Insights

Human factors, industry trends, and lessons from the field.

What Changed in FDA's 2026 Human Factors Guidance Revision (And What Didn't)FDA revised the human factors guidance in August 2026, the first time since 2016. Appendix A is deleted and Section 9 now defers to the Content guidance — but Section 8.1.1's participant requirements are unchanged. What moved, what didn't, and what it means for study planning. How Much Does a Medical Device Usability Study Cost? (2026 Breakdown)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. Formative vs. Summative Usability Testing: What's the Difference and When Do You Need Each?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. How Many Participants Do You Need for a Usability Study? FDA Sample Size RequirementsFDA 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. What Goes in an FDA Human Factors Engineering Report (HFE/UE Documentation Guide)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. How to Choose a Usability Testing Facility: A Checklist for Human Factors TeamsThe right facility comes down to five things: observation setup, recording, simulated-use configurability, recruitment integration, and participant logistics. A checklist for evaluating any facility. You Shouldn't Have to Leave Minnesota to Run Your StudyMinnesota 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. How to Plan a Summative Usability Study for FDA SubmissionWhat 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. The Complete Guide to IEC 62366-1 for Medical Device TeamsWhat the standard requires, how it translates into practical study planning, and what your facility and recruitment setup needs to support it. How to Recruit Healthcare Professionals for Usability StudiesHow to recruit physicians, nurses, and clinical staff for medical device usability studies. Covers screener design, sourcing, FDA blinding requirements, no-show rates, and incentives. Home Use Medical Devices: The 7 Human Factors Mistakes That Tank FDA SubmissionsThe 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. 3 Common Human Factors Mistakes in Medical Device DevelopmentAfter 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. Designing for Home Users: The Human Factors Challenge of Direct-to-Patient Medical DevicesDevices 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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