Allison Strochlic

Allison Strochlic is senior research director of the Human Factors Research & Design (HFR&D) team at Emergo by UL, where she has been a driving force since co-founding the organization in 2005 and subsequent integration into UL Solutions in 2012. With two decades of experience, Allison is pivotal in advancing the application of human factors engineering (HFE) to medical and drug delivery combination products and Software as a Medical Device (SaMD) products. Allison holds degrees in HFE from Tufts University and Bentley University and is a Certified Human Factors Professional. She has been recognized by the William Henry Merrill Society as a Distinguished Member of Technical Staff (DMTS), an honor reserved for those making significant scientific contributions to UL Solutions’ safety mission and growth. Through her leadership and expertise, Allison continues to guide the HFR&D team in collaborating with customers and helping develop user-centered, safe healthcare technology.

Expert advisory for safer, more effective medical devices

As senior research director, Allison is instrumental in advising global healthcare organizations on designing, evaluating and validating medical devices to meet the U.S. Food and Drug Administration (FDA)’s HFE guidance, as well as HFE-related standards upheld worldwide, including by regulators in Europe, China and Japan. Through early research, rigorous use-related risk analysis, and product evaluation and usability testing, her team helps customers apply HFE thoroughly while navigating the regulatory process. Allison and her team help organizations gain critical insights and implement an HFE strategy that facilitates regulatory success and gets safe, effective and user-friendly medical technology into the hands of healthcare professionals, patients and the general public. Allison also directly supports customers in their communications with regulators, helping justify planned or completed HFE work and assisting with alignment and compliance.

Leading innovation in HFE regulatory standards

As the role of HFE in the medical device field quickly evolves, Allison continues to be an influential voice at the movement’s leading edge. As a prominent subject matter expert, she frequently shares her expertise at international forums, interacts with industry leaders, and authors white papers, articles and presents in webinars hosted on the Emergo by UL website. She also co-authored the widely known and highly regarded book, “Usability Testing of Medical Devices.” Through her collaboration with industry peers and role as editor for Human Factors in Healthcare, Allison stays ahead of emerging trends and the evolving HFE regulatory landscape.

“By applying human factors engineering and user-centered design principles, we help our customers develop safe, usable medical devices that meet users’ needs, comply with global regulations and reduce their customers’ business risk.” – Allison Strochlic

Panels and boards

• Panel moderator. Hello (Again) from the Other side: Cross-Industry Trends in FDA Feedback from HF Consultants. Human Factors & Ergonomics Society Health Care Symposium. 2024, 2023 and 2022
• Panel moderator. Conducting Usability Tests with Participant Teams: Case Studies and Lessons Learned. Human Factors & Ergonomics Society Health Care Symposium. 2022
• Panel moderator. Human Factors in a Multi-Component World: Use-Related Risk Analysis, HF Validation, and Related Regulatory Considerations for System of Systems. Human Factors & Ergonomics Society Health Care Symposium. 2021
• Panel moderator. Putting your users in the designers’ seat. Injectables Summit. 2020
• Panel moderator. Applying HFE to Platform Drug Delivery Devices: Pitfalls and Lessons Learned. 8th PFS & Injectables Summit. 2018
• Panel moderator. Demystifying HF Considerations – FDA’s 2017 Generics and Interchangeable Biosimilars Guidance Documents. Human Factors & Ergonomics Society Health Care Symposium. 2018
• Panel moderator. Best Practices for Evaluating and Validating Medical Device and Combination Product Labeling. Human Factors & Ergonomics Society Health Care Symposium. 2016
• Panel moderator. Risk management and human factors. Risk Acceptability and Life Cycle Risk Management Conference. 2016

Connect with Allison Strochlic

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Within UL Solutions we provide a broad portfolio of offerings to many industries. This includes certification, testing, inspection, assessment, verification and consulting services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL Solutions has processes in place to identify and manage any potential conflicts of interest and maintain the impartiality of our conformity assessment services.