Medical Wearable: FDA-Cleared Remote Patient Monitoring Device for Cardiac Care
End-to-end development of an FDA 510(k) cleared wearable ECG monitor with 14-day battery life, achieving 99.2% arrhythmia detection accuracy and enabling remote monitoring for 50,000+ cardiac patients.
The Challenge
A US-based digital health startup needed to develop a medical-grade wearable ECG monitor that could continuously monitor cardiac patients for up to 14 days, detect arrhythmias in real-time, and achieve FDA 510(k) clearance for the US market.
Regulatory Compliance
The device needed to meet stringent FDA requirements including IEC 62304 software lifecycle, ISO 13485 quality management, and IEC 60601-1 electrical safety standards.
Impact: 18+ month typical timelineBattery Life Requirements
Continuous ECG monitoring with BLE transmission required 14 days of operation on a single charge while maintaining a form factor acceptable for patient comfort.
Impact: < 30g weight targetClinical-Grade Accuracy
The device needed to match or exceed Holter monitor accuracy for arrhythmia detection, with sensitivity and specificity targets above 95%.
Impact: Predicate device comparisonCost Constraints
To enable wide deployment, the BOM cost needed to be below $35 at volumes of 100,000 units while meeting all medical-grade requirements.
Impact: $35 BOM targetOur Solution
We developed a complete medical-grade wearable ECG monitoring system including custom hardware, embedded firmware, mobile app, cloud platform, and all regulatory documentation required for FDA 510(k) clearance.
System Architecture
End-to-end medical IoT architecture designed for regulatory compliance, reliability, and scalability.
Wearable Device
- Medical-grade analog front-end (AFE)
- Ultra-low-power MCU with DSP
- On-device arrhythmia detection
- Bluetooth Low Energy 5.0 connectivity
- Skin-friendly medical adhesive
Mobile Gateway
- iOS and Android companion apps
- Real-time ECG visualization
- Offline data buffering
- Patient symptom logging
- Automatic cloud sync
Clinical Platform
- HIPAA-compliant cloud infrastructure
- AI-powered ECG analysis
- Clinician dashboard
- Alert management system
- EHR integration (HL7 FHIR)
Custom Hardware Design
| MCU | nRF52840 (BLE 5.0, DSP capable) |
| AFE | ADS1292R (24-bit, medical-grade) |
| Electrodes | Ag/AgCl dry electrodes |
| Battery | 180mAh Li-Poly (rechargeable) |
| Dimensions | 55mm x 25mm x 8mm |
| Weight | 18g (with adhesive) |
| Protection | IP67, IEC 60601-1 certified |
Firmware Architecture (IEC 62304 Class B)
- FreeRTOS-based architecture with watchdog supervision
- Real-time 256Hz ECG sampling with DMA
- On-device R-peak detection and HRV calculation
- QRS complex classification (normal, PVC, PAC)
- BLE GATT service for ECG streaming
- Encrypted firmware OTA updates
- Comprehensive fault detection and logging
- Battery management with 1% accuracy
On-Device AI for Arrhythmia Detection
We implemented a lightweight neural network on the device for real-time arrhythmia screening, with cloud-based analysis for detailed diagnosis.
Beat Classification
1D CNN (Convolutional Neural Network)
99.2% for VEB/SVEB detection
Atrial Fibrillation Detection
LSTM with attention mechanism
97.8% sensitivity, 98.5% specificity
< 2 second detection delay
Signal Quality Assessment
Random Forest classifier
96% noise/artifact detection
Implementation Timeline
Phase 1: Requirements & Architecture
8 weeks- User needs analysis and clinical workflow study
- Regulatory strategy and predicate device analysis
- System architecture and risk analysis
- Design input documentation
Phase 2: Hardware Development
16 weeks- Analog front-end design and simulation
- PCB layout (4-layer, flex-rigid)
- 3 prototype iterations
- IEC 60601-1 design verification
Phase 3: Firmware Development
20 weeks- IEC 62304 compliant software architecture
- Real-time ECG acquisition and processing
- BLE stack implementation
- On-device ML model integration
- Unit and integration testing (98% coverage)
Phase 4: Software Development
16 weeks- iOS and Android app development
- Cloud platform development
- Clinician dashboard
- Cybersecurity implementation
Phase 5: Verification & Validation
12 weeks- Bench testing per IEC 60601-2-47
- Clinical validation study (200 patients)
- Usability testing
- Biocompatibility testing
Phase 6: Regulatory Submission
6 weeks- 510(k) submission preparation
- FDA review and response
- Clearance received
- CE Mark submission
Results & Impact
The device achieved FDA clearance on first submission and has since been deployed to monitor over 50,000 cardiac patients, with clinical outcomes significantly better than traditional Holter monitoring.
Arrhythmia Detection Accuracy
vs 94% for traditional Holter
Battery Life
vs 24-48 hours for competitors
Patient Compliance
vs 68% for chest-strap monitors
Time to FDA Clearance
vs industry avg 18-24 months
Manufacturing Cost
Below $35 target
Patients Monitored
First 18 months post-launch
“Rapid Circuitry didn't just build us a device - they helped us navigate the complex regulatory landscape and delivered a product that exceeded our clinical requirements. The FDA clearance on first submission was remarkable.”
CEO & Co-Founder
Client Digital Health Startup
Technologies Used
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