Medical Innovations Incubator
Home of 4C - Enabling Life Science Innovations
4C Services
Our startup-friendly services are targeted at startups from the medical life sciences and are based on our Regulatory Thinking® approach and the 4C concept. 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.
Services in the area C1 | Commercialization
What do we mean by C1?
Many interest groups (e.g. patients, doctors, Ärztekammer, nursing home) and market peculiarities (e.g., self-payer, reimbursement rules of health insurances such as AMNOG or selective contracts) make market access and the generation of revenue more difficult.
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
Services in the area C2 | Certification
What do we mean by C2?
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, Medicines Law) are mostly the basic requirements for a successful market entry.
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
Review of …
- TD according to MDR/IVDR/AMG, ISO 13485/GxP
- QMS according to MDR/IVDR/AMG, ISO 13485/GxP
Services in the area C3 | Clinical Studies
What do we mean by C3?
Proof of the clinical evidence, safety and performance of the product (in accordance with e.g., ISO 14155, ISO 13612, ICH Guidelines) is essential and also costly and time-consuming for startups.
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/ICH
- Study protocol regarding selected endpoints and study design
- Study protocol according to MDR/IVDR/ICH, ISO 14155, ISO 13612
- Patient information and informed consent
Services in the area C4 | Copyright
What do we mean by C4?
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.
Enabling to …
- Negotiations with universities for IP clearance
- IP strategy
- Data protection according to GDPR