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 our 4C Accelerator, we enable medtech startups to overcome the specific hurdles of the healthcare industry through knowledge transfer in the 4Cs and practical training on Regulatory Thinking®. Founders 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 I: 15 interactive 4C Workshops
Part II: 1 year of individual 4C Coaching - Why | Faster “Investor-Ready
- Format | Online workshops & meetings in English
- In addition | You get access to the 4C community and exclusive MII events.
- Costs | Thanks to funding by the State of Baden-Württemberg, the B. Braun Stiftung, the Hector Stiftung and the Stiftung für Medizininnovationen, the program is free of charge for founders.
Your added value through training in the 4Cs & Regulatory Thinking®
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.
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 program
Procedure: 4C Workshops & 4C Coaching
Part 1 – Interactive 4C Workshops
In the first part, our MII 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 8 teams of the current batch
- Lecturers | 14 MII internal and external 4C experts
- Outcome 1 | Individual project plan based on integration of the 4Cs
- Outcome 2 | Regulatory Thinking® as team-wide mindset
Part 2 – Individual 4C Coaching
The second part of the program consists of individual, needs-oriented coaching. Over the course of one year, you will be further accompanied by one of our 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
Structure and dates: 4C Workshops
Curriculum
- Kick-off 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 #6
- Kick-off Workshop | Oct. 5-10, onsite in Tübingen, Germany
- Online-Workshops | Every Friday, Oct. 13, 2023 to Feb. 2, 2024, 9 am – 5 pm (excl. Christmas vacations BaWü; 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, 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 have to prove a (future/potential) connection to Baden-Württemberg, e.g., planned cooperation with a partner from Baden-Württemberg.
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
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 – established by the Stiftung für Medizininnovationen – 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
Per batch of the accelerator, 8 startups can participate in the workshops and the subsequent coaching. 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
Become part of the 4C Community
As a participant in the 4C Accelerator – whether workshop & coaching or bootcamp – 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
4C Coffee
4C Alumni Gathering
Female Community
Interested? The next application phase starts in December 2023.
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