cost-effective support for regulatory submissions and helping life-saving devices reach patients without compromising safety or efficacy.

The NEST Mark is a framework designed to evaluate RWD for ‘fit-for-purpose’ use in regulatory submissions, ensuring that data from clinical practice can effectively address regulatory research questions. Through enhanced cooperation between regulators and industry, NEST uses the NEST Marking process to integrate RWE alongside clinical trials, streamlining the regulatory pathway and potentially reducing approval timelines from years to months. This approach offers substantial cost savings and market advantages, making RWE a viable alternative to traditional trials for medical device companies.

Take Johnson & Johnson’s experience with the Thermocool SmartTouch catheter as an example. Working with NEST, they utilized patient registry data to support the FDA’s expansion of the device’s labeling. Through our guidance, we ensured the RWD were solid enough to demonstrate the catheter’s long-term safety and effectiveness, meeting regulatory expectations while optimizing efficiency. Similarly, Intuitive Surgical collaborated with us to use RWE in support of a labeling change, showcasing the device’s performance over extended use. These kinds of partnerships illustrate how NEST is helping companies make RWE an integral part of their regulatory strategies, using it not just as a supplement but as a core component.

Overcoming Data Quality Challenges with SBARC

To fully leverage RWE, ensuring data quality and consistency is essential. Unlike clinical trial data, which are gathered in controlled conditions, RWD can vary widely in its sources and reliability. At NEST, we address these challenges with our Study-Based Assessment and Rating Criteria (SBARC), a structured approach that evaluates whether RWD meets the quality and relevance standards needed for regulatory submissions.

SBARC gives device developers and regulators a systematic way to assess RWDfor “fit-for-purpose” use. By establishing a clear process for evaluating data quality, we’re reducing uncertainties and helping to create a more predictable, transparent pathway in the FDA review process. We aim to make RWE a viable, trusted source for regulatory decisions, supporting a streamlined review process that benefits both developers, regulators and ultimately patients.

Beyond Compliance: RWE as a Strategic Advantage

Real-world evidence is more than just a compliance tool; it’s also a valuable resource for strategic insights. By integrating RWE early in the development cycle, companies can gain insights into device performance across a range of patient populations and real-world conditions. This approach doesn’t just support regulatory submissions—it also helps identify improvements that can enhance a device’s safety and effectiveness over time.

In a fast-paced healthcare landscape, RWE provides a practical approach to balancing regulatory rigor with the speed needed to bring modern technologies to market. At NEST, we’re committed to helping developers move forward with confidence, knowing their data align with regulatory expectations and meets the needs of both the FDA and the broader healthcare ecosystem.

Building the Future with Real-World Evidence

As more organizations adopt RWE for regulatory submissions, we are helping to build a regulatory system that is adaptive and responsive to modern healthcare needs. At NEST, we’re dedicated to creating a future where real-world data complements traditional evidence, providing a more efficient pathway for device evaluation. Our commitment to integrating real-world evidence into the regulatory landscape is ultimately about advancing patient care—ensuring that innovative, life-saving devices are not just developed, but responsibly brought to those who need them most.