Gaet Tyranski, global growth and change management executive business unit director—medical, Jabil Inc., St. Petersburg, FL.
As OEMs explore new markets and new types of products, outsourcing partners with broad and deep capabilities can help smooth the way. Some large contract manufacturers meet customer challenges by expanding their geographic reach, technological capabilities, and value-added services. They diversify beyond the production line to include design and development, testing, assembly, packaging, logistics, order fulfillment, and aftermarket services. From work on cutting-edge electronics to processes in other sectors, these service providers can offer OEMs a shortcut to new or esoteric technologies that would require significant investment if implemented in-house.
Just as critical are corporate attributes, including compliance. By demonstrating robust systems for security and compliance, contractors can prove their trustworthiness in working with intellectual property. Membership in the Electronic Industry Code of Conduct also indicates that partners are good corporate citizens.
After the OEM has narrowed down the list of candidates based on these criteria, it must ask: Does the manufacturer have experience working with medical device firms, producing a mix of devices for multiple markets? Can it provide high-mix, low-volume or low-mix, high-volume manufacturing? Does it understand RoHS, WEEE, REACH, and other regulations, and does it have ISO 13485 certification and understand FDA, CE, or other market-specific regulations?
Next, the OEM must ascertain whether prospective electronics outsourcers are skilled in PCB design, including the use of new technologies such as flex circuits. Does it have software experience, including in the areas of programming, coding, and embedded controls? Can it provide electrical engineering design, simulation, RFI/EMI shielding, and testing, and does it have system-integration experience? Outsourcers can complement these core skills by displaying expertise in plastics molding and tooling, providing a one-stop shop that understands how all the pieces fit together to make a quality product.
EMS Provider Offers Parts for Implantable Medical Devices
An electronics manufacturer provides Schottky diodes, Zener diodes, high-voltage diodes, transient voltage suppressors, thyristor surge-protection devices, insulated gate bipolar transistors, and MOSFETs for such medical implant applications as defibrillators, pacemakers, and neurostimulators. The company also offers bare dies, die arrays, and a range of discrete and integrated packaged parts. In addition to electronic components, the supplier provides RoHS-compliant packaging options to satisfy the needs of high-reliability application designs.
Supplier Specializes in Electronics Manufacturing Services
An electronics manufacturer provides flexible production capabilities to medical device OEMs. Specializing in midvolume through-hole and surface-mount assembly operations, the ISO 9001–, ISO 13485–, and AS9100-certified company produces components for such equipment as medical pumps, x-ray equipment, laser surgical equipment, DNA-analysis products, and high-end instrumentation. It also offers scalable manufacturing solutions, including materials procurement, printed-circuit assembly, testing, and systems build.
Contractor Provides Electronic Components and Hardware
A contract manufacturer provides electronic components and hardware for medical devices. Featuring a diverse manufacturing base, the ISO 9001:2000–certified and RoHS-compliant company can support new designs and emerging technologies. It offers a fully integrated tool room utilizing CAD/CAM software and EDM equipment to assist its tool-making group in developing tools and dies for the manufacture of standard and custom parts. In addition, the service provider’s in-house applications engineering team offers product modifications or customer-requested special designs. The company’s products include battery holders, clips, contacts, and hardware; fuse and circuit protection hardware; screw terminals, spacers, and standoffs; brackets and handles; USB plugs, sockets, terminals, and lugs; panel and computer hardware; and terminal blocks, test points, and quick-fit terminals.
Keystone Electronics Corp.
Service Provider Focuses on Multilayer Flex and Rigid-Flex PCBs
A manufacturer of multilayer flex and rigid-flex PCBs offers components for use in medical applications. Featuring a Class 10,000 cleanroom, the ISO 9001:2000–certified company specializes in 18-layer rigid-flex boards. The standard dielectric in
its flexible circuits is 0.001 to
0.002 in., making them suitable for ultrathin, ultralight packaging applications. Featuring adhesiveless laminates, high-density interconnects, and thin copper layers, the PCBs are also suited for fine-line technology. Among the company’s past products are boards for medical imaging equipment, a wearable insulin pump, and a speech processor used in hearing implants.
Printed Circuits Inc.
Full-Service Electronics Manufacturer Makes Medical Device Components
Providing components for low-volume, high-mix or high-volume, low-mix electronic applications, a contractor designs, produces, assembles, tests, packages, and services a host of medical components. In addition, the company offers single-use devices ranging from drug-delivery products to lab and diagnostic disposables that may require sterilization. Providing components used in such devices as patient-monitoring equipment and diagnostic imaging machines, the Tier 1 EMS contractor specializes in long product lifecycle support and components traceability, in addition to producing small volumes of specialized products to enable medical device companies to meet their production velocity needs and lower lifecycle costs for complex products.
St. Petersburg, FL
St. Petersburg, FL