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

Abstract

Since the FDA published guidance on the application of human factors engineering to medical devices and combination products, the concerns about the quality and success of human factors validation projects have put a strain on key stakeholders. Failed HF validation submissions can have serious negative impact not only on manufacturers and HF service providers, but also on the regulatory system and patients. Previously, we remarked on the need for alignment between key stakeholders, and strategies that increase the quality and success of HF validation projects. Leveraging the application of project management was recommended for that purpose. However, there is currently no research about characteristics, practices and critical success factors of these projects. An online survey instrument was developed tailored to this specific context to inform the development of an industry-focused project management maturity assessment tool (which will be Phase II of this research). In this opportunity, the high-level, preliminary findings are presented and briefly discussed. This effort contributes much needed literature regarding the current practices and factors that influence the quality and success of FDA HF validation projects.