16 Apr 2024 Human Factors and Ergonomics Society (HFES) Symposium Takeaways
“If you’re not a user, end patient, caregiver, etc. today, someday you will be.”
Melissa Lemke, a Senior Principal Human Factors Engineer at Kymanox, delivered this impactful quote last month at the 2024 HFES International Symposium on Human Factors in Health Care. She was one of several HF engineers, alongside designers, researchers, and FDA representatives who gather annually at the symposium to share practical experiences and the latest methods for practicing human factors engineering in health care. I had the opportunity to attend this year for a day, where I listened to presentations and a discussion panel in the Medical and Drug Delivery Devices track. Below are some of my top takeaways.
Leveraging the Power of HFE
Many presenters spoke about the benefits of involving human factors engineering (HFE) in the entire product development lifecycle. One presentation, in particular, highlighted a common misconception held by both those outside and inside the field: that HFE is limited to use testing and use-related risk analyses. However, HF experts can (and should) be involved in so much more of the process. HFE is critical while developing product requirements, generating concepts and down-selecting, creating early prototypes, and managing risk. Especially in the early stages of the product development process, when many times there might not be much user data, an HF practitioner can serve as a proxy for the user and advocate on their behalf. An HF perspective guarantees user needs are not forgotten in stages where it can be common that technical or cost perspectives drive decisions. Investing in HFE early on is an investment in shortening the product development cycle.
Navigating Generic Combination Products
Applying HFE to generic combination product development (i.e. drug delivery devices) was the hot topic of the day, with an entire track dedicated to the subject. Presentations focused on methods for categorizing differences between a proposed generic combination product, categorizing differences between a proposed generic product and its Reference Listed Drug (RLD), and how to plan and execute a Comparative Use Human Factors (CUHF) study. Of particular interest was the summary of a recent FDA-funded project where researchers developed a visual and language-based ‘User Interface (UI) Taxonomy’. Individual cards were created for each interface element and sorted under either a ‘labeling’ or ‘interaction points’ tree. While it is currently in spreadsheet form, researchers plan to eventually develop it into a flexible web-based tool. This could be a game-changer in medical device design and validation by providing a common UI language to be used between different stakeholders (academia, HF experts, FDA, sponsors, product designers, manufacturers, etc.).
Exploring AI Applications in HFE
The most engaging presentation demonstrated AI’s ability to streamline key HFE activities, along with some of its pitfalls. Presenters shared a series of live demos where they asked ChatGPT to write a use-related risk analysis, list user needs, and translate them into a product requirements table. While the AI was able to provide logically organized tasks and subtasks and applied some knowledge of human factors concepts, it still made some rookie mistakes and lacked specificity. Many audience members were quick to point out other concerns with ChatGPT: its inability to provide sources and some versions running on outdated information. Presenters concluded that in their current state, new AI tools may help us perform simple tasks more efficiently but cannot replicate or replace a practitioner’s nuanced knowledge of how to effectively apply HFE. Overall, like in most other industries, there was a mixed sense of curiosity as well as anxiety surrounding the discussion. Perhaps the most profound quote from the session was by presenter Alexandra Benbadis: “ChatGPT takes the ‘human’ out of human factors.”
Collecting Data in New Ways
The day concluded with a discussion panel summarizing two case studies where advanced testing methods were used to produce robust and reliable data for the design of pre-filled syringe devices. The discussion highlighted the ‘missing data problem’ that was a Key Tech takeaway from prior years at the symposium. Much of the HF force and anthropometric data that exists today is based on a general population ranging from the 5th percentile female to the 95th percentile male. However, some patient populations possess characteristics that exist outside of these generalized percentiles. Presenters shared how they used Newtonian force measurements, 3D spatial tracking, electromyography, eye-tracking, and micro-facial expression analysis to create robust data for different user groups. More reliable data will become increasingly important as there is a rise of medical product use by lay individuals (patients, caregivers, & adolescents), the human population is aging, and large molecule, high viscosity drugs are more prevalent.
Overall, my day at the symposium was extremely educational and engaging. Staying up to date on current trends in the HF field increases the quality of the products we design at Key Tech and will ultimately lead to better health outcomes for us all, now and in the future.
Alli is a native of Milwaukee, WI and graduated from the University of Cincinnati with a BS in Industrial Design and a Minor and Business Certificate in French. Prior to Key Tech, she designed watches for Fossil Group in Dallas, TX. When not designing, she can be found listening to live music, making travel plans, or hanging out with her cat Disco.
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