Ventricular Assist Device Real-time Control Software

MEDICAL SYSTEM:

Ventricular Assist Device (Class III)

WORK SCOPE:

Develop a data logging service for an embedded software system comprised of multiple inter-connected microprocessors, and provide a means to connect real-time monitors to view streaming data using a USB interface.

BACKGROUND:

The startup company was facing many challenges, including: finalizing hardware design, complexities in software architecture due to a distributed processor architecture, and design areas still being researched meanwhile system integration is underway to meet tight schedule for verification and validation before certification testing and PMA submission.

RESULTS:

Designed and developed a robust data logging service providing simple interfaces to multiple processors using SPI and UART serial protocols. The design incorporated two data channels for logging; the first channel supported asynchronous logs that can be created by any subsystem within the software system (w/ variable payload sizes), and another channel to transport real-time streaming data to an external monitor connected with a USB link. Additionally a sync buffer was resident on the device for future downloads of the last 24 hours of high resolution data. The streaming data allowed the algorithm team to efficiently optimize and validate the production measurement algorithms. It also supported critical system testing functions that studied various reliability characteristics of electro-mechanical components within the system.

The design used a uSD (Class x10) memory card as the storage media enabling easy scaling for future needs of extra storage capacity, and integrating high performance wear-leveling for durability. Generated the related IEC-62304 documentation for Class C software, including requirements, design, unit testing and integration testing records for inclusion in the design history file.

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