Model-Based Design and Modularization

Model-based development is the logical advancement of digitalization in the development process. In the beginning of this process, system engineering can be used to employ a central model to harmonize all information existing in document form and to grant access to all users as a database that is always up-to-date. This facilitates improved handling of the complexity of modern cyberphysiological systems, simplification of the coordination between the actors in the development process, and storage of all relevant information about the product life cycle independent of any single person.

Further along the development process, computer models are increasingly used in the selection and optimization of suitable technology concepts and as a basis for virtual verification of a system to be developed. In medical technology, the use of patient models also allows for preclinical validation, thus keeping animal and subject studies to a minimum. The models created during development can then be used as digital twins of a device to provide information about its maintenance status and thus prevent critical failures during operation.

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Newly emerging medical approaches and techniques in therapy and diagnostics, often enabled by general technical advancements, usually require long transition times for their integration into medical devices. This means they can only unfold their true potential years later. One reason for this are strict regulatory requirements, demanding clinical validation on large patient cohorts in order to ensure effectiveness and safety. On the other hand, the delay is also often caused by the manufacturers’ limited capability to integrate new technologies into existing products due to a lack of development resources or missing interface options to extend existing products by adding a component. As these interface options are rarely available, the post-developmental extension of an existing product carries substantial risks due to a high rise in complexity.

At Fraunhofer IMTE, current research focuses on system architectures for medical devices to enable modular devices that can be extended during the product life cycle, while at the same time guaranteeing safety of the patient and compliance with standards of the system as a whole. The goal is to enable the development of modules that can be verified at their interfaces for the correct intended operation and afterwards can be directly integrated into a host system without requiring a complete reverification. These kinds of architectures can enable a faster transition of novel therapy and diagnostic technologies from research to clinical application. Furthermore, these device architectures can lead to the establishment of a supplier industry for medical devices, providing new development resources.

Digital Twins in Medical Technology

Digital twins are models of processes, people or devices that describe parts or the entire system and its behavior in a digital environment. Through the feedback of environmental parameters, as well as sensor data and usage statistics of the system, the digital twin can achieve a high degree of coherence with the real system during the product life cycle. Through the possibility of virtual observation and simulation of the system, possible future system errors and failures can be predicted and interventions such as service, replacement of consumables or even a visit to a specialist can be planned for a patient. This avoids delayed interventions with a high potential for damage as well as premature actions with the resulting unnecessary expense and effort.

At Fraunhofer IMTE, digital twins are being developed for the medical technology sector. The use of digital twins is of particular significance in this sector since failure due to defective device components and exchangeable parts can have devastating consequences. With the help of digital twins, medical devices as well as their interaction with patient models can be tested in a timesaving, cost-effective and ethically responsible manner. Another advantage of using digital twins is that the model of a medical device can be used to simulate different components and working modes to support both internal testing and external audits. This means that compliance with relevant norms and standards can be supported and the development process accelerated, while the safety of the devices is increased further.