Originally Published EMDM May/June 2001
Regional Focus
Partnering for Success in SwitzerlandIn Biel/Bienne and to the east, highly specialized companies form a virtual network of suppliers to the medical industry.
Benjamin Lichtman
In the northernmost tip of Switzerland, near the German border, lie the famous Rhine Falls, which constitute Europe's largest waterfall by volume. Developed over hundreds of thousands of years of gradual erosion, the falls offer a breathtaking sight of ancient limestone rocks jutting out of the Rhine River.
Nearby, in the city of Neuhausen am Rheinfall, a different kind of erosion is taking place: electrical-discharge machining. "I believe that a mould maker must be able to make his own hot-runner system," says Charles Bodenmann, managing director of the Swiss mould company Kebo Formenbau AG. "I feel responsible for the whole thing," he says, noting that his company even produces its own mould frames. The firm—which provides cleanroom-ready moulds for such products as inhalers, syringes, and laboratory disposables—prides itself not only on the quality of its work, but also on its ability to meet its own production needs in-house. "We are completely independent," Bodenmann asserts.
Quality through Focus
While this independent streak and pursuit of perfection are not uncommon in Switzerland, the "do-it-yourself" attitude highlights an interesting paradox. Namely, medical OEMs sourcing suppliers in Switzerland will find that the concept of a "one-stop shop" is not the norm. Instead, Swiss firms tend to be highly specialized, offering expertise in one particular part of the supply chain, such as mould making or packaging. When another product or service is required, a Swiss company is certain to have close associations with other highly specialized suppliers.
Specialization is a hallmark of Swiss industrial culture. "We work on high-tech, niche applications, which I suppose is typically Swiss," says Beat Hurni, managing director of the firm Polar AG Kunststofftechnik (Eschenbach). Polar offers contract manufacturing, specializing in cleanroom injection moulding, assembly, and packaging of medical components. "There will always be someone to manufacture big components on a large scale, but we cannot compete in that market," he says, citing labour costs and the technical expertise of the national workforce as a whole.
For the Swiss, quality workmanship is as inescapable as the mountains. Werner Hess, marketing manager at the moulding firm Treff AG (Degersheim), confirms this observation. "We are very quality minded. You simply can't tell Swiss workers to produce a second-rate product," he says, pointing out that the country's suppliers are thus perfectly suited to the medical industry.
This philosophy has served the Swiss well indeed. Along with a small group of well-known domestic medical manufacturers, several leading international OEMs have taken up residence in Switzerland. Altogether, medical manufacturers in Switzerland comprise more than 500 companies, employ a workforce of some 30,000 people, and invest nearly {455 million each year in R&D.
Cooperative
Research "The
Swiss system of contractors and subcontractors is amazing," says
Hans Schmotzer, director of the firm Precision Implants. "There is
an incredible network of highly specialized companies that perform only
one part of the manufacturing process," he adds. Next door to his
company's facility in Aarau, this philosophy of networking is put into
action. Precision
Implants coooperates with its neighbour, the KATZ Plastics Training and
Technology Centre, in research focussed on the wear and degradation properties
of implant materials. KATZ—a nonprofit technical centre that is supported
by 230 Swiss manufacturers—performs applied R&D and offers
training courses for its members in the areas of plastics processing,
product development, and materials testing. In the medical arena, KATZ
has worked on prostheses for joints, as well as various microtechnology
projects. Werner Raupach,
director of KATZ, explains that the centre's expertise in tribology led
to the partnership with Precision Implants, which manufactures knee and
hip components. The KATZ tribology laboratory performs studies of friction
and wear, simulating the simultaneous impact of mechanical load and body
humours. Raupach recently launched a project with Precision Implants'
Schmotzer aimed at finding a replacement material for high-molecular-weight
polyethylene in knee implants. Raupach adds
that his team can develop custom equipment when necessary to conduct reproducible
wear, corrosion, and fatigue tests. The centre also offers consulting
services, and works closely with the Plastics Technology Department of
the University of Applied Science, Aargau. On-site equipment is donated
by member companies and includes machines for injection moulding, extrusion,
welding, thermoforming, stress testing, and atomic force microscopy analysis. New Technologies, Old Traditions
In addition to its focus on quality, the Swiss high-tech industry maintains a unique sense of its history. The evolution of Swiss technology has produced textbook examples of the transfer of old technology such as watchmaking into the medical sector. A modern example of this trend is seen in the firm Sefar Inc. (Rüschlikon), a company that has its roots in the silk-weaving trade made famous by the canton of St. Gallen. Today, Sefar leverages its weaving expertise to provide a range of biocompatible filtration media to medical OEMs.
Similarly, Leister Process Technologies (Kägiswil) originally developed its core competence in process heat equipment and plastic technologies. "We've been welding plastics for 50 years," says Thomas Hessler, a physicist at Leister. Commenting on the firm's development of precision laser welding equipment, he says, "If you're working on a new scale, you need a new technology." Although it still supplies its original product line, Leister now boasts additional business units dedicated to laser systems and microsystems.
Despite the high-tech nature of the miniature drives produced at RMB (Biel/Bienne), a brief tour of the company's production facilities includes a glimpse of some vintage grinding and polishing machines. Sales manager Axel Drapp explains that it would be wrong to think that a process could be improved simply by introducing newer machinery. "In addition to having the right equipment, our industry requires the expertise of workers, who know which step to use at each point in the grinding and testing processes," he says.
Companies
Pool Resources to Offer Medical Outsourcing Services In a region
that is famous as a centre of pump technology, two companies have joined
forces to provide medical OEMs with an unusual range of services. Medivice
AG, located in Balzers, Liechtenstein, is a young company that manufactures
and markets medical air compressors and measurement components for critical-care
devices. Nearby, IMT AG (Buchs, Switzerland) specializes in information
management and embedded systems. Together, the companies offer OEMs a
suite of services incorporating both hardware and software development. The two firms,
which enjoy close ties to the Technical University in Buchs, recently
collaborated to produce a compact ventilator for eVent Medical Ltd. (Galway,
Ireland) that can transmit patient data over the Internet. Medivice supplied
the unit's body and components, which include an oil-free air compressor
suited for use with ICU ventilators. The unit's quiet operation and intuitive
display were designed with critical-care environments in mind. Meanwhile,
the integration of IMT's Mini Web interface launched the ventilator into
the Internet age, allowing for extended diagnostics and interfacing via
the Web. The small, lightweight interface includes both Ethernet and RS-232
ports, and can give Internet connectivity to virtually any device, using
software that can be customized for various needs. IMT believes the interface
will find a home in telemedicine, home-healthcare, and after-sales service
applications. According to Jakob Däscher, CEO of IMT, the firm's
expertise in embedded systems and software engineering is well suited
to a market that requires modular solutions. He notes that when a redesign
was requested for the eVent ventilator, his company was able to provide
new features by modifying the unit's internal software. "Five or
10 years ago when you made a ventilator, it was all hardware," he
says. "Now it's 70% software." Suppliers Abound
Given Switzerland's history, it should come as no surprise that in early March, the nation's voters once again said "no" to a ballot initiative aimed at moving the country into negotiations to join the EU.
The vote reinforced Switzerland's independent image, but the county remains central to Europe in so many ways: geographically, linguistically, and as a hub of precision technology.
Even in a brief survey of Switzerland, technological trends start to emerge. From the strong culture of moulding and mould making in the northeast to the production of miniature motors, device manufacturers shopping for Swiss suppliers may experience what German speakers call the Qual der Wahl, or the burden of choosing among many. In the following pages, readers will find an array of companies offering services and products that are well suited to medical applications, from moulding, grinding, and packaging to customized assembly systems. If your company has been looking for a medical supplier in the heart of Europe, your timing couldn't be more...Swiss!
RMB S.A.
Specializing in the production of miniature motors, the Micro Precision Systems division of RMB (Biel/Bienne) is well known for its smoovy product line. The company creates microdrives ranging in size from 3 to 8 mm. Medical applications include portable pumps, surgical tools, measurement instruments, and scanners, as well as the miniaturization of existing devices.
The company can provide medical-grade components that will resist autoclaving. According to sales and application engineer Axel Drapp, the Micro Precision Systems division of the company is moving toward temporarily reducing its standard lines in order to focus more on custom applications.
Medical clients benefit from the company's high-precision brushless components, which feature low contamination and are assembled in cleanroom settings. Planetary gear systems allow for motors with lower speeds and higher torques. Hall sensors can be used for feedback loops that increase efficiency and accuracy.
Monnier + Zahner AG
Founded in 1964 as a machine and equipment supplier to the watchmaking industry, Monnier + Zahner (Safnern) began offering machines for medical and dental implant components in 1972. According to the company's director Roland Wälti, innovation is no stranger to the firm's workshops. "Per year, two to three machines leaving this company are prototypes," he says.
Monnier + Zahner produces about 35 machines for the medical market as well as 15 to 20 machine tools each year, including thread-milling and thread-whirling machines for bone screws, milling machines for the production of self-cutting flutes, rotary transfer machines for the production of hexagons on medical screw heads, eight-spindle production centres for bone plates, and honing units for hip joints. The M640 model is specialized for the honing of hip balls and cups, and features a turret head for five honing tools, a measuring unit for both internal and external measurements, and a conversational programming interface.
Drawing on its experience in the watchmaking industry, the company also offers duplex models that simultaneously process two parts to the same specifications. According to Wälti, such units can offer customers up to 25% savings compared with the purchase of two separate machines.
Monnier + Zahner, which also retrofits old machines to incorporate CNC technology,
is in the process of building a new production facility. Customer training is provided for all machines.
Sefar Inc.
Sefar Inc. (Rüschlikon) first opened shop in 1830, providing woven silk sieves for flour and semolina. True to its roots, Sefar still supplies millers with its original core product, but the medical industry now provides a third of the company's business.
According to marketing manager Helen Vogt, the company's long history of technical weaving has served it well in the medical sector. "Our Medifab product line comprises precise, biocompatible, and cost-efficient filters, as well as spreading and wicking media, for the medical device and diagnostic industries," she says. Applications include infusion and transfusion sets, arterial and cardiotomy blood filters, dialysis sets, and diagnostic test strips. Filters can be surface treated to enhance hydrophilic and hydrophobic properties.
"What our medical clients appreciate most in Sefar is the company's ability to produce consistently high-quality filtration media in sufficient capacity," says Vogt. But she adds that even a company with such a strong sense of history can play an important role in introducing new technologies to the medical industry. Vogt notes that new developments in Sefar's medical activities include research into implantable applications such as stent adhesion, and the production of PEEK filters via an exclusive agreement for fine PEEK yarns with a leading yarn manufacturer.
Sefar has weaving facilities in Switzerland, France, and Asia, with cleanroom converting facilities in Switzerland and the United States.
Polar AG Kunststofftechnik
"We do it all for our customers, from start to finish," proclaims Beat Hurni, managing director of Polar AG Kunststofftechnik (Eschenbach). Polar offers contract manufacturing under cleanroom conditions, supplying medical OEMs with injection moulding, assembly, and packaging of medical and biotechnical components, as well as finished devices, according to EN 46002 and GMP guidelines.
Cleanroom injection moulding is performed on machines with 400- to 4200-kN clamping forces in shot weights from 0.5 to 1500 g. Polar is in the process of adding six new moulding machines to its facility. Hurni explains that the company uses a unique method to process high-density polyethylene using a specialized screw and cylinder system developed in collaboration with Sulzer. "We're the only ones in Europe [who can do this],"
he says.
Assembly and finishing services include ultrasonic welding, manual assembly, and inspection. Devices can be supplied in both blister and double-bag packaging. All services are carried out in a Class 10,000 cleanroom. Past projects have included catheters, implants, liquid-handling systems, and bioreactors for cell culturing. "We're also looking at silicone injection moulding,"
says Hurni.
Product development, tooling, and prototyping services are also available, as well as printing, sterilization, and surface treatment.
Kebo Formenbau AG
With a strong client base in the medical and pharmaceutical industries, Kebo Formenbau AG (Neuhausen) is accustomed to meeting high standards on tight schedules. "Time is the most important factor for our clients," says Charles Bodenmann, the firm's managing director, adding that more than 35% of the company's turnover is generated by the medical industry.
The need for speed led Kebo to install a new mould service and maintenance centre in December of last year. The facility, which adjoins the company's main building, serves to treat both Kebo and third-party moulds. But according to Bodenmann, the service centre will also facilitate the production of new moulds. "Moulds need regular maintenance, and in the past, we found that overhauls were interrupting the production of new moulds," he says. "But we will soon have 10 qualified employees dedicated to mould servicing and spare parts production." On-site facilities for testing and polishing are also included in the new service centre, as well as extra floor space for customers' injection machines and robots.
Kebo has experience in the production of high-precision moulds for laboratory disposables, syringes, inhalers, and other plastic components with complex structures. In addition to its mould-making activities, the company offers its customers mould installation services, as well as instructions on precise mould operations.
Leister Process Technologies
The Novolas M laser welding machine uses a semiconductor diode laser that quickly sweeps across plastic components to create a precise, seamless transmission weld. A detailed mask in the shape of the desired weld acts as a stencil, shielding the component from exposure to the passing laser beam. The welding machine is suitable for use with products such as filter housings (pictured), catheter balloons, sensors, syringes, and microfluidic and micromechanical components. According to engineers at Leister Process Technologies (Kägiswil), the machine can weld practically any thermoplasts, creating strong, gastight weld lines with widths down to 100 µm.
Thomas Hessler, a physicist and manager of the microsystems division at Leister, explains the advantages of using lasers in welding processes: "There is no particle emission or component displacement, and it is a fast, low-temperature process," he says, adding that laser welding "is repeatable, and parts are only heated where they should be heated." He notes that the Novolas M system is cost-effective, because the detailed outline of the weld is created in the mask, eliminating the need for expensive laser components. Also available are the Novolas C machine for contour welding, and the Novolas S for simultaneous, multibeam welding.
Leister has four business units, which are dedicated to laser systems, microsystems, plastic technologies, and process heat.
The company is also developing a silicone flow sensor that holds promise for spirometry.
Treff AG
Technical consulting, product development, mould production, and cleanroom injection moulding are provided by Treff AG (Degersheim). The company supplies precision plastic components for manufacturers of diagnostic and laboratory equipment, as well as component assemblies. In addition to its OEM services, Treff produces and markets its own line of lab components.
"We are recognized as a company that can master multicavity moulding," says sales and marketing manager Werner Hess. "We know the industry." Treff produces plastic parts using more than 60 injection moulding machines. The company can create parts weighing from 0.2 to 1200 g in a range of thermoplastics, including conductive polymers. Rapid prototyping services are available from one of the company's partners.
The company does a significant portion of its work for the diagnostic industry, and it is used to meeting the most stringent demands, explains Hess. Following moulding, plastic parts are automatically inserted into racks by computer-controlled handling machines, and then placed in the manufacturer's original packaging. "The first time somebody touches the parts is when they are shrink-wrapped," says Hess. The company builds its moulds in an in-house tool shop, and has two on-site cleanrooms that meet Class 10,000 and Class 100,000 standards. Finishing services include ultrasonic welding, pad printing, and hot stamping.
Bruwag AG
A firm offers complete plastics solutions, beginning with CAD/CAM constructions and continuing through mould construction, plastic injection moulding, printing, welding, and assembly. Bruwag AG für Formenbau und Kunststoffspritzerei (Bad Ragaz) can produce precision plastic parts from all technical plastics, including silicone and reinforced plastics.
The company's injection moulding department is equipped with 30 highly automated machines and includes facilities for two-component moulding and silicone injection moulding. A Class 10,000 cleanroom is available for medical projects. Encouraged by strong growth in its medical client base, Bruwag is putting the finishing touches on
a new 4000-m2 complex—including an additional 800-m2 cleanroom—that will be dedicated to the production of medical components. Production is expected to begin in the new facility this summer.
After moulding, finishing, and assembly, Bruwag can package its customers' products with client-supplied labelling, using blisters or boxes. "This is the trend in the industry," says managing director Fridolin Eberle. "We often take charge of the whole project, and deliver the finished device to the OEM." Eberle cites a growing number of small, complex parts that Bruwag is asked to mould, including blood coagulation analysis plates.
Medipack AG
A company's main service to medical OEMs is the production of blisters for implants. Medipack (Schaffhausen) also produces bags and pouches. The company currently occupies a space four times as large as it did in 1993. And business is so good, that the firm is already planning its next expansion, which includes the opening of a new tooling centre.
Medipack can take on large, small, and medium quantities in its three Class 100,000 cleanrooms. More than 50 roll sizes are in stock. "Quick response is important to our customers, and we can provide this because we are not a big company," says managing director Reto Artusi. The company thermoforms PETG, PS, Barex, and PP into blisters up to a maximum size of 1300 x 620 mm. Each pack is visually checked for air pockets and particle contamination and sealed into double polyethylene bags. Die-cut Tyvek lidding can be supplied with or without printed matter.
Medipack has created a variety of innovative packages for its customers, including an adjustable-depth plastic casing for hip implants. Label printing, documentation and organization of bioburden tests, and sterilization are also offered. The company, which is certified to DIN/EN/ISO 9001, also supplies its own line of heat-sealing equipment to the medical sector.
Netstal-Maschinen AG
Founded in 1857 as an iron foundry, Netstal-Maschinen AG began producing injection moulding machines in 1945. The company's SynErgy moulding machines are in widespread use in the medical industry.
"SynErgy systems are fast, precise, reliable, user-friendly, and efficient," says Patrik Gallati, marketing spokesman at Netstal. The machines, which take approximately two months to construct, are available in models with clamping forces from 600 to 6000 kN. Typical products created using the machines include syringes inhalers and medical packaging components. Netstal produces SynErgy machines that are configured for cleanroom operation. These units feature specialized surface treatments, lubricant-free mould compartments, and a US FDA–approved, nontoxic oil. Validation documents are available upon request.
The company prides itself on its after-sales service and keeps spare parts in stock at its facility in Näfels so that it can supply them quickly should the need arise. A new building under construction will double the company's assembly room space.
Montech AG
Components for shock-free transport systems are available from Montech AG (Derendingen). Transport systems built from the company's Montrac components are used for the production of blood bags, syringes, catheters, and pharmaceuticals.
Montrac is a monorail system suitable for applications requiring smooth or antistatic transport, including operation in cleanroom environments. Conveyors and longitudinal transfer systems can be modified to satisfy specific customer requirements. The company also produces pneumatic linear units, rotary drives, grippers, slides, and lifting devices. The Servoline range of products includes a large assortment of modular, programmable servomotor-driven linear units and axes, which can also be used to build Cartesian systems.
"Just as Swiss watches are famous for their precision, our products are renowned for their quality," says Reto Porta, manager at Montech's automation division. Although Montrac components find most of their applications in manufacturing settings, the company is in discussions with an Italian firm that is exploring the possibility of using the components for computer-operated knee surgery.
Maxon Motor AG
A brushless dc micromotor with an external diam of 22 mm and a length of 62.5 mm is capable of reaching speeds up to 50,000 rpm and has an output of 20 W and above. Conversion to lower speeds and higher torques is achieved through the attachment of planetary gearheads.
Maxon Motor AG specializes in the development, manufacture, and marketing of such high-precision, high-efficiency drive components. The company's products are used in battery-powered devices, high-precision proportioning devices, analysis
and dialysis instruments, and micropumps. Products can be designed to customer specifications.
All of the essential motor components are manufactured in-house with custom machinery at the company's Sachseln facility. The firm uses a patented coil-winding technique to produce its motors. Maxon's product range includes dc motors in a range of configurations, precision spur and planetary gearheads, servo amplifiers and positioning controls, encoders, and various accessories. A new high-resolution magnetoresistance digital encoder for use with the company's smaller motors has a range of 16 to 1024 counts per turn.
Marketing manager Albert Bucheli says that Maxon's former focus on consumer products has provided a solid foundation for its current medical activities. "We learned to produce motors in a cost-effective manner," he explains.
Paro AG
Custom systems for assembly and handling are supplied by a firm offering consulting, design, construction, installation, and support services. Among the medical projects that the firm has undertaken are assembly systems for the production of spirometers, insulin pumps, and infusion bags. A current project at Paro AG (Subingen) involves the assembly of LCD components, and the company is in negotiations with a major healthcare client for the creation of a unit to assemble needleless injector systems. The firm is capable of building systems designed for operation in Class 10,000 cleanrooms and is looking to expand its activities in the medical sector, according to sales manager Roger Viau.
"Our strength is that we offer the customer everything under one roof, including feasibility studies, planning, construction, and even the electrical control of the system," says Viau. He adds that Paro enjoys close working relationships with its clients. "We meet with the customer every week," he says.
In addition to complete custom services, the company offers standard Paromat modules for flexible linear transfer. Modules are also available for loading, manual assembly, turning, welding, cleaning, storing, testing, and a variety of other operations.
Tanner Formenbau AG
Multicavity hot-runner moulds for the production of medical disposables are manufactured by Tanner Formenbau AG (Feuerthalen). The company's core products in the medical sector include injection moulds for syringe barrels, plungers, needle protectors and holders, and pipette tips. Moulds for laboratory articles are also produced.
Hot-runner moulds for syringe barrels are a specialty at Tanner. "There is hardly a size, a number of cavities, or a distinctive design that we have not yet produced," says Christoph Humbert, technical sales manager at Tanner. The company's moulds are designed to achive both short cycle times and long service lives.
An on-site testing facility contains injection moulding machines with clamping forces between 600 and 3500 kN. Customer machines can be brought to the facility for configuration and testing.
According to Humbert, one of the primary features of the company's moulds is their easy changeover capability, which allows tools to be changed within the press. As a result, manufacturers don't have to remove a mould to change a part. And because the gating is within plain view, he says, incompletely filled mouldings can be easily identified and ejected.
Schöttli AG
A designer and manufacturer of hot-runner moulds for medical, laboratory, closure, and packaging components uses computerized mould-flow analysis and stress calculations of moulded parts. Schöttli AG (Diessenhofen) also specializes in the production of stack moulds with up to 192 cavities. The company, which believes it is Switzerland's largest mould maker, produces more than 140 moulds per year.
Fast cycles and minimal maintenance requirements are achieved through proprietary mould designs and ultraprecision machining. An application engineering centre is on-site, and a new department is dedicated to hot-runners and the servicing of moulds, both internal and third-party.
According to Fritz Seelhofer, sales manager at Schöttli, the company's services extend well beyond mould making into the realm of consulting. "Designers aren't always production-minded," he says. "Whenever possible, we like to work early with our customers in order to create an optimal product design." Seelhofer reports that moulds for disposable syringe projects account for a substantial portion of the company's turnover in the medical sector.
TDS International
"The harmonization of the in vitro diagnostic directive confirmed that more focus is required to produce high-quality technical documentation in the healthcare industry," says Heinz Hügli, business development director at Total Document Solutions International (TDS; Bonaduz). According to Hügli, this presents new challenges for medical device companies, which must address areas such as process management, product standardization, and timeliness of information.
TDS International specializes in technical documentation for the global healthcare industry, producing documentation sets for medical devices and biological sample–handling devices. The firm provides complete solutions for documentation needs including content creation, translation, localization, design, and content management.
Hügli underscores the need for device companies to invest time and money in documentation: "Up-to-date product information that is tailored to a specific audience is a strong quality issue that should be achieved by all medical manufacturers," he says. "Companies that invest at the beginning of a new project in an information management concept have a huge advantage."
Copyright ©2001 European Medical Device Manufacturer
A testing laboratory at the KATZ Centre includes stress measurement equipment as well as a portable AFM unit. The centre provides expertise in plastics processing to medical manufacturers.
A medical-grade air compressor with low noise levels is suitable for integration into intensive-care ventilators. The unit contains a Web interface that allows data to be transmitted via the Internet.
