Presentation
Knowledge Task Questions: Best Practices for Complex Medical Systems
SessionPoster Session 2
DescriptionWhen conducting human factors engineering and usability testing of complex medical devices, knowledge task questions play a pivotal role in assessing user comprehension of critical safety information. These tasks are designed to evaluate how well users understand labeling, instructions, and warnings—elements essential for safe and effective device operation. Our poster will outline best practices for implementing knowledge task questions for complex medical devices during formative and validation testing.
Key recommendations include:
Timing of Assessment: Knowledge tasks should be administered either after simulated-use scenarios or integrated within them to capture both observational and cognitive insights. The choice depends on study goals and regulatory alignment.
Setup Strategies: Use either direct setups—where participants refer to labeling to answer questions—or indirect setups that assess recall and interpretation without immediate reference. Direct setups are ideal for evaluating labeling clarity; indirect setups test retention and real-world applicability.
Question Design: Questions must target high-risk use scenarios, focusing on warnings, contraindications, and operational limits. They should be clear, unambiguous, and tailored to the device’s user population.
Metrics and Analysis: Responses should be coded for accuracy, rationale, and information navigation. Trends in misunderstanding can inform design revisions and risk mitigation strategies.
Key recommendations include:
Timing of Assessment: Knowledge tasks should be administered either after simulated-use scenarios or integrated within them to capture both observational and cognitive insights. The choice depends on study goals and regulatory alignment.
Setup Strategies: Use either direct setups—where participants refer to labeling to answer questions—or indirect setups that assess recall and interpretation without immediate reference. Direct setups are ideal for evaluating labeling clarity; indirect setups test retention and real-world applicability.
Question Design: Questions must target high-risk use scenarios, focusing on warnings, contraindications, and operational limits. They should be clear, unambiguous, and tailored to the device’s user population.
Metrics and Analysis: Responses should be coded for accuracy, rationale, and information navigation. Trends in misunderstanding can inform design revisions and risk mitigation strategies.
Event Type
Poster Presentation
TimeTuesday, March 244:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices