“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"
New York – June 8, 2023 – Ongoing research reveals a notable gap between present practices and the essential best practices needed for successful Human Factors Engineering (HFE) projects. This underlines a significant obstacle within the medical device industry – the ineffective implementation of HFE. The issue has become more apparent in recent years, as […]
Continue reading "Research Urges Standardization of FDA’s Human Factors Engineering Practices Within the Medical Device Industry"
In the fast-paced world where innovation and patient safety converge, Human Factors (HF) engineering plays a critical role that cannot be underestimated. However, beneath the surface of this dynamic landscape lies a pressing issue that demands the immediate attention of key stakeholders: HF service providers, the Food and Drug Administration (FDA), and manufacturers of medical […]
Continue reading "So – Has Anything Changed? A Silent Crisis: Addressing the High Failure Rate of Human Factors Submissions in the Medical Device Industry"
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?"
