“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"
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"
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 […]
Continue reading "Emerging Best Practices for Successful Human Factors – Benchmark Report"
Previously, this author pioneered exploratory research regarding the concerns, underlying variables, key success factors, and best practices pertaining to Human Factors (HF) projects for medical devices and combination products that seek Food and Drug Administration (FDA) approval. Because of this research, it was observed that the great majority of HF submissions to the FDA fail. […]
Continue reading "Validating a Project Management Maturity Framework Based on the Emerging Best Practices for Successful Human Factors Projects that Require FDA Approval -Summary of Key Findings"
SHF 2.0 maturity model provides a comprehensive framework for HFSPs to assess their maturity levels, understand the necessary steps for improvement, and establish best practices for successful HF validation projects.
Continue reading "Assessing Organization’s Human Factors Maturity (Capabilities) with the SHF 2.0 Framework"
