Automated Nitric Oxide Therapy System: Connected iNO Delivery for NICU Patients
Development of an FDA-compliant automated inhaled Nitric Oxide (iNO) therapy system for NICUs treating newborns with persistent pulmonary hypertension. Features precise gas delivery, real-time monitoring, cloud connectivity for remote oversight, and comprehensive safety systems. Reduces iNO therapy costs by 60% while improving treatment outcomes.
The Challenge
Newborns with Persistent Pulmonary Hypertension of the Newborn (PPHN) require precise inhaled Nitric Oxide therapy, but existing systems are prohibitively expensive and lack remote monitoring capabilities. An affordable, connected solution was needed for NICUs in emerging markets.
Prohibitive Treatment Costs
Traditional iNO therapy systems cost $15,000-$25,000 per patient treatment course. This limits access in developing countries where PPHN mortality is highest.
Impact: Limits treatment accessPrecise Dosing Requirements
iNO requires extremely precise delivery (1-80 ppm) as both under-dosing (ineffective) and over-dosing (toxic NO2 formation) are dangerous for fragile newborns.
Impact: Life-critical precisionContinuous Monitoring Need
NO2 and methemoglobin levels must be continuously monitored. Manual monitoring is labor-intensive and prone to gaps in coverage.
Impact: 24/7 vigilance requiredRemote NICU Challenges
Many NICUs lack specialist availability 24/7. Remote expert consultation and monitoring was essential for safe therapy management.
Impact: Limited expertise accessOur Solution
We developed a fully automated iNO delivery system with precise gas mixing, real-time monitoring, cloud connectivity for remote specialist oversight, and comprehensive safety interlocks - achieving FDA clearance while reducing treatment costs by 60%.
System Architecture
Complete iNO therapy ecosystem from gas delivery to cloud monitoring.
Delivery System
- Precision NO/N2 gas blending
- Mass flow controllers (0.1 LPM resolution)
- Electrochemical NO/NO2 sensors
- Integration with ventilator circuits
- Cylinder pressure monitoring
- Automatic cylinder switchover
Monitoring Unit
- Real-time NO concentration display
- NO2 level monitoring with alarms
- SpO2 integration capability
- Methemoglobin tracking prompts
- Treatment logging and trending
- Touch-screen operator interface
Connected Platform
- Cloud-based therapy monitoring
- Remote specialist consultation
- Multi-NICU dashboard
- Treatment protocol management
- Automatic adverse event reporting
- Predictive maintenance alerts
Custom Hardware Design
| MCU | STM32F7 (Safety-critical rated) |
| Flow Control | Mass flow controllers (±1%) |
| NO Sensor | Electrochemical (0-100 ppm) |
| NO2 Sensor | Electrochemical (0-10 ppm) |
| Display | 7" Medical-grade LCD |
| Connectivity | WiFi + Ethernet + 4G backup |
| Power | Medical-grade PSU + 4hr UPS |
| Enclosure | IP54, IEC 60601-1 compliant |
Safety-Critical Firmware (IEC 62304 Class C)
- Dual-core architecture with safety processor
- Watchdog supervision with safe-state fallback
- Real-time NO/NO2 PID control loop (100 Hz)
- Alarm management with priority escalation
- Comprehensive event logging (1-year storage)
- Secure OTA updates with rollback capability
- Self-test routines on startup and continuously
- FDA 21 CFR Part 11 compliant audit trail
Implementation Timeline
Phase 1: Requirements & Architecture
10 weeks- Clinical requirements with neonatologists
- Regulatory strategy and predicate analysis
- FMEA and risk management planning
- System architecture and safety design
Phase 2: Gas Delivery System
16 weeks- Precision flow control design
- Gas mixing chamber optimization
- Sensor integration and calibration
- Pneumatic safety system design
Phase 3: Electronics & Firmware
18 weeks- Safety-critical PCB design
- IEC 62304 Class C firmware development
- Alarm system implementation
- Dual-processor safety architecture
Phase 4: Software Platform
14 weeks- Cloud monitoring platform
- Mobile app for remote access
- EMR integration module
- Cybersecurity implementation
Phase 5: Verification & Validation
14 weeks- IEC 60601-1 electrical safety testing
- Gas delivery accuracy validation
- Clinical simulation testing
- Biocompatibility assessment
Phase 6: Regulatory Submission
8 weeks- 510(k) submission compilation
- FDA review and response
- CE technical file preparation
- Manufacturing validation
Results & Impact
The automated iNO therapy system has been deployed to 500+ NICUs, dramatically improving access to this life-saving treatment while reducing costs by 60%. The connected platform enables remote expert oversight for NICUs lacking specialized staff.
Dosing Accuracy
Exceeds FDA requirements
Cost Reduction
vs traditional iNO therapy
NICUs Deployed
Across 8 countries
Uptime
Device reliability
Remote Consultations
Expert sessions conducted
Lives Treated
Newborns receiving therapy
“Before this system, we had to transfer PPHN babies to tertiary centers 200km away - many didn't survive the journey. Now we can treat them here with remote specialist support. It's genuinely saving lives in our community.”
Head of Neonatology
District Hospital NICU, India
Technologies Used
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