Many of you may have read Part 1 in our series on Understanding Costs And Risks For HFE Usability Studies, which discussed the factors that device development teams should consider when executing HFE studies internally. We recently published the second article in this series, which discusses how to optimize data quality while controlling for study costs and time constraints when employing an independent HFE testing agency.

The goal of a device development team should be to obtain the highest quality data possible, given budgetary and time constraints. High-quality data is a non-negotiable requirement for HFE testing because device development teams need it to make critical design decisions or even consider submission for FDA review and approval. Thus, teams must evaluate whether a given HFE testing agency will deliver high-quality data at the price proffered in a formal bid. Such evaluation involves two questions: whether the independent agency is capable of delivering quality data, and whether the agency’s proposed study design is based on a robust understanding of HFE best practices.

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