The Project / The Challenge
We are developing the Calliope software for the fully automated PoET diagnostic system of the Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH (GFE). GFE is a subsidiary of the German Red Cross (DRK). Calliope is subject to the European harmonized standard IEC 62304, titled “Medical device software – Software lifecycle processes.”
IEC 62304 specifies the minimum requirements for medical devices and in vitro diagnostic medical devices. IEC 62304 covers requirements for the entire lifecycle, including development and maintenance. In the case of software as well, the key challenge is to comply with the standard’s requirements at a reasonable cost.
Our Approach
Our team is trained in the application of the IEC 62304 standard and has developed a development plan that complies with the standard, which we are implementing using an agile SCRUM process.
To ensure traceability across the entire development process—from planning through requirements, specifications, development, and testing to verification—we use a software lifecycle management system (Codebeamer by PTC).
The Result
The fully automated PoET diagnostic system represents the next generation of automated diagnostics for detecting viruses in blood samples. It is based on PCR technology, which enables rapid and multiplex detection. The intuitive user interface, control system, data analysis algorithms, and report generation are all handled by the Calliope software. PoET handles every step of the process, from sample collection to the visualization of results.
The diagnostic analysis workflow in high-throughput laboratories is handled efficiently and fully automatically. The pooling method enables a significant increase in output. In this process, pools of individual samples are created, analyzed together, and in the event of positive results, traced back to the specific individual samples.
Technologies Used
We develop Calliope primarily using the C# programming language with a GUI based on ASP.NET and Razor. In addition, we bring extensive expertise to the project, including:
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A detailed understanding of the processes in blood diagnostics laboratories
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Controlling the Hamilton Vantage Liquid Handling System: Running scripts to control device commands in INSTINCT V
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Application Lifecycle Management (ALM) mit Codebeamer, der ALM-Plattform von Parametric Technology GmbH (PTC)
Application Lifecycle Management (ALM)
For nearly ten years, we have been successfully implementing Application Lifecycle Management (ALM) using Codebeamer, the ALM platform from Parametric Technology GmbH (PTC). With the help of Codebeamer, we have implemented a development process for in vitro diagnostic devices and medical devices in accordance compliant with IEC 62304 that enables traceability throughout the entire application lifecycle.
We use our expertise and customized templates to help third parties establish an IEC 62304-compliant development process using Codebeamer.
Did You Know?
Around 6.5 million blood donations are made each year across Germany.
Blood donations must be approved within 24 hours.
The number of pooled samples depends on the prevalence of the pathogen in question and is adjusted throughout the year.
Since 2018, HB Technologies has been developing, testing, and documenting the Calliope software for our PoET system in collaboration with us. HBT is our partner for the entire application lifecycle and has continued to support us with further developments and optimizations since the product’s market launch in 2021. HBT efficiently implements the regulatory requirements of IEC 62304, and through the use of Codebeamer, we are well-prepared for audits.
Dr. Petra Rehberger
CEO, GFE Blood
