May 17, 2022
In March 2022, eight of Emergo by UL’s Human Factors Research & Design (HFR&D) team members attended the annual Human Factors Ergonomics Society (HFES) Health Care Symposium in New Orleans and reconnected with clients and industry colleagues in person for the first time since 2019. Below, we share our key highlights from the event and look ahead to participating in the “virtual edition” of the symposium in early June.
Impacting human factors through digitalization
From using digitalized content to implementing digital tools to developing software as a medical device (SaMD), digitalization has made its way to the forefront of the human factors field. Considering the product end-user’s perspective, Emergo by UL’s Design Director, Cory Costantino, presented on the usability and utility of electronic instructions for use (eIFUs). Throughout Cory’s well-attended presentation, he emphasized the need for designers and developers to make sure that devices containing eIFUs, such as smartphones and tablets, are available when needed at the point of use/care, and that the devices have a sufficient screen size to present information in a clear and effective manner. He also addressed the tradeoffs of incorporating eIFU content into products in various methods, including embedded within the primary user interfaces or as a separate app.
Other presenters also discussed using digital tools to streamline human factors engineering (HFE) activities. One presenter built a system that conducts a heuristic analysis and scores IFUs against HFE guidance and standards across several design categories (e.g., illustrations, writing). Additionally, at the exhibition booth, the Emergo by UL team introduced our new software as a service (SaaS) offering, the OPUS (Optimal Product Usability Suite), to conference attendees and demonstrated how OPUS’ training, tools, and templates can help people working on human factors problems get their work done properly and efficiently.
Evolving FDA expectations at the forefront of discussions
While the US Food and Drug Administration (FDA) presence was relatively light this year due to travel limitations, attendees enthusiastically discussed FDA feedback and how to design and execute, in particular, HF validation tests that meet FDA’s nuanced and evolving expectations. Emergo by UL’s Andrea Dwyer (Associate Research Director) presented a poster about HF validation testing of combination products that led to interesting discussions with many attendees. The sole FDA representative at the event was Dr. Hanniebey Wiyor, a Senior HF Specialist and reviewer with FDA’s Center for Devices and Radiological Health (CDRH), who participated virtually in a panel moderated by Emergo by UL Research Director Allison Strochlic on the topic of conducting usability tests with participant teams. During the panel, Dr. Wiyor stressed the importance of ensuring that participants have experience working together, or have time to meet and establish some rapport, before a test session to reduce potential test artifacts related to communication.
In a very well attended session, Allison Strochlic and four other senior leaders of highly-regarded HFE consultancies shared latest trends in FDA feedback. The panel provided a rare opportunity to hear about a wide cross-section of FDA feedback about various products, and the consultancy leaders shared their interpretations of FDA feedback provided on HFE submissions. Panelists shared their “read” of the current human factors landscape with a focus on the following topics: participant interviewing and debriefing, training, user groups and sample sizes, critical task identification, and threshold analysis and comparative use studies. Panelists recommended pre-submitting HF validation test protocols to FDA for review before conducting tests to align proposed methods with FDA’s evolving expectations.
Revisiting HFE documentation and analyses
To kick off the symposium, Emergo by UL’s Michael Wiklund (General Manager), Erin Davis (Associate Research Director), and Alexandria Trombley (Lead Human Factors Specialist) delivered an engaging, full-day workshop leveraging material from their recently published book titled User Interface Requirements for Medical Devices. During the workshop, they explained how early user research generates deep insights that can be translated into user needs and preferences to provide a strong foundation for user requirements. They also discussed that user interface requirements should be grounded in up-to-date research, human factors science and quantifiable data to keep design teams on track.
Several presentations discussed techniques to improve and streamline HFE analyses and documentation, particularly use-related risk analyses (URRA) for complex devices. During one session comparing URRA and use-related failure modes and effects analysis (uFMEA), the presenter suggested modifying and expanding a uFMEA template to cover the needs of the URRA, creating one master use-related risk management document instead of developing and maintaining two separate documents.
Seeing Emergo by UL’s work in action
A notable highlight for the Emergo by UL team was Dr. Matthew Weinger’s inspiring keynote presentation that traced his personal history as an anesthesiologist working in HFE and medical product development. As part of his speech, he highlighted his work on the Ivenix Infusion System and complemented the Emergo by UL HFR&D team’s contributions to the system, which included designing a sizable portion of the software user interface and conducting multiple rounds of usability tests to help refine and then validate the state-of-the art infusion system.
Looking ahead at what is to come
The 2022 HFES International Healthcare Symposium was abuzz with positive energy that traveled home with the attendees. Reinvigorated to continue sharing our experience on HFE topics, we are looking forward to other upcoming events and presentations, including:
Follow-up virtual edition of the HFES Health Care Symposium from June 7-9, 2022. Erin Davis will deliver a presentation about how digitalization can address challenges faced by HFE practitioners, and Alexandria Trombley will participate in a panel titled The Human Factors of Connected Devices. FDA will also be delivering two workshops – one led by CDRH and one by the CDER (Center for Drug Evaluation and Research) – to share their current HFE-related expectations. Such workshops, which often include presentations as well as opportunities to interact with and ask questions to the agency’s HFE reviewers, are always highly anticipated and well-attended.
OPUS Instructor-Led Training: Advanced Use-Related Risk Analysis
Thursday, May 19, from 9 AM – 12 PM EST
OPUS Instructor-Led Training: Advanced HF Validation Testing
Thursday, May 26, from 9AM – 3 PM EST
HFR&D Webinar: Applying Human Factors Expertise Early in the Medical Product Development Process
Wednesday, June 1, from 11 AM – 12 PM EST
OPUS Instructor-Led Training: Advanced Root Cause Analysis
Friday, June 3, from 9 AM – 12 PM EST
Katelynn Larson is Technical Writer at Emergo by UL's Human Factors Research & Design division.
Additional human factors engineering (HFE) and usability resources:
- Human factors design and prototype development support
- HFE user research for medical devices, IVDs and combination products
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