Medical Innovations Incubator

Home of 4C - Enabling Life Science Innovations


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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 then have transferred the insights gained from this into our concept of Regulatory Thinking and made it the central starting point of our 4C Accelerator. 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.

Why 4C?

With the help of extensive knowledge around the 4C, medical life science startups close the gap between innovation in general and successful medical innovation in particular. Knowledge of the so-called Entrepreneurship Essentials using common methods such as Business Model Canvas, Business Plans, Design Thinking or Lean Launchpad are essential for the education of successful life science startups, but in our view not sufficient. We are convinced: Only a deep understanding of the following 4C will really help you to achieve more investor readiness!

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 (e.g. ISO 13485) and the creation of the technical documentation for the product approval (e.g. Medical Device Regulation, In-Vitro-Diagnostic Regulation) 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.

Your individual added value through the training in the 4C

  • 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.
  • 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.
  • We create transparency about the different objectives and designs of clinical studies and transfer knowledge for the concrete implementation of clinical studies.
  • We provide knowledge about the possibilities of appropriate IP protection as well as requirements of data protection in the healthcare sector.

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.

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.

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)

How does the application process work?

As soon as the application portal has been opened, you can apply here 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 short 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 experts 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 staff of the Medicial Innovations Incubator or the Foundation for Medical Innovations, but by our so-called Idea Evaluation Board, consisting of the following members:

  • Prof. Dr. Hugo Hämmerle (former director of the NMI Tübingen and chairman of the Idea Evaluation Board)
  • Prof. Dr. Michael Auer (Chairman of the Steinbeis Foundation)
  • Dr. Ute Fink (Team Leader at Project Management Jülich)
  • Prof. Dr. Ralf Kindervater (Managing Director of BIOPRO Baden-Württemberg GmbH)
  • Dr. Klaus Maleck (Chief Financial Officer at ITM Isotopen Technologien München AG)
  • Prof. Dr. Oliver G. Opitz (Head of Coordination Office Telemedicine BW)
  • Dr. Alfred Stett (Managing Director of Okuvision GmbH)

Timeline:

  • Application Deadline: 03.09.21
  • Inform selected startups: 26.09.21
  • Start of the program: 01.10.21
How do previous participants rate the Accelerator?

„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.“
(Thomas Sühn | SURAG Medical GmbH i.G.)

“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. The 4C Accelerator is highly professionally organized and very competently managed. We are not aware of a comparable training concept for medical life science startups in Germany. It really moves things forward and is fun. Great!!!”
(Rüdiger Schulze | KLAVANT 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.“
(Vera Claas | Mental Stark)

Background information

The Medical Innovations Incubator GmbH and the Foundation for Medical Innovations 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 as well. The accelerator is funded by the Ministry of Economics, Labor and Tourism of state of Baden-Württemberg, its campaign Start-up BW and the B. Braun-Foundation.

Dates (Part 1: 17 days Training & Feedback)

Dates for next cycle:
01.10.2021 – 11.02.2022 (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: 19.07. – 03.09.2021