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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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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SHF 2.0 Framework – Use Cases

The SHF 2.0™ framework is designed to assess capabilities for successful human factors validation projects in the medical device industry, and can be used either at the organizational (processes) or project level (e.g. audit an HFE report). The SHF 2.0™ framework offers versatile applications and benefits multiple stakeholders, including internal or external human factors service providers (HFSPs) and […]

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