Medical Manufacturing: A Strong Pulse

We all know the adage about the difficulties of teaching an old dog new tricks.

For those wondering if a well-established manufacturer can learn new ways of staying competitive, look no further than Columbia Plastics Ltd.

The 65-year old Surrey, B. C.-based plastics processing company made a recent move into the world of medical parts molding, and hasn’t looked back since.

Founded in 1945, and maintained as a family-held corporation since 1961, Columbia Plastics weathered numerous recessions and industry changes over the decades, acquiring a great deal of experience manufacturing small, high tolerance parts along the way.

Some five years ago, though, the company’s management sensed the approach of something that threatened to alter the fundamental shape of the business landscape. “We came to realize how serious the threat from offshore competition was becoming, and began looking for types of molding that offshore companies wouldn’t be very strong in,” said Greg Howard, Columbia Plastics’ president. “Given our long history of working with small, high tolerance parts, we decided that medical-device molding would be a good fit.”

GOING CLEAN

An early step in this new direction was the installation of a permanent Class 10,000 cleanroom, a particularly high certification standard that provides an environment with between 50 to 100 times fewer particles per cubic foot of air than is found in a typical office building. The cleanroom allows Columbia Plastics to mold particularly critical medical parts, such as components used in invasive surgical procedures. “We decided at the outset that we weren’t going to approach medical molding halfheartedly, and that having this cleanroom was crucial to opening up new possibilities,” Howard explained. “At present, we’re still one of only three Canadian molders to have a permanent Class 10,000 cleanroom.”

Armed with a cleanroom, the company’s next step involved building a client base one customer at a time, usually by attending and making contacts at medical industry trade shows.

After that, the molding itself presented only limited challenges. “From the time of our first contracts, the main adjustment we had to make didn’t relate to the technical aspects of medical molding, but rather to the fact that everything is driven by procedure,” Howard said. “But since we’d been ISO-certified for over 10 years by that point, we were able to adjust to this fairly quickly.”

At present, Columbia Plastics carries out a mixture of both cleanroom molding and molding that meets the lesser standard of so-called clean manufacturing environment. “The surgical and diagnostic parts that we make require Class 10,000 cleanroom molding, assembly, and packaging,” Howard said. “Our health care parts require only a clean manufacturing environment.”

GROWING OPPORTUNITIES

Perhaps ironically, having the cleanroom opened up possibilities in other types of injection molding at the company’s 50,000 square foot, 28 injection molding machine-strong facility. “We also use our cleanroom for sterile non-medical molding, such as electronic parts, that need either cleanroom molding or cleanroom assembly,” Howard said. “On some electronic parts, the wafers or RFID tags, for example, need to be packaged in a cleanroom environment.”

Medical parts molding, for both domestic and foreign customers, currently accounts for approximately 10 per cent of Columbia Plastics’ business, Howard said, although this figure is growing. The competition for medical molding contracts is growing too, but Howard takes this in stride. “When it comes to medical molding, we’ve shown our customers that we’re early adopters,” he said. “We’re happy to be at the head of the pack.”

Columbia Plastics Ltd. (Surrey, B. C.);

www.columbiaplastics.com;

604-530-9990 There’s no shortage of plastics processors looking to break into the medical parts market nowadays. Not many of these shops, however, engineer their products in the U. S., manufacture them in China, and then sell them into Canada. And even fewer have prolonged experience working with the type of high performance materials required in most medical parts.

China Array Plastics fits the bill on all counts.

Founded in 1980, the custom injection molding company has sales and engineering offices in Pittsfield, Mass., an injection molding facility in Wuhan, China, and customers that include award-winning medical parts supplier Canica Design, of Altamonte, Ont.

A longtime molder of complex electronic and aerospace components, China Array began manufacturing medicaldevice parts in 2008. According to Carl Olson, vice president of sales and marketing, the company was able to adjust to the demands of medical suppliers relatively easily, due to its history of molding high performance materials. “Our company was set up specifically for molding high performance plastics in China,” he said. “This gives us the experience to work with polysulfone (PSU), polyetherimide (PEI), polyetheretherketone (PEEK), all of which are commonly used in medicaldevice parts.”

Branching off into the medical molding industry was a welcome development for the company, Olson said. “Compared to other injection molding markets, the traditional markets for high performance parts are limited, because the materials are very expensive and the volumes fairly small,” he explained. “The medical parts market, by contrast, is growing rapidly, even through the present economic slowdown. Medical OEMs are seeing the advantages that high-end thermoplastics have over metals, glass and lower-performing plastics, offering a tremendous opportunity not only to China Array, but to the plastics industry as a whole.”

THE BEST OF BOTH WORLDS

Olson points to the mix of Asian and North American elements as one reason for China Array’s success in the medical-devices market. “We’re able to combine the low manufacturing costs associated with molding in China with the expertise of our U. S. technical staff; too many mold shops have a limited number of technical people that they can call on when doing high performance molding of medical parts,” Olson said.

Medical manufacturing currently makes up approximately 25 per cent of the company’s business, Olson said, a number that is expected to grow. He also noted that, at present, the company is not molding any implantable medical devices. “Our products are used either in general surgery or analysis,” he said. “They have to be clean, of course, but we don’t have to guarantee sterility.” China Array uses portable, softwall cleanrooms, but is planning a dedicated cleanroom for an expansion project set for the end of 2009, allowing the company to compete for an even wider range of contracts.

The company is also planning to mold medical parts for the Chinese consumer market. “This is a huge growth market, given the growth of a middle class that is now expecting and demanding health care,” Olson said.

Although the core of China Array’s business is high performance materials for high performance applications, the company will also take on less stringent jobs. “We’re quite happy to do low volume production runs to accommodate our customers, and then work to get larger orders of high performance parts,” Olson said. “It’s a necessary step nowadays in setting yourself apart from the competition.”

The company also assembles many of the parts that it molds. “Our interest in doing assembly is that it allows us to control the tolerances,” Olson said.

“I’ve seen mold shops that were quite proficient at certain types of molding but didn’t have the experience of controlling quality or controlling other features,” Olson said. “We feel the advantages we have are a good working knowledge of the medical industry, and an even better working knowledge of what it takes to do high performance parts.”

China Array Plastics (Pittsfield, Mass.);

www.ch
inaarray.com;

413-499-9890 Demand for medical plastics in North America is forecast to expand 2.6 per cent annually to five billion pounds in 2012, valued at US$6.55 billion, according to a recent study by Chicago-based market research firm The Freedonia Group. With plastics processors finding more and more opportunities for manufacturing for the medical-device market, resin suppliers are stepping up production of higher performing materials suitable for a wide range of challenging health care applications.

TPEs

GLS Corporation is launching a portfolio of specialty Versaflex TPEs, engineered for dynamic-seal gaskets and static-seal stoppers for the health care industry. The GLS materials support regulatory and eco-initiatives by avoiding halogens, poly-nuclear aromatics (PNAs), nitrosamines, 2-MBT, and other controversial additives. For gasketing applications such as drug storage seals, the new grades are said to provide good coefficient of friction. Both dynamic sealing grades are available in black. For stoppers, the new Versaflex grades for static sealing avoid the issue of coring -bits of material breaking off during needle insertion -that is typical of thermoset rubber. According to GLS, it has successfully tested the resealing performance of its Versaflex HC 2110-43N grade with needles as large as 16 gauge. Both static sealing grades are autoclavable and are available in natural colour. Applications include blood collection and pharmaceutical containers. Versaflex HC 2110-43N is said to offer good reseal performance and good compression set for stoppers for fluid delivery devices such as IV bottles and medical vials.

Teknor Apex Company is introducing a new medical-grade TPE guide called Medalist, containing extensive data on each of 33 Medalist high-purity elastomer compounds for health care applications. According to the company, information includes a grade selector plus data on toxicology, sterilization, chemical resistance, physical properties, processing parameters, process guidelines, and design considerations. Complete information in all of these categories is available for each of the 33 Medalist elastomer grades currently available. This initial range of 33 Medalist compounds includes grades with Shore A hardness from 5 to 87. Clear, translucent, and opaque formulations are available.

New from Saint-Gobain Performance Plastics, Tygon S-95-E is a clear, non-DEHP medical-grade TPE designed to provide good peristalic pump life and flexibility. According to Saint-Gobain, the material meets USP Class VI and FDA standards, and is able to withstand both EtO and gamma sterilization. Tygon is offered in a range of tubing formulations and sizes. Non-DEHP PVC formulations are also available.

COLOURS

Clariant Masterbatches is offering new colour concentrates specifically formulated for use with Purell medical-grade polyolefins from Lyondell- Bassell. According to Clariant, Purell PE and PP resins were developed to deliver high performance, flexibility, and stability in applications in the cosmetic, pharmaceutical, medical device, laboratory, syringe, and diagnostics industries. The standard Purell-based Remafin MD masterbatches include a wide range of solid, opaque colours, as well as translucent and transparent tints. Class-VI-compliant custom colours are also available. The company has also made available colour concentrates Last year, in order to gauge how interested Canadian processors were in the growing medical products market, Canadian Plastics sent out a medical manufacturing survey to molders and extruders.

We have conducted a second medical manufacturing survey this year, and the results are quite revealing.

Over 70% of this year’s respondents were injection molders, but we also heard from several pipe (8.8%), profile (23.5%) and tubing (14.7%) extruders.

When asked if they manufacture devices or components for the medical sector, nearly half of the manufacturers surveyed responded in the affirmative. This is a significant increase when compared to last year’s survey, where only 36.4% of respondents were manufacturing medical products.

Additionally, manufacturers also seem to be more interested in entering the medical market. Out of the respondents that don’t currently serve the medical industries, 48.1% said they hope to manufacture products for the sector in the next two years, compared to 36.4% in 2008.

Increases in the number of companies serving or looking to serve the medical field shows that manufacturers are looking at the emerging market in the face of weakening traditional business segments.

Canadian manufacturers also continue to invest in technologies that support medical manufacturing. Fifty per cent of this year’s respondents have cleanrooms and controlled environments at their plants, and processors are also investing in micro molding machinery and equipment (23.5%), other machinery or equipment related to medical applications (20.6%), and special certification or compliance with industry standards (23.5%).