• T1.1 Strategic, organisational and administrative management
o Activities included defining the company's mission, vision, and values, establishing management policies, setting strategic objectives, and communicating plans. Managing shareholder relations, company funds, and monitoring objectives were also crucial.
o Delivered: Strategic plan (D1.1)
• T1.2 Technical and operational management
o Activities completed include defining clear objectives for activities, time, budget, and deliverable quality, alongside establishing a robust management framework. This involves setting measurable performance indicators, conducting regular meetings, and reporting project status for corrective actions. Effective communication plans were designed for team connectivity, along with managing risks and ensuring regulatory compliance.
o Delivered: Project objectives and execution plan & Management Plan (D1.3)
• T2.3 HTA Initial Assessment
o Activities required for the development of the evidence to prepare the right strategy to provide policymakers, funders, health professionals, and patients with the necessary information to understand the benefits and comparative value of our technology and procedures.
o Delivered: Preliminary HTA dossier (D2.4)
• T2.4 FDA pre submission
o Tasks completed for FDA Q-Sub supplement involve drafting a cover letter explaining the purpose, device description, and pre-submission meeting details. Background information was collected, specific questions formulated, and a slide presentation prepared. All documents were sent to the FDA for feedback, and received guidelines were implemented into clinical strategy protocols and trial plans.
o Delivered: Pre-sub written feedback (D2.6) and Meeting minutes (2.5)
• T3.1 Market product development
o Activities completed to obtain the first representative batch of the market product include defining high-level architecture, user and product requirements, and identifying and mitigating risks. Rapid prototyping and development of the complete device were conducted, along with supply chain management. Verification plans were executed and documented to ensure product quality.
o Delivered: Design files (D3.1) Supply chain plan (D3.2) Tests plans and reports (D3.3).
• T3.3 Second Indication Research: Induction of Labour
o Activities conducted for labor induction research involved reviewing guidelines, protocols, and scientific literature, establishing a work plan, and designing potential solutions. Expert clinician interviews were conducted to understand standard procedures, leading to the standardization of a clinical induction protocol.
o Delivered: Research report (D3.6)
• T4.1 Pivotal Clinical Trial preparation
o Activities conducted to prepare for the clinical study validating FineBirth included preliminary research and defining the CT2 strategy, considering required clinical and economic evidence outlined in WP2. Additionally, the clinical protocol and all necessary trial documentation were generated. Collaborator centers and a Contract Research Organization (CRO) were selected and contracted.
o Delivered: Clinical protocols, dossier and plans (D4.1) and Contracts of collaborator centres and CRO (D4.2)
