Wiklund's Perspective: 2025 Human Factors Insights In Medical Design
Dick Huang módosította ezt az oldalt ekkor: 7 órája


From my perspective as UL Solutions’ Leader of Life Sciences Industry Practice, Emergo by UL’s human components staff had a busy and productive yr. We saw particularly excessive demand from the pharmaceutical industry for a large variety of human components services starting from desktop work, equivalent to recognized issues analysis, use-associated risk analysis, and threshold evaluation, to protocol development adopted by palms-on usability testing in any respect phases of product development. In particular, the Human Factors Research & Design (HFR&D) group carried out loads of knowledge testing (assessing how well customers understand instructions and warnings in the course of the IFU development and validation stage) and comparability analyses (assessing whether or not a generic drug delivery machine is substantially just like the reference system). All year long, the crew helped many medical system and combination product builders get hold of regulatory approval to market their merchandise in the US, Europe, and beyond. OPUS, Emergo’s sturdy human elements software platform, has continued to supply unmatched worth to human elements and product improvement groups.


We've continued to expand OPUS to include a Use Error Wizard, Design Recommendation Library, and pre-recorded training on superior HFE strategies to streamline and expedite HFE actions for in-home practitioners. In 2023, a whole bunch of businesses took advantage of OPUS, starting from small human factors teams growing their first product to industry-leading medical machine companies engaged on subsequent era merchandise for anesthesia delivery, interventional cardiological procedures, and superior imaging. Continuing this pattern from 2022, the number of tasks involving synthetic intelligence (AI) continued to grow in 2023. One notable challenge our human elements crew carried out this year involved a product that makes use of AI to identify skin cancers from digital pictures, increasing the application of AI to new diagnostic modalities. We expect to use human factors engineering to many more AI-enabled technologies in 2024 and beyond, noting that guaranteeing these good applied sciences are safe, effective, and usable in human fingers remains integral to the products’ success. A pattern we saw in 2023 included products that promise higher simplicity and ease of use to match technological enhancements, particularly within the wearables category.


One such product was a wearable medical machine that adheres to the chest to monitor important functions, changing what was an ungainly field, cables, and electrodes that interfered with a patient’s actions of daily residing. Several of Emergo by UL’s human factors research concerned robot-assisted surgical systems . The robots we worked on included some utilized in varied minimally invasive procedures and some that allow specific procedures, comparable to inspecting the lungs for lesions and retrieving clots in the Brain Health Supplement to reverse an ischemic stroke. Most of the usability studies called for surgical groups to engage in critical use eventualities and for our HFR&D group to collect Neuro Surge performance support and subjective data and rework insights into actionable system design suggestions. Our human factor’s analysis and design crew routinely engaged in initiatives to elevate preliminary draft instructional materials (e.g., fast reference guides, instructions to be used, technical manuals, labeling) to a superior degree at which they could enable safe, effective, and satisfying product use.


Typically, this course of included simplifying and organizing instructional text