Advising and assisting market access strategy for your medical devices.
We work with you to define the key success factors for your medical devices.
_ Evaluate level of innovation.
_ Estimate MD’s market access value.
_ Leverage clinical and medical-economic materials.
_ Define reimbursement channel.
_ Establish clinical, medical-economic, and pricing argumentation strategy.
_ Prepare file for common law reimbursement (List of Reimbursable Products and Services - LPPR, Brand Name, Additional List, Generic Line, Homogeneous Stay Group - GHS) or reimbursement waiver (innovation rate, Art. 51, Temporary Usage Authorization - ATU).
We set up actions for health authorities and appropriate national agencies.
_ Meeting organization.
_ Advisory support during meetings.
_ File presentation.
_ Elaboration of adapted argumentation based on target’s issues.
_ Implementation of a file co-elaboration approach with authorities.
We integrate regulatory strategy into the market access process to optimize efficiency, accelerate market release, and optimize financial means.
_ Analysis of regulatory framework.
_ Preparation of CE marking file (global assistance or occasional advisory role).
_ Preparation of FDA approval file – 510(k) premarket notification.
_ Handle formalities in EU and around the world.
_ Perform post-market follow-up.
_ Establish regulatory compliance.
We integrate clinical strategy into the market access process to optimize reimbursement.
_ Help target clinical criteria and appropriate methodology.
_ Identify Contract Research Organizations (CROs) adapted to the project.
_ Coordinate relations with CROs.
_ Segment clinical needs from CE marking and reimbursement.
We carry out the medical-economic and market studies necessary for your MD’s market access and for evaluating market opportunities.
_ Market studies in France and abroad.
_ MD market access value studies.
_ Medical-economic study for reimbursement file argumentation.
_ Price comparison studies.
_ Access to specialized databases.
_ Studies on public funding channels for collecting clinical data.
We work with you to develop international deployment strategy, taking the specifics of each market into account.
_ Market studies.
_ Procedures for obtaining indispensable regulatory approvals.
_ Networking with local partners.
_ Elaboration of marketing strategy adapted for your health products and market constraints.