To outsource, or not to outsource electronics manufacturing: That is the question. But once OEMs have decided to contract out their manufacturing needs, how should they select a suitable partner? Thomas Allen, vice president of sales and marketing at Tricor Systems Inc. (Elgin, IL), highlights the expertise and skills the OEM should expect in an
MPMN: What capabilities must an EMS provider be able to deliver?
Allen: The best EMS partners will be able to provide the “whole package.” This package includes not only the ability to manufacture a product but also value-added services such as in-house engineering for problem solving and support of purchasing, manufacturing, and the OEM directly. The OEM should ensure that the EMS provider is certified to ISO 9001:2008 or GMP standards, although ISO 13485:2003 certification is preferable. The most important technical services that an OEM should look for in an EMS provider include the ability to populate circuit boards; build cables and perform complete wiring; and manufacture, test, and ship products.
MPMN: Why should the OEM outsource at all? Why not establish in-house EMS capabilities?
Allen: All OEMs face the question, “Should we set up manufacturing ourselves?” The obvious reasons for partnering with an EMS provider are to reduce costs, conserve resources, limit headaches, and speed up time to market. OEMs can reduce costs and devote more resources to marketing and promotion by leaving the development work, UL and CE testing, and FDA submittals to an outsourcing partner. Even when money is not a problem, finding qualified personnel, manufacturing equipment, and facilities is time-consuming—a luxury most companies don’t have. By outsourcing, the OEM can also gain the not-so-obvious advantages of allowing the partner to establish quality systems, obtain proper certifications, establish supplier lists, and maintain inventories.
MPMN: What qualities should the OEM expect of an EMS partner?
Allen: The EMS firm will need to possess good communications skills to keep the OEM apprised of issues or changes that may present themselves during the manufacturing process. Good communication helps manage expectations and fosters a partnership rather than a customer-client relationship. Thus, the partner should also be able to consult with the OEM about reducing product costs and improving manufacturability.
A full-service outsourcing partner provides turnkey design, development, and manufacturing of electromechanical instrumentation to the medical device industry. Focusing on finished goods manufacturing—including box builds—the FDA-registered and ISO 13485–certified company designs and manufactures Class I, II, and III medical devices. Its engineering capabilities cover all major medical device disciplines, including fluidics, thermodynamics, motion control, optics, photonics, and radio-frequency engineering.
California MedTech LLC
Operating a Class 100,000 cleanroom, a contract manufacturer provides electronic and mechanical subassemblies, PCB assemblies, full-system box-build assembly, medical instrumentation, single-use device assembly and packaging, and molded plastic components. In support of its full-system, box-build assembly services, the company has developed vertically integrated manufacturing capabilities that enable it to control the quality of the PCB assemblies used in its products and to produce its own cable and harness assemblies.
Multichip-module, system-in-package, and SMT capabilities
Specializing in the design, development, production, and testing of advanced medical electronic modules, a turnkey provider offers standard and 3-D multichip-module, system-in-package, and SMT services. Quality systems for design, manufacturing, test, and traceability are certified to ISO 13485:2003 and ISO 9001:2008 standards and audited to FDA 21 CFR 820 guidelines. Among the company’s products are electronic modules for Class III implantable medical devices. Driven by convergence of functions and miniaturization, the company applies its interconnect technology roadmap to mixed-signal digital, analog, and radio-frequency chips on rigid boards, ceramics, rigid-flex boards, flex circuits, laminates, and films. Virtual manufacturing capability using 3-D mechanical design and modeling enables the manufacturer and customers to view a product’s expected performance, comprehend packaging parasitics, match networks, and make adjustments.
VLSIP Technologies Inc.
Electromechanical, PCB, wire-harness, and cable assemblies
Providing electromechanical, PCB, wire-harness, and cable assemblies, a contract manufacturer operates two facilities with a combined manufacturing footprint of 175,000 sq ft. The company offers a variety of surface-mount, through-hole, ball-grid-array, chip-scale-packaging, and mixed PCB technologies, and its wire-harness assemblies range from simple jumper wires to complex wiring harnesses. The supplier’s facilities are ISO 9001:2008– and ISO 13485–certified for medical device manufacturing. In addition to providing electronics manufacturing services, the company provides repair and refurbishment services.
Medical electronics prototyping and production services
A provider of contract electronic, electromechanical, and electrooptical design, engineering, and manufacturing support services offers prototyping and production capabilities to medical device and instrumentation manufacturers. Certified to ISO 9001:2008 and ISO 13485:2003 standards, the company makes specialized stock and custom test instrumentation, electronic equipment, and software. It also manufactures complete products—including PCB and mechanical assemblies—while offering test and burn-in of electronically controlled medical devices. The company designs, develops, validates, and manufactures Class I, II, and III electronic medical devices, including thermo therapy systems, anesthesia delivery systems, stimulators, and endoscope leak-detection systems.
Tricor Systems Inc.