Our Process
The five stages
Getting Started
We research your market and competitors, help you protect your intellectual property, and, for international companies, help set up the US entity you need to do business here.
Rules and Testing
We identify the right FDA pathway (510(k), De Novo or PMA), coordinate clinical and lab testing, and set up a quality system that passes audits.
Build and Ship
We select and manage qualified manufacturing partners, handle import requirements, and arrange warehousing so your product is ready when orders come in.
Selling
We build your marketing, line up distributors and sales reps, and put billing and reimbursement in place so customers can buy your product and get paid for using it.
Grow and Expand
After launch, we support your post-market requirements and build the partnerships that grow your sales in the US and beyond.
One partner, every stage, driving innovation
Who We Are
Shorelight Medical is a US-based commercialization partner helping inventors, startups, and international life-science companies bring medical devices and pharmaceuticals to the U.S. market.
What We Do
Full-Stack Commercialization Services:
- Product Development – From concept to prototype to manufacturing
- U.S. Market Entry – Regulatory, distribution, sales, and marketing for foreign firms
- Regulatory & Quality – FDA pathways, compliance, audits, clinical/lab testing
- IP & Legal – Patent strategy, international IP protection
- Sales & Distribution – U.S. networks, OEM, licensing, hospital systems
- Manufacturing – U.S. and international CDMO and device manufacturing partners
- Marketing services – medtech-focused branding, messaging, web design, press releases
Innovation Partners: Mayo Clinic Berg Innovation Exchange, MUSC, Clemson University, Innovate UK