Research

Research

Has Anything Changed Regarding How Often the FDA Rejects your HF Submission?

Posted on Discussions & Trendsby Dr. Katia Rojas

The image reflects results from 3 years ago, when a diverse group of participants, including HF service providers (HFSPs) from pharma, biotech, and consultancies, responded to the question: How often does the FDA reject your HF submission? The results were as follows: Never: 35%, Sometimes: 60%, Most of the Time: 5%. However, as per data shared […]

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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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Assessing Organization’s Human Factors Maturity (Capabilities) with the SHF 2.0 Framework

Posted on HFE Strategy & Implementationby Dr. Katia Rojas

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.

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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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