Bold Insight is proud to announce that Managing Partner Korey Johnson and Director Kaitlin Stinson have contributed to the newly released ANSI/AAMI HE75:2025 Human Factors Engineering—Design of Medical Devices, the first major update to this foundational standard in more than fifteen years.

Published by the AAMI Human Factors Engineering Working Group, the updated HE75 spans over 500 pages of guidance covering device design, usability, safety, workflow fit, and accessibility. It reflects the growing complexity of medical technology, the increased integration of digital interfaces, and the critical need for products that support safe and effective use across diverse patient and clinician populations.

With this release, AAMI highlights the standard’s expanded focus on accessibility. This strengthened guidance underscores the industry’s commitment to equitable, human-centered medical device design.

“We are honored to have played our small part to advance a standard that shapes how safer, more inclusive medical devices come to market,” said Johnson. “HE75 remains one of the most important resources for aligning design decisions with the realities of clinical use. I would also like to extend my thanks to my colleagues and friends on the committee, many of whom made much more significant contributions than myself, and especially Molly Story and MaryBeth Privatera for their significant efforts as Co-Chairs of the committee through this entire process.”

Johnson and Stinson supported the refinement of human factors recommendations that help manufacturers understand user needs, mitigate use-related risks, and align device design and documentation to regulatory expectations. Their contributions draw from Bold Insight’s two decades of experience conducting formative and validation studies, usability evaluations, IFU and labeling assessments, workflow analyses, and risk-linked evidence generation in clinical, home, and simulated-use environments.

The full ANSI/AAMI HE75:2025 standard is available through the AAMI Store: https://my.aami.org/store

To learn more about Bold Insight’s human factors and medical device research expertise, visit: https://boldinsight.com/services/human-factors-research