Reduced medication errors with Intelligent Medical Device - Medicine Infusion Pump
Client Overview

US-based leading global biotechnology company focused on serving people with rare diseases for more than 30 years with their medication present in 100+ countries. It is a global leader with a strategy to deliver innovative medicines to patients.

Business Challenge

The client wanted to verify and validate working of the infusion pump and to ensure it meets all the relevant medical standards. With this they wanted to:

  • Ensure the accuracy of the amount of dosage infused into the patient’s body
  • Reduce human errors in the injection process
  • Regulatory tests for the infusion pump
Volansys Solution

VOLANSYS developed GUI for the client’s infusion pump through which the injection process can be controlled. Also, helped validate the working of the pump performing a various set of tests on it. The infusion pump has features like:

  • Class B safety device
  • Key component of the Organ Care System (OCS) with two primary components: HYQVIA and IG, both are immunity medicines to be injected via infusion pump
  • Provides accurate dosage necessary to sustain organs during transport
  • 1-channel syringe pump for inclusion
  • Easy configuration of dosage
  • Alerts notifications: Replace Battery, Infusion Step Ending, End Of Flush, Near End Infusion, Low Battery, End Of Infusion, Air In Line, Occlusion Line set, Shutdown Batter, Intern Fault
  • Battery operated device
  • Certified VectorCast software
Software Development
  • Firmware development for the infusion pump (STM32F479NIH6)
  • Developed GUI based on MICRIUM OS (UC OS2)
  • Software source code compatible with FDA
  • Provided multiple drivers support: SPI, UART, I2C, USB
  • Multiple alerts detection and notification
  • Air in line and Occlusion detection
  • Integrated IR, PRESSURE, HALL Sensors
Quality Engineering
  • Prepared test plan for the Unit testing, Functional testing and Integration testing of the product
    • Test Case for Stepper Motor, ADC, NVRAM, Pressure sensor, an Infusion port, Syringe actuator, Syringe refilling, etc.
  • UI testing
  • System testing complying FDA and HIPPA protocols
  • Covered 10800+ line of code (LOC)
  • Generated test case using VectorCast
    • Test case for Unit Testing, Individual functionality testing, Integration testing
  • Generated test report with more than 90% of code coverage
    • Coverage summary that provides a Color-Coded view of source code that is completely covered, partially covered or uncovered
    • Metrics summary that provides a tabular list of code complexity
    • Modified Condition / Decision Coverage (MC/DC) test summary
Benefits Delivered
  • Automate medicine injection process
  • Reduced medication errors occurred during its infusion
  • Handy and easy to use for the patients and medication management system