April 14, 2010
Amy Davis, marketing manager, Plastomer Technologies, Houston.
When choosing a machining partner for medical device applications, OEMs should consider a range of issues, beginning with the desired application. Will the component be used in medical equipment such as imaging machines? Or will it be used in applications placed on or inside the patient? OEMs should partner with suppliers that can address such specifics, ensuring that the chosen vendor is qualified to work with the required component material.
In many cases, the component materials may require the OEM to partner with multiple machining vendors. For example, if a device requires both plastic and metal parts, the manufacturer should contract the production of plastic parts to plastic specialists and metal ones to metal specialists in order to obtain optimal components and avoid the danger of cross-contamination.
The OEM should also consider the vendor's equipment and level of expertise. While choosing a supplier to manufacture simple components is generally unproblematic, higher levels of intricacy or tighter tolerances make it incumbent on the OEM to inquire about the experience of the vendor with medical device machining applications in which both tight tolerances and cleanliness are crucial. In certain instances, the supplier must be able to run advanced production and quality equipment, such as five-axis CNC mills, which are typically used for fashioning complex components that otherwise would have to be made using multiple machines, or coordinate-measuring machines, which are used to inspect parts for dimensions such as parallelism, concentricity, and flatness.
Another consideration is the contractor's ability to offer pre- and postproduction services. Does it offer material selection or engineering assistance? An experienced vendor will be able to provide information on material properties to aid in material selection. In addition, will the vendor be able to clean and package the part to required cleanliness standards? Some contractors have relationships with cleaning houses or maintain on-site cleanrooms to ensure contaminant-free manufacturing.
By following these recommendations and asking the right questions of potential vendors, the OEM will find the appropriate machining sources to meet its requirements.
Contractor Offers Turning Services
A provider of turning services machines a variety of materials in bar, tube, or loop form in sizes ranging from 0.3 to 300 mm. The contract manufacturer supplies machined components for such medical applications as bone screws, hip prostheses, flow-control parts, and connectors. Offering prototype to high-volume manufacturing, the company specializes in a range of machining operations using CNC and CAM machines, multispindle equipment, and coil machines. It also performs transfer and secondary operations, including milling, grinding, honing, broaching, and stamping. In addition, the company offers assembly, subassembly, and sintering services.
Service Provider Performs Precision Machining Operations
Providing machining of medical parts, a contract manufacturer fabricates close-tolerance components made from a variety of materials. In-house processes include multiaxis Swiss CNC machining with tolerances to ±0.00002 or less, full five-axis simultaneous vertical machining, micromachining for part features less than 0.005 in. with an inspection accuracy to 0.00002 in., and injection molding of implantable grades of PEEK and polyurethane. The FDA-registered and ISO 9001:2000- and ISO 13485:2003-certified company also offers device assembly, packaging, and sterilization management services.
New Brighton, MN
Vendor Focuses on Automated Machining of Medical Assemblies
A vertically integrated firm with expertise in automated machining and precision welding operations supplies complex, high-level assemblies. Providing design, engineering, and project management services, the company has fabricated a range of parts for medical applications, including a table for nuclear MRI diagnostics and a C-arm image intensifier and x-ray machine for surgical procedures. The company's machining capability relies on twelve stand-alone CNC milling machines; vertical milling equipment with a 160-in. x-axis, a 36-in. y-axis, and a 44-in. z-axis; a 39-in.-cube horizontal milling machine; three flexible machining lines with 10 horizontal machining centers; and in-house CNC programming. The company also uses a multilevel automation system with pallet- and material-storage capacity.
Supplier Specializes in CNC Machining
A contract manufacturer offers in-house CNC milling, turning, and screw machining. Capable of fabricating custom tubular parts and machined components from such materials as stainless steel, titanium, cobalt chrome, aluminum, and plastics, the company employs a MIL-I-45208 inspection system and an ANSI/NCSL Z540-1 calibration system, enabling it to control process and part quality throughout all manufacturing stages. The vendor's CNC machining capabilities allow it to produce complex design prototypes during production. Operating a 40,000-sq-ft manufacturing facility, the ISO 9001:2000- and ISO 13485-certified company also provides nondestructive testing.
Judson A. Smith Co.
Manufacturer Machines Custom Plastic Components
Using medical-grade and other plastics such as PEEK, PTFE, Ultem, acrylic, UHMWPE, and polypropylene, a manufacturer of medical components specializes in intricate custom machining and fabrication services. To ensure that end products meet specifications, the company works exclusively with high-performance polymers to prevent contamination from metals or other sources. Used in imaging, laboratory, surgical, and other medical applications, potential machined plastic components include connectors, couplings, seals, check valves, diaphragms, and plugs. Small or large quantities can be run, depending on customers' needs. In addition to CNC machining, turning, routing, and fabrication, the company offers cleaning services in an ISO Class 5 cleanroom.
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