During ARFM project, Nateohealthcare conducted the following activities:
- To prepare clinical trials, a regulatory study was carried out for Nateohealthcare’s CTG. For Europe, further assessment of the new EMA regulations for medical devices validated the medical device classification of Nateohealthcare’s CTG. Furthermore, design of the clinical trial protocol to obtain CE marking of maternity CTG has been initiated with Nateohealthcare’s subcontractors: patient number, clinical trial design… This work led Nateohealthcare to modify the clinical trial design to adapt the study to the targeted indications for Nateohealthcare’s CTG (study population, intended use evaluated: intrapartum or prepartum use…).
- For market access strategy, a market study on wireless foetal monitoring systems allowed Nateohealthcare to identify the first European markets targeted for Nateohealthcare’s deployment, according to CTG market but also to the use of digital technology in healthcare pathway. A discrepancy between European countries in the integration of digital technology in healthcare pathway has been shown. Nateohealthcare will hence first target countries which already have implemented telemedicine.
- Refining Business Plan: In a first approach, Nateohealthcare performed a preliminary market analysis and built up a simplified business plan regarding the ARFM project. These studies showed a favourable market context. During the SME Instrument Phase 1 feasibility study, Nateohealthcare consolidated a detailed business plan related to the commercialisation of its products, including further analysis of barriers to entries and market opportunities.
