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Ambulatory Infusion Pump

Problem

A global pharmaceutical company wanted to improve product safety of an existing ambulatory infusion pump in order to reduce programming errors by clinicians.

Solution

This project involved developing communication protocols, coding, unit testing, formal software verification, as well as high-level and detailed software design. Each function was critical to meet government regulations and maintain the integrity of the device.

    Advantages:
  • Defined and implemented data transfer protocols of therapy programming safety limits
  • Redesigned serial communication firmware to interface with the desktop pump configuration application
  • Implemented numerous usability and safety enhancements

Result

The project required interfacing and integration with a new desktop application which created seven unique pump configuration profiles.

    Highlights:
  • Functionality was added to support the transfer and storage of hospital-defined therapy-specific programming safety limits
  • Increased usability through updates to the programming workflow
  • Significantly reduced device setup time by supporting electronic transfer of configuration settings from a desktop application
  • Provided documentation for 510 (k) submission to the FDA
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