REGIONAL FOCUS
Western Switzerland
Medical device OEMs benefit from local suppliers' expertise in the development and manufacture of micromechanical assemblies.
Norbert Sparrow
Switzerland has been called an anomaly. Devoid of raw materials and squeezing a population that speaks four languages into an area that represents 0.5% of Europe's land mass, Switzerland shouldn't work. Yet it does, and famously so.
In global competitiveness ratings, the country is consistently ranked among the leaders in productivity. The quality of Swiss workmanship is recognized around the world, and the country exports proportionately four times more of its output than the United States. The most recent statistics from the World Economic Forum put Switzerland in sixth place for overall global competitiveness, ahead of all other European countries.
On the healthcare front, an article published in Switzerland's economic journal Bilan boldly states that the country has the resources to surpass the United States as a leader in medical technology. Switzerland represents a haut lieu for micromechanical technology, the author argues. Indeed, a workforce skilled in the development and assembly of miniaturized products, an infrastructure that historically has been supportive of industry and technological innovations, and a surprisingly diverse pool of suppliers does augur well for the country's position in the upper echelon of medical innovation. Perhaps the author is overstating the case, but after visiting a number of suppliers in the Neuchâtel-Lausanne area that have translated their expertise in micromechanical products and services to the device sector, I'm not so sure.
Building a Better Valve
While the presence of device companies in Western Switzerland has undoubtedly contributed to expanding the supplier base, key OEMs were drawn here initially by a highly skilled and creative labour pool. That was one of the key factors behind Medtronic's choice of Tolochenaz, located between Lausanne and Geneva, for its European, Middle East, and African headquarters. It was also the reason Medos S.A., which produces implantable valves for the treatment of hydrocephalus, came to be in Le Locle.
Salomon Hakim, a neurosurgeon from Colombia, theorized that hydrocephalic patients could be treated by implanting a programmable valve. Looking for a region that possessed the technology necessary to produce the device and a workforce with the requisite skills, he and his son Carlos, an engineer and graduate of MIT, came to Le Locle and found a local engineer who helped to develop the product in 1986. The Hakim programmable valve is implanted into the heads of hydrocephalic patients to drain excess cerebrospinal fluid. The pressure of the opening is regulated by a miniature step motor that is triggered noninvasively by means of a magnetic programming device. The valve has revolutionized the treatment of hydrocephalus by eliminating the need for a second surgical procedure to modify pressure settings, as is the case with conventional implanted valves. The company also manufactures a miniature version of the valve designed for use with infants.
Creative Solutions, Focus on Quality Distinguish Area Suppliers
That tradition—if you come, they will build it—lives on in such companies as AP Technologies in Le Brassus. Commercial director Jan Vermeulen cites one client who came to the office with what was essentially a Lego model of a device for use with contrast agents. "The product needed to agitate and inject the contrast agent, and we were able to develop a plunger to perform this operation based on his Lego contraption."
Part of the Audemars Piguet group, AP Technologies was incorporated in 1998 and has seen its medical device engineering outsourcing services grow from 11% of annual turnover in 1990 to more than 50%. A focus on total quality management and providing a breadth of services and the partnerships the firm has cultivated with major US and Swiss companies have also been key factors in AP Technologies' success, says Vermeulen. "We are very export oriented, and we can provide an array of services from product development to subcontracting, even distribution and after-sales service in some cases," he adds. The company is manufacturing an autotransfusion unit for Medtronic and has developed and manufactured a digital pipette for another device manufacturer. AP also markets a guidewire straightening machine under its own name.
Laser Automation, a supplier of laser machining and processing services as well as turnkey automation systems, opened up shop more than 30 years ago offering welding services to the watchmaking industry. The firm began providing services to device manufacturers in 1981, and word of its expertise eventually reached the ears of Johnson & Johnson. "Some of their people came to see us in 1991 and asked if we had the capabilities to laser cut small tubing," says marketing and sales director Jean-Christophe Kullmann. "We were able to do that, but the discussions fell apart once it became clear that we would have to set up operations in the United States." A few years later, Kullmann recalls, European companies began calling on Laser Automation asking some strikingly similar questions. "That's when we realized that the application was stents," says Kullmann. Today the company is a very busy supplier of stent fabrication
"We can handle the entire manufacturing process, starting with a sketch of the product," says Kullmann. "We can source the material, laser cut and electropolish the component, provide surface treatments, and ensure final 100% inspection and packaging of the product," he adds. To keep up with growing demand, the company inaugurated a department exclusively dedicated to stent manufacture in 1995. Looking ahead, Kullmann is closely watching developments in the microstent area. Despite the small size of these products, which measure between 0.5 and 0.6 mm, laser cutting does not pose any difficulties, according to Kullmann. "The real challenges," he says, "involve the smaller-diameter balloon, crimping, and polishing the product."
Polishing expertise has been one of the primary calling cards of Maret S.A., a company that specializes in the fabrication of miniature components from ceramic, ruby, sapphire, and other extra-hard materials. Founded in 1907 in Bôle, the company developed its polishing technique over several decades to meet the demands of high-end watchmaking, which requires a flawless surface finish that does not affect part geometry. Maret's method achieves that by removing as little as 1 µm of material. A variety of materials can be polished in this manner, and the company has developed a method for polishing titanium that has gotten the attention of medical device OEMs, notes sales manager Christian Farine. "We have a niche presence in several industries, from aerospace to information technologies, but we have seen substantial growth in the medical sector," adds Farine.
Device Industry Target Market for Automated Assembly Equipment
Equipment manufacturers in the region have also had notable success in the production of machine tools and assembly equipment for use in the medical device sector.
Tornos-Bechler, a supplier of turning machines located in Moutier, has developed a thread-cutting technology that is suited for the production of metal implants.
Ismeca, a supplier of automated assembly equipment to the watch and semiconductor industries in La Chaux-de-Fonds, recently established a global business unit devoted to medical device assembly that is already the fastest growing division within the company. CEO Bernard Lacoste projects that device assembly equipment will generate approximately one-quarter of the firm's revenue by 2001.
The medical sector is also a focus at Mikron S.A. in Boudry. The company's modular assembly cells designed to facilitate individualized system configurations for high-output applications are used by such companies as Glaxo Wellcome France to assemble inhalation devices. Mikron also has a division that produces moulded components and subassemblies in a clean environment. Being able to provide machine and assembly technology along with moulding services creates a synergy within the company that is extremely attractive to device OEMs, according to marketing manager Jean-François Bauer. In that spirit, Mikron recently formed an alliance with Phillips Plastics Corp. (Prescott, WI, USA), which provides plastic and metal injection moulding services to the device industry. Mikron expects to benefit from Phillips's expertise in the design and engineering of moulded components.
On the following pages, the companies mentioned in this article along with numerous other suppliers of products and services from Western Switzerland are profiled. All of them share a commitment to meeting the needs of device manufacturers. If you would like additional information on these companies, simply circle the appropriate reader service number on the attached product information card.
Products & Services from Western Switzerland
Microgears
Spur-, helical-, and bevel-shaped microgears, high-torque and low-backlash gear trains, and machined precision parts are supplied by a company with a 3000-m2 facility that houses an array of turning, stamping, grinding, and CNC machines. Automated assembly equipment is also on-site. Heat and surface treatment and welding services can be provided, and quality control is ensured by an attentive staff and testing equipment that monitors the hardness, surface roughness, and other characteristics. Vorpe S.A., Sonceboz.
Engineering services
A company applies a total quality management approach to its subcontracting projects. Machining, prototyping, and production services are offered by the firm, which has undertaken the engineering and production of mechanical and electronic assemblies for a number of US and Swiss medical device companies. In some cases, it has also been responsible for the distribution and servicing of the products. The firm, which is certified to ISO 9001, develops and markets several products under its own name, including a fine-wire straightening and cutting machine. AP Technologies S.A., Le Brassus.
Connectors
Self-latching circular plastic connectors are available in polysulphone, which can withstand up to 20 cycles of gas or steam sterilization, and polyetherimide, which can endure more than 100 steam sterilization cycles. Gold-plated copper and nickel contacts maintain the component's effective operation for at least 1000 mating and unmating cycles. A keying system combined with colour coding can be incorporated with all connector models to prevent mismatching. The self-latching mechanism allows the connector to be mated by pushing the plug axially into the socket. Once latched, it cannot be pulled apart by tugging on the cable or any connector part other than the outer release sleeve. Lemo S.A., Ecublens.
Metal tubes and profiles
Thin-walled precision tubing is produced from a range of materials including stainless steel, titanium, nickel alloys, and special metals. The tubing is supplied in diameters from 0.2 to 40 mm and in wall thicknesses from 0.02 to 5 mm. Profiles are available in sections measuring up to 100 mm2. Products are manufactured according to customer-specified surface finishes, hardnesses, and dimensional tolerances. They can be delivered in straight random lengths, cut
fixed lengths, or coils. The company's quality systems are certified to ISO 9001.
LN Industries S.A., Grandson
Testing services
A laboratory's testing services fall into several principal categories. Metallographic specialists perform tests of metal material properties and structure and measure the performance of metals under conditions of wear, corrosion, and UV influence. 
An industrial chemistry section conducts analyses of plastics, elastomers, and other materials, and the tribology laboratory performs studies of friction and wear, including tests of lubricants and self-lubricating materials. The laboratory
develops original apparatus when necessary for conducting reproducible wear, corrosion, and fatigue tests. Consultations and expert opinions are offered as well. Laboratoire Dubois S.A., La Chaux-de-Fonds.
Electrical storage products
Disposable and rechargeable batteries, capacitors, chargers, and related products are supplied to medical device OEMs. The product range includes high-voltage capacitors for radiology and electron microscopy, electrolytic capacitors for laser equipment, disposable batteries for portable lighting equipment, and lithium, nickel-cadmium, and nickel—metal hydride batteries for medical instruments. The company is certified to ISO 9001. Leclanché S.A., Yverdon-les-Bains.
Linear bearings
Linear ball bearings can be produced in large quantities or as customer-specified individual parts by a company with more than 40 years of machining experience. The product line includes ball bearings with polyamide housings that achieve low noise levels and smooth operation even under preloading conditions. Accessories such as shafts and guiding supports are also supplied. Sferax S.A., Cortaillod.
Disposable products
Single-use medical and surgical products are developed and manufactured in close collaboration with client companies. Insert moulding, tip forming, ultrasonic welding, bonding, and blister packing are among the operations that can be performed in the on-site Class 10,000 cleanroom. With the use of laminar-flow equipment, environmental conditions can achieve Class 100 status. Custom design and prototyping services are available, as are sterilization services. Products manufactured by the firm include balloon and thoracic catheters, implantable chambers, tubing sets, and perfusion cannulae. The company is certified to ISO 9002 and EN 46002; its products carry the CE marking. Clinical Plastic Products S.A., La Chaux-de-Fonds.
Needles and metal tubing
Stainless-steel and chrome-plated brass needles, adapters, and stopcocks are among the standard products supplied by a company that has been manufacturing hypodermic needles since 1936. Special-purpose needles for anaesthesia, radiology, or ophthalmology, and stainless-steel or nickel-plated carbon steel suture needles with a regular or spring eye are available. Custom products are manufactured in stainless steel, titanium, nickel, silver, platinum, and other materials. Quality systems are certified to ISO 9002 and EN 46002. Unimed S.A., Lausanne.
Brushless motor
A 22-mm-diam brushless dc motor uses a Neodyme magnet with a single polar pair and a core-free cylindrically wound stator inside a laminated iron tube. The advantages of this type of construction include an absence of détente torque, low iron losses, and speeds up to 40,000 rpm. The torque can be tripled by augmenting the current during short periods of time. Two commutation systems are available: the 22BC-3C based on back-EMF curves is designed for continuous operation at high speeds, while the 22BC-8B includes Hall sensors and is suited for incremental motion and positioning applications. API Portescap, La Chaux-de-Fonds.
Circular four-pole connector
A circular four-pole connector with an additional leading earth contact ensures the proper sequencing of power and ground signals and provides a high level of grounding safety. The Type 105 A112 connector's lead achieves contact before the four high-voltage contacts and breaks it after the other four are opened. The connector's electrical and mechanical performances are equivalent to the high-voltage five-pole Type 105 A039 connector. W. W. Fischer S.A., Apples.
Machining services
Synthetic sapphires and rubies, metal carbides, technical ceramics, and other hard materials are machined on equipment that was developed in-house to accommodate demanding specifications. The company performs all of the machining operations; only laser drilling and etching operations and metal and antireflective surface treatments are outsourced. The company provides extensive technical assistance and routinely advises customers as early as the design stage of a product. Products supplied by the company include blades for surgical instruments, sensor elements, microtubes, and lenses. Reymond & Co. S.A., Lucens.
Assembly equipment
Modular assembly equipment is articulated around autonomous assembly cells and a pallet that transports the product being assembled from one station to the next. The pallets circulate freely on a conveyor belt and are captured mechanically and indexed when they enter one of the Flexcell stations. The units come in three sizes, and the cells' overall dimensions are common to the entire family of products. Thus, systems can be easily expanded and tooling can be added as production needs evolve. Output rates can exceed 60 cycles per minute. All of the modules are compatible with Class 10,000 cleanroom requirements. In addition to cam-driven units with a PC-based controller or optional programmable logic controller, numerically controlled models are available. Mikron S.A., Boudry.
Metal fabrication services
Solid and hollow profiles, semifinished metal products, and dental alloys are supplied by a company that processes precious metals, steel, and copper alloy materials. Capabilities include continuous profile machining, precision cutting, rolling, melting, drawing, and the manufacture of metal powder by means of atomization. The company's expertise in the manufacture of semifinished products can lead to a substantial reduction in the cost of a customer's finished product. Precinox, La Chaux-de-Fonds.
Hard-material components
Miniature components are machined from materials such as ceramics, sapphire, and ruby that range between eight and nine on the Mohs' hardness scale. Characterized by their resistance to wear, corrosion, heat, stress, and aggressive atmospheric conditions; their dielectric strength; and their biocompatibility, these materials are suited for a variety of medical applications. Balls and seats for pipettes, pumps, and flowmeters as well as check valves, pistons, and shafts are routinely produced to precise tolerances. Custom products are a specialty. The firm's eponymous polishing technique achieves a high-quality surface finish while removing only 1–5 µm of material. Maret S.A., Bôle.
Testing services
A firm that supplies quality control services to watchmakers also tests medical devices such as insulin pumps and pacemakers. Electrical characteristics, shock and vibration sensitivity, insertion force, and chemical and climatic resistance can be verified. The company also routinely performs cleanliness analyses on the inner diameters of cannulae. Chronofiable S.A., La Chaux-de-Fonds.
Metal products
Wires, strips, tubes, and profiles are manufactured from precious metals for medical device OEMs. Clad wires, x-ray-opaque marker rings and disks, electrodes, implantable microcomponents, and powders, grains, and salts used for surface treatment processes are among the products supplied. 
The engineering staff is accustomed to working with customers to jointly develop solutions and assist in the design, development, and manufacture of components and equipment suited for medical or pharmaceutical use. The firm can also provide assistance in product approval procedures. Metalor, Neuchâtel.
Metal wire and tubing
Metal wire and tubing in dimensions under 2 mm diam are supplied by a company that has expertise in wire drawing, straightening, profiling, laminating, and tapering. Braided fine wire comprising up to 32 individual wires can be produced in sizes between 0.04 and 0.20 mm diam. Various types of assemblies can also be manufactured in diameters as small as 0.02 mm. Stainless steel, nickel titanium, cobalt alloys, and other materials are routinely processed for use in cardiology, endoscopy, urology, and related applications. Microfil Industries S.A., Cossonay-Gare.
Laser processing
Needles, implants, devices used in minimally invasive surgery, and related products can be drilled, cut, welded, or marked by a provider of laser processing services. Stainless steel, titanium, nitinol, ceramics, polymers, and other materials routinely used in device manufacturing can be processed with tolerances in the micrometre range. The production equipment, which may or may not incorporate lasers, and automation systems are designed and built on-site; the firm can conduct feasibility studies and offer turnkey solutions to companies that prefer not to outsource production. The company also offers system validation and will produce prototypes or run pilot production batches. Processes carried out by its machines include welding and marking dental implants and ophthalmology instruments, drilling surgical needles, cutting endoscope
tubing, and assembling medical products. Laser Automation Gekatronic S.A.,
La Chaux-de-Fonds
Fine wires
A company with expertise in the drawing, rolling, and profiling of fine wires can produce products ranging in size from less than 0.007 to 1.2 mm. Ferrous and nonferrous alloys, stainless steel, and biocompatible materials such as Elgiloy are processed. The availability of laser and microplasma welding equipment enables the company to produce microassemblies without the addition of metals. Electroplating in precise and repeatable layers is also performed. Applications of the company's wire products include probes for pacemakers, catheters, and biopsy forceps. The company also applies its expertise in microtechnology to the manufacture of micropumps used in drug delivery devices. Nivarox-Far S.A., Le Locle.
Automated assembly systems
Flexible synchronous/asynchronous linear assembly systems offer a wide range of operating speeds and precise product location, even at the highest rates of operation. They easily accommodate new component sizes and shapes as product assembly needs evolve. Any combination of one-up, two-up, or multi-up operations can be accommodated in one chassis or in adjacent chassis. Easy-to-connect modular elements are designed for rapid pallet transfer into and out of each unit. Each pallet is identified by code and traced by central computer, thus permitting monitoring of product residence time throughout the system. Ismeca Europe S.A., La Chaux-de-Fonds.
