Presentation
Navigating Post-Market Human Factors in High Stakes Medical Device Decisions
SessionPoster Session 2
DescriptionBackground:
Post-market human factors engineering (HFE), the implementation of human factors processes in devices which have already been released to market, poses unique challenges. In addition to the challenges faced in pre-market development such as maximizing usability and safety within a device’s technical constraints, post-market HFE often requires navigating complex trade-offs between usability, safety, and therapeutic urgency. When working with devices that are currently in use, the speed of development is critical to ensure potentially life-saving design changes are implemented as soon as possible. As such, post-market HFE requires unique definition of usability and safety in which the user’s current mental model of the device, time to market, and risk-benefit tradeoffs are considered. This presentation discusses three anonymized examples where HFE played a critical role in supporting safety decisions for a life-saving medical device undergoing updates and post-market scrutiny.
Case 1 – Urgency Over Perfection:
In one instance, the therapeutic urgency of a software update outweighed the need for perfect usability. Despite known user interface limitations observed during HF Validation, including detectability of safety relevant features on the user interface, the benefit-risk analysis supported immediate deployment, with HFE contributing to documentation of residual risk and mitigation strategies.
Case 2 – Alarm Escalation Dilemma:
Another situation involved the redesign of an alarm scheme in an emergency situation that risked inducing either panic or complacency. This redesign was complicated by considerations of the users’ mental model of the current alarm scheme where alarm clarity, urgency, and learnability were sometimes at odds. Here, HFE led multiple rounds of user research and a deeper investigation into user perception and cognitive load, resulting in a redesigned escalation logic and interface that balanced urgency with clarity in the context of the user’s mental model.
Case 3 – Proactive Usability Risk Mitigation During CAPA Investigation:
In the third case, a Corrective and Preventative Action (CAPA) was initiated following a series of user complaints regarding the changing malleability of a critical device component over time. Through rapid contextual inquiry and simulated use testing, the HFE team uncovered root cause, as well as the use environments and use conditions under which replacement would need to occur. Rather than waiting for further adverse events or regulatory scrutiny, the team collaborated with engineering and regulatory stakeholders to design a procedure and tools to safely and effectively replace the component, resulting in successfully preventing any adverse events.
Post-market human factors engineering (HFE), the implementation of human factors processes in devices which have already been released to market, poses unique challenges. In addition to the challenges faced in pre-market development such as maximizing usability and safety within a device’s technical constraints, post-market HFE often requires navigating complex trade-offs between usability, safety, and therapeutic urgency. When working with devices that are currently in use, the speed of development is critical to ensure potentially life-saving design changes are implemented as soon as possible. As such, post-market HFE requires unique definition of usability and safety in which the user’s current mental model of the device, time to market, and risk-benefit tradeoffs are considered. This presentation discusses three anonymized examples where HFE played a critical role in supporting safety decisions for a life-saving medical device undergoing updates and post-market scrutiny.
Case 1 – Urgency Over Perfection:
In one instance, the therapeutic urgency of a software update outweighed the need for perfect usability. Despite known user interface limitations observed during HF Validation, including detectability of safety relevant features on the user interface, the benefit-risk analysis supported immediate deployment, with HFE contributing to documentation of residual risk and mitigation strategies.
Case 2 – Alarm Escalation Dilemma:
Another situation involved the redesign of an alarm scheme in an emergency situation that risked inducing either panic or complacency. This redesign was complicated by considerations of the users’ mental model of the current alarm scheme where alarm clarity, urgency, and learnability were sometimes at odds. Here, HFE led multiple rounds of user research and a deeper investigation into user perception and cognitive load, resulting in a redesigned escalation logic and interface that balanced urgency with clarity in the context of the user’s mental model.
Case 3 – Proactive Usability Risk Mitigation During CAPA Investigation:
In the third case, a Corrective and Preventative Action (CAPA) was initiated following a series of user complaints regarding the changing malleability of a critical device component over time. Through rapid contextual inquiry and simulated use testing, the HFE team uncovered root cause, as well as the use environments and use conditions under which replacement would need to occur. Rather than waiting for further adverse events or regulatory scrutiny, the team collaborated with engineering and regulatory stakeholders to design a procedure and tools to safely and effectively replace the component, resulting in successfully preventing any adverse events.
Event Type
Poster Presentation
TimeTuesday, March 244:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices