Feature Article

If Switzerland had a motto, it might be something like “precision is our tradition,” and the accompanying crest would bear a rendering of a timepiece with grandes complications. A luxury watch represents more than 300 precision parts and many hours of meticulous craftsmanship. The expertise required to manufacture minute parts to precise tolerances transfers remarkably well to the manufacture of medical devices. That fact alone makes Switzerland, especially the area bordering the Jura mountain range, a manufacturing Mecca for global medical device OEMs sourcing suppliers.

The start of a medical manufacturing era
As the watch crisis began to unfold in 1970—the most profound economic event that the local watchmaking industry has ever lived through—a lot of companies were forced to find new customers. Many turned to the medical device industry, where their expertise would be valued. “The watch crisis caused us to shift production to machines for the medical and dental industry in 1972,” explains Roland Wälti, Managing Director and Machine Engineer at machine manufacturer Monnier + Zahner. The company had originally started out producing machine tools for watch cases in the 1960s. Monnier + Zahner is located in Safnern, near Biel/Bienne, the heart of the Swiss watchmaking industry. The historicbilingual town and environs at the foot of the Jura Mountains thrive on precision and micromechanics. Today, the region has fully recovered from the crisis in the 1970s. In fact, it has emerged from those economic depths stronger than ever.

The cradle of precision manufacturing
In addition to the Rolex and Swatch headquarters, Biel is home to a technical college focusing on precision engineering. Many companies that supply products and services to the medical device industry are located in and around Biel. An array of expertise is available here, from precision cleaning technology and implant fabrication to injection moulding, but precision metal fabrication is the core skill set. “This is the Silicon Valley of the metalworking industry,” says Jürg Aegerter, Marketing and Sales Manager at Ypsotec. “Precision is our tradition here in Switzerland.” Ypsotec is located in Grenchen, a few kilometres from Biel, and produces precision milled and turned parts.

Companies that supply the medical device industry are scattered throughout Switzerland, but the Jura region can be considered a hub for precision manufacturing. To support companies located in the canton of Bern that are involved in precision manufacturing, the Precision Cluster promotes networking among companies, facilitates technology transfers and supports high-level training.

Switzerland has a lot to offer, and not just when it comes to quality of life. In 2010, the World Economic Forum (Davos) ranked Switzerland as the most competitive country in the world and the European Union named it as the most innovative country in Europe (even though Switzerland is not part of the European Union). One of the world’s most stable economies, Switzerland has a highly qualified labour force performing highly skilled work. The main sectors include microtechnology, biotechnology and pharmaceuticals, all of which are associated with medical technology. Clearly, the Swiss healthcare industry plays a fundamental role in the country’s economic well-being.

The Precision Cluster
Founded in January 2006 in Biel, the Precision Cluster (www.cluster-precision.ch) provides a platform for companies involved in precision and microengineering. Currently, 85 companies are members of the Precision Cluster, including Cendres+Métaux, Adval Tech and Amsonic. Heading the cluster is Freddy Lei of Cendres+Métaux. Supported by the Bern Economic Development Agency (www.berneinvest.com), the Bern precision industry is highly export oriented: more than 80% of the production is sold to other countries.

Ypsotec AG
In five years, Ypsotec (Grenchen; www.ypsotec.com) will celebrate its 100th anniversary. Founded in 1916, in the midst of World War I, the supplier of bespoke and standard implants, instruments and precision components today is one of the leading Swiss manufacturers of precision parts requiring high-quality surface finishing or laser welding. “The combination of turning and laser welding sets us apart,” says Jürg Aegerter, Marketing and Sales Manager. “Our location in Grenchen at the Jura-Südfuss couldn’t be better. The Jura region has a long tradition in turning and milling.” Aegerter says that many customers come from the eastern part of Switzerland, because that expertise is lacking over there. “This is the Silicon Valley of the metalworking industry,” he says. “Precision is our tradition.”

The company manufactures laser-welded parts and subassemblies and assembles turned and milled parts at its new state-of-the-art finishing centre. The firm processes a variety of materials including light and nonferrous metals, steels and titanium ranging in size from 2.0 to 65 mm. Certified to ISO 9001, ISO 13485 and ISO 14001, the firm guarantees traceability and validated processes.

Jacques Allemann SA
Part of the Notz Group since 2002, Jacques Allemann SA (Brügg; www.jacques-allemann.ch) has been turning fine wires for the medical device industry for 20 years. The firm supplies high-precision and surface-finished fine wires to the automotive, aeronautics, textile, electronics and watch industries, among others, but the medtech sector still represents the majority of the company’s business. “We process 52 different materials, and have 8000 different dimensions in stock right now and 100 tons of solid stock,” says Marco Wichtermann, Production Manager. “Because we belong to the Notz Group and are located on the same premises, we benefit from great synergies, including buying our wire in-house.” The turned wire is used in dental drills, tools for eye surgery, pacemaker cables, guidewires and endoscopes, among other applications. The company also performs surface treatments such as refining, copper and gold plating and etching.

Lamineries Matthey SA
Cold rollers par excellence, the Mattheys have a long history in the art of strip rolling, with the first Matthey emigrating from his native France to the Jura region almost 200 years ago. A few generations later, Lamineries Matthey SA (La Neuveville; www.matthey.ch) was founded in 1901 and is still family owned. Providing precision metal components, the firm processes speciality alloys for relays and switches; strip, rod and wire alloys for connectors; strip and foil for chemical etching; and precision strip for pressure sensors and other membrane applications. Bone screws, for instance, are made from drawn products such as titanium rods. “Our speciality lies in the production of thin and ultra-thin strip—less than 0.004 mm thick—and foil in more than 80 alloys and metals including titanium, beryllium copper, cobalt and speciality stainless steel,” says Jürg Haefeli, General Director. “The heart of a roller is the precision of the roll,” he adds, “because the quality carries over to the surface of the material.”

The firm’s newest product is a plate made of a cobalt-base alloy for the dental industry. Here, implants are milled from the plate. Offering full material traceability as required by the medical industry, precision cold rolling is the company’s forté. “A hundred years ago, precision was the most important quality in the watchmaking industry, so that’s where our mentality comes from,” notes Haefeli. “We are in the cradle of precision technology.” To this day, the watchmaking industry is the largest buyer of cold-rolled products in the Jura region. Without this kind of expertise, medical precision technology may not be where it is today.

Monnier + Zahner AG
Starting out in 1964 producing machine tools for the manufacture of watch cases, Monnier + Zahner (Safnern; www.
monnier-zahner.ch) had to change direction when the watch crisis began in the early 1970s. It was the largest economic crisis the local watchmaking industry has ever endured. “The crisis caused us to shift production to machines for the medical and dental industry in 1972,” explains Roland Wälti, Managing Director and Machine Engineer. The company started to develop machines for the production of medical implants such as bone screws and bone plates as well as artificial hip joints. Today, the firm develops and builds machines for making torx tools; rotary transfer grinding machines for helicoidal drills; honing machines for heads and inserts; polishing machines for hip heads and inserts; special machines for milling self-cutting flutes on medical screws; and thread milling machines for medical screws. “We develop every machine from design to assembly,” says Wälti. The firm’s new honing machine for heads and inserts (pictured), for instance, features short changeovers facilitated by user-friendly programming, a turret head that holds five honing tools and a device that measures interior and exterior dimensions.

Riwisa AG
Founded in 1946, Riwisa (Hägglingen; www.riwisa.ch) is one of the first plastics processing companies in Switzerland. From the start, it focused on injection moulding technologies. Today, the company serves the medical, industrial and consumer markets with a range of injection moulded products. Riwisa entered the medical market with the development, manufacture and fully automated assembly of dry powder inhaler (DPI) devices. The firm managed all of the medical-specific requirements of the project including process documentation, 100% traceability from the raw materials to the finished product and the training of operators.

In 2001, the firm completed a new Class C cleanroom with 2000 sq m of production space. In 2002, Riwisa started CGMP-compliant production and in 2009 it expanded its medical production capabilities by opening a new building with Class C cleanrooms and more than 1500 sq m of additional production space. Certified to ISO 9001:2008, ISO 13485:2003 and BRC/ IOP Global Standard Packaging, the company develops, manufactures and fully assembles medical devices, implants made of biodegradable polymers such as ligament anchors, and diagnostic disposables such as tips, cups, racks, cuvettes and sample carriers. In addition to injection moulding, the company offers a range of secondary services that include pad printing, laser marking, ultrasonic welding, vibration welding, hot stamping, annealing and CNC milling. Today, Riwisa has a modern infrastructure with approximately 4000 sq m of cleanroom space.

KNF Flodos AG
A manufacturer of diaphragm liquid pumps, KNF Flodos (Sursee; www.knf-flodos.ch) specialises in the research and development of diaphragm pump technology. “Our speciality is the development of very, very small pumps that you cannot find anywhere else,” says Jean Delteil, Marketing Manager. “That’s a big technical challenge, especially maintaining the pressure. So we invest about 20% in R&D, which is above average.” The company’s latest product, the compact micro diaphragm liquid pump NF 1.5 can be used in disinfection applications. It can work against a pressure of 6 bar, which can be extended to 10 bar on request. The pump achieves up to 60 ml/min flow rates and can be installed in any position with minimal space requirements. The NF 1.5 is self-priming, maintenance-free and can be run dry. Areas of application are medical and pharmaceutical analysers, cuvette cleaners, sterilisers and laboratory filtration and chromatography.

Polyfil AG
Coated or bare ultrafine wires, ribbons, fine tubes and microcables for electronic and medical applications are the speciality of Polyfil (Zug; www.polyfil.ch). The company offers stainless-steel wires and tubes, platinum-iridium wires, biocompatible coatings and related products for various medical applications. Barely visible under a microscope, the company’s microcable, for instance, consists of seven single wires in PtIr10 (Platinum Iridium Alloy 90/10)—each of which measures 0.03 mm diam—that are twisted together and coated with medical-grade silicone.

Company President Brizio Gaetani founded Polyfil in 1985 and initially supplied the micro-electronics industry. In 1990, he started working with the medical sector. “About 40% of our turnover [now comes from] the medtech sector,” he says. “We found our niche market—and the bigger the niche, the better.” Among the firm’s products are stainless-steel tubing for medical applications in different sizes and shapes and guidewires, stylets and straightened wires partially coated with biocompatible materials.

“Switzerland has a very good reputation when it comes to precision,” Gaetani says. “That’s why the medtech industry is so well positioned here in Switzerland. And the expertise really comes from the employees who [transferred] their knowledge from the watchmaking and automotive industry to the medical device industry.” Gaetani himself has a background in watchmaking.

Schurter
Founded in 1933 by Heinrich Schurter, Schurter (Lucerne; www.schurter.com) is run by third-generation family members. Located near scenic Lake Lucerne, Schurter has been producing components for the medical device sector for approximately 20 years. The firm has developed products that are in compliance with IEC 60601-1 and UL 544 guidelines, including splash-proof IEC 60320 appliance couplers and input systems, low leakage current EMC filters and shockproof fuseholders.

Schurter’s newest product—the V-Lock system—can be used in medical appliances such as respirators to prevent unintentional unplugging. The V-Lock system can be used with 10- and 16-A power inlets and IEC 60320 connectors. A pin in the socket interlocks with a notch in the plug, thus preventing accidental unmating of the power cable. The system does not require a specific socket system or retaining device. To unlock the device, the user simply presses on the release lever, which is a bright yellow to distinguish it from other cable connections. The extraction force is a minimum of 200 N. Medical appliances, analysis and laboratory instruments are typical applications.

Ruetschi Technology AG
Christoph Ruetschi’s father, Charles Ruetschi, founded Ruetschi Technology AG in 1960. Since then, it has evolved from an engineering contract manufacturer to a complete supplier to the medical device industry. Like many other firms in the Jura region, Ruetschi has its origins in the watchmaking industry; by 1979, the firm was producing its first parts for the medtech sector. Today, the company manufactures medical instruments such as drill bits, wrenches and decompression systems; implantable screws, plates and housings; and endoscopy components and electrodes or microcomponents for hearing aids. The company has expertise in a range of sophisticated manufacturing techniques such as turning, milling, grinding, eroding, laser welding and cutting and plastic injection moulding. “The medical and life science sectors make up approximately 70% of our business,” Ruetschi notes.

Certified to ISO 9001-2000 and ISO 13485, the company also offers product development, prototyping, validation and CE certification in addition to manufacturing, assembly and packaging. A Class 8 cleanroom is on site. Ruetschi is still a 100% family-owned company today.

Sphinx Werkzeuge AG
Precision instrument manufacturer Sphinx Werkzeuge AG (Derendingen; www.sphinx-tools.ch) specialises in the manufacture of drilling, milling, cutting and related tools that require precise cutting geometries. In the medical arena, the company fabricates precision instruments for use in trauma surgery, minimally invasive procedures and orthopaedics, among other applications. Founded in 1876 as a turning shop, the firm’s output today includes surgical bone drills, cannulated instruments, thread cutters and dental drills. “We specialise in precision mechanics,” says Reto Rüttimann, General Management. “And precision machining and medical device technology perfectly complement each other.”

Building on a foundation of more than 100 years of machining expertise and more than 50 years of experience in medical technology, Sphinx is certified to ISO 9001:2008 and ISO 13485:2003, and is registered with US FDA.

Teuscher Kunststoff-Technik AG
Supplier of plastic components Teuscher Kunststoff-Technik AG (Grenchen; www.advaltech.com) provides injection moulding and assembly services to the medical device industry. The company belongs to the Adval Tech Group, which is active in stamping and forming technology and injection moulding. Teuscher produces components for drug-delivery systems, diagnostic products and medical devices under cleanroom conditions. The firm manufactures plastic components in runs of millions and assembles them into complex systems. Among the company’s products are injection pens, injection devices and syringes.

Micro Crystal AG
Micro Crystal AG (Grenchen; www.microcrystal.com), a subsidiary of the Swatch Group Inc. Switzerland, was founded in 1978 as a producer of timing crystals for watches. Today, Micro Crystal manufactures miniature quartz crystals in frequencies from 32 kHz to 250 MHz, real time clocks, oscillators and OCXOs for manufacturers of medical implantables and sundry other products. “The first part that we produced that wasn’t for the watch industry was for a pacemaker,” says Silvio Dalla Piazza, Vice President, Research and Development. He says that the company has a 70% global market share for implantable quartz crystals. All crystals are etched from accurately machined wafers using a photolithographic batch process.

Amsonic AG
Amsonic AG (Biel; www.amsonic.com) develops and manufactures precision cleaning machines for the medical device and other industries. “Our Amsonic 4000, for instance, is a parts cleaning system that uses hydrocarbons at high temperature under vacuum to clean, vapour degrease, and dry automatically in a closed circuit,” says Maurizio Rasori, Sales and Marketing Director. “This system can be used to clean hip, knee and shoulder implants, plates and screws.”

Providing water- and solvent-based cleaning technologies, the firm offers cleaning tests and process development in its application laboratories in Biel and Chaponnay/Lyon (France), qualification support and documentation, calibration, process validation and documentation, compatibility inspections, maintenance and repair work.