ANAHEIM, CALIF. — Mack Molding Inc. is making a move into medical disposables.
The Arlington, Vt.-based custom injection molder and contract manufacturer is investing $2 million to expand its clean room molding and assembly operations to handle what it calls a significant new project.
Mack already does medical molding — about 40 percent of the company's sales are for medical products, including orthopedic disposables and enclosures. But President Jeff Somple said the new project is Mack's first foray into high-volume, single-use components for a Class III medical device.
“That's driving some significant investment in equipment and personnel,” Somple said in a Feb. 10 interview at the Medical Design & Manufacturing West show in Anaheim.
Initially it includes four all-electric JSW presses, ranging from 44-199 tons of clamping force. Two of the presses are vertical machines. Within a year, Mack will add two more JSW presses. The work will be done at Mack's headquarters plant in Arlington.
Mack also is building its third molding and assembly clean room in Arlington. The 3,500-square-foot Class 8 facility is scheduled to be certified by April 1. The cell for the new project also will include a 500-ton automated hydraulic press that will be adjacent to the new clean room, in a soft-walled clean room area. The project also includes new servo-controlled radio frequency and ultrasonic welding systems.
Somple declined to identify the customer or details about the medical disposables project, other than to say that the volumes will be in the hundreds of thousands of parts annually. He described the work as a natural progression in its growing medical molding business, which started with clean room molding, assembly, medical part molding, and then experience with Food and Drug Administration regulations.
“We've had our credentials in order,” Somple said. “We're pretty confident that this will open the floodgates to higher-volume work.”
“In five years I think we'll be at around 50 percent medical,” he added. “We're going to continue our strategy of doing BBC work — molding big, bulky and complicated parts. Things that are difficult to ship and unlikely to be moved offshore.”
Kevin Bradley, business unit director for Mack Medical, said work on the new project will be phased in gradually this year. Mack expects to be in full production by the fall.
In addition to this investment, Mack has two other Class 100,000 clean rooms — a molding clean room with six electric presses and an assembly cleanroom that is used for non‐sterile packaging of medical disposables, light sonic weld assembly, and temperature‐ and humidity-controlled functional testing. Mack also has a white room operation with four hydraulic presses that make small medical parts.
New engineering talent
Mack also has added new expertise in medical device engineering and realigned staffing.
David Clatworthy and Timothy Hutchings have more than 50 years of combined engineering and manufacturing experience.
Clatworthy, a Six Sigma Black Belt, came from AngioDynamics Inc. of Glens Falls, N.Y., where he worked in manufacturing and quality engineering for catheter products and molded components.
Hutchings was a senior project engineer for Covidien/Tyco Healthcare in Argyle, N.Y. He is a Six Sigma Green Belt.
Both engineers report to Scott Hodges, who has been promoted to manufacturing engineering manager. Hodges has worked at Mack for nearly 20 years in quality and manufacturing engineering. Most recently, he was responsible for all engineering, operations, production planning and compliance for the manufacture of several FDA Class III medical devices.
Hodges' promotion is part of a manufacturing reorganization designed to separate engineering from production at the headquarters plant. Engineering will focus on cost reductions, continuing improvement efforts and new program launches. Mack added headcount to create new customer-focused production teams that each include a planner, supervisor, manufacturing engineer, quality engineer and buyer.
Mack ranked No. 23 in Plastics News' most recent survey of North American injection molders. The company has $287 million in annual sales and 11 plants.