From small garage shops to vertically integrated global suppliers, there is an abundance of contract manufacturers to choose from. So what should the medical device OEM look for when choosing an outsourcing partner? Is it the supplier’s equipment list, its capabilities brochure, or ISO certifications? Once an OEM has explored its options and found prospective suppliers that fulfill its basic requirements, how should it make the final determination, ensuring that its outsourcing goals are met?
OEMs should strive to contract their manufacturing needs to suppliers with established vertically integrated engineering, development, and production operations. Such full-contract manufacturers have a complete range of services in place, helping to shorten lead times, reduce errors, and improve quality.
When implementing a new product idea or extending an existing line, the OEM that partners with a full-contract manufacturer will start by drawing on the supplier’s engineering expertise for reviewing drawings or solid models. This collaboration combines the OEM’s application knowledge with the outsourcer’s design and manufacturing knowledge.
But a drawing or model is just the beginning of the product-design phase. In addition, the OEM must ensure that a prospective supplier understands the design intent. If this intent is grasped clearly, the OEM will not have to field multiple questions from the supplier as a product launch moves from the design-development stage to the manufacturing floor.
Throughout this cycle, the supplier will consult with the OEM and provide the resources required for the program, such as prototypes, EDM, specialty finishes, laser-marking, or cleanroom assembly and packaging services. If the supplier must outsource these services, it is either not a true full-contract manufacturer, or it has potentially lost control over its processes to outside sources.
Standard operating procedures, preventive maintenance, material verification, and testing protocols are all part of process development and control, contributing to the successful completion of the manufacturing cycle. The OEM must be aware that only by partnering with a full-contract manufacturer can it ensure that an effective process is in place for every part and assembly it outsources.—Jim Stertz, quality assurance manager, Lowell Inc.
Full-contract manufacturing of Class I, II, and III devices
Certified to ISO 13485:2003 standards, a full-contract manufacturer performs custom injection molding services in an ISO Class 8 cleanroom and assembly and packaging services in an ISO Class 7 cleanroom. The company’s molding area accommodates up to five vertical/vertical or horizontal injection molding machines that are used to manufacture Class I, II, and III medical devices, including surgical equipment and disposables. Relying on automation, scientific injection molding, and lean manufacturing principles, the company also offers design and development, mold-building, and value-added services.
Crescent Industries Inc.
New Freedom, PA
Active in the field of micromanufacturing, a full-service contract manufacturer provides prototyping, turning and machining, assembly, subassembly, and sintering services. The company is capable of fabricating components in sizes ranging from 0.2 to 300 mm from bars, tubes, and loops. Offering microcomponents as kits or complete subassemblies per customer specifications, it manufactures devices and components for both implantable and nonimplantable applications, including bone screws, hip prostheses, flow-control parts, and connectors.
Molding, extrusion, packaging, and sterilization services
A manufacturer offers injection molding in a cleanroom environment, in addition to a variety of other manufacturing services. Capable of molding a range of materials, from polyethylene and polypropylene to ABS and polyurethane, the ISO 9001:2000–certified and FDA-registered company offers medical bags, transfusion and IV sets, catheters, components, and subassemblies. In addition, the company provides bag-sealing services, extrusion of rigid and flexible tubing, radiopaque coextrusions, and multilumen extrusions. It also offers compounded PVC materials according to customer hardness and transparency specifications, cleanroom assembly and packaging services, and EtO and steam sterilization services.
Industrias Plásticas Médicas
Full-service PCB manufacturing
Specializing in PCB surface-mount, through-hole, hybrid, box-build, test, and fulfillment services, a full-service PCB contract manufacturer provides a range of offerings, from individual PCBs to completely assembled and tested systems. Offering turnkey medical product manufacturing services, the ISO 9001:2008–certified company operates a 175,000-sq-ft facility that provides complex product builds, including low- to medium-volume production runs, high-mix assembly types, and quality assurance services. The manufacturer also specializes in the fabrication of components for Class III medical products.
Fabrication of orthopedic and cardiovascular parts and devices
A full-contract manufacturer certified to ISO 9001:2008 and ISO 13485:2003 standards offers engineering, machining, and assembly services for the orthopedic and cardiovascular markets. Operating Class 100 and Class 10,000 cleanrooms and employing more than 60 CNC machining and turning centers, the company fabricates screws, caps, rods, spacers, lateral connectors, cross-connectors, and other products for the orthopedic industry. For the cardiovascular industry, it produces left ventricular assist devices, implanted vascular-access devices, and internal components. Converting such materials as titanium, stainless steel, cobalt chrome, PEEK, Ultem, Torlon, and UHMWPE, the company also provides a variety of machining services, such as CNC milling and turning, CNC multiaxis milling, CNC lathe turning, wire EDM, and assembly. Secondary processes include finishing; marking and labeling; grinding and lapping; abrasive flow machining; microdrilling, threading, and tapping; and packaging.