Presentation
Alternative Approaches for Knowledge Task Assessment in Medical Device Research
SessionValidation/Testing (MDD8)
DescriptionIn accordance with FDA guidance, simulated use and knowledge tasks are viewed as distinct, yet critical components of medical device human factors testing. Knowledge task methodology is primarily used to assess safety risks and critical information that is “difficult to ascertain by observing user behavior” (i.e., simulated use). A traditional approach to assessing critical tasks that are difficult to observe through simulated use is to directly ask participants open-ended and neutrally worded questions. This methodology assesses participants' perception and comprehension of the intended information within the instructions-for-use (IFU).
While this knowledge task approach has provided a solid foundation to conduct medical device research, this HFES presentation investigates alternative approaches to knowledge tasks. Approaches outlined in this HFES presentation include but are not limited to alternative coding, effective integration of knowledge tasks within simulated use, and realistic knowledge task context and scenarios. The goal of these approaches is to preserve the natural flow of tasks, ensuring user interaction with limited moderator intervention while enabling a comprehensive evaluation of participant comprehension and decision-making. Furthermore, this presentation investigates the downstream impacts of each approach, particularly focusing on how the research findings and data may be presented in final research reports.
This HFES presentation does not advocate for the elimination of knowledge tasks. Instead, this HFES presentation aims to discuss the various approaches to evaluating knowledge tasks whether it involves a direct line of questioning or better integration within simulated-use testing. This presentation will break down these alternative approaches and provide the risks and benefits, as well as research execution examples informed by FDA feedback and guidance. By presenting our findings and discussing the implications of this approach, the goal is to further the dialogue within the Human Factors Research community and contribute to the ongoing evolution of medical device testing methodologies.
While this knowledge task approach has provided a solid foundation to conduct medical device research, this HFES presentation investigates alternative approaches to knowledge tasks. Approaches outlined in this HFES presentation include but are not limited to alternative coding, effective integration of knowledge tasks within simulated use, and realistic knowledge task context and scenarios. The goal of these approaches is to preserve the natural flow of tasks, ensuring user interaction with limited moderator intervention while enabling a comprehensive evaluation of participant comprehension and decision-making. Furthermore, this presentation investigates the downstream impacts of each approach, particularly focusing on how the research findings and data may be presented in final research reports.
This HFES presentation does not advocate for the elimination of knowledge tasks. Instead, this HFES presentation aims to discuss the various approaches to evaluating knowledge tasks whether it involves a direct line of questioning or better integration within simulated-use testing. This presentation will break down these alternative approaches and provide the risks and benefits, as well as research execution examples informed by FDA feedback and guidance. By presenting our findings and discussing the implications of this approach, the goal is to further the dialogue within the Human Factors Research community and contribute to the ongoing evolution of medical device testing methodologies.
Event Type
Oral Presentations
TimeWednesday, March 279:37am - 10:00am CDT
LocationContinental Ballroom, Lobby Level
Medical and Drug Delivery Devices