Pharmaceutical Company Medical System DevOps

The Challenge
An international pharmaceutical company specializing in immunomodulatory therapy to enhance immunologic response in cancer patients needed to develop a prototype software of an all-new single board computer and Operating System for their Photopheresis System. Key objectives included modernizing the device user experience and demonstrating that the QNX microkernel could replace the existing operating system thereby reducing failure risk and streamlining design, coding and regulatory documentation requirements for future upgrades.

The Solution
A development process was implemented compliant with IEC 62304 standards and the client’s ISO-13485 development process. A team of four (4) QNX developers lead by an Engagement Manager leveraged a DevOps methodology to engage technology partners, QA, design developers, and other stakeholders to define the UX/UI of the GUI and its inputs, actions, and outputs. This enabled the QNX development team to provide feedback on the compatibility of the QNX software across multiple boards, optimize design and development and more comprehensively manage and mitigate risks in design and function to the client.

The Result
The team made significant contributions to the evolution of the system identifying risks and issues with the proposed system design and operational protocols. This saved incalculable challenges which the project would have faced downstream. A developed GUI prototype was tested, reviewed, and accepted by the client for inclusion in the new device in three (3) months. The full-scale development for the go-to-market device, with an expanded team, is now underway.

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