English Tutorial: Entering the US Market – What every MedTech Startup Needs to Know before Expanding

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
  • Why the US market: the opportunity and what makes it attractive for European startups
  • The roadmap – basic overview of American MedTech:
    • Product journey
    • FDA submissions – what is the FDA?
    • CMS + Payers: how do the American health system financials work?
    • Where to sell your product: points of service and commercial success in America
    This section is a high-level series overview that will cover basic principles. The topics will be discussed in detail later and during the other tutorials.
  • EU vs. US regulatory differences: a high-level comparison to frame how different the US system is
• Foundations to Start Now
  • IP & Freedom to Operate (FTO) and your QMS: secure IP early and run an FTO analysis; stand up a compliant QMS (ISO 13485 / 21 CFR 820) before clinical – both take months
  • US market research & the redesign risk: validate product, use case, off-label use, and pricing with US-based providers; findings can trigger a redesign before FDA submission
• FDA Overview
  • The FDA & how it's structured: orienting founders to the regulator
  • Main regulatory pathways & how to choose – 510(k), De Novo, PMA, BLA/NDA: framed as an early business decision, not a late-stage compliance step
  • Q-Subs & Pre-Submissions: how to engage the FDA early to de-risk
  • Standards, testing & quality systems: an overview of evidence and QMS expectations
• Q&A

Speakers:
Carlos Encinas | Chief Science Officer - BioLab Holdings Inc.

Jens Kirsch | Senior Advisor Plasma & Technology - BioLab Holdings Inc.

John Stella PhD | Director of Product Management - BioLab Holdings Inc.

Ned Milosavljevic | Research Development Consultant - BioLab Holdings Inc.

Sydney Schmid | Product Research & Development Associate - BioLab Holdings Inc.

Pauline Shand | Regulatory Affairs Consultant