Gender Impact Assessment for Medical Devices: A Compass to Find the Way in the Gender-Technology Reciprocity

In literature, data shows that medical devices generally do not intercept gender - referenced elements as well as the regulatory framework for their design. This perspectival study aimed to emphasize the features of gender, introducing health determinants to the common male-female identification, as also required by European Regulation. We conducted an evaluation on the presence of the term "gender" in the Regulations, identifying a first model approach to the reciprocity between gender and technology, accordingly, integrating gender, not only in the clinical dimension but also in the technological dimension. For the evaluation of the actual efficiency and safety of gender-related technology design, the importance of a common language to be able to report characteristics for the population as broad as detailed is presented in our study. This leads to a refinement of expertise through a combined approach involving physician and biomedical engineer in a synergic manner aimed at optimizing health economic resources, reducing side effects and potential clinical complications resulting from design imbalance. The presented model, based on Gender Impact Assessment (GIA) tool by European Institute for Gender Equality (EIGE), allows for refining the design process of medical devices, highlighting the real but so far undetected gender gaps.