ANAHEIM, CALIF. — Some medical molders are taking on additional duties, and a few plan to register with the Food and Drug Administration as full-blown device manufacturers. Courtesy Corp. and InteSys Technologies Inc. say they plan to register this year with the FDA, and Tech Group Inc. said it is doing more medical assembly work. The firms were at the Medical Design and Manufacturing West 2000 show, held Jan. 18-20 in Anaheim.
Becoming registered is a significant step that will let them handle more work that traditionally has been left to original equipment manufacturers.
Device registration, for example, would let processors go from just making a blister pack case to putting in pills and dosage information and sending that to hospitals, said Michael Cullen, sales manager with Courtesy in Buffalo Grove, Ill.
"It will open up even more doors for us," he said.
These firms would not be the first processors to get FDA certified — Nypro Inc. has been registered for more than a decade. And many contract manufacturers in the medical field carry that distinction, like ACT Medical Inc. and Atrion Medical Products Inc.
But it does reflect stepped-up pressure on molders to provide more soup-to-nuts services. That pressure also is leading to consolidation among medical processors.
"The general pressure is the medical OEMs are looking to pawn off overhead in terms of assembly and engineering," said Tim Reis, health-care business unit manager with GW Plastics Inc. in Bethel, Vt. GW is registered as a device manufacturer.
Making a drug delivery device is pushing InteSys to register as a device maker, said Lance Decker, operations manager of the Costa Mesa, Calif., injection molding plant. That plant will seek device registration.
InteSys would manufacture the plastic components, assemble the finished devices and distribute it to 3,000 locations, he said.
"I think it is a requirement of the industry," he said. "Manufacturers are recognizing the value of having one manufacturer in charge of the whole product."
"It's a function of liability in the medical industry," he said. "They want a molder who has more control."
Tech Group also sees assembly opportunities in pharmaceuticals, including things like powder inhalation devices, said James Dolan, vice president of business development for Tech in Scottsdale, Ariz.
Drug makers in particular want to focus on their product and have less expertise in how to make devices to deliver it, Dolan said. Tech used to be a certified device manufacturer for a specific medical assembly project, but its customer later took the assembly work in-house, he said. Tech still does the molding.
Device registration requires much more documentation of operating procedures, and requires much more formal manufacturing controls and full traceability in case problems develop. It also puts the molder in much closer contact with the FDA.
"With device manufacture you get into regulatory issues, not just quality systems," said Randy Barko, corporate vice president at Clinton, Mass.-based Nypro.
Still, many molders probably will not need to pursue the complexities of device registration. There still will clearly be plenty of demand for component manufacturing, Tech's Dolan said.
For example, Pacific Plastics & Engineering has not had customers tell it to get into full device manufacturing, said Stephanie Harkness, chief executive officer of the Soquel, Calif., company.
"Our customers do final assembly and packaging and then pass it on to sterilizers," she said. "We are always asking, `Is there more we can do?' And they say, `No.'|"
Pacific Plastics is an injection molder with about $10 million in annual sales, with medical work accounting for about half of the total.
Gilbert McMoran, sales manager for Trademark Plastics Inc. in Rancho Cucamonga, Calif., said his company has beefed up medical capabilities and has been getting more inquiries about device manufacturing.
It's not just large medical manufacturers that are outsourcing and want more expertise from contract manufacturers. Small start-up companies also need that, said Bill Partridge, vice president of sales with ACT Medical, a contract medical device manufacturer and extruder in Newton, Mass.
ACT is a registered device maker but is not worried about an influx of molders joining it, because ACT has expertise that is much broader than plastic, Partridge said.
"For one of these companies with just one type of technology, they will be very limited in what they can do," he said.