Introduction to Human Factors Engineering – The Key to Developing Safe, Effective, and Usable Medical Devices

Join Emergo by UL’s Human Factors Research & Design team to learn about the regulatory imperatives – and commercial benefits – associated with applying Human Factors Engineering (HFE) throughout medical device development. HFE is a field focused on ensuring users can interact with medical technology safely and effectively. The end goal is to produce a product that is intuitive to use, and resistant to use errors (a.k.a. mistakes) - especially use errors that could lead to harm. The US Food and Drug Administration, and regulators around the world – including those in Europe, China, and Japan, among other countries – require medical device, in-vitro diagnostic (IVD), and combination product manufacturers to implement a robust HFE program and generate data to demonstrate that a product can be used safely and effectively by the intended users. 

During this 60-minute presentation, Allison Strochlic, co-founder and Senior Research Director of Emergo by UL’s HFR&D team, will cover the following topics: 

•        An introduction to the field of HFE, including specific “human factors” that influence people’s interactions with products 
•        The primary standards and guidance documents that make up the regulatory imperative for applying HFE throughout medical device development 
•        The commercial benefits of applying HFE, including those impacting the end-users and your business 
•        A high-level overview of the activities that comprise a robust and compliant HFE plan, including key deliverables