Advanced Human Factors Validation Testing for Medical Devices

About this course

The instructors will assume that you already know the fundamentals of usability testing, including how to plan, execute, and report the results of an HF validation usability test in accordance with regulators’ guidance and industry standards of care. Therefore, they will focus on advanced topics of concern to test specialists who are under pressure to conduct a proper and hopefully successful HF validation test. The 6-hour course will include lecture material and many exercises, as well as a discussion period to address non-confidential matters of concern to the course participants. During the course, you will gain an enhanced understanding of how to conduct a thorough human factors validation test, and how to run a test that reveals a medical device’s actual use-safety and effectiveness.

Within a 1-month period following the online course, you may schedule a 1-hour, complimentary consultation with the instructors to ask any specific and company-confidential questions about conducting an HF validation test.

Further coaching on how to conduct an HF validation test is available upon request, and priced based on the nature of the support desired.

Meet the instructors

The instructors, who have written books on usability testing, will lead you through discussions and activities that address the many nuances of conducting HF validation tests.

Stephanie Larsen, managing human factors specialist

Stephanie Larsen is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team. She has been with the team since 2012. She has experience delivering (HFE) services to the medical device, pharmaceutical and therapeutic device industries. A board-certified human factors professional, Larsen leads and oversees research activities such as usability testing and expert reviews. Furthermore, she helps clients develop key HFE documents for their design history files, including use-related risk analyses and HFE reports. She is co-author of “Writing Human Factors Plans & Reports for Medical Technology Development.” She holds a B.A. in Psychology and Mathematics from Binghamton University and an M.S. in Human Factors Engineering and Ergonomics from Virginia Tech.

Allison Strochlic, research director

Allison was one of the Emergo by UL, Human Factors Research & Design team’s co-founders in 2005. She has spent her entire career applying human factors engineering principles to medical and pharmaceutical product development. She advises clients on how to apply human factors engineering (HFE) in a manner that meets FDA’s and other regulators’ expectations, including developing program plans and leading key meetings on various HFE topics with regulators. Allison contributes to and oversees a wide range of research and evaluation activities and helps manage the team’s Quality Management System. Allison is a co-author of a book titled Usability Testing of Medical Devices, an author of several technical articles, and is an editor for the Human Factors in Healthcare journal. She frequently delivers conference presentations, leads panels, and presents webinars on various HFE topics. Allison is a Certified Human Factors Professional and holds undergraduate and graduate degrees in human factors from Tufts University and Bentley University, respectively.