Funding program supports MedTech start-ups with market entry

The 4C Accelerator of the Medical Innovations Incubator supports founders in the medtech sector in overcoming hurdles to market launch and successfully implementing their product ideas. Applications are open until August 4, 2023.

Tübingen - The 4C Accelerator of the Medical Innovations Incubator is once again launching the application process for its qualification program. Thanks to the support of the "Startup BW" initiative, founders with innovative product ideas in the field of medical devices and in-vitro diagnostics have the opportunity to apply until August 4, 2023.

The program focuses on the specific challenges that MedTech start-ups face on their way to market entry. Participants will be helped through a combination of 15 workshops with experts, training sessions on the so-called 4C topic areas and Regulatory Thinking®. In addition, the start-ups receive individual coaching over the course of a year in the practical implementation of their projects. The ultimate goal is to support the founders in developing a successful entrepreneurial model that meets regulatory requirements and convinces investors.

The program addresses the following key questions:

C1 | Commercialization: how to generate revenue in the healthcare sector?

Market access and revenue generation in the healthcare sector are extremely complex due to the diverse interest groups (such as patients, doctors, medical associations, nursing homes) and special market conditions (e.g. self-payers, reimbursement rules of health insurance companies such as selective contracts).

C2 | Certification: How are the product and the company approved?

The establishment of a quality management system for company approval (e.g. ISO 13485, Good Manufacturing Practice) and the preparation of technical documentation for product approval (e.g. Medical Device Regulation, In-Vitro Diagnostic Regulation) are of crucial importance for successful market entry.

C3 | Clinical Studies: How is the required evidence provided by clinical data?

Evidence of a product's safety, performance and clinical/health economic benefit (e.g. ISO 14155) is essential, but is a costly and time-consuming challenge for start-ups.

C4 | Copyright: How can data and property rights be used to your own advantage?

The strategic use and maintenance of intellectual property rights (e.g. patents) is of great importance for the valuation of the company, negotiations with investors or licensees and for planning exit strategies. In addition, data protection regulations (such as the GDPR) and in particular the protection of personal health data place demands on product development as well as preclinical and clinical trials.

Objective

The workshops provide founders with a deep understanding of the 4Cs and train them in Regulatory Thinking® as a mindset. This enables them to link the 4Cs to their content, challenges and opportunities, which is the key to a holistic business model that includes and realistically evaluates all relevant scenarios. A business model that works for medical innovation.

Who can participate?

The program is open to national and international founding teams and innovators who want to implement innovative product ideas in the fields of Medical Devices (devices, instruments, machines, implants, software) and In Vitro Diagnostics (laboratory tests, laboratory procedures, software). The working language during the Accelerator is English.

The 4C Accelerator starts with a kick-off workshop on October 5 and 6, 2023 in presence in Tübingen. Subsequently, the online workshops will take place from October 13, 2023 to February 2, 2024, each Friday from 9 a.m. to 5 p.m. (with the exception of the Christmas vacations in Baden-Württemberg). Participation in the program is made possible by the Start-Up BW of the Baden-Württemberg Ministry of Economic Affairs as well as the Foundation for Medical Innovations, the B. Braun Foundation and the Hector Foundation.

Interested individuals and teams can apply until August 4, 2023 on the Medical Innovations Incubator website: https://mi-incubator.com/de/4c-accelerator-de/