Best Practices for Engaging with the US FDA on Human Factors Strategy

Engaging with the U.S. Food and Drug Administration (FDA) on your human factors engineering (HFE) strategy is an important step toward achieving a successful medical product submission and subsequent U.S. market access.

In this on-demand webinar, the presenters share best practices related to engaging with the FDA regarding the HFE work planned and performed during product development. The presenters reflect on decades of relevant experience, share case studies and present actionable advice on making FDA interactions more productive and insightful. The presenters also share what to expect during each key phase of FDA interaction and the current topics in focus for the FDA’s HFE reviews.

About the presenters

Allison Strochlic, M.S., Senior Research Director  

Allison Strochlic 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 and other regulators’ expectations, including developing program plans and leading key meetings on various HFE topics with regulators. Strochlic contributes to and oversees a wide range of research and evaluation activities and helps manage the team’s quality management system. Strochlic is a co-author of a book titled “Usability Testing of Medical Devices,” an author of several technical articles and an editor for the Human Factors in Healthcare journal. She frequently delivers conference presentations, leads panels and presents webinars on various HFE topics. Strochlic is a Certified Human Factors Professional and holds undergraduate and graduate degrees in human factors from Tufts University and Bentley University, respectively.  

Andrea Dwyer, M.S., Associate Research Director – Human Factors  

Andrea Dwyer is an Associate Research Director with Emergo by UL’s Human Factors team. She has been with the team since 2010. A board-certified human factors professional, Andrea leads and oversees research activities required to meet regulators’ expectations for applying human factors engineering (HFE) during medical and drug delivery device development. She helps medical device and pharmaceutical manufacturers develop key HFE documents for their design history files, including authoritative HFE reports and comprehensive use-related risk analyses, and guides clients in engaging with the FDA on clients’ HFE strategies. She frequently conducts workshops, speaks at industry events and advises clients on how to implement HFE in the medical device development process. Andrea is a co-author of Medical Device Use Error – Root Cause Analysis. She holds a B.S. in Human Factors and an M.S. in Engineering Management, both from Tufts University.