Expertise

Sylvia GERMAINSylvia Germain is the Founder and current President of SGE Consulting, a company created in July 2016, with more than 30 years of experience in the field of market access for innovative health technologies.

The creation of SGE Consulting was motivated by the identification of various needs in the market access field for innovative health technologies through multiple exchanges and meetings with industry, expert users and passionate decision-makers.

Health technologies include medical devices, In Vitro Diagnostic Medical Devices, software, connected devices and others, and are associated with a wide and complex field of development activities: clinical, marketing, reimbursement, monitoring and post-marketing follow-up.

The complex and evolving environment in which health technologies progress, the multitude of market access channels, as well as the early and long term reimbursement pathways, force the stakeholders to identify at a very early stage the best suited opportunities for the development and the dissemination of their technology.

The experience acquired in the exploitation of the diffusion of percutaneous aortic valves in France has enabled the stakeholders to better understand the health authorities expectations. Over the past 10 years, two first national successes of derogatory and temporary reimbursement with the first devices, known as “rupture” devices, have been achieved in France. It is this culmination that showed the strong interest in the development and dissemination of innovative health technologies.

Interest in innovation support mechanisms was subsequently confirmed in France with the validation in 2014 of an innovation package, legislated in the Article L 165-1-1-1 of the Social Security Code, for an epiretinal prosthesis.

In this context, SGE Consulting, with its multidisciplinary team and partners, supports manufacturers and distributors of innovative health technologies to develop specific and relevant reflections in the context of their clinical development, implementation activities and then dissemination on the market.