The #4CAccelerator goes into the 5th round! Startups in medical life science can apply for the internationally sought-after and free qualification program of the Medical Innovations Incubator GmbH until January 20, 2023.
What is it about?
In 17 workshop days, startups receive focused training in the 4Cs and the Regulatory Thinking® approach. Together with experts, their own business model is further developed and made "investor-ready". The program addresses the following questions:
C1 | Commercialization: How do I generate sales in the healthcare sector? Many interest groups (e.g., patients, doctors, Ärztekammer, Pflegeheime) and market peculiarities (e.g., self-payer, complex reimbursement rules of insurances, like AMNOG or selective contracts) make market access and generation of revenue more difficult.
C2 |Certification: How does the certification of my product and my company work? The establishment of a quality management system for the company certification (e.g., ISO 13485, Good manufacturing practice (GMP)) and the creation of the technical documentation for the product approval (e.g. Medical Device Regulation, InVitro-Diagnostic Regulation, Medicinal Products Act) are mostly the basic requirements for a successful market entry.
C3 |Clinical Studies: How do I prove safety and performance of my product? Proof of the clinical evidence, safety, and performance of the product (e.g., according to ISO 14155, ICH Guidelines) is essential and also costly and time-consuming for startups.
C4 |Copyright: How can I use data/property rights for my own advantage? Using and maintaining intellectual property rights (e.g., patent) and data rights (DSGVO) strategically is important for company valuation, successful negotiations with investors or licensees and for planning exit scenarios.
Following the workshop phase, each startup is supported by the MII startup coaches over a period of 1 year in the implementation of the work packages that have been created.
What is the goal?
Through the interactive workshops, founders gain a deep understanding of the 4Cs and are trained in Regulatory Thinking® as a mindset. This enables them to bridge the gap between innovation in general and successful medical innovation in particular.
At the end of the Accelerator, you as a founder will have achieved the following:
You will have identified corresponding barriers to shorten the time-to-market and considered them in an individual project plan
You will be familiar with the reimbursement options in the healthcare market
You will know how quality management systems and regulatory processes become a strategic concept and how they effectively lead to approval of your product
You will be able to assess whether and what kind of clinical studies you need and how to best implement them
You will know how to deal with data protection requirements and how to strategically protect and exploit the product idea
Who can participate?
Eligible are all national and international students, professionals, founding teams and innovators, including clinicians, nurses, lab technicians, scientists who want to translate their innovative ideas into health solutions of the following domains:
Medical Devices (gadgets, machines, instruments, implants)
Therapeutics (drugs, active ingredients)
Diagnostics (laboratory tests or procedures)
Digital Health (data, analytics, software, monitoring)
The working language is English.