PRODUCT UPDATE
EUROFLEX GmbH
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High-grade semifinished products of nitinol were the original focus of a metal materials supplier that now offers a programme of various special alloys for medical device and industrial applications, including Type 316LVM and 316L stainless steel (and nickel-free alloys), the cobalt-based alloys L605 and MP35N, titanium alloys, tantalum, platinum alloys, and magnesium. EUROflex GmbH (Pforzheim, Germany) manufactures these semifinished materials to customer specifications. The products are available in a variety of dimensions and can be supplied with specifically desired properties.
Typical medical applications for the metal stock materials are stents, filters, baskets, guidewires, and flexible surgical instruments. Parts are delivered as pressure, drawn, bent, or torsion elements in the shape of spiral springs, flat drawn strips, or wire, the last of these generally in nitinol with a one-way shape-memory effect. The manufacturer has a quality management system certified to ISO 9001 and ISO 13485:2003.
Wytech Industries
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Straightened and cut fine-wire and tubing components are manufactured for use by producers of medical devices for procedures in cardiology, neurology, electrophysiology, gastroenterology, peripheral intervention, vascular surgery, and urology. An ISO 9001:2000–certified manufacturer, Wytech Industries (Rahway, NJ, USA) features among its products PTFE-precoated mandrels that are designed to offer a cost advantage over mandrels that are conventionally spray-coated. These mandrels are free of perfluorooctanoic acid and chromic acid and are flake resistant. Their coatings are stronger, thinner, and more consistent than spray coatings. The mandrels come in a variety of colours, alloys, and sizes, and as round, flat, or shaped wire and tubing.
Besides straightening and cutting, the service provider can form and precision-grind wires, produce miniature assemblies, and perform other processes. Other products available include core wires and PTFE-coated hypotubes.
Through its FastLane programme, the supplier provides overnight delivery of R&D quantities of wire made of Type 304 stainless steel. This programme includes PTFE-coated wire in every 0.001-in.-diameter increment between 0.004 and 0.080 in., and uncoated wire in diameters running from 0.003 up to 0.125 in. Statistically based quality control ensures that diameters, lengths, and other specifications are held within tolerances measured in ten-thousandths of an inch.
Hader S.A.
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A company specializing in design, conception, and production to suit OEM requirements is equipped to perform turning, milling, and injection moulding. Hader S.A. (La Chaux-de-Fonds, Switzerland) uses turning technology to produce extremely precise medical device parts as large as 51 mm in diameter. Plastic components are produced on in-house injection moulding machines for which the company makes moulds. Other capabilities of the ISO 9001:2000–, ISO 13485:2003–, and ISO 14001:2004–certified manufacturer include laser processing, part cleaning, product development in a dental laboratory, and processing under ISO Class 7 cleanroom conditions.
The company has developed and produced medical torque limiters with values of 1–15 N•m. These easily customized devices generate an audible click when the torque value is reached, require no lubrication, and need no calibration over their long operating lifetime. Also manufactured are dental torque wrenches, in value ranges of 10–35 N•cm and 15–70 N•cm, with a ratcheting design.
EPflex Feinwerktechnik GmbH
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An ISO 13485–certified OEM supplier of metal components for medical technology applications now can also boast certification to Annex II of the Medical Devices Directive 93/42/EEC for its production of guidewires and baskets. EPflex Feinwerktechnik GmbH (Dettingen/Erms, Germany) manufactures percutaneous transluminal coronary angioplasty (PTCA), Lunderquist, and other types of guidewires in diameters of 0.012 to 0.094 in. In addition, the firm makes hypotubes, stylets, nitinol baskets, and snares. It applies biocompatible coatings of various types to these interventional devices, including PTFE, hydrophilic surfaces, precoatings, and spray coatings. Special capabilities are high-precision wire grinding and application-specific customization.
The company works with the customer as a partner from development of the first prototypes through transfer into serial production. Its facility is equipped with automated process equipment complemented by manual processes that together ensure the efficient realization and delivery of complex precision parts.
Popper & Sons Inc.
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High-speed precision electrochemical cutters and grinders are used to cut metal tubular medical device components. With these advanced technologies, Popper & Sons Inc. (New Hyde Park, NY, USA) can achieve burr-free results and produce extremely accurate parts having cut lengths as short as 0.100 in. and diameters as small as 30 gauge, or 0.31 mm OD. All types of stainless steel in the 300 series are worked, as are titanium, Inconel, and other alloys. In addition to cutting and grinding, the company offers capabilities in the fabrication of metal tubular components. It is equipped to perform swaging, bending, flaring, tip reducing, coiling, electrical-discharge machining, computer numerical control turning, and laser welding. Its full portfolio of services comprises laser engraving, wire bending and forming, general machining, and surface finishing by means of electropolishing, micropolishing, and grit blasting.
P.I. Castings Ltd.
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Investment casting of parts for medical devices offers a design freedom that most other methods of metal forming cannot provide. P.I. Castings Ltd. (Altrincham, Cheshire, UK) has been producing medical parts via this process for more than half a century. Because investment casting is relatively inexpensive and requires only short setup times, the process is good for low quantities as well as medium and large production runs. In fact, it is well suited for rapid prototyping; metal parts can be produced from solid computer-aided-design models quickly and without tooling. The service provider can use any rapid prototyping technique to make one-off investment castings or preproduction runs of the product. The company also owns a 3-D printer for making wax models that in turn can be made into a variety of air-melted materials.
Investment castings can be produced to close tolerances and have near-net shapes, minimizing the amount of machining necessary to create finished components. Medical devices, surgical instruments, and similar items with complex shapes can be manufactured by this method in stainless steels, nickel and cobalt alloys, aluminium, and most other metals.
The company supplements its capabilities in investment casting with facilities for x-ray analysis, dye penetrant studies, mechanical testing, spectrographic analysis, heat treatment, and machining.
IncisionTech
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Next-generation bone saw blades are available from a manufacturer that offers orthopaedic OEMs leading-edge manufacturing capability. Operating as a centre of excellence for cutting and piercing technologies, IncisionTech (Staunton, VA, USA) is equipped to optimize tooth shapes, tooth set, saw-blade materials, surface finish, and delivery of the developed custom product. A dedicated in-house laboratory can produce the evidence that saw-tooth surfaces are smoother and edges are sharper than previously possible. The company’s advanced facilities enable orthopaedic tool manufacturers to more quickly provide surgeons with new bone saws and enhanced custom variations that they can test in practice, which in turn has the potential to create an opportunity to increase market share.
Ceramaret S.A.
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Precision parts for medical devices and analytical instruments are made out of advanced ceramics. Besides 99.9%-pure alumina and TZP zirconia, Ceramaret S.A. (Bôle, Switzerland) forms parts from 96% and 99.7% alumina and from zirconia-toughened alumina. These materials are inert, resistant to aggressive solvents, biocompatible, insulating, and resistant to elevated temperatures, making them suited for healthcare applications including insulators for endoscopes and electrosurgical instruments, blades, and feed-throughs. The ceramics are also used in flow control systems.
The ISO 9001:2000– and ISO 14001:2004–certified manufacturer of these components uses several techniques to form near-net-shape parts. If secondary machining operations are necessary, the company is equipped to perform computer numerical control machining, centreless grinding, and honing.
MeKo Laser Material Processing
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A contract manufacturer uses laser technology to process materials with high precision for medical device companies. Laser cutting, laser welding, and mechanical manufacturing are areas of expertise offered by MeKo Laser Material Processing (Sarstedt, Germany). Certified to the ISO 13485 standard, the company is able to control all manufacturing processes at a very high level in-house and thus can meet each customer’s specific requirements. All production processes are adjustable to most designs and materials, and the experienced staff of engineers can solve complex cutting challenges. The manufacturer will process the customer’s materials or supply the raw materials itself.
A range of sheet or tube materials can be laser cut, including stainless steel, nickel titanium, tantalum, Nebo, titanium, ceramics, and plastics. The company is experienced at cutting fine contours, complex part geometries, and such tiny components as stents. It offers dimensional tolerances of 0.005 mm, a burr-free cut edge, very small kerfs, and accurately cut struts. Laser welding services include high-strength helium-tight spot and seam welding, a minimal heat-influenced zone, and low thermal distortion. Welding of thin foils and wires, heat-sensitive sensors, surgical instruments, and medical implants is available. The complete range of mechanical processing capabilities offered by the contractor encompasses such postprocessing services as bending, heat treatment, milling, and surface finishing, as well as ultrasonic finishing, polishing, and electropolishing.
Medical Injection Mouldings Ltd.
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Metal injection moulding (MIM) of intricately detailed small parts that could not easily be machined from a solid is the specialty of a company that can use the MIM process to manufacture components for medical device applications from stainless steel and other high-strength metals. Metal Injection Mouldings Ltd. (Altrincham, Cheshire, UK) is also able to use powder versions of nickel- and cobalt-based alloys, low-alloy steel, and tool steels to mould small parts with complex shapes and close tolerances via MIM. The fine surface finish achievable with MIM is suitable for many medical applications and can be polished to greater smoothness. However, the moulding process does enable most finish-machining operations to be eliminated.
MIM can be used to produce components for surgical instruments and dental equipment, as well as medical devices. The process accommodates production runs of just a few thousand or large, regular mass-production quantities. Moulded metal components can be made from metal masses up to 100 g. They can be bent, hardened, welded, or riveted just as solid metal parts can. Besides giving device manufacturers greater freedom in part design, the process is economical enough to be used for disposable components.
