Understanding medical device regulations, P&R, and access landscape

Our client approached us to map a medical device regulatory pathway 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 regulations and 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 medical device regulations, P&R, access, and funding processes. 
  • High-level opportunities and risks for the manufacturer were outlined per market. 

Client Impact 

  • Clearly defined medical device regulatory pathways across markets, leveling 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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