The pharmaceutical company needed to evaluate whether the intended audience could use the device safely with and without training. The first step involved defining the audience demographics and the study parameters that would yield the needed data.
Our user base included children age eight and older as well as adults, some with the rare medical condition the device treats. Recruitment was not simple, so Mad*Pow leveraged partnerships and secured 65 participants.
Sixty-five user sessions ensured the company met FDA requirements and yielded a rich data set for the necessary FDA usability validation report, authored by Mad*Pow. The pharmaceutical company used this report as part of the Usability Engineering File to submit documentation to the FDA for requested approval to market and sell their medical device in the U.S.
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