Subtractive Solutions: New developments in machining enable unprecedented levels of miniaturization for medical device manufacturers.

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Author: Mark Crawford
Date: Sept. 2020
From: Medical Product Outsourcing(Vol. 18, Issue 7)
Publisher: Rodman Publishing
Document Type: Article
Length: 2,954 words
Lexile Measure: 1460L

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Computerized numerical control (CNC) machining is a critical manufacturing process for fabricating medical device parts and components. Equipment manufacturers continue to improve these machines to meet the ever-increasing performance metrics expected by the medical industry, especially those for an expanding array of minimally invasive surgical procedures. Therefore, medical device manufacturers (MDMs) are designing smaller and more complex devices with tighter tolerances. Engineers continue to push the limits of current machining technologies in their designs, asking for more capabilities and greater functionality. The urgency by MDMs to meet these needs is passed down through the supply chain to cutting tool manufacturers, robotics companies, and computer-aided manufacturing (CAM) software engineers to innovate and collaborate on machine solutions--and beat the competition to the market.

Automation and robotic-assisted CNC machining are a key focus because they improve efficiency, quality, and tolerance control. Advanced software continues to improve the automation of tasks such as welding, hole punching, and laser cutting. The efficiencies of automation help CNC machines stay competitive with additive manufacturing (AM) by manufacturing many of the complex shapes and extremely tight tolerances required for high-precision medical devices and durable complex parts. For example, high-volume machines can produce machine parts from 0.01 inches up to 1.25 inches in diameter, while holding tolerances as tight as 0.0002 inches for both turning and hole making.

"As the medical device industry continues to focus on improved patient outcomes, it is vital to have production processes that provide stringent, repeatable, precise, and accurate finished components," said Ray DeFrain Jr., regional metallurgist for Carpenter Technology, a Philadelphia-based provider of high-performance alloy-based materials and process solutions for the medical device market. "Additionally, by linking these performance metrics with cost-down pressures of the industry at large, we see a shift toward lights-out manufacturing and Internet of Things [IoT] mobile control of multiple CNC cells."

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MDMs are making a greater variety of micro-medical components with complicated features, which are typically processed with Swiss-style machining. They seek the speed, precision, reproducibility, and tight tolerances that these machines can provide. For example, "robotic surgical components are flooding our current requests," said Craig Green, staff engineer for Cadence, a Staunton, Va.-based contract manufacturing partner that provides advanced products, technologies, and services to medical device and diagnostics companies. "These components are small, complicated, and in some cases, very delicate."

Lasers are still one of hottest market segments in CNC machining--laser cutting, laser welding, laser texturing, and laser knurling. Combining laser processing with machining in hybrid equipment eliminates steps and saves time. For example, by combining laser cutting and welding with traditional Swiss turning, laser-Swiss machines can perform multiple processes in a single set-up, which can also streamline the validation process. The trend toward hybrid equipment also drives down costs by shortening lead times for prototyping and production volumes.

"Customers want to integrate these two processes into one platform to save on the assembly of individually machined and laser-cut parts," said Damian Zyjeski, CNC production development manager for Okay Industries, a Berlin, Conn.-based manufacturer of...

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Gale Document Number: GALE|A635667442