Therapeutic Innovation & Regulatory Science
https://doi.org/10.1007/s43441-019-00022-4
Authors: Teodora Miclăuş · Vasiliki Valla · Angeliki Koukoura · Anne Ahlmann Nielsen · Benedicte Dahlerup · Georgios‑Ioannis Tsianos · Efstathios Vassiliadis
ABSTRACT
The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre- and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.
