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difficult to fixture.” Measurement accuracies are between 2 and 5 µm. He notes typical medical parts inspected with IM series machines include needles, sutures, stents, or syringes.


machining company, such as processing PEEK plastics. “Our established processes for machining, inspecting, and handling of implantable PEEK materials are tightly controlled,” says Jeff


“Utopia is if our skilled associates do not have to walk away from the machine to measure a part”


Te perspective from Micropulse (Columbia City, IN) is a


bit different from that of a general job shop. “We decided long ago to focus our expertise on medical manufacturing alone, which is quite challenging all to itself,” says Brian Emerick, president and CEO. While acknowledging that cost pressures are becoming more important in an industry once solely dedi- cated to quality, he predicts growth across the board of 5–10% annually. It is especially promising to be a contract manufac- turer. “Some contract manufacturers are better than the medi- cal OEMs at making things,” he says. “OEMs are outsourcing 60–70% of their products and we are seeing a new trend with some OEMs that have no manufacturing capability at all.” Variety, small lots, and ever-tighter tolerances characterize


his business. “Twenty percent of what we do on a monthly ba- sis is a new part,” he says. “Some months, 35% of what we are processing is brand new.” Tat includes materials new to the


Hicks of Micropulse. “Manufacturing equipment and trained personnel have been dedicated to processing implantable PEEK to ensure that the product is consistently produced and handled according to specifications. In addition, the prod- uct is transported throughout the facility in visually unique containers. Tis provides notification to all employees that special handling is required in order to prevent contamina- tion of the product.” Dedicated quality technicians will typically run exhaustive


first-article inspections for part approvals. Tey also check first runs of every new lot to ensure process stability aſter machine setup. Two quality labs are set in strategic locations in their 100,000 ſt² (9290 m²) facility, with one CMM and optical comparators set-up on the shop floor itself. Teir CMMs are also equipped only with touch probes and scan- ning analogue probes. Metrology at Micropulse is not for dedi-


cated technicians alone. “Te machinists and quality technicians both have access to the same inspection equipment. Machinists are able to use the appropriate inspection tools to verify product as it is being manufactured,” explained Hicks. “Inspection activities for prototype devices, which are manufactured in a dedicated cell, are primarily performed by prototype personnel.” Of course, the goal is to not burden opera-


tors with quality checks at locations distant from their machine. Micropulse uses dedicated expediters to track lots as they move through operations and physically move the material from machine to machine and into metrology stations. Tis keeps machines humming and operators dedicated to what they know best. “Implantable devices are becoming more


Using walk-up metrology stations like this Oasis system designed for fast, easy operation brings quality checks to the shop floor.


common and there are more manufacturers of them,” says Jamie Murray, Senior Applica- tions Engineer at OGP. “Because of the critical nature of implantable parts, manufacturers are doing more measurements to validate processes, even as we see smaller lots and ever tighter tolerances.” Today, nanometer–level measurement repeatability is a common re- quirement with some manufacturers. Tat level


Medical Manufacturing 2013 67


Photo courtesy Bruce Morey and C&A Tooling


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