Wiklund's Perspective: HFE for Medical Devices

By Michael Wiklund

One day in the late 1990s, Peter Carstensen served as convener at an Association for the Advancement of Medical Instrumentation (AAMI) human factors committee meeting that I attended. Coming from aerospace, where he became well acquainted with human factors, Peter founded and led the first human factors team at the US Food and Drug Administration (FDA). Peter and his FDA colleague Dick Sawyer had recently visited my organization’s usability testing lab (along with a few others’) to learn how we conducted usability tests of medical devices. Subsequently, FDA released its guidance on applying HF to medical devices, including human factors validation testing (i.e., summative usability testing) to support device applications (e.g., 510(k)s and Premarket Approvals (PMAs].  

During the AAMI meeting, Peter spoke of slow progress at getting the medical industry to recognize the importance of HF in assuring medical device safety and effectiveness, even after FDA released its landmark guidance. I recall him saying that he and his human factors-focused colleagues at the agency were happy – I’m paraphrasing here – if a medical device company even knew the term human factors. Indeed, it took a while for the guidance released in 1996 to drive change within the medical industry. But eventually change occurred, driven by FDA pushback on some 510(k) and PMA submissions due to the lack of sound human factors work. It was also driven by companies “discovering” human factors as a way to boost the commercial success of their products. As such, the medical industry was catching up to other industries (e.g., consumer products, software) that already took fuller advantage of human factors.    

Today, human factors is fairly ubiquitous; part of every medical device company’s vocabulary and possibly the name of an internal department or group within your organization. After the FDA initially called upon manufacturers to apply human factors rigorously while developing a medical device, implementation varied across companies from energetic to disregard. Then, as mentioned above, the negligent ones faced regulatory impasses and learned that human factors should be applied early and throughout the development process. About a decade after FDA first guided manufacturers to apply human factors, IEC standard 60601-1-6 (later transformed into IEC 62366) compelled manufacturers in the European Union and beyond to do the same. As a result, human factors is now a worldwide phenomenon in the medical device industry, and by extension to combination products, the pharmaceutical industry. 

In early June, our human factors team will deliver a Webinar on global human factors requirements, with emphasis on new developments in China and Japan. Emergo by UL’s webinar will recap progress in the US and the European Union (EU). Audience members will also hear how the human factors phenomenon has now spread into and is evolving in the Asia Pacific region. Emergo by UL team members based in Japan and China will share details about their countries’ human factors expectations based on published information and their own experiences supporting clients.  

More information about our global webinar will be available on May 29, 2023. This page will be updated to display the corresponding registration link. Until then, please check out our upcoming and on-demand webinars.  

Michael Wiklund is Leader, Life Science Industry Practice at Emergo by UL.