Originally Published MPMN
Aaron Lahann, senior process engineer, Airtronics Metal Products Inc., San Jose.
Once skittish about outsourcing, most medical device OEMs today consider outsourcing vital to success. They know that contracting out metal fabrication to a precision supplier can help them improve product design while reducing production costs. Metal fabricators stay up to date on metal trends and technologies, such as laser cutting, machining, milling, stamping, surface treating, and testing. Below are some tips on how to select a metal fabrication provider:
Not all metal fabrication shops are created equal. The OEM should ensure that the prospective partner is certified to the standards required for the application. For most OEMs, this means ISO 9001 and/or ISO 13485 certification.
Tour the shop.
Is the facility clean and orderly? Is the manufacturing equipment up to snuff and is the work flow smooth and efficient? The supplier should use a paperless enterprise resource planning (ERP) system to manage production, scheduling, pricing, and quality. It should also use the latest 3-D modeling software to verify the form, fit, and function of devices.
Meet the engineers.
An experienced and collaborative engineering team is vital to good product development. The outsourcer’s team should be eager to share ideas, find mistakes, and suggest design for manufacturing (DFM) changes to improve product design. The team should assist through all phases of production, including concept, prototyping, qualification, validation, and full-scale production.
Check quality and capabilities.
The OEM should ask the vendor about past and current clients and projects. Has the vendor manufactured for a medical device OEM before? Does it perform most or all of the work in-house, or does it outsource? The supplier should accommodate both the OEM’s rapid prototype and finished production schedules.
Take a tool inventory.
Once the OEM has selected a fabrication partner, it should research the company’s tool inventory. Using the vendor’s tools can expedite the project.
Contractor Supplies Chemical-Machined Medical Parts
Using a process called chemical machining—also known as etching or milling—a supplier manufactures prototype and production quantities of metal parts featuring complex geometries. In addition, the company performs all secondary operations, including forming, passivation, electropolishing, and plating, on a variety of metals such as titanium, nitinol, zirconium, stainless steel, and copper. An ISO 9001:2000–certified contract manufacturer, the company also offers radio-frequency and EMI shielding, as well as metal-stamped parts with thicknesses ranging from 0.002 to 0.135 in.Fotofab
Vendor Offers Metal Fabrication Services
A manufacturer provides an array of metal fabrication services, including photochemical machining, metal stamping, electroplating, and passivation. Specializing in the processing of light-gauge metals as thin as 0.0007 in., the company offers circuit-board-level EMI shielding for medical electronics and sieves, screens, filters, gaskets, and washers for medical applications. In-house capabilities range from quick-turnaround prototype runs to production-level manufacturing.Orbel Corp.
Manufacturer Provides CNC Machining of Implants and Instruments
Offering CNC machining and orthopedic implant and instrument assemblies, a supplier specializes in spine, joint-replacement, fracture-management, hand and extremity, and endoscopy applications. Its services include five-axis CNC milling, CNC turning, 12-axis CNC Swiss-screw machining, CNC wire and plunge EDM, and assemblies. Using titanium, cobalt chrome, stainless steel, and other materials, the
ISO 13485–registered company offers prototyping, product launching, full-scale production, and project management. Additional support services include vendor-managed inventory, and nonsterile packaging and labeling.Marox Corp.
Supplier Specializes in Contract Machining and Turning Services
Fabricating small to large metal parts in volumes ranging from a few pieces to large production runs, a contract manufacturer supplies base and side plates for biomedical test and analysis equipment, pump and compressor components and bodies, and parts for imaging equipment. The company manufactures parts from a variety of materials, including aluminum, carbon steel, ductile iron, stainless steel, and titanium. Certified to ISO 9001:2000 standards, the manufacturer processes materials using vertical machining centers, bridge mills with pallets, horizontal machining centers with and without pallet pools, and turning centers.TCI Precision Metals
Outsourcer Manufactures Sheet-Metal Components
A full-service sheet-metal design, engineering, and manufacturing company serving the medical device industry offers design and mechanical engineering support, prototyping, precision fabricating, CNC machining, laser processing, painting, silk screening, and final assembly. The ISO 9001:2000–certified vendor provides custom engineering and value-added manufacturing using CAD design software; machining, milling, stamping, and other types of production equipment; and enterprise resource planning (ERP) systems. Quick-turnaround manufacturing capability allows the supplier to deliver prototypes and first articles, expediting confirmation of design concept and integrity.Airtronics Metal Products Inc.
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