Originally Published EMDM March/April 2005
Spotlight
Metal Fabrication Outsourcing |
Metal fabrication
Specializing in the development and manufacture of products as small as 0.05 mm diam, a firm provides comprehensive metal fabrication outsourcing services for OEMs. The company offers product development, prototyping, manufacturing, assembly, packaging, labelling, and fine cleaning. Class 10,000 cleanrooms are on-site. Components and assemblies are manufactured in series ranging from single units to millions. Machining processes including turning, milling, grinding, mounting, laser cutting, welding, soldering, marking, and surface cleaning are possible. The manufacturer can develop and produce dental and surgical implants and instruments, stents, bone screws, guidewires, and artificial heart valves. It is certified to ISO 9001:2000, ISO 14001, and ISO 13485. Pinol a/s, Gørløse, Denmark.
Tubular components
 |
High-speed, precision electrochemical cutters and grinders are used to process burr-free metal tubular components. The cutters achieve precise results with minimum cutting lengths of 0.100 in. and sizes as small as 0.31 mm OD. Materials processed include all varieties of 300 series stainless steel, titanium, Inconel, and other alloys. Other services available include swaging, bending, flaring, tip reducing, coiling, EDM, CNC turning, and laser welding. In addition, laser engraving, surface finishing, and wire bending and forming are offered. Popper & Sons, New Hyde Park, NY, USA.
Miniature tubing and parts
 |
Components are fabricated with outside diameters as small as 0.20 mm by a Switzerland-based metal fabricator. Small-bore tubing can be configured with elbows, ports, branches, and other features from materials such as stainless steel, titanium, and Phynox. The manufacturer offers such products as hypodermic, puncture, and biopsy needles; surgical suture needles; and adapters. In addition, stopcocks with luer locks or plastic tubing connectors for normal (4-bar) or high (80-bar) pressure are available. Unimed S.A., Lausanne, Switzerland.
Stainless-steel components
 |
A manufacturer offers stainless-steel components to medical device OEMs. Each component is electropolished, visually inspected, and packaged in a clean environment. The parts are routinely used in wound drainage devices, laparoscopic trocars, and trocar and cannula sets. Guide pins, obturators, k-wires, Steinmann pins, tunnelers, and introducers are also specialties. Particular attention is paid to the points, handles, and smoothness aspects of each component. Disposable Instrument Company, Inc., Shawnee Mission, KS, USA.
Benchtop machining equipment
 |
A six-axis benchtop machine is capable of machining, rapid prototyping, parts replication, welding and cutting, and laser-based deposition. The equipment can machine a three-dimensional part in one cycle, eliminating the need for fixturing. Accompanying software allows it to machine parts based on a CAD model or by laser scanning an existing device and replicating it. Using CAD software, alterations to moulds or machined parts can be made within the machine. Because it is fully automatic, the machine can be used by operators who are not skilled machinists. An optional automatic tool changer is available to enable various heads to be used for multiple-stage machining. Guidewire Solutions Ltd., Lurgan, Co. Armagh, UK.
Components and assemblies
 |
A company certified to ISO 9001:2000 and ISO 13485 offers machined components and assemblies for medical implants and orthopaedic instruments and devices. Its product range includes spine and joint replacement and fracture management parts. The company uses five-axis CNC milling, turning, 12-axis Swiss screw machining, and wire EDM equipment. Services offered include prototyping, product launching, and project management. Marox, Holyoke, MA, USA.
Micromechanical metal components
 |
Micromechanical medical device components are made to order from precious metals processed in an in-house foundry. Homogeneous alloys are cast from recycled materials following purity tests; after the castings have been analyzed in accredited laboratories and documented by certified precious metal assayers, they are transformed into semifinished products such as wires, profile sections, metal sheets, and tubes by means of wire- and tube-drawing systems, stamping presses, and strip rolling and straightening machinery. The products are heat-treated to achieve desired mechanical properties before being machined into precision components for medical engineering. Precious metals, titanium, and titanium alloys are turned and milled by the vertically integrated company. CM Medical, Cendres & Métaux S.A., Biel-Bienne, Switzerland.
Machined metals
|
Metal fabrication is a specialty of a supplier certified to ISO 9001:2001 and ISO 13485:1996. Among the company’s capabilities are multiaxis CNC Swiss turning, wire and plunge EDM, five-axis machining, deburring, precision cleaning and finishing, and resistance and laser welding. Additional services include R&D, prototyping, in-house CAD/CAM-based tooling design and fabrication, micromoulding, insert moulding, overmoulding, white room moulding,
and Class 10,000 and 100,000 cleanroom assembly. Other contract services
are also available. Donatelle, New Brighton, MN, USA.
Copyright ©2005 European Medical Device Manufacturer
