Dave Splett, director of business development, Injectech LLC, Loveland, CO.
Many OEMs prefer to outsource assembly production to contract manufacturers. However, once a device manufacturer has decided to go the outsourcing route, how does it choose the right company to meet its needs?
As an OEM, the first question you should ask is whether a prospective vendor meets your exact needs. One way to answer this question is to ensure that a contractor offers customized procedures and work instructions that are specific to your project and that can easily be incorporated into its documentation system.
The next step is to determine whether a vendor’s tooling and fixtures can be modified easily to suit your components and assembly goals. If you are looking for a molding company, prospective candidates should offer items that are similar to those you wish to have manufactured. In addition, their tooling must be modular enough to provide the components you require.
Another factor to consider is a prospective vendor’s workload. It may be difficult for a contractor to adjust its schedule for a prototype run. Or it may have difficulty fitting a high-volume assembly job into its current schedule. The contract manufacturer’s willingness to work with you to meet these challenges will affect your decision.
When the field has been narrowed down to a handful of capable candidates, you should ask whether the prospective contractors are flexible. Because projects change, people come and go, and schedules will be readjusted, flexibility is crucial. The companies in question must be able to adjust to unforeseen production conflicts.
Perhaps most important of all is whether or not a vendor’s current clients are satisfied with the work they have contracted out.
Contract Manufacturer Offers Electronic, Electromechanical Assemblies
In offering turnkey services to OEMs from material procurement to assembly, a contract manufacturer works with customers from the product design and prototype stages through ongoing production to deliver finished products. Manufactured in an ISO 9001:2001–certified facility, its offerings include electronic assemblies, subassemblies, electromechanical assemblies, wire-harness assemblies, plastic injection-molded products, metal stamping services, FCC and other types of testing, and packaging. The company also employs statistical process control and stringent quality control practices for monitoring all aspects of production.
GlobTek Inc., Northvale, NJ
Assembler Makes Plastic Components
An ISO 9001:2000–certified manufacturer for the medical device industry furnishes services such as assembly, product design, tooling and mold fabrication, and injection molding. Assembly capabilities include solvent and adhesive bonding, ultrasonic welding, and automation for rapid assembly. The manufacturer also provides check valves, components, and tube sets for the cardiac and surgical markets. It can weld wire harnesses as well. The company designs and manufactures to specifications and also offers customized procedures for each product. Plastic components, subassemblies, and full assemblies are manufactured in a Class 100,000 cleanroom that houses all electric molding presses and assembly lines.
Injectech LLC, Loveland, CO
Manufacturer Assembles Sterile Disposables
A contract manufacturer assembles and packages sterile disposable medical devices such as infusion sets and safe, easy-to-fill disposable infusion pumps for antibiotics, chemotherapy, and pain management needs. The company’s American staff manages an integrated Thailand-based manufacturing facility. To control costs and maintain quality, the company extrudes, molds, assembles, packages, and sterilizes its products under the one roof. Its consulting operation provides quality and regulatory oversight, sterilization validation, process validation, packaging validation, laboratory testing, outsourcing and supply-chain management, and a range of additional services.
First Medical Source, Laguna Niguel, CA
Contractor Offers Electronics Manufacturing Services
A full-service electronics manufacturer provides complex electronic and electromechanical products for high-cost-of-failure environments. Certified to ISO 9001:2000 and ISO 13485:2003 standards, the RoHS-compliant company offers printed circuit assemblies (PCAs), box-level assemblies and panel builds, mechanical and electromechanical assemblies, wiring harnesses and interconnect systems, and system integration support. The manufacturer has expanded its PCA capability with the addition of a high-speed surface-mount line equipped with a 10-zone convection reflow oven and automated dual-flux selective solder. The line performs screen printing, 3-D automated paste inspection, component placement at 100,000 cph, and automated optical inspection.
LaBarge Inc., St. Louis
Injection Molder Provides Production and Assembly Services
Offering design assistance, mold construction, injection molding, final assembly, and packaging, a full-service manufacturer specializes in riveting, sonic welding, heat staking, tapping and drilling, pad printing, hot stamping, bonding and gluing, radio- and electrical-frequency interference shielding, painting, and labeling. In addition, the company provides value-added services such as final assembly. Working with customers, it evaluates whether to start up new processes to achieve final product goals. To concentrate product management at one location, some customers have chosen this manufacturer to perform assembly services that they previously carried out in-house or contracted to other companies.
Hi-Tech Mold & Tool Inc., Pittsfield, MA