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May 1, 2008

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Medical market shows little slowdown (web-exclusive content)

Medical market shows little slowdown

While processors serving the automotive and building and construction markets often must weather intense economic storms, demographic swings continue to make for relatively calm sailing for those serving the medical market.

By 2017, the U.S. government estimates total healthcare spending in the country will double to more than $4 trillion/yr, accounting for one of every $5 the nation spends. The 6.7% annual jump in spending, about triple the inflation rate, will be driven mainly by higher prices for medicines and medical devices, coupled with an aging population. Prospects for market growth in Western Europe and Japan are nearly as rosy, and the sky’s the limit for growth potential in countries with less-developed public health systems.

Among first-time exhibitors at the Medtec show were Netstal, with an Elion 800 (photo, left) molding an insulin pen in an 8-cavity mold, and hot runner manufacturer Ewikon, which offers systems with electrically driven nozzles, of interest for cleanroom molding, and systems with the tight cavity spacing needed for many medical applications.

Though overall market growth seems assured, increased competition has forced healthcare providers to watch their budgets even more closely. One result, according to exhibitors at March’s Medtec trade show in Stuttgart, Germany (organized by MPW parent Canon Communications LLC), is that plastics may receive an above-average slice of the growing pie, compared to alternative materials, especially as demand increases for disposable medical devices.

During Medtec, Jan-Bernd Heitkemper, sales industrial packaging at films processor Bischof+Klein (Lengerich, Germany), said a continuing trend is increased demand from medical customers for cleanroom-produced films and extrusion-coated paper. Many of these applications were previously processed in near-cleanroom facilities, he noted, but now purchasing officers demand cleanroom-made products to give them extra assurance of spotless hygiene for safety and legal reasons. This has forced competitors, Heitkemper said, to imitate what Bischof+Klein has been doing for the last 10 years. In that time it has invested more than €2 million in Class 5 cleanroom production facilities at its headquarters, where polyethylene, polypropylene, and DuPont’s Tyvek high-density polyethylene are processed and converted.

Custom molder and contract manufacturer Plastic Engineering & Development Inc. (PEDI; Carlsbad, CA) has expanded its 5000-ft2 Class 100,000 cleanroom by another 3000 ft2, initially using the additional space to house a turnkey line for the production of an aseptic cap for a needleless injection system. Jack Sparacio, president and CEO of PEDI, told MPW at the Plastec West trade show in late January that the product, which is made up of four parts (outer cap, ring, foam, foil cover), is indicative of the growing portion of PEDI’s business that requires some degree of assembly.

“Our focus is to find customers where we can help with design, tooling, QC, and certification,” Sparacio said. “In the future, we will be able to do more and more assembly.” PEDI accommodated the addition within its existing 50,000-ft2 facility, expanding its current cleanroom into what was previously warehouse space. PEDI, which also offers two whiteroom spaces for assembly, runs 28 injection molding machines ranging in size from 18 to 500 tons, with most presses in the 50- to 110-ton range. According to Sparacio, medical makes up roughly 80% of PEDI’s business.

Nelipack (Venray, the Netherlands), since January 2006 part of Sealed Air, is one of a still-small group of thermoformers with cleanroom processing; much of Nelipack’s business is within the medical market. During Medtec, officials said the firm is considering expansion in India, Russia, and China, as the medical device market grows quickly in all three countries. At Wild+Küpfer (Schwerlikon, Switzerland), Edgar Hubeerm, product development manager, says the molder is adding a new cleanroom with 500m2 of space to house “at least” three all-electric IMMs. Most of the space will be Class 7 certified, with the rest achieving GNP certification. He says “near-patient disposables” are one category of part to be molded there.

Plastics safety labels on medical packaging, developed by medical processor identif GmbH and Fraunhofer Institute, make forgery more difficult. More on this development online at www.modplas.com.

Other avenues offer entry into medical market

Even with the increasing emphasis on cleanroom processing, there are still ways to enter the medical market without cleanroom capacity. For instance, about 10 years ago, processor Lang GmbH, a German molder mostly of eyeglass cases, was able to add new customers in the medical market who required similar cases for products like personal insulin injection sets. Obviously, there’s no need to add a cleanroom for these kinds of products.

But such business, just barely considered ‘medical’, can be tough to keep. Jan Juipers, manager of the medical business at Rosti’s facility in Tilburg, the Netherlands, recalled his firm used to do a lot of high-end molding of cases, for example for Mont Blanc pens, but that business has moved to China as the labor needed to assemble the cases is so much cheaper there. “Those were good times, but they’re gone,” he said at Medtec.

What Rosti does have is an expanding footprint in the medical device market, starting about five years ago with molding of a drum that holds the capillaries of blood from a personal test device for diabetics. New is its injection molding of parts for a cervical cancer home-test device, seen as a potential replacement for PAP tests done at a doctor’s office. A woman can perform the new test at home, send off the sample to a testing agency in a bag that comes with the product, and about two weeks later her doctor has the results. “We expect a lot from this product,” he says.

A number of processors at Medtec identified polyphenylsulfone (PPSU) as a material increasingly specified by medical device manufacturers. Shown are parts made of BASF’s Ultrason P-brand PPSU.

As in other markets, it can also help a processor’s chances if he can offer more than his competitors, said Karl-Heinz Gritsch, technical sales manager for Swiss processor Novoplast (Wallbach). “A big advantage for us is that we offer thermoforming, extrusion blowmolding, and injection molding,” he said. Much of its medical work is in molded or thermoformed housings for medical devices. He says the firm sees increasing customer interest in polyetheretherketone (PEEK), “but it’s challenging as the volumes requested are small and the material can be difficult to process.” The firm makes it own molds, to include those for polyphenylsulfone (PPSU), another material he said is increasingly in demand.

Medtec web exclusive: PVC group defends material’s place in the medical market

Ole Grøndahl Hansen, director of the PVC Informationsrädet (Copenhagen, Denmark) was at the Medtec show to represent the European polyvinyl chloride (PVC) industry under the auspices of the European Council of Vinyl Manufacturers (ECVM; Brussels), said in European medical markets there appears to be little movement away from vinyl for single-use medical devices such as tubing and bags. He said hospitals have looked closely at both price and benefits compared to polyolefins or glass and have opted to continue using PVC, despite hefty anti-PVC marketing efforts by group such as Health Care without Harm. Although some arguments against the polymer were voiced in recent years regarding plasticizer use, the effectiveness of those, he said, has dwindled with the advent of environmentally-friendly alternatives such as BASF’s Hexamoll DINCH plasticizer and similar products coming to the market.

Hansen noted that DEHP, the phthalate used in most medical PVC applications, remains one of the best-tested chemicals available. The relationship with Health Care without Harm has proved very negative, with that group not letting the PVC industry speak at its last conference nor letting it rent a booth at the accompanying trade fair. “We want a dialogue; they’re not interested,” he said.

Despite the sometimes negative news on PVC and especially phthalates, he foresees no great change in the materials’ regulatory status in the near future. “It’s not very easy to substitute when you’re dealing with these applications,” he says, referring to sensitive medical products. “The most important requirement for medical tubing is that it doesn’t kink—so far, no one (material) can compete with PVC,” he said.

Medtec web exclusive: New technology helps prevent counterfeiting

One concern still found in the medical market is the explosive growth of counterfeit medicines that endanger patient’s health. Germany’s Fraunhofer Institute IGB (Stuttgart) and its industrial partner, identif (Erlangen, Germany), have developed a new approach to anti-forgery security for flexible plastic packaging. “We coat plastics films with fluorocarbon nano-layers, on top of which the metal layer generating the color effect is applied,” explained Michael Haupt, project manager at Fraunhofer IGB, during the Medtec show in mid-March. “The advantage is that the basic characteristics of the material remain unaltered, while the surface of the film is optimized by the nano-coating for further processing.”

The nano-layers are applied in a low-pressure plasma chamber by placing a label in a vacuum chamber where fluorine gases are introduced and ignited. “We can deposit different coatings with defined properties on the label surface, depending on the proportions of electrons, ions, neutrons, and photons in this luminous gas mixture,” said Christian Oehr, department head at Fraunhofer IGB. Subsequently, identif applies an additional layer of thin metal to the polymer surface, with that metal generating color effects. Due to the underlying flurocarbon layer, the color-change effect can be copied only with extreme difficulty, while the label is more easily machine readable, he says. The two organizations introduced this new product during last year’s K2007 trade show.

Medtec web exclusive: Medical Technical Center offered online

Eastman Chemcal (Kingsport, TN) launched a new online Medical Technical Center at www.eastman.com/Markets/Medical_Technical_Center to assist with the medical product development process. Glenn Petrie, marketing manager for medical packaging at Eastman, told MPW that one year ago the supplier of copolyester launched its web-based Innovation Lab, geared towards the design community. The Technical Center will consider viable materials by process and product.

Eastman offers its Eastar copolyester 6763 for rigid packaging, with 15 grades available for injection molding. The company also offers Ecdel elastomer as a polyvinyl chloride (PVC) replacement for products like IV bags.

Medtec web exclusive: VEM Tooling works to separate itself from the pack

One first-time exhibitor at the Medtec show in Stuttgart, Germany in mid-March was VEM Tooling of Shatin, Kong Kong and Shenzhen, China. Günter Koch, a trained moldmaker, represents the firm in Germany and says medical is just one of the markets served by the firm, which he claims is one of China’s top 10 moldmakers. “We want to separate ourselves from the ‘cheap molds’ crowd,” he said, noting the firm’s U.S. and European ownership includes persons with experience in top-notch moldmaking firms.

About 60% of the firm’s molds are ordered by North American processors, the remainder by ones in Europe, Koch said. “We have service partners in the U.S., France and Germany to service the molds” if necessary, he said. “We don’t just deliver the mold.”

Koch expects a major shakeout in China’s moldmaking industry, with the result a number of low-end manufacturers will go out of business. “I think the boom times in China are past—only good moldmakers really have a chance now,” he said. This summer, the firm will add additional moldmaking capacity in Taiwan, he said.

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