Michael Wiklund is a William Merrill Society corporate fellow and the principal consultant with Human Factors Research & Design, where he is a leading authority on human factors. He co-founded Wiklund Research & Design, a human factor consulting firm that UL Solutions acquired in 2012. With over four decades of experience, Michael has been instrumental in advancing human factors engineering for medical devices, focusing on creating safer, more user-friendly designs that meet rigorous regulatory standards. As a Certified Human Factors Professional he has authored several books on medical device usability. He has been a primary contributor to essential industry standards such as AAMI HE75, IEC 62366-1 and IEC TIR 62366-2, shaping practices that elevate patient safety and innovation in healthcare technology. Through his leadership and recognized expertise, Michael helps guide his team’s work with customers worldwide to enhance usability and safety across medical device technologies.
Medical device usability
Michael has set industry standards throughout his distinguished career that make medical devices safer and more intuitive to use. Since his firm’s acquisition by UL Solutions in 2012, he has continued to advance the field as an expert and an ambassador for human factors engineering. Leveraging his background as a Professor of the Practice at Tufts University, he translates fundamental human factors principles into practical design strategies and solutions, helping companies understand the importance of usability across the product life cycle. He helps manufacturers address the challenges posed by evolving regulatory requirements in multiple regions, helping ensure that their products support safe and effective patient care.
Global compliance leadership
Michael has been a key figure in establishing standards that shape human factors engineering in the medical device industry, contributing to foundational guidelines like AAMI HE75, IEC 62366-1 and IEC TIR 62366-2. His expertise helps companies navigate a rapidly changing regulatory landscape in the U.S., European and Asia Pacific regions, supporting them as they balance innovation with compliance. He helps customers address complex regulatory demands and ensure their products are ready for safe and effective use.
“As an ambassador for human factors engineering, I’m committed to guiding companies in applying human factors principles that raise the standards for safety, usability and compliance in medical devices.” – Michael Wiklund
Awards
Connect with Michael Wiklund
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Attributed content
Published books
- “User Interface Requirements for Medical Devices.” CRC Press, 2021
- “Designing for Safe Use: 100 Principles for Making Products Safer.” CRC Press, 2019
- “Medical Device Use Error – Root Cause Analysis.” CRC Press, 2016
- “Usability Testing of Medical Devices, Ed. 2.” CRC Press, 2015
- “Handbook of Human Factors in Medical Device Design.” CRC Press, 2010
- “Designing Usability into Medical Products.” CRC Press, 2004
- “Medical Device and Equipment Design – Usability Engineering and Ergonomics.” CRC Press, 1995
- “Usability in Practice.” Morgan Kaufmann Publishing, 1994