Karakoyun Toeresin, Podhaisky Hans-Peter, Frenz Ann-Kathrin, Schuhmann-Giampieri Gabriele, Ushikusa Thais, Schröder Daniel, Zvolanek Michal, Lopes Da Silva Filho Agnaldo
eHealth and Medical Software Solutions, Bayer AG, Wuppertal, Germany.
Regulatory Medical Device Excellence, Bayer AG, Berlin, Germany.
JMIR Med Inform. 2021 Jul 13;9(7):e24633. doi: 10.2196/24633.
Women choosing a levonorgestrel-releasing intrauterine system may experience changes in their menstrual bleeding pattern during the first months following placement.
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.
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.
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.
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.
选择左炔诺孕酮宫内节育系统的女性在放置后的头几个月可能会经历月经出血模式的变化。
尽管医疗保健专业人员（HCPs）可以提供咨询，但目前尚无方法为经历放置后出血变化的女性提供关于预期出血模式的个性化信息或持续支持。我们旨在开发一款基于手机的医疗应用程序（MyIUS）来满足这一需求，并在放置宫内节育系统后为女性提供数字陪伴。
MyIUS应用程序被归类为医疗设备，并使用基于人工智能的出血模式预测算法来估计女性未来出血模式的强度和规律性。我们在一个多学科团队的帮助下，在不断变化的监管环境中，通过使用稳健且高质量的设计流程来开发该应用程序。开发框架包括一个分阶段的方法，包括构思、可行性和概念确定、产品开发以及产品部署或本地化阶段。
HCPs认为MyIUS应用程序很有用，在开发过程中咨询过的女性也认为它易于使用。在选定的试点国家推出可持续应用程序后，将收集性能指标以促进进一步的技术和功能更新与增强。还将进行一项真实世界性能研究，以使我们能够根据欧盟委员会新的医疗器械法规对应用程序进行升级，并在真实环境中验证出血模式预测算法。
通过对出血模式进行有意义的估计，并允许采用个性化方法进行咨询以及讨论避孕方法的选择，MyIUS应用程序提供了一个有用的工具，可能会使女性和HCPs都受益。需要进一步开展工作，以在真实环境中验证预测算法和MyIUS应用程序的性能。
