February 28, 2023
On February 22, Michael Wiklund (Leader of the UL Solutions Life Sciences Industry Practice and Senior Advisor to Emergo by UL’s Human Factors Research & Design team) participated in a panel discussion held at the International Consumer Products Health and Safety organization’s Annual Meeting in Orlando, Florida. The panel focused on making consumer products safer by applying human factors during the development process. Wiklund shared his experience working on a wide range of products, especially medical products.
Wiklund described human factors engineering (HFE) as a necessity when problems involving users interacting with a product can lead to personal harm and property damage. Furthermore, he explained that HFE is mandated when you develop such items as military equipment, an airliner or a medical device. He asked the audience to consider how nervous they would be if they needed an operation and HFE had not been applied during the development of the anesthesia machine. He acknowledged that some consumer products appear at first fairly benign, but many of them can cause harm if not designed and tested to ensure safe, effective user interaction. As examples, Wiklund invited the listeners to consider the consequences of making a mistake while using a ladder, electric heater, power tool and infant rocker, just to name a few products.
When asked about the importance of risk analysis, Wiklund described his view as a bit militant in the sense that he considers anything less than rigorous use-related risk management to be a sign of negligence. He pointed out that the US Food and Drug Administration (FDA) mandates risk analysis for Class II and III medical devices that are considered potentially riskier to use. He described the work as straightforward and rewarding in many ways, and prescribed steps to analyze the characteristics of users, use environments and use scenarios, as well as learning from past accidents as necessary for effective risk analysis.
Wiklund also shared that in the medical industry specifically, you must identify all foreseeable use errors; consider their likelihood and severity of the potential resulting harm; and determine which of these errors warrant risk mitigation.
Finally, Wiklund encouraged product developers to perform a comprehensive risk analysis, and do an especially through job of task analysis and hazard analysis. He reasoned that doing so gives you two perspectives on how people could possibly interact with a product and get hurt, and informs your risk mitigation efforts.
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