Past & Ongoing Research

Get a deeper understanding of the theoretical underpinnings, research articles, and other scholarly sources that have informed the development of the SHF 2.0 framework, as well as any ongoing research or case studies.

Past & Ongoing Research

Get a deeper understanding of the theoretical underpinnings, research articles, and other scholarly sources that have informed the development of the SHF 2.0 framework, as well as any ongoing research or case studies.

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Emerging Best Practices for Successful Human Factors – Benchmark Report

Posted on Past & Ongoing Researchby Dr. Katia Rojas

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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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

Posted on Past & Ongoing Researchby Dr. Katia Rojas

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. […]

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How Often, and Why, Will the FDA Reject your Medical Device Human Factors Submission?

Posted on Discussions & Trends, Past & Ongoing Researchby Dr. Katia Rojas

The Food and Drug Administration (FDA) requires the application of human factors (HF) in the development of medical devices and combination products. The previous is checked through proper validation testing. The purpose of the HF validation is to demonstrate whether a device can be used by its intended users without any serious errors or hazards, […]

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Understanding Practices and Critical Success Factors of FDA Human Factors Validation Projects – Preliminary Findings

Posted on Past & Ongoing Researchby Dr. Katia Rojas

The quality and success of human factors validation projects have put a strain on key stakeholders since the FDA published guidance. Learn about a new study on the characteristics, practices, and critical success factors in this field. Findings are presented to inform an industry-focused project management maturity assessment tool.

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Developing an Industry-Focused Maturity Assessment Tool Based on Key Factors Critical to Quality and Success in FDA Human Factors Validation Projects – Overview

Posted on Past & Ongoing Researchby Dr. Katia Rojas

This work is Phase II of a research theme on the topic of human factors validation projects for medical devices and combination products. Initially, a review and analysis of the persisting concerns and also of the implications of failed FDA HF validation projects took place. One main problem delineated was that key stakeholders (namely procurers and […]

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