Mastering the regulatory architecture of disruptive innovation.

Reimbursement Strategy

We secure the economic trajectory of innovative medical devices.

Even before CE marking, we determine whether your innovation can — or cannot — access reimbursement in France and Europe.

We intervene at the critical moment when a misaligned strategic decision can compromise:

• HAS assessment outcomes
• LPPR or PEC-AN access
• Fundraising potential
• Hospital deployment

Our role: transforming technological innovation into a credible reimbursable pathway.

Strategic Engineering: LPPR & PEC-AN Pathways

We build your reimbursement trajectory.

• Definition of the optimal access scenario (generic LPPR listing, brand-name LPPR listing, PEC-AN fast-track pathway, “liste en sus”, GHS/T2A hospital funding)
• Identification of the appropriate French clinical comparator
• Clinical alignment with CNEDiMTS expectations (HAS medical device committee)
• Anticipation of regulatory friction points
• Economic arbitration and strategic sequencing

Objective: avoid regulatory dead-ends and secure valuation.

Public Affairs & Health Advocacy

• Stakeholder mapping
• Strategic positioning with public decision-makers
• Alignment with public health priorities
• Securing integration into reimbursed care pathways

Funding & Economic Model Structuring

• Analysis of public funding options
• Strategy for integration into the healthcare financing system
• Structuring of a sustainable reimbursed business model

Institutional Crisis Management

• Management of sensitive regulatory situations
• Executive media training
• Strategic influence during critical periods

A 360° strategic advisory.