Medical device regulation as an anchor point for high-quality product development

© Johannes Kepler University Linz, Institute of Polymer Product Engineering

How can the requirements of the Medical Device Regulation (MDR) provide helpful input for hardware and software development to develop a safe, effective, and high-quality neurosurgical simulator? It is especially the so called “Essential Safety and Performance Requirements” listed in MDR, Annex I, the verification of which provides an important basis for the development of a safe and high-quality medical device.

In the development of the hybrid simulator MEDUSA – which requires the combination of hardware (realistic haptic models) and software components – activities arise in the development of these safety-critical components that require interdisciplinarity.

For example, the requirement of biocompatibility, i.e., the compatibility of the materials used for us humans and the environment in which they are used, plays a major role in the development of haptic models, such as skin, skull bones, brain, and vascular tree. In this context, the requirement for a clearly defined procedure for cleaning and reprocessing should also be mentioned. In the future, several medical students and neurosurgeons will train on the neurosurgical simulator. A clear specification regarding the correct cleaning process of the haptic components is essential to avoid damaging the materials themselves and to effectively counteract a possible danger regarding any resulting germ transmission. At this point, a variety of safety-critical aspects, such as the software functionality or the usability of the menu navigation, could be discussed. All these aspects have one thing in common: risk management.

Risk management is a central component of the medical device industry. During development, proactive risk management must be carried out to create product functionalities and a product design that represents a safe and effective medical device. The risk management process is a living and life-cycle-accompanying process, which must also be actively carried out after the medical device has been placed on the market. For example, customer feedback must be processed in a structured manner and must be analysed for any risks associated with the medical device. In this way, risks can be minimized and, in the best case, prevented.

Due to its interdisciplinarity, the research project MEDUSA offers the perfect opportunity to use MDR requirements as an assistance to develop a realistic and, above all, safe neurosurgical simulator for aneurysm clipping surgeries.