Recognizing the role of human factors engineering (HFE) in the development of medical devices and combination products that involve devices, the Food and Drug Administration (FDA) now requires human factors (HF) validations before market approval. Manufacturers are responsible for ensuring their products are safe and effective through the application of HFE. However, key stakeholders are still learning and developing capabilities to adapt to the regulatory component. Nonetheless, the lack of the corresponding HF capabilities hinders compliance with the FDA’s expectations, and though ultimate success. No known previous work has looked into FDA HF validation projects to assess the underlying factors and implications of failed submissions. Applying system dynamics (SD), a causal loop diagram (CLD) was developed. CLDs are useful for the exploration of the causal interactions among factors or variables, as well as the underlying feedback structure of a complex system. This work can serve to help manufacturers better understand the FDA’s HF requirement to enable overall product success. Further, with patient safety as a common goal, HF service providers (HFSPs) and regulators should be aware of the need to ensure the consistent quality of the HF element in premarket submissions.

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 Multiple issues and bottlenecks have emerged since the publication of the draft guidance in 2011.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.

Incorrect use of acetaminophen that results in severe liver injury is among the most common adverse drug events (ADEs) in the United States of America (USA), and other countries around the world. Compared to any other drug, it is also on the top for emergency calls, emergency room visits, and acute liver failure in the USA. Consequently, regulating acetaminophen has become a heated and unresolved public debate. During the last decades, multiple efforts have taken place to address the issue, mostly focused on the premise that inappropriate labeling is a leading cause of such ADEs, for failure in communicating the associated risks through warnings. Unlike previous studies, this paper illustrates the importance of considering human factors principles. Three different warning labels were designed and evaluated. The results showed no statistically significant effect, despite the application of best practices for label warning design. Non-design factors, the warning process and why a warning could fail are also illustrated. Implications could help researchers, policy makers, and manufacturers to consider focusing less on traditional labeling interventions, and to invest efforts more systematically considering also the current trends and the current needs of consumers.

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 providers of HF services) are lacking the necessary tools to adapt to current and future demands of a changing and evolving quality system regulation (QSR). Under the QSR, manufacturers are responsible for the assessment and control of critical suppliers, such as HF service providers. However, there is a need for tools that enable integration and alignment so that stakeholders can develop the necessary capabilities. To increase the quality and success of HF validation projects and help HF service providers meet the QSR, an industry-focused project management (PM) maturity assessment tool was proposed. Phase I consisted of a survey that gathered interesting information to help understand practices and key success factors in FDA HF validation projects. This Phase II summarizes the method and process followed to develop the PM maturity assessment tool. An overview and description of the tool and its resulting components is also presented.

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.