Wiklund's Perspective: 2023 Human Factors Insights in Medical Design

By Michael Wiklund

An overview of 2023 for our human factors team 

From my perspective as UL Solutions’ Leader of Life Sciences Industry Practice, Emergo by UL’s human factors team had a busy and productive year. We saw especially high demand from the pharmaceutical industry for a wide variety of human factors services ranging from desktop work, such as known problems analysis, use-related risk analysis, and threshold analysis, to protocol development followed by hands-on usability testing at all stages of product development. In particular, the Human Factors Research & Design (HFR&D) team conducted a lot of knowledge testing (assessing how well users understand instructions and warnings during the IFU development and validation stage) and comparison analyses (assessing whether a generic drug delivery device is substantially similar to the reference device). Throughout the year, the team helped many medical device and combination product developers obtain regulatory approval to market their products in the US, Europe, and beyond. Below, I share some of my highlights from 2023. 

Expanding the OPUS human factors software to meet an industry need 

OPUS, Emergo’s robust human factors software platform, has continued to provide unmatched value to human factors and product development teams. We have continued to expand OPUS to include a Use Error Wizard, Design Recommendation Library, and pre-recorded training on advanced HFE methods to streamline and expedite HFE activities for in-house practitioners. In 2023, hundreds of businesses took advantage of OPUS, ranging from small human factors teams developing their first product to industry-leading medical device companies working on next generation products for anesthesia delivery, interventional cardiological procedures, and advanced imaging. 

Incorporating human factors in AI to supplement diagnostic modalities 

Continuing this trend from 2022, the number of projects involving artificial intelligence (AI) continued to grow in 2023. One notable project our human factors team conducted this year involved a product that uses AI to identify skin cancers from digital images, expanding the application of AI to new diagnostic modalities. We expect to apply human factors engineering to many more AI-enabled technologies in 2024 and beyond, noting that ensuring these smart technologies are safe, effective, and usable in human hands remains integral to the products’ success. 

Streamlining wearable medical technology to replace bulky systems 

A trend we saw in 2023 included products that promise greater simplicity and ease of use to match technological improvements, particularly in the wearables category. One such product was a wearable medical device that adheres to the chest to monitor vital functions, replacing what was an awkward box, cables, and electrodes that interfered with a patient’s activities of daily living.     

Conducting human factors studies of complex medical devices 

Several of Emergo by UL’s human factors studies involved robot-assisted surgical systems   . The robots we worked on included some used in various minimally invasive procedures and some that enable specific procedures, such as inspecting the lungs for lesions and retrieving clots in the brain to reverse an ischemic stroke. Many of the usability studies called for surgical teams    to engage in critical use scenarios and for our HFR&D team to collect performance and subjective data and transform insights into actionable device design recommendations. 

Elevating instructional design to improve the user experience of medical devices  

Our human factor’s research and design team routinely engaged in projects to elevate preliminary draft instructional materials (e.g., quick reference guides, instructions for use, technical manuals, labeling) to a superior level at which they could enable safe, effective, and satisfying product use. Typically, this process included simplifying and organizing instructional text; making key steps (i.e., primary content) stand out from secondary and supporting information. Once we differentiated key steps, we supplemented this written content with clear, visually appealing graphics and illustrations to convey critical information. We avoided using some of the following things to help increase the intuitiveness and visual appeal of the instructional materials: 

• Dense blocks of text 

• Ambiguous graphics 

• Disorganized layouts 

Avoiding these things increases the likelihood that medical device users will better utilize the more important design features and enjoy their experience during product use.  

Taking a global HFE perspective to medical device regulatory requirements 

We also worked with individual medical device and combination product manufacturers seeking to deepen their understanding of global HFE-related regulatory requirements. With Japan and China ramping-up their enforcement of human factors engineering for medical devices, Emergo by UL’s customers were eager to know if they could draw upon their human factors efforts related to marketing products in the US, European Union, and/or the UK when seeking approval to sell products in Asia. The interest in how to meet these varied medical device regulatory requirements of different markets was solidified during the 2023 Human Factors and Ergonomics Society’s International Symposium on Human Factors and Ergonomics in Health Care, where the Emergo team delivered a workshop on meeting human factors requirements globally and how to perform various human factors studies in an effective and economical manner. 

Wrapping up 2023 for Emergo by UL’s human factors team 

Taking a global view, 2023 has been a turbulent year in many regards. While hoping for more peace and prosperity in 2024, I attest that Emergo by UL’s human factors team made important contributions in line with UL Solutions’ mission to make the world a safer place. In the medical and pharmaceutical product development domain, our work indirectly — but absolutely — helped clinicians deliver their best medical care to patients, as well as helped patients care for themselves in ever more effective ways.