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Continue reading "Original Insights: Success Factors of Human Factors Validation in Medical Device Development"
“Imitation may be the sincerest form of flattery, but originality is the mark of true innovation.” – Unknown
Continue reading "Navigating the Shadows: A Tale of Innovation, Plagiarism, and the Battle for Ethical Standards in Human Factors and Usability Engineering"
“The opinion of 10,000 men is of no value if none of them know anything about the subject.” (Marcus Aurelius)
Continue reading "From Research to Policy: Exploring Precedents of HFES Maturity Framework Policy Recommendations to the FDA"
Robust tools and methodologies are essential for achieving success in human factors (HF) validations for medical devices and combination products. Recognizing this importance, the Successful Human Factors (SHF 2.0) framework places great emphasis on “tools & methodology” as a fundamental pillar of best practices. By addressing the unique challenges of integrating human factors into product […]
Continue reading "Understanding the Key Success Factors in ‘Tools & Methodology’ within the Successful Human Factors 2.0 Framework (Part I)"
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 […]
Continue reading "Redefining Human Factors Validations: Strategies to Increase Maturity for Successful Human Factors in Medical Devices and Combination Products"
