Entering the U.S. market: a playbook for overseas healthcare companies
The U.S. rewards companies that prepare for it as many markets, not one. A practical sequence for getting there.
Emilio Fernandez, Owner & CEO
· 4 min read
For many healthcare companies outside the U.S., the American market is the prize that changes the trajectory of the business. It is also one of the most complex markets in the world to enter. Over two decades in commercial leadership, I have seen the same pattern: the companies that succeed are not always the ones with the best product. They are the ones that respect the complexity and sequence their entry deliberately.
Here is the playbook I would follow.
Start with the regulatory path, and bring in specialists
Everything begins with the FDA pathway, and it differs by product. Drugs, biologics and medical devices follow different routes, each with its own evidence expectations and timelines. This is specialist territory. The right move is to work with experienced U.S. regulatory partners from the start, and to connect their plan tightly to the commercial plan, because the label you are likely to get shapes the market you can address.
A common mistake is to treat regulatory and commercial as two separate projects that meet at approval. They should be one plan.
Understand that "the U.S. market" is many markets
The U.S. is not one buyer. Coverage and reimbursement run through commercial insurers, Medicare, Medicaid and others, each with different rules. Care is delivered through a mix of academic centers, integrated delivery networks, community practices and specialty channels. Purchasing for devices often runs through group purchasing organizations and hospital value committees.
Before you plan a national launch, map where your first customers really are and how they buy. Many successful entries start focused, prove the model, and expand from there.
Build the value story for U.S. payers and providers
Evidence that persuaded regulators and clinicians at home may not answer the questions U.S. payers ask. What outcomes matter to them? What does the treatment pathway look like today, and where does your product change it? What will it take for an account to adopt it operationally? Build the U.S. value story early, test it with real stakeholders, and let it inform pricing, contracting and evidence generation.
Choose your route to market
There is more than one way in. You can build your own commercial organization, partner with a U.S. company, license the asset, or work through distributors and specialty channels. Each option trades control for speed and capital differently. The right answer depends on the product, the size of the opportunity, your balance sheet and your long-term ambition in the U.S. Make the choice explicitly, with the alternatives on the table, rather than defaulting to what worked at home.
Sequence the U.S. team
If you build, hire in the right order. The first senior hire, often a U.S. general manager or commercial lead, should help shape the plan and recruit the rest of the team. Access and medical capabilities typically need to be in place before a full field organization. Hiring too late compresses the launch. Hiring too early burns cash while the market is not yet open.
Design governance with headquarters
This is the part companies underestimate most. The U.S. team needs real decision rights on pricing, contracting, hiring and promotion, within clear guardrails from headquarters. Decide up front which decisions are local, which are global, and how quickly the two will resolve disagreements. Speed in the U.S. market is a competitive advantage. Slow approvals from across an ocean can erase it.
Plan the first 100 days before you need them
Finally, write the launch plan for the first 100 days after approval: the accounts you will activate first, the access milestones you expect, the leading indicators you will track, and the decisions each one will trigger. The plan will change. Having it is what lets you change it quickly.
The opportunity is worth the preparation
Entering the U.S. is demanding, but it is also one of the most rewarding moves a healthcare company can make. The companies that get it right treat it as a strategic program, led by people who have operated in the market, with regulatory, commercial and organizational plans moving as one.
If you want the checklist version, our U.S. Market Entry Playbook summarizes the key steps and pitfalls on a single page.
