Human factors, industry trends, and lessons from the field.
What it takes to plan a summative human factors validation study: defining user groups, recruiting participants, selecting a facility, writing the protocol, and documenting results for FDA.
Read article →What the standard requires, how it translates into practical study planning, and what your facility and recruitment setup needs to support it.
Read article →How to recruit physicians, nurses, and clinical staff for medical device usability studies. Covers screener design, sourcing, FDA blinding requirements, no-show rates, and incentives.
Read article →The FDA estimates that use error contributes to thousands of medical device adverse events annually. For home-use devices, that number climbs even higher. Here are the seven most common mistakes that derail submissions.
Read article →After working with dozens of medical device companies, we see the same mistakes repeatedly. Starting testing too late, testing with the wrong users, and underestimating use environment complexity.
Read article →Devices that once required trained clinical staff are now being designed for use by patients in their own homes. This shift creates a profound human factors challenge.
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