Redefining Human Factors Validations: Strategies to Increase Maturity for Successful Human Factors in Medical Devices and Combination Products

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 […]

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Research Urges Standardization of FDA’s Human Factors Engineering Practices Within the Medical Device Industry

SHF 2.0 Framework as Practical Solution to Drive Continuous Improvement 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. […]

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So – Has Anything Changed? A Silent Crisis: Addressing the High Failure Rate of Human Factors Submissions in 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 […]

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Has Anything Changed Regarding How Often the FDA Rejects your HF Submission?

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 […]

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