Strong medicine for growth: A New Jersey shop that specializes in medical work combines the latest hardware with innovative software to gain a competitive edge

Modern Machine Shop, Jan, 2002 by Bill Dundas

A substantial portion of the shop's work consists of lights-out machining. Mr. Tarantino's EDM department is equipped with a fully automated cell that consists of two wire-EDM machines served by a robotic system manufactured by System 3R (Totowa, New Jersey). The shop operates two daily shifts and, on a typical workday, the second shift prepares the automated cell for overnight operation.

Rules Of The Game

Although the machinery and processes are essentially the same in medical machining as they are in other metalworking businesses, some key factors distinguish medical related work. First, quality control requirements for medical devices are more stringent than is true for the majority of parts produced by conventional job shops. Consequently, a machine shop that produces medical components must exercise strict control of part lots and batches, while maintaining careful documentation.

Because specific batches of parts are separately tested and certified by customers, mixing batches or substituting materials is prohibited. Customers also conduct periodic audits of medical manufacturing operations to ensure compliance with these standards. Additionally, customers insist on high levels of cleanliness in their suppliers' machining facilities. For example, employees at New Jersey Precision are not permitted to take food into the shop area. According to regulations of the U.S. Food and Drug Administration (FDA), the shop also maintains a segregated quality control area that qualifies as a Class 10,000 cleanroom (containing less than 10,000 contaminant particles of 0.5-micron particle size per cubic foot).

Due to the environment in which they are used, materials for medical machining must be highly resistant to chemical reaction. Typically, these metals are also much harder than those used for non-medical purposes. While titanium alloys and cobalt chrome are the principal workpiece materials for medical devices, New Jersey Precision also uses hardened stainless steels and tool steels to fabricate mold and die components.

Certain factors specific to medical practice and human psychology have important impacts on shops that specialize in medical machining. For example, a substantial reduction in the average length of hospital stays in recent years has also shortened the lead times demanded by customers for delivery. This is particularly true of special medical devices and implants. Although New Jersey Precision's business had previously been growing at a steady rate of approximately 3 percent per month, some flatness has now occurred in the market for devices that are used in elective surgeries. Mr. Tarantino believes this is the result of the current economic uncertainty that makes people more reluctant to take time away from their jobs to undergo nonessential operations. But this temporary reduction in growth is a relatively minor problem in view of the negative returns experienced recently by other metalworking shops.

Because a substantial portion of New Jersey Precision's work consists of prototype or just-in-time production, customers realize--and have come to expect--that the shop will respond rapidly to their requests. Thus, it's quite common for Mr. Tarantino to receive a phone call from an important customer who wants an order filled within 24 hours. A customer who needs a single prototype or an immediate replacement for a unique part will sometimes call early in the morning to place the order, then send someone to the shop the same day to take delivery. Although this seems to strain the definition of JIT manufacturing, any shop that does a substantial amount of medical work must be flexible enough to respond rapidly to these periodic requests.