“There is a tendency for human factors to be very closely tied to regulatory requirements and nothing else, but human factors as a core discipline is about user-centered design.”
In this Let’s Talk Risk! conversation, Korey Johnson highlights how the current practice of human factors engineering in the medical device industry is mainly driven by regulatory requirements, which often leads to a check-the-box approach and nothing more.
But human factors is more about applying a user-centered design philosophy starting from early feasibility and throughout the product development process.
“Are we designing the right thing, and how do we design the thing right to be able to used well by people, not just safe and effective, but does it drive satisfaction?”
When viewed as a driver of customer/satisfaction, a user-centered design approach can deliver a sustainable competitive advantage.
Listen to this Let’s Talk Risk! conversation with Korey Johnson, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.
00:01:47 Introduction
00:04:25 Regulatory emphasis on human factors in medical devices
00:06:45 Barriers to implementing user centered design philosophy
00:08:20 Connecting with risk management and design controls
00:10:15 Assessing impact of changes in software, AI/ML enabled devices
00:14:30 Why human factors must be integrated throughout product development
00:16:50 Audience Q&A and general discussion
00:37:30 Closing comments and key takeaways
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Suggested links:
AI and UX: Why artificial intelligence needs user experience, Published 2020.
FDA: Applying human factors and usability engineering to medical devices, Published February 2016.
ISO: IEC 62366-1:2015; Application of usability engineering to medical devices, Published 2015.
About Korey Johnson
Korey Johnson is the Managing Partner at Bold Insight, a leading research and consulting agency providing services in UX research, usability testing and human factors engineering. With over 25 years of industry experience, Korey is passionate about transforming the practice of human factors engineering in medical devices through empowerment, creativity and collaboration. He holds a B.S. degree in Psychology and an M.S. in Human Factors Psychology.
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
LTR 61: Treat human factors as a driver of customer satisfaction, not a check-the-box activity