Medical Innovations Incubator

Home of 4C - Enabling Life Science Innovations


We are official Pre-Seed partner of the federal state BW.
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Our approach: focused on medical innovations

Promoting medical innovations. This is the purpose of our non-profit parent company, the Foundation for Medical Innovations and our common goal since 2014. Due to this narrow focus, we are really aware of the additional and special challenges of the medical life science industry – and it’s precisely this awareness which is the foundation of our daily actions!

This is why we have developed our concept of 4Cs and Regulatory Thinking® in recent years, which serves as the starting point of our startup services and our accelerator. It allows us to set an industry-specific focus in startup support. We believe that knowledge and skills regarding Entrepreneurship Essentials and Innovation Management are essential for the success of startups in general. However, additional know-how is needed for medical life science startups in particular.

Working with promising startups is just one component of our service portfolio. In addition, we offer medical life science specialized services for corporates, investors, academia and communities, such as incubation as a service, technology transfer, idea evaluation, events and access to our unique network.

So if you are looking for a highly specialized connector between medical life science on the one hand and innovation on the other, we really look forward to getting in touch.

 

Why 4C?

With extensive knowledge around the 4Cs of medical lifes sciences, the gaps between innovation in general and successful medical innovation in particular can be closed. 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 4Cs will really help innovators 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 health insurances like AMNOG or selective contracts) 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, GxP) and the creation of the technical documentation for the product approval (e.g. Medical Device Regulation, In-Vitro-Diagnostic Regulation, GxP) are mostly the basic requirements for a successful market entry.

C3 | Clinical Studies

Proof of the clinical evidence, safety and performance of the product (in accordance with ISO 14155, ICH Guidelines) is essential and also costly and time-consuming for startups.

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.

What is Regulatory Thinking®?

  • Regulatory Thinking® is a mindset developed by partners from Research and Teaching as well as the Startup Ecosystem.
  • Regulatory Thinking® offers tools, processes and thinking approaches that help to develop a convincing business model in this complex sector.
  • Regulatory Thinking® combines regulatory topics with business modeling – two seemingly incompatible worlds.
  • Regulatory Thinking® is your competitive advantage as you develop your business model from a regulatory perspective

E.g.: Our “Regulatory Canvas” combines Business Model Canvas + Design Thinking + Personas + Patient Journeys via the lens of regulatory requirements for medical innovation.

For more information visit Regualtory Thinking® or write an email to regulatorythinking@mi-incubator.com!

Research and Teaching

Startup Ecosystem