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4C Accelerator to Enable Your MedTech Startup

4C Accelerator to Enable Your MedTech Startup

Since 2021, the team behind the “4C Accelerator” has already successfully supported over 55 medtech startups. With the start of the application phase for the 8th round of the program, even more teams can now take advantage of this opportunity. Founders with pre-competitive product ideas in the fields of Medical Devices and In-Vitro Diagnostics can apply until July 19, 2024.

What is it about? The program focuses on the specific requirements that MedTech startups face on their way to the market– the so-called 4Cs – and how they can be connected in a smart way.

C1 | Commercialization:
How do I generate revenue in the healthcare industry? Many stakeholders (e.g., patients, physicians, medical associations, nursing homes) and market characteristics (e.g., self-pay, complex reimbursement rules such as selective contracts) make market access and revenue generation difficult.

C2 | Certification:
How do I get my product and company certified? The establishment of a quality management system for the company certification (e.g., ISO 13485, Good Manufacturing Practice) and the preparation of the technical documentation for the product approval (e.g., Medical Device Regulation, In-Vitro Diagnostic Regulation) are the most fundamental requirements for a successful market access.

C3 | Clinical Studies:
How can I provide the necessary evidence by collecting clinical data? Proofing safety and performance as well as the clinical and/or health economic benefit of a product (e.g., ISO 14155) is essential, but also costly and time-consuming for startups.

C4 | Copyright:
How can I use data/property rights for my own advantage? Using and maintaining intellectual property rights (e.g., patents) is important for company valuation, successful negotiations with investors or licensees, and for planning exit scenarios. In addition, data rights (GDPR) and especially, the protection of personal health data, set requirements for product development and pre-clinical and clinical testing.

How is the program structured?

Part 1 | 4C Workshops hosted by the Stiftung für Medizininnovationen
During 15 interactive workshops with top experts, the founders gain a deep understanding of the 4C topics and are trained in Regulatory Thinking® as a mindset.

Part 2 | 4C Coaching provided by the Medical Innovations Incubator GmbH
Startups that have successfully participated in the 4C workshops receive individual coaching for one year. The MII startup coaches support them in the practical implementation of their milestones.

Goal:
The 4C Accelerator enables founders to connect the 4Cs, their content, challenges and opportunities in order to develop an entrepreneurially successful and regulatory plausible business model and to set up a realistic roadmap – they become "investor ready".

Who Can Participate?
The program is aimed at all national and international startup teams and innovators who want to implement their innovative, pre-competitive product ideas within the following areas:
- Medical Devices (gadgets, machines, instruments, implants)
- Software as Medical Device
- In Vitro Diagnostics (laboratory tests or procedures, software)

The working language is English.

The program is funded by Startup-BW of Baden-Württemberg’s Ministry of Economic Affairs, the B. Braun Stiftung, and the Hector Stiftung.

Individuals and teams can apply until July 19, 2024, via the MII website: https://mi-incubator.com/en/4c-accelerator/

Sponsors

  • University of Mannheim
  • Institut für Mittelstandsforschung
  • Gründerverbund
  • ESF
  • Europäische Union
  • Baden-Württemberg - Ministerium für Finanzen und Wirtschaft
  • Absolventum