Developing Next-Generation Heart-Lung Machine Software for Critical Care Systems

Heart-lung machines are critical during open-heart surgery, ensuring continuous blood circulation, oxygenation and real-time patient monitoring. To support a next-generation platform, a global medical technology company partnered with T&S to strengthen the software, firmware and validation activities of critical components - improving reliability, accelerating verification and supporting safer clinical operations through robust testing and traceability.

Client context

The client, a major international medical-device manufacturer specialising in cardiovascular technologies, was developing a new generation of heart-lung systems for highly demanding surgical environments. Extracorporeal circulation systems require extremely high reliability, software quality and validation rigour, while the client needed to accelerate development and integration cycles and maintain full compliance with medical-device regulations across multiple interconnected subsystems.

Business challenges

• Strengthen software verification with full traceability between requirements, test protocols and results
• Make testing scalable for future product evolutions and subsystem integrations
• Coordinate firmware, hardware validation and subsystem integration in a highly regulated environment
• Overcome manual-testing limitations slowing verification cycles

The T&S solution

T&S combined embedded software development, V&V expertise and automated testing engineering. The teams led software verification and validation protocols for critical subsystems, including test-case development, requirement-traceability management and validation support aligned with medical-device quality practices. T&S engineers contributed to embedded firmware development and supported hardware-validation phases, and designed and implemented dedicated automated test benches to accelerate validation cycles while increasing reproducibility and integration quality. Close collaboration with the client's teams ensured subsystem-integration consistency across the platform.

Technologies & expertise

• Embedded software engineering
• Firmware development
• Verification & Validation (V&V)
• Automated testing
• Requirement traceability
• Hardware validation
• Medical device integration

Results & business value

• Delivery of compliant, reliable software and firmware components for next-generation heart-lung technologies
• Accelerated verification and improved subsystem-integration quality via scalable automated testing
• Reinforced traceability and more efficient test management across the lifecycle
• Strengthened the client's ability to develop critical medical systems with greater reliability

Conclusion

The project highlights T&S's expertise in complex medical-device development involving embedded systems, critical software validation and automated testing, contributing to advanced cardiac-care technologies for demanding surgical applications.