Date & Time
Jul 26, 2023 10:00am EST
In this webinar, Emergo by UL’s human factors experts will review the US Food and Drug Administration’s (FDA) latest expectations for knowledge tasks. Knowledge tasks serve to assess users’ understanding of important use-related information, often located within a product’s labeling, including the instructions for use (IFU) and packaging. They will explore the intricacies of developing and administering knowledge tasks, with a focus on a two-phase knowledge task approach.
During usability test sessions, knowledge tasks follow hands-on use scenarios and should be used especially when critical tasks cannot be evaluated effectively during such hands-on participant–product interactions. Knowledge tasks are typically included within human factors (HF) validation tests, though they can — and often should — be included within formative usability tests as well.
Although the purpose of knowledge tasks is clear, it can prove challenging to design and implement knowledge tasks that meet all of the FDA’s current expectations. In this webinar, our presenters will provide practical guidance on knowledge task design and administration based on their extensive experience conducting hundreds of usability test sessions involving knowledge tasks.
Webinar attendees will come away with a deepened understanding of topics including:
- The broad purpose of knowledge tasks
- The FDA’s formal guidance and informally communicated expectations regarding knowledge tasks
- The design, administration and analysis of knowledge tasks in a two-phased approach
- Key considerations to facilitate effective critical task evaluation via knowledge tasks
Andrea Dwyer, associate research director — HFR&D
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 HF 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 composes HFE project plans and 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. She frequently conducts workshops, speaks at industry events and advises customers 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 Bachelor of Science in human factors and a Master of Science in engineering management, both from Tufts University.
Laura Birmingham, associate research director — HFR&D
Laura Birmingham is an associate research director with Emergo by UL’s Human Factors team. She has been with the team since 2011 and has extensive experience delivering HFE services to the medical device, pharmaceutical and laboratory equipment industries. Laura leads and oversees usability testing throughout the development process, including early-stage formative evaluations through HF validation testing that aligns with regulatory expectations. Furthermore, she helps customers develop key HFE documents, such as HFE reports, and advises customers on how to apply HFE during product development to meet regulators’ expectations. Laura is a co-author of “Writing Human Factors Plans and Reports for Medical Technology Development” and holds a Bachelor of Science in engineering psychology from Tufts University.
THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.