From France to the US
Intech
A French maker of orthopedic surgical instruments. Since 2014 we have built its name with OEMs in the US, through six acquisitions folded into one brand. Intech is now part of Exalta.
The Exalta announcement ↗Home / Who we help / International companies entering the US
US market entry for medical device companies
Win the US market with a team that speaks MedTech.
Strategic advisors and a full marketing team, in one. We take you from your first US plan to meetings with American buyers.
Some of the international companies we’ve helped
- Hellstern medical
The problem
Successful at home. Unknown in the US.
American buyers don’t know you
Surgeons and hospitals buy from companies they already trust.
Your story was written for home
What works in Germany or France often falls flat in the US.
Your team is far away
Six hours of time difference, and nobody on the ground to follow up.
Meanwhile, your board approved the US budget and is waiting for results.
Some of the companies we have taken to the US
From Germany, France, Australia and Israel to the US.
From Germany to the US · In progress
Realists
Realists makes surgical training simulators in Leipzig. We started taking it to the US market in 2026, and the work is ongoing.
- The storyFrom “high fidelity simulation” to what it changes for an OEM: training that no longer depends on cadavers.
- The US websiterealistsusa.com, written for US OEM education and sales leaders, with a US demo booking.
- The launch momentA private suite at NASS 2026 in San Antonio, with meetings booked before the show.
From Australia to the US
Headsafe
An Australian MedTech company bringing Nurochek, an FDA cleared portable concussion assessment system, to the US. We act as its US marketing department: US buyer profiles, the American story and the launch plan.
US launch in progressVisit headsafe.com ↗Headsafe’s US press release ↗
From Israel to the US
Mazor Robotics
From 2015 to 2018 we were Mazor’s marketing team as it grew in the US with robotic guided spine surgery. In 2018, Medtronic acquired Mazor Robotics.
Medtronic’s announcement ↗
From Germany to the US
Hellstern medical
A German surgical robotics company bringing noac, a robotic surgeon assist for open surgery, to the US. Its US launch started with spine and built toward NASS 2026.
US launch in progressRead the press release ↗Read the Digest interview ↗Our plan
Our plan is simple.
Every quarter, we review the plan and the results with your leadership.
1We audit
How American buyers see you today: your website, your claims and your US materials.
2We listen
Your goals, your timeline and your US budget, until we clearly understand them.
3We plan
Your three stage US launch plan, built with MT-7, our Framework for Growth. You approve it.
4We execute
Our team runs it as your US marketing department, with a shared Gantt chart and a weekly and a monthly action report.
Your US launch plan
Stage by stage.
Each stage ends with something you can use. You can start with stage 1 on its own and keep the plan either way. Below are the first six months, taken from the plans we run for clients today.
Your US launch planMaster framework
This is our master framework, and your plan is made to measure. We cut every Gantt for one company: your products, your buyers, your shows, your budget and your dates. No two of our plans look alike.
StrategyLaunch foundationDemand and growthNumbered moments you approve or launch
Month 1Month 2Month 3Month 4Month 5Month 6
Stage 1 · StrategyWeeks 1 to 5 · You walk away with: A written US marketing plan: segments, messaging, competitors, KPIs and timeline. Yours to keep, even if you stop here.
Kickoff and the shared plan
US market and competitor analysis
US buyer profiles
Goals and KPIs your board can track
Your Americanized story and claim guidelines
Brand adapted for the US
Stage 2 · Launch foundationWeeks 5 to 15 · You walk away with: A company US buyers take seriously.
US website, live by week 12
Sales deck, one pager, investor deck
Press release: US market entry
Distributor and rep introductions
KOL map and advisory board
Stage 3 · Demand and growthWeek 6 onward · You walk away with: Meetings your sales team can close.
LG6 lead generation setup: lists and LinkedIn outreach
LG6 lead generation outreach to target accounts
Newsletter and social, every month
Show: outreach, meetings, follow up
Investor outreach
Pipeline report, every month
1US story approved
2US website live
3Launch show
4Round closes: scale
- 1US story approved
- 2US website live
- 3Launch show
- 4Round closes: scale
How to read it. Each row is a workstream, each bar is when we work on it. The numbered markers are the moments you approve or go live.
What it means for you. You see the US story approved in about five weeks and meetings booked before your launch show. This framework is drawn from the real plans we run for our US launch clients.
How we build your plan
See how MT-7 works, in eight minutes.
MT-7, our Framework for Growth, builds your plan in seven steps, always in the same order:
- 1Buyer personaTargeting
- 2Brand messageYour story
- 3Brand identityValues
- 4Content marketingSolutions
- 5Marketing engineInterconnection
- 6Lead generationTargeted content
- 7Analytics and ROISuccess
Your US team
Some of the people who run your US launch.
We act as your US marketing department until you build your own, and we stay as long as you need us. We also advise your leadership on the big US decisions. We are based in Orlando, Florida, and our network gets you introductions you would struggle to get on your own.
Your US strategic advisor
Guillaume Viallaneix
Founder and President
European and American. Advises your leadership on every key US decision: positioning, partners, distributors and investors. In English, French or Spanish.
LinkedIn →
The MedTech Digest
We pitch your US launch story to the editors, so you do not arrive cold.
Not ready to talk yet? Start with a free audit
How do American buyers see you online?
Within 5 business days: where you stand next to two or three US competitors, the three problems that cost you most, and what to fix first. Then a 30 minute call, in English, French or Spanish.
Free for medical device companies planning their US launch.Thank you. Your free audit is underway. Within 48 hours, a short report lands in your inbox: where you stand next to two or three competitors you know, the three problems that cost you most, and what to fix first. We’ll reach out to set up a 30 minute call to go through it together.
Get your US news in front of the industry.
We founded The MedTech Digest to cover the people building MedTech. When you have news worth telling, we pitch it to the editors. They decide what runs.
Free monthly newsletter. Interviews, industry news and MedTech marketing.
Featured interviewDr. Luis Bernal, CEO of REALISTSHow a German surgical training company is bringing its spine simulators to the US. Read the interview ↗
SubscribeArticlesOne WorldArtificial IntelligenceInterviewsEditorial BoardSubmit an Article
Experts in Motion interviewFrom Leipzig to the OR: How REALISTS Is Bringing Next Generation Spine Simulation to the United StatesMay 14, 2026Recent Interviews
MedTech InterviewsNo More Guesswork: Philip Gower on How Headsafe Is Changing the Way America Diagnoses Concussions
MedTech InterviewsHospitals Are Losing Surgeons. Hellstern medical Built the Fix
MedTech InterviewsBuilding on a solid scientific basis, US based CaP Biomaterials transformed into leading Calcium Phosphate contract manufacturer with global reach
MedTech InterviewsPredictable Setups, Reliable Execution: David Holdford on Building IOS
MedTech InterviewsNanovis Built Implants to Prove Its Nanotechnology. Now the Technology Is the Business.
MedTech InterviewsThe VA Had One Microscope. She Stopped Waiting.
Experts in Motion interview
Dr. Luis Bernal, CEO of REALISTS Training Technologies
No More Guesswork: HeadsafeHospitals Are Losing Surgeons.FAQ
Questions about launching a medical device in the US
What is a medical device go to market strategy for the US?
It is the plan that takes a device, or a new manufacturing capability, from approval to steady US sales. It defines who buys, what they need to hear, the proof they need, how you reach them and in what order. At MedTech Momentum it starts as a written US marketing plan: target segments, messaging for each, competitors, KPIs and a timeline, built backward from your US sales goal.
What changes when a European company enters the US market?
Almost everything around the device. A hospital committee decides, not only the surgeon. The message has to be clear and about outcomes. Claims must match your FDA clearance. Sales run through independent reps, distributors and group purchasing. And US buyers want US proof.
How long does a US launch take?
Stage 1 takes about five weeks. The launch foundation runs through month four, and demand generation starts in the second month and keeps going. Building steady US sales takes longer, so every stage has milestones you can track.
Do you help us find US distributors and reps?
Yes. We map the distributors and independent reps who cover your specialty and regions, give them the materials they need, and make introductions through our network. You choose and sign your partners.
Do you handle FDA clearance or reimbursement?
No. We work from your FDA cleared claims, alongside your regulatory and reimbursement advisors, and every message is reviewed before it goes public. If you do not have those advisors yet, we can introduce you.
Can you work with our team in Europe?
Yes. We work in English, French and Spanish, with your headquarters and your US lead together, and we plan calls in the hours our time zones share.
Do you also work with component and service suppliers?
Yes, with a different plan. They sell to OEM engineering, quality and sourcing teams, so the message, the proof and the materials are different. See how we help manufacturers.
US readiness callGuillaume ViallaneixFounder and President
Guillaume ViallaneixFounder and PresidentBook a US readiness call.
In 30 minutes, we check six things: clearance, evidence, your US owner, target customers, budget and sales support. Then we tell you where your US launch should start.
- 30 minutes with Guillaume Viallaneix, our founder
- In English, French or Spanish
- Your first step, whether you hire us or not
Not ready for a call? Get a free audit of your digital footprint
Prefer email? [email protected] · +1 (321) 946 1303
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