Medical Innovations Incubator

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4C Accelerator Tübingen

We specialize in promoting medical innovations. That’s why we know: Life science startups have to overcome higher hurdles than startups from other industries. At the same time, however, there are rarely experts in these critical areas in the founding teams. With the help of our accelerator, we solve this discrepancy and anchor a specially developed mindset in the heads of the participants, enabling the successful overcoming of the challenging hurdles. To achieve this, we first have studied and analyzed the differences between innovation in general and medical innovation in particular. We have transferred the insights gained from this into our concept of 4Cs and Regulatory Thinking® and made them the central starting point of our 4C Accelerator, which we offer twice a year since 2020.

Not only we, but also our sponsors, the Ministry of Economics, Labor and Tourism of Baden-Württemberg, its Startup BW campaign and the B. Braun Foundation, are convinced of this approach.

Logo Stiftung für Medizininnovationen

Your added value through training in the 4C

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-payer, reimbursement rules of health insurance companies such as AMNOG or selective contracts).

C2 | Certification
You will be able to build quality management systems and processes and link them as a company approval to a strategic concept for effective product approval (e.g., ISO 13485, GxP).

C3 | Clinical Studies
We create transparency about the different objectives and designs of clinical studies and transfer knowledge for the concrete implementation of clinical studies (e.g., ISO 14155, ICH Guidelines).

C4 | Copyright
We provide knowledge about the possibilities of appropriate IP protection (e.g., patent) as well as requirements of data protection (DSGVO) in the healthcare sector.

Thomas Sühn, SURAG Medical GmbH

The 4C Accelerator has helped us enormously in our development. Especially as a young startup, we benefited from the input, the working sessions and the feedback of the extremely experienced coaches and were able to develop solutions and strategies for our individual situation. Above all, however, participation had a lasting impact on our approach: 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.

Rüdiger Schulze, KLAVANT GmbH

As a life science startup, you often can’t see the forest for the trees when it comes to regulation. With its excellent speakers, the 4C Accelerator is able to explain the core of the relevant regulatory fields. 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. By tackling Regulatory Thinking® issues in small, doable steps, the pieces of the puzzle come together over time to form a whole. We are not aware of a comparable training concept in Germany.

Vera Claas, Mental Stark 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. Implementing regulation does not always mean implementing every single word. It means navigating your own company with common sense and pragmatism. As startups, we are speedboats, not ocean liners. We need a safe inflatable boat and life jackets. And not a bible on safe container shipping in the Panama Canal. The experts at the 4C Accelerator find the right mix.

Our approach

The 4C Accelerator Tübingen helps you to help yourself. This means that we equip you with methods, ways of thinking and tools that you can then use in your entrepreneurial practice in a targeted manner. Therefore, our program consists of two parts:

In the first part, our experts impart knowledge around the 4C relevant for medical life science startups in live sessions and always put this into direct practical relevance with interactive and individual involvement of the participants. To maximize the practical relevance and individual involvement, the pattern of these live sessions is always the same: input – exercise – presentation – feedback and discussion. Therefore, be aware: 4C is not a lean back, 4C is a lean forward event. But it is worth it!

The second part of the program ensures continuous project management: For a period of one year, one of our startup coaches will support you in planning work packages that have emerged from the expert sessions of the first part. The progress will be evaluated in regular project review meetings and the necessary tasks will be derived. This means that you gain an additional human resource for this period, which can contribute to the success of your startup. As soon as you realize that you need deeper input on specific topics, you can ask for our additional startup services without obligation in the next step.

The program

Overview
  • For whom? Tailored to the needs of start-ups in the medical life sciences (medical devices, digital health, therapeutics, diagnostics).
  • What?
    • Interactive workshops over 17 days with experts in the 4Cs
    • Individual support after the workshops by one of the MII startup coaches over 1 year
  • Why? Faster way to „Investor Readiness“
  • Costs? Free of charge thanks to funding from the state of Baden-Württemberg and the B. Braun Stiftung
  • Our timeline for the next run:
    • Application: Dez. 9, 2022 to Jan. 20, 2023
    • Selection of participants: until March 3, 2023
    • Start of the program: March 24, 2023
Course of Action

Two-stage format with individual training in workshops & expert advice (Part I) plus individual supervision & project management with prioritisation of work packages, progress monitoring, valuable processes and methods plus an extensive network (Part II).

 

Part I – Interactive Workshops with individual Feedback
  • Total duration | 136 hrs. over 17 days
  • Startup teams | 8
  • Experts | 14
  • Outcome 1 | Individual project plan
  • Outcome 2 | Regulatory Thinking®
Part II – Individual Supervision & Project Management
  • Total duration | 1 years
  • Startup Teams | 8
  • Startup Coaches | 4
  • Outcome 1 | Investor Readiness
  • Outcome 2 | Participant confimation
Main Focus

This free training program focuses on the life science-specific topics and conveys specific knowledge for single elements of a business model in this industry. Basic entrepreneurship content has a subordinate role, whereas this program i.e. seeks to answer the following questions:

  • Am I actually developing a product with a medical effect and if so, how do I determine this?
  • Which norms and standards do I have to consider?
  • Do I know the similarities between company certification and product approval?
  • What renumeration options does my product have in the health system?
  • Is a reimbursement by health insurance companies desirable for my product?
  • Is my product attractive for the self-payer market?

As a central element of our training concept, we use the legal regulation (e.g. Medical Device Regulation, In-Vitro-Diagnostic Regulation) and quality management system processes (e.g. ISO 13485), to train “Regulatory Thinking®” from the very beginning. Our actions are aligned with these structures which is why controlled documents relevant for the approval of product and company are continuously produced.  Due to its procedural approach, the method integrates the other key topics mentioned almost automatically and thus leads to perfect preparation for a due diligence review by experienced life science investors.

In the case of additional individual needs of startups, the program is accompanied by the integration of complementary programs of other startup-relevant institutions. We remain the central point of contact within the scope of intensive support, guiding the start-ups via professional project management before, parallel and after the 17-day training. We ensure the achievement of defined milestones. Due to this close support, we know how to open the right doors in our network at the right time, which are of great importance, especially for strategic situations such as the first round of financing.

Who can apply?

Eligible are all students, professionals, founding teams and innovators, including clinicians, nurses, lab technicians, scientists who want to translate their innovative ideas into health solutions of the following domains:

  • Medical Devices (gadgets, machines, instruments, implants)
  • Therapeutics (drugs, active ingredients)
  • Diagnostics (laboratory tests or procedures)
  • Digital Health (data, analytics, software, monitoring)

Participation is independent of where the startups and their team members are located.

How does the application process work?

As soon as the application portal has been opened, you can apply for the free participation in the 4C Accelerator Tübingen. All you have to do is provide us with the most important information about your project and your team and answer a list of questions. Answering the questions is not about knowledge or not-knowledge, it is more about your self-assessment on some important topics. The answers will then help our Idea Evaluation Board to get to know the applicants better and then select the startups that, from their point of view, can generate the most added value by participating in our program.

How does the selection process work?

Which applicants are finally allowed to participate in the 4C Accelerator Tübingen is not decided by the team of the Medicial Innovations Incubator or the Stiftung für Medizininnovationen, but by our so-called Idea Evaluation Board, consisting of the following members:

Dates (Part I: 17 days Workshop & Feedback)

Dates for next cycle:
Every friday starting from March 24, 2023.

Time: 9 a.m. to 5 p.m.
Total hours: 136 h
Format: Online video conference

Attention: Kick-off event and 1st workshop day (March 23-24, 2023) will take place in attendance in Tübingen!

Curriculum:

  • 4 days in C1-Commercialization
  • 4 days in C2-Certification
  • 4 days in C3-Clinical Studies
  • 1 days in C4-Copyright
  • 1 day Workshop with a statutory health insurance company
  • 3 days in project planning

Interested? The next application phase will take place from Dez. 9, 2022 to Jan. 20, 2023!

Not the right thing? We will also find the right support offer for your startup!

Together with experts, we have developed further startup services that we can individually adapt to the needs of your startup. Find out more here. You are also welcome to contact us directly with your request.