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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Communicating the Importance of Human Factors to MedTech Stakeholders and Investors

Recognizing the crucial role of human factors in achieving product excellence within the medical technology industry is paramount for ensuring success. Incorporating human factors into product design, development, and testing enables companies to meet consumer needs, enhance user satisfaction, and mitigate the risk of product failure. Effective communication and reporting play a vital role in […]

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Emerging Best Practices for Successful Human Factors – Benchmark Report

Assessing and Advancing HFE Excellence This comprehensive industry benchmark report highlights the significant influence of the SHF 2.0 Framework on industry best practices. By exploring this report, stakeholders in medical device human factors gain unparalleled insights into their performance, enabling them to identify strengths and areas for improvement across the five core categories of best […]

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