Integrating Human Factors Usability Testing Into Clinical Studies

Human factor usability testing performed only during clinical testing does not adequately fulfill FDA’s HFE & U reporting requirements for validating that the product design-user interface is reasonably safe and effective for the intended users, uses and use environments.

Distinct differences in the objective and thus methodology of clinical testing versus HF testing can present challenges to integrating HFU testing into clinical studies.

One potential advantage of integrating HFU testing methods into clinical evaluations is that outcomes from the study may be more typical of what may be expected for both product safety and therapeutic performance/efficacy in the real world.

There are viable opportunities to integrate HFU testing with early, exploratory clinical studies of all types of combination products to inform product design and development prior to design freeze and pivotal clinical trials.

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