Real-world evidence (RWE) captured during the testing phase for medical devices and during the post-approval period helps key stakeholders understand the clinical outcomes that can be achieved by using a particular device—including by population. RWE also offers important opportunities to ensure medical devices are used safely and effectively and, per the FDA Center for Devices and Radiological Health, informs decision-making by regulatory agencies, promoting more timely access to devices. That’s one reason why reliance on RWE for regulatory decisions has increased in recent years and why the market for this data is expanding.
For device manufacturers, registry data holds strong potential to assist providers in making the case for approval of devices and their long-term use. Typically, registries include data from hundreds of thousands of procedures as well as information captured during follow-up visits. The level of granularity of the data—including device identifiers—provides detailed information around device performance for the procedures captured within a given registry. It also offers a basis for evidence-based standards of care that reduce complications and costs.
Here are four areas where device manufacturers can strengthen value by partnering with a registry to gather real-world evidence for evaluation of medical devices.
Use of a registry to assist with post-approval surveillance enables device manufacturers to meet FDA standards for surveillance. It also results in post-approval studies and label-expansion projects that are faster (with 45% to 71% more rapid enrollment), higher in quality (more representative subjects), and more cost effective (143% return on investment, compared with industry average) than post-approval studies performed without incorporating registry data, according to one recent study. That’s because registries draw data from an organized network of healthcare organizations across the U.S. and other countries. Partnering with a registry for post-approval surveillance offers the ability to easily add customized variables or follow-up time points for specific device-evaluation projects.
Expanding use of a device beyond the population for which it was originally intended requires robust clinical data. For instance, some vascular device manufacturers have found success in expanding indications for off-label device usage by supplementing registry data with the additional data elements required. In doing so, one analysis found that the total time required to deliver the data needed for label expansion was less than the time it likely would have taken manufacturers to enroll patients in a study and perform the necessary follow-up.
Supporting EU MDR Approval
In recent years, both the U.S. and the EU have begun to recognize the value of RWE in evaluating medical devices—and not just before devices are released. Long-term medical device approval is increasingly contingent on RWE submitted to clinical registries after the device has been more broadly used in the market. By leveraging a clinical registry, device manufacturers can more effectively create EU MDR reports—including blinded comparison with similar device types—to support device approval.
Evidence Development for Reimbursement
There are early indications that the Centers for Medicare & Medicaid Services (CMS) is making health system reimbursement for specific procedures contingent on the submission of real-world data (RWD) to a medical device registry to track the effectiveness of the device across populations and use cases. “[CMS] has incorporated some use of RWE to design value-based models for Medicare and state Medicaid programs,” according to McDermott+Consulting.
CMS has also acknowledged the importance of RWE in determining whether a medical product demonstrates “substantial clinical improvement” compared with other products—a factor that could be used to determine whether a device qualifies for temporary value-based add-on payments under Medicare. Clinical registry data provides a strong basis of RWE for new device comparison that could support value-based reimbursement. It also meets CMS requirements for evidence development.
By working in partnership with a clinical registry to gather RWE, device manufacturers can more effectively gain access to high-quality data that supports regulatory decisions and value-based reimbursement. They can also reduce the time and administrative effort associated with collecting this data, increasing efficiency while decreasing costs. It’s an approach that provides value for manufacturers and improves access to medical devices for patients.