Open Forum: Use-Related Risk Analysis Q&A

Conducting a use-related risk analysis (URRA) is one of the most important steps when applying a human factors engineering (HFE) process during the development of your medical device or combination product. This is understandable noting your goal is to develop a product that is safe and effective to use. Your risk analysis will be key in determining if you achieve this objective. Whether it’s helping determine user interface requirements, the scope of your HF validation efforts, or whether the device has acceptable residual risk, the URRA is the foundation for your most critical HFE activities. Given its importance, it’s no wonder there are often questions amongst teams when it comes to performing this key activity. 

About our presenters

Merrick Kossack, Research Director, HFR&D

For over 25 years, Merrick has helped companies develop processes and strategies to address their human factors engineering needs, particularly for complex and high-risk systems. His areas of expertise include integrating human factors engineering into established design and development processes, conducting complex usability studies, and advising on human factors strategy to satisfy regulatory needs. He received an M.S. degree in Human-Machine Systems Research from the Georgia Institute of Technology and a B.S. degree in Industrial Engineering from the University of Illinois. Merrick is a contributing author to Applied Human Factors in Medical Device Design (2019) and has delivered numerous presentations on the subject. He is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) Human Factors Engineering subcommittee as well as IEC TC 62/SC 62A/JWG 4, both responsible for the creation of human-factors-related standards and guidance. He is also a member of the AAMI faculty staff teaching their Human Factors for Medical Devices course. In 2020, Merrick was inducted into UL’s William Henry Merrill Society as a Distinguished Member of Technical Staff.

Yvonne Limpens, Managing Human Factors Specialist

Yvonne Limpens is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team based in Utrecht, Netherlands. She has been with the team since 2013 and has experience delivering HFE services to the medical device, pharmaceutical and laboratory equipment industries. Yvonne leads and oversees research activities and helps customers develop key HFE documents for their design history files. Furthermore, she advises and trains customers to apply HFE during product development to meet regulators' expectations.

Yvonne holds a bachelor’s in Industrial Design and a master’s in human technology interaction, both from Eindhoven University of Technology (NL).

Alexandria Carlson, Lead Human Factors Specialist

Alexandria is a Lead Human Factors Specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team. She has been with the team since 2016 and has experience leading various Human Factors Engineering activities during the product development lifecycle. She has gained particular expertise conducting formative and HF validation usability tests and developing key documents for customers’ design history files, including user profiles, use environment descriptions, known problems analysis, and risk analysis. Alexandria also serves as one of the HFR&D team’s Quality Management System leaders. Notably, Alexandria holds a B.S. in Human Factors Engineering and an M.S. in Human Factors Engineering, both from Tufts University and now teaches a course on Human Factors Analyses at Tufts.