Navigating Regulatory Uncertainty: U.S. GTM Strategy and Legal Structure for International HealthTech Founders

​Expanding into the U.S. healthcare market requires aligning legal structure, compliance readiness, and payer strategy in a way that supports long-term growth.

​This workshop is designed to help leaders make the foundational decisions that increase credibility with payers, providers, and investors from the outset.

​Dennis Sponer and Demi Radeva bring complementary experience across U.S. healthcare law, operational structuring, Medicaid, Medicare, and commercial payer strategy. Together, they will provide a practical framework for evaluating how and when to establish a U.S. entity, how structural decisions influence contracting and reimbursement pathways, and what signals U.S. stakeholders look for when assessing new market entrants.

​You will gain clarity on:

• ​How to solve for recent trends and regulatory changes

• ​How to determine whether a light footprint approach or a fully established U.S. presence best supports your growth goals

• ​How entity structure, governance, and compliance planning affect payer trust and procurement timelines

• ​How to break into Medicaid, Medicare, and commercial plans

• ​How to align legal architecture with reimbursement and go-to-market strategy to avoid costly restructuring later

​The goal of this session is to equip founders, executives, and investors with a clear decision-making framework.

​You'll leave with actionable guidance to structure U.S. expansion in a way that accelerates adoption, supports reimbursement strategy, and positions the company for scalable, long-term success.