About Christophe
Bridging Clinical Evidence & Market Access for MedTech, IVD & Personalized Medicine
Innovative MedTech and diagnostics rarely fail because of weak science. They fail because the reimbursement strategy wasn't built into the evidence plan from day one. This is exactly where I step in.
With 15+ years bridging clinical evidence and payer decision-making, I help MedTech, IVD, and Personalized Medicine companies turn complex clinical data into market access outcomes, in France and across EU5 markets.
My clinical evaluation expertise is hands-on and regulatory-grade: 25 Clinical Evaluation Reports (CERs) authored for clients including Guerbet, Vygon, and Robocath, spanning Class I to III devices, fully compliant with MDR 2017/745 and MEDDEV 2.7/1 rev.4, and consistently aligned with reimbursement objectives and clinical value demonstration.
On the market access side, I built and scaled an HTA practice managing 15+ simultaneous client projects, from RIHN NGS submissions to EU5 coverage strategies and precision oncology dossiers, growing from near zero in 2016 to €3.5M in revenue by 2023, with an average annual growth of +87% over six years. I also structured RIHN reimbursement pathways for NGS diagnostic panels where no coverage route previously existed in France, a methodology since deployed across multiple oncology and rare disease programs. As part of EU-funded consortia, I delivered cross-border HTA strategies spanning five European countries, contributing to policy frameworks now feeding into EU Joint Clinical Assessment discussions.
Beyond technical delivery, I have a strong track record in business development, C-suite engagement, and leading complex multi-workstream engagements end-to-end.
Core expertise: HTA for Devices & IVDs · RIHN 2.0 & LPP · MDR/IVDR Clinical Evidence · EU HTA Regulation · Real-World Evidence · Precision Oncology · Rare Diseases · Pricing & Market Access
🎓 Ph.D. Biomedical Engineering | DIU FIEC | HTAi Member
French
Native or bilingual
English
Native or bilingual
Spanish
Conversational
Can work on-site
Paris (up to 50km), Marseille (up to 50km), Lyon (up to 50km), Metz (up to 50km), Nancy (up to 40km)
Experience
- Alira HealthDirector of Market Access for Medical DevicesPHARMACEUTICALS INDUSTRYMarch 2021 - March 2023 (2 years)Paris, France🏗️ Built and supporting a 15-consultant cross-functional team, 3 locations for EU/APAC markets, driving best-in-class Pricing & Market Access deliverables for MedTech and Pharma clients — combining strategic oversight with hands-on mentorship to scale both talent and performance. 🌏🎯 Architected end-to-end P&R strategies for EU5 payers across oncology, rare diseases, and precision medicine — leveraging HTA frameworks (HAS, G-BA, NICE, AIFA) and real-world evidence to craft value dossiers that turned clinical complexity into compelling reimbursement cases. 💊🔬 Bridged the gap between clinical innovation and patient access in full alignment with Alira Health's mission to humanize healthcare — designing unconventional evidence generation strategies for pre-launch MedTech innovations, including connected devices, CDS tools, and NGS panels facing Class IIb/III regulatory pathways. 💡📊 Drove business development by expanding the GMA client portfolio through key opinion leader engagement, congresses, and cross-practice collaboration — consistently identifying early-access financing opportunities (RIHN, ATU/AAP, earlyaccess schemes) where traditional pathways fell short. 🤝
- n816 LifeManaging Director / Global Market Access & Innovation Planning LeadPHARMACEUTICALS INDUSTRYJune 2015 - Today (11 years)Paris, France📈 Grew company revenue by 87% since inception — by developing up to 283 projects participation to advisory boards and top Healthcare innovation technologies insertion into patient pathways — driving sustainable business expansion through disciplined cost management and a lean, high-expertise team of biomedical specialists. 🔬🧭 Designed unconventional market access pathways for oncology, rare diseases, and precision medicine innovators — leveraging DRG coding, RIHN submissions, and EU5 HTA frameworks to unlock reimbursement where traditional approaches failed. 🎯🔗 Built and delivered early market access programs for connected medical devices and remote monitoring solutions across Europe, bridging the gap between clinical evidence, payer expectations, and regulatory constraints. 🌍💡 Turned clinical complexity into payer-ready strategy — leading systematic data syntheses and HTA analyses that accelerated time-to-market for diagnostic and therapeutic innovations facing Class IIb/III regulatory hurdles. ⚡🤝 Expanded client portfolio in personalized medicine and CDS landscapes, establishing company presence at European congresses and EU Horizon consortia (CGI-Clinics, HECoPerMed). 🏆
- RobocathDirector of CA RA QAMEDICALJune 2020 - August 2020 (2 months)Rouen, FrancePioneering the next chapter of interventional vascular medicine — where regulatory rigor meets robotic precision.🤖 Directed clinical affairs, regulatory compliance, and quality assurance for Robocath's R-One™ — a CE-marked robotic platform achieving >95% technical procedure success in coronary angioplasty — ensuring full MDR alignment for one of Europe's most advanced Class III vascular robotics devices. ✅📋 Architected a comprehensive Quality Management System aligned with ISO 13485 and EU MDR requirements — designing clinical study protocols, regulatory submission packages, and post-market clinical follow-up plans to sustain CE marking and support market expansion across Europe, Africa, and beyond. 🌍🔬 Built evidence generation strategies from the ground up — establishing clinical evaluation frameworks that translated robotic-assisted PCI clinical data into regulatory-grade proof of safety and efficacy, bridging R&D innovation with notified body expectations. 💡🏗️ Led cross-functional alignment across R&D, clinical operations, regulatory affairs, and quality assurance teams — ensuring seamless coordination between engineering precision and clinical compliance in a fast-scaling MedTech startup environment. 🎯
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Education
- Clinical investigator DIU –FIEC, Marseille university, school of medicine2012Clinical investigator DIU –
- Doctor of PhilosophyNancy University, school of medicine1998Biomedical engineer ing Ph.D.,