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Komax Systems LCF S.A.

Methodology is a watchword at Komax Systems LCF S.A. (La Chaux-de-Fonds; www.komaxgroup.com), a builder of automated assembly systems for healthcare and other applications. “It is important for my team to be involved early in a project,” stresses Christophe Tivollier, QA and validation director. “That way, we can apply our methodology effectively.”

To even begin to satisfy customer expectations in the med-tech arena, companies must have a thorough understanding of CGMP, GAMP 5, the medical device directives, and US FDA’s
21 CFR Part 11, notes Tivollier. “We have developed that knowledge over many years,” he says. It is the foundation upon which Komax builds its methodology, he adds.

When taking on a project, the firm typically establishes a validation steering committee and a qualification and quality team. Their mandate is to act in a collaborative manner with the customer’s validation team. Stresses Tivollier: “Validation methodology is in strict compliance with GAMP. That is my Bible!”

The company’s single-minded focus has led to undeniable success in its chosen field. Specializing in high-speed assembly systems, the company delivers 15 to 20 lines per year to med-tech customers. Its machines have been used to assemble everything from insulin pens and inhalers to catheters and diagnostic devices. Platforms range from pallet-based systems to indexed rotary or linear designs. It has also developed a compact cam-driven linear platform that is well-suited for cleanroom use, says François Obegi, regional sales manager. “The workpiece can be accessed from the top, front, and sides,” he notes, adding, “all four sides can be made accessible if desired by the customer.”

Cendres+Métaux S.A.

In 1993, Theo Gautschi, PhD, experienced his first US FDA audit. He had been working at Cendres+Métaux S.A. (Biel/Bienne; www.cmsa.ch) for five years. “It was shortly after getting our ISO 9001 certification,” recalls Gautschi, “and I was the only quality management (QM) official at the company.” It must have been a bit harrowing at the time, but the audit turned out well for the firm and for Gautschi, who is celebrating his 20th year at the company. Director of development and a member of the executive board, Gautschi has played a fundamental role in building the firm’s quality control and quality management processes. In fact, the firm’s ability to offer integrated validation has become a valuable sales proposition.

Cendres+Métaux produces micro­mechanical components from materials characterized by their purity and homogeneity. The precious-metal-based products are almost all fabricated by the company without the involvement of outside suppliers. Its products are routinely sourced by global manufacturers of cardiology devices, orthopaedic products, hearing aids, and dental implants. To continue to meet and exceed customer demand, however, the firm must offer more than machining services, no matter how advanced, says Francis Vonrospach, head of sales, medical division.

“The trend I see developing is an expectation among OEMs that suppliers be able to provide not just a component but the whole chain of services that goes with it,” says Vonrospach. “They want a single source for surface treatment, cleaning, packaging, and labelling . . . basically, a finished product, packaged and ready to go.” That sort of customer-vendor relationship requires a great deal of trust, he adds, and that is why rock-solid validation practices must be in place.

Cendres+Métaux typically offers customers in the med-tech industry a complete qualification package, explains Gautschi. “We have used fairly similar procedures for several years, but they were not implemented as systematically as the programme that we put in place a couple of years ago,” he says. Proper validation procedures allow the company to ensure repeatability, even when special processes are involved, and minimize defects and, ultimately, product failure, Gautschi adds.

“Process validation is expensive,” acknowledges Gautschi. It can be challenging to find ways to show its value to management. But it can help prevent product recalls and lawsuits. “Under those circumstances, a lack of validation would be much more costly,” Gautschi adds.

Fischer Connectors

When you are developing connectors for use in a medical environment, don’t underestimate the importance of durability. That piece of advice comes from Dominique Glauser, and he should know. Glauser is CEO of Fischer Connectors (Apples; www.fischerconnectors.com).

“We tend to imagine medical staff as being very conscientious when it comes to handling their equipment, but in the operating room, they are completely focused on the patient,” says Glauser. “They don’t have time to think about the equipment they are using.” So things may get banged around, but that cannot affect reliability. Consequently, Fischer builds its sterilizable connectors to last for more than 5000 mating cycles. “They can go well beyond that,” adds Glauser, “without any signal deterioration.” The robust architecture of the product combined with its user-friendly push-pull design and high-quality seal go a long way toward explaining the company’s ongoing success as a supplier to med-tech OEMs.

In 2006, the company introduced its line of Limited Use Connectors (LUC) suited for disposable applications. Mateable with standard Fischer high-performance receptacles, the LUC can be directly mounted on a disposable hand piece or overmoulded or mounted to a disposable cable. Although its price level allows for single-use applications, the connector withstands EtO and gamma sterilization.

“LUCs not only save time and money—you would not believe the resources hospitals can put into the cleaning of instruments—but they promote safety,” says Glauser. “When we introduced these connectors, it was the right technology at the right time. You are going to start seeing this product integrated into more and more instruments,” he predicts.

Creaholic

Rarely has a company name captured its essence so well. Founded in 1986 by Elmar Mock, one of the inventors of the Swatch, Creaholic (Biel/Bienne; www.creaholic.com) is composed of eight partners and 35 employees who share a dependency on creativity. In addition to taking on projects for customers, approximately one-third of which hail from the healthcare industry, many employees of the design bureau spend considerable time developing projects on their own to fill a perceived need in the marketplace. Some of these projects lead to concrete developments, others go nowhere, but in all cases they keep the creative juices flowing, and that’s what matters, according to co-owner and board member Marcel Aeschlimann.

“One of our strengths is the cross-fertilization we can bring to a project, from ultrasonic welding expertise gained on various projects like Tetra Pak and Swatch to acoustic engineering from a member of our staff who builds organs,” says Aeschlimann. Another is an emphasis on simplicity of design, which is in short supply in the medical arena, he adds. “It’s true that engineers tend to complicate devices unnecessarily,” explains Aeschlimann. “But doctors are a big part of the problem, as well. They like to use a language that no one else understands,” he says, noting that the exclusivity they project as a group influences product design.

Keeping it simple, the firm has had a hand in designing hearing aids, drug-delivery products, and diagnostic devices.

Maillefer S.A.

Designed specifically for the fabrication of FEP capillary tubing for use in IV applications, an extrusion line is characterized by its stable, linear polymer melt output and the tight product tolerances that can be achieved. It joins several high-speed manufacturing systems for medical tubing at the Ecublens facility of Maillefer S.A. (www.mailleferextrusion.com).

“This particular configuration was designed [to satisfy] an important customer’s request,” says marketing manager André Gosselin. “Our previous experience in FEP medical tubing extrusion allowed us to quickly launch the new line.”

The line configuration includes a 30-mm 24 L/D main extruder and an optional 30-mm 13 L/D auxiliary extruder. When coupled to a monolayer head fitted with a striping mechanism, single- or multistriped capillary tubes can be produced.

The system processes tubing measuring 0.71 to 2.20 mm OD and 31.5 to 198 mm long. The maximum line speed is 30 m/min, with typical production speeds averaging 12 to 15 m/min, depending on tube specifications.

Calibration is achieved without contact with the extruded tube. Downstream equipment includes a vacuum trough, open cooling troughs, haul-off, a precision cutter, and an ionization device.

Dynatec S.A.

Founded in 1992, Dynatec (Préverenges; www.dynatec.ch) has experienced significant growth both in the size of its staff and its turnover. Specialized in processing technical-synthetic materials, the company’s ambition is to expand its customer base in the med-tech industry, which accounts for about 15% of its revenue.

“We are currently producing small parts in PEEK, PPSU, and polyethylene, in combination with stainless steel,” says founder and director Daniel Bertschi. “We are doing quite a bit of work in titanium, too. It takes time to build a reputation in the medical technology field,” he adds, “but thanks to our technical expertise and dedication to quality—we earned ISO 13485 certification in July 2007—we are making good progress.”

The company routinely works with thermoplastics, elastomers, duroplastics and composites, and alloys. CNC machining, casting, welding, bending, and marking services are available.

Cicorel S.A.

A maker of high-resolution flexible printed circuits has expertise in the development and manufacture of extremely small flexible, rigid, or rigid-flex printed circuits. That technique, combined with the ability to supply PCBs in panel or reel-to-reel formats, has made Cicorel S.A. (Boudry; www.cicorel.ch) a much sought-after partner of companies that manufacture hearing aids, pacemakers, and related products.

“The ability to develop and produce extremely small parts to demanding specifications has brought us a lot of business from the medical industry,” says general manager André Mueller. “For example, we are making a copper component for use in hearing aids that is 9 µm thick.” Although most medical device manufacturers seek panel PCBs, “having the capability to go reel-to-reel for high-volume applications has been a plus. In fact, we are seeing more and more requests for that,” says Mueller.

Cicorel’s business strategy is to get its foot in the door early in a product’s life cycle, explains Mueller. “We want to be involved at ramp-up and be the main supplier for two years at least. After that, we would accept to shift to being a secondary supplier and keep anywhere between 20 and 70% of the business. We are OK with that,” says Mueller.

To ensure that it maintains its edge, the company typically invests 10% of its turnover in its infrastructure. That initiative seems to be paying off. “Other Swiss and European companies in our field just gave up because they felt they could not compete with suppliers in Asia,” says Mueller. Cicorel, by contrast, trumpets the Swiss precision and quality of its products, and that has been music to the ears of med-tech manufacturers. More than 30% of Cicorel’s revenue comes from medical device manufacturers. “We have created a niche for ourselves,” says Mueller, “and increased our profitability in the process.”

ATI Stellram

A turning technology originally developed for aerospace applications is also finding some down-to-earth uses. Specifically designed for the machining of aerospace components made from high nickel, high cobalt, and titanium-based alloys, 4E turning geometry from ATI Stellram (Gland; www.atistellram.com) caught the eye of a medical device manufacturer based in Udine, Italy. Ultimately, the technology reportedly allowed the maker of prosthetics to improve the surface finish of the products and increase tool life by 40%.

When it first took on the project, ATI Stellram’s turning team, based near Geneva, consulted with metallurgical experts from sister company ATI Allvac, a speciality metals producer. They recommended that the med-tech OEM use a WNMG ISO Utility turning insert with a 4E geometry and new grade SP0819 material on its Okuma lathe.

During the machining process, the cutting speed is maintained at 32 m/min with a feed rate of 0.12 mm/rev, resulting in a 2 m/min improvement and 20% productivity increase compared with prevailing methods. An emulsion coolant is used to help prevent built-up edges on the tool. The insert’s Nano TiAIN PVD coating and carbide substrate are designed to withstand the heat and wear demands of high-temperature alloy machining.

The precise, reinforced chip-breaker profile and positive cutting action result in a smooth surface finish and ensure the part’s dimensional integrity. The 4E geometry is also suitable for machining components made from stainless steel and titanium-based alloys.

SPT Roth

Ceramic injection moulding techniques bring a vast amount of freedom to design engineers, enabling the creation of extremely small parts to exacting tolerances, but the ability to repeatably and precisely predict shrinkage is a critical part of the process. SPT Roth (Lyss; www.sptroth.com) has developed valuable expertise in this area. The company routinely manufactures nozzles with holes measuring 15 µm in diameter.

“Material shrinkage during the injection moulding process is precisely repeatable, but you have to be able to control that process,” says Martin Sutter, product and sales manager. “That is our know-how.” The other part of the equation is keeping everything in-house, he adds. “We control the whole process from producing the material feedstock to designing and building the tooling. It is all done on site,” says Sutter.

The company operates facilities in the United States and Asia, but almost all of its medical and dental parts are produced at its plants in Switzerland.

AlpVision S.A.

A supplier of digital imaging products for brand protection and document security has developed an authentication system that requires no added markings. Fingerprint technology, developed by AlpVision (Vevey; www.alpvision.com), is suited for use with solid objects such as medical devices or timepieces.

Fingerprint identifies products based on the natural microscopic imperfections that are generated by the manufacturing process and the raw materials used in its fabrication. New digital imaging technologies can generate an imprint that is unique to a product. This allows its identification and tracking throughout its life cycle. The photo shows a magnified image of two items from the same production run; the microscopic differences are sufficient to establish a unique individual identification.

The proprietary process uses a standard office scanner to capture an image of the product. This image is sent to a secure server, via the Internet, for subsequent comparisons, as needed. Digital images of the genuine product as well as known counterfeits are stored on the server. Sophisticated mathematical algorithms allow images to be compared with millions of stored reference images in a matter of seconds. The technology will identify the sample as genuine, fake, or unknown.

Medelec Minimeca S.A.

Made-to-measure precision metal tubing, including high-precision metal tubular profiles, are produced according to customer specifications by Medelec Minimeca S.A. (Puidoux; www.medelec-tubes.com).The cold-drawn tubing is manufactured from stainless steel, gold, platinum, titanium, copper, aluminium, and other implantable alloys in prototype to series volumes. Large-volume orders are bound by no quantity limit.

Tubes are available with wall thicknesses down to 0.015 mm and with outside diameters ranging from 0.1 to 10 mm. Tolerances under 5 µm and roughness averages better than 0.4 (4 rms) are possible. Quality systems are certified to ISO 9001: 2000.

Metrolab Technology S.A.

A company that develops Tesla meters that measure high-intensity magnetic fields in MRI scanners has introduced a three-axis Hall magnetometer. The instrument from Metrolab Technology S.A. (Plan-les-Ouates; www.metrolab.com) ensures the safety of the magnetic field around an MRI system.

Dubbed a “magnetic endoscope,” the magnetometer simultaneously measures all three axes of the magnetic field. This ensures a correct reading of the total field regardless of the probe’s orientation. Factory calibration with the company’s NMR precision Tesla meter, considered the gold standard of magnetometers, provides ±1% accuracy with automatic temperature compensation.

Fitted with a compact endoscope-like probe that fits into the smallest nooks and crannies, this product is suited for use in mapping magnetic fields in a range of applications.

Ceramaret

About 10 years ago, the medical industry represented just 3% of business for Ceramaret (Bôle; www.ceramaret.ch), which designs and produces components from hard materials. “But we noticed more and more demand for ceramics coming from the medical industry,” recalls Christian Farine, vice president, sales and marketing. “We decided to explore the potential of this market, and to invest in it. Ten years later, med-tech applications represent 18%—and growing—of the company’s business.

Known far and wide for the polishing technique it developed for watchmakers—polissage Maret is an industry benchmark—Ceramaret also has established a reputation for the precision ceramic parts it makes for medical devices and analytical instruments. Besides 99.9%-pure alumina and TZP zirconia, it forms parts from 96 and 99.7% alumina and from zirconia-toughened alumina. These materials are inert, resistant to aggressive solvents, biocompatible, insulating, and resistant to elevated temperatures. They are typically used to manufacture insulators for endoscopes and electrosurgical instruments, blades, and feed-throughs. The ceramics are also used in flow control systems.

Certified to ISO 13485, the company is extremely attentive to traceability issues, notes Farine. That has been a factor in its success as a supplier to the med-tech industry, as has its ability to repeatably produce parts in small dimensions to very tight tolerances.

The company will soon break ground on a new facility that will double, and perhaps even triple, production capacity.

Unimed S.A.

A custom manufacturer of specialty components made from small-diameter stainless-steel tubing and wire, Unimed S.A. (Lausanne; www.unimed.ch) does not believe in going out and getting your business at any cost. If you are looking for the type of products it excels at making, you will probably end up at its door (or, more likely these days, at its Web site). “Our business grows about 20% per year,” says marketing director Christian Martens. “We offer precisely what our customers in the medical industry are looking for: a good combination of quality, price, and lead time,” says Martens.

Offering cut-to-length tubing and wire, needles and cannulae, assemblies, connectors and stopcocks, and related products, Unimed’s niche is in the production of small parts for sophisticated diagnostic devices in production quantities of 1 to 100,000 units per year.

“In an industry where time is of the essence, customers simply cannot wait months for tubing to be redrawn,” says Martens. “Because of our large stock of tubing and wire, we can submit a quotation within three days and produce a first series of parts in a few weeks.”

The company is extremely attentive to traceability and quality systems, adds Martens. “We will maintain control of our customers’ specifications and drawings, production processes, and inspection protocols so they don’t have to. They can rely on our traceability,” says Martens. “Our quality system is a major value we provide to our customers.”

RMS Foundation

Contract materials testing and research related to orthopaedic implants are among the services provided by an independent nonprofit organization. The RMS Foundation (Bettlach; www.rms-foundation.ch) is staffed with a multidisciplinary team that has a solid background in medical technology. This team, which strives to bring its problem-solving expertise to a range of med-tech projects, is finding ever greater demand for its surface analysis and material testing services, according to Beat Gasser, PhD, head of testing and consulting and coleader in research.

“Verifying the cleanliness of an implant after manufacture and prior to sterilization is an important area of activity for us,” explains Gasser. In addition to electron microscopy, the company uses a state-of-the-art XPS spectrometer to provide this service. This instrument can determine the chemical composition of the first 5 to 10 nanometres of a substrate. “There is no absolute state of cleanliness,” notes Gasser, “but we can analyze an implant’s cleanliness and benchmark it according to the company’s specifications.”

Testing services are also in great demand. “With every new development, you have to show that the technology does what you claim, and we can help with that,” says Gasser. “Our materials-testing capabilities include fatigue, wear, stress, and so forth.” Dynamic testing can be performed using a hydraulic ram setup (pictured) to determine fatigue resistance and endurance under various loads.

Basic and applied research is conducted on biomechanics, technical biomaterials, and skeletal substitutes. The foundation routinely cooperates with technical, scientific, and clinically oriented universities as well as industrial partners.

Hader S.A.

Surgical torque limiters are available with fixed torque values between 0.7 and 6 N•m. Developed and manufactured by Hader S.A. (La Chaux-de-Fonds; www.hader-swiss.com), the instrument requires no lubrication and will not need recalibration during its lifetime. Engineered to provide repeatable and precise performance, the torque limiter emits an audible click when the desired torque value is reached. Company logos can be laser marked on the tool. Higher torque values are available on demand, and custom features, such as silicone handles in different dimensions and special couplings and cannulae, can be accommodated.

Specializing in design, conception, and production to suit OEM requirements, Hader is equipped to perform turning, milling, and injection moulding. Turning technology is used to produce extremely precise medical device parts up to 51 mm diam. Plastic components are produced on in-house injection moulding machines for which the company makes moulds. Other capabilities of the ISO 9001: 2000–, ISO 13485:2003–, and ISO 14001: 2004–certified firm include laser processing, part cleaning, product development in a dental laboratory, and processing in an ISO Class 7 cleanroom.

Lemo S.A.

Offering an array of standard and custom connectors, Lemo S.A. (Ecublens; www.lemo.com) operates three primary plants in Switzerland and one in Hungary. Focused on maintaining control of the entire manufacturing process from the raw materials to delivery of the finished product, the company has organized production in such a way that reliance on outside suppliers is kept to a strict minimum. More than 90% of production is done in-house.

The company recently added the medical-grade Redel 1P right-angle socket to its catalogue of 50,000 products. Designed for use with printed circuit boards, it withstands EtO and gamma sterilization. The product is available with 2, 4, 5, 6, 7, 8, 9, or 10 contacts and can be supplied in a wide selection of colours.

Ruetschi Technology AG

At first blush, you wouldn’t expect Christoph Ruetschi, CEO of Ruetschi Technology (Muntelier; www.ruetschi.com), to be an advocate of plastic products. After all, his company has established an enviable reputation as a supplier of intricately crafted bone screws, surgical and dental drill bits, instruments, implants, and sundry miniature metal parts to medical device OEMs. And yet he welcomes the transition to plastic. The reason is that he acquired an injection moulding company a couple of years ago, and business is booming. When EMDM spoke with Ruetschi, he was in the process of erecting a plant to house his injection moulding operations in Yverdon and setting up a cleanroom.

“We have a Class 100,000 cleanroom, but we are adding a Class 10,000 cleanroom to our new facility, which will be completed this fall,” says Ruetschi. “We see lots of growth for injection-moulded components,” he adds, noting that plastic is increasingly the material of choice for complex medical parts.

The company isn’t turning its back on its metal heritage, however, and it continues to provide a full array of turning, milling, grinding, and assembly services. “We have a significant focus on secondary operations as well,” says Ruetschi, who cites welding, marking, and assembly as core areas. Packaging is also available, as is sterilization, which is provided by a partner company. That breadth of expertise has Ruetschi tackling bigger projects.

“In some respects, we are shifting from supplying components to manufacturing finished instruments,” explains Ruetschi. “We can ship the packaged and sterilized device on behalf of the customer. All they need to worry about is the design and marketing of the product.”