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.
