Human Factors in a Multi-Component World: Use-Related Risk Analysis, Validation, and Related Regulatory Considerations for System of Systems
TimeWednesday, April 143:30pm - 4:30pm EDT
LocationMedical and Drug Delivery Devices
DescriptionThe authors propose to lead and participate in a panel comprising of six Human Factors (HF) experts (panelists listed below), including a Senior representative from the FDA and specialists in the medical device industry, to discuss topics related to medical devices that operate within a continuous integrated system of systems (SoS) framework.
An SoS might be comprised of multiple components intended to be used only within that specific system, such as is the case with a single manufacturer’s robot-assisted surgical system that includes various compatible tools and accessories. Or, a device might be designed to interface with a range of medical devices and accessories produced by the same or other manufacturers, to provide emergent functionality. Some systems might include components and accessories that are developed and submitted to FDA concurrently, while other systems might include components and accessories that are already FDA-approved, or components that have yet to be developed.
System components range widely and might include hardware elements, desktop and/or mobile software user interfaces (including Software As a Medical Device, or SaMD products), and disposables or other ancillaries.
The panelists will draw upon their expertise and vast professional experience to present case studies, answer prepared “seed” questions, and answer ad-hoc audience questions related to the following three key themes:
1. Use-related risk management. Sample topics include:
a. Accurately evaluating and documenting risks transference between sub-systems. For example, cases in which a risk might originate through the use of one component, but be mitigated via the user interface of another component.
b. Recognizing emergent risks, i.e., risks that emerge when one or more sub-systems, which when used individually could not lead to harm, can lead to harm when used in combination.
c. Accounting for component-level malfunctions or data integrity issues. While traditionally not considered in the use-related risk analysis for single component systems, in SoS, these component-level malfunctions or data integrity issues can, if undetected by the user, lead to system-level use-related risk.
2. HF Validation. Sample topics include:
a. Classifying system- and component-level critical tasks that are in versus out of scope, given the above topics related to system-level risk management, and designing representative use scenarios while respecting scope boundaries.
b. Scoping the HF validation test method and associated data collection and analysis activities related to different system components, and handling data related to system components that are already marketed and/or manufactured by a third party.
c. Performing root cause and residual risk analyses of use errors and other issues, at system-wide and component levels.
3. Submission strategy and documentation. Sample topics induce:
a. Defining the boundaries HFE activities and documentation, noting that various HFE aspects (e.g., use-related risk analysis, usability test findings) might relate to marketed devices, third-party components (for which design history documentation might not be available), or future, yet-to-be developed components.
b. Defining a framework to guide submission strategy decisions. For example, when should a manufacturer consider submitting a full system (with all components) versus smaller component or partial systems for regulatory clearance?
If this proposal is accepted, the following individuals have confirmed they will participate in the panel:
Sami Durrani, Ph.D - Head of Human Factors, Eli Lilly & Company
Allison Strochlic - Research Director, Emergo by UL’s HFR&D team
Hanniebey Wiyor, Ph.D - Senior Human Factors Specialist, US FDA – CDRH
Leah Swanson - Senior Principal Human Factors Engineer, Baxter Healthcare
Kevin M. Ten Brink - Principal Human Factors Engineer - Robotics & Digital Solutions, Johnson & Johnson
Sabine Kipp, Ph.D - Director Program Application Management at Fresenius Medical Care