Experienced • Qualified • Responsive.
Medical device manufacturing and assembly demands high quality and timely delivery. Our medical manufacturing experience, qualifications, and responsiveness helps our clients consistently meet those demands.
35 Years of Manufacturing
Coastline has manufactured products for medical device and biotechnology OEM clients for over three decades. We know what it takes to meet the increasingly demanding quality standards associated with assembly and packaging in the medical device, biotech, life science, and pharmaceutical industries.
Consistent Quality at Lower Cost
OEM clients typically find the cost of our medical device manufacturing services to be 30% or more below other contractors or the client's own in-house costs. Our clients also know we are fiercely committed to meeting their expectations for product quality, delivery, and service. Since Coastline is a nearshore manufacturer, OEM clients may also benefit from lower transportation costs and reduced transit time.
ISO Class 8 Clean Rooms
We operate several Class 8 (Class 100,000) clean rooms within our FDA registered medical device manufacturing facilities. Of the total 50,000 square feet of manufacturing space, Coastline has expanded to over 9,000 square feet of cleanroom space. All medical production is completed in ISO 13485 standards (ISO 13485:2016).
Procurement - Logistics & Import-Export Services
- Materials management, warehousing
- Tracking and lot traceability
- Can provide end-to-end turnkey solution
- Procurement: components & supplier sourcing
- Mexico-USA importation/exportation services
- Coastline manages the Customs processing, with ability to release goods landed in the US
- OEM clients rely on Coastline's import-export expertise to also ship finished medical device products to the US and global destinations
Coastline minimizes customer investment of time and resources by handling all logistics for transporting (importing as appropriate) all raw materials and components for medical devices to its manufacturing facility in Tijuana Mexico.
- Manual assembly of components & subassemblies
- Finished device assembly
- Secondary manufacturing processes
- Mechanical assembly
- Solvent bonding
- UV curing
- Ultrasonic welding
- RF welding (Radio Frequency)
- Friction fit assembly
- Clicker press die cutting
- Hot stamping
- Adhesive processes; gluing and bonding
- Packaging and bagging - finished product
- Kitting - surgical kits, thermoform trays, lidstock
- Packaging - pre-sterilization
- Private labeling - printing and application
- ETO & E-beam sterilization (outsourced)
- Medical textiles; soft goods sewing
- Tooling & Fixture development
- Lean Manufacturing principles
- Program Management
Major Product Categories
- Disposables and consumables
- Infusion therapy
- Surgical devices
- Ophthalmic devices & assemblies
- Class I & Class II devices
- Sterile and non-sterile
- Medical - aesthetics products
- Medical electronics
Examples of products include:
- Various tube set assembly
- IV administration & extension sets, enteral feeding sets
- Blood collection devices, blood management
- Catheter set assembly & packaging
- Ophthalmology devices
- Laparoscopic surgical devices
- Specialty suture devices
- Surgical kits
- Diagnostic test kits
- Surgical hoods & gowns
- Wound treatment (including vacuum drains)
- Custom liners, pads, straps
- Specialty products for medical & aesthetics industries
- Full transfer of production lines
- Program Management
- Quality assurance testing
- Part measurement
- First article inspection
- Production qualifications
- Process qualifications
- Fixture qualifications
- Multi-run validations
- Sterilization management
- IQ - OQ - PQ
Frequently Asked Questions
What is medical device contract manufacturing?
Contract manufacturing in the medical industry is very common, in which OEMs (original equipment manufacturers) work with contract manufacturing organizations, often referred to as CMOs or third-party manufacturers, to manufacture their product. The contract manufacturers are required to manufacture the product to the original specifications and meet all quality requirements, effectively having no difference than being produced by the original manufacturer.
There is a vast array of products used in the medical industry (diagnostics, surgical, treatment, therapeutic, monitoring, aesthetics, and more) of which have immensely high usage volume. These products and devices require sufficient manufacturing resources to support the demand and as such medical contract manufacturing has become a viable solution to provide such scalable solution. This often includes international sites and strategic partners to provide support in design, manufacturing, and transportation/logistics to healthcare locations throughout the world.
What are the major steps in manufacturing a medical device?
The pathway from product concept to scalable manufacturing status can be quite daunting. While having a great idea for a medical solution is fantastic, it requires some major steps to get from idea to manufactured finished good. The major steps in manufacturing a medical device are:
- Initial concept
- Product design
- Regulatory Requirements (if applicable)
- Device testing
- Design verification and validation
- Product manufacturing
- Sterilization (if applicable)
How is Coastline’s nearshore medical manufacturing better than offshore?
Outsourcing your medical manufacturing needs is a great step when it comes to increasing efficiency, reducing costs, and increasing overall production capacity. However, choosing where to outsource plays a significant role in the outcome.
Nearshore medical manufacturing in Mexico can offer you easy access to the facility, quick shipments of finished products, and a highly trained, quality manufacturing team, while also achieving the cost reduction and increased capacity to scale.
What are the benefits of using Coastline for my medical manufacturing?
Coastline International has been providing medical manufacturing support to leading global OEMs for many years. Established in 1982, Coastline has been manufacturing in Mexico for over 40 years and has developed a well-established team and facilities to provide manufacturing solutions across many applications. We have all witnessed how strained the healthcare system in the U.S. can get during a crisis. If you have a medical device or a piece of medical equipment that needs to be manufactured, you need to have the confidence that it can be handled by an experienced, qualified facility with a thoroughly trained team. You want your finished product to arrive where it is needed when it is needed.
At Coastline, we meet your demands - without sacrificing quality - to provide you with finished products that meet all necessary standards. The entire process saves your company both time and resources.
How can I learn more?
If you are ready to learn more about Coastline International and how it can meet your medical manufacturing needs, call us at (888) 748-7177.
"Coastline has been a manufacturing partner for many years, supporting the growth of our business and increased volume in production as our product demand has scaled. Coastline is committed to Quality, and consistently reliable. The team is always available and we appreciate the ability to visit the site conveniently as needed. Transferring production to Coastline has provided a cost-reduction solution while also providing increased capacity."
—President, US-based Medical Device OEM