Article

How to handle payer engagement after receiving 510(k) regulatory clearance from the FDA

Market access for medtech companies

Jan. 12, 2022 · Authored by John FinanKeith Needham

Some companies can find success without their medical devices receiving payer coverage, but more often than not, receipt of payer coverage is not only a key to financial success, but also the key to prolonged market access success.  

The pathway to payer coverage is one that demands clinical safety and utility, economic outcomes and RWE-backed product value propositions. Each pillar is crucial for payers to effectively understand the true benefits and risks associated with the device. Additionally, medical technology (medtech) companies increasingly need to engage in value-based care (VBC) agreements as a pathway to strengthen their product access and utilization.  

VBC arrangements enable a more advanced partnership approach with payer that can lead to more market share if the technology performs as expected. These arrangements may also allow medtech companies to gain more direct access to their target physician audience and gain an affinity for the true clinical value associated with its use. There is financial risk involved with this approach, although it provides an opportunity for devices to “prove” their utility and gain expanded coverage by payers. Therefore, it’s critical for medtech companies to initiate a payer engagement strategy as soon as 510(k) clearance is gained and once real-world evidence (RWE) is available.  

A payer engagement strategy should not only focus on identifying specific payers, but it should be informed by the existing coverage decisions and treatment guidelines, as well as involve the development of payer-specific value propositions. Because the success of payer engagement strategies is heavily dependent on which payers are selected, the importance of payer profiling cannot be underestimated.