Services Areas
Medical Device Contract Assembly
Each of us relies on hospitals and their services to provide us with emergency care and when it comes to our health, taking chances is unacceptable. That is why manufacturing medical devices carries with it an inherent responsibility to provide a quality product. Because we feel that it is our responsibility to deliver, we use our 30+ years of experience to provide comprehensive medical device assembly service to our San Jose clients. From material procurement and logistics, to assembly and quality inspection, each aspect of each project is managed with safety and efficiency in mind.
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Why Choose Coastline International Inc?
There are various benefits to making Coastline International Inc. your medical assembly contractor. Most of those benefits, such as our incredible price point, stem from the fact that we do everything in house. The benefits of choosing Coastline International Inc. include:
- -First article inspections and production, process, and fixture qualifications
- -FDA registered medical device manufacturing facilities, including Class 8 (Class 100 000) clean rooms
- -Multiple run validations
- -Quality assurance testing and part measurement
Coastline International Inc Medical Device Services
Because of our extensive facility capacities and thorough knowledge of medical device processes, we are able to provide inclusive assembly processes, such as:
- -Medical textiles and sterilization
- -Gluing and solvent bonding
- -Ultrasonic and laser beam welding
- -Pre-sterilization packaging and finished product bagging
- -Printing and applications private labeling
- -Manual assembly of components and subassemblies, as well as secondary manufacturing
Years of Safe, Reliable Products
Your health is important and being provided with quality medical equipment is equally vital. At Coastline International Inc, we understand that. That is why we use our 30+ years of experience to provide OEM clients in San Jose with the best manufacturing experience possible.
In-house manufacturing can be expensive and unwieldy, call us today for a free estimate.
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Medical Device Contract Assembly - Infusion Therapy
Within medicine, there's no room for error, and delays can be disastrous. At Coastline International, we are dedicated to the swift and efficient assembly and delivery of medical devices to our clients. Our results-driven mentality has made us a favorite for many international markets, as well as medical organizations located within the United States.
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With over 30 years of experience providing local and international clients with medical devices that are meticulously assembled, Coastline International is a trusted source for all your medical device needs.
Since 1981, Coastline International has maintained the same high standards for medical device manufacturing and assembly, so whether your decision to choose an external company is economic, to reduce costs, or strategic, to reduce delivery time, we are here to help.
Coastline International Has International Medical Device Solutions
Coastline International has worked hard to establish itself as a key player within the medical device industry, and in doing so has developed lasting relationships with key players in the medical industry. We have experience working with companies both big and small, handling contracts of all sizes, always with the same dedication to quality medical device products and service.
When you work with Coastline International, you are working with a company that is wholeheartedly devoted to on-time delivery of high grade medical devices, expertly assembled by detail-oriented staff.
FDA Registered, ISO certified Medical Device Assembly
Coastline International's strategic position as a nearshore manufacturer also helps lower the cost of medical devices produced by the company; clients can benefit from reduced travel time and, as a result, more affordable rates, without a compromise in quality or service.
We are able to assemble medical equipment at a speed which rivals larger companies, while also maintaining competitive prices that make us an excellent alternative to other organizations. Companies we work directly with have reported that they save an average of 30% compared to when they work with competing companies or use their internal services, all without a drop in quality.
As an FDA registered, ISO certified manufacturing company, Coastline International is committed to delivering products that our clients can count on to save lives. We see ourselves as an integral part of the medical process, something which drives us to constantly be working to better the quality of work and client care we provide.
Reach out to Coastline International Today
If you're an OEM company seeking to reduce the cost and waiting time associated with your medical device assembly needs, we encourage you to get in touch with Coastline International today. As a highly skilled and respected company, we are uniquely positioned to provide you with medical devices that rival larger companies in terms of quality and affordability.
For medical device assembly you can trust, reach out to Coastline International today for more information on how to establish a long-lasting, professional relationship with our company. We look forward to exceeding your expectations with our medical device assembly services.
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Medical Device Contract Assembly - San Francisco Bay Area / San Jose
Each of us relies on hospitals and their services to provide us with emergency care and when it comes to our health, taking chances is unacceptable. That is why manufacturing medical devices carries with it an inherent responsibility to provide a quality product. Because we feel that it is our responsibility to deliver, we use our 30+ years of experience to provide comprehensive medical device assembly service to our San Jose clients. From material procurement and logistics, to assembly and quality inspection, each aspect of each project is managed with safety and efficiency in mind.
Read More
Why Choose Coastline International Inc?
There are various benefits to making Coastline International Inc. your medical assembly contractor. Most of those benefits, such as our incredible price point, stem from the fact that we do everything in house. The benefits of choosing Coastline International Inc. include:
- -First article inspections and production, process, and fixture qualifications
- -FDA registered medical device manufacturing facilities, including Class 8 (Class 100 000) clean rooms
- -Multiple run validations
- -Quality assurance testing and part measurement
Coastline International Inc Medical Device Services
Because of our extensive plant sizes and thorough knowledge of medical device processes, we are able to provide inclusive assembly processes, such as:
- -Medical textiles and sterilization
- -Gluing and solvent bonding
- -Ultrasonic and laser beam welding
- -Pre-sterilization packaging and finished product bagging
- -Printing and applications private labeling
- -Manual assembly of components and subassemblies, as well as secondary manufacturing
Years of Safe, Reliable Products
Your health is important and being provided with quality medical equipment is equally vital. At Coastline International Inc, we understand that. That is why we use our 30+ years of experience to provide OEM clients in San Jose & San Francisco Bay Area with the best manufacturing experience possible.
In-house manufacturing can be expensive and unwieldy, call us today for a free estimate.
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Medical Device Contract Assembly - Disposable Surgical Kits
With more than 30 years of experience in the manufacture of medical devices for OEM clients, Coastline International is fully qualified to meet the highest standards required for medical device contract assembly. As an FDA registered and ISO manufacturer with a large pool of skilled employees and Class 8 clean rooms, we are established as trusted partners for a range of companies offering medical assembly services within the following major product categories:
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- Disposable and consumables
- Sterile and non-sterile
- Medical devices
- Medical electronics
- Medical & Aesthetics assemblies
World Class Quality at a Lower Cost: Seattle WA - Provo UT - Minneapolis MN - Boston MA
Specializing in the assembly of full devices and sub-assemblies for finished devices; Coastline operates globally to provide the highest quality skilled manual assembly as well as state-of-the-art automated manufacturing and testing. Experienced at maintaining the controlled environments necessary for achieving the highest level of accuracy required for medical device assembly, our 40,000 square foot facilities are fully equipped the latest and most advanced equipment operated by a skilled labor force capable of fully accommodating the most precise customer specifications. Since Coastline is a nearshore manufacturer offering assembly services, OEM clients also benefit from lower transportation costs and prompt delivery.
Service Capacities
Our fully equipped facility offers a range of customized services including various marking and labeling options in addition to:
- Manual assembly of all component parts
- Gluing and solvent bonding
- Customized labeling (including printing and application)
- Packaging and Pre-Sterilization
- Sterilization (outsourced) :
- Kitting
- Bonding
- Forming
- Swaging
- Foil marking
- Laser marking
Safe and Secure Work Environments
We have consistently maintained an excellent safety record and quality work environment in our Seattle manufacturing facilities implementing safety programs and comfortable and clean work environments that include an on-staff nurse, and on-site cafeteria.
- Excellent work safety record
- Facilities built to U.S. standards
- On site security systems
- Organized access to manufacturing facilities
Cost Effective and Comprehensive Service and Support
Coastline International incorporates efficient procurement and logistics with our medical assembly services that includes the shipping and handling of all hardware and components further reducing the overall costs and time investments for customers
- Import/Export Management
- Materials Management
- Lot tracking and Tracing
The Benefits of Outsourcing Medical Device Assembly for Large and Small Companies
We seek to offer benefits to organizations of all sizes by offering a wide range of manufacturing and assembly related services. Outsourcing medical device assembly allows companies to function more fluidly and focus solely on their primary functions. Once alleviated from the day to day procedures and commonplace concerns required for meticulous medical device assembly - in addition to the added in house expense - smaller companies benefit from the reduced demand on resources, allowing them to make better use of their limited funds. Larger companies also profit from reduced overhead, labor costs and time saved from outsourcing medical device assembly services to an experienced service provider.
Why Choose Coastline Contract Medical Assembly Services?
- Lower production costs
- Save as much as 30% on in-house assembly costs
- Proven Medical Device Assembly Expertise
- Import/Export Capability
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Mexico Medical Manufacturing - Single-Use Devices
At Coastline International, we have specialized in the manufacturing of medical products for over 30 years, and are proud to be a trusted source for medical manufacturing in Mexico. We believe that our dedication to consistent quality, punctuality and attention to detail has allowed us to succeed in the field of medical manufacturing for so long. We have clients all over the world, and we ship internationally to most countries around the globe.
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Medical Manufacturing in Mexico
We take pride in knowing that many OEM clients rely on our products to get their jobs done. Beyond that, we understand that our products are directly affecting the patients who rely on their quality. That is why at Coastline International, we take quality, consistency, and customer satisfaction very seriously. Without our clients, we would not be where we are today. Our focus is on an unwavering dedication to meet the high-quality demands and standards associated with the manufacturing of medical Equipment components.
Industry Standard Medical Products
At Coastline International, we believe in producing extremely high quality products at an affordable price. We are proud of the fact that the cost of our medical device manufacturing service is typically 30% lower than most contractors. We believe that this kind of service increases the chance for many medical providers to do their job at a lower cost which in turn positively affects patients and those in need. We know that the high demands of the medical industry require manufacturing companies to be meticulous about time and ensure that they are meeting quality and delivery expectations. We abide by these industry standards from manufacturing to delivering and tracking your order.
Clean Manufacturing Environment
When it comes to the manufacturing of medical components, the cleanliness of a work environment cannot be taken lightly. At Coastline International, our products are always scrupulously manufactured in ISO Class 8 cleanrooms. Our industry standard, FDA registered equipment is continuously updated at our Mexico medical manufacturing location. Likewise, our employees are rigorously trained and abide by FDA regulations and cleanliness standards. To ensure this, we regularly perform reviews and evaluation of our work force and facilities.
Accurate Tracking Service
Quality medical manufacturing is our primary focus, but even the most technologically advanced equipment is functionally useless if it cannot reach its intended location. That is why we provide accurate and reliable tracking services for your lot. You can rest assured that you will always be able to know where your order is at any given time. Additionally, as Coastline International is conveniently located near the Mexican shoreline, our customers enjoy lower prices on shipping and quicker delivery options.
We know firsthand that customers do not want to invest time and resources in figuring out the shipping logistics to receive the products they have already paid good money to have manufactured. By handling all logistics for transporting our goods, as well as importing when necessary, we can minimize any stress associated with receiving the medical products you have had manufactured.
What Coastline International Can Manufacture
Coastline International has many different manufacturing specialties, but the medical manufacturing we specialize in includes: Class I and II products, disposables and consumables, sterile and non-sterile products and medical electronics.
Class I and II Products
Class I devices are subject to very limited regulatory control as they are not intended to help support or sustain life. The types of products that are typically associated with the Class I designation include:
- Elastic bandages
- Examination gloves
- Hand-held surgical instruments
As for Class II products, they are subject to safety and effectiveness controls because they are designed to perform as indication without causing injury or harm to the patient or user. Some of the products you may be familiar that fit into this class include:
- Infusion pumps
- Surgical drapes
- Acupuncture needles
Disposables and Consumables
No health care facility can function to its full capacity without being fully stocked with disposable and consumable medical products. Some of the medical disposables and consumables we can manufacture include:
- Blood collection tubes
- Medical thermometers
- Catheters
- Medical waste disposal kits
Sterile and Non-Sterile
Manufacturing disposable, polypropylene medical products allows us to provide customers with bowls, trays, kidney dish receivers, gallipots and jugs in non-sterile bulk or pre-sterile. We can cater to your needs, just simply tell us what you need and we’ll get it to you.
Medical Electronics
Given that these products are often used in critical life-and-death situations, you need to make sure the manufacturer of your medical electronics is reliable and has the highest possible commitment to quality. That is exactly what you get when you get your medical electronics through Coastline International, so reach out to us today to find out what we can do for you and your practice or facility.
Why Mexico?
We are often asked by clients why Coastline International chooses to operate our medical manufacturing services in Mexico. The simplest explanation for our choice to set up shop in Mexico is because it is the most cost-effective nearshore location. In 2008 alone, manufacturers in Mexico shipped nearly $5.2 billion worth of medical devices to the United States, ranging from disposable devices, precision instruments and medical apparel.
The overall costs of labor, utilities, land, taxes and transportation for a medical manufacturing company to operate in Mexico is far lower than if we were located stateside. Given the millions of dollars we save in operational costs, we can provide our clients with:
- Shorter supply chain supports
- Reduced working capital
- Shorter to market time
- Close proximity to technical support and customized production markets
By cutting costs without sacrificing the quality of the medical products manufactured, we can provide customers and clients with the best available products for less.
Contact Us
If you are interested in partnering with a professional, quality driven and affordable medical manufacturing company, consider Coastline International. Contact us today to find out more about how Coastline International and out Mexico based medical manufacturing facility can help contribute to your mass production needs. We will gladly answer any questions that you may have in regards to shipping and delivery.
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Clean Room Manufacturing
Manufacturing clean rooms that are effective and cost efficient can mean all the difference to long term success in your line of business. Partnering with Coastline International contractors means your facility is designed, engineered, installed and maintained by highly accredited professionals with years of experience delivering innovative air particle control solutions.
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Clean Room Manufacturing Engineering & Design
Manufacturing clean rooms that are effective and cost efficient can mean all the difference to long term success in your line of business. Partnering with Coastline International contractors means your facility is designed, engineered, installed and maintained by highly accredited professionals with years of experience delivering innovative air particle control solutions.
We offer a variety of portable, modular, turn-key and customized secure rooms with a focus on medical assembly and your complete confidence and satisfaction.
Clean Room Construction Standards
Coastline International combines clean-room construction standards and unique building and classification specifications to engineer forward thinking particle free environments designed for your specific purposes. We’ll match your budget with the highest quality services from electrical engineering and water flow installation, to filtration expertise and more. We are a leading, full service provider of complete controlled environment innovations at value driven pricing. Allow us to take the lead on your build with a full suite of custom options, accessories, and components.
Ceilings: Incorporate sprinkler systems, filters, fire detection and lights into the ceiling components we prefabricate for you, in our facility, to reduce construction debris during on-site assembly.
Wall Panels: Walls can be designed to suit any spatial challenges and purpose and can include a variety of window and accessory options to suit your operational needs. Panels are fabricated offsite to fit together perfectly during installation with no buffering required.
Flooring: Contamination typically accumulates on floors. We’ll make sure yours are up for the task, from seamless vinyl, rubber and epoxy floor options to urethane, MMA, and raised flooring, we will engineer a product that performs.
HVAC: Coastline International will work with you to design the HVAC system that provides the best value, filtration, and long term functionality for the space. Air flow is critical to ensuring particle control and ensuring classification standards are met.
Doors: From airlocks and air shower systems to pass throughs and change stations, getting the entry and exit points right is critical to keeping the area clear of airborne contamination.
Accessories: We provide safe, clean equipment such as; clean tools, safety and particle shedding prevention garments, hand washing stations, tables, glassware, and certified supplies for a variety of uses.
Equipment & Technology
Coastline International manufactures top of the line clean room components and equipment using state of the art innovations and advanced technology. We have built our reputation on delivering comprehensive service, actionable trouble shooting on complex environmental controls, and fast turn around times. From initial planning stages, to installation, and future maintenance or upgrades, we are your affordable, recommended contaminate controlled room specialists.
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Clean Room Assembly
When it comes to medical facilities, it is critically important to the health and safety of the occupants that all medical devices and equipment are void of foreign materials and fragments. The most effective way to achieve this level of sterility is by outsourcing the manufacturing of medical equipment to a clean room manufacturing company. There, devices are assembled in a controlled environment and monitored by a team of experts to ensure all equipment is free of particles and meets all necessary protocols.
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When it comes to medical facilities, it is critically important to the health and safety of the occupants that all medical devices and equipment are void of foreign materials and fragments. The most effective way to achieve this level of sterility is by outsourcing the manufacturing of medical equipment to a clean room manufacturing company. There, devices are assembled in a controlled environment and monitored by a team of experts to ensure all equipment is free of particles and meets all necessary protocols.
Experienced Clean Room Manufacturers
At Coastline International Inc., we are a premier clean room assembly and manufacturing company committed to manufacturing equipment in a clean and controlled environment. As an FDA registered facility, we strive to provide each our clients with the highest level of professionalism and efficiency. Our technicians are highly experienced and participate in ongoing training to ensure assembly meets stringent protocols. If you have a blueprint, we are here to take that design and transform it into a useable product. Our skill and years of experience means that we possess the capabilities to assembly a wide range of equipment, including surgical clip guns, feeding tube sets, esoteric diagnostic pouches, electrophoresis devices, and more.
Timely Medical Device Delivery
Ask anyone who works in the medical field and they’ll tell you how important timely delivery is when it comes to medical equipment. At Coastline International Inc., we strive to get you what you need when you need it, and because we are a nearshore manufacturer, transit time is greatly reduced. For us, this is much more than a job. We are passionate about becoming partners in the success of your facility. What’s more is that our clients can benefit from duty-free movement of goods under the North American Free Trade Agreement (NAFTA) because we are a nearshore company. What this means is that our products are manufactured in neighboring Mexico and then transported to the United States. In general, our manufacturing services are 30 percent lower than other clean room assembly companies.
Medical Clean Room Supplier
OEMs in North America choose us because we have the capabilities to perform each aspect of medical manufacturing under one roof. For three decades, we have offered:
- Assembly of components
- Ultrasonic welding
- Laser beam welding
- Gluing and solvent bonding
- Packaging and bonding
- Private labeling
- Soft good sewing
- ... and more
When you partner with Coastline International Inc, you are working with a company that is committed to providing you with exceptional service from beginning to end. We handle all the logistics to ensure all raw materials are transported in an efficient and safe manner. This allows you to focus on what you do best. If you have any questions or would like to schedule an appointment to discuss your needs, then we encourage you to get in touch with us today. A member of our seasoned staff will gladly answer any questions that you have and provide you with a quote. We are looking forward to working with you.
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Catheter Assembly in Mexico
If you don't ever want to have to second guess the quality of the catheters you use, then get in touch with Coastline International today. Coastline International is a medical device manufacturing company based in Tijuana, Mexico with over 30 years' experience assembling catheters of the highest quality.
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Medical companies and markets demand high-quality and timely delivery on all sorts of different equipment. Catheters are no different. While the word catheter typically connotes a device used to extract urine from patients, medical professionals know that they have all kinds of different uses. Catheters are tubes that deliver medications, fluids or gases to patients or alternatively drain bodily fluids. Because they are inserted into a body cavity, duct or blood vessel, catheters are an essential piece of equipment for virtually any medical practice. Whether they are soft or hard, the one thing catheters cannot be is unreliable.
If you don't ever want to have to second guess the quality of the catheters you use, then get in touch with Coastline International today. Coastline International is a medical device manufacturing company based in Tijuana, Mexico with over 30 years' experience assembling catheters of the highest quality. Our extensive experience in the industry has helped our clients meet their demands and we know what it takes to meet the high-quality standards associated with medical device manufacturing.
One of the reasons Coastline International continues to be one of the top choices for catheter assembly is because our medical device manufacturing services are at least 30 percent cheaper than other contractors or the client's own in-house costs. Our clients also benefit from lower transportation costs and reduced transit time thanks to our nearshore location.
For more cost-effective catheter assembly with even higher standards than what the competition can offer, get in touch with Coastline International. We are capable of:
- Manual assembly of catheter components and subassemblies
- Secondary manufacturing processes
- Ultrasonic welding
- Gluing and solvent bonding
- Packaging and bagging
- Pre-sterilization packing
Call 888.748.7177 today for pricing on our catheter assembly services.
Catheter Assembly Services With the Highest Standards
With any medical device, catheters included, it is imperative to maintain the highest standards of quality at all times. At no point in Coastline International's assembly process do we waiver from operating with the highest standards of quality in mind. We operate several Class 8 clean rooms within our FDDA registered medical device manufacturing facilities.
We also offer some of the most meticulous quality assurance testing in the industry. After all, when a catheter needs to be inserted, there is no time for medical professionals to second-guess its quality. That's why we take our role in the quality assurance process so seriously. We will never ship anything that we don't wholeheartedly sign off on, so you can be confident that when your catheters arrive, they have been approved by the industry-leading professionals.
Custom Catheter Assembly
Whether you prefer silicone, rubber, latex or thermoplastic elastomers, we can assemble catheters to your specifications. Some medical professionals prefer thin, flexible tubes, others prefer more inflexible, hard catheters. All you have to do is specify what you would like when you place your order and our highly qualified staff will take care of the rest.
Contact Us Today
If you have any questions about our catheter assembly services, give us a call at 888.748.7177 today.
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Contract Manufacturing San Francisco | Packaging Mexico | Sterilization Mexico | Catheter Assembly Mexico | Clean Room Assembly | Clean Room Manufacturing
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CPI White Paper Info (Archived)
Medical Device Manufacturing in Tijuana and Mexico: Advantages of Nearshoring in Mexico, Key Highlights and 2016 Industry Overview
Mexico has rapidly become a top global destinationfor medical device manufacturing. Executives and trade organizations cite major cost savings and ease of doing business benefits including:
- Low-Cost, Highly-Skilled Workforce
- Proximity to Major Markets (US, Canada)
- NAFTA, Free Trade Zone
- Maquila Duty-Free Temporary Imports
- Strong Intellectual Property (IP) Protections
- Established Infrastructure
This white paper will assist executives in understanding the benefits of manufacturing in Mexico by analyzing Mexico as a potential site for medical device manufacturing activities. Important factors such as proximity to major markets, infrastructure, labor cost and supply, transportation and ease of doing business, will be covered. Additionally, this paper will also focus on the established medical device industry of both Mexico and Tijuana, Baja California.
Mexico an Attractive, High- Growth Market to Watch
Mexico grew from third in 2012 and is now ranked first for lowest business costs according to the annual KPMG Competitive Alternatives: Guide to International Business Location Costs 2016.3 Mexico’s exports of medical equipment and supplies were valued at $8.5 billion in 2015, of which exports to the US accounted for $6.45 billion.
From temporary imports for final assembly to full production operations, Mexico’s medical device sector is equipped to handle a broad range of medical device manufacturing activities.
Mexico is Latin America’s leading exporter of gloves, gauze and bandages; the third-largest exporter of tubular metal and suture needles; the fifth largest exporter of medical, surgical, dental and veterinary instruments and devices; and the sixth largest exporter of mechanotherapy, psycho technical equipment.
TIJUANA, BAJA CALIFORNIA: Mexico’s Medical Device Industry Capital
Baja California is home to 79 of the 740 manufacturing companies that comprise Mexico's medical device industry. Though Baja California has approximately 10% of Mexico’s medical device manufacturers, it is responsible for half of the country’s exports in the industry, reaching $4.917 billion for 2015.
With more than 44 of these companies calling Tijuana home, the industry has named the northern Mexican city as a “Medical Device Cluster,” with 91% of the medical device industry direct foreign investments (DFI) coming from the United States.
92.5% Medical Devices Manufactured in Tijuana that are Exported to the US
Medical Device Cluster of Tijuana
Over 44 major medical device manufacturers operate in Tijuana, including global players such as Medtronic who has had a facility in the region since 1970. Other large medical device companies in Tijuana include Avail, Cardinal Health, Gambro Avantti MediClear and Welch Allyn. In 2013, Avantti Mediclear opened their 30,000+ square foot facility in Tijuana becoming the first company in Mexico to offer sterilization services to medical device companies using the modern “E- Beam” technology.
Co-Production International has assisted many major medical device companies including US market giants; Teledyne Medical and DJO Global with establishing operations in Tijuana, corporate framework, administrative tasks and other business process outsourcing (BPO) services.
TIJUANA SUCCESS STORY: DJO Global
Operating in Tijuana for over 17 years, DJO Global (DJ Orthopedics) has become a shining regional success story for nearshore expansion. Starting with 20 employees and 3 SKUs, DJO has now grown to manage over 11,000 SKUs and 2,000 employees.
DJO Global’s Tijuana facility has received US and international awards for quality and operational excellence, including AME’s Manufacturing Excellence Award, IndustryWeek’s Best Plants, and the Shingo Prize for Operational Excellence. After analyzation, DJO has realized a lead time reduction of 80% and an inventory reduction from 84 to 14 days.
Major Medical Device Companies in Tijuana
Medtronic (Covidien) Cardiovascular disease treatment & technology, orthopedic devices, medical instruments
Nelcor Puritian
Bennett Medical instruments, respiratory therapy equipment
Greatbatch Orthopedic devices
Becton DickinsonGlass & plastic prefilled syringes, hypodermic products
Össur Non-evasive orthopedics
Medline Wound care products, medical uniforms, gloves
DJO Global Orthopedic devices, surgical reconstructive implant products
Carl Zeiss Ophthalmology devices and products
San Diego Biotech Cluster
San Diego, located just minutes north of Tijuana, is considered the top National Biotech Cluster for the United States and is known as a hub for its world-renowned life sciences industry. Proximity to San Diego is also a huge plus for some medical device manufacturers, choosing San Diego for R&D and Tijuana for production. Additionally, the now called Cali-Baja Megaregion includes over 800 biotech companies. These two sister city’s geographic, economic and cultural ties make the region rich in industry and industry support services.
High Quality, Safe & Sterile Facilities
Many industrial facilities carry international and industry recognized accreditations and comply with global standards for quality and safety. Companies will find first class facilities that are FDA, CE and ISO 13485 certified, as well as special processing plants offering clean rooms ranging from Class 100 to 100,000.
NAFTA: How Manufacturers Get It Done for Less
Welcome to an Effortless, Free Trade Zone
During the last 15 years, Mexico’s Foreign Trade Policy has focused on establishing strong commercial trade partnerships with other countries. Mexico has entered into 13 major free trade agreements giving preferential treatment to 51 markets on three continents.
Despite multiple strong agreements with the European Union and Latin America, it’s the North American Free Trade Agreement (NAFTA) that remains the most attractive to international companies selecting Mexico for their next facility. Signed by the United States, Canada and Mexico in 1994, NAFTA created one of the largest trade zones in the world with more than 160 million consumers within its borders.
“Mexico has a free market economy in the trillion-dollar class,” according to the same KPMG report, with trade to the US and Canada nearly tripling since it’s signing in 1994.NAFTA has proven to be a successful 20-year global case study on how lucrative trade agreements can be, especially between neighboring countries.
An Infrastructure of Support Services
After nearly 20 years since the signing of NAFTA, Mexico has fostered a pro-business environment ideal for manufacturing activities. From industry support service companies such as legal consulting firms and administrative services outsourcing, as well as call centers and trade and logistics specialists, a long-established network of support services are available for medical device manufacturers to consult or contract.
Most support service companies carry decade’s long expertise in leaning operations by nearshoring to Mexico, shortening the supply chain, and assisting your business in maximizing benefits from trade agreements such as NAFTA. For businesses looking to establish operations in Mexico, Co-Production Interntational (CPI) is one of these whose purpose is to take on the logistical and legal tasks of establishing your new operations, managing day to day administrative activities, along with trade and logistics support.
Free Trade Zone
NAFTA’s main purpose is to gradually reduce or eliminate trade barriers between its three member nations, with 99% of imports currently duty-free in Mexico, and the remaining 1% benefiting from preferential duty. In very few cases where NAFTA does not apply, the Mexican government established programs such as IMMEX and PROSEC to fill these gaps.
TPP: Benefits for Manufacturers in Mexico
The establishment of a free trade zone for 12 countries under the Trans Pacific Partnership in 2016 will open up NAFTA-style preferential tariffs or liberalization of tariffs. The member states include the USA, Canada, Mexico, Peru, Chile, Australia, New Zealand, Japan, Malaysia, Singapore, Vietnam and Brunei. Ratification is expected by 2018 and is expected to boost exports in strategic sectors such as vehicles & auto-parts, aerospace, medical devices, electric equipment, cosmetics, tequila, mescal, beer, avocado, beef, pork and orange juice.15
IP Protections
Mexico is regarded as having strong IP protections and enforcement. Two main Mexican laws govern intellectual property. The Industrial Property Law, enforced by the Mexican Trademark Office (IMPI), and is mainly for inventions, trademarks, industrial designs, and appellations of origin. The second is the Copyright Law enforced by the Mexican Copyright Office (INDAUTOR), and is primarily for literary, musical, artistic, photographic and audiovisual works.
Both of these laws were modeled after international standards set by the World Intellectual Property Organization (WIPO) and carry similar legal provisions for IP protection and enforcement as seen in the United States. The Mexican Patent and Trademark Office will cooperate with its counterparts in other countries to reduce the local examination process for patents that have already been registered in other countries.
An Infrastructure Built for Commercial Logistics
Rapid Ground Transportation to Major North American Markets
Baja California is Mexico’s most western state located just south of California. The Tijuana/San Diego border region is one of the largest in the world for both tourism and commercial trade. With the enactment of NAFTA, Mexico has invested significantly in infrastructure improvements to maintain existing, as well as attract new commercial trade to the region.
Highways & Transportation
Tijuana and the Otay Mesa Commercial border crossings are located just minutes south of San Diego, California, giving commercial transportation rapid access to all major North American trade corridors and highways. Baja California has a strong network of well-maintained highways with Highway 1 as the major artery connecting the entire state to the US via San Diego. Running east from Tijuana, Highway 2 provides direct connection to eastern commercial land ports of entry like those in Nogales, AZ and El Paso, TX.
In addition to several thousand miles of highways and railways used to move raw materials and finished products throughout the region and to major North American markets, Baja California also has one deep water port located in Ensenada. A mere 63 miles south of Tijuana/San Diego, Ensenada’s deep water port is directly linked to major international ports in Los Angeles, Long Beach and Hong Kong. Port to port, Ensenada is only 140 nautical miles from Long Beach.
Industrial Facilities & Real Estate
The Tijuana industrial real estate market offers more than 57.3 million square feet of pre-owned and new buildings throughout the city. From Class A to Class C facilities, companies will find shell, semi-finished and built-to-suit options, as well as inexpensive land for new facility construction. Tijuana has over 52 industrial parks making it one of the top four industrial markets in Mexico.
Utilities Infrastructure
Utility costs include electricity and natural gas costs and represent up to 8 percent of total location-sensitive costs. Mexico has very low utility costs when compared to other
For example, the city of Mexicali lying just east of Tijuana and capital of Baja California, supplies most of its inhabitants from hydroelectric power provided by the Colorado River.
Within the last 2 years Mexico also made the electrical infrastructure for new facility sites easier to obtain by streamlining procedures, offering training opportunities to private contractors, using a geographic information system (GIS) to map the electricity distribution network, and increasing the stock of materials.
A majority of the water supply for Tijuana is obtained from the Colorado River. The Baja Californian State Water Commission (CESPT) opened two new water treatment plants in Tijuana in 2010 for recycled water meant specifically for industrial use. These two new facilities were certified by the North American Bank.
NEW, FASTER PROCESSING: Otay Mesa Commercial Crossing
Otay Mesa is located just 15 minutes east of Tijuana and 20 minutes south of San Diego, California. Designated as the only commercial crossing in all of Southern California, Otay Mesa sees more than 1.4 million commercial trucks crossings into the United States annually.
A new facility located at the Otay Mesa port of entry was recently completed in 2013 by the Mexican government and will have customs officers from both the US and Mexico. From laboratory rooms and cold storage, to state of the art inspection equipment, the purpose of joint operation is to speed processing of produce coming into the US. Its these types of investments in infrastructure and legal process improvement by the Mexican government that continue to prove the country’s dedication to increasing efficiency in trade and commerce for its region.
In the summer of 2013, US Customs and Border Protection began two new pilot programs at the Otay Mesa commercial crossing for empty trucks heading both north and southbound. These pilot programs are meant to help ease traffic and wait times. Now, the northbound import facility will open at 5am (instead of 6am) and the southbound export facility will open at 7am (instead of 8am). Investments by the US in these types of pilot programs also show the country’s commitment to its commercial trade relationship with Mexico.
Supply Chain & New Exposure
Medical device manufacturers identify many financial benefits of expanding or moving operations to Mexico. In addition to lowering costs, medical device companies also enjoy the lucrative nature of being geographically located in the heart of Mexico’s largest Medical Device Manufacturing Cluster, giving them access to new clients and new industry sectors.
Companies like DJO Global and Carefusion found that their proximity to other medical device production and assembly operations opened themselves up to new suppliers and a new supply chain. No decision has ever been easier than an expansion of operations for cost-effectiveness that also exposes your business to new markets and an expansive supply chain.
Mexico’s Low Cost, Highly Skilled Workforce: Expect Employees to be University Educated and Technically Trained
Mexico and Baja California’s workforce is educated, plentiful and reliable. Graduating around 115,000 engineering and technical students per year, Mexico produces roughly three times more graduates, per capita, in the field than the United States. Baja California’s medical device industry is responsible for over 50,000 jobs in the state, with nearly 41,000 direct medical device manufacturing jobs in Tijuana.
The Baja California State University (UABC) is located in most major urban centers of the state and offer Bachelor of Science degrees in Aerospace, Electronics, Electrical, Mechanical, and Industrial engineering fields. The manufacturing industry in Tijuana represents 47% of the permanent private jobs in the city.
IMMEX Program for Temporary Import - This program is ideal for medical device manufacturers who are looking for low cost manufacturing and assembly solutions that also shorten the supply chain to major markets.
Under the Manufacturing, Maquiladora and Export Service Decree, the IMMEX Program allows for goods, raw materials and components to be imported into Mexico on a temporary basis, duty-free and VAT-free, as long as they are returned abroad within the established timeframes (most are 18mos).
Over the years of NAFTA and the IMMEX program, three main types of maquilas have emerged; service maquilas, manufacturing maquilas, and maquilas operating under manufacturing agreements or shelter operations.
Tijuana’s workforce is extremely reliable with a low average turnover rate of 2.6% reported in 2011. Additionally, executives cite benefits of the closer cultural ties with the mostly bilingual workforce versus the difficulties observed in offshore locations like those in the Asia-Pacific.
Highly Skilled & Highly Trained
Baja California is home to 35 universities and 14 technical schools offering over one hundred professional degrees including Biotechnology, Physics, Oceanography, Digital Geothermal Technology, Astronomy, Aerospace, Electrical Engineering, and Sustainable Energy. 7 Most universities and technical schools are located in major urban centers such as Tijuana (35) and Ensenada (12) and many participate in direct education exchange programs with the leading universities in Southern California and San Diego.
Globally Competitive Labor Rates
In the high growth markets, total labor costs account for approximately 30 percent of total location-sensitive costs in manufacturing and approximately 65 percent of total location- sensitive costs in service operations. Labor costs are lowest in India, China, and Mexico. 3
In the last 10 years Mexico has significantly closed the gap in labor costs compared to its offshore competitor China. Labor cost in Mexico went from being 200% more expensive than China, to an impressive 14% difference today. Adding in transportation and logistics time and cost, companies are finding nearshore operations in Mexico dramatically less expensive, even with the very slight difference in labor costs.
Close Cultural Ties to the United States
Strong cultural, economic and familial ties have existed between Tijuana and San Diego for decades, some would say as long back as when California was still a part of Mexico. With over 59 million northbound crossings from Tijuana to San Diego a year, executives find that the region is not only largely bilingual, but also engrained with many American customs. Additionally, the US Dollar is a widely accepted and used form of currency, especially along Northern border regions and in city metropolises. It also the main currency for most trade in the region.
Nearshore vs. Offshore - World Bank: Mexico Top Ranked Global Destination for Doing Business
Mexico is ranked 38 under the "ease of doing business category, surpassing all the BRIC countries and also including Costa Rica (58), China (84), Brazil (116), and India (130), according to the World Bank’s annual report “Doing Business 2016,” which compares business regulations for domestic firms in 185 countries.8 This represents a marked improvement of Mexico’s rank of 48 in 2012.
Improving five positions since 2012, Mexico’s pro-business government made notable improvements including eliminating minimum capital requirements for LLCs, and reducing the number of times a company pays taxes from 27 to 6 times a year.
The cost of manufacturing medical instruments, electronic devices and precision components, concept testing, operating and labor costs in Mexico are all substantially lower than in other countries across all levels of specialization.
Mexico is the largest exporter of medical devices to the US and Latin America
International Certifications & Accreditations
Tijuana’s industrial and manufacturing facilities hold many accreditations including ISO9001, ISO13485, ISO/TS16949, AS 9100, Nadcap, Six Sigma, 5S, Kaizen, in addition to major project management and lean manufacturing industry best practices. Of the facilities in Tijuana with over 250 employees, 90% are ISO certified. Where offshore locations in the Asian Pacific may boast similar commitments to international standards for quality, the mere proximity of Tijuana to the US allows for immediate oversight of quality issues and on-site verification of adherence to international accreditations.
Getting Started in Mexico: It Doesn’t Get Any Easier!
Starting or expanding your business in any foreign country can be a daunting decision process for any sized business. Fortunately it couldn’t be any easier than it is in Mexico. In addition to the long history of social and cultural ties between the Mexico and the United States, the two countries have also mastered a mutually beneficial and supportive environment for trade and commerce.
An Industry at Your Service
Considering close geographic proximity, over 20 years of NAFTA, and an established network of industry support services, executives exploring Mexico for their next facility can rely on established and experienced services and organizations whose sole purpose is to facilitate or handle it all for you. Not only are there many companies such as Co-Production International (CPI), to establish and facilitate your operations in Mexico, but also government organizations waiting to get you through the legal steps so you can get up and running as soon as possible.
Security & Safety in Mexico
One last consideration by executives is the safety and security of the country they are considering to do business in. Much of the news reports of unrest in Mexico, especially along the US/Mexico border, have been shown to be exaggerated.
Co-Production International has an expanded paper that covers of security and safety issues in Mexico. Please see the last page of this white paper.
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Summary
Mexico: A New State of Manufacturing
Executives and companies consider a handful of factors when exploring new facilities for medical device manufacturing activities. An almost entirely financially motivated decision, the cost-effectiveness of production (labor & materials) and proximity to major markets, are the top considerations in new site selection, with infrastructure and ease of doing business following closely behind.
Years ago businesses wouldn’t hesitate to cite offshore countries such as China as the hands-down lowest cost option for manufacturing. After examining various factors crucial to a low cost, efficient and lean manufacturing supply chain, Mexico has emerged as a global leader for the medical device industry.
Mexico has rapidly become a top global destination
for manufacturing. The entire California and Baja California is known as the “CaliBaja Mega Region” with the manufacturing hub of Tijuana boasting an over 50 year-old history in manufacturing activities.Executives and trade organizations cite major cost savings and ease of doing business benefits in Mexico, including:
- Low-Cost, Highly-Skilled Workforce
- Proximity to Major Markets (US, Canada)
- NAFTA, Free Trade Zone
- Maquila Duty-Free Temporary Imports
- Strong Intellectual Property (IP) Protections
- Established Infrastructure
This white paper will assist executives in understanding the benefits of manufacturing in Mexico by analyzing Mexico as a potential site for manufacturing activities. Important factors such as proximity to major markets, infrastructure, labor cost and supply, transportation and ease of doing business, will be covered.
Mexico: Manufacturing Global Powerhouse: How Nearshoring is Outshining the Offshore Competition
Even a decade ago, offshore locations such as China were considered the de facto destination for US manufacturers seeking to reduce overall costs. Attention is now returning to the United States’ southern neighbor, due to not only low cost manufacturing , but the stones throw proximity to major North American markets. Nearshoring operations is now considered the most cost effective strategy for the most lucrative cost reduction.
Tijuana and Baja California Leading Mexico
Manufacturing activities in Mexico are flourishing, from central states like Querétaro; to the border states like Baja California. Above and beyond the long list of benefits to manufacturing in these northern border states, it’s the proximity to major North American markets in the United States and Canada that remains the top reason for expanding or moving operations to the nearshore country.
Though products that are produced in Mexico are bound for locations across the globe, it’s the northern border states just south of the US that are the most attractive to US executives. For example, in Baja California alone, 84.6% of all exports are bound to the United States.
Mexico’s Electronics Exports in 2014 totaled $80 billion
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