From the design stage through product trials to full-blown manufacturing, the lucrative medical-device market is fraught with difficulties for companies that don't do their due diligence before starting out.
Several experts at the Plastics in Medical Devices 2010 conference, held April 12-14 in Westlake, reinforced that in their presentations.
“This can't be a hobby. The medical community has cost pressures from all sides,” Taras Konowal, president of Waldorf Technik Inc., the U.S. arm of Waldorf Technik GmbH of Engen Germany, said in an April 13 talk.
Waldorf Technik specializes in producing robotics and automation systems for injection molding. Konowal's presentation focused on getting injection molders to switch from batch molding to in-line production, to maximize efficiency, keep labor costs down, and improve quality.
In traditional batch molding, inspection occurs after the machinery has run, which can lead to costly shutdowns and retooling to correct faulty parts, Konowal said: “When do you find out that cavity 14 is producing bad parts?”
In in-line systems, cameras and other inspection devices can cut down on irregularities, and each shot can be separated and each cavity in a machine checked for flashing, short shots and improper wall thicknesses, he said.
There's a lot of upfront cost: Cameras, for example, can cost between $4,000 and $30,000 per machine. “But the only parts that are moving out of the system are 100 percent quality-controlled, inspected, good parts,” he said.
Molding medical-device components is only the end of a process that needs to be comprehensive, said Michael Pereira, vice president of program management at Ximedica LLC.
Ximedica, with more than two decades doing design and product development, is ISO 13485:2003 certified and Food and Drug Administration registered. Pereira cited FDA guidelines on medical-device design as a waterfall process that starts by defining problems, doing proper user-needs research, developing functional design, describing products before beginning production and achieving validation.
“The user needs to define what's necessary for that product to succeed, he said. “If you're talking to your supplier and then only starting to think about certain aspects of design inputs at that point, the costs and the scheduled impact to the process are far greater.”
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