27 May Key Takeaways from the 2025 HFES International Symposium: Streamlining Human Factors for Global Medical Device Approvals
The 2025 HFES International Symposium on Human Factors and Ergonomics in Health Care brought forward a lot of out of the box thinking, focusing on how to navigate the evolving landscape of human factors. Three notable sessions shared how human factors can be more efficient, less burdensome, and more compassionate.
Optimizing Human Factors Testing
Christina Mendat and Liz Mauer of Eurofins ask, “When is Enough, Enough? How Many Times Do We Have to Demonstrate a Commercially Available Platform Device is Safe for the Public?” The FDA emphasizes in their own guidance to provide the least amount of information they need in order to make a decision, so why are we re-producing results for products that have billions of analogous commercial units already sold?
Our speakers suggest Human Factors Engineers rely more heavily on existing URRA guidance as well as DMEPA reviews, that can be accessed in the Drugs@FDA database. These databases contain a wealth of Known Use Problem Analysis, exiting Validation Testing data, and complete URRAs.
Eurofins used this novel approach to FDA submission for a nasal sprayer used for chronic conditions by laymen. In the report they provided:
- Proof that their product did not introduce any novel concepts or unique use errors.
- Known Use Problem Analysis of 5 similar products
- Human Factors Validation Testing for comparator products.
- Comparative Analysis for 5 commercially available nasal sprayers
- A completed URRA for the new product
The FDA liked it, and no Human Factors testing was required as a result. This approach can reduce cost, simplify labeling and design controls, and could lead to a more efficient approval process.
Navigating Diverse Regulatory Landscapes
A presentation from Briana Rawson, Julee Henry, and Layne Hartment of Takeda Development Center proposed a step-by-step strategy for approaching global standards as a Human Factors Engineer. Understanding the regulatory boards and standards that govern human factors in medical devices across the globe.
The proposed three-step strategy is:
- Determine the Appropriate Global HFE Scope: Understanding how various regulatory bodies define HFE expectations. For instance, the FDA focuses on product novelty and critical tasks, while China’s NMPA is chiefly concerned with Use-risk classification level, product maturity, and manufacturing location. China defines high use-risk classification, these devices require extensive testing and validation.
- Determine Whether a Region’s Evaluation Applies Globally: This step simply encourages HFE’s to find commonalities across regions regarding users, user characteristics, cultural influences, use environments, etc.
- Strategize Early and Execute: Plan your HF activities based on those commonalities. Make sure your proposed HF activities cover as much ground as possible for the intended markets.
Using this strategy, we can make sure we are covering all our bases and ensure we hit a home run when it comes to Human Factors.
Designing with LMICs in Mind
On day three, Doctor Mark Ware of Starfish Medical gave an informative and compassionate talk about Contextual Research in Low and Middle Income Countries (LMICs). Dr. Ware brought to light that roughly 90% of medical devices are developed in high income countries and arrive in LMICs primarily through donation.
However, altruism doesn’t always have meaningful results. Healthcare in high income countries looks very different than LMICs. Use environment, disease burden, access to healthcare, and lack of digital record keeping often mean these donated devices end up in the “Graveyard of Good Intentions”.
Things to think about:
- “What are this device’s maintenance needs?”
- “What are the training needs of this device?”
- “How can we better design devices to work in high heat/inconsistent electrical supply/inconsistent internet access use environments?”
Considerations can be made during the design process that can help detour the pathway to the graveyard and ensure that the medical devices we are designing today can have longevity in multiple use environments.
My week at HFES eye opening to a number of topics. It’s exciting to see the field of Human Factors growing and evolving with the current technological landscape and I’m looking forward to helping Human Factors continue evolve at Key Tech!
Cole’s passions outside of work are sustainable gardening, powerlifting, and football. Cole plays defensive tackle for Baltimore’s women’s tackle football team, the Baltimore Nighthawks, and can be found picking up heavy things and putting them back down again during the off-season.