JMIR Publications

ABSTRACT

Women choosing a levonorgestrel-releasing intrauterine system (LNG-IUS) may experience changes in their menstrual bleeding pattern during the first months following placement. While healthcare professionals (HCPs) can give counseling, no method of providing both individualized information on expected bleeding pattern or continued support is currently available for women experiencing bleeding changes post-placement. The MyIUS application (app) has been developed to meet this need and provide a digital companion to women post-IUS placement. The MyIUS app is classified as a Medical Device and uses an artificial intelligence-based bleeding pattern prediction algorithm to provide an estimation of a woman’s future bleeding pattern with respect to intensity and regularity. The app was developed by a multidisciplinary team using a robust and high-quality design process in the context of a constantly evolving regulatory landscape. The development framework consisted of a phased approach including ideation, feasibility/concept finalization, product development, and product deployment/localization stages. Following launch of the sustainable app in selected pilot countries, performance metrics will be gathered to facilitate further technical and feature updates and enhancements. A real-world performance study will also be conducted to allow upgrade of the app in line with new European Commission Medical Device Legislation, as well as to validate the bleeding pattern prediction algorithm in the real world setting. The MyIUS app offers a useful tool that may benefit both women and HCPs by facilitating a meaningful estimation of bleeding pattern, allowing an individualized approach to counseling and discussions around contraceptive method choice.