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Readying a Medical Device for FDA Approval

Before pursuing the demanding FDA approval process, a global pharmaceutical company wanted to be confident its device worked as anticipated with the intended audience. The company leveraged Mad*Pow’s research capabilities and partnerships to prepare a report that assisted their effort in earning the coveted stamp.

Product Highlights

  • Defined parameters of the necessary study to confirm safe use of the device
  • Designed and implemented user sessions to fulfill FDA requirements
  • Analyzed data and prepared accompanying report for FDA filing

Evaluation of Self-Guided Medical Device Use

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.

Recruitment of Study Participants

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.

Culling the Data

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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Global Pharma Organization
Readying a Medical Device for FDA Approval

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Team
Chris Hass SVP Experience Design   Contact Chris
Dan Berlin VP, Experience Research   Contact Dan
Samantha Louras Experience Strategy Director
Susan Mercer Experience Research Director

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