OPP003 📄 Overview A SaMD platform combining continuous wearable sensor data (e.g., vital signs, activity, wound status via smart bandage) with AI-driven analytics to monitor patients post-surgery at home. It detects early signs of complications (infection, DVT, worsening vitals) and provides alerts to clinicians, while offering patients personalized recovery guidelines and progress tracking. Key technologies: 👤 Target users: 👍 Benefits Reduced hospital readmissions and emergency room visits • Earlier detection and intervention for post-surgical complications • Improved patient comfort and satisfaction with home recovery • Significant cost savings for healthcare systems • Enhanced data for personalized post-operative care protocols Use bullets or new lines. 👎 Challenges Accuracy and reliability of wearable sensor data in diverse home environments • Alert fatigue for clinicians if thresholds are not finely tuned • Ensuring patient adherence to wearing devices and following instructions • Interoperability with hospital EHR and existing clinical workflows • Cybersecurity of sensitive patient data during transmission and storage 📋 Regulatory & Validation Requires SaMD classification for monitoring and alerting (Class II or III depending on specific claims). • Robust clinical validation demonstrating diagnostic accuracy and ability to improve outcomes. • Usability testing for both patient and clinician interfaces is critical for safety and effectiveness.