Best Practices for Use-Related Risk Analysis Through Collaboration of Human Factors and Clinical

Abstract

Integrating the human factors engineering (HFE) process, and its user-centered approach, into the medical device and combination Product and Development Process (PDP), has been an ongoing challenge for its respective industries and Human Factors (HF) practitioners within it for decades. Yet, despite continuous process adaptation and evolution of the HFE process, as well as the introduction of standards and health authority guidelines, the early integration of a risk-based and user-centered approach within the development and design process remains an ongoing practical challenge occupying the minds of most. With the introduction of the European MDR 2017/745 in 2017, an additional emphasis was put on the importance of use-related risk identification, assessment, and data based evaluation within the clinical evaluation process, and with such introduces clinical teams to (new) ‘use-related risk challenges’ as well. This paper provides a framework for early integration of an iterative use-related risk analysis approach, addressing common practical challenges, and providing best practices for such. Furthermore, it highlights how applying a collaborative approach between HF and clinical efforts would permit for collection of more robust use-related data sets, thus potentially optimizing use-related risk, residual risk, and risk-benefit analyses and their processes.