Advanced Human Factors Engineering Report Writing For FDA Submissions

About this course

This course focuses on how to write an accurate, complete and compelling HFE report. The instructors, who have served as the primary authors of innumerable HFE reports, will review FDA’s requirements against a background of successful reporting efforts. They will share advice on the scope of each of eight major HFE Report sections so that it satisfies the goals of being fully informative but also concise — just the way the FDA seems to like it. The instructors will identify potential reporting pitfalls and ways to avoid them. Additionally, they will point out the importance of conducting the necessary HFE work with an appropriate commitment to excellence as a preamble to writing an excellent HFE report. They will describe why the FDA does not always accept the results presented in an HFE report and how to respond effectively to requests for clarifying information. You will emerge from the course with newfound confidence that you understand what goes into an HFE report writing effort, which has ramifications for how HFE activities are conducted from the start of a project. Finally, the instructors will share some tips on making the reporting effort a satisfying, efficient experience rather than fraught with stress and doubts.

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 writing an HFE report.

Meet the instructors

The instructors, who are co-authors of “Writing Human Factors Plans & Reports for Medical Technology Development,” will walk through considerations, tips and pitfalls that you can leverage to ensure your next HFE report tells a compelling story about how you applied HFE effectively during your product’s development.

Laura Birmingham, managing human factors specialist

Laura Birmingham has been with Emergo by UL’s Human Factors Research & Design team since 2011 and has extensive experience delivering human factors engineering (HFE) services to the medical device and pharmaceutical industries. Laura leads and oversees usability testing throughout the development process, including early-stage formative evaluations and HF validation testing that align with regulatory expectations. Furthermore, she helps clients develop key HFE documents, such as HFE reports, and advises clients on how to apply HFE during product development to meet regulators’ needs. Laura is a co-author of Writing Human Factors Plans & Reports for Medical Technology Development and holds a B.S. in Engineering Psychology from Tufts University.

Michael Wiklund, general manager

Michael is responsible for the direction and quality of human factors consulting services that Emergo by UL provides to its clients. He identifies and develops new market opportunities where his consulting team can effectively apply its expertise, focusing specifically on use-safety, effectiveness, and usability. Historically, he has led projects requiring expertise in user interface research, design, prototyping, and usability testing. Michael delivers university and industry courses on user interface design, publishes books and articles on the subject, and makes technical presentations to industry, academic, and government audiences. He also serves as Professor of the Practice at Tufts University where has taught in the Engineering College’s Human Factors Program for over 30 years. In 2005, he co-founded Wiklund Research & Design, a human factors consulting firm that subsequently was acquired by UL in 2012. Michael was inducted as a Corporate Fellow into UL’s William Henry Merrill Society, which includes members of the UL community who are leading authorities in their fields of expertise, in 2018.