Rethink Medical has further investigated the technical parameters and technological and regulatory requirements regarding product design and final manufacturing. The company evaluated several providers and selected one that with all the technological knowledge can meet price expectations and regulatory/quality requirements.
Rethink Medical has listed the regulatory steps for CE Mark notification, and we have started to work on the preparation of the technical filing procedures. A notifying body was in fact selected.
A Market research was conducted at a deeper level including clients, payers, insurers, hospitals... It included validation surveys, consultation of market reports/groups, and analysis of trends. We have seized the exercise to broaden our contacts list by healthcare professionals, hospitals, and potential licenses.
Based on the information gathered, a detailed commercial plan was prepared, paving special interest in Spain, where the company plans to start the commercialisation, with local agents. Several Spanish hospitals in our network have shown interest in using the product and participating in the clinical trials. At international level (EU at the cornerstone of the international expansion), potential license and/or distribution partners were analysed and contacted.
A Cost effectiveness study design started, confirming the pricing strategy.
An operative planning (production, warehousing, logistics and market access activities) has been envisaged.
The Go-to-market strategy was elaborated on a global level, with detailed Business Plan including scientific and commercial information.
Is important to highlight our Innovative purchasing model for the first years of operation. Exploitation, once the product is manufactured, can start without being registered. Such purchasing models offers financial support from the Administration and facilitates the organic growth of the company, with several advantages: 1. VC dilution can be avoided or at least diminished, 2. TTT (Time-To-Tomb) can be significantly broaden.
A Risk assessment was performed determining all the possible risk factors, contingency plans and analysis of the consequences.
An IP plan was updated: apart from the already approved patent, trademark registration was filed internationally (approved in the EU) in order to protect all the data published so far and in the future. Exclusivity agreements with specific providers are under discussion, aimed to create further barriers to competition.
