The push to reduce product weight, make packaging and products more sustainable, minimize patient risks and hospital liabilities, and drive down overall costs is giving plastic material suppliers more opportunities to develop new resins and compounds.
Patient safety and comfort, cost and sustainability, or any combination of those are the drivers for medical companies to make changes in materials, said Dante Rutstrom, vice president and general manager of specialty plastics business at Eastman Chemical Co. in Kingsport, Tenn.
Tom O'Brien, Sabic Innovative Plastics US LLC's global product marketing director of health care, said his firm is dealing with those same issues. After safety, cost is the key in this industry. So we have to come out with new materials that are cheaper, get [our customers] into new space or give them better performance, he said in an interview at the Medical Design & Manufacturing West show. O'Brien and Rutstrom were among executives attending the Anaheim show from Feb. 8-10.
What's more, the emphasis on reducing costs is likely to intensify if the 2.3 percent tax on medical devices that is part of the federal health-care reform law goes into effect as scheduled, in 2013.
I don't know if the medical-device tax will squash innovation, but it will increase the focus on taking costs out, thinning down walls of products and components, and replacing metals with plastics, O'Brien said.
Perceived risks associated with certain materials also are an impetus to creating new materials, finding new applications for existing materials or improving them through reformulation. That's why the thermoplastics elastomer unit of Teknor Apex Group Inc. in Pawtucket, R.I., developed its first wire and cable compound for the Medalist elastomer product line which Teknor introduced two years ago as an alternative to PVC in tubing.
We took our existing Medalist material and reformulated it into a new injection medical grade, Medalist MD458, targeting patient-monitoring applications, said Nick Sandland, senior market manager for medical products in Teknor's TPE division. It is based on technology for non-medical insulation and jacketing applications that have been in the marketplace for 20 years.
The new Medalist TPE is aimed at companies making cables for medical-device customers that want to replace PVC cables Teknor Apex also is a large global PVC compounder.
Simultaneously, the firm introduced three patented bonding solutions a light-cured adhesive system, a solvent bonding system and a room-temperature-cured adhesive system for bonding MD458 TPE medical tubing to conventional connectors.
We want to fill the gap in the market, said Sandland. If companies are going to move away from PVC, we want them to stay with Teknor Apex. We are not going after that business on a cost basis, but as a functional material in applications where people don't want PVC. The new compound will be made at the company's medical compounding facility in St. Albans, Vt.
For similar reasons, Eastman introduced MX811, a third grade for its medical family of Tritan copolyesters its alternative to resins containing the controversial bisphenol A. The new Tritan grade specifically targets higher-temperature big-part applications like renal medical-device housings, requiring companies to run their machines hotter and faster. The firm also offers a grade of Tritan for medical packaging.
At Minntech Corp., the therapeutic technologies group is awaiting regulatory approval from the Food and Drug Administration to use MX811 in two of its products, replacing other materials. One product is a fluid-removal device used in cardiac bypass surgery; the other is used in intensive care units to treat acute renal failure, including fluid removal and kidney-stabilization procedures.
Relaunching our products with this material will help us retain our leadership position in products used for kidney dialysis and open heart surgery, said Randy Wenthold, the group's vice president. Tritan MX83l also provides more protection for the membranes in those products and reduces manufacturing costs and processing time, he said.
Eastman also said LiNA Medical of Glostrup, Denmark, will be using an earlier version of Tritan, MX731, in its MaxFlow suction and irrigation single-use device for gynecological procedures, and for a 5-millimeter trocar system used in laparoscopic surgeries, the FleXeal.
Henrik Bisgaard Poulsen, LiNA business unit manager for minimally invasive gynecology, said the switch to MX731 in the MaxFlow let the firm create a device with heat and chemical resistance for sterilization that also has clarity without black specks. Using Tritan's MX731 also will offer significant cost savings by letting LiNA decrease injection and processing time of the device housing by 60 percent, he said.
Although Pittsfield, Mass.-based Sabic did not debut any new materials at MD&M, it did promote the fact that GE Healthcare's Optima XR220amz mobile X-ray machines are using Sabic's Valox resin for the housing and Xylex resin for the storage bins. Launched last fall, the GE machines are not yet on the market.
O'Brien said Sabic will pursue other housing application opportunities for Valox, which offer resistance to the harsh cleaning chemicals hospitals are using to reduce the risk of hospital-acquired infections.
Altuglas International in Bristol, Pa., also is tackling medical applications where the plastic is under constant attack by chemicals or lipids, such as drug-delivery devices and IV components, said Carmen Rodriquez, business manager for resin products at Altuglas, a unit of Arkema Inc. That's why the company launched Plexiglas CR50 resin, Rodriguez said.
It is especially important for dialysis and delivering fluids intravenously, she said. There are regulatory concerns over material safety, new designer drugs tend to be harsher on plastics, and hospitals are using more vigorous chemicals and disinfectants for cleaning.
Also, Plexiglas CR50 contains no BPA, which is important to some medical-device makers, and it is easier to process than copolyester, she said.
Companies are interested in materials that are clear, have good transparency, and don't shatter especially in areas where fluid management and drug delivery come into play, Rodriguez said.
Also driving new material applications is the desire to make products smaller and portable yet more aesthetic, as more health care moves into the home.
Home health care is still one of the biggest drivers, said O'Brien. We have to find material solutions for customers that meet those market trends for self-diagnostic devices and other products that are starting to creep their way into the market.
One such soluton is a non-slip finger grip for a pre-filled syringe designed to be used by people with arthritis. The device was developed jointly by New York-based kitchen gadget manufacturer Oxo International Ltd. and PolyOne's GLS Thermoplastic Elastomers unit for Brussels-based biopharmaceuticals giant UCB SA's drug Cimzia, which treats symptoms of Crohn's disease.
Both the non-slip finger grip and an overmolded ergonomic thumb pad are molded from GLS' Versaflex OM 1060X-9 TPE.
We already have TPE grips on toothpaste, and TPE caps on bottles for pain relievers, said Joe Kutka, GLS global market development manager of health care. As the population ages, that is where the health-care market is going and where our materials will be going. You have to look at how packaging will change in the next five to 10 years.
The trend toward greater use of home medical care will create more applications, said GLS global marketing director Rick Noller.
What we have to do is look at how we design a package or a product so that when you grab a package or a product, it grabs you back and you say, 'Wow,' Kutka said. To do that, I have to understand what are the main processes that support the market.
GLS TPE received a boost from PolyOne's acquisition of New England Urethanes 15 months ago, he said. It has opened the doors to see how people are using our materials and has opened the door to different ways of thinking about how our materials can be used.
In addition, as the marketplace demands changes, and materials companies develop more complex engineered materials, the approach to selling is changing. For years, companies have been coming to us, but now we have to go to them because a lot of people don't understand what's out there and what's possible, Kutka said.
Daniel Lazas, executive vice president of sales and marketing for PolyMedex Discovery Group in Putnam, Conn., agreed: We're actually seeing that sometimes people don't know what's possible with blends of different polymers and additives, he said. So it is our job to solve fundamental problems for them with materials that allow them to do new things.
If there is one common theme today, it is that you need to a technology leader in creating new medical applications, Lazas said.
Other products introduced at MD&M West:
* From PolyMedex company Putnam Plastics, the first combination of multilumen and braid-reinforced tubing. Used for minimally invasive procedures, the tubing eliminates the need to assemble two pieces and gives physicians more operating room.
* From Teleflex Medical in Kenosha, Wis., a coextruded tubing made from perfluoronated ethylene-propylene copolymer that does not require etching.
* From PolyOne GLS, new Versalloy HC grades designed for high-stress, harsh-environmental applications and Class VI medical devices with long, thin flow paths. Based on thermoplastic vulcanizate technology from ExxonMobil Chemical Co.
* Evonik Cyro LLC's Cyrolite acrylic-based multipolymer compound that includes antimicrobial agents, designed for Class 1 and Class 2 medical devices.
* Saint-Gobain Performance Plastics' Tygon ND Series of non-DEHP, phthalate-free medical-grade tubing for Class 6 medical applications and devices.
* Momentive Performance Materials Inc.'s Addisil UV 60 EX elastomer, for medical applications where silicone rubber's physical properties are needed, but lower temperatures are required during manufacturing.
* GE Energy's patent-pending hydrophilic expanded polytetrafluoroethylene membrane Aspire that eliminates the need for filter manufacturers to pre-wet cartridge filters with alcohol before shipping and helps prevent bacteria growth during storage because filters are shipped and stored dry.