“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"
Suabix™ is the ultimate AI-enhanced usability mate for achieving human factors excellence in medical device design.Continue reading "Introducing Suabix™ by Successful Human Factors™ – First AI Solution to Optimize and Standardize Human Factors in Medical Device Design"
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"
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 […]Continue reading "Leveraging the SHF 2.0 Framework to Overcome Common Challenges in Human Factors Validation Projects: A Strategy & Implementation Approach"
SHF 2.0 Framework as Practical Solution to Drive Continuous Improvement 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. […]Continue reading "Research Urges Standardization of FDA’s Human Factors Engineering Practices Within the Medical Device Industry"