Software for medical technology

Many medical devices utilize software designed to meet the special requirements of current regulation. The software developer CODIALIST GmbH in Berlin (Germany) supports various customers in the MedTech sector. We spoke to Dr. Dominik Karch about the exciting projects they have conducted and the challenges within this business area.

Dr. Karch, for which areas of medical technology are you available to companies?

Karch: CODIALIST develops software on behalf of customers for medical devices used in diagnostics or therapy. Software in medical devices typically has the task of recording signals. For example, from pressure sensors, electronic components or batteries. The software processes these signals, evaluates them or controls the device. This could be a motor that needs to be driven or an alarm that is triggered.

We can develop the software or parts of it that are needed for this. We do this with state of the art technology respecting the requirements of the Medical Device Regulation (MDR) in Europe and the specifications of the Food and Drug Administration (FDA) in the USA. Our offer to companies is, therefore, the provision of software for a product.

Can you give us an example of a successful project?

Karch: We developed the software for a heart support system, the EXCOR® Active from Berlin Heart. The mobile device is particularly suitable for use in children and is used in cases of heart failure. The waiting time for a donor organ can be long. During this time, an external pump takes over the work of the heart. In contrast to other devices, this mobile device has the advantage that it improves the quality of life of patients and their families because it allows them to leave their hospital room and move freely around the hospital grounds.

Is there a back-up system for the device? A malfunction outside the clinic would certainly be fatal.

Karch: Yes, that is a particularly important issue with a device like this. Risk management precisely takes such considerations into account: What happens if a component fails? For these reasons, redundancies are built into the system. For example, the power supply has multiple redundancies. This means that if one part fails, another takes over. The pump system is also redundant so that the blood flow is always guaranteed.

All these considerations are part of our development work for the software. We always think carefully about what could go wrong. What errors could occur? To build in functions in advance that prevent damage.

How do you ensure that the software is protected?

Karch: We have just talked about security in terms of functional security, for example the failure of a device. In the meantime, IT security has also become a major issue. We must protect the software, for example, from an external attack. We see this as an integral part of the entire software development process. This means that we consider this aspect in all phases of software development, right through to verification.

It is crucial that we create a so-called threat model. From this, we derive the necessary protection functions for the software.

With this approach, we implement the IEC 81001-5-1 standard, which defines security in the software life cycle for medical devices. This naturally generates a lot of documentation. We use this as proof that we have protected the software well according to the current state of the art.

What is the life cycle of a heart pump? Do they need to be updated, for example?

Karch: The system consists of several components. The diaphragm pumps, for example, are only used for one person. But the drive system can be used for several patients and over several years. That's why it was planned from the outset to install software updates. And this has now been done.

You were an exhibitor at COMPAMED 2023. How did you use the tradefair?

Karch: We use various digital channels to present our range. But for us, a tradefair like COMPAMED is a very good opportunity to supplement our presence and present ourselves in a different way. You can contact visitors at the trade fair and get to know them personally. This is very important in order to build relationships. And we can tangibly show what we are working on. We also receive feedback that you don't get online in this form. That's why our visit to COMPAMED 2023 was very valuable for us.