OUTSOURCING OUTLOOK: METAL FABRICATION
Thomas Osypka, president and CEO, Oscor Inc., Palm Harbor, FL
As consolidation in the medical device industry is approaching its peak, the requirements for medical component OEMs, particularly in the field of metal fabrication, are rising more quickly than ever. Rapid turnaround times, tight tolerance requirements, and the use of extremely corrosion-resistant materials are a must. Where once lead times of several weeks were acceptable, it is now necessary to provide results in days. State-of-the-art equipment, as well as continuous process optimization, is needed in order to handle short lead times, tight dimensional tolerances, and extensive surface characteristics.
Medical OEMs looking for a parts manufacturer should look for companies with complete vertical integration, multiaxis Swiss turning machines, five-axis CNC machining centers, CNC EDM, and precision laser processing equipment. The company should also be using the latest CAD and CAM and simulation software, as it allows the manufacturer to take full advantage of multiaxis and high-speed machining while reducing development and cycle time.
Metals that are commonly used to make short- and long-term implantable medical components include difficult-to-machine stainless steels, MP35N, titanium, tantalum, carbide, and combination materials of platinum and iridium. In order to work with these materials, the complete integration of secondary operations, such as deburring, passivation, electropolishing, and laser processing, is necessary.
Process optimization is possible by implementing statistical process controls and six-sigma certification programs throughout the manufacturing operation.
CNC Software Used to Make Complex Components
A company uses state-of-the-art CNC software to manufacture complex 3-D parts, such as surgical instruments for use in minimally invasive procedures. Some of the 3-D parts were previously unobtainable. Materials processed range from Teflon to titanium. Prototyping and production are performed to customer-specified tolerances. The firm is ISO 9001:2000 certified and operates 6 days a week to facilitate 2-week delivery. Most of the company’s machinists are journeymen who program their own jobs.
Reliance Machine Products, Fremont, CA
Wire-Cutting and Machining Services Offered Worldwide
A wide range of precision micromachining and forming services are available. Services for medical manufacturers include slitting, slotting, notching, hole punching, forming, Swiss turning, coining, angle cutting, and deburring in metals such as tungsten, stainless steel, nitinol, super alloys, and MP35N. The company works with wire in diameters ranging from 0.0005 to 0.250 in., lengths from 0.050 in., and straightness from 0.001 in. per 4 in. Wire shapes such as round, half-round, triangular, square, rectangular, and custom can be accommodated.
Razor-edged tubing features ultrasharp submicron wall edges that are completely burr-free. Applications include aortic punches, microbiopsy punches, microtrephines for ophthalmic use, and catheter hole punches.
A development center provides R&D to large-scale production, prototyping, small custom orders, design assistance, and complete project management.
Manufacturing facilities are located in Illinois, Colorado, and Costa Rica, and are equipped with conventional, unconventional, and proprietary machining equipment.
Point Technologies Inc., Boulder, CO
Firm Produces Implantable-Grade Metal Components
A manufacturer can produce precision implantable-grade metal components. Available materials include stainless steel, MP35N, titanium, and other implantable-grade metals. CAM software and CNC machining equipment are used to produce parts quickly. Capabilities include multiaxis Swiss turning, five-axis machining, EDM, laser processing, braiding, electropolishing, passivation, and statistical process control monitoring. Value-added services include injection molding, thermoplastic and silicone overmolding, cleanroom assembly, packaging, and sterilization.
Oscor Inc., Palm Harbor, FL
Cell-Based Process Used in Metal Fabrication
A manufacturer uses cellular processing techniques to produce enclosures, chassis, cabinets, and other metal components. The cellular structure enables the firm to offer both high-mix, low-volume and high-volume, low-mix production. Capabilities include metal stamping, milling, welding, and prototype development. Complete mechanical and electromechanical assembly services are also available. The company reduces risk for new product introductions by developing and initiating the manufacturing process before transitioning to mass production. It is fully equipped to produce quick-turnaround prototypes and short-run orders, as well as large volumes.
Craftsman Custom Metals, Schiller Park, IL
Stents and Stent-Like Devices Available for Emerging Applications
A company has expertise in the fabrication of self-expanding (nitinol) and balloon-expanding stents, and a broad range of stent-like devices for emerging applications. In-house fabrication capabilities include laser cutting, nitinol heat-treating and forming, electropolishing and other surface finishing, device characterization, and device and material testing. Laser machining capabilities are used to achieve tube diameters from 0.01 to 1 in., wall thicknesses from 0.001 to 0.03 in., and kerfs from 0.6 to 1.2 mil. Surface finishing techniques include electropolishing to achieve mirror smooth, highly passive surfaces as well as precision deburring, mechanical polishing, and chemical etching operations.
In addition, the company offers integrated design and development services for stents and stent-like devices. Its engineering staff can rapidly develop designs from initial concept to the production of devices for clinical trials. Customers range from entrepeneurs with very-early-stage designs to large, established stent and device suppliers. The company is ISO 13485 and ISO 9001 certified.
Burpee Materials Technology LLC, Eatontown, NJ
Indian Firm Offers Precision Metal Parts
An Indian manufacturer offers machined parts and assemblies to customers worldwide. Specializing in machining stainless-steel components, the company works with all grades of stainless steel, as well as aluminum grades 6061T6 and 6053T6. Several grades of carbon steel are also available. Precision CNC-turned parts are made from bar stock, castings, and forgings. Applications include cryogenic pumps, valves, and medical equipment. More than 70% of the company’s parts are exported to U.S. and European OEMs each year.
Abhijeet Manufacturing, Makarpura, Vadodara, India
Company Expands Metal Fabrication Services
A maker of complex geometric metal components has moved its CNC lathe and Swiss screw machine operations to a new facility. Services have been expanded to include passivation and welding. A cleanroom is also available. The firm specializes in producing complex, precision-machined components from materials such as Inconel, nickel, brass, copper, aluminum, Hastelloy and Haynes, titanium, Kovar, and stainless steel. The company’s equipment includes one 5-axis, two 6-axis, and two 10-axis robotic loading and unloading CNC Swiss screw machines.
Precision Swiss Products, San Jose, CA