Drug-device Human Factors

A combination product developer sought Chimera’s input into how to incorporate human factors engineering into the development program for a prefilled drug delivery device. Chimera assisted in designing summative design validation studies to assess device usability and the satisfaction of user needs. Chimera worked with the drug and device manufacturers to develop risk analyses, draft Instructions for Use, and to design formative human factors studies and develop risk mitigations which ultimately lead to the conduct of a summative human factors study. Chimera assisted the pharmaceutical manufacturer in selecting a vendor with expertise to conduct the summative study.