The need to reduce costs, provide safer materials and improve patient safety — along with the shift to more home health care — continues to provide a wealth of opportunity for companies that compound and engineer materials for medical devices.
“Hospitals are concerned about whether devices or components contain halogens, phthalates and bisphenol A,” said Scott Hanson, global industry leader for the medical market segment of the specialty plastics business of Eastman Chemical Co. in Kingsport, Tenn. “When there are alternatives, they are willing to consider them if you can provide them at the same or lower price point.”
In addition, the roughly 100,000 deaths that occur annually from hospital-acquired infections — as estimated by the federal government's Centers for Disease Control and Prevention in Atlanta — have hospitals looking for ways to reduce bacteria that can collect on medical devices and equipment.
“Companies who supply devices and hospitals are concerned about viral infections, so the knowledge we bring to the table helps them make the choice of what resin to use,” said Larry Johnson, health-care marketing director for compounder and distributor PolyOne Corp., headquartered in Avon Lake, Ohio.
Johnson points to the new WithStand antimicrobial additive, which can be used as a concentrate or compounded into the polymer, as an example of a possible solution to that problem. The additive was introduced at Medical Design & Manufacturing East, held June 8-10 in New York.
“It will hopefully solve the problem of keeping bacteria out of people who are in hospitals and help manufacturers trying to combat surface microbe growth on plastic parts in medical devices,” said Johnson. “It can enhance the actual performance and perceived value of products and devices.”
“The biggest current driver in the medical industry is improving patient safety and comfort,” agreed Hanson. “That continues to lead to the development of devices that provide better care and take costs out of the system.”
“The cost pressures the health-care industry are facing are both an opportunity and a challenge for us,” said Hanson. “It is an opportunity for us to bring high-performance materials into an application or a device and improve their costs.”
Tom O'Brien, health-care product marketing manager for Sabic Innovative Plastics in Pittsfield, Mass., agreed. “The focus on protecting the patient and the staff” is driving the switch to plastics and the replacement of metals in a number of products, he said.
“But taking costs out and eliminating secondary operations” in the design of a new device is equally as important because of the pressure on hospitals to reduce costs, O'Brien said. “New devices still need to have the right price and have the same, or an improved, functionality to succeed. You have to help hospitals increase throughput so that surgeons are more effective and patients spend less time in the hospitals.
“Everything also has to be smaller and more portable because health care is being brought to the patient, whether it is home health care in the U.S. or to rural areas of third-world countries,” O'Brien said.
Two other key drivers are sustainability and the need for more durable products, Hanson said.
“There is a continued trend to make devices more durable and there is a much stronger drive to improve sustainability at hospitals,” Hanson said. Hospitals want devices that weigh less, have thin-gauge walls and reduce the amount of materials used, to help solve end-of-life waste problems.
“Our pace of activity continues to increase, so we believe that we are satisfying the needs” of medical customers, he said. “We are looking at double-digit growth across all geographic regions — very significant across-the-board growth.”
He points to Eastman's Tritan medical-grade resin introduced one year ago as an example.
“It is very encouraging to us that it is being adopted as fast as it is,” Hanson said. Tritan has been chosen for a number of intravenous and blood-therapy applications and has gotten a boost because it is BPA-free, he said.
“We knew it would attract interest for clear and lipid-resistant applications, but we didn't see that it would have a unique fit with durable products,” Hanson said. “It is quite a bit more successful than we anticipated. It typically takes a material 18-24 months to find its way into commercial applications. But with Tritan, that has been shortened by six to 12 months.”
At MD&M East, Eastman and its partners unveiled a mobile wireless device worn on the patient's arm for continued monitoring of a patient's vital signs. The ViSi Mobile system from Sotera Wireless Inc. in San Diego was developed in collaboration with Eastman, PolyOne, DD Studio and injection molder Phillips Plastics Corp. in Hudson, Wis.
“We have taken the monitor off the pole and put it on the patient's wrist,” said Jim Moon, chief technology officer of Sotera Wireless. “It gives the patient mobility and gives the hospital non-stop monitoring.”
The five companies are targeting the first quarter of next year to get ViSi Mobile to market — but possibly at an accelerated rate of production. The original plan was to produce 1,000 units, but “we have got requests for tens of thousands,” said Scott Clear, product development vice president at DD Studio in Carlsbad, Calif.
“It seems to be the Holy Grail because it is the first and only body-worn, wireless patient monitor that constantly captures all core vital signs, including continuous blood pressure,” Clear said.
The device's housing, lens and printed circuit board assembly and connectors are made from Tritan copolyester MX711 because of its durability and chemical resistance, and its cold-swaging abilities, which allow it to be fit together without adhesives, chemicals or mechanical fasteners.
To protect the device from water and fluids found in a hospital environment, it is overmolded with GLS Versaflex OM 360 thermoplastic elastomer from PolyOne, which makes it submersible.
“It needs to be cleaned, be durable and look good,” Hanson said. “It was very important for us to collaborate so that everyone knows what's possible, and to improve the feel and functionality of the device. We need to continue to collaborate with our other partners to help device companies bring products to market faster and with better properties.”
The continued integration of drugs with delivery devices and the shift of more health care into a home environment are also providing a boost to companies that develop materials for the medical market, Johnson said. “Drugs and devices continue to come together, and that means you have to handle materials differently and rethink what you need,” he said.
“In addition, anytime you take something to the consumer level, that means costs become more of an issue and you need to find materials that improve overall performance and durability — and reduce costs.”
“Home health care is a big driver and it provides a boost to companies that can develop engineered and compounded resins,” Johnson said.
Hanson agreed. “We feel home health care is a positive trend for our materials,” particularly Tritan. “As more and more health care moves into the home, there will be a need for materials that are very durable. That will open the doors for materials that have that needed durability.”
There will be a need for greater collaboration as design becomes more of an issue since home medical devices and medical equipment need to blend into a home environment, O'Brien said.
“You are starting to see a lot of design firms popping up at the show due to the increase in home health care,” he said. “You need products that have curves, colors and sleeker looks. Cost is still the key, but you have to have a product that looks right.”
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