As with every aspect of clinical research, the cost of post-market surveillance and other post approval studies is rising fast – and in some cases, exceeds projected revenues. Generating and applying real-world evidence (RWE) early in the device development cycle is one way to reduce the costs and delays associated with post-marketing requirements.
RWE is derived from real world data (RWD), which includes data from sources such as electronic health records, registries, and pharmacy and insurance records. Devices are especially good candidates for early RWE use since evidence collected in the context of actual patient care from previously approved versions or similar devices often can be used to supplement findings from clinical trials of the latest version in development.
Integrating RWE and clinical trial evidence into an ongoing life cycle management strategy can greatly lessen the demand for, and cost of, post-market research. When developed to directly address known payer and regulator needs, RWE can demonstrate the practical value of medical products even before they are approved.
In this first of two blogs, we will examine why post-marketing costs are rising so quickly, and how starting RWD collection early in the device development cycle can reduce post-market delays and save money. Our second blog will assess current and future opportunities for gathering RWD and developing it into compelling RWE that supports earlier approval and coverage decisions that maximise device portfolio value.