Medical Device Machining: Precise and Reliable Parts for Critical Applications

Halcyon Manufacturing
San Jose, CA

For the medical device industry, the cutting edge of parts machining goes far beyond having the latest CNC equipment and accessories. It also means engaging at the earliest stages of the process using the latest in design for manufacturing (DFM), simulation, and process verification processes prior to cutting the first part. It is then critically important to have the commitment to inspect with the most precise tools throughout the process. The goal of this approach is to give customers the knowledge that when machining begins, the parts are going to be 100 percent right, with zero defects, the first time and every time.

Typically, potential customers seeking a machine shop to make a complex part are looking for the latest equipment and current certifications including ASQ, ISO 9001 and AS9100. There is a tremendous benefit, however, for a customer to look beyond these prerequisites for a machine shop that will work with them from the design phases through manufacturing to predict and resolve failures before they happen. The ability to predict when failures could occur requires proactive communication and early engagement with an expert machine shop.

Design for Manufacturing

A DFM process enables the machine shop to anticipate possible complications and limitations in the machining process upfront.

“With design for manufacturing, the goal is to make the product manufacturable in an efficient and cost-effective way and that starts with reviewing the parts and discussing the specifications openly,” says Tony Doan, CEO of San Jose, California-based Halcyon Manufacturing, an advanced ITAR registered and AS9100/ISO9001-certified manufacturing shop for complex parts.

This analysis and feedback are part of an ongoing manufacturing collaboration between a medical device client and their contract machining partner well before production starts from the inception of a project through prototyping. Halcyon, for example, applies the DFM protocol across a wide spectrum of metal machining from bar grade 6061 aluminum, brass, copper, titanium, stainless steel, and plastics. The company also works with quartz, ceramic, graft, titanium, and a variety of steels and serves customers in the medical, aerospace, home defense, automotive, and semi-conductor sectors.

“When you can use the latest simulation and process verification technologies prior to cutting the first chip of metal or plastic, then when you start manufacturing, you know that the parts are going to be 100 percent right the first time, every time,” says Doan.

Inspecting Quality Upfront

To complement the machining capabilities and nimbleness, a shop must also have state-of-the art metrology equipment for advanced inspections guided by a proactive zero-defect mindset.

“It’s not about making parts and sorting out the bad ones and shipping the good ones,” says Doan. “You need a machine shop committed to not making the bad parts at all. To produce the most precise parts, you must be able to inspect more than the finished goods,” he adds. “A machine shop should be inspecting in real time such things as the setups and the speed throughout the process which enables data to be captured for statistical predictive process control.”

For medical device manufacturing, machine shops should use automated coordinate measuring machines (CMMs) that perform process inspections and produce first article reports. In addition, they should use a digital multimeter (DMM) with scanning capability that can take thousands of data points during a scan of a complex curved surface. This results in very precise and accurate repeatable product evaluations.

Ensuring Zero Defects

Medical device and other sectors that rely on machine shops to produce precision parts to extremely tight tolerances with consistency should look beyond the basic certifications and CNC capabilities for those with the expertise to optimize the manufacturing process before any items are manufactured. By ensuring a zero-defect approach, OEMs and medical device contractors can be certain their parts are of the highest reliability for their most critical applications.

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