4 📄 Overview A comprehensive system comprising a smart GLP-1 injection pen or an attachable sensor for existing pens, paired with a mobile application. The system automatically records injection dates, times, and dosages, provides reminders, and offers educational content. It uses behavioral nudges and motivational feedback to encourage consistent medication adherence, providing real-time data to both patients and clinicians. Key technologies: 👤 Target users: 👍 Benefits Significant improvement in medication adherence rates • Better clinical outcomes due to consistent drug exposure • Reduced burden on clinicians for adherence monitoring • Empowered patients with clear adherence visibility Use bullets or new lines. 👎 Challenges Cost of smart injection devices or sensors • User acceptance and ease of integration into daily routines • Data privacy and security for personal health data • Interoperability with existing EHRs for clinician access 📋 Regulatory & Validation Likely Class IIa or IIb SaMD, particularly if it provides feedback or prompts impacting therapy management. Needs robust validation of data accuracy, cybersecurity, and user-friendly design.