Industry: MedTech
Customer: Siemens Healthineers AG (D&A)
Topic: Validation & Verification
Siemens Healthineers has made significant progress in stroke care with the development, implementation, and integration of components for a mobile CT scanner and Stroke Connect. This innovative solution combines state-of-the-art technology with efficient testing processes to revolutionize the treatment of stroke patients.
A mobile CT scanner is integrated into a special medical vehicle, delivering image quality comparable to that of stationary devices. The special telescopic gantry allows for easy positioning of the patient, which increases the efficiency of the examination.
Stroke Connect adds a telemedicine approach that enables a doctor in the hospital to remotely begin examining and diagnosing the patient while they are still in the special vehicle.
Siemens Healthineers has implemented a flagship project to pave the way to becoming a comprehensive solution provider in the field of stroke care.
The purpose of this project was to develop a service for the diagnosis and treatment of stroke patients, to be used both in the pre-hospital and hospitalization phases. A new cross-functional test team was set up to improve communication processes in stroke cases, aggregate and present patient-relevant data, digitize the stroke treatment pathway, combine various Siemens Healthineers and third-party products, and integrate stroke case management with audio and video functionality.
Integrating a mobile CT scanner into a specially designed medical vehicle posed a considerable technical challenge. Ensuring image quality comparable to that of stationary devices required innovative solutions and precise calibrations. In addition, the special telescopic gantry had to be designed to allow quick and easy positioning of the patient without compromising image quality.
Another complex element was the combination and interoperability of various Siemens Healthineers and third-party products. This required seamless integration and extensive testing to ensure that all systems worked together smoothly. The digitization of the stroke treatment pathway and the aggregation of patient-relevant data from various sources (MSU, EMR, etc.) placed additional demands on data processing and security.
Working in a cross-functional team during the test phase required a high degree of flexibility and adaptability. This was particularly important in order to take into account the different time zones, cultures, and working methods in an international environment. Compliance with strict regulatory requirements (ISO 13485, ISO 14971, IEC 62304) was essential to ensure the safety and quality of the developed solutions.
All work was carried out in accordance with the regulatory requirements for medical technology, including:
For over 125 years, Siemens Healthineers has been developing innovative medical technology to improve healthcare worldwide. Today, the Erlangen-based company is one of the leading providers of imaging systems, laboratory diagnostics, and digital health solutions.
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