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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Leveraging the SHF 2.0 Framework to Overcome Common Challenges in Human Factors Validation Projects: A Strategy & Implementation Approach

We have previously discovered through research the challenges that Human Factors (HF) Validation projects in the medical device and combination products industry often face – study participant-related, changes to IFU and packaging design, engaging sponsors, and more (Rojas et al., 2020). To effectively address these challenges, organizations can leverage the Successful Human Factors (SHF) 2.0 […]

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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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How Often, and Why, Will the FDA Reject your Medical Device Human Factors 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, […]

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