Dr. Tobias Luksch
Robotics
Get in touch with us. Your personal contact is:
Dr. Tobias Luksch
Robotics
* Mandatory fields
Thank you for getting in contact.
We have received your inquiry and we'll get back to you shortly.
Robotic systems have gained significant importance in applications such as minimally invasive surgery in medicine. However, as their usage increases, so does the responsibility for ensuring safety. Malfunctioning can have serious consequences for patients. We help you design and implement your customized safety system.
Risk minimization and functional safety in the development of medical robots require a delicate balance between safety and disruption-free operation – despite high system complexity. The aim is to prevent hazards caused by malfunctions without unnecessarily restricting clinical operations. In addition to electrical and mechanical safety, the software plays a particularly important role in medical robots. Ensuring its safety is one of the greatest challenges, given the complexity of the algorithms, high computational demands and real-time requirements.
The European Medical Device Regulation (MDR) requires manufacturers to design their products in a way that delivers the intended medical benefits without compromising the safety of patients and users. A systematic risk management process in accordance with ISO 14971 is mandatory. Any remaining risks must be outweighed by the benefits of the product, and all risk mitigation measures must be based on the state-of-the-art in a traceable way and documented in the risk file. In addition, further standards must be taken into account during development.
IEC 62304, the central standard for the software lifecycle, emphasizes that software can never be considered completely error-free. As it is not possible to argue with the probability of errors occurring in software, medical robot systems generally require an additional and, above all independent monitoring system as a risk-reducing measure.
Since many medical robots must perform rapid movements close to critical tissue such as blood vessels or nerve pathways for their intended use, there is a risk that malfunctions can lead to serious damage within a very short time. Therefore, a monitoring system must be able to detect critical errors, such as deviations from intended movements, within milliseconds. Two key approaches here are redundancy and plausibility checks.
In practice, performing plausibility checks of control commands on independent hardware has proven to be a successful concept for ensuring software safety. This kind of monitoring system not only fulfills regulatory requirements but also improves the quality of the control software. Ideally, this system is designed in the early development phase and implemented in parallel with the development of the control software.
Developing safe robotic systems requires more than just technical excellence – it demands interdisciplinary collaboration and a deep understanding of the risks. From the beginning of the development process, our ITK experts from the fields of systems engineering, software, mechanical and electronics development, safety, usability and risk management work closely together. This is the only way to harmonize safety, functionality, availability and user-friendliness, and thus ensuring market success.
