Summary
Key results
Automation of testing and integration with the CI/CD process
Full compliance of the testing process with medical device standards
Lack of test repeatability as a risk to certification
Blatchford was developing a new embedded software platform (C++ / ARM Cortex) for the next generation of intelligent prosthetics and orthoses. In this type of solution, testing is not an “add-on to quality” – it is the foundation of product safety and predictability, as well as a prerequisite for conducting development in compliance with medical industry requirements. The project required stable and repeatable automated testing, the ability to simulate hardware, and full integration with the development and tracking process in Azure DevOps.
The client needed capabilities combining embedded engineering, test automation, CI/CD, and C++/Python development, along with support in BLE, OTA, and module testing. An additional requirement was alignment of the testing process with medical industry quality expectations, including the context of ISO 13485 and IEC 62304 standards (without audit activities on Sii’s side).
Integrated automated testing framework for embedded systems
Sii Poland assembled a team of Embedded Test Engineering specialists and embedded development experts who, together with the client’s R&D team, built the testing and development foundation for the new platform. The work was carried out in a long-term collaboration model (since 2022), with close communication and alignment with the team in the United Kingdom.
The scope of work included:
- Creation of an Embedded Automated Test Framework – enabling execution of C++ and embedded C code in a virtual environment, mocking of electronic interfaces, simulation of input signals and dynamic parameters, and the ability to run tests locally and in Azure Hosted Agents
- Integration with Azure DevOps – linking testing activities with Azure Test Plans and Azure Boards to unify planning, tracking, and reporting of results
- Module and requirements testing – use of VectorCAST and Robot Framework, supplemented with tests in C++ and Python
- CI/CD for embedded – integration of VectorCAST and Robot Framework tests into pipelines, support in creating and optimizing pipelines, and enabling automated executions (Jenkins was also used as part of the CI/CD environment)
- Over-The-Air (OTA) – development of OTA functionality for the Tectus device, creation of Python tools for firmware encryption, signing, and flashing, implementation of security elements (keys, encryption, signing), and porting OTA to the new Avior platform
- Bluetooth Low Energy (BLE) – development of BLE scripts in Python, communication analysis, and recommendations for protocol improvements
- TestRig and extended testing – development of a TestRig for testing device motors and parameters, support for data collection, and automation of tests from the device-usage perspective
- Maintenance and handover of the framework – Sii also maintained the solution in the initial phase and subsequently transferred the framework to Blatchford
The new solution enables fast, repeatable testing in a production-like environment, ensuring full control over software quality and project documentation.
Higher quality, shorter validation time, greater operational confidence
With the solution developed by Sii Poland, Blatchford gained a repeatable and scalable embedded software testing process aligned with medical industry requirements. The implementation of full module test coverage using VectorCAST, along with functional testing, resulted in higher software quality, easier platform maintenance, and greater readiness for further development.
Automating testing within CI/CD pipelines shortened feedback loops, accelerated detection of regressions and defects, and improved collaboration between teams in Poland and the United Kingdom through a unified operating model.
The collaboration covered not only test automation but also development of key device features, including OTA and BLE, as well as support in maintaining and transferring the solution to the client’s team. Work on the OTA area improved the security and stability of updates, including eliminating the risk of unauthorized firmware access and fully automating the update process.
As a result, Blatchford achieved a more predictable validation process and more stable development of subsequent platform versions, while the collaboration contributed to greater reliability of prosthetic devices, improved patient experience, and a solid foundation for developing the next generation of devices.