4C Accelerator
We specialized in the promotion of innovations in medical technology (MedTech). Therefore, we know: Startups with medical devices or in vitro diagnostics (IVD), as part of the healthcare industry, have to overcome higher hurdles than startups from other industries. At the same time, there are rarely experts on the industry-specific, highly regulated and thus critical topics of the 4Cs: C1 | Commercialization, C2 | Certification, C3 | Clinical Studies and C4 | Copyright. Moreover, it is not only know-how in the 4Cs that is crucial, but also their integration into the business model. This can be achieved with the “4C Business Modelling” method we have developed.
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.
At a glance
- For whom | Startups with innovative MedTech product ideas
- What | Teaching the 4Cs and training in “4C Business Modelling”
Part 1: 15 interactive 4C Workshops by the Stiftung für Medizininnovationen
Part 2: 6 months of individual 4C Coaching by the Medical Innovation Incubator GmbH - Why | Faster “investor ready”
- Format | Online workshops & meetings in English
- In addition | Access to the 4C Community & exclusive events
- Costs | Thanks to the funding partners the program is free of charge for founders
Since 2020, the 4C Accelerator has been offered to support founders in developing an entrepreneurially successful and regulatory plausible business model. While the MII is responsible for Part 2 – the 4C Coaching –, the Stiftung für Medizininnovationen hosts Part 1 – the 4C Workshops.
Not only we are convinced of this programme, but also the funding partners: Baden-Württemberg Ministry of Economics, Labor and Tourism and its Startup BW campaign, the B. Braun Stiftung, and the Hector Stiftung.
Your added value through training in the 4Cs & Regulatory Thinking®
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.
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.
We 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.
We 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.
4C Business Modelling
By training the “4C Business Modelling” method as a mindset, you will learn to understand the regulatory requirements in the topics of the 4Cs in an interconnected way and to integrate them holistically into your business model. This will enable you to create a well thought-out roadmap, to calculate and negotiate realistic investment volumes and to develop a regulatory plausible and entrepreneurially successful business model.
Find out more about this opportunity here.
At the Medical Innovations Incubator – MII for short – we specialize in the targeted support of MedTech innovations in the fields of medical devices, in-vitro diagnostics and digital health. To this end, we have developed a holistic consulting approach that takes a networked view of the challenges and opportunities in the healthcare market.
With the unique combination of many years of experience in industry, science and the startup world, tailor-made strategies and a specialized network, we help to successfully and sustainably establish medical innovations in the healthcare sector.
