Understanding the regulatory, P&R and access landscape for medical devices

Our client approached us to map pathways for medical devices used as part of inpatient and ambulatory procedures. Outputs were used to support an internal decision on whether to invest in a drug delivery system for use with a key asset.

CRA Approach

  • Aligned on a framework to provide a general overview of medical device pathways, supplemented with analogue analysis to inform hypotheses about the likely route to market for the device under consideration
  • Secondary research was used to develop a healthcare system stakeholder map and an overview of regulatory, P&R, access and funding processes
  • High level opportunities and risks for the manufacturer were outlined per market

Client Impact

  • Clearly defined medical device pathways across markets, levelling up client knowledge
  • Client plans to use information to inform strategic partnership decision with a medical device company
  • Detail on current landscape highly transferable to other products in the client portfolio, where treatment involves diagnostics or complex administration routes
Countries Involved
  • United States
  • France
  • Italy
  • Germany
  • Japan
  • China
  • Brazil
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