April 5, 2024
By Allison Strochlic and Merrick Kossack
Nearly 20 Emergo HFR&D team members attended the 2024 HFES International Symposium on Human Factors in Health Care. Our team, excited to attend, contributed nine total presentations, including a workshop, panels, posters, and oral presentations. While our team spent the most time in the Medical and Drug Delivery Devices (“MDDD”) track, we sampled presentations and posters from other tracks that were equally as insightful, engaging and thought-provoking.
Below, we describe some of our top takeaways from the symposium:
Diving into HFE and robotics
The inaugural Healthcare Robotics Summit kicked off the symposium. This event drew over 100 attendees dedicated to the application of Human Factors Engineering (HFE) in the research, design, and development of healthcare robotics. The summit included presentations highlighting the latest research as well as various methodologies and tools for innovation in healthcare robotics. Emergo’s Merrick Kossack participated in a panel discussing topics of interest when considering human factors and healthcare robotics, one outcome of which will be a taxonomy of benefits and considerations when designing various robotic systems. The event concluded with a town hall discussion of what future summits might hold, such as participation from healthcare providers and regulatory experts.
(Still) keeping up with FDA expectations
Mirroring a key takeaway of past symposia, manufacturers’ representatives and consultants alike remain eager to keep their “finger on the pulse” of FDA’s evolving expectations. This year’s event included an engaging panel with five consultancy leaders (including Emergo’s Allison Strochlic) reflecting on trends in FDA feedback on various HFE topics, including critical care device alarms, use-related risk analyses, task success criteria and user groups. FDA representatives from the Center for Devices and Radiological Health (CDRH) also presented, sharing expectations for “self-selection assessments” of over-the-counter (OTC) medical devices. The energetic Q&A that followed demonstrated a shared desire among stakeholders for increased alignment in FDA’s expectations and the industry’s understanding, and a strong drive by industry to confirm that FDA expectations can be met in the course of practical HFE activity planning and execution.
Exploring practical ways to apply HFE during generic combination product development
Combination products (i.e., drug delivery devices) also received their due time in the spotlight. In particular, there was a full MDDD track session dedicated to applying HFE during generic combination product development, which featured HFE practitioners, researchers and FDA regulators. These presentations addressed (1) key pitfalls to avoid when designing a generic combination product and (2) refined methods for categorizing differences between a proposed generic product and its Reference Listed Drug. There was also lively discussion regarding how to plan and execute a Comparative Use Human Factors (CUHF) study. The conversation focused on parsing the FDA’s expectations as communicated via direct sponsor correspondence and its 2017 draft guidance that, distinct from other FDA HFE guidance, calls for a detailed statistical analysis plan including non-inferiority testing.
Exploring Artificial Intelligence (AI) applications in HFE
Like in most industries, curiosity and low-level anxiety surrounded discussions of how AI will change our HFE work, as well as the products and systems we help develop. With engaging demos and audience participation, one MDDD track presentation highlighted where ChatGPT can help streamline key HFE activities. The presenters concluded that AI cannot replicate or replace a practitioner’s nuanced knowledge of how to effectively apply HFE, in part due to how easily ChatGPT can offer incomplete or inaccurate responses, but that these new tools might help us perform some tasks more efficiently.
Another presentation discussed designing digital interfaces for products that incorporate generative AI (e.g., radiology or diagnostic software). Users of such products have varying opinions about AI’s industry influence, and they have varying degrees of confidence in AI’s output. Consequently, an interface’s design must build users’ trust in the AI and provide the appropriate level of transparency regarding how AI formulates decisions.
Remembering the power of HFE – throughout the product development lifecycle
While presentations related to HF validation testing and use-related risk analysis topics were as present as ever, presentations demonstrating how HFE concepts and methods can (and, of course, should) be applied throughout the product development lifecycle provided a nice complement. Presentations covered the value that HFE can bring during product conceptualization and down-selection, collecting anthropometric data, establishing user interface requirements, and analyzing and mitigating post-market adverse events. Several presenters recognized that HFEs are not always atop the invite list for the aforementioned activities and encouraged us all to keep our “ears and eyes open” for opportunities to jump into – or organize – multi-disciplinary, collaborative efforts throughout the product development lifecycle.
The future of HFE is bright!
This year’s symposium, as usual, was educational, fun, and engaging. With over 850 attendees, the event provided unmatched opportunities for sharing practical experiences and HFE methods and connecting with colleagues, customers, fellow HFE practitioners, healthcare professionals and students. Please reach out if you have any questions about our team’s presentations or key takeaways. We hope to see you all in Toronto in March 2025 to do it again!
Allison Strochlic is a Senior Research Director at Emergo by UL
Merrick Kossack is a Senior Research Director at Emergo by UL
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