Key Considerations for International MedTech Companies Entering the United States
Expanding Your MedTech Business Into the United States: What International Companies Need to Know
The United States remains one of the most attractive — and most complex — markets for MedTech innovation. With a highly commercialized health care system and strong investment in digital health and telemedicine, the United States offers unparalleled opportunities for international MedTech companies looking to scale.
These opportunities come with a complex web of legal, regulatory, and business challenges that require sophisticated and experienced advisors. In this series, we look to provide practical advice based on years of working with companies who have undertaken these steps.
Key Legal, Regulatory, and Business Considerations for Entering the U.S. Market
In Entering the United States Blog Series, we will break down key issues international MedTech companies should understand before and during U.S. market entry, including:
- Corporate Compliance – Building a compliance program that scales as your U.S. footprint expands
- FDA – Navigating U.S. Food and Drug Administration (FDA) requirements for drugs, devices, and digital health solutions
- Corporate Formation – Choosing the right U.S. entity structure for your MedTech business
- Intellectual property protection – Safeguarding your technology and brand in a competitive market
- Reimbursement strategy – Understanding Medicare, Medicaid, and private payer pathways to support commercial success
Each post will focus on practical, actionable insights tailored to the realities facing international MedTech innovators.
Supporting MedTech Companies Through U.S. Formation, FDA, and Compliance Challenges
Throughout the series, we will also highlight how Foley can support you at every stage of your U.S. expansion, including:
- Structuring and executing pharmaceutical and MedTech transactions
- Forming U.S. entities and ensuring ongoing corporate and regulatory compliance
- Identifying and pursuing FDA regulatory pathways appropriate for your product
- Assessing and optimizing reimbursement opportunities
- Securing and enforcing intellectual property rights in the U.S.
If you are considering — or already pursuing — entry into the U.S. MedTech market, this series is designed to help you ask the right questions, avoid common pitfalls, and build a strategy that aligns legal, regulatory, and commercial objectives.
