Software Development for Eckert & Ziegler BEBIG GmbH

The starting point

The task is complex: a medical device with a high proportion of software is to be developed within a heavily regulated environment. The safety requirements are stringent, and the architectural decisions to be made are far-reaching. Furthermore, staff availability is limited, which is why Eckert & Ziegler BEBIG realised early on that the project could not be implemented as desired without external support.

One of the first tasks is therefore to find the right partners for various aspects of the project. Fraunhofer IESE is brought on board for the specification phase, taking responsibility for several areas: requirements specification, context, user and task analysis, software risk analysis, initial architectural consulting and assessment, usability engineering, and the design of the graphical user interface.

Once the specification phase is complete, it is clear that external support is also required for the implementation – the collaboration with t2informatik begins.

The development process

We propose and implement Scrum as the project methodology. For the first six months, we will take on the role of Scrum Master. This part of our remit includes training Eckert & Ziegler BEBIG staff, facilitating meetings, implementing and customising the in-STEP BLUE project management software, and using a Kanban-inspired task board. [Scrum, in-STEP BLUE, task board]

Test-driven multi-layer architecture

As the focus is on maximising maintainability and system security, we design the software architecture of the WPF application using the MVVM pattern. A clear separation of layers, the use of code generators based on T4 templates, and numerous unit tests ensure that all layers can be tested independently of one another. In addition, we configure the Jenkins CI server, customise the build processes in particular, and automate them. [WPF, C#, .NET, T4 Templates, MVVM, NUnit, NSubstitute, Jenkins]

Communication layer

To facilitate system maintenance, we decouple the connection to the medical device using interfaces. In addition, we create a separate reference implementation in C# that defines the behaviour of the medical device. The WPF application can be run and tested via the extracted interface even without a connected medical device. The unit tests are written against the interfaces and must be passed by both the reference implementation in C# and the communication implementation. We use the OPC UA machine-to-machine protocol, with the aid of a third-party library, to establish communication with the medical device. As part of the analysis of the communication technology, we establish a generation technique using CSV files and T4 templates, which allows the connection between the OPC UA client and the server to be fully generated. [OPC UA, C#, .NET, NUnit]

Data model and database upgrade

The software’s data structure is described by an Enterprise Architect model and generated into entity classes using XMI and T4 templates. To this end, we are developing a migration component that allows the database schema, including the data, to be updated in a version-safe and loss-free manner. [NHibernate, C#, SQL, MS-SQL, Enterprise Architect]

Web application and device management

We are developing a web application capable of managing shared data across the HDR brachytherapy product family and exporting it in various formats. [Entity Framework, MS-SQL, C#, ASP.NET MVC]

Automatic upgrade mechanism

The system is capable of updating itself independently via an update package. Running the WPF application in Windows kiosk mode creates a standalone and secure solution that can update and restart the system. The resulting application is developed using a test-driven approach and can be generically extended via a component model.

Creation of a PDF-A generator

All system and customer reports must be generated in PDF-A format. To this end, Eckert & Ziegler BEBIG is developing a technology based on iTextSharp with XHTML/CSS, XML serialisation of model data and XSL transformations, which we are extending for new reports. XSL templates make creating new reports very straightforward, as common sections can be reused from both the XML serialisations and the XSL transformations. [XML, XSLT, iTextSharp, NUnit, C#, .NET]

Conducting system tests

All functional requirements specified in the specifications must be verified for each release of the product through system tests. To this end, we create test report templates based on the requirements and execute them in an integrated system. In the event of extensions and/or changes to the requirements, the test reports are adapted accordingly. [Requirements management, Test management, in-STEP BLUE]

Maintenance, support and servicing

During the pilot phase, we assist internal support staff with complex fault analysis and respond to enquiries from international customers. Today, we support Eckert & Ziegler BEBIG with the ongoing maintenance and servicing of the system: we carry out code reviews, improve performance, migrate individual components and assist with the implementation of customer requirements. [C#, .NET, B&R Automation, Visual Studio]

Knowledge transfer

The sustainable development of the product requires coaching for internal staff. Our tasks include an introduction to WPF development, practices such as clean code, adherence to architectural standards, and the approach to fault analysis. [C#, .NET, UML]

Experience combined with high motivation of the t2informatik employees

Eckert & Ziegler BEBIG

Eckert & Ziegler BEBIG is a young, dynamically growing company with around 145 employees all over the world. With annual sales of around 25 million euros, the company pursues a strategy of continuous market expansion and permanent improvement of its product portfolio in order to optimally support the fight against cancer. The company has been listed on the Euronext stock exchange since 1997.

Here you can find more information about Eckert & Ziegler BEBIG.

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