Preparation needed to enter medical market

By Frank Esposito | PLASTICS NEWS STAFF

WESTLAKE, OHIO (April 20, 1:40 p.m. ET) — The medical device market can be a rewarding one for plastics processors, but it’s not a market you can wander into and hope to succeed.

The volume of requests for medical projects is growing at Parker Hannifin Corp., a Cleveland-based manufacturing giant that uses engineering resins, fluoropolymers and urethanes in its seal products. But Dale Ashby — vice president of technology and innovation for the firm’s sealing and shielding group — said that those increased requests bring with them a lot of work in material selection, as well as part production.

“The main question that every customer has is : ‘How long can I expect this product to last in my application?’ “ Ashby said at the Plastics in Medical Devices conference, held April 12-14 in Westlake.

“We need well-defined expectations of performance from our customers to make predictions on seal life,” he added. “Modeling is very important. It’s step No. 1 in proving useful life. Tools and modeling continue to improve, and OEMs have more knowledge than ever before.”

Parker, a supplier to many major OEMs, rang up sales of more than $10 billion in 2009. The firm employs 62,000 at almost 300 plants worldwide.

Parker made a big move in the medical field in 2008, when it created a new medical systems division in its seals group. The new division was based on six businesses — five in California and one in Indiana — that Parker had acquired from HTR Holding Corp. Those businesses make plastic and elastomeric components for medical devices such as intravenous equipment, drug-infusion pumps, respirator hoses and catheters sold directly to OEMs. The group performs injection molding, rapid prototyping and similar services.

Ashby said that in material selection, it’s important for processors to consider physical properties such as elasticity and lubricity, and mechanical properties such as flex resistance and toughness. In thermal properties, processors need to be aware of melt flow index and thermal conductivity; while in electrical properties, surface resistivity and arc resistance can impact material choice. Chemical resistance to solvents and cleaning solutions also plays a role.

Injection molder PMC LLC of Cincinnati is among the ranks of firms that successfully have entered the medical field in recent years. But even for PMC, doing so took a pretty big leap of faith, according to President Lisa Jennings.

“We bought the equipment for medical molding, had a clean room ready and did sample molding before we even had a customer,” she said at the event. “But based on our evaluation of what PMC is capable of — making millions of parts at 0 PPM quality levels — we determined that medical was a good niche for us.

“We had best-in-practice standards that weren’t available to most of the medical device group.”

PMC also “had to develop a medical culture” that was different from automotive and other markets it had participated in over the course of its 81-year history.

“We needed to consider all areas of our business and manufacturing systems,” said Jennings, who is also a fourth-generation owner of the firm. “For clean-room classification, we had to create an environment to insure that implant molding is controlled and consistent.”

“We learned that having the right processing equipment is the foundation for repeatable processing of implantable polymers. We also learned that customer validations are custom and are up to interpretation.”

PMC — which operates plants in Indiana, Mexico and Germany — now produces medical items used in orthopedics, sports medicine, spinal care, cardiovascular care and drug delivery. PMC’s medical products are based on polyetheretherketone (PEEK), thermoplastic polyurethances and ultra-high-end bioabsorbable and bioresorbable resins, which are used in implants and other devices.

“Some of these materials can cost from $125 a pound to thousands of dollars per pound, so there can’t be any material wasted,” Jennings said. “That’s a huge consideration.”