Some medical devices, whether sex-specific (IUDs) or universal (surgical mesh, hip replacements, etc.), produce harm in women and have bad reputations as the subject of costly legal challenges. However, as the body adapts to the foreignness of a medical device, it is not known if sex and sex hormones undermine device safety or effectiveness. Laura Wells (Chemical Engineering) and Katrina Gee (Biomedical and Molecular Sciences) will lead a team to use surgical mesh as a prototype to develop humanized cellular and tissue models to test sex-specific immune responses to implantable medical devices. Their proposal will integrate sex-focused immunological data with a detailed probing of socially accepted definitions of patient outcomes to better define device failure/success. By challenging the conventional ‘one size fits all’ approach to device manufacturing, their research validates sex as a biological factor in device performance. This effort not only addresses theoretical concerns about greater female inflammatory potential but also seeks to untangle the complexities contributing to device failure in women. Ultimately, their findings could lead to improvements in testing and approval processes for medical devices, despite potential challenges from industry interests.
New Frontiers in Research Fund Exploration Program
