Equipment management for blood centres and processing labs

For Terumo, a medical device manufacturing company leading in blood component, therapeutic apheresis, and cellular technologies, Itransition created TOMEs, an operational medical device solution. It empowers blood centres and processing labs to achieve operational excellence through comprehensive data management, consistent process control, and complete operational visibility.
The software is designed to help blood centres and lab operations collect and manage a large amount of critical data related to the collection, processing, and storage of blood in a highly regulated environment, complying with the requirements of IEC 62304, HIPAA, FDA, GDPR. The solution can interface with multiple medical devices of different functionality and manufacturers along the blood supply chain, automatically integrating and managing them and their data in real time. With each device sending data every 10-15 minutes and accumulating data over time, we solved the challenge of connecting a large number of medical devices simultaneously and enabled blood centres and processing labs with a device-heavy infrastructure to use the solution.
Central to the medical device management system is bidirectional communication. TOMEs provides bidirectional connectivity with medical devices and other company systems, enabling blood center leadership to build a network that helps them make procedural decisions, support compliance and traceability, maximise donations, ensure process control, and improve efficiencies and productivity.
To centralise device configuration, process customisation and enforcement, and automate data capture for traceability, we created a module that combines several peripheral devices of different types and manufacturers into one station to be managed as a single procedure.
The solution is currently used by 400+ blood centres and processing labs globally, helping track and optimize blood manufacturing operations, with hundreds of devices simultaneously connected to the app.