2026-08-18T18:30:18.257Z http://ezaposleni.singidunum.ac.rs/rest/sciNaucniRezultati/oai

ezaposleni.singidunum.ac.rs/rest/sciNaucniRezultati/oai:3:12137 2026-08-06T19:21:01Z 3

Leveraging Open Innovation and Systems Thinking to Enhance the Success of AI-Driven HealthTech Ventures: A Case Study of BabyFM in South-East Europe 2026 http://ezaposleni.singidunum.ac.rs/rest/sciNaucniRezultati/oai/record/3/12137 https://link.springer.com/chapter/10.1007/978-3-032-24513-7_28 T. Papić P. Dakić B. Gutić This paper presents BabyFM, an AI-powered wearable medical device for continuous temperature monitoring in pediatric and immunocompromised patients. Developed in Southeast Europe (SEE), BabyFM demonstrates regional entrepreneurship advancing local healthcare while supporting EU digital innovation agendas. The device integrates clinical feedback loops, user-centered design, and cross-sector data integration through an open innovation model involving universities, hospitals, startups, and funding agencies. Clinical validation at the University Clinical Centre of Serbia achieved ±0.1 C measurement accuracy, with AI algorithms showing 91.2% accuracy and 89.4% sensitivity for fever detection. Using mixed-methods research including clinical trials, stakeholder interviews, and systems thinking analysis, the study addresses four research questions regarding device effectiveness, stakeholder-driven design evolution, healthcare integration, and EU policy alignment. Results show successful integration into healthcare workflows, with stakeholder feedback directly shaping key features including real-time alerts, user interfaces, and AI-based thermal analysis. The project’s compliance with EU Medical Device Regulation (MDR) and GDPR standards, combined with Vitalink OS integration, positions BabyFM as a replicable model for regional health technology innovation. bookPart Springer 333 346 https://doi.org/10.1007/978-3-032-24513-7_28 Communications in Computer and Information Science