Presentation
MDD21 - Methodology for HF Evaluation of Digital Instructions for Combination Products
SessionPoster Session 2
DescriptionThis poster reviews the opportunities presented by digital instructions and proposes methods for evaluating their effectiveness and influence.
The regulatory landscape mandates that combination products are provided with clear and comprehensive instructions for use (IFU), usually provided in paper format. However, industry professionals acknowledge that use errors often occur in simulated-use studies when participants rely on their intuition and prior experience with similar devices when using these products for the first time. By leveraging digital formats (such as online interactive guides, mobile applications and video tutorials), key information can be made more accessible and engaging, potentially reducing use and compliance error.
Developing effective methods to evaluate the effectiveness of digital instructions alongside traditional paper formats is essential. The impact of simultaneously presented instruction formats, and translating traditional IFU validation methods to online formats presents challenges for HF professionals to consider.
The regulatory landscape mandates that combination products are provided with clear and comprehensive instructions for use (IFU), usually provided in paper format. However, industry professionals acknowledge that use errors often occur in simulated-use studies when participants rely on their intuition and prior experience with similar devices when using these products for the first time. By leveraging digital formats (such as online interactive guides, mobile applications and video tutorials), key information can be made more accessible and engaging, potentially reducing use and compliance error.
Developing effective methods to evaluate the effectiveness of digital instructions alongside traditional paper formats is essential. The impact of simultaneously presented instruction formats, and translating traditional IFU validation methods to online formats presents challenges for HF professionals to consider.
Event Type
Poster Presentation
TimeTuesday, April 14:45pm - 6:15pm EDT
LocationFrontenac Foyer