Human factors, industry trends, and lessons from the field.
A formative study runs $15,000–$35,000 and a summative $40,000–$90,000+. Here's the real 2026 cost structure — facility, recruitment, honoraria, and moderation — line by line.
Read article →Formative testing finds and fixes use problems during development; summative testing proves, with evidence, that the final design is safe. How they differ in purpose, timing, sample size, and rigor.
Read article →FDA expects at least 15 participants per distinct user group for summative validation. Where that number comes from, what counts as a user group, and how to size formative studies.
Read article →The HFE/UE report tells the complete story of your use-safety work. The eight sections FDA expects — from intended users through the final residual-risk conclusion.
Read article →The right facility comes down to five things: observation setup, recording, simulated-use configurability, recruitment integration, and participant logistics. A checklist for evaluating any facility.
Read article →Minnesota is one of the largest medical device hotbeds in the country, yet teams routinely leave the state to recruit specialists and run human factors studies. Here's why — and what we're building to change it.
Read article →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.
Read article →