Apply for the 4C Accelerator Program (Germany)

In the 4C Accelerator, MedTech startups and their founders get enabled to overcome the specific hurdles of the healthcare industry through knowledge transfer in the 4Cs and practical training in “4C Business Modelling”. Participants learn how to integrate the regulatory requirements of the 4Cs, such as MDR/IVDR, ISO 13485, DSGVO and of the German reimbursement system, into their business model development at an early stage and to consider them in their entrepreneurial activities.

In the 4C Accelerator, participants gain knowledge about the regulatory requirements in the respective 4C topics (e.g., MDR/IVDR, QMS according to ISO 13485, risk management according to ISO 14971, clinical study plan according to ISO 14155, selective contracts, DiGA guideline, GDPR) and learn strategies for their implementation. As a central element, they use the Intended Use Document, which is constantly supplemented and specified by the interaction of the 4Cs. Similar to a Business Model Canvas – it structures the strategic aspects of your business model.

Aims

• The program aims to answer the following questions:
  • Am I developing a product with a medical purpose, and if so, how do I determine this?
  • Which product class does my product fall into according to MDR/IVDR?
  • Which norms and standards do I have to take into account in order to bring my product onto the market?
  • How do I obtain company certification and product approval?
  • What reimbursement options are available for my product in the healthcare system?
  • Is it worthwhile for my product to be reimbursed by health insurances?
  • Is my product attractive for the self-payer market?
  • What do I have to consider regarding the protection of my innovation?
  • What role does personal health data play during product development and after market entry?

Focus Areas

• This free qualification program focuses on the industry-specific and highly regulated topics of the healthcare industry. It provides in-depth knowledge for business model development within medical technology, without neglecting cross-sector entrepreneurship competencies.

Topics

• 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-payers, reimbursement options of the health insurances, like selective contracts and DiGA). You will also identify topics from C2 to C4 that will be relevant for marketing your product – the interlinking of the 4Cs begins.
• C2 | Certification:
  • You will be enabled to set up a quality management system (QMS) according to ISO 13485 and its processes and to set up the technical documentation according to the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR) to obtain the medical CE marking of your product – key steps for market access taking into account your claims.
• C3 | Clinical Studies:
  • They provide transparency on the process of clinical evaluation, on the different objectives and designs of clinical studies and convey knowledge for their concrete implementation (e.g., ISO 14155/ISO 13612). Always keeping in mind: the certification of your product (C2) on the one hand and your commercialization strategy (C1) on the other.
• C4 | Copyright:
  • They provide knowledge about the possibilities to protect your innovation (e.g., patents) – including software components – as well as about the requirements of data protection (DSGVO) in the healthcare sector.

Eligibility Criteria

• Startups with innovative MedTech product ideas
• All founding teams and innovators who want to implement their pre-competitive business idea within the following areas can apply:
  • Medical Devices (apparatus, instruments, machines, implants, in-vivo)
  • In Vitro Diagnostics (laboratory tests, laboratory procedures)
  • Digital Health (Software as Medical Device/IVD)

For more information, visit Medical Innovations Incubator GmbH.