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Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House

Image courtesy of MedDeviceOnline


Executing HFE studies internally is often far more complex and time-consuming than drug delivery device development teams realize. MUS recently published part one of a two-part article detailing the factors that need to be considered by device development teams in order to produce high-quality usability testing data appropriate for decision-making and HFE optimization while maximizing cost-effectiveness.

The U.S. Food and Drug Administration (FDA) is increasing demands[i],[ii] for drug delivery device developers to demonstrate the human factors engineering (HFE) effectiveness of their devices and related labeling systems. Therefore, rigorous HFE usability testing is required to ensure a given medical device meets HFE standards prior to submission for FDA approval.

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Keep an eye out for part two of this series in which we will describe in detail how device development teams can best understand and manage the costs of high-quality usability testing, should they decide to retain an independent testing agency.

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