Articles discussing and exploring emerging trends in the field of human factors and medical technology.
“Imitation may be the sincerest form of flattery, but originality is the mark of true innovation.” – Unknown
Continue reading "Navigating the Shadows: A Tale of Innovation, Plagiarism, and the Battle for Ethical Standards in Human Factors and Usability Engineering"
“The opinion of 10,000 men is of no value if none of them know anything about the subject.” (Marcus Aurelius)
Continue reading "From Research to Policy: Exploring Precedents of HFES Maturity Framework Policy Recommendations to the FDA"
The integration of human factors (HF) engineering (or human-centered design) in the development of medical devices and combination products has become increasingly crucial for ensuring their safety, usability, and overall effectiveness. However, the implementation of HF practices has been accompanied by various challenges, hindering successful validation projects and regulatory compliance. It is clear that traditional approaches […]
Continue reading "Redefining Human Factors Validations: Strategies to Increase Maturity for Successful Human Factors in Medical Devices and Combination Products"
The image reflects results from 3 years ago, when a diverse group of participants, including HF service providers (HFSPs) from pharma, biotech, and consultancies, responded to the question: How often does the FDA reject your HF submission? The results were as follows: Never: 35%, Sometimes: 60%, Most of the Time: 5%. However, as per data shared […]
Continue reading "Has Anything Changed Regarding How Often the FDA Rejects your HF Submission?"
The Food and Drug Administration (FDA) requires the application of human factors (HF) in the development of medical devices and combination products. The previous is checked through proper validation testing. The purpose of the HF validation is to demonstrate whether a device can be used by its intended users without any serious errors or hazards, […]
Continue reading "How Often, and Why, Will the FDA Reject your Medical Device Human Factors Submission?"
