Challenge
A healthcare startup needed to develop an ECG wearable that met FDA Class II requirements,
using medical-grade components and biocompatible materials. The device also required
ultra-low power consumption (under 2mA average) while maintaining clinical-grade accuracy.
Solution
- Medical-Grade Components: Selected components meeting AEC-Q200 equivalent standards.
- Biocompatible Design: Silicone enclosure and electrode materials safe for prolonged skin contact.
- Precision ECG Front-End: Low-noise amplification and filtering for accurate signal capture.
- Embedded Processing: ARM Cortex-M4 for real-time signal processing and anomaly detection.
- Wireless Connectivity: BLE used for efficient and low-power data transmission.
- Optimized Battery: Medical-grade battery chemistry designed for safety and longevity.
- Rigorous Validation: Extensive testing including EMC, biocompatibility, and electrical safety.
Outcome
- Regulatory Approval: Achieved FDA Class II clearance.
- Ultra-Low Power: Maintained under 2mA average consumption with 14-day battery life.
- Clinical Accuracy: ECG accuracy within ±5 bpm, meeting medical-grade standards.
- Market Deployment: Successfully deployed over 50,000 devices in real-world use.
