Case study
End-to-end research program for new drug delivery system
Challenge
A pharmaceutical company planned to bring a new drug delivery system to market. The system included an injector, instructions for use (IFU), training, and packaging. They needed a research program that would inform and support all design elements leading into FDA validation.
Solution
We built and executed a multi-phase research program that started with early iterative design studies and progressed into formal formative studies. Each round of testing built on previous findings, ensuring continuous improvement across all system components.
Impact
By approaching the development holistically, we created a cohesive research narrative that supported every design decision.
Bold Outcomes
- Identified usability issues early and refined the injector, IFU, training, and packaging
- Maintained design continuity across all studies
- Prepared a robust data set that aligned with FDA expectations
Result
We partnered with the manufacturer to submit a robust data set and validation study plan for FDA review and subsequent validation study.