Breathing Pacemaker

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The Challenge

A complete redesign of a life-sustaining breathing pacemaker, intended for use by patients who have lost neurological control of respiration. This Class III device with Major Level of Concern software needed a modern digital solution, improved user interface and software refinements to mitigate patient safety concerns.

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The Complexity
  • Complete redesign of the external controller from analog to digital, mirroring the predicate device’s inputs, outputs, and overall functionality to serve as a one-to-one replacement
  • Refined user interface to include a keypad and a custom LCD screen
  • A fully independent, redundant hardware solution in the external controller in case of software failure
  • Multiple microprocessors, each dedicated to a unique task
  • Rewrite of existing requirements to improve testability and support defining and testing for uncommon processes not considered in the existing DHF

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