Medical Innovations Incubator

HOME OF 4C - Enabling Medical Innovations

4C Services

Our startup-friendly services are targeted at MedTech startups with medical devices, in vitro diagnostics or digital health applications and are based on our approach of 4C concept and Regulatory Thinking® methode. By that, we have the ability to take a linked view of the regulatory requirements of the 4C topics and the associated challenges and opportunities, and to have a holistic view on your business model.

We provide you with strategic and implementation support for all 4C challenges that await you as a MedTech startup: from QMS, Technical Documentation and clinical studies to matters of reimbursement by health insurance companies and discussions with investors.

“As the idea giver of the technology, it was important for me to initiate this project, which was extraordinary for us, with the MII. Although I have been accompanying the product idea for more than eight years now, the fruitful cooperation with the MII as a competent but also critical project partner enabled me to get to know it even better and, above all, to see the advantages in its application even more clearly. For me, the project was definitely worth it.”

– Prof. Dr. Markus Enderle, CSMO, Erbe Elektromedizin GmbH

Reference project with Erbe

“There is an absolute relationship of trust between the MII team and OSORA, which alllows an open and relentless approach to business model development. In combination with their expertise in the healthcare market, this is an important accelerator for our market entry!”

– Dr. Andreas Arnegger, Co-Founder, OSORA medical GmbH

Reference project with OSORA

“With the MII’s jump-start, we have successfully mastered the first important milestone on the way to becoming a medical technology company in the shortest possible time. The support took away the fear of the big mountain and enabled us to simply take it into our own hands. In this way, we have shown that a research-focused project can become a market-oriented company.“

– Dr. Ramona Samba, CEO, sync2brain GmbH

Reference project with sync2brain

“What do you need on the journey from the idea to the first protected product sold profitably? So many things! One’s own expertise and perseverance, are just as important as travel companionship and a willingness to learn. In the meantime, I’m on a good course with a tailwind, meeting people and opportunities I never would have expected. Without the support and guidance of the MII, I would never have embarked on this journey.”

– Mark Kässer, CEO & Co-Founder, Fysor GmbH

Reference project with Fysor

“Thanks to the excellent advice from the MII, we were not only able to ensure the regulatory conformity of our therapeutic app, but also achieve the desired CE marking more quickly. We are very grateful for the great cooperation.“

– Nina Kiwit, CEO & Co-Founder, MindAhead UG

Reference project with MindAhead

“We are a startup with a high amount of research and development, so having a QMS tailored to our needs and resources is very important. The MII team is very familiar with the special demands of small companies like ours and was therefore not only able to support us in setting up a QMS tailored to our needs, but also helped us to anchor the underlying quality and customer-oriented thinking throughout the company.“

– Dr. Dennis Zelle, CTO & Co-Founder, EARLAB GmbH

Reference project with EARLAB

4C Boost

Precise answers to your specific questions in the 4Cs in relation to your chosen business model.

How? Non-binding, 30-minute mini-consultation by one of our experienced 4C Experts.

Quick, free of charge, & 4C Connected

Request an appointment!

4C Check-up

Detailed reflection of your business model and analysis of the requirements in the 4Cs.

How? One-day workshop with our 4C Experts guided by our 4C Connected tool set.

Compact, strategic, & 4C Connected

Request now without obligation!

4C Deep Dive

Implementation of your business model and the milestones in the individual 4Cs.

How? Individual consulting contingent with 4C Expert, incl. 4C Connected tool set and access to the MII network.

In-depth, hands-on, & 4C Connected

Request now without obligation!

Our 4C Deep Dive Services

We ENABLE you!

We empower you through individual consulting, seminars, workshops, pre-filled templates incl. methodical guidance or the combination of different formats. In doing so, we always consider the relevant regulatory aspects as well as your individual level of experience. Our goal is to enable you to continue to work with the results independently.

Depending on the topic and individual requirements, the services are carried out by our interdisciplinary team or together with highly qualified partner companies.

We REVIEWE your documents!

Together with regulatory experts, e.g. from the certification body QS Schaffhausen AG, we support you with pre-assessments and internal audits. We check your documents, and you receive a written report. If required, we can prepare the results in a joint workshop.

This is the ideal preparation for the submission of application documents, for an external audit or for other official document checks.

Hands-on in C1 | Commercialization

Enabling to …

  • Stakeholder mapping
  • Product/market fit analysis
  • Market access strategies
  • Reimbursement variants
  • Preparation of reimbursement application
  • Cash cycle/cashflow mapping
  • Pricing strategy incl. validation

Review of …

  • Business plan
  • Sales strategies and distributor contracts
  • Reimbursement applications

Hands-on in C2 | Certification

Enabling to …

  • Basic understanding of Technical Documentation (TD)
  • Definition of indented use
  • Determination of risk class
  • Requirements engineering
  • Design and development plan
  • Usability engineering according to IEC 62366
  • Risk management according to ISO 14971
  • QMS process landscape according to ISO 13485, GMP

Review of …

  • TD according to MDR/IVDR, ISO 13485, GMP
  • QMS according to MDR/IVDR, ISO 13485, GMP

Hands-on in C3 | Clinical Studies

Enabling to …

  • Strategy on required pre-/clinical data for certification
  • Flow of clinical evaluation/performance evaluation process according to MDR/IVDR
  • Preparation of Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER)
  • CEP and CER templates
  • Process of literature search and literature appraisal
  • Conception and planning of a clinical study/performance study
  • Definition of primary and secondary endpoints for a clinical study
  • Application for approval of a clinical study to ethics committee and/or authority (BfArM)
  • Preparation of study protocol and/or study report

Review of …

  • CEP and CER according to MDR/IVDR
  • Study protocol regarding selected endpoints and study design
  • Study protocol according to MDR/IVDR, ISO 14155/ISO 13612
  • Patient information and informed consent

Hands-on in C4 | Copyright

Enabling to …

  • Negotiations with universities for IP clearance
  • IP strategy
  • Data protection according to GDPR