Software erosion protection for embedded software in medical devices

Success Story in collaboration with B. Braun

Software erosion protection for embedded software in medical devices

B. Braun uses the Axivion Suite as a quality gate for internally and externally developed components. Assuring the internal quality and maintainability of infusion device software gives B. Braun a crucial competitive advantage

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THE CHALLENGE ++

Device-based infusion technology at B. Braun has a long, rich history, which has been shaped considerably by its invention of the first syringe pump in 1951. Since then, all subsequent developments have prioritised high standards of quality in conjunction with innovative solutions that simplify daily tasks – resulting in a strong track record spanning more than half a century. Infusion pumps from B. Braun support a wide variety of therapies and can be specifically tailored to the particular conditions of use. This core competence is one of B. Braun’s USPs, but at the same time, it presents a daily challenge in terms of developing the hardware and, even more so, the software due to the resultant number of different versions. One of the key strategic requirements is that B. Braun has to have in-house expertise in the core competencies of the therapies concerned.

At very busy times, however, the internal development teams have to be supplemented with external collaborators in order to process large projects quickly and flexibly.

The first challenge here is to guarantee seamless communication with a view to achieving flexible collaboration with multiple partners. The second is to meet the extremely high requirements demanded by medical technology. This calls for strict quality controls, especially with respect to externally developed components.

THE SOLUTION ++

When developing new infusion pumps, B. Braun relies on a product line with a uniform architecture. This architecture was designed by B. Braun itself and implemented by external partners. To allow flexible collaboration with multiple partners, conformity to the architectures and the specifications for the internal software quality is absolutely essential.

For this reason, the Axivion Suite is used during the development phase to check conformity to the architectural specifications, as well as other guidelines covering the internal quality and maintainability of the infusion device software. As part of the acceptance procedure for externally developed components, the Axivion Suite also functions as a quality gate, ensuring that internal and external development both meet the same architectural specifications and quality guidelines.

Due to the generic and open nature of the Axivion Suite, the automated analyses of the software erosion protection could be tailored perfectly to the technologies used by B. Braun.

THE SUCCESS ++

By analysing and checking internally and externally developed software in this way, the subsystems of different development strands can be perfectly dovetailed. Deviations from the uniform product line architecture and the specified quality benchmarks are detected immediately so that appropriate measures can be taken promptly. New development partners of B. Braun quickly find their way around the architecture, enabling them to become productive in next to no time. Plans can be executed based on the architecture without the need for extensive training. Hidden dependencies and the resulting side effects are eliminated for good.

The product line architecture is actually implemented in practice and does not just exist on paper. The multitude of different versions is now easier to manage, freeing up more resources for development and for improving the actual therapies.

B. Braun is thoroughly fit for the future in the highly competitive environment of infusion device manufacturers. By using the Axivion Suite to check the maintainability and internal quality of its software, B. Braun will be able to retain this competitive advantage over the long term.

ABOUT B. BRAUN ++

B. Braun supplies the global healthcare market with products for anaesthesia, intensive medicine, cardiology, extracorporeal blood treatment and surgery, as well as services for hospitals, general practitioners and the homecare sector.

Through dialogue with those who are using B. Braun‘s products on a daily basis, the company is continually gaining new knowledge which it incorporates into its product development. In this way, the company creates innovative products and services that help to optimise working procedures in hospitals and medical practices all over the world and help to improve safety – for patients, doctors and nursing staff.

With some 44,000 employees in over 50 countries, B. Braun achieved a turnover of 4.6 billion euros in 2011.

 

Sources of images: B. Braun