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

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 roadmap – basic overview of American MedTech:
  • EU vs. US regulatory differences
• Foundations to Start Now
  • IP & Freedom to Operate (FTO) and your QMS
  • US market research & the redesign risk
• FDA Overview
  • The FDA & how it's structured
  • Main regulatory pathways & how to choose – 510(k), De Novo, PMA, BLA/NDA
  • Q-Subs & Pre-Submissions
  • Standards, testing & quality systems
• Q&A

Speakers:
Carlos Encinas | Chief Science Officer & Jens Kirsch | Senior Advisor Plasma & Technology | BioLab Holdings Inc.

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This tutorial will not be recorded.