Digital Medical Device Companion (MyIUS) for New Users of Intrauterine Systems: App Development Study

Abstract

Background Women choosing a levonorgestrel-releasing intrauterine system may experience changes in their menstrual bleeding pattern during the first months following placement. Objective Although health care professionals (HCPs) can provide counseling, no method of providing individualized information on the expected bleeding pattern or continued support is currently available for women experiencing postplacement bleeding changes. We aim to develop a mobile phone–based medical app (MyIUS) to meet this need and provide a digital companion to women after the placement of the intrauterine system. Methods The MyIUS app is classified as a medical device and uses an artificial intelligence–based bleeding pattern prediction algorithm to estimate a woman’s future bleeding pattern in terms of intensity and regularity. We developed the app with the help of a multidisciplinary team by 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 and concept finalization, product development, and product deployment or localization stages. Results The MyIUS app was considered useful by HCPs and easy to use by women who were consulted during the development process. Following the 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 us to upgrade the app in accordance with the new European Commission Medical Device legislation and to validate the bleeding pattern prediction algorithm in a real-world setting. Conclusions By providing a meaningful estimation of bleeding patterns and allowing an individualized approach to counseling and discussions about contraceptive method choice, the MyIUS app offers a useful tool that may benefit both women and HCPs. Further work is needed to validate the performance of the prediction algorithm and MyIUS app in a real-world setting.

The Definitions of Health Apps and Medical Apps From the Perspective of Public Health and Law: Qualitative Analysis of an Interdisciplinary Literature Overview

“…We identified more papers providing a description. For example, Karakoyun et al [ 49 ] referred to the FDA definition of medical apps [ 42 ]. In contrast, Azad-Khaneghah et al [ 50 ] cited the definition of health apps by Morse et al [ 51 ], and Sun et al [ 52 ] used the description of health apps by Aitken and Lyle [ 53 ].…”

Development and usage of a health recommendation web tool (HeaRT) designed to inform women of personalized preventive health recommendations

“…A systematic review from 2018 showed that mobile health application usage has a positive impact on health-related behaviours and clinical health outcomes ( Han and Lee, 2018 ). Several studies have shown the benefits of specific health apps, such as an app aimed to improve self-care quality in heart failure ( Bakogiannis et al, 2021 ), an app to counsel women who use an intrauterine system ( Karakoyun et al, 2021 ), and an app to improve health outcomes of diabetics ( Ghose et al, 2022 ); however, there are fewer holistic web tools that offer a comprehensive preventive health approach. One such tool, the Wellness-Portal, is a novel web-based patient portal focused on wellness, prevention, and longitude health.…”

Exploring the Use and Implications of AI in Sexual and Reproductive Health and Rights: Protocol for a Scoping Review

“…In addition, the use of AI to power “software as a medical device” [ 15 ] presents an opportunity to leapfrog access to diagnostic devices, such as ultrasounds [ 16 ] and blood pressure equipment [ 17 ]. This has also been seen with the emergence of contraceptive and fertility software applications [ 18 , 19 ], which are increasingly securing regulatory approvals from national authorities [ 20 , 21 ].…”