Medical Innovations Incubator

Home of 4C - Enabling Life Science Innovations


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4C Accelerator Tübingen

Qualification program for founding teams & start-ups interested in a business model development up to its “investor readiness” by the interconnected elaboration of the 4Cs of the medical life sciences:

  • C1 – Commercialization | Revenue planning in the healthcare system (e.g. reimbursement by insurances)
  • C2 – Certification | Approve product & company
  • C3 – Clinical Studies | Prove evidence of the product
  • C4 – Copyright | Use data / property rights strategically

The program is funded by the Ministry of Economics, Labor and House of state Baden-Wuerttemberg.

Why 4Cs ?

Compared to other industries the survival of life science start-ups is particularly challenging  due to long time periods and the capital requirement until market maturity. This is due to the 4Cs.

C1 | Commercialization

Many interest groups (e.g. patients, doctors, Ärztekammer, nursing home) and market peculiarities (e.g. self-payer, complex reimbursement rules of the statutory health insurances) make market access and the generation of revenue more difficult.

C2 | Certification

The establishment of a quality management system for the company certification and the creation of the technical documentation for the CE approval of a medical product are mostly the basic requirements for a successful market entry.

C3 | Clinical Studies

Proof of the clinical evidence, safety and performance of the product is essential and also costly and time-consuming for start-ups.

C4 | Copyright

Using and maintaining patents, property and data rights strategically is important for company valuation, successful negotiations with investors or licenses and for planning exit scenarios.

The past years of start-up support activities demonstrated that a specialisation in the health industry by using the common methods for training start-ups (Lean Launchpad, Business Model Canvas, Pitch training, Business Plan, Ideation, Design Thinking, etc.) is not sufficient. Thus, an intelligent specialisation within the specialisation is needed in order to be able to develop effective business models that are suitable, for example, to withstand a due diligence review by Venture Capital companies or strategic partners from the healthcare industry and to obtain relevant financing. This is also confirmed by experienced industry experts and organisations.

The program

Overview
  • For whom? Tailored to the needs of start-ups in the medical life sciences (medical devices, digital health, therapeutics, diagnostics).
  • What?
    • Individual training (17 days with experts on the 4Cs).
    • Individual support after the training (1 year of project management for the 4Cs)
  • Why? Faster way to „Investor Readiness“
  • Costs? Free of charge thanks to funding from the state of Baden-Württemberg
  • When? 2 application deadlines per year | 05.03.21 & 03.09.21
Course of action

Two-stage format with individual training in workshops & expert advice (Part 1) plus individual supervision & project management with prioritisation of work packages, progress monitoring, valuable processes and methods plus an extensive network (Part 2).

Part 1 – Individual Training & Feedback

  • Total duration | 136 hrs. in 17 days
  • Start-up teams | 8-12
  • Experts | 14
  • Outcome 1 | Individual project plan
  • Outcome 2 | Mini Diploma from a Lead Auditor (Medical Device Regulation requires this for approval of company and product)

Part 2 – Individual Supervision & Project Management

  • Total duration | 1-1,5 years
  • Start-up Teams | 8-12
  • Start-up Consultants | 5
  • Outcome | Investor Readiness
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 medical device 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 interconnected training concept, we use the Medical Device Regulation (MDR) and ISO 13485 (quality management system for the design and manufacture of medical devices). Our actions are aligned with these structures which is why controlled documents relevant for the approval of product and company are continuously produced.  Thereby we train “Regulatory Thinking” from the very beginning and practice working together in a controlled environment. 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 start-ups, the program is accompanied by the integration of complementary programs of other start-up-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.

Benefits
  • Free participation | The program is funded by the ministry of economy Baden-Württemberg
  • Top-class Experts | The program works with top-class experts who represent a decisive added value for participating teams. These hold senior positions in industry, are proven subject matter experts or seasoned entrepreneurs which guarantees the appropriate experience and quality of guidance to offer.
  • Individual Training & Feedback | During 17 days high-profile external experts will elaborate the 4C’s on the individual needs of each team in workshops and 1:1 coaching sessions that are individually tailored.
  • Individual Supervision & Project Management | During 1 year we will guide you in processing the work packages resulting from the 14 days of feedback & education. Progress is discussed in frequent project review meetings and necessary measures are derived.
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)

The working language is English. Individuals and teams can apply here on Eventbrite! (application possible from July 16th)

What is the objective?

The participants can survey the life science-specific start-up topics of the 4Cs and thus plan ahead. The early strategic consideration of possible complications in the 4Cs creates the prerequisite for attaining the necessary maturity in the shortest possible time and for convincing investors. Corresponding barriers to shortening the time to market have been identified and structured in an individual project plan.

At the end of this program the participants will be familiar with the reimbursement options in the healthcare market. They will know how quality management systems and regulatory processes become a strategic concept and how they effectively lead to market approval of a medical product. Participants can decide whether and what type of clinical trials they need and how best to implement them. At the end of the program, they will know how to deal with data protection requirements and how to strategically protect and exploit the product idea.

Background Information

The Medical Innovations Incubator GmbH and the Stiftung für Medizininnovationen have already been offering qualification programmes for medical start-ups since 2014, working closely with the Start-up Centre at the University of Tübingen. The predecessor programme called „MedTech Startup School“ was funded by the state of Baden-Württemberg from 2017-2020 as part of a state-wide collaboration with locations in Heidelberg and Mannheim. The new programme called “4C Accelerator Tübingen” has been rated very positively. The accelerator is funded by the Ministry of Economics, Labor and Housing of state of Baden-Württemberg and its campaign Start-up BW.

Dates (Part 1: 17 days Training & Feedback)

Dates for next cycle:
02.04.2021 – 23.07.2021 (Fridays)

Time: 09:00 – 17:00 h
Total hours: 136 h
Format: Online video conference

Curriculum:

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

Interested?
Next application period: 16.07. – 03.09.2021