Medical Innovations Incubator
HOME OF 4C - Enabling Medical Innovations
Our Blog: Worth reading for everyone who is enthusiastic about medical innovations!
In our blog, MII experts and partners from our network address key issues and questions in the healthcare industry. From practical tips and reports on the experiences of founders to insights from the perspective of investors and auditors.
Click through to find out how medical innovations are successfully brought to market.
4C Community x FEMture
With FEMture, Nadine Zimmemann gives female executives more visibility and discusses topics relating to female leadership.
Listen to the MedTech series with female founders from the 4C Community!
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QMS According to ISO 13485: From Regulatory Obligation to Strategic Success Factor
In our conversations with MedTech founders, our partners at ipp Dr. Klügl and we at the Medical Innovations Incubator repeatedly observe the same pattern: The product idea is strong, the technology compelling, yet regulatory requirements such as the MDR (Medical Device Regulation) and ISO 13485...
4C Unplugged 2025 – Where Innovation Meets Networking
On October 16, 2025, Tübingen once again became a hotspot for MedTech innovations. Founders, investors, and established companies came together to share ideas, initiate collaborations, and shape the future of healthcare collectively. With 4C Unplugged 2025, the region once again demonstrated the...
4C Unplugged 2025 – Looking Forward to October 16
On October 16, 2025, Tübingen will once again transform into a vibrant meeting place for creative minds, visionary founders, and established companies. Our goal: to foster exchange, enable collaboration, and jointly drive forward medical innovation. Whether at the exclusive satellite event with...
You Can’t Be What You Can’t See!
Increasing Visibility for Female Founders in Medical Technology:Diverse teams are more successful – as highlighted in McKinsey’s recent report, Diversity Matters Even More [1], which means both ethnic and gender diversity. Despite the clear advantages of diversity, women are still underrepresented...
MII x IntegraSkin – Aligning business model with regulatory requirements
Bringing an in-vitro diagnostic (IVD) to market successfully requires not only regulatory compliance, but also a business model that takes into account the particularities of the healthcare market. The startup IntegraSkin had several promising market access options open to it. However, it was...
Clinical evaluation – more process than paper
The new version of the European regulatory framework for medical devices in the form of the MDR has resulted in a dynamization that affects existing medical devices as well as new products. The central elements "Clinical Evaluation Plan & Clinical Evaluation" should not be considered as static...
4C Unplugged 2024 – A day of innovation and collaboration
On 10 October, we welcomed over 130 guests to our annual networking event for MedTech innovation, the '4C Unplugged'. 37 startups from all over Germany – and with Tengable from Israel even from beyond – as well as 36 of our network partners met at the Amazon Development Centre in Tübingen for a...
MII x MindAhead – With confidence to the CE mark of a medical device class I
The digital health startup MindAhead faced the challenge of declaring self-conformity for its risk class 1 product while meeting all regulatory requirements for safety and performance. In addition, the upcoming DiGA study also needed to be planned in compliance with the regulations. To this end,...
MII x EARLAB – From a research team to an audit-ready QMS
Bringing a medical device or in-vitro diagnostic (IVD) product to market requires industry-specific expertise that startups often lack. Public funding programs such as BioMan4R2 provide founders with the necessary financial resources to work with service providers such as the MII. With the help of...
The role of the Notified Body – An interview with an auditor
Certification of the quality management system and obtaining the CE marking for their product are important milestones for future medical device manufacturers. The Notified Body plays a central role in this process as a testing authority. We spoke to Dietmar Schaffarczyk, auditor at QS...
Pitch Contest “4C Check-up” – Team Semanux convinces the expert jury
A total of nine medical startups competed against each other in the "4C Check-up" online pitch contest. The aim of the five-minute pitch was to convince the expert jury of the product idea, the business model and the team. In the end, Lukas Schmelzeisen from Semanux succeeded. The team has now...
Planning, approval and implementation of a clinical investigation – Experiences of the startup Skinuvita
In order for medical devices and IVDs to receive a CE marking, proof of their safety and performance is required. In most cases, there is not enough clinical data available for innovative products – for example from similar products – so that it is necessary to collect one's own data as part of a...
MII x OSORA – Faster go-to-market and why the medical device is now at the end of the roadmap
OSORA has gathered a variety of starting points for market entry in order to position the technology for bone healing simulation. Market segments exist in the areas of education and training, implant development and clinical fracture management. By using the MII concepts "4C" and "Regulatory...
MII x Fysor – How an idea became the product “Apelvo”
An innovative product idea with a pure training approach can be launched on the market as a lifestyle product. But such a business model must also take into account the requirements and opportunities of the 4Cs in order to be successful. At the beginning of this journey, Mark Kässer, idea giver...
MII x sync2brain – From business model development to a certified legal manufacturer
Medical innovations often emerge from research and are driven by a scientific perspective. However, in order for such product ideas to actually reach patients, a market-oriented view must be developed. This was the challenge faced by the startup sync2brain GmbH. As part of a service project, the...
The 4C Alumni Gathering 2023 – Driving medical innovation together
A strong network, peer-to-peer learning and collaboration with established partners in the healthcare industry are important factors for the success of MedTech startups. In order to support startup projects and young companies on this level, we invite alumni of the 4C Accelerator and our network...
Seeking investment? – The relevance of the 4Cs from an investor’s perspective
Questions about the 4Cs and their interrelations play a central role in the development of a plausible business model in the healthcare sector. Obviously, networked 4C knowledge is also a key advantage in fundraising. We spoke to Christian Kraft, Director M&A and External Innovation at...
Selective contracts as an opportunity for startups to enter the market? – Insights by Experts of BKK Linde
74 million people in Germany, and thus almost 90 % of the population, have statutory health insurance. So when it comes to the question of how to bring a new, innovative product to market, medtech start-ups often find a quick answer in the statutory health insurers (SHI) and their reimbursement...
MII x Erbe Elektromedizin – Bringing valuable medical innovations into use despite strategy change
Highly innovative companies are often spoilt for choice: which technologies have potential and strengthen the overall strategy? Which ideas are valuable but create inefficiencies in implementation and should not be pursued due to limited resources? And how can the latter still be used to generate...
From an auditor’s perspective: pros & cons of eQMS
As the healthcare industry continues to grow, it is essential to ensure quality and compliance with regulatory standards. Electronic Quality Management Systems (eQMS) are increasingly being used to manage and maintain quality processes in organizations. This article provides an overview of...
„There is no such thing as one price!” – Interview with sales expert Claus Michelfelder
With 11 years of experience in the top management of established healthcare companies, including B. Braun, as well as over 20 years as an independent consultant with an internationally represented team, Dr. Claus Michelfelder can truly be called an expert for the successful distribution of medical...
Clinical evaluation as a central knowledge management process – Interview with Robert Radloff
Clinical studies - that's what the C3 in our 4C concept stands for. Our C3 also includes the clinical evaluation, a central process for medical device manufacturers and those who want to become one. We spoke to Robert Radloff, Director of Product Development at Research Solutions, about the...
4C Christmas Pitch – Team nanoshape enters Startup BW state finals
Shortly before Christmas, we at the MII were able to give a very special gift to one startup: a ticket to the state finals of the Startup BW Elevator Pitch in summer 2023. And the team of nanoshape made it. On December 19, 8 teams from the medical sector presented their exciting projects to...
Medical device on the rocks – The importance of design freeze for a medical device
As an early-stage startup, you are usually in the middle of your development process in order to implement your innovative idea as a first prototype and later as the final product ready for series production. At the end of a development phase, there is a design freeze. But what is it about? And...
Recap: 4C Alumni Gathering 2022
After 2 years of remote meetings, the alumni startups of the 4C Accelerator Tübingen finally met in person on October 6. At the same time, we welcomed the teams of the new accelerator round in the MII community. The goal: promote exchange of experiences and foster collaborations - both among the...
Sales launch as a lifestyle product through the 4Cs – The startup tinus in an interview
Not every product that was originally intended as a medical device actually is one: it depends on the intended use! That's what the startup tinus learned at the 4C Accelerator. Since their product has no medical purpose, is non-invasive and poses no risk to the user, the team has now realized...
Clinical data for the clinical evaluation of a medical device – How to proceed?
The requirements for clinical evaluation and the significance of clinical data for medical devices have become greater as a result of the MDR - everyone knows that by now. But what does this mean for startups in the medtech sector? And what do you have to consider on your way to product approval?...
The way to a QMS – How startups overcome this hurdle
In most cases, distributors of medical devices or in vitro diagnostics need a certified Quality Management System – QMS for short. The development and establishment of QMS pose new challenges, especially for startups. Not only personnel and monetary resources are limited. As a newcomer to the...
Why we are more than an accelerator – 7 questions to our CEO
The MII is best known for its "4C Accelerator" - and rightly so: more than 20 teams have now successfully completed the program and are on their way to help shaping the healthcare market of tomorrow with their innovative products. But as the name of the Medical Innovations Incubator (MII) reveals,...