Prof. Dr. Dr.-Ing. Thomas M. Grupp (left) with HFU Prof. Dr. Hadi Mozaffari Jovein
Event from the “CoHMedConnect” medical technology series on the Tuttlingen campus of Furtwangen University
How can medical innovations be translated into clinical practice in a safe, scientifically sound manner that complies with the Medical Device Regulation? This question was the focus of an event organised by the Connected Health in Medical Mountains (CoHMed) innovation and transfer partnership at Furtwangen University (HFU). The “CoHMedConnect” event “New Approaches to Product Validation in Medical Technology” took place on the Tuttlingen campus.
The guest speaker was Prof. Dr. Dr.-Ing. Thomas M. Grupp, FIOR, from Aesculap AG in Tuttlingen, Principal Expert Engineer for Research & Development, Biomechanics, Orthopedic & Spine Surgery at Aesculap AG, as well as Professor of Experimental Orthopedics and Biomechanics at Ludwig Maximilian University of Munich. In his presentation, he introduced the “EFORT European Consensus – Medical & Scientific Research Requirements for the Clinical Introduction of Innovation under MDR 2017/745” and discussed its significance for medical technology.
The focus was on the requirements for the clinical introduction of innovations under the Medical Device Regulation 2017/745. Prof. Grupp made it clear that new medical devices must not only be technically convincing. They must also be scientifically verifiable, regulatory viable and evaluated with regard to patient safety. Product validation thus becomes a central link between research and development, clinical practice, regulatory requirements, and industrial implementation.
The 1st EFORT European Consensus focuses in particular on orthopedic implants and associated instruments. It formulates practice-oriented guidelines that provide guidance to various stakeholders including physicians, research institutions, testing laboratories, medical device manufacturers, notified bodies, regulatory authorities, and patient advocacy groups. Among other things, the aim is to determine suitable preclinical and clinical evaluation methods, ensure innovations are managed responsibly, and at the same time identify practical pathways for the further development of medical devices within the MDR framework.
The event was led and moderated by CoHMed partnership spokesperson Internal link opens in the same window:Prof. Dr. Hadi Mozaffari Jovein. Organisational support was provided by the CoHMed team, including Internal link opens in the same window:Kathrin Eckerlin and Internal link opens in the same window:Victoria-Katharina Martinelli. The exchange highlighted how important dialogue between academia, industry, clinical practice and regulators is for the future of medical technology. Especially in Tuttlingen, a hub of medical technology, this dialogue is particularly important for responsibly advancing innovations and bringing them to market.
Internal link opens in the same window:CoHMed supports this exchange through its “CoHMedConnect” event series. The goal is to bring together key stakeholders from academia, research, medical technology, healthcare and industry to discuss current topics at the intersection of technology, medicine and clinical practice.