English Tutorial: US Reimbursement Strategy – Getting Paid After FDA

This introductory tutorial provides European MedTech founders with a high-level roadmap for entering the US market. The session is designed to help startups understand the major components of the US commercialization journey, including the regulatory landscape, reimbursement ecosystem, market access considerations, and foundational activities that should begin early, such as intellectual property strategy, quality systems, and market validation. By establishing this framework upfront, the tutorial prepares founders for the deeper topics that will be explored throughout the remainder of the series and helps them understand how critical business, regulatory, and commercial decisions intersect during US expansion.

The experts of BioLab Holdings provide an overview and practical guidance on the following topics:

• Opening & Context

  Building on the FDA overview in the first tutorial, this session addresses the second major hurdle to US commercialization: reimbursement. FDA clearance or approval does not guarantee that a product will be paid for or purchased. The tutorial explains how US coding, coverage, and payment work and what they mean for pricing, customers, adoption, and investment, including how US hospitals and physicians decide whether to buy. Through a real-world wound care case study and interactive activities, founders leave with a clearer view of the reimbursement strategy for their own technology.

  The experts of EmeraNova (formerly BioLab Holdings) provide an overview and practical guidance on the following topics:

  • Opening & Recap
    • Introduction to EmeraNova and Catalyst
    • Recap of the first tutorial and why reimbursement is the second hurdle to US market entry
  • How the US Pays
    • Germany vs. the US at a glance
    • Who pays: Medicare, Medicaid, and private payers
    • The three pillars of reimbursement: coding, coverage, and payment
    • How site of service drives payment
  • Coding, Coverage & Payment in Practice
    • Securing codes and coverage from Medicare and private payers
    • Faster paths for innovative devices
    • How payment sets the ceiling on price
  • The Buyer's Perspective
    • Hospital and physician economics: why coverage alone does not drive adoption
    • Case study: skin substitutes and the 2026 payment shift
  • Clinical Evidence for FDA vs. Payers
    • Designing one evidence plan for regulators, payers, and buyers
  • Building Your Reimbursement Strategy
    • Reimbursement readiness timeline
    • Reimbursement Strategy Canvas: a first-draft strategy for each participant's product
    • How Catalyst & EmeraNova can help
  • Q&A

  Speaker:
  Carlos Encinas | Chief Science Officer - EmeraNova

  Jens Kirsch | Senior Advisor Plasma & Technology - EmeraNova

  John Stella PhD | Director of Product Management - EmeraNova

  Ned Milosavljevic | Research Development Consultant - EmeraNova

  Pauline Shand | Regulatory Affairs Consultant - EmeraNova

  Weston Quinn | Research Strategist - EmeraNova

  Sydney Schmid | Product Research & Development Associate - EmeraNova

  Recording & privacy: This session will be recorded by BioLab Holdings for marketing purposes. By completing your registration, you agree to the recording. Participants will not appear in the recording, as there is no video or audio from the audience. You can ask your questions anonymously via the Q&A window (the chat will be disabled). The feedback survey after the session will also be anonymous.