US market entry and launch
Traditionally, launching a medical or life science product in the US means hiring separate firms for regulatory, reimbursement, manufacturing, logistics and sales, and coordinating them all yourself. Shorelight Medical streamlines that into one team and one plan. Whether you’re a US company launching something new or an international company entering the US market, we run the entire launch, starting with a US Market Entry Blueprint and continuing through launch and growth, so you save time, lower total cost and stay focused on what you do best.
Who It's For
- International companies entering the US market for the first time
- US established companies, startups and inventors launching a new product without in-house regulatory, manufacturing or commercial teams, or tired of juggling a long list of outside firms and vendors
- Companies already selling in the US that want to expand into new regions, channels or customer groups
What's included
- US Market Entry Blueprint: a step-by-step plan covering regulatory, reimbursement, manufacturing, channels, timelines and budget
- Go-to-market strategy and commercialization planning: how, where and to whom you'll launch
- Product positioning and messaging: how your product is presented to buyers, clinicians and partners
- US launch sequencing: which customers, regions and channels to go after first
- Pilot program architecture: designing pilots with health systems and clinics to prove value before full launch
- Healthcare partner and business development: partnerships with health systems, distributors, OEM and licensing partners
- Healthcare ecosystem navigation: guidance through the US mix of providers, payers, group purchasing organizations and regulators
- International expansion support: for international companies, coordinating US entity setup, import and US Agent services through our partners
How it works
1. Free 1-hour discovery call
We learn about your product, who will pay for it, and where you are in development. No cost and no obligation.
2. Proposal
If there’s a fit, we send a written proposal with scope, timeline and fees. Paid work, including any further discovery sessions, begins only after you approve it.
3. Blueprint
We build your US Market Entry Blueprint.
4. Launch
We take you through our five-stage process: Getting started, Rules and testing, Build and ship, Selling, and Grow and expand.
5. Grow
Pilots, partnerships and expansion into new customers and markets.
Why Shorelight
Awarded four State Trade Expansion Program (STEP) grants through the South Carolina Department of Commerce (2025–2026), with a US network of regulatory, reimbursement, manufacturing and distribution partners.
- More than 30 years of combined experience in medtech and life science commercialization, spanning sales, product development, marketing strategy and market launch.
- Founder-led. Founder and CEO Stephen Brown brings 17 years of sales experience, 13 of them in medical device sales, along with experience in product development and new product launches.
- Marketing and commercialization expertise. Our team brings marketing strategy and execution plus hands-on commercialization experience, so your product launches with a clear message and a plan to reach buyers.
- One team, trusted partners. A vetted network of partners across every service (product development, regulatory and quality, reimbursement and market access, sales and marketing, and manufacturing and supply chain), all coordinated by Shorelight.
FAQ
Is this only for international companies?
We work with US established companies, startups and inventors launching new products, as well as international companies entering the US market. The process is the same; for international clients we also coordinate import, US Agent services and US entity setup.
What is a US Market Entry Blueprint?
A written, step-by-step plan for bringing your product to the US market: regulatory pathway, reimbursement, manufacturing and logistics, sales channels, timeline and budget. Many clients start here.
Do we need a US company to sell in the US?
Not always. We help you choose between a US entity, a distributor model or a licensing partner.
Can we use only part of the service?
Engagements can be a full launch or individual stages, billed by project or by the hour.
Planning a US launch?
Let’s talk.
Schedule a discovery call: a one-hour conversation where we get to know your product, your company and your goals, so we can see if and how we can help.