PRODUCT UPDATE
Make Your Moulding Supplier an Outsourcing Partner
Norbert Sparrow
By tapping into a contract moulder's range of expertise, OEMs can achieve cost savings and speed time to market.
Are you taking full advantage of your contract moulder's breadth of knowledge? For some OEMs the answer is no, and they may be paying dearly for it.
What OEMs need to realize, says Paul Flavell, account manager at West Pharmaceutical Services (Lewes, E Sussex, UK), is that there is more to injection moulding than squirting hot plastic into moulds. Manufacturers who make an effort to leverage the moulder's skills can save themselves considerable expense and accelerate their products' time to market.
"The injection moulder has a broad portfolio," explains Flavell. "He's really a project manager who can get involved in product development, materials selection, and the coordination of sterilization and packaging suppliers," he says. The sooner an OEM involves the contract moulder in a project, he adds, the more likely the supplier will be to identify and remedy problems that could become a drain on resources and waste valuable time further down the road. Material selection is a prime example, says Flavell.
Moulding and a range of other contract services are provided to device OEMs at Wilden's facilities in Europe and the United States.
"A manufacturer might specify a particular material for an application and have tooling made for that purpose," says Flavell. "What he may not know, however, is that the material scuffs easily, making the end product cosmetically unacceptable. This means he has to switch to a different material that is functional but won't scuff." The new material may have different shrink characteristics, he adds, and to accommodate this the tooling would need to be modified in order to produce the correct dimensions for the component. "That's expensive and delays development," says Flavell. "The problem could have been avoided simply by sitting down with the moulder and discussing the project from the outset."
There's a consultancy aspect, Flavell adds, that can encompass product design, material selection, tooling manufacture, and so forth that OEMs would be well advised to exploit. In fact, many companies are doing precisely that as they rely increasingly on outsourcing to maintain their competitive edge.
The One-Stop Shop
"Many OEMs don't build devices in their own facilities anymore," says Johan Lindqvist, marketing manager at Perlos Oyj (Nurmijärvi, Finland). "As soon as they have the basic idea, they begin looking for subcontractors to become part of the project, and that, of course, is driven by the need to get products to market fast," says Lindqvist. This evolving demand has prompted Perlos to almost double its controlled environment moulding and assembly capabilities. The 11,000-m2 expansion will enable the company to be more flexible to demands from its OEM customers.
Wilden Engineering- und Vertriebsgesellschaft mbH (Regensburg, Germany) also touts its wide range of abilities to meet customer needs. "When a customer comes to us with an idea, we can take the concept into the design phase, build the mould, and design automation equipment, if necessary, to perform the assembly and testing," says Norbert Kaspers, sales manager, medical plastic components. In addition to development, production, and assembly, the company is even set up to handle logistics. "And if the customer wants us to manage the recycling process, we can do that too," notes Kaspers.
Cost cutting, defect reduction, and quality assurance, not surprisingly, are also high on the list when OEMs are striking deals with contract moulders. One full-service moulder has found a way to satisfy those demands by routing work through its facility in Slovakia. Plastic Molding Technology (PMT), a US firm headquartered in Seymour, CT, has operated a plant in Bratislava since 1991.
Tooling designed and manufactured at the Slovakia factory may cost 40% less than comparable products originating in Western Europe or the United States, according to managing director Chuck Sholtis. The question of quality is raised by potential customers, concedes Sholtis, but PMT can allay those concerns. "You really have to prove yourself to the customers, and we do that by showing them testimonials from satisfied clients," says Sholtis. (Currently, nearly 30% of the company's output goes to device OEMs.) "And we have an aggressive policy of investing in sophisticated equipment and focussing on quality systems," he adds. The facility is scheduled to have ISO certification by April.
Continuous Improvement
Meeting OEM expectations does not have an end point, contract moulders agree, and the challenge for them is to anticipate the evolution of demands.
"ISO certification is a given. Today, our customers are looking for environmental, waste management, and continuous improvement policies," says Flavell. Illustrating the pressure to show continuous improvement, Sholtis cites a recent meeting with a customer. "According to their records, we had 194-parts-per-million defects last year. They want us to bring that number down to less than 50," says Sholtis. "And we will, but those are the types of demands that are becoming common in terms of quality improvement."
"The medical device industry," says Flavell, "has high expectations of quality, service, and technical support. You really have to be on the ball if you want to be taken seriously as a player."
If you are currently or will be sourcing a supplier of moulding services or equipment, take a moment to read the company profiles on the following pages. All of the firms included in this section have demonstrated a commitment to providing OEMs with products and services that are uniquely adapted to the medical device market.
Perlos Oyj, CEP Plastics Div.
Being responsive to rapidly shifting customer demands is a priority at Perlos Oyj (Nurmijärvi, Finland), a company that supplies moulding and assembly services. Indeed, flexibility was one of the key criteria for leading mobile telephone companies when Perlos entered that sector as a main supplier of plastic parts. "There is a lot of assembly involved in the production of mobile phone parts along with constantly changing demands, and that got us accustomed to doing rapid changeovers," says marketing manager Johan Lindqvist. "In the mobile phone business, change is the only constant," he adds.
The firm brings this tradition to its partnerships with medical device OEMs as well. Lindqvist cites one project that involved the moulding and assembly of parts for an insertion unit used with an intrauterine device. "We moulded about 10 separate parts that had extremely tight tolerances to enable automated assembly," notes Lindqvist.
To provide its customers in the device field with additional services, Perlos will launch a new facility in March that is entirely dedicated to the moulding and assembly of medical parts. The expansion will add 11,000 m2 to the firm's controlled environment production area, almost doubling the current capacity of CEP Plastics. The plant, which will include a Class 100,000 cleanroom, will house approximately 100 injection moulding machines ranging from 20 to 125 t. Being able to handle projects of varying quantities was a key consideration in designing the production facility, according to Lindqvist. "This is not just one big hall," he says. "It was constructed in a modular layout. The air filtration, for example, can be modified to suit a range of projects in different parts of the facility."
The expansion will enable the company to respond quickly to changing demands from medical device OEMs, thereby increasing its flexibility, says Lindqvist. "Device companies don't build devices in their own facilities anymore. They have the basic idea for the project and then look for a subcontractor early in the project to manage it," he explains. "The whole idea is to get the product to market faster, and we have the capabilities to help OEMs achieve that," says Lindqvist.
Groupe Roland Bailly S.A.
Located in Besançon, France, the Groupe Roland Bailly S.A. initially produced moulds for the production of microparts used in the watchmaking industry. The company rapidly gained expertise in micromoulding, producing gears as small as 0.0428 mm. "We began to work with the device industry as an extension of our activities with watchmakers," says managing director Thierry Bailly, "because both sectors are focussed on the moulding of very small components." Although medical production currently accounts for 20% of its turnover, the capabilities of Groupe Roland Bailly increasingly make the company an attractive partner for device OEMs, according to Bailly.
"Initially, our customers just wanted a mould. But more and more they want us to produce the parts and to do the assembly and perform quality control," says Bailly. "Our secondary activity—the production of bowl feeders and related equipment—gives us an advantage in this area." The firm manufactures vibrating bowls and centrifuges in a variety of diameters, as well as loading units and orientation devices. Automated assembly devices are also produced. "This diversity allows us to develop and manufacture the tooling, produce the injection-moulded parts, and supply the automated assembly equipment," says Bailly.
The company is equipped with an array of mould-making equipment, including lathes, CNC milling machines, grinders, and electrical discharge machines. On-site metrology equipment includes profile machines and measuring columns. Two Battenfeld injection moulders—a 35-t horizontal and a 25-t vertical unit—are also installed at the facility. "The production of injection-moulded parts is a relatively new field for us," says Bailly, "but our objective is to develop this sector."
Harmac Medical Products Inc.
Specializing in the production of custom medical disposables, Harmac Medical Products Inc. (Buffalo, NY, USA) offers an array of services from product design and moulding to packaging and sterilization. Its facilities in the United States and Ireland are equipped with Class 100,000 cleanrooms with Class 10,000, Class 1000, and Class 100 capabilities. The company currently has 21 moulding machines in operation, including several insert moulding presses. In fact, says sales manager Dick Malo, insert moulding technology is an area of expertise at Harmac.
"We tend to take on moulding projects that have some added value attached to them," says Malo. "Insert moulding is a good example. We produce a biopsy needle, for instance, with a stainless-steel needle and a stylet. The needle is placed into the mould and we shoot the plastic around its base where the hub would be," he explains. "This is an efficient way of bonding dissimilar materials."
The firm is certified to ISO 9001 and EN 46001 and is US FDA registered. In addition to the aforementioned capabilities, Harmac provides extrusion and impulse and RF welding services, tooling design and fabrication, and in-house quality assurance.
TAV Medical Ltd.
A company that designs and produces multicavity moulds with or without hot-runner systems serves such industries as the medical sector where accelerated time-to-market is desirable. TAV Medical Ltd. (Shlomi, Israel) favours a collaborative approach with its customers, using CAD systems to draw up design blueprints that include detailed mould production drawings suited for the fabrication and assembly of as many as several hundred moving parts. The firm sets all tolerances, based on material contraction characteristics and the client's own production tolerances.
Mould fabrication can be designated according to the company's advance planning or rolling planning methods. While the former is more commonly used, the latter is especially useful when time is a critical factor. Rolling planning enables mould production to begin as soon as the customer agrees to the part concept. Specific details are finalized as production progresses.
Tooling that is routinely produced for medical device OEMs includes two-cavity full-hot-runner moulds and four- and eight-cavity semi-hot-runner moulds. All of these models feature two-step ejection and incorporate Kistler pressure sensors to enable monitoring of the actual cavity pressure.
Tanner Formenbau AG
Reportedly the first mould maker to gate syringe barrels below the gripper plate, Tanner Formenbau AG (Feuerthalen, Switzerland) combines sprueless mould technology with high-precision engineering. Its multicavity hot-runner injection moulds are used globally for the production of pipette tips, syringe barrels, and related devices. One reason the company has been successful as a supplier to the device industry, according to technical sales manager Christoph Humbert, is because it has consistently allocated substantial resources to research and development and shown a commitment to in-depth specialization.
"Unlike other toolmakers that work with OEMs in different sectors of activity, we have specialized in medical," says Humbert. This specialization has enabled the firm to fabricate hot-runner injection moulds attaining 128 cavities suited for the large-scale production of medical parts. The most popular models, however, adds Humbert, remain the 32- to 96-cavity moulds.
Tanner recently began producing tooling for the cosmetics industry as well as for medical OEMs, and this has created some new opportunities for customers in the device field, says Humbert. "In cosmetics, you work with different polymers and colours. In medical, we have essentially been limited to the use of clear polypropylene and polystyrene," he says. Tanner, Humbert notes, is looking forward to applying these new processes to the development of products for the device sector.
One of the primary features of Tanner's moulds is their easy changeover capability. "The tools are constructed so that they can be changed within the press," he says. "You don't have to remove the mould to change the part." And because the gating is within plain view, incompletely filled mouldings can be easily identified and ejected.
Labplast International
Equipped with 16 injection moulding machines ranging in size from 35 to 200 t, Labplast International (Shipley, W Yorks, UK) offers full-service contract manufacturing for analytical and diagnostic equipment OEMs. Four of the injection moulders feed into a 650-m2 clean air facility; a Class 100 cleanroom incorporates Class 1000 process lines for aseptic manufacture and custom assembly. Ancillary processes such as filling, capping, sonic welding, and labelling are also offered.
"Labplast began about 20 years ago producing blood collection tubes," explains business development manager Richard Scott. "We were one of the world's largest manufacturers of conventional blood tubes, which were marketed under the LIP brand name. Injection moulding was initiated mainly for the production of our own laboratory consumables," says Scott, "and we expanded on that to develop the contract moulding side of the business." The company's turnkey manufacturing services has attracted device manufacturers in impressive numbers: its OEM business grew 22% in 1998 and the company projects 18% growth for 1999, according to Scott. Part of the reason for this expansion, says Scott, is the firm's focus on its core activities.
"We are dedicated to the injection moulding side of the business, which is where our expertise lies," says Scott. "We manufacture the plastic parts and provide the assembly of consumables for use in diagnostic and analytical equipment, and we only take on projects that can benefit from our expertise in plastics manufacture."
Individual assembly lines are tailored to the client's product requirements, and all automation processes are project specific. From product development to packaging redesign, the company prides itself on providing a rapid response to changing market requirements.
Battenfeld
To respond to the surging demand for miniature moulded parts, Battenfeld (Meinerzhagen, Germany) launched its Microsystem almost two years ago. The electric system that produces components weighing as little as 0.8 mg is more than an injection moulding machine: it incorporates a handling module, 100% optical quality control, and integrated cleanroom conditions for the production, packaging, and feeding of the part to downstream assembly stations. At its world premiere, the Microsystem was shown moulding a hearing-aid housing weighing 2.2 mg. Since then, additional testing on parts and materials for use in devices has been conducted, according to project manager Martin Ganz.
"We have tested two other medical parts recently," says Ganz. "One is a hearing aid and the other is a product that involves the use of biodegradable materials. That project is still ongoing and requires modified moulds and injection units," he adds. The company has encountered some difficulties obtaining moulds that achieve the dimensions and tolerances required for parts with such small dimensions while maintaining clean production methods. "When we manage to successfully produce those parts, we will feel like we have truly accomplished something," says Ganz.
Other materials slated for testing on the Microsystem include PEEK, PPS, and liquid crystal polymers. "Metal injection moulding applications are also on the schedule," adds Ganz. "So you see, there are many potential medical device applications using this system."
One application for which Ganz sees a bright future is the production of lenses used in diagnostic equipment. "Manufacturers require extremely small and highly accurate lenses," says Ganz, adding that Battenfeld's equipment is well suited for the moulding of these components.
The company also offers a gas-assisted injection moulding process called Airmould (in which nitrogen is introduced into the interior of the mould cavity) or Airmould Contour (the gas flows between the rear of the moulding and the part wall). This technique enables a reduction in cycle times and tonnage requirements while enhancing the moulded part's surface finish by eliminating sink marks. Dimensional stability is improved and part weight reduced, thereby lessening the amount of material used.
Ghilardi Stampi S.r.l.
Custom solutions based on specialized knowledge of the needs of device OEMs is one of the fortes of a mould maker based in Cologno Monzese (MI), Italy. Ghilardi Stampi S.r.l. recently developed two high-throughput moulds for the device industry that exemplify this business philosophy.
A 252-cavity mould (pictured) was designed and built using conventional tooling for the production of medical protectors. The firm also developed a stack mould, with 144 cavities per stack, for the manufacture of needle hubs. Both moulds, according to marketing director Giampiero Tagliabue, are examples of the company's commitment to the production of tooling that boosts productivity while being simple to maintain. "Both moulds are equipped with hot-runner systems conceived and manufactured by Ghilardi," notes Tagliabue. "Throughput on the stack mould achieves 134,600 pieces per hour while the 252-cavity model produces 153,700 parts per hour," he says.
Approximately 50% of Ghilardi Stampi's output currently is directed toward the medical device industry; 60% of total production is exported.
Plastic Molding Technology Inc.
A complete package of injection moulding services, from product design and mould construction to assembly and packaging, is offered to device OEMs from a facility in Bratislava, Slovakia. Headquartered in Seymour, CT, USA, Plastic Molding Technology Inc. has operated the Slovakia plant since 1991. The company claims it can design and build moulds at the facility that are comparable in quality to those produced in Western Europe or the United States but at a significant cost saving.
"Typical savings can be as much as 40%," says managing director Charles Sholtis. And there is no trade-off in quality, he adds. "The region has a highly skilled toolmaking workforce and we have installed state-of-the-art CAD equipment to streamline the critical initial phase of mould building," says Sholtis. The facility is scheduled to obtain ISO 9000 certification in April.
The Slovakia plant has eight presses, ranging in clamping force from 28 to 110 t. Expansion plans are in the works, and the company is currently negotiating a joint venture with a US manufacturer of printers. That will complement the company's already substantial range of services, according to Sholtis. "We have the capabilities and technical knowledge to offer technologies such as insert moulding, overmoulding, and two-shot moulding with thermoplastics and rubber," he notes.
Wilden
A company with a total of 240 injection moulding machines in operation at facilities around the world reports that 55% of its turnover involves the production of plastic components used in medical devices. In addition to its moulding activities, Wilden Engineering- und Vertriebsgesellschaft mbH (Regensburg, Germany) provides a full array of contract services to device OEMs.
"We can take a project from development through engineering and mould making to final production of the part," explains Norbert Kaspers, sales manager, medical plastic components. "If necessary, we can develop the automated assembly equipment and perform any required testing. Manual assembly is also an option. And we offer logistics support and even recycling, if the customer wants us to handle that," says Kaspers.
Wilden's mould construction capabilities include the design of multicavity and two-shot moulds, a selection of hot-runner systems, and the fabrication of insert-mould tooling. The company's production services are articulated around a turnkey approach, which Kaspers describes as the ability to efficiently manage every step of the process. Included in the package are such secondary operations as printing, embossing, and welding; the procurement of purchased parts and election of qualified suppliers; and parts assembly and packaging.
A core activity at the company is the production of drug-delivery devices. "Wilden has extensive experience in the design, manufacture, and assembly of inhalation devices in Class 100,000 and Class 10,000 cleanrooms with 100% control of the parts," says Kaspers. Sterile production in Class 100 conditions is also available. Building on this expertise, Wilden recently received approval from a national regulatory body to fill pharmaceutical devices.
Degania Silicone Ltd.
The mechanical characteristics, temperature range, heat conductivity, electrical insulation, and other properties of silicone have made it one of the most sought-after materials in the medical and industrial fields, according to Jan Rotem-Bar, international marketing and sales manager, medical division, at Degania Silicone Ltd. (Degania Bet, Israel). In fact, he adds, some experts predict that demand for silicone in the next several decades will parallel the polymers boom of the 1990s.
Degania Silicone's main activity is the manufacture of components and finished medical products for device OEMs. Capabilities include transfer, compression, and injection moulding, and all manufacturing is conducted in accordance with US FDA CGMP guidelines in a cleanroom environment. The company is certified to ISO 9001 and EN 46001 and benefits from FDA 510(k) marketing clearance and CE-marking approval on several products.
Depending on the application, the company will select an existing compound or formulate a more suitable one. An in-house tooling facility and team of engineers enable the rapid creation of a first prototype as well as an accelerated shift to full production.
West Pharmaceutical Services
Concurrent engineering is used to speed the development process at a firm that offers full contract manufacturing services to device and pharmaceutical OEMs. West Pharmaceutical Services (Lewes, E Sussex, UK) oversees development from product design to modelling to machining of the tools, and each step of the process is generated from a single file created by the firm's technical centre. Rapid global scale-up to full validated production is enabled by the use of dedicated presses for engineering evaluations in North American and European facilities. The Lewes facility is also equipped with a Class 10,000 moulding and assembly cleanroom, which features a novel airflow system, according to account manager Paul Flavell.
"The cleanroom is located in the middle of the facility with injection moulding machines on either side," says Flavell. "Class 10,000 air flows from the cleanroom with positive pressure through the moulding area, so you actually have Class 10,000 quality air flowing through the machines themselves. The moulding equipment is contained within a controlled area, which allows users to change the tooling and carry out machine maintenance without risking contamination of the cleanroom. "You simply close the port into the clean area," he says.
Expertise at West includes research and development of drug-delivery systems and the design and manufacture of packaging components, systems, and devices. The firm also has extensive experience providing contract laboratory services, clinical services, and commercialization processes for the manufacture, filling, and packaging of pharmaceutical and healthcare products. Process capabilities include insert moulding, moulding of transparent materials, bonding, printing, and blister, peel, pouch, and other packaging solutions.
Biwi S.A.
Although medical parts account for a little less than 20% of current turnover, injection moulder Biwi S.A. (Glovelier, Switzerland) predicts that this sector will become an increasingly important source of business in the years ahead. "Producing parts for the watchmaking industry is our principal activity, but we are seeking to diversify production into other sectors," says sales director Joseph Dal Busco. "The medical industry seems like a perfect fit for us," he adds, "because it requires highly precise technical parts. Producing reliable, precise components in small dimensions is very much a part of our savoir faire."
Medical parts that the company currently moulds include dental implants and components used in hearing aids and blood separation devices. The firm has particular expertise in processing rubber but it also works extensively with polymers and silicones.
Dal Busco stresses that Biwi, which is certified to ISO 9002, is not simply a contract moulder. Elastomers are developed and formulated at the on-site laboratory according to customer requirements, while the technical design department is equipped with advanced 3-D CAD/CAM systems. The company also manufactures its moulds and can fulfill production requirements ranging from single-series items to full-scale runs. "From design and development to tooling fabrication, parts production, assembly, and secondary services, Biwi has the capabilities and expertise to provide complete project management," says Dal Busco.
PHOTO COURTESY OF WILDEN ENGINEERING- UND VERTRIEBSGESELLSCHAFT MBH
