Skip to main content
Back to Case Studies
Healthcare / Critical Care
|Medical Equipment Manufacturer - India|
16 months
9 engineers

AI-Powered Oxygen Therapy: Intelligent FiO2 Titration System for Critical Care

Development of an FDA-compliant AI-powered oxygen therapy system that automatically adjusts FiO2 levels based on real-time SpO2 monitoring and predictive algorithms. Reduces oxygen consumption by 35%, prevents hyperoxia-related complications, and decreases nursing workload while maintaining optimal patient oxygenation.

CE Marked
Class IIb Device
35%
Oxygen Savings
< 30 sec
Response Time
98.5%
Target SpO2 Achievement
AI-Powered Oxygen Therapy: Intelligent FiO2 Titration System for Critical Care - Rapid Circuitry embedded systems case study hero image

The Challenge

Manual oxygen titration in hospitals is labor-intensive, often delayed, and frequently results in hyperoxia or hypoxia. A leading medical equipment manufacturer needed an intelligent system to automatically maintain optimal oxygen levels while reducing oxygen waste and nursing workload.

Manual Titration Delays

Nurses check SpO2 and adjust oxygen flow every 1-2 hours. Between checks, patients may experience dangerous oxygen fluctuations that go undetected.

Impact: Delayed intervention risk

Oxygen Overconsumption

Conservative clinical practice leads to unnecessarily high FiO2 settings. Hospitals waste 30-40% of supplemental oxygen, increasing costs significantly.

Impact: $2M+ annual waste/hospital

Hyperoxia Complications

Prolonged high oxygen levels cause lung damage, ROP in premature infants, and increased mortality in some patient populations. Prevention requires precise control.

Impact: Preventable patient harm

Nursing Workload

ICU nurses spend significant time on manual oxygen adjustments. Automated titration would free them for more critical patient care activities.

Impact: 15% nursing time saved

Our Solution

We developed an AI-powered closed-loop oxygen therapy system that continuously monitors SpO2, predicts oxygenation trends, and automatically adjusts FiO2 to maintain target saturation levels - achieving 98.5% time-in-target while reducing oxygen consumption by 35%.

System Architecture

Complete automated oxygen therapy ecosystem with bedside controller, central monitoring, and AI analytics.

Bedside Controller

  • High-precision SpO2 monitoring (Masimo SET)
  • Proportional oxygen blender valve
  • Flow rate sensing (0.1 LPM resolution)
  • FiO2 analyzer for delivery verification
  • Touch display for manual override
  • WiFi + Ethernet connectivity

AI Engine

  • Real-time SpO2 trend analysis
  • Predictive oxygenation modeling
  • PID control with adaptive tuning
  • Patient-specific learning
  • Anomaly detection and alerts
  • Edge inference (< 100ms latency)

Hospital Platform

  • Multi-patient monitoring dashboard
  • Oxygen consumption analytics
  • Clinical decision support
  • EMR integration (HL7 FHIR)
  • Regulatory audit logging
  • Remote specialist consultation

Custom Hardware Design

MCUSTM32H7 (Safety-critical)
SpO2 ModuleMasimo SET (motion-tolerant)
Oxygen ValveProportional solenoid (0-15 LPM)
FiO2 SensorParamagnetic (21-100%)
Flow SensorMass flow (0.1 LPM resolution)
Display7" Medical-grade touchscreen
PowerMedical PSU + 2hr UPS backup
EnclosureIP54, IEC 60601-1 compliant

Safety-Critical Firmware (IEC 62304 Class B)

  • Dual-core architecture with safety supervisor
  • Real-time SpO2 processing at 100 Hz
  • Closed-loop control with 200ms cycle time
  • Watchdog monitoring with safe-state fallback
  • Comprehensive event logging (30-day storage)
  • Secure OTA updates with rollback
  • Continuous self-test routines
  • FDA 21 CFR Part 11 compliant audit trail

Implementation Timeline

Phase 1: Clinical Requirements & AI Research

10 weeks
  • Clinical workflow analysis in ICUs
  • Oxygen therapy protocols review
  • AI/ML algorithm research and selection
  • Regulatory strategy for AI-based SaMD

Phase 2: Hardware Development

14 weeks
  • Proportional valve selection and testing
  • SpO2 module integration (Masimo SET)
  • Safety-critical PCB design
  • Enclosure design per IEC 60601

Phase 3: AI Model Development

16 weeks
  • Training data collection (10,000+ patient hours)
  • SpO2 prediction model development
  • Adaptive PID controller optimization
  • Edge deployment and optimization

Phase 4: Firmware Development

14 weeks
  • IEC 62304 Class B development process
  • Closed-loop control implementation
  • Safety monitoring and alarm system
  • EMR integration protocols

Phase 5: Verification & Validation

12 weeks
  • IEC 60601-1 electrical safety testing
  • Clinical accuracy study (150 patients)
  • AI performance validation
  • Usability testing with ICU staff

Phase 6: Regulatory Submission

8 weeks
  • CE technical file compilation
  • AI/ML documentation (GMLP)
  • Clinical evaluation report
  • Manufacturing validation

Results & Impact

The AI-powered oxygen therapy system has been deployed in 60+ ICUs across India and Europe, significantly reducing oxygen waste while improving patient outcomes through precise oxygenation control.

Oxygen Savings

Reduced consumption vs manual

Time in Target

SpO2 within prescribed range

Response Time

To correct desaturation

Hyperoxia Events

Reduction vs manual care

Nursing Time

Freed for other care

ICUs Deployed

Across India & Europe

“The AI oxygen system has transformed our ICU care. Our nurses no longer spend hours adjusting oxygen flows, and we've virtually eliminated hyperoxia events. The oxygen savings alone paid for the system in 6 months.”

Medical Director, Critical Care

Multi-Specialty Hospital Chain, India

Technologies Used

STM32H7Masimo SETProportional ValvesTensorFlow LiteLSTMReactNode.jsAWS IoT CorePostgreSQLHL7 FHIRMQTT/TLS

Related Case Studies

Healthcare / Neonatal Care

Automated Nitric Oxide Therapy System: Connected iNO Delivery for NICU Patients

Read Case Study
Healthcare / Medical Devices

Smart Urinometer: Automated ICU Urine Output Monitoring System with Real-Time Analytics

Read Case Study

Ready to Build Your Success Story?

Let's discuss how our expertise can help bring your vision to life with measurable results like this project.

Start Your ProjectView More Case Studies