Manufacturing, packaging and logistics
Whether you manufacture in your home country and import into the US, or want to make your product here, Shorelight Medical helps you build a supply chain that meets US requirements, from production through packaging, storage and delivery to your customers. Through our partner network, we select, qualify and manage manufacturing, packaging and logistics partners with the right experience and certifications for your product, whether it’s a medical device, a pharmaceutical or another healthcare product.
Who It's For
- International companies that manufacture at home and import into the US
- Domestic companies and startups scaling from prototype to commercial production
- Companies adding or moving production to the US for cost, supply-chain or "Made in USA" reasons
- Companies preparing to launch that need packaging, storage and fulfillment in place, including direct-to-consumer and HCP sampling
What's included
Importing into the US
- Import readiness: with our regulatory partners, making sure FDA registration, listing and labeling are in place before your product ships
- US Agent coordination: through our partners, for foreign manufacturers
- Customs and logistics: coordinating customs brokers and shipping partners
- Supplier quality oversight: audits of your existing manufacturing against US quality expectations
Manufacturing
- Manufacturer selection: matching your product to qualified partners with the right experience and certifications (for example, ISO 13485 for devices or cGMP for drugs), including contract drug manufacturing and OEM manufacturing
- Engineering and prototype-to-production: moving your design from prototype to repeatable manufacturing
- Fabrication and assembly: precision fabrication, machining, electro-mechanical assembly, enclosures and medical carts through our partners
- Supplier qualification and oversight: audits, quality agreements, schedules and change management between you and your manufacturer
Packaging, fulfillment and logistics
- Healthcare and pharmaceutical packaging: including thermoforming and contract packaging
- Serialization and DSCSA support: meeting drug supply chain traceability requirements
- Specialized storage: cold chain and DEA-compliant storage
- Warehousing, fulfillment and 3PL logistics: US storage and delivery to your customers
- Direct-to-consumer distribution: shipping directly to patients
- HCP sampling programs: getting samples to physicians and other healthcare professionals
- White-label operational support: operations run under your brand
How it works
Free 1-hour discovery call
We talk through your product, where it is made today, and how it needs to reach customers. No cost and no obligation.
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.
Supply Plan
Import your existing product, manufacture in the US, or a mix of both, plus the packaging, storage and distribution you’ll need.
Set Up
We select and qualify manufacturing, packaging and logistics partners and get them ready for launch.
Manage
We oversee ongoing production, shipments and fulfillment.
Why Shorelight
Whether you import or manufacture in the US, we coordinate the partners (regulatory, manufacturing, packaging, storage and logistics) so you don’t have to manage them one by one.
- 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
Do we have to manufacture in the US?
Many of our clients manufacture in their home country and import. We help you meet FDA requirements and set up customs, logistics and warehousing. If US production makes sense for you, we can help with that too.
Does Shorelight own a manufacturing facility or warehouse?
Manufacturing, packaging, storage and logistics are all handled through our network of qualified partners, and we manage the relationships for you.
What types of products can you help with?
All types of healthcare products: medical devices, pharmaceuticals and more. We match each product to partners with the experience and certifications it requires.
Can you support direct-to-patient shipping and HCP sampling?
Through our partners, we can set up direct-to-consumer distribution and HCP sampling programs, including serialization and specialized storage where required.
Importing into the US, looking for a manufacturer, or getting product to customers?
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.