Medical device OEMs interested in evaluating a plastics processor should consider capabilities such as scientific molding, automation, and assembly. In particular, in reviewing prospective suppliers’ injection molding capabilities, OEMs should ascertain whether they can provide scientific injection molding.
The ability to perform scientific molding requires a certain infrastructure, such as a properly designed cooling system. Without such a system, calcium builds up, impeding proper heat removal. Furthermore, molding machines with capabilities such as volumetric injection functionality are essential. Most importantly, scientific molding demands a knowledgeable and experienced staff that understands the science of polymers and polymer behaviors and that can analyze data extracted from molding machines. Unfortunately, many manufacturers do not have such systems in place.
When seeking an outsourcing partner, OEMs should also consider manufacturers that are willing to develop creative ways for reducing production costs. This can be done by utilizing runnerless systems or equipment that does not generate waste, such as hot-runner systems. Suppliers should also be able to build ‘smart’ molds equipped with sensors, process controls, and automated cavity-separation features.
Another area that OEMs should review is suppliers’ environmental systems. All waste materials that cannot be recycled end up in landfills. While this represents an environmental burden, it also increases production costs. Over the last several years, technology has advanced to the point at which it is possible to produce completely runnerless and flashless molds. OEMs should ensure that their suppliers consider these options. —Anura Welikala, executive vice president, global business development, Helix Medical.
Plastics molding and assembly
Offering turnkey medical device manufacturing to OEMs, a full-service contractor produces plastic components for diagnostic devices, drug-delivery devices, and pharmaceutical packaging. The company can also assemble end products while handling complex projects and manufacturing customized solutions. The service provider takes customers’ concepts from design through full-scale manufacturing, helping to select appropriate materials, production processes, and packaging. Providing injection molding, two-material molding, silicone injection molding, insert and overmolding, blow molding, and stretch blow molding, the company also specializes in product design, in-house toolmaking, welding, and sterilization.
Polycarbonate bezels, Teflon and polycarbonate manifolds, and components for arthroscopic and orthopedic devices are among the plastic medical parts offered by a machining specialist. The company processes dozens of different materials and makes large parts as well as microcomponents with precision-drilled holes and dimensions as small as 0.060 in. Concentrating on machining Teflon, Ultem 1000, polycarbonate, PEEK, glass-filled PEEK, Delrin, and polysulfone, the manufacturer can perform a range of machining and turning techniques. Using vapor polishing and other polishing methods, its machinists can produce plastic components with optically clear or other specified finishes.
East Coast Precision Manufacturing
Cleanroom plastic molding
A molding services provider offers single-resin injection molding; two-, three-, and four-shot in-mold assembly tooling systems; and continuous-extrusion shuttle blow molding. The company manufactures components such as luer fittings and other connectors, disposable plastic cannulae and piercing devices, and housings for diagnostic, transfusion-therapy, and drug-delivery applications. Its facilities include four Class 100,000 cleanrooms, the newest of which is scalable to suit future production needs. Each press in the new cleanroom is capable of performing multishot molding, and automation equipment facilitates such value-added operations as assembly, inspection, decoration, and packaging.
MGS Mfg. Group
Tube extrusion and processing
Offering services to medical device OEMs, a designer and fabricator of standard and custom extruded plastic products operates a manufacturing facility with 23 extrusion lines and two Class 100,000 medical cleanrooms. The company specializes in medical-grade flexible tubing, rigid tubing, and custom profiles made from such USP Class VI materials as PVC, non-DEHP and nonphthalate alternatives, polyethylene, polypropylene, polyurethane, polycarbonate, nylon, polyimide, high-impact styrene, thermoplastic elastomers, and thermoplastic rubber. It can produce single- and multilumen tubing, thermobonded paratubing, multilayer tubing, flared and bump tubing, high-pressure tubing, radiopaque tubing, striped tubes, coextrusions, triextrusions, and custom profiles. In-house contract manufacturing and general assembly capabilities include specialty tube cutting, coiling and banding, solvent-bonding of components to tubing, and chamfering.
Injection and insert molding
Specializing in the manufacture of plastic medical components in volumes ranging from 500 to 50 million units a year, a custom molder is equipped with valve-gate and open-tip hot-runner systems and two-shot injection molding machinery for processing such materials as silicone and thermoplastics. With competencies in rapid prototyping as well as insert and vertical insert molding, the manufacturer can produce parts with complex geometries and zero defects. It operates FDA-registered and ISO 13485–certified medical device production facilities featuring Class 10,000 and Class 100,000 cleanrooms. It also offers scientific molding and design of experiments capabilities. In addition, the company can provide extrusion services; the development and manufacture of complex catheter systems; and assembly, packaging, and sterilization services.
Helix Medical LLC
Published in MPMN, October 2010, Volume 26, No. 8
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