Case Study 1: Remote Patient Monitoring Wearable – FDA-Cleared Product

Futuristic AI Processor on Neon Circuit Board

Ultra-Low Power Wearable ECG/PPG Monitor Firmware

Challenge

A healthcare startup required an ultra-low power wearable ECG/PPG monitoring device that meets
FDA Class II compliance, delivers medical-grade accuracy, and supports
BLE connectivity with secure cloud integration — all while maintaining
<2mA average power consumption.

Solution

  • Bare-metal firmware optimized for extreme low power using event-driven architecture and intelligent sleep states
  • Secure BLE 5.x stack with HIPAA-compliant encryption
  • Crash-safe data logging with robust OTA (Over-the-Air) update infrastructure
  • IEC 62304 compliant software development lifecycle with complete documentation
  • Cloud gateway integration with hardware-backed secure key management

Outcome

  • Battery Life: 14 days on a single charge (vs. 2-day competitor baseline)
  • Time-to-Market: 16 weeks from firmware kickoff to FDA submission
  • Deployment: 50,000+ devices in the field with zero critical firmware recalls
  • Cost Reduction: 30% lower firmware engineering cost compared to offshore teams
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