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Medical Device Design

Algorithm and System Design


Experience developing Non-Invasive Class II Medical Devices

  • 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