Early Bird ends Feb-20. Use Coupon Code 'EARLY' to save $500'
MedTech
U.S. Reimbursement
Masterclass
A Strategic Roadmap for Aligning Regulatory, Evidence, Coding, and Coverage Decisions in the U.S. Market
A clear mental model of how U.S. reimbursement actually works
A framework that connects regulatory, evidence, coding, and coverage
A structured way to identify and manage reimbursement risk
Download the masterclass outline
DATE & TIME
March 11, 2026
8:00 AM (Pacific Standard Time)
FORMAT
Live Virtual Masterclass
DURATION
2 Hours
INVESTMENT
$2,500
$3,000 Ends 20 Feb
Why U.S. Reimbursement Is the #1 Barrier to MedTech Commercialization
If you're entering the U.S. market, reimbursement will shape every regulatory, clinical, coding, and commercial decisions — yet most founders don't fully understand how these systems fit together.
Inability to plan realistic timelines for stakeholders
Costly rework of market access strategy after launch
Investor concerns about commercialization readiness
Delayed commercialization despite technical readiness
Stalled adoption even after FDA approval
What You're Actually Getting
Your registration includes:
Live masterclass access
Live Q&A with expert guidance
Time-limited access to session recording
Full masterclass slide deck
The U.S. Reimbursement Roadmap (A Founder-level Strategy Playbook & Reference Guide)
1-hour 1:1 Reimbursement Strategy Consultation
Why Join the MedTech U.S. Reimbursement Masterclass
Fast Enough to Matter
Designed to deliver clarity when decisions can't wait.
Grounded in Real MedTech Experience
Informed by hands-on MedTech reimbursement work.
Expert-Guided Application
(1:1 Consultation)
Includes a 1-hour 1:1 consultation to apply insights to your strategy
Is This Masterclass Right for You?
This masterclass is designed for founders and senior leaders who are already making high-stakes decisions about evidence, coding, coverage and commercialization and in need of clarity, not theory.
International innovators entering the U.S. market
MedTech companies needing a U.S. reimbursement roadmap
Teams confused by inconsistent consultant advice
Innovators stalled in U.S. adoption after FDA clearance
Companies unsure how to align regulatory, clinical, and coding strategy
Fundraising startups needing strategic clarity
Market Access, Regulatory, Clinical and Commercial leaders
Meet the Speakers
Nicole Coustier
Founder and Principal Consultant
Nicole Coustier is a seasoned MedTech advisor and U.S. reimbursement strategist with over 20 years of experience guiding medical device companies through complex market access challenges. She specializes in reimbursement strategy, payer engagement, evidence planning, and coding alignment across the product lifecycle — from early validation to commercialization.
She has led multi-year reimbursement and market access strategies that helped breakthrough innovations — including HeartFlow, Glaukos, Thoratec, and Spiration — achieve over 90% payer coverage in the U.S., positioning them for successful adoption, acquisitions, and IPOs.
Mitali Stevens, PharmD, BCPS
Founder and Principal
Dr. Mitali Stevens is a healthcare strategist with 20+ years of experience across pharmaceuticals and medical devices, specializing in market access, HEOR, reimbursement strategy, and evidence generation from early development through commercialization.
She has led and advised market access initiatives for companies including Edwards Lifesciences, Takeda, Novo Nordisk, and Sunovion, supporting coverage decisions, optimal reimbursement, and product adoption across a wide range of therapeutic areas and technologies. Dr. Stevens holds a Doctor of Pharmacy from The Ohio State University and is a licensed pharmacist with Board Certification in Pharmacotherapy Specialty.
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