For non-U.S. digital health startups, the United States can look like the promised land: a massive, innovation-hungry healthcare market with deep budgets and clear appetite for new solutions. But the reality on the ground is messier — and far slower — than most expect.
Unlike other markets, the U.S. isn’t a single buyer or even a coherent system. It’s a fragmented, risk-averse patchwork of payers, providers, employers, and intermediaries, all with different incentives and priorities. Getting a meeting isn’t the hard part. Getting a contract — and then scaling it — is where most international teams often stall.
This guide lays out what to do first, what to delay, and what many startups learn too late.
How the U.S. Healthcare System Actually Works
The U.S. doesn’t have a single healthcare system — it has dozens. That’s what makes market entry so tricky. Before you can sell, you need to understand who makes decisions, who pays the bills, and how those incentives shape what gets adopted.
At the top level, there are three primary buyer types:
- Providers: Hospitals, clinics, and health systems. These organizations deliver care, and often have the clinical workflows your product needs to plug into.
- Payers: Insurance companies (like Aetna or UnitedHealthcare), government programs (like Medicare and Medicaid), and other third-party payers. These groups decide what gets reimbursed and at what rate.
- Employers: Especially in the U.S., many large companies self-insure. That makes HR and benefits teams powerful buyers for solutions that impact cost, absenteeism, or workforce health.
Then there are the intermediaries: Pharmacy Benefit Managers (PBMs), Accountable Care ORganizations (ACOs), Integrated Delivery Networks (IDNs), and Third Party Administrators (TPAs) — all of whom can influence or control access to patients, data, and dollars.
This fragmentation means one simple truth: there is no such thing as “selling to U.S. healthcare.” You need to narrow your focus.
Pick a beachhead. That means choosing a specific customer segment (e.g., self-insured employers in tech, community hospitals in the Midwest, or Medicare Advantage plans) and solving a problem they care about now. The tighter your target, the faster you’ll learn what works, and what doesn’t.
What Reimbursement Really Looks Like in the U.S.
One of the biggest commercial blind spots international startups face when entering the U.S. is reimbursement. Many teams focus on “who would use this?” without asking, “who can get paid for this?”
In U.S. healthcare, reimbursement determines buyer behavior. If your product doesn’t fit into how a provider or payer gets paid — or doesn’t help them save money they’re on the hook for — it’s much harder to sell, no matter how good your tech is.
Two Paths: Fee-for-Service and Value-Based Care
There are two dominant ways your product might generate revenue in the U.S.:
This is the traditional model. A provider delivers a service and bills a payer using a code — often a CPT or HCPCS code. If your product enables, supports, or qualifies for a reimbursable service, you need to understand:
- What code applies
- What documentation is required
- Who can bill for it (physician, nurse, facility, etc.)
- What payers actually reimburse—and how much
Fee-for-service models are rule-heavy and regionally inconsistent. But if your product fits, this path gives you a direct way to plug into revenue streams your buyer already uses.
In value-based care, providers or health systems are paid based on outcomes or cost savings — not volume. These groups are often more open to solutions that improve care coordination, close gaps, reduce readmissions, or lower total cost of care.
If you’re not tied to a code, value-based buyers may still pay you — but only if you can prove impact on their financial or quality metrics.
This model gives you more flexibility but demands evidence and trust. You’ll often need pilot data to show you help your buyer succeed under risk-based contracts.
What If No Code Exists for Your Product?
That’s common, especially for software and digital interventions. It’s not the end of the road, but it does mean your path may be longer. You may need to:
- Prove value through a pilot and secure coverage via a custom contract
- Bundle your solution into existing services that are already billable
- Work with a channel partner who can bill and embed you under their model
Some startups pursue a new code creation, but that’s a multi-year effort. For early-stage teams, focus instead on working within existing structures while collecting data that supports your future case.
Reimbursement Drives Your Pricing, Positioning, and Proof
Your reimbursement path will influence:
- Your buyer: Clinical director vs. CFO vs. care management
- Your proof requirements: Clinical outcomes vs. cost savings vs. satisfaction
- Your pricing model: Per member per month? Per encounter? Subscription?
You can’t wing this. Even the most innovative product may stall in the U.S. without a clear and realistic reimbursement story.
Don’t Skip the FDA Question Or Overbuild for It Either
The moment you start talking about digital health in the U.S., someone will likely ask: “Are you FDA approved?” It’s a fair question — but also one that trips up international teams who either overreact or underprepare.
The truth is: you need regulatory clarity, but not necessarily full FDA clearance before entering the market. What you don’t want is to stall for a year pursuing the wrong classification — or build a heavy regulatory process you don’t yet need.
Start by Knowing Your Regulatory Lane
In the U.S., the Food and Drug Administration (FDA) oversees digital health products that meet the definition of a medical device. This includes tools that:
- Diagnose or treat conditions
- Drive clinical decisions
- Modify treatment based on patient data
Based on risk, products fall into one of three classes:
- Class I (low risk): Often exempt from premarket review
- Class II (moderate risk): Likely require 510(k) clearance
- Class III (high risk): Requires full premarket approval (PMA)
Some digital health tools — especially wellness apps or non-clinical decision support tools — may fall outside FDA scope. But don’t assume that just because it’s “just software” you’re safe. The FDA has increased oversight of certain algorithms, remote monitoring, and AI-driven tools.
This is why it’s smart to get a regulatory read early. One conversation with an experienced FDA consultant can save you months of guessing.
Don’t Overbuild for the Wrong Classification
One of the most expensive mistakes is designing your product for a Class II or III pathway without fully understanding the requirements — or whether it’s necessary. You’ll burn time, money, and momentum chasing a standard you might not need until much later.
Start lean, validate your regulatory path, and collect the right evidence as you go. FDA compliance is a serious asset — but only when it aligns with your real market path.
How to Use Partnerships to Unlock Traction (Faster Than You Can Alone)
If you’re new to the U.S. healthcare market, partnerships aren’t optional — they’re your fastest route to credibility, distribution, and buyer access. U.S. buyers are slow to trust. But they do trust the systems, tools, and advisors they already work with.
That’s where the right partnerships come in. They help you plug into existing workflows, ride existing sales channels, and signal legitimacy without needing years of brand-building.
Integration Partners Help You Fit Into Workflows
No matter how valuable your product is, if it doesn’t work inside a clinician’s or care manager’s workflow, it will get ignored. Integration partners solve this.
These are companies that already serve your target users and can embed your solution into daily operations. Examples include:
- EHR vendors like Epic, Cerner, or Athenahealth
- Remote patient monitoring (RPM) platforms
- Population health or care management tools
If you can plug into a system that providers already use — via API, SMART on FHIR, or app marketplace — you remove a major adoption barrier. You also give yourself a better story: “We’re already embedded in your existing tools.”
Channel Partners Help You Reach More Buyers Faster
A channel partner already has distribution. That might be a care management company with payer contracts, benefits consultant working with self-insured employers, or a disease-specific vendor (e.g., diabetes platform) that wants to expand offerings.
Instead of selling one-on-one, you can bundle into their solution or co-sell under their umbrella. That gives you access to buyers you wouldn’t reach on your own — and cuts down on procurement and trust hurdles.
Channel partnerships work best when you share a buyer (e.g., both sell to Medicaid plans), your solution fills a clear gap in their offering, and there’s a clean way to divide pricing and delivery.
Be realistic: partnerships take time to develop, and not every one will convert. But the right few can accelerate your market entry dramatically.
Partnerships Aren’t Shortcuts, But Leverage
Don’t think of partnerships as a workaround because you can’t sell directly. Think of them as market leverage. The right partner helps you validate your fit, prove your value, and scale without having to build every relationship yourself.
Especially in your first 12 months in the U.S., partnerships can be the difference between slow traction and real commercial momentum.
Sequence Your First Moves Like a Founder, Not a Tourist
Many international teams treat U.S. market entry like a checklist: localize the product, hire a rep, land a pilot, raise a round. But that sequence only works if you’ve already nailed product-market fit for this market. Otherwise, you’re throwing time and money at tactics that don’t connect.
U.S. digital health buyers don’t move fast, and they don’t typically take bets on unproven value. That’s why sequencing — what you do, when you do it, and why — often matters more than speed.
Start With a High-Signal Pilot, Not Broad Outreach
Don’t aim for 10 pilots. Aim for one that proves value. A focused, well-run pilot in your beachhead market can give you:
- ROI data
- Workflow insights
- A credible customer reference
- A story for the next buyer
Pick a use case where you can deliver measurable results in 6 to 12 months. Define what success looks like before you start. And make sure your buyer has internal champions who actually want to scale if the pilot works.
Narrow Your ICP Before You Scale Outreach
Your ICP (ideal customer profile) in the U.S. may not be the same as in your home market. Even if your tech works broadly, your messaging won’t. Buyers want specificity. Refine who the buyer is (title, budget owner, department), what problem they’re trying to solve, what barriers they face internally, and what incentives shape their decisions.
Once you’ve sold to one buyer successfully, you can expand your playbook. But don’t go wide until you’ve proven what works narrow.
Don’t Scale Until Your Process Is Repeatable
You don’t need to be perfect before growing — but you do need a repeatable path:
- How do you generate leads in this segment?
- What messaging resonates?
- What objections show up again and again?
- What’s the path from first call to signed deal?
If you can’t answer those questions, you’re not ready to hire more sellers or expand into adjacent markets.
Your Messaging Matters — Get It Right
In U.S. healthcare, your messaging isn’t just about clarity — it’s about credibility. Buyers are overwhelmed with pitches. What stands out isn’t a flashy demo or a long feature list, but a sharp, specific story that matches their priorities.
That means your messaging needs to do four things:
1. Name the problem in their terms.
Don’t lead with your tech. Lead with the pain — framed in the buyer’s language. Whether it’s reducing readmissions, improving HEDIS scores, or cutting ER overuse, you need to sound like someone who understands their world.
2. Show how you solve it — simply.
Be clear, not clever. What does your product do, and how does it fit into existing workflows? Skip buzzwords and focus on practical outcomes.
3. Back it with proof.
U.S. buyers want validation: pilot data, named customers (even if international), integration examples, or regulatory clarity. If you’re early, directional metrics or letters of intent may help — but match proof to the buyer’s risk.
4. Explain how you’ll go live.
Implementation is a dealbreaker. Buyers need confidence you can train teams, handle integration, and support adoption. A straightforward plan builds trust.
Build a clear message house early — starting with a five-word description of your value, then expanding to 10, 25, and full-length versions. This lets your team speak consistently across channels and buyer types. Make sure your messaging aligns across clinical, operational, financial, and patient/provider experience — because most decisions in U.S. healthcare are made by cross-functional teams.
Foundational assets to prepare:
- A one-page overview with outcomes, buyer fit, and go-live plan
- A 10–12 slide deck that walks through problem, solution, and proof
- Optional clinical or economic briefs if you’ve got results
- A pilot playbook showing what success looks like
The goal isn’t just to sound good — it’s to get traction. And in this market, precision matters more than polish.
When to Hire in the U.S. (And When to Hold Off)
A common misstep among international digital health startups: hiring a U.S. sales rep too early. Founders assume that a local hire will “open doors” or “unlock the market.” In reality, hiring before you’ve validated your message, buyer, and value proposition often leads to wasted time and lost runway.
The U.S. is not just a geography shift — it’s a go-to-market shift. That’s why you, the founder or co-founder, should lead the early traction work.
Founders Need to Lead Early Sales and Discovery
In the early stages, you’re not just selling — you’re learning:
- Who responds to your pitch?
- What objections come up?
- What proof points matter?
- What pricing structures resonate?
This learning loop doesn’t work well when filtered through a hire. Founders are best positioned to adapt, test, and course-correct in real time. No one else can shape the go-to-market strategy as effectively in the early innings.
Hire Only Once You Have Commercial Signal
You’re ready to hire in the U.S. when you’ve:
- Closed at least one real buyer
- Seen clear interest from similar prospects
- Refined your U.S. pitch and buyer profile
- Built a repeatable sales motion, even if it’s still scrappy
At that point, a commercial hire can help you scale what works — not figure it out from scratch.
Don’t Hire for a Rolodex, Hire for Range
Your first U.S. commercial hire should be able to, sell, shape messaging, run point on early accounts, and work through ambiguity.
This is not the job for someone who only knows how to “manage relationships” or expects strong inbound. Look for someone comfortable wearing multiple hats — someone who’s played in early-stage environments and knows how to build from zero.
Hire In Twos for A/B Testing
If your budget allows, consider hiring two early sales reps instead of one. Joe DiMento of Bain Capital Ventures also advises this approach — not to double output, but to increase learning.
With two reps, you can compare styles, messages, and early traction, helping you identify what’s working faster. It also forces clarity: you’ll need to document your pitch and buyer profile in a way others can follow.
And if one approach stalls, you’re not left guessing whether it’s the strategy or the person. This setup turns early sales into a more structured test, rather than a single-point gamble.
Plan for Long Sales Cycles and Limited Early Revenue
U.S. enterprise healthcare sales cycles can range from 9 to 18 months. Even when a buyer is interested, they’ll need to get through legal, IT, procurement, and budget review.
That means your first hire will need time to succeed, you’ll need cash to support that time, and success shouldn’t be measured in closed deals alone — but in pipeline quality and process validation.
Hiring too early burns cash. Hiring too late slows learning. Hiring with the right expectations — and sequence — is how you get both speed and focus.
What U.S. Buyers Actually Expect From a “Localized” Solution
Localization isn’t about switching your website to American English or converting pricing to U.S. dollars. In U.S. healthcare, localization means fit — with workflows, regulations, billing processes, and patient expectations.
Even teams with strong global traction often underestimate how different the U.S. market is. Buyers don’t just want to know that your product works — they want to know it works here.
Clinical Workflows Are Shaped by Billing and Burnout
In the U.S., clinicians don’t just chart for care — they chart for payment. That means documentation burden is high, systems are rigid, and workarounds are risky.
Care providers are also burnt out. If your solution adds clicks, time, or complexity to the workflow, it will struggle. That’s especially true if you don’t integrate with the core electronic health record (EHR) system, like Epic or Cerner.
You don’t need to be a full-stack integration partner on day one. But you should understand the clinical workflow and show that you’ve designed your product with it in mind.
Buyers Expect Billing and Compliance Alignment
Even if your product isn’t directly billed for, buyers will want to know:
- How it aligns with reimbursement workflows
- Whether it supports value-based care reporting
- How it handles HIPAA compliance and patient data security
Failure to speak this language is a fast way to lose buyer trust. You don’t have to be perfect — but you do need to be credible.
Patients Have U.S.-Specific Expectations
In the U.S., patients are used to online access to results and communication, transparent (or at least visible) pricing, and responsive customer support.
If your solution touches the patient experience, you’ll need to match those expectations — or explain clearly how you support partners who do.
Support and Implementation Matter More Than Features
A great product with poor implementation will fail in the U.S. Implementation is often complex, involving IT, clinical staff, and training. You’ll need to offer strong onboarding, provide responsive support (ideally U.S.-based or time-zone aligned), and help your buyer manage internal adoption.
The more you reduce friction, the more likely they are to renew — and refer.
Speed Matters, but So Does Sequence in the U.S. Digital Health Market
The U.S. digital health market offers scale, funding, and influence, but it also slows down teams that skip steps. Many international startups move fast but misfire, thinking early momentum will carry them through.
In reality, success here isn’t about how quickly you launch. It’s about whether you’ve earned the right kind of traction, in the right order.
If you don’t understand how buyers get paid, how they make decisions, and how your solution fits into their workflows, you’re not just early — you’re almost irrelevant. To win, you have to respect the market’s complexity, show clear value, and move deliberately through the stages that matter.
Move fast, but only after you’ve mapped the path.
If you’re an international digital health team exploring the U.S. market — and you’d rather not waste your first year chasing the wrong buyers or burning capital on guesswork — let’s talk.
We work with founders to define their beachhead, refine their pitch, and run entry pilots that actually convert.
