Medical Innovations Incubator
Home of 4C - Enabling Life Science 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.
Depending on the topic and individual request, the services are carried out by our experienced and interdisciplinary team or implemented together with highly qualified partner companies. Our startup services are divided into ENABLING and REVIEW services.
ENABLING Services
Our goal
Our goal is to ENABLE you to develop your own way of thinking in order to implement things independently – true to the motto: help for self-help!
In our experience, startups often buy expensive knowledge in the form of consulting hours or templates without being able to integrate this knowledge into their own structures in a meaningful and sustainable way. Our enabling services, on the other hand, are tailored to the individual needs of each startup.
… and how we achieve it!
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. With our templates, we attach great importance to the fact that you can continue to work with them independently, which is why we take your individual wealth of experience into account via the “Document Readiness Level”.
As a platform for medical innovation, we involve our network of experts in the development and implementation of our services. For some of the offered seminars and individual workshops certificates can be obtained in cooperation with a certification body (QS Schaffhausen AG).
REVIEW Services
Our goal
We want to make sure that your official documents, such as applications for approval or reimbursement, technical documentation or quality management documents, are formally correct, complete and, above all, plausible in terms of content. This is because institutions that are in high demand, such as Notified Bodies, authorities (BfArM, PEI, G-BA, GKV-SV ) and Ethics Committees are not in the business of advising startups or improving their documents. With our review services, we maximize your chances of success in external audits or document reviews from the outset, so that you receive the certification, approval or reimbursement you are seeking and save time and money.
… and how we achieve it!
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.
What do we mean by C1?
How can I generate revenue with my product? What are the possibilities for reimbursement by health insurances? Which interest groups do I have to consider? All these topics are behind C1 and the commercialization of your product.
Even in the C1 scope, we always keep all 4Cs in mind. Why? Find out here!
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
What do we mean by C2?
What is the risk class of my product? How do I carry out systematic and regulatory-compliant product development? What does the TD according to MDR or IVDR contain? How do I set up a QMS according to ISO 13485? Knowledge of these and other C2 topics is essential for market entry.
Even in the C2 scope, we always keep all 4Cs in mind. Why? Find out here!
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
What do we mean by C3?
How is the clinical or performance evaluation performed according to MDR/IVDR? Do I need clinical data for this? If so, how do I plan and implement a clinical study? Which endpoints do I have to define for the proof of safety, performance, clinical or health-economic benefit of my product? What are the costs and time requirements I need to anticipate? In the context of C3, questions like these must be considered and clarified at an early stage.
Even in the C3 scope, we always keep all 4Cs in mind. Why? Find out here!
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
What do we mean by C4?
How can I strategically use property rights, e.g., patents, to protect my innovation and the intellectual property of my company? What measures do I need to take to protect personal data, such as that of patients, in accordance with the GDPR? Knowledge about the possibilities of intellectual property rights as well as the obligations for data protection are essential.
Even in the C4 scope, we always keep all 4Cs in mind. Why? Find out here!
Enabling to …
- Negotiations with universities for IP clearance
- IP strategy
- Data protection according to GDPR