Support program assists 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 Medical Innovations Incubator's 4C Accelerator 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 faced by medtech startups on their way to market entry. Through a combination of 15 workshops with experts, training sessions on the so-called 4C topic areas and Regulatory Thinking®, participants will be helped. In addition, the start-ups receive individual coaching over the course of a year on the practical implementation of their projects. The ultimate goal is to help the founders develop a successful entrepreneurial model that meets regulatory requirements and convinces investors.

The program addresses the following key questions:

C1 | Commercialization: How can revenue be generated in the healthcare industry?

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

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

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

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

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

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

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

Through the workshops, founders:inside gain a deep understanding of the 4Cs and are trained in Regulatory Thinking® as a mindset. This will enable them to link the 4Cs their content, challenges and opportunities, which is the key to a holistic business model that encompasses and realistically evaluates all relevant scenarios. A business model that works for medical innovations.

Who can participate?

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

The 4C Accelerator will start with a kick-off workshop on October 5 and 6, 2023 in Präsenz in Tübingen. Subsequently, 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 Start-Up BW of the Baden-Württemberg Ministry of Economics as well as the Foundation for Medical Innovation, 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/