Medical Innovations Incubator

Home of 4C - Enabling Life Science Innovations

4C Accelerator

We specialized in the promotion of innovations in medical technology (MedTech). Therefore, we know: Startups with medical devices or in vitro diagnostics (IVD), as part of the healthcare industry, have to overcome higher hurdles than startups from other industries. At the same time, there are rarely experts on the industry-specific, highly regulated and thus critical topics of the 4Cs: C1 | Commercialization, C2 | Certification, C3 | Clinical Studies and C4 | Copyright. Moreover, it is not only know-how in the 4Cs that is crucial, but also their integration into the business model. This can be achieved with the Regulatory Thinking® method we have developed.

In the 4C Accelerator, MedTech startups and their founders get enabled to overcome the specific hurdles of the healthcare industry through knowledge transfer in the 4Cs and practical training on Regulatory Thinking®. Participants learn how to integrate the regulatory requirements of the 4Cs, such as MDR/IVDR, ISO 13485, DSGVO and of the German reimbursement system, into their business model development at an early stage and to consider them in their entrepreneurial activities.

At a glance

  • For whom | Startups with innovative MedTech product ideas
  • What | Training on the 4Cs and Regulatory Thinking®
    Part 1: 15 interactive 4C Workshops by the Stiftung für Medizininnovationen
    Part 2: 1 year of individual 4C Coaching by the Medical Innovation Incubator GmbH
  • Why | Faster “investor ready”
  • Format | Online workshops & meetings in English
  • In addition | Access to the 4C Community & exclusive events
  • Costs | Thanks to the funding partners the program is free of charge for founders

Since 2020, the 4C Accelerator has been offered to support founders in developing an entrepreneurially successful and regulatory plausible business model. While the MII is responsible for Part 2 the 4C Coaching , the Stiftung für Medizininnovationen hosts Part 1 the 4C Workshops.

Not only we are convinced of this porgramm, but also the funding partners: Baden-Württemberg Ministry of Economics, Labor and Tourism and its Startup BW campaign, the B. Braun Stiftung, and the Hector Stiftung.

Your added value through training in the 4Cs & Regulatory Thinking®

C1 | Commercialization
You will gain knowledge of the reimbursement opportunities in the healthcare market and know how to leverage them and map them in your business plan (e.g. self-payers, reimbursement options of the health insurances, like selective contracts and DiGA). You will also identify topics from C2 to C4 that will be relevant for marketing your product – the interlinking of the 4Cs begins.
C2 | Certification
You will be enabled to set up a quality management system (QMS) according to ISO 13485 and its processes and to set up the technical documentation according to the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR) to obtain the medical CE marking of your product – key steps for market access taking into account your claims.
C3 | Clinical Studies
We provide transparency on the process of clinical evaluation, on the different objectives and designs of clinical studies and convey knowledge for their concrete implementation (e.g., ISO 14155 / ISO 13612). Always keeping in mind: the certification of your product (C2) on the one hand and your commercialization strategy (C1) on the other.
C4 | Copyright
We provide knowledge about the possibilities to protect your innovation (e.g., patents) – including software components – as well as about the requirements of data protection (DSGVO) in the healthcare sector.
Regulatory Thinking®
By training the Regulatoy Thinking® method as a mindset, you will learn to understand the regulatory requirements in the topics of the 4Cs in an interconnected way and to integrate them holistically into your business model. This will enable you to create a well thought-out roadmap, to calculate and negotiate realistic investment volumes and to develop a regulatory plausible and entrepreneurially successful business model.
“The philosophy of “Regulatory Thinking®” runs as a common thread through all sessions and has gradually changed our awareness of this elementary topic without being overwhelmed by the sheer volume of requirements and documents.”

Thomas Sühn, SURAG Medical GmbH

“In the 4C Accelerator, regulation is thought out from the perspective of the startup. Experts pick up the founders where they are and develop “feasible” solutions and concrete next steps.”

Vera Claas, MentalStark GmbH

“It works for teams at different stages of development. All teams have visibly progressed over time – this speaks for the quality of the program.”

Björn Tränkle, TheraIC

“The participants are guided in many practical exercises and intensive feedback loops to transfer the knowledge imparted to their own company. This makes the knowledge concretely usable for the startups.”

Rüdiger Schulze, Klavant GmbH

“We have lost our shyness about regulatory issues. Now we have new motivation and concrete points of attack to drive Regulatory forward.”

Stefan Raith, Inzipio GmbH

“The 4C approach doesn’t give you all the information, but it gives you the tools you need to properly deal with incomplete information in the complex healthcare industry.”

Alexander Knoch, Empident GmbH

“Within the 4C Accelerator, we were challenged again and again, so now we can talk to experts at eye level. That gives us self-confidence and security.”

Max Starkmann, Eversion Technologies

The program

Procedure: 4C Workshops & 4C Coaching

The 4C Accelerator provides help for self-help. This means that during your participation we will provide you with knowledge, methods, ways of thinking and tools that you can use in your entrepreneurial practice. Our program consists of two parts:

Part 1 – Interactive 4C Workshops

In the first part, hosted by the Stiftung für Medizininnovationen, our internal experts together with specialists from our network provide relevant knowledge and methods on the 4Cs in 15 workshop sessions. Through hands-on exercises you will apply this knowledge directly to your case and receive individual feedback. Each session follows the same pattern: input – exercise – presentation – feedback and discussion. So be aware: Our workshops are not lean back, but lean forward sessions. But it is worth it!

  • Duration | 15 days à 8 hrs.
  • Format | Online sessions with the teams of the current batch
  • Lecturers | 14 internal and external 4C experts
  • Outcome 1 | Individual project plan based on integration of the 4Cs
  • Outcome 2 | Regulatory Thinking® as team-wide mindset
  • Host | Stiftung für Medizininnovationen
Part 2 – Individual 4C Coaching

After successful participation in the workshops, the second part takes place, provided by the MII. It consists of individual, needs-oriented coaching. Over the course of one year, you will be further accompanied by one of the MII Startup Coaches in monthly 1-to-1 meetings. We will support you in developing the business model, identifying relevant milestones, exploring possible business model options and positioning your team. Our roll here is to support, plausibilize, challenge, enable, mediate, and motivate! As soon as you realize that you need deeper input on specific topics, you can request our additional 4C Services without obligation. Accelerator participants receive a voucher for these services!

  • Duration | 1 year
  • Format | monthly 1-1 meetings between startup and coach
  • Coaches | 4 MII experts
  • Outcome 1 | Investor Readiness based on integration of the 4Cs
  • Outcome 2 | Confirmation of participation
  • Provider| Medical Innovations Incubator GmbH


Structure and dates: 4C Workshops
  • Kickoff with pitch on status in the 4Cs
  • 3 workshops on C1 | Commercialization
  • 4 workshops on C2 | Certification
  • Halftime Review with reflection on the integration of the 4Cs
  • 4 workshops on C3 | Clinical Studies
  • 1 workshop on C4 | Copyright
  • Final Review with pitch of the 4C integrated business model
Save the Dates: Batch #7
  • Kickoff workshop | October 9-10, 2024, onsite in Tübingen, Germany
  • Online workshops | Every Friday, October 18, 2024 to February 04, 2025, 9 am to 5 pm (excl. November 01, 2024, December 23, 2024, January 03, 2025; subject to date shifts)
Content focus
This free qualification program focuses on the industry-specific and highly regulated topics of the healthcare industry. It provides in-depth knowledge for business model development within medical technology, without neglecting cross-sector entrepreneurship competencies. Among others, the program aims to answer the following questions:

  • Am I developing a product with a medical purpose, and if so, how do I determine this?
  • Which product class does my product fall into according to MDR/IVDR?
  • Which norms and standards do I have to take into account in order to bring my product onto the market?
  • How do I obtain company certification and product approval?
  • What reimbursement options are available for my product in the healthcare system?
  • Is it worthwhile for my product to be reimbursed by health insurances?
  • Is my product attractive for the self-payer market?
  • What do I have to consider regarding the protection of my innovation?
  • What role does personal health data play during product development and after market entry?

In the 4C Accelerator, participants gain knowledge about the regulatory requirements in the respective 4C topics (e.g., MDR/IVDR, QMS according to ISO 13485, risk management according to ISO 14971, clinical study plan according to ISO 14155, selective contracts, DiGA guideline, GDPR) and learn strategies for their implementation. As a central element, we use the Intended Use Document, which is constantly supplemented and specified by the interaction of the 4Cs. Similar to a Business Model Canvas – it structures the strategic aspects of your business model.

Conditions of participation
We can MedTech!

Therefore, all founding teams and innovators who want to implement their pre-competitive business idea within the following areas can apply:

  • Medical Devices (apparatus, instruments, machines, implants, software, in-vivo)
  • In Vitro Diagnostics (laboratory tests, laboratory procedures)
  • Digital Health (Software as Medical Device)
We love THE LÄND!

Teams that want to participate in our accelerator formats and are not based in Baden-Württemberg must demonstrate a regional connection, e.g., a (planned) cooperation with a partner located in Baden-Württemberg. This criterion does not play a role in the evaluation of your documents.

We count on your commitment!

Thanks to the funding, participation in the program is free of charge. However, we reserve the right to charge a “no-show-fee” for workshop dates not attended.

Application and selection process

As an institution dedicated to promoting the transfer of research results to patients, the application and selection process is organized by the Stiftung für Medizininnovationen. It consists of the following steps:

1. Submit your application during one of the 2 application periods per year

The required documents include a standardized application form and your individual pitch deck. Our tip: Answering the questions is not about what you know or don’t know, it’s rather about your self-assessment on some important topics. The answers will help the reviewers of our Idea Evaluation Board to select the startups that can benefit the most from the specific content of the program.

2. The Idea Evaluation Board will review your documents

The interdisciplinary Idea Evaluation Board decides which startups will ultimately be accepted into the 4C Accelerator. The evaluators pay particular attention to the following aspects: degree of innovation, medical relevance of your product idea, its entrepreneurial feasibility and scalability as well as the qualification of your team.

In addition to this purely content-related evaluation by the reviewers, we are also interested in promoting diversity in the medtech industry. Therefore, in case of a tie, the more diverse team will be given priority.

3. We will inform you personally about the decision

Only a limited number of startups can take part in the 4C Workshops per accelerator batch. We will inform you personally at the respective deadline whether you have been selected by our reviewers.

4. You have made it among the 8 participating startups?

Congratulations! Then the program will start for you with an onsite kickoff workshop in Tübingen.

5. You were not selected?

Then you will receive written feedback from us based on the reviewers’ evaluation, which you can use to improve your application for the next round.

Idea Evaluation Board

The Stiftung für Medizininnovationen provides the Idea Evaluation Board, which consists of the following members:

Become part of the 4C Community

As a participant in the 4C Accelerator you become part of our 4C Community and benefit from exclusive networking formats and events. You will meet all current and former accelerator participants as well as our partners from the healthcare industry and the startup scene.



Matching with startup-relevant organizations and collaboration partners in the 4C Workshops

4C Coffee

Monthly peer-to-peer exchange on one of the 4C topics guided by the MII Startup Coaches

4C Alumni Gathering

Annual networking event with the entire 4C Community and partners from the healthcare industry

Female Community

Exchange among female founders and impulses from role models on topics related to female entrepreneurship

Interested? The next application phase will take place from June 7 – July 22, 2024 !

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Not the right thing? We will find the right offer for your startup as well!

We are happy to support you with our individual 4C Services, where we always keep a holistic view on your healthcare industry-specific business model.

Learn more about our 4C Services here or contact us directly!