Streamlining Clinical Evaluation processes across multiple device groups

A large medical device manufacturer had several devices on the market with similar characteristics — yet the clinical evaluations were handled by different teams working in silos, each using its own templates and search approaches. This fragmentation led to duplicated efforts, inconsistent documentation, and unnecessary workload.

To prepare for upcoming submissions, I reviewed the existing documentation across all device lines, grouped the products in a logical structure, and streamlined the templates to ensure consistency and clarity.

I then developed three unified literature search strategies — replacing more than ten previous versions — covering all device-specific terms, competitor technologies, and the relevant standard of care. Together with the core team, we validated this approach in an interactive workshop.

As a result, the effort for the clinical evaluation was significantly reduced. The teams now work together with aligned methods, consistent templates, and more time to focus on meaningful data analysis rather than repetitive copy-paste tasks.