Medical Device Development within a Modern Embedded Software Ecosystem
Syringe Pump Development from Simulation to HIL
Developing modern medical devices requires more than embedded software expertise. Manufacturers must demonstrate traceability, verification, risk control, cybersecurity awareness, and regulatory readiness throughout the product lifecycle. To showcase a practical and scalable development methodology, SwiftAct developed a syringe pump as a reference project for the application of state-of-the-art engineering practices in the medical domain. The project demonstrates how continuous testing, virtualization, and quality-driven development can be integrated from the earliest concept phase through final product validation.
About SwiftAct
SwiftAct is a globally operating engineering company specializing in embedded software, functional safety, cybersecurity, and regulated product development. The company supports customers throughout the entire product lifecycle, from requirements engineering and system architecture to verification, validation, and compliance readiness, with a strong focus on safety-critical industries including medical technology.
Challenge
A key challenge in medical device development is maintaining engineering efficiency while hardware, software, and regulatory artifacts evolve simultaneously. Traditional approaches often delay testing until hardware becomes available, creating bottlenecks and increasing project risk. SwiftAct pursued a different strategy: establish a reusable verification environment early and evolve it together with the product. To achieve this goal, SwiftAct relied on the Vector ecosystem as a common foundation for simulation, test automation, quality assurance, and validation. This enabled development teams to start validating requirements long before the final hardware platform existed and to reuse test assets throughout the entire development process.
Engineering Methodology
The project began with software-only prototyping. Using CANoe, SwiftAct created virtual representations of syringe pump subsystems and user interfaces. In parallel, automated test suites were implemented in vTESTstudio, creating a test-first environment that supported architecture evaluation and requirements verification. Unit testing was expanded with VectorCAST, while PC-lint Plus provided static analysis to identify potential defects early in the lifecycle. The test cases from the simulation phase were re-used in a Software-in-the-Loop scenario for dynamic software testing, eliminating most issues before moving to real hardware.
Continuous Quality and Validation
Following component selection, development moved toward modular PCBs and product variants. At this stage, SwiftAct expanded its continuous integration and continuous testing strategy. Test results, development metrics, and quality indicators were consolidated and visualized within SQUORE dashboards, providing objective visibility into product maturity and supporting engineering decision making through defined quality gates. Once the final hardware became available, the syringe pump was integrated with the Vector VT System for Hardware-in-the-Loop testing. CANoe panels mirrored the device interface and enabled both automated and exploratory testing of the physical system. This approach allowed complete system verification using the same engineering principles that had already been established during the earliest prototyping activities.
Outcome and Partnership Value
The syringe pump project highlights the value of the strategic partnership between SwiftAct and Vector. Rather than applying isolated tools to individual development phases, SwiftAct benefits from a cohesive engineering workflow spanning simulation, automated system testing, unit testing, static analysis, quality monitoring, and Hardware-in-the-Loop validation. The result was a continuous and traceable development process that supported product quality, reduced technical risk, and improved engineering efficiency. For medical device manufacturers facing increasing regulatory and cybersecurity demands, the combination of SwiftAct’s engineering expertise and the Vector ecosystem provide a scalable framework for bringing innovative products to market with greater confidence and predictability.
