Market Snapshot: Medical devices 22335

The recession has taken its toll on nearly every industry, and that includes medical devices, to some extent. OEMs are feeling the pressure and depending more on their supply chain—materials suppliers, moldmakers, and molders—to help them get products approved and to market faster.

Medical device OEMs are getting ready to confront new challenges in the healthcare market, particularly in the medical device segment. However, the uncertainty hasn’t stopped them from developing new products. Stephen J. Ubl, president and CEO of the Advanced Medical Technology Assn. (AdvaMed; Washington, DC), writing for Ernst & Young’s Pulse of the Industry Medical Technology report 2009, said, “The U.S. Congress is considering a significant overhaul of the U.S. healthcare system, and its outcome is as uncertain as a weather prediction.”

Ubl’s prediction? “I am convinced that whatever shape health reform takes, the unique and essential role that medical technology plays in healthcare will become increasingly important,” he wrote, citing as reasons an increase in U.S. life expectancy (currently 78.1 years, an all-time high) and an annual death rate that has dropped to an all-time low of 760 deaths per 100,000 people.

Medical technology is providing the means for people to live longer, more productive lives, as it is “improving the quality of care and achieving better patient outcomes.” Also, stated Ubl, “[The medical technology industry] contributes significantly to the U.S. economy, providing jobs that pay on average 30% more than the average U.S. job. Thanks to the ‘multiplier effect,’ every medtech job also results in 4.5 additional jobs across the nation. And our industry is competitive. Medical device price changes have been consistently low, lagging behind both the Consumer Price Index and the Medical Services Price index from 1989-2006.”

These might be the reasons why innovation in both medical device design and material innovation continues apace in spite of future challenges that changes in the healthcare system might bring. While the medtech industry has always been seen as recession-proof, Ernst & Young’s report notes that the question remains whether or not this would hold up amid one of the worst recessions in more than seven decades.

“The industry’s financial performance . . . has largely held steady,” notes the report. “The revenues of publicly traded medtech companies in the U.S. and Europe grew 11% to $289 billion,” states the report. “And while net income fell by 11% in 2008, this was mainly due to large one-time charges.” However, the report acknowledges what any company in this market segment knows: “The recession does appear to have taken a toll in the first half of 2009, when revenues remained essentially flat (a decline of less than 1%) compared to the same period in 2008.”

Material developments aplenty
There’s been little slowdown, if any, in suppliers’ development of new materials for the healthcare industry. For drug delivery devices, one of the most critical issues is ensuring patients receive consistent dosages, something essential to successful treatment, notes custom plastics compounder RTP Co. (Winona, MN). When medication is delivered by aerosol inhalation, such as for asthma sufferers, administering inconsistent dosages can be problematic. It has been shown that VHCs (valve holding chambers) can attract and hold residual amounts of medication due to static buildup, especially with the new inhalers that have replaced chlorofluorocarbon (CFC) propellants with hydrofluoroalkane (HFA). RTP was called upon to solve static buildup issues for Philips Respironics, a leading OEM in the sleep and respiratory markets, by developing a material for its OptiChamber Advantage II VHC for asthma patients.

Ticona Engineering Polymers (Florence, KY) recently made available its Hostaform MT (Medical Technology) 8U05, a UV-detectable acetal copolymer (POM) for enhanced quality control in the production of complex medical devices. Deven Patel, Ticona medical marketing manager, says, “Hostaform MT 8U05 contains a special additive that enables easy, reliable inspection of components with ultraviolet light. Manufacturers can now use Hostaform MT 8U05 to reduce the reject rate of final products, which will minimize production costs and raise capacity.” The UV-detectable polymer can also be used in original equipment components to identify counterfeit products, he adds. The new Hostaform grade complies with the requirements of several healthcare authorities, including those of the U.S. Food & Drug Administration (FDA) and of the European Union relative to food compatibility.

A cyclic olefin copolymer (COC) from Topas Advanced Polymers’ (Florence, KY) is being used for a number of healthcare applications, from transparent pharmaceutical containers and prefilled syringes to surgical instruments and diagnostic equipment. Topas COC offers low extractable ions, helps extend shelf life, eliminates the need for overfilling, and ensures the proper dosage is delivered to the patient.

Another material, Crystal Zenith (CZ), is replacing glass in vials for pharmaceuticals. Daikyo CZ, made by Daikyo Seiko Ltd., is West Pharmaceutical’s (Lionville, PA) Japanese partner in providing this durable material, which is non-flaking, highly transparent, very low in extractable ions, and high-heat resistant. One application is West Pharmaceutical’s ConfiDose auto-injector system for self-injection of a fixed-needle, prefilled syringe. The Tech Group, a West company, manufactures the device.

Molders, moldmakers step up
Molders and moldmakers that specialize in supplying medical device OEMs are aware of the complex processes these OEMs go through to gain approval. “Medical OEMs are looking to drive down costs while driving up profits to satisfy stakeholders,” says Jerry Seidelman, sales and marketing manager for Tech Mold Inc. (Tempe, AZ), a mold manufacturer primarily for the medical and pharmaceutical industries. “New products are often difficult to get into the marketplace because of lengthy and costly FDA protocols, which means many mature products can’t readily change significantly. FDA approvals for medical products are, in a way, like PPAP in the automotive industry, since it can take anywhere from six to eight months or longer to gain approval.”
Seidelman also notes that these OEMs expect much more from their suppliers than they did a decade ago. “Medical device OEMs expect their mold manufacturers to have a range of capabilities that might include collaborative engineering, new product development assistance, prototype or preproduction mold capabilities, ability to design molds for automation, and even integrate complete manufacturing cells for optimum molding in a cleanroom environment.”

Mack Molding’s Application Development Center (ADC) and Mack Prototype Inc. (Gardner, MA) recently purchased two Stratasys FDM (fused deposition modeling) machines to enhance Mack’s engineering capabilities for its medical OEMs. Each machine has unique capabilities to fit the needs of the two divisions. Randy Pell, senior staff design engineer in the ADC, notes that the FDM machine in his division is smaller and builds parts of ABS resin in an 8-by-8-by-10-inch envelope, and in 0.010-inch-thick layers.

“We use the FDM equipment to perform design verification and to ensure that snapfit parts are functional, as just a couple of examples,” he says. “Using this allows us to set up our quality processes, such as how to measure a part, determine the fixtures we’ll need, and even print out our fixtures using the FDM machine. In the orthopedic market, many of the components used in surgery might look identical, but actually differ in size by a few millimeters, so we can set up fixtures to ensure each component is being measured correctly. We can help our customers bring new products online faster.”

Mack Prototype’s FDM machine (Fortus 400) runs two different materials—ABS 30i (ISO 10993 biocompatible material), and a PC/ABS, which allows the division to make parts that not only can be used in testing and clinical trials, but also can be in an end-use product. The machine will print a much larger part—14 by 16 by 14 inches in resolutions between 0.005- and 0.013-inch-thick layers—which is one of the largest build envelopes available through a custom manufacturer in the New England region, notes Ric Perry, president of Mack Prototype.

“We’re finding that we do a lot of CNC machining of components, and this FDM process is closer to a machined part than the SLA was,” says Perry. “We can make parts in ABS or PC/ABS, and in a parallel path with the machined parts. We can be machining multiple parts as well. The FDM process is also suitable for low-volume parts. It can be cost effective to print the parts rather than making a metal mold and molding parts, depending on the part and the geometry.”

Pell adds that end-use resins are strong enough today to work in surgical environments where metal used to be the only material suitable, and thus reduce costs. “Hospitals have to autoclave metal instruments, so by offering a way to convert a metal instrument into resin, we can help our customers bring down the cost of the instrument by making the actual instruments disposable. In this instance, we use FDM to print out resins that would be like the disposable trials, so you wouldn’t have to build prototype molds—another time and cost savings.”



Getting help from your resin suppliers
Like many polymer suppliers, Sabic Innovative Plastics (Pittsfield, MA) has worked hard to make sure data on its medical-grade materials is readily available and already approved by the relevant authorities for medical use, so that the choice of material is no brake to a new product’s speed to market. The company’s healthcare product policy is contributing to faster marketing approval—something that all OEMs are striving for—and successful commercialization of a range of medical devices.

“Our medical device customers look to Sabic Innovative Plastics to help them comply with toughening regulations imposed by the FDA, European Food Safety Authority, and other agencies to enhance patient safety,” says Tom O’Brien, product marketing manager for Lexan and performance healthcare products. “Our solution was to proactively develop an industry-leading healthcare product policy to simplify regulatory compliance, both during the marketing approval and throughout the device lifecycle. Pre-assessing biocompatibility of our healthcare products helps speed up marketing approval in the regulatory process, while internal controls and change management help assure consistent quality and reliability.”

O’Brien says that the healthcare product policy is important because of the obvious focus on safety. “Safety is key for device manufacturers, so there is push-back on material suppliers to perform biocompatibility assessments,” he says. “When we put this policy together, our intention was to supply materials within our healthcare portfolio to ensure that we had a clear understanding of this, which resulted in our ‘formula lock’ as a way to manage change, an FDA master file listing, and biocompatibility assessments that show device manufacturers that we’re helping them get to their final approval.
“It basically makes life easier for the device OEMs,” he continues. “It doesn’t mean the device manufacturers don’t have to do things from their end, but we can say unequivocally, as long as you’re using our biocompatible materials, it shouldn’t hamper getting your approvals.”

Dave DeVito, product marketing manager for LNP and specialty healthcare products at Sabic IP, says the healthcare product policy is key in compounding because there are more raw material variables involved. In addition, a big concern of medical device OEMs today, he says, is the continuing supply of their qualified material.

“There are two key parts of our healthcare product policy, and first is addressing the surety of supply,” he says. “Top sourcing people say that is number one on their list. Any change in material causes a lot of headaches for the healthcare OEMs, including engineering, money, and time to qualify another material. Many of our recent LNP innovations are designed to improve efficiency to reduce OEM and patient costs as well. In addition to efficiency, another key area of our healthcare innovation focus is to improve product safety. We have a series of new LNP products specifically designed to improve safety.” Three new bio-assessed, clear, inherently antistatic LNP Stat-Loy specialty compounds are among these products, which will be introduced at the MD&M West show in Anaheim, CA (Feb. 8-11), and are intended to improve the efficiency of pharmaceutical inhalation devices. —Clare Goldsberry