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

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 […]

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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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