Evidence Assessment for a Digital Medical Technology

stethoscope on a digital board

Evidence Assessment for a Digital Medical Technology

VALUE TO CLIENT

The client was able to use our summary report to make strategic decisions about additional evidence generation and to refine their approach to market access in the UK.

OPPORTUNITY 

Our client’s digital diagnostic technology had previously undergone a health technology assessment by the National Institute for Health and Care Excellence (NICE) in the United Kingdom and was not recommended for use based on insufficient clinical evidence. 

CHALLENGE 

The client’s digital diagnostic technology was in a busy disease area with multiple guidelines. This made differentiating their product and demonstrating benefit difficult with the available evidence. 

APPROACH 

  • We assembled a team of HEOR and medical technology experts to review the client’s data. Our team included researchers who have worked at NICE on the development of Medtech Innovation Briefings and NICE guidance on medical devices, diagnostics, and digital technologies. 
  • Our team reviewed clinical data on the technology that had not previously been assessed by NICE and evaluated its relevance in meeting NICEs evidence recommendations to trigger a review of the guidance. Our review included the client’s unpublished evidence as well as protocols for future evidence generation. 
  • We developed a summary report that included information on existing evidence gaps, the likelihood that the data assessed would facilitate a change to the current NICE guidance recommendations – and potentially lead to a positive recommendation – and advice on next steps.