LTR 103: Start treating human factors as a science, not an art

Summary

“Many devices that pass the FDA human factors engineering review simply are not acceptable when they reach the marketplace.”

In this Let’s Talk Risk! conversation, Naveen Agarwal engages with Charles Mauro, a pioneer in human factors engineering. They discuss the importance of usability in medical devices, the challenges faced in the industry, and the need for rigorous human factors research. Charles shares insights from his extensive experience, emphasizing the significance of designing for the least capable user and the differences in regulatory approaches between the FDA and EU. The conversation also touches on the role of training, the impact of user profiles, and the necessity of integrating human factors into the design process early on.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:15 Introducing Charles Mauro

01:48 HFE Challenges in MedTech

05:10 HFE Lessons Learned From Apple

07:34 Understanding Risk Criteria Acceptability in Usability

11:27 Quantitative Measurement Methods in Human Factors

13:12 Regulatory Approach to Use Risks: FDA vs EU

14:53 User Profiles: Trained Professionals vs Lay Users

17:03 Designing for Extreme Percentiles

20:26 Designing Effective Instructions for Use (IFUs)

22:25 Encouraging Human Factors in Product Development

24:48 Key Takeaways and Closing Thoughts

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Suggested links:

LTR: Understanding human factors aspects of AR applications in MedTech.

LTR: Treat human factors as a driver of customer satisfaction, not a check-the-box.

ACHIEVE: Post-market surveillance workshop.

Key Takeaways

* Human factors engineering is a science, not an art.

* Designing for the least capable user captures the entire user distribution.

* Apple excels in first user experience but can be complex beyond that.

* Training should be mandatory for device use to minimize errors.

* Regulatory differences exist between FDA and EU in risk assessment.

* User profiles significantly impact usability testing outcomes.

* Quantitative measurement methods enhance understanding of human performance.

* Early integration of human factors research reduces usability errors.

* Market success can drive the adoption of human factors principles.

* The future favors human-centered design in product development.

Keywords

Human Factors Engineering, Usability Testing, Medical Devices, Risk Assessment, User Experience, FDA Regulations, Design Principles, User Profiles, Quantitative Measurement, Training

About Charles Mauro

Charles L. Mauro CHFP is President and Founder of MAURO Usability Science, a leading provider of neuroscience-based design research focused on UX optimization and usability for complex products and services. He was selected by the Human Factors and Ergonomics Society as a "Titan of Industry" for HF research. He is a Certified Human Factors Engineering Professional (BCPE 1312) with 50 years of experience consulting for demanding clients globally. He specializes in combining science-based research methodologies with structured problem-solving. Clients include Nike, Dyson, Apple, Microsoft, Goldman Sachs, Pfizer, Merck, Amazon, META, and industries covering high technology, medical/pharmaceutical, financial, heavy industrial, consumer, government/DOD, and startups.

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, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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