Richard P. Bodine Jr., BCA Contract Assembly and Manufacturing,
Outsourcing, particularly in the area of contract assembly, continues to be a steadily expanding part of the U.S. manufacturing economy. While significant resources are dedicated to new product development and design, many OEMs are still reluctant to commit the capital for equipment and personnel needed to produce and assemble parts in-house. This tendency is often seen in the medical device and medical disposable industries, where delivery time frames are tight and product life cycles tend to be short or unknown. Contract assembly can offer the best solution to these challenges.
Medical OEMs must be diligent in selecting a contract assembler. They should look for companies that can provide the highest quality assemblies and on-time deliveries. They should also look for a variety of solutions to their requirements. The best contract assemblers can offer their customers a full range of assembly options, from low-volume manual or semiautomated lean cell production to fully automated assembly systems with little or no capital requirements. Contract assemblers must also be fully capable of complete supply chain management.
Manufacturing and Assembly Offered in Costa Rican Facility
An ISO-13485 certified, FDA-registered contract manufacturer offers low-cost manufacturing and assembly to medical device OEMs. The vertically integrated company maintains complete manufacturing and process validation capabilities to support the manufacture and packaging of disposable devices as well as reusable electromechanical assemblies. With Class 100,000 and environmentally controlled cleanrooms, the company’s capabilities include injection overmolding, electropolishing, microgrinding, soldering, UV curing, and ultrasonic welding, all supported by an in-house engineering team.
Precision Concepts Costa Rica, SA, Alajuela, Costa Rica
Medical Device Assembly Can Be Performed in Mexico
A contract assembler and manufacturer of medical devices has a 32,000-sq ft facility in Tijuana, Mexico. The company is U.S. owned and man-aged, and its operations are ISO 13485 as well as ISO 9001:2000 certified. Its manufactur-ing expertise includes a variety of medical devices, such as surgical clip guns used in the operating room, breast pump kits and collection devices, and battery packs for integration in monitoring devices. Its additional services include PC board and electronics assembly. Specialties are labor-intensive medical device assembly and cleanroom assembly operations. Most contracts involve using customer-supplied materials and returning the final assemblies on a piece-price basis.
Roberson & Associates, Corona, CA
Flexible Manufacturing Methods Allow for Small and Irregular Batches
A company offers medi-cal device subcontract manufacturing, as-sembly, and packaging from its Class 10,000 cleanroom in the United Kingdom. Its flexible manufacturing methods enable small and ir-regular batches to be handled, along with high-volume runs. Full sourcing of all com-ponents can be provided, with EtO gas, gamma, steam, and Sterrad sterilization options. Other services include soldering, ultrasonic cleaning, electronic assembly, and injection molding.
Wesley Coe (Cambridge) Ltd.,Cambridge, Cambs, UK
Company Offers Chinese Factory to Fulfill Outsourcing Needs
A U.S. company with a Chinese manufacturing plant is a contract manufacturer of medical devices and box builds, electromechanical assem-blies and subassemblies, PCB assemblies, custom medical cables, and plastic-molded components. With an experienced staff of medical product design engineers, the firm offers medical product fulfillment from initial design to prototyping and on to economical full-scale production. The company is ISO 13485:2003 and ISO 9001:2000 certified and FDA registered.
Sanbor Medical, Allentown, PA
High-Speed Assembly Systems are Fully Automated
From initial product engineering support to finished product packaging and distribution, a company provides turnkey contract assembly and manufacturing services. Product engineering support, supply chain management, metal and plastic forming, automated assembly, automated inspection and testing, automated packaging, third-party logistics, and worldwide distribution services are offered. High-speed fully automated assembly systems are used, as well as flexible semiautomated assembly cells. Typical medical applications include safety syringes, IV sets and subassemblies, dosage dispensers, inhalers, valves, and diagnostic kits. The firm’s facility operates a Class 10,000 cleanroom and is FDA registered and ISO 9002 certified.
BCA Contract Assembly and Manufacturing, Bridgeport, CT