Contact:  303-746-2462

​Medical Device Design

Algorithm and System Design

Experience developing Non-Invasive Class II Medical Devices

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• Non-Invasive Parameters
  • Regional Saturation RsO2 (Brain Oxygenation)
  • Pulse Oximetry
    
    • SpO2 (Arterial Oxygenation)
    • Respiration Rate 
    • Heart Rate
  • Severity of Asthma (Concentration of Nitric Oxide in Exhaled Breath)
• Design Controls
  
  • User Needs, Plan, Inputs, Outputs, Verification, Validation, Transfer, Change Control 
    
• Algorithms
  • Signal Processing
    
    • Equations calibrated from clinical Hypoxia studies 
    • Neural Networks to compensate for "Outliers"
  • Calibrations:  Cable crosstalk, dark sensor and electronic offsets
  • Sensor On/Off Detection
  • Desaturation Detection Alarm
    
  • System power minimization for battery powered applications
    
  • Algorithms developed in Matlab and converted to C for embedded implementation
• ​Sensors
  
  • ​LED specification and characterization
    
  • Light Emission Pattern with Sensor Padding
    
  • Patient Interface (i.e. adhesion, comfort, compliance)
    
  • Cabling for signal integrity and cable management
    
• ​Pre-Amp Electronics
  
  • ​Trans-impedance amplifier
    
  • Analog and Digital Signal processing
    
  • Time Multiplexing LED Turn-On/Off and Signal Sampling
    
  • ADC Conversion (Sample Rate, Resolution, INL, DNL, SNR, Anti-Alias)
  • Signal Integrity (i.e. SNR, Cross-Talk, Offsets, Error Budget)
• Testing
  • Patient Simulation
  • Phantoms
  • Corner Cases
  • Statistical Performance Analysis
• Clinical Studies
  • Objective(s)
  • Design including Sample Size and Demographics
  • Site(s) Selection
  • Data Analysis and Conclusions
  • 510K Submission
• Manufacturing
  • Design for Manufacturability