A Narrative Review of FDA Human Factors Validation Requirement: The Needs of Key Stakeholders and Proposal of an Industry (Human Factors Service Providers) Maturity Assessment Tool

Abstract

As part of a comprehensive Quality System Regulation (QSR), the human factors (HF) validation requirement by the Food and Drug Administration (FDA) is a relatively recent topic. Multiple issues and bottlenecks have emerged since the publication of the draft guidance in 2011. The scientific literature on the topic of ‘FDA HF validation requirement’ is mostly focused on HF methods to ensure success from that perspective. However, the development of across-the-board strategies that can address other critical factors is necessary. No previous scientific research has outlined and addressed the problems considering the QSR and the needs of key stakeholders. For that purpose, this effort presents a narrative review of how the HF requirement for medical devices and combination products developed, as well as the issues and the interventions that have taken place to address the bottlenecks. Some essential considerations such as notorious knowledge-based and process-based gaps are discussed. Similarly, because of the demands of a changing QSR, attention is brought to the need to align key stakeholders, namely manufacturers and HF service providers (HFSPs). Also, the development of an industry (HFSPs) maturity assessment tool and future research for that purpose are proposed.

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

“…A survey instrument was developed tailored to this specific context and industry. The initial variables for the survey were drawn from the previous work by Rojas et al (Rojas, Cosler, et al, 2019;Rojas, Sharareh, et al, 2019). In addition to the previous work and review of literature on the topic, the survey-questionnaire was reviewed by 3 subject matter experts, to ensure questions effectively addressed the research goals.…”

“…Since the Food and Drug Administration (FDA) published guidance in 2011 on the application of human factors engineering (HFE) to medical devices and combination products, the concerns regarding the quality and success of HF validation projects have put a strain on key stakeholders. Previously, Rojas et al reviewed and analyzed the persisting concerns regarding FDA's HF requirement and the implications of failed HF validation projects (Rojas, Cosler, et al, 2019;Rojas, Sharareh, et al, 2019).…”

“…Failed FDA HF validation projects can have a serious negative impact not only for HF Service Providers (HFSPs) and manufacturers of medical devices and combination products, but also for the regulatory system and patients (Rojas, Sharareh, et al, 2019). Similarly, Rojas et al (Rojas, Cosler, et al, 2019) described the persisting gaps that limit the consistent and proper application of HFE methods among FDA HF validation submissions. The previous is confirmed by the high failure rate in HF validation submissions, as explained next.…”

“…Clearly, there is need for strategies that increase the quality of FDA HF validation projects and enable alignment between key stakeholders are needed to avoid further chaos (Rojas, Sharareh, et al, 2019). Because FDA HF validations are projects, and projects can only be successful through effective project management (PM), proposed the improvement of PM capabilities through an industry-focused PM maturity assessment tool (Rojas, Cosler, et al, 2019;Rojas, Sharareh, et al, 2019).…”

“…While HFSPs are not yet directly being required to comply with ensuring project quality by implementing suitable quality systems, it is just a matter of time before that happens. The ongoing and future interventions (including harmonization of the QSR with international standards) will impact HFSPs so that they will need to comply with the QSR and provide measures of excellence (Rojas, Cosler, et al, 2019).…”