At confinis we recently had several conversations with clients about leveraging Real World Data (#RWD) to generate clinical evidence for medical devices.  

In some circumstances, Real-World Evidence (#RWE) offer the opportunity to answer broader questions than traditional clinical trials. They can provide a more inclusive perspective of safety and effectiveness and better reflect the actual benefits of a device when integrated in complex healthcare workflows.  

Although RWE generation initiatives can be seen as an alternative to costly and resource-intense traditional trials, manufacturers should not underestimate: 

  • the efforts needed to ensure the right relevance; 
  • data quality; 
  • and bias consideration.  

Moreover, RWE might not be appropriate for every scope, particularly when interacting with regulatory authorities.  

Although still a draft, the FDA guidance (Use of Real-World Evidence for Medical Devices ) released in December 2023 provides extremely valuable insights into the expectations of regulators when it comes to the use of RWE in support of medical devices decision-making.  

Among other important concepts, three elements of the guidance are worth mentioning: 

  • it identifies the requirements to support the evidence relevance and reliability; 
  • it provides recommendations on the content of relevant submission to authorities;  
  • it shares some examples of the appropriate use of RWE.  

Have you already used or are you planning to use RWE to demonstrate the safety and effectiveness of your device?  

Our clinical team can best support your RWD regulatory strategy and review your RWD initiatives. Get in touch!  

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