Medical Innovations Incubator

Home of 4C - Enabling Life Science Innovations


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Webinar Series: 4C Close-up – Insights into …

Have you ever wondered what a clinical evaluation of a medical device looks like? Or what its scope with regard to its corresponding documents is? We provide remedy!

In our webinar series “4C Close-up”, our internal MII-experts discuss practical topics focusing on one of the 4Cs with experienced practitioners from advanced startups or established companies. We provide you with close-up insights into real world examples (e.g., regulatory documents). Always with our goal in mind: Enabling you to help yourself!

December 5, 2022: 4C Close up – Insights into C2 | How to just do QMS

Just do QMS! Join our next 4C Close-up Webinar and learn how our guests Dr. Ramona Samba (CEO) and Niko Mangold (RA) from the startup sync2brain built their QMS according to ISO 13485. They will provide insights into their QMS, its scope, the manual and SOPs. Together with our MII startup coach Dr. Henrike Stutzki, we discuss how to build your own QMS as a startup so that it meets regulatory requirements and is livable in everyday life.

  • What? C2 | How to just do QMS
  • Who? Dr. Ramona Samba, Niko Mangold (sync2brain GmbH), & Dr. Henrike Stutzki (MII)
  • When? Dez 5, 5-6 pm CET
  • How? Register here for the free online webinar!
Review: 4C Close-up - Insights into C3 | Clinical Evaluation Process, July 27, 2022

Our first 4C Close-up Webinar provided insights into C3 and the Clinical Evaluation process. Our guest Dr. Ruth Schippert from Okuvision GmbH, together with our MII expert for Clinical Affairs, Henrike, gave insights into the documents of the Clinical Evaluation Plan and Report as well as into the processes of literature search and evaluation.

Lecture series: How does the new enter medicine?

Many interesting ideas are born in the laboratories and in the daily work of patient care that can improve diagnostics and therapy or help patients cope with health problems. However, young people interested in founding a healthcare company have a particularly difficult time in the medical field. Medical devices, including medical apps, require special testing, and approval of even simple technical products usually requires clinical trials. It is a long and expensive road until the costs for a new product are reimbursed by health insurance companies. To increase the chances of success for start-ups, the many stumbling blocks from medical product development must be brought into focus at an early stage.

Together with its parent organization, the Tübingen Foundation for Medical Innovation, and funded by the non-profit Hertie Foundation, the MII has therefore launched the six-part event series “How does the new get into medicine?” (starting Dec. 3, 2020), which is intended to shed light on the challenges for new ideas in the healthcare industry and discuss improving opportunities for those interested in founding a company. At the end, the most important basic rules for successful market access should be worked out.

Review: The premiere event, Dec. 3, 2020

In the first three-hour event, the challenges were first discussed in keynote speeches by Dr. Nicole Hoffmeister-Kraut MdL (Minister of Economics, Labor and Tourism of the State of Baden-Württemberg), Dr. Ingmar Hoerr (founder of CureVac AG) and Prof. Ralf Kindervater (Managing Director of BIOPRO Baden-Württemberg GmbH).

After the presentations, the speakers then debated with Prof. Katja Schenke-Layland from the Natural and Medical Sciences Institute at the University of Tübingen (NMI), Dr. Matthias Perleth from the Federal Joint Committee (G-BA), Dr. Diedrich Bühler from the National Association of Health Insurance Funds (GKV-SV), Mr. Tobias Brode from the Fraunhofer Institute for Manufacturing Engineering and Automation (IPA) and Prof. Eberhart Zrenner from the non-profit Foundation for Medical Innovation in a roundtable format.

Finally, additional individual consultation sessions with sector/industry experts were offered for specific questions regarding market access in the healthcare sector, approval of medical products, clinical trials and intellectual property rights in separate online sessions.

Review: The second lecture evening, Feb. 2, 2021

After a very successful first event in December 2020 with more than 200 participants, the challenges of startups in the medical life sciences were discussed in three short keynote speeches by Prof. Dr. med. Thomas Gottwald (startup founder & CEO Ovesco Endoscopy AG), Prof. Dr. Ing. Thomas Bauernhansl (Institute Director Fraunhofer IPA as well as IFF of the University of Stuttgart) and Günther Steffen (Fund Manager at Zukunftsfonds Heilbronn as well as supervisor of biotech and medtec companies) in a second evening on February 4, 2021.

After the presentations, the speakers then debated with Winfried Plötze (State Manager Baden-Württemberg, BARMER), Prof. Dr. Stefan Laufer (Startup Founder, Head of Chair Pharm./Med. Chemistry, Tübingen Center for Academic Drug Discovery, Department of Pharmacy & Biochemistry, EKUT), Dr. Timo Schmelzpfenning (Authorized Representative and Head of Research & Development, SPORLASTIC GmbH), Prof. Dr. Ralf Kindervater (Managing Director, BIOPRO Baden-Württemberg GmbH) and Prof. Dr. med. Eberhart Zrenner (Charitable Foundation for Medical Innovation) in a round table format.

Finally, additional individual consultation sessions with industry experts were held for specific questions regarding the 4C’s (Commercialization: plan sales in the health care sector, e.g. reimbursement by health insurance companies, Certification: approve product and company, Clinical Studies: Proving the Evidence of the Product, Copyright: Using Protective Rights Strategically) offered in separate online sessions.