Presentation
MDD8 - Early Formative Testing Strategies for User-Driven IFU Development
DescriptionHuman Factors testing is important for the development of Instructions For Use (IFU) because it facilitates data driven IFU updates and guides design changes to eliminate or mitigate use-related hazards identified during product development. Despite efforts to create an effective, user-friendly IFU, usability testing with real device users will almost always uncover needed improvements. Testing the IFU on the intended user population will not only uncover IFU usability issues but will also facilitate a better understanding of real-world use of the IFU and the product. However, it is often the case that IFU related Root Causes (RCs) are discovered late in product development cycle which can make them difficult to reconcile, especially in projects where many of the User Interface (UI) design components are locked in place.
Beyond the "rules" established by FDA's guidance documents and current thinking, there are few (if any) standard guidelines that apply to all labeling studies. Testing and iterating the IFU early and often ensures that usability issues are addressed prior to validation testing. In order to design an effective labeling evaluation protocol, it is imperative to consider aspects such as the user groups and their unique characteristics, the environments and contexts of use, and the critical tasks. To be most effective, IFU-focused testing should incorporate real-world simulated use scenarios in addition to knowledge task questions. This holistic approach helps manufacturers identify and mitigate risks early and enables user-driven optimization of the IFU. We will present formative IFU testing approaches that incorporate:
• Knowledge questions to assess whether users can find and comprehend information provided in the IFU.
• IFU-optional simulated use scenarios to observe whether and how users choose to engage with the IFU and to explore the reasons for their choices.
• IFU-guided simulated use scenarios to assess whether users can follow the IFU easily without use errors or difficulties.
Beyond the "rules" established by FDA's guidance documents and current thinking, there are few (if any) standard guidelines that apply to all labeling studies. Testing and iterating the IFU early and often ensures that usability issues are addressed prior to validation testing. In order to design an effective labeling evaluation protocol, it is imperative to consider aspects such as the user groups and their unique characteristics, the environments and contexts of use, and the critical tasks. To be most effective, IFU-focused testing should incorporate real-world simulated use scenarios in addition to knowledge task questions. This holistic approach helps manufacturers identify and mitigate risks early and enables user-driven optimization of the IFU. We will present formative IFU testing approaches that incorporate:
• Knowledge questions to assess whether users can find and comprehend information provided in the IFU.
• IFU-optional simulated use scenarios to observe whether and how users choose to engage with the IFU and to explore the reasons for their choices.
• IFU-guided simulated use scenarios to assess whether users can follow the IFU easily without use errors or difficulties.
Event Type
Poster Presentation
TimeMonday, March 254:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives