Kidney and liver patients sometimes have to wait up to 4 years for a donor organ. The medical equipment that XVIVO develops to preserve these organs under optimal conditions is decisive for their future. The long-term collaboration with ICT Group as a software partner for medical devices, associated innovative cloud platform and QA/RA advice supports XVIVO in their mission.
Focus on the concept
XVIVO does not produce its own medical equipment. Nevertheless, she is one of the world leaders in the field of medical devices for donor kidneys and donor livers. Arjan van der Plaats, Research & Development Director at XVIVO, consciously opts for this strategy: "We don't physically make anything ourselves. We focus entirely on the concept, we know what the customer wants and translate their user requirements into the concept and technology. That's what we're good at. We do this until the moment you want to turn it into a medical device. Then we engage production partners who supply hardware, fluids, tubes and therefore also the software. We have been working this way since we started in 2005 and both our customers and ourselves still like this very much."
Experts in healthcare
"There are up to 1200 hospitals worldwide that transplant organs. So we have a maximum of 1200 customers. That's why our product must be perfect and continuously evolve with the needs of surgeons and technological innovations. That is why the collaboration with a specialist in healthcare such as ICT Group is so important. They know all about the high requirements that apply to software development, device firmware, gateways and cloud solutions for medical applications. Their engineers and healthcare experts are very familiar with European (MDR) and American (FDA) laws and regulations, and the applicable standards, such as ISO13485 and IEC 62304. They have specialists in every field and we work closely with them."
We just fit together
"At the end of the day, it's about trust. We know that ICT is a good partner. Their people want to know everything, think along with us and control all aspects of our product. They are positively critical and pleasant to work with, also with our other partners, informal, flexible, and also like short lines of communication. ICT Group is large enough to have all the expertise in-house and, for example, to quickly meet the demand for specific capacity. On the other hand, they don't consider us a small customer. What we do is groundbreaking and that also triggers their organization. I don't see any reason why we can't continue in this partnership for a very long time."
Market
"The market for medical equipment for donor organs is completely new. 25 years ago, organs were still stored in a bag of ice in a cooler. Now we have proven that pumping organs is substantially better.
Pump required
All kidneys in the Netherlands are already required to be stored on a pump. We see this happening in more and more countries. Everyone adopts our technology. At the same time, we are taking our concept to an even higher level with technological innovations.
App
For example with our online database 'Insights', our Azure cloud platform that ICT Group renewed and expanded at the end of 2023 with an app that generates overviews and insights. In combination with the SIM & GPS connectivity board, surgeons can now track exactly where an organ is located and how the organ is doing, the so-called perfusion parameters."
Data
"An important innovation is that surgeons have access to more and more operational and historical data. Our machines send their data to the database and our web application visualizes that data in graphs. Surgeons can then request information via any device and monitor the machines realtime. At the same time, the app offers all kinds of options for the future. Surgeons, for example, want to be able to make comparisons and make better decisions based on algorithms, for example about which donor is the best fit for which recipient. Other options include adding donor details or setting up a messaging community for everyone involved in a transplant. Our idea is to streamline all of that in one app. In fact, our product is never finished."
“We have been working together since we started in 2005 and both our customers and ourselves still like this very much.”
End-to-end
ICT Group sees the collaboration with XVIVO as a perfect example for the development of medical equipment and related applications within the healthcare market for which the highest requirements apply. ICT Group delivers an end-to-end solution for firmware and software that fully complies with CE certification. Experts, in close collaboration with the XVIVO product team, take care of every stage of product definition, design, implementation, testing and the required documentation according to the standards of ISO 13485 and IEC 62304. A recurring process that guarantees the highest quality. Product risk management in the donor organ market requires maximum attention and the best specialists for software development, cloud solutions and QA/RA for quality assurance. ICT Group is committed to always providing these and contribute to the care of donor organs as a software partner of XVIVO for years to come.
About XVIVO
Nobody should die waiting for a new organ
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