OPP_ALS_001 📄 Overview Develop and validate a SaMD platform leveraging wearable sensors (e.g., smartwatches, patches with accelerometers/gyroscopes) and smartphone-based speech analysis to continuously monitor key ALS progression markers like gait speed, fine motor dexterity, balance, and speech intelligibility. This platform would capture subtle, day-to-day functional changes in the home environment, providing high-frequency, objective data superior to infrequent clinical assessments. Key technologies: 👤 Target users: 👍 Benefits Earlier detection of therapeutic effect • Reduced sample size requirements for trials • Shorter trial duration • More objective and sensitive endpoints • Reduced patient burden from clinic visits • Enhanced understanding of disease progression variability Use bullets or new lines. 👎 Challenges Sensor validation for medical accuracy • Ensuring patient adherence to wearing devices • Data security and privacy at scale • Regulatory acceptance of novel digital endpoints • Interoperability with existing clinical trial systems • Accessibility for patients with advanced ALS 📋 Regulatory & Validation Requires SaMD classification (e.g., FDA Class II, EU Class IIa/IIb) with full QMS compliance. • Validation studies demonstrating clinical meaningfulness and analytical validity of digital biomarkers are essential. • Clear guidance on data ownership and informed consent for continuous data collection.