US Market Entry FAQ

Answers to the questions we hear most from medtech and life science companies planning a US launch, from FDA pathways and reimbursement to sales models, cost and timelines.

Why does the US market matter for an international medical device, biotech, or pharma company?

The US is the single largest life sciences market in the world by a wide margin. The US medical device market alone was valued at roughly $191 billion in 2025 and is projected to reach $346 billion by 2035, and the US holds an estimated 38% of global medical device revenue, more than any other country.

Total US healthcare spending is estimated at approximately $5.15 trillion in 2026 and is projected to reach $8.09 trillion by 2034.

How does an international medical device company enter the US market?

An international medical device company enters the US market by running three workstreams in parallel: FDA regulatory clearance, reimbursement and market access strategy, and a commercial go-to-market plan.

Shorelight Medical structures this as a Blueprint phase (mapping the regulatory, reimbursement, and commercial path before spending on execution) followed by Execution (hands-on delivery through a 50+ partner ecosystem covering regulatory affairs, reimbursement, CDMO/manufacturing, and distribution).

Regulatory: classify the device and choose an FDA pathway (510(k), De Novo, or PMA); foreign manufacturers also need a registered US agent.
Reimbursement / market access: identify applicable billing codes and the coverage evidence payers will require, ideally before regulatory strategy is finalized.
Commercial: decide how the device will actually be sold in the US (distributor, direct sales team, or a hybrid) and build the infrastructure for it.

Why does Shorelight build commercial strategy into every engagement from day one, instead of treating it as the last step?

Shorelight’s founder built the company after 13+ years in outside medical device sales calling directly on hospitals, seeing firsthand how many well-designed, FDA-cleared devices still failed commercially because nobody built the sales and adoption case until after the product was already on the market.

Regulatory pathway choices get evaluated for what a sales team can actually claim to a clinician, not just for speed to clearance.
Reimbursement strategy is built around the real purchasing and budget conversation a hospital committee will have, not just the coding mechanics.
Commercial launch planning starts alongside the Blueprint itself, instead of waiting until Execution begins.

What is the FDA pathway for a foreign-made medical device to get US clearance?

Most medical devices reach the US market through one of three FDA pathways (510(k), De Novo, or PMA), chosen based on how much risk the device carries and whether a comparable device is already legally marketed.

Pathway	Used for	Requires a predicate?	FDA review-time goal	Relative cost
510(k)	Class II devices similar to one already on the market	Yes	95% of decisions within 90 FDA review days; ~112 calendar days total (FY2025–27 goal)	Lowest
De Novo	Novel low-to-moderate risk devices with no predicate	No	70–90% of decisions within 150 FDA review days, depending on fiscal-year performance targets	Moderate
PMA	High-risk Class III devices (life-sustaining, long-term implants)	No	90% within 180 FDA days (no advisory panel) or 320 days (with panel); ~285 calendar days total on average (FY2025–27 goal)	Highest

A foreign manufacturer pursuing any of these three pathways must also designate a US agent (a US-based point of contact for FDA correspondence) as part of establishment registration.

These are FDA’s own negotiated performance goals under MDUFA, not guarantees, and they don’t include the months typically spent preparing the submission itself; actual review time varies with submission quality and any additional-information requests.

How does reimbursement and insurance coverage work for a new medical device entering the US market?

US device reimbursement runs on three linked pieces (coding, coverage, and payment), and a device can clear FDA review yet still fail commercially if any one of the three isn’t in place.

Coding (CPT, HCPCS, or DRG codes) identifies what procedure or device was used; coverage is a payer’s decision, usually Medicare/CMS through a National or Local Coverage Determination, or a private payer’s own technology assessment, about whether it will pay for that code at all; payment is the dollar amount actually transferred.

One coverage mechanism worth knowing by name: Medicare’s New Technology Add-On Payment (NTAP) program pays hospitals up to 65% (75% for certain technologies) of the cost gap between a new device and the standard DRG rate, provided the technology is new, costly enough that standard payment is inadequate, and shows a substantial clinical improvement over existing care (FY2027 criteria, effective October 2026).

What's the difference between FDA clearance and getting paid for a device in the US?

FDA clearance answers “can this device be legally marketed in the US”; reimbursement answers “will anyone actually pay for it.” They are two entirely separate approval systems run by different bodies, and clearing one says nothing about the other.

As NIH’s own reimbursement guidance puts it, commercial payers “frequently require additional clinical validity and clinical utility evidence above what is required for FDA approval.”

Should a foreign medtech company sell through a US distributor or build a direct sales team?

A distributor gets a foreign medtech company to US revenue faster with less upfront cost, but a direct or outsourced sales team gives more control over how the product is actually sold. The right choice depends on how much the company wants to invest before proving demand.

Model	Timeline	Control	Key tradeoff
Distributor / reseller	Fast to list, slower to real revenue	Lowest	Thin (often single-digit) margins; a listing isn't a sale if the distributor deprioritizes the product
Full US entity + direct team	3–9+ months	Highest	Highest control, but largest upfront cost and longest setup
Employer of Record (EOR)	1–2 weeks to hire	Moderate	Solves hiring paperwork only; still need a separate sales strategy
Outsourced/dedicated sales team	45 days	High	Speed and control without entity costs or distributor margins

How much does US market access cost for an international medtech company?

There is no single price tag for US market access. Cost depends on device risk class, how much clinical evidence payers will demand, and which commercial model is chosen, but each workstream has a rough shape.

Regulatory costs scale sharply by pathway: a straightforward 510(k) is the least expensive route, while a PMA requiring clinical trials can run into the millions. Reimbursement strategy work (coding, coverage, and payer evidence planning) is typically a smaller, fixed-scope engagement layered on top. Commercial setup varies the most by model: forming a full US entity commonly runs $5,000–$40,000+ before the first sale, while an outsourced or hybrid sales structure avoids most of that upfront cost.

How long does it take for an international medtech or biotech company to reach US commercial launch?

Most international medtech and biotech companies take roughly 12–24 months from first serious US planning to first commercial revenue, though device risk class and reimbursement pathway can push that well past two years.

Regulatory review alone runs about 112 calendar days on average for a straightforward 510(k) versus roughly 285 calendar days for a PMA under FDA’s current MDUFA performance goals, and that’s review time only, before the months typically spent preparing the submission.

Commercial launch timing depends on the model chosen: an outsourced sales team can be operating in as little as 45 days, while standing up a full US entity typically takes 3–9+ months. The companies that move fastest overall are the ones that start regulatory, reimbursement, and commercial planning together instead of waiting for clearance before addressing the other two.

What is a market access blueprint, and why does a medtech company need one before commercial launch?

A market access blueprint is a single, sequenced plan covering regulatory strategy, reimbursement strategy, and commercial go-to-market before a company spends money executing any of the three. It exists so decisions in one area don’t quietly break another.

At Shorelight, the Blueprint is the diagnostic and planning phase: assessing the device, mapping the regulatory and reimbursement path, and defining the commercial model. Execution is everything that follows, delivered hands-on through Shorelight’s partner ecosystem (regulatory, reimbursement, CDMO, and distribution specialists) rather than handed off as a report the client has to implement alone.

What happens during Shorelight's Execution phase, and how is it different from a typical consulting engagement?

Execution is where the Blueprint gets carried out hands-on. Shorelight and its partner ecosystem directly manage regulatory submissions, reimbursement and payer engagement, manufacturing setup, and commercial rollout, rather than handing a strategy document to the client’s own team to implement.

Regulatory: preparing and managing the FDA submission itself, responding to additional-information requests, and coordinating the required US agent relationship.
Reimbursement: building the coding and coverage dossier, engaging payers directly, and pursuing add-on payment programs (such as NTAP) where a device qualifies.
Commercial: identifying and negotiating with distributors, or standing up a direct or outsourced US sales structure, depending on which model the Blueprint recommended.
Manufacturing: selecting and managing CDMO relationships for US-bound production where needed.
Program management: tracking progress against the Blueprint’s timeline and coordinating every partner involved, so the client has one point of contact instead of five separate vendor relationships to manage.

How does Shorelight's partner network reduce time to market and risk?

Shorelight’s 50+ partner ecosystem lets a company run regulatory, reimbursement, and commercial workstreams in parallel through already-vetted specialists, instead of spending months sourcing, vetting, and separately managing five different vendors before work can even start.

Time to market: workstreams that would otherwise run one after another (find a regulatory consultant, then a reimbursement specialist, then a distributor) start in parallel because the partners are already vetted and already coordinated through one Blueprint.
Risk: the most common failure mode in US market entry is a decision in one workstream quietly breaking another (a regulatory pathway chosen without checking which reimbursement codes it unlocks, for example). Coordinating specialists through a single plan catches that before it turns into expensive rework.
Success rate: a company gets partners who already have a track record in their specific device category, rather than a single generalist team stretched across regulatory, reimbursement, manufacturing, and sales.

Does Shorelight only help international companies enter the US, or does it work with domestic companies too?

Shorelight also works with US-based medical device, biotech, and pharma companies that are already selling domestically (helping them grow top-line sales) and with select startups to help them get their first products to market, not only with international companies making their first US entry.

Does Shorelight only bring companies into the US, or can it help companies expand into other international markets too?

Shorelight’s network runs in both directions: the same partner ecosystem that brings international companies into the US also helps US companies, and international clients already established in the US, expand outward into other markets, particularly Europe, through reciprocal relationships with international regulatory, market-access, and commercial partners.

Does Shorelight work across all life sciences categories, or just medical devices?

Shorelight works across the life sciences spectrum (medical device, medtech, biotech, pharmaceutical, and laboratory/diagnostics companies) rather than specializing in a single vertical, because market entry follows the same underlying structure (regulatory pathway, reimbursement strategy, commercial launch) across all of them, even though the specific pathway differs by category.

Life sciences category	Typical FDA pathway
Medical device / medtech	510(k), De Novo, or PMA
In vitro diagnostics (IVDs)	The same device pathways: 510(k), De Novo, or PMA
Pharmaceuticals	New Drug Application (NDA), or Abbreviated NDA (ANDA) for generics
Biologics	Biologics License Application (BLA)
Laboratory-developed tests	Currently unsettled: FDA’s 2024 rule bringing LDTs under device-style premarket review was vacated by a federal court in 2025, and the regulatory framework remains in flux

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