Medical Innovations Incubator
HOME OF 4C - Enabling Medical 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 “4C Business Modelling” 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 in “4C Business Modelling”. 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 | Teaching the 4Cs and training in “4C Business Modelling”
Part 1: 15 interactive 4C Workshops by the Stiftung für Medizininnovationen
Part 2: 6 months 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 and 4C Business Modelling
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.
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.
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.
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.
4C Business Modelling
By training the “4C Business Modelling” 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 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 | 4C Business Modelling 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. For another 6 months, 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 | 6 months
- Format | monthly 1-1 meetings (approx. 1 h) between startup and coach for 1 year after the end of part 1
- 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
,Curriculum
- Kickoff with pitch on status in the 4Cs in front of investors
- 3 workshops on C1 | Commercialization
- 4 workshops on C2 | Certification
- Halftime Review with reflection on the integration of the 4Cs
- 3 workshops on C3 | Clinical Studies
- 1 workshop on C4 | Copyright
- 1 workshop on “4C Business Modelling”
- Final Review with pitch of the 4C-connected business model in front of investors
Save the Dates: Batch #10
- Kickoff workshop | Oct 14-15, 2025, onsite in Tübingen, Germany
- Online workshops | Every Friday, from Oct 24 to Feb 13, 2026, 9 am to 5 pm (excl. Oct 31, Dec 26, Jan 2; subject to date shifts)
Content focus
- 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, in-vivo)
- In Vitro Diagnostics (laboratory tests, laboratory procedures)
- Digital Health (Software as Medical Device / IVD)
We love THE LÄND!
Teams that would like to participate in our Accelerator and are not based in Baden-Württemberg must provide evidence of a regional connection by the end of their participation in the program. When applying, the (planned) connection, e.g. a cooperation with a partner based in Baden-Württemberg, must be described in the application form. This criterion will not be taken into account when evaluating the content of the documents.
Not sure how to meet this criterion? Our colleague Lea will be happy to help you!
- Phone: +49 152 52998535
- Email: rebholz@mi-incubator.com
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.
Note: Any startups that have already been founded must comply with the requirements of the General Block Exemption Regulation (see p. 44).
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. You have made it on our shortlist?
If our Idea Evaluation Board has positively evaluated your written application documents and classified your startup as a good fit for the program, you will receive one of 12 places on our shortlist. This means that you will be invited to our 2-day kickoff workshop in Tübingen, where you will have to demonstrate your commitment and dedication. Your live performance will be reviewed by the MII team, two investors and a representative from the Idea Evaluation Board. Only the 8 teams that can also convince live will receive one of the sought-after places in the 4C Accelerator.
Watch out: The 4 teams that do not pass this hurdle will still receive access to our exclusive 4C Community formats.
4. You have made it among the 8 participating startups?
Congratulations! Then you are now officially a 4C Accelerator participant and will take part in 14 additional online workshops and receive 1 year of coaching from an MII startup coach. You will also benefit from exclusive formats for the 4C Community.
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.
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.
Kneipenstraße
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 Unplugged
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 13 to July 25, 2025!
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