The following text does not reflect the entire content of the announcement, but contains individual extracts from the guideline.

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.

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.

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

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.