Design research program for new drug delivery system

This multi-study program of research used a combination of early iterative design studies and later formative studies to refine all elements of the drug delivery system.

Challenge

A pharmaceutical manufacturer sought to bring a new drug delivery system to market. The system included an injector device, instructions for use (IFU), training, and packaging.

Approach

Our learnings from each study in the research program fed into the next, and our cohesive body of research informed all design aspects for the new drug delivery system. 

Outcome

We partnered with the manufacturer to submit a robust data set and validation study plan for FDA review and subsequent validation study.