Will the new FDA Human Factors Guidance Help Curb Ethical Dilemmas in Healthcare Usability Testing?

Abstract

While the FDA provides guidance documents on the application of human factors and usability engineering (HF/UE) to medical devices, the non-specific, recommendatory nature of these documents can lead to varying interpretation by the different entities involved in the HF/UE process. While appropriate HF/UE processes are beneficial to all stakeholders, whether it be the end user, the patient, the medical device manufacturer, a third party HF/UE consultant, or the FDA, the lack of a common understanding of the process combined with the differing perspectives, constraints, and drivers of each party, can lead to inconsistent, and less-than-ideal, implementation of HF/UE. This is exacerbated by the fact that financial incentives may not be aligned with optimizing safety and usability at the expense of development time. This presents the potential for business and ethical conflicts among the involved parties. Our expert panel will review the perspectives of the various stakeholders involved in the HF/UE process and facilitate a meaningful discussion on how a common understanding of HF/UE as it relates to medical device development and regulatory approval can be achieved across the medical device industry. We will focus on the implications of improper application of HF/UE processes and methods to better manage discrepancies in HF/UE implementation, and discuss the impact of the recently-released FDA final guidance.