Artificial Pancreas (Class III)
Development of secure data communications over a Bluetooth (BLE) link connecting legacy insulin pump (pod) with a 3rd party user interface device and a system controller module. Support validation of hardware architecture (processor module, BLE transceiver), signal quality assessment, system integration and testing, and complete IEC-62304 life cycle documentation for a Class III device.
The company was set out to augment a closed-loop control system to automate insulin management based on new algorithms. The control algorithms incorporate predictive (future) sampling and its performance was highly sensitive to link delays, making the BLE communication link a safety critical component in the system design. The BLE link also enables connectivity to a remote data management system.
Designed a binary data storage function purpose built for the 2nd edition alarm settings saving and recovery in the event of power loss. The resident flash memory map was modified to allocate a segregated memory partition for alarm management (2nd edition compliance). In order to minimize the change impact, the changes were limited to the Alarm Management subsystem saving significant time in regression testing. Further, automated unit testing simulating power loss sequences was performed to obtain assurance of the safety and effectiveness of the changes made. Finally, all IEC-62304 lifecycle documentation were updated and formally reviewed, including: requirements, design, code, unit tests and integration tests.
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