Presentation
Deconstructing Complexity: Practical Considerations to Streamline Use-Related Risk Management Tools
SessionPoster Session 2
DescriptionHuman factors engineering plays a pivotal role in the safe and effective use of combination products and drug only products, where interactions between the user and the drug, biologic, and/or device introduce use-related risks. Task analyses, hazard analyses, and use failure mode and effects analyses (uFMEAs) / use-related risk analyses (URRAs) are foundational tools in human factors and risk management to identify tasks necessary to use the product as intended, analyze and estimate use-related risks associated with normal use and reasonably foreseeable misuse, determine risk control measures through the design of the product user interface to reduce risks, and evaluate the effectiveness of risk control measures. However, these tools have a tendency to become overly complex, which may lead to negative consequences downstream, such as unnecessarily complicated and conservative human factors validation studies as well as complex labeling that shifts the focus away from usability and human-centered design, without meaningfully improving the risk profile of the product.
This poster presentation explores strategies to simplify and streamline these foundational human factors risk assessment tools, aligned with regulatory expectations and standards, with the ultimate goal of developing more human-centric products. Through examples drawn from drug delivery systems, such as combination products and drug only products, challenges with developing and using these human factors tools are discussed and potential solutions to address them are presented. Some examples of strategies that will be included are setting reasonable assumptions upfront that scope the risk analysis appropriately and further differentiating between critical vs non-critical aspects of tasks to help inform HF validation study assessments. Human factors practitioners are provided with practical considerations that can improve efficiency of the overall use-related risk management process, streamline identification and assessment of tasks in a human factors validation study, simplify use-related risk evaluations, and enable usability to remain central to product design, among others.
This poster presentation explores strategies to simplify and streamline these foundational human factors risk assessment tools, aligned with regulatory expectations and standards, with the ultimate goal of developing more human-centric products. Through examples drawn from drug delivery systems, such as combination products and drug only products, challenges with developing and using these human factors tools are discussed and potential solutions to address them are presented. Some examples of strategies that will be included are setting reasonable assumptions upfront that scope the risk analysis appropriately and further differentiating between critical vs non-critical aspects of tasks to help inform HF validation study assessments. Human factors practitioners are provided with practical considerations that can improve efficiency of the overall use-related risk management process, streamline identification and assessment of tasks in a human factors validation study, simplify use-related risk evaluations, and enable usability to remain central to product design, among others.
Event Type
Poster Presentation
TimeTuesday, March 244:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices