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A Strategic Roadmap for Aligning Regulatory and Reimbursement Decisions for Sustainable Payment and Adoption in the U.S. Market

A clear model of how U.S. reimbursement actually works

Guidance on what decisions matter most, and when they need to be made

A structured way to identify and manage reimbursement risk
DATE & TIME
March 19, 2026
7:00 AM (Pacific Standard Time)
FORMAT
Live Virtual Masterclass
DURATION
2 Hours
IINVESTMENT
$2,000
$2,500 Ends March 12

Your registration includes:
Live masterclass access
Live Q&A with expert guidance
Access to session recording
Full masterclass slide deck
The U.S. Reimbursement Decision Framework
A Practical Model for Early Risk and Strategic Alignment
1-hour 1:1 Reimbursement Strategy Session
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
Companies unsure how to align regulatory, clinical, and coding strategy
Fundraising startups needing strategic clarity
If you're entering the U.S. market, reimbursement can shape every regulatory, clinical, coding, and commercial decisions.
Inability to plan realistic timelines for stakeholders
Costly rework of market access strategy after launch
Investor concerns about commercialization readiness
Stalled adoption even after FDA approval
Designed to deliver clarity when decisions can't wait.
Informed by hands-on MedTech reimbursement work.
Includes a 1-hour 1:1 session to apply insights to your strategy
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.
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.
Not at all. Many reimbursement outcomes are shaped by early regulatory and evidence decisions. This masterclass helps you understand those connections.
Many MedTech leaders attend to gain confidence before committing time and capital, helping them move forward with greater clarity. One misaligned reimbursement decision often costs far more than the price of this masterclass.
Yes. You'll gain clearer language and logic to explain reimbursement strategy and risk.
Yes. While technologies differ, the way reimbursement decisions are made is consistent and the frameworks are designed to be applied to your context.
If reimbursement factors into your U.S. plans, now or soon, this masterclass is designed to support your decisions and next steps.
Need help or have questions?
Email our team at [email protected]