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CeMIT – professional innovation management for the medical device sector

With the establishment of the Centrum für Medizintechnische Innovationen Tübingen, or CeMIT, the University Hospital of Tübingen is building a bridge between hospitals and medical device companies, which share the aim to develop new and better medical technology products and methods. Partners from small and medium-sized companies are expected to particularly benefit from the services that CeMIT provides and the guidance it can offer in finding new cooperation partners.

The CeMIT is offering its industrial partners better access to clinical expertise and research infrastructure. © University Hospital of Tübingen

It should not just be left to chance that an idea with great clinical application potential is seen by the right person – this is where the future centre comes in. ”Many collaborations between hospitals and companies are based on personal contacts between medical doctors and developers. We want to increase the options available and professionalise access to clinical infrastructure for all companies. With the establishment of the CeMIT, the University of Tübingen facilitates access to university and hospital infrastructures for medical technology companies. The idea of setting up the CeMIT is also a logical consequence of the existence of the IZST, the Inter-University Center for Medical Technologies Stuttgart – Tübingen,” says Dr. Ines Dünkel who heads up the IZST Tübingen branch, and, together with Prof. Dr. Arnulf Stenzl and Thomas Gerlings, also runs the Centrum für Medizintechnische Innovationen CeMIT that is currently being set up.

The CeMIT team is convinced that the industry has a major interest in the planned service portal as, since 2012, the IZST’s “Industry-on-Campus” projects have been paving the way for many medical innovations. Until the end of 2016, the IZST research projects were funded in equal parts by the Baden-Württemberg Ministry of Science, Research and the Arts, the Universities of Stuttgart and Tübingen and the medical technology industry. “The huge commitment, including financial, of the industry is a clear sign of the need for such cooperations,” says Dünkel. In addition, the new European Medical Device Regulation and the European In Vitro Diagnostics Devices Directive make this need even more pressing. “One of the major challenges in the proposed regulation is that companies have to provide substantially more clinical evidence to get medical products to market. This includes small suppliers,” says Dünkel. In the future, it will be possible to close potential gaps using the modular building blocks in the CeMIT’s service portfolio in cooperation with established medical technology centres in Tübingen.

CeMIT, a service provider and partnering platform that opens access to clinical settings

The CeMIT has clinical know-how and many years of experience working with medical technology companies. It also has access to doctors and research infrastructures in hospitals offering different levels of medical care and funded from different sources. The CeMIT also has long-standing working relationships with established and professionally equipped preclinical centres and research facilities. The CeMIT sees itself as a guide and companion for companies that are seeking to bring medical technology innovations to the market.

Practical experience is a decisive factor in the optimisation of surgical methods and medical products. © University Hospital of Tübingen

Whether it is a case study, (pre-)clinical study, usability study, job shadowing, certification, project management, training or expert report, CeMIT provides companies with the right service package and innovation management guidance. It provides simple, central access to clinical expertise and the entire research infrastructure. Companies no longer need specific insider knowledge to find a suitable cooperation partner.

Medical and technical progress is pooled at the following institutions in Tübingen. The competences of these institutions form the pillars of the CeMIT.

  • Department of Clinical Anatomy
  • tüpass – Tübingen Patient Safety and Simulation Centre
  • Surgical Technology and Training (CTT)
  • Experimental Surgical Endoscopy (CETEX)
  • Experimental Medicine, Medical Technology and Training
  • Center for Clinical Trials (ZKS)

The Department of Clinical Anatomy at the University of Tübingen specialises in authentic scenarios in operating theatres. Medical device companies have access to state-of-the-art infrastructures for testing new products and procedures on human corpses. The companies can also run courses for their employees in the operating theatres. 27 medical device companies are already working with the Department of Clinical Anatomy and using the ten work stations, the operating table and the fully equipped operating theatre. Audio and video streaming into conference rooms and lecture halls complement the services offered. “Doctors that are released from their normal work to carry out research can thoroughly test, compare and evaluate the handling or further development of a device,” says Dünkel referring to the successful events organised as part of Sectio chirurgica, a platform that enables medical students to follow surgical operations online in real time.

tüpass offers medical product manufacturers professional support for the validation of products. Different medical emergencies can be simulated and device safety optimised. In the areas of surgery, technology and experimental surgery, doctors and medical technicians have access to professional hospital equipment. The in-house workshop gives interested parties the option to test products and work on individual parts. Many medical products, both high- and low-end, have been perfected at this workshop. The Center for Clinical Trials (ZKS) assists industry partners in cost calculations, project management and the design of (pre-)clinical studies.

Testing products and procedures in authentic clinical environments

The fully equipped operating theatre in the Department of Clinical Anatomy is excellently suited for product testing and training. © Institute of Clinical Anatomy and Cell Analysis, University of Tübingen

The CeMIT also offers cooperation opportunities with the University of Stuttgart. “If necessary, experts from the fields of system dynamics, construction or technical design, will be brought in,” says Dünkel referring to the Industry-on-Campus project “Interaction-based robot-supported assistance systems” which has developed a prototype-like functional pattern for hand and arm supports for surgeons who experience exhausting postures during long surgical interventions. The system helps to counteract these challenges and assists in the tremor-free guiding and holding of surgical instruments, thus contributing to preventing postural defects. The system has been tested and adapted to operating theatre scenarios and surgical procedures involved in abdominal surgery. CeMIT also pools clinical and engineering competency with the aim of developing technical innovations in cooperation with companies. “CeMIT is committed to giving its industry partners easy access to clinics and doctors,” confirms Dünkel.

Glossary

  • Genetic sequences are successions of the bases adenine, thymine, guanine, and cytosine on the DNA (or uracil instead of thymine in the case of RNA).
  • Computer tomography (CT) is a imaging technique to display the structures within the body. Therefore, radiograms are taken from different directions and are analysed by a computer to get a three-dimensional image.
Website address: https://www.gesundheitsindustrie-bw.de/en/article/news/cemit-professional-innovation-management-for-the-medical-device-sector/