Case Study | Projekt mit IntegraSkin
Bringing an in-vitro diagnostic (IVD) to market successfully requires not only regulatory compliance, but also a business model that takes into account the particularities of the healthcare market. The startup IntegraSkin had several promising market access options open to it. However, it was unclear which strategy should be prioritized in the context of the regulatory requirements. With the help of the MII, the startup was able to obtain BioMan4R2 funding and then draw on the expertise of the MII experts. In the joint project, the regulatory roadmap was then aligned with the business model.
Our solution
The startup IntegraSkin was faced with the question of a clear regulatory roadmap for the approval of its IVD. During consultation by the MII, it was crucial to consider this roadmap in context of the commercialization of the product. After all, only a 4C-connected business model can work in the healthcare industry in the long term. Therefore, the question of an efficient – i.e. cost and time-saving – and at the same time sustainably successful market access was therefore also discussed. The MII experts developed alternative market access strategies and identified their pros and cons – both from a business and regulatory perspective. The comprehensive analysis of alternative scenarios helped the startup to make a key decision for its business model. The decision-making process was accompanied and supported by regular consultation meetings with the MII experts. Finally, a regulatory roadmap for the selected business model was jointly developed.
Our formats and methods
- Regular consulting meetings with a MII consultant
- Discussions with and evaluation of potential suppliers
- Preparation of alternative market access scenarios, including the regulatory framework for each case
- Development of the regulatory roadmap for the prioritized scenario
The result
The consulting provided by the MII enabled the startup IntegraSkin to make an informed decision about its business model. The team not only gained clarity about the regulatory roadmap, but also gained speed at the same time. Thanks to the strategic decision to offer the product as a service, as opposed to the original plan, IntegraSkin can now move into implementation in a targeted manner.
“We worked with the MII to assess our market potential and to identify key regulatory and commercial barriers to the delivery of our services for patients with chronic inflammatory skin conditions (CISC). The project focused on assessing the feasibility of launching in Germany and the United States to pave the way for effective market entry.”
IntegraSkin leverages cutting-edge biomedical analysis tools, advanced cognitive computing, and a comprehensive disease-relevant data repository to uncover the molecular mechanisms underlying Chronic Inflammatory Skin Conditions (CISCs). By enhancing the understanding of these conditions, IntegraSkin aims to optimize treatment efficacy for patients. The startup offers tailored services for patients, dermatologists, and the pharmaceutical industry, bridging the gap between research and clinical application.