Custom & Contract Manufacturing

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Minnesota Rubber and Plastics, Minneapolis, a leading global supplier of custom molded components and assemblies for medical device applications, has published a new brochure detailing the company’s 65 years of experience in the medical components and assemblies industry and their innovative solutions approach. These include: product design, process development, manufacturing, assembly, sourcing, quality systems, material sciences expertise, rapid mold design and build, prototype production, and program management.
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Foster Corporation (Putnam, CT) has introduced custom extruded film and rod from drug/polymer blends for implant, patch, and oral drug delivery applications. The company blends polymers with active pharmaceutical ingredients with twin screw extrusion technology in a cGMP clean room environment. Custom blends are provided in pellet form for conversion into shapes used for drug delivery; shapes include film for mucosal and transdermal patches, and rods for implantable drug delivery. Foster now also offers a range of custom film and rod extrusions for these applications.
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Medical device OEMs face ongoing pressure to develop and commercialize innovative products faster, at lower costs, and in compliance with increasingly stringent regulatory standards. As in other industries, device manufacturers often look to partner with outsource providers to fulfill both core and non-core functions within their product life cycle. OEMs from startups to Fortune 100 companies leverage outside resources to reduce fixed costs, benefit from external expertise, and mitigate business, technical, and regulatory risks.
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Curtiss-Wright Controls Electronics Systems (Littleton, MA) has announced new additions to its Electronic Manufacturing Services (EMS) capabilities: new, faster flying probe test equipment and new highly efficient Automated Optical Inspection equipment. The new equipment provides additional test capabilities for high-reliability electronics.
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Via Biomedical (Maple Grove, MN) offers SPECTRAL medical balloons fabricated for medical applications using a series of proprietary processes and custom equipment. The balloons are robust, clear, and durable. Other services include R&D, product development, project management, and design control and manufacturing.
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Vesta (Franklin, WI) utilizes advanced capabilities, including encapsulation, bonding, reinforcing and robotics, to assemble finished medical devices. The company has also introduced a Quick Turn thermoplastic extrusion program for designers and engineers with short lead times. Typical Quick Turn lead times in commonly available medical grade materials will be two weeks or less.
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Patent-pending process would allow 1000-plus layers from a single extruder.

Although the concept of nanotechnology (controlling matter on an atomic scale) dates back to 1959, it is only now becoming more commercially realized. It has the potential to challenge the way all products are extruded in almost every type of medical tubular or related industrial product applications.
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Additive, layer-by-layer manufacturing process allows for the manufacture of complex geometries in plastic and metal implants and orthoses.

Engineers have long been aware of the potential of laser sintering to create innovative and beneficial medical products. Because it is an additive (layer-by-layer) manufacturing process, laser sintering can build parts free of the traditional constraints imposed by machining or molding.
Recent medical applications of laser sintering are now demonstrating the technology’s unique capabilities for mass customization and the manufacture of designs with complex geometries in both plastics and metals.

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Premold Corp. (Oconomowoc, WI) offers the PREMOLD PROCESS™, an approach that includes design consultation, detailed engineering, and comprehensive manufacturing solutions for medical equipment manufacturers. Design consultation offers guidance on how to make part designs more efficient for the Reaction Injection Molding (RIM) process and ensures that assemblies meet precise design specifications. Detailed engineering addresses potential production problems and offers advice on lowering part and tooling costs without loss of quality. Comprehensive manufacturing solutions are also offered as a part of the process.
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Premold Corp. (Oconomowoc, WI) offers the PREMOLD PROCESS™, an approach that includes design consultation, detailed engineering, and comprehensive manufacturing solutions for medical equipment manufacturers. Design consultation offers guidance on how to make part designs more efficient for the Reaction Injection Molding (RIM) process and ensures that assemblies meet precise design specifications. Detailed engineering addresses potential production problems and offers advice on lowering part and tooling costs without loss of quality. Comprehensive manufacturing solutions are also offered as a part of the process.
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A device manufacturer was trying to design a complicated dose delivery monitoring system for an inhaler. The monitoring system is meant to rectify a significant problem: the incorrect tracking and reporting by patients of the amount of medication consumed and the intervals between doses. The system tracks and reports doses delivered with readouts showing delivery frequency and total doses delivered. The unit also time stamps each dose for medication study compliance.

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In July 2010, the FDA released a warning on a number of fibrin-based bleeding control products that were demonstrated to cause air embolisms in patients when used improperly during surgery. The article reported that the embolisms, though rare, could be caused by the clinician using pressure settings that were too high, or when the sprayer tip was held too close to the bleeding site. The FDA has emphasized that clinicians need to follow the manufacturer’s recommendations for use and those instructions have been rewritten to make the hazard more clear. The FDA also recommended that clinicians should monitor patients for signs of embolism.
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Alpha Wire (Elizabeth, NJ) offers a cable, wire, and tubing solution set for the medical device market. It is suitable for applications in diagnostic equipment such as MRI and CAT scanners, laboratory equipment, and other noninvasive testing and treatment equipment. Xtra-Guard® 1 cables feature tough PVC insulation and jackets, stranded conductors for flexibility, and a choice of shielding options for imaging and diagnostic devices. Supra-Shield® foil/braid combination provides exceptional EMI protection. The Xtra-Guard Flex cable withstands continuous flexing, including multiaxis torsional movements. Hook-up wire is available in a variety of insulations to meet requirements for temperature and electrical performance.
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Xcentric Mold & Engineering (Chesterfield, MI) offers custom molded parts for medical products using all-electric machines that use 80% less energy than hydraulic oil machines. Press sizes range from 50 ton to 400 ton clamping forces and shot sizes from .1 ounce to 34 ounces.
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Vesta (Franklin, WI) has introduced medical-grade silicone kink-resistant tubing, which consists of a silicone inner and outer layer, with an imbedded reinforcing member that includes a spiral wind the length of the extrusion. The tubing is available with inner diameters from 1 mm to 6 mm.

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Plastics One (Roanoke, VA) custom designs, molds, and assembles medical connector/cable systems for applications in areas such as body-worn diagnostic testing and monitoring components. Standard connector component products also are available.
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Avicenna Technology (Montevideo, MN) offers data-matrix marking services for the medical device industry, including laser, mechanical, and organizational energy services. Laser machining capabilities include data-matrix marking that allows data to be stored in a very small space. The process typically is used for marking small and difficult surfaces such as catheter components and long-term implantable leads. Data-matrix marking includes the creation of permanent traceability for medical devices. The product data can be entered via an electronic scanning process, which eliminates the possibility of manual data entry errors.
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ProtoFast custom medical parts from Rubber Industries (Shakopee, MN) are available in custom rubber and liquid silicone rubber. The ProtoFast service uses production-grade tooling and dedicated molding equipment to produce prototype quantities. Various silicone and rubber formulation options for color and performance can be evaluated. The parts are used as custom seals, insulators, diffusers, valves, gaskets, bellows, and components used in non-implantable medical devices and equipment. The liquid silicone rubber has low compression set and resists effects of light, ozone, and moisture. LSR grades include UL, FDA, Heal Care, oil-resistant, and high-strength.
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Soldiers returning from the conflict in Iraq, accident victims, cancer patients, or those with muscle-wasting diseases often end up with grossly misshapen bodies for which there is no off-the-shelf prosthetic. For these individuals, obtaining reconstructed, rebuilt body parts is as essential to treatment as addressing core activities of daily living. Yet even today, there’s no such thing as a spare cranium or jawbone.
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Texcel (East Longmeadow, MA) offers custom medical device development and manufacturing, including surgical, interventional, and implantable devices such as endoscopic instruments, spinal/orthopedic implants, and artificial hearts and neurostimulators. The company specializes in bone-fastening devices, cardiac assist devices, metal and non-metal biocompatible materials, and general instrumentation such as disposable catheter devices.
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