Sylvia GermainIn 2013, I wrote in DM Mag: “The strategic analysis and positioning of the MD must not be neglected. Filing an application for reimbursement of a MD for individual use with the assessment authorities (HAS/CEPS) too quickly is equivalent to increasing the risk of a negative guidance.”

SGE Consulting defines a strategy relevant to each situation.

The consulting services offered by SGE Consulting focus mainly on medical devices and innovative diagnostic devices.

Depending on the project needs, SGE Consulting may rely on external resources such as consultants and/or experts specialized and experienced in health economics, clinical methodology, European strategy, etc.

A wide range of services

SGE Consulting with its multidisciplinary team and partners supports manufacturers and/or distributors of innovative health technologies throughout their clinical development and market access processes to:

  • Define strategic action plans for market access and reimbursement in France and Europe.
  • Build requests for covering/reimbursement: examples for France: LPRR, CCAM, NABM, or RIHN act evaluation files, intra-GHS registration, etc. for Europe: EUnetHTA.
  • Develop communication strategies with key decision-makers and stakeholders in the French and European healthcare systems: ministries, “HTA” evaluation bodies (HAS, NICE, KCE, KCE, IQWIG, etc.), KOLS, learned societies, CNP and other national, regional or local health institutions.
  • Identify departmental programs for early funding of health technologies in clinical development and support them in submitting appropriate applications (file writing and clinical or medico-economic protocol): “Innovation package”, PHRC, PRME, PSTIC, etc.

Other services

SGE Consulting also offers support to its clients to:

  • Carry out regulatory processes for the implementation of clinical studies and market access (marketing communication with the ANSM, advertising, labelling verification, CPP/ANSM submissions, etc.).
  • Carry out scientific, technological and regulatory monitoring.

Training courses

SGE Consulting operates in the academic field and regularly provides market access and reimbursement training (IPIL in Lyon, ISIFC in Franche Comté…).