Getting the Most Out of Your Investment in Human Factors Engineering (HFE)

Michael Wiklund of Emergo by UL, will be presenting sobering data about the epidemic of medical device use error and associated deaths. He will speak about the medical device industry’s moral obligation to produce devices that protect against potentially harmful use error. He will also speak about the positive results that can arise from a major investment in HFE, going well beyond ensuring a device’s safe and effective use. Specifically, he will cite why $1 spent on HFE could return $5-$10 of your organization’s money. He will dive deep into why a product with a high-quality user interface can offer many more benefits including fewer product recalls or returns, reduced demand on customer support, simpler instructions, shortened training, good online reviews and enhancements to a company’s reputation (i.e., brand image).

Sep 12, 2019

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Ever since a Quality System Regulation update made in 1996, there has been a mandate to apply human factors engineering (HFE) methods in the course of developing a medical device. Over the ensuing decades, the medical device industry first moved sluggishly and then more hastily to embrace HFE. In the intervening time, HFE became a mandate in the EU and several other regions. Today, it’s fair to say that HFE is standard practice, although the quality of HFE practice varies widely from company to company. Some companies have established robust HFE programs in their pursuit of excellence. Others have taken what can be called a minimally viable approach.


  • Michael Wiklund serves as General Manager of the Human Factors Research & Design practice at UL (Underwriters Laboratories). Previously, he founded Wiklund Research & Design, a human factors consulting firm that UL acquired in 2012. He has over 30 years of experience in human factors engineering, much of which has focused on medical technology development—optimizing hardware and software user interfaces as well as user documentation. He is a Certified Human Factors Specialist and Licensed Professional Engineer. He is author, co-author, or editor of several books on human factors, including Writing Human Factors Test Plans and Reports for Medical technology Development, Usability Testing of Medical Devices, Handbook of Human Factors in Medical Device Design, Medical Device Use Error – Root Cause Analysis, and Writing Human Factors Plans and Reports for Medical Technology Development. He is one of the primary authors of today's most pertinent standards and guidelines on human factors engineering of medical devices: AAMI HE75, IEC 62366-1, and IEC 62366-2. In addition to leading UL's human factors engineering practice that now includes over 60 HFE and user interface design specialists, he is a Professor of the Practice at Tufts University where he teaches graduate courses on HFE, including applying human factors engineering in medical technology development.