REGIONAL FOCUS

AUVERGNE, FRANCE

A tradition of medical research and a dynamic group of subcontractors are making Auvergne a sourcing centre for device manufacturers.

Norbert Sparrow

"L'Auvergne est un grand plateau de fromage" was an effective advertising campaign that used a clever topographical pun to tout the region's celebrated cheeses. The catch phrase has proven to be durable, and that leaves something of a tart taste in Patricia Auroy's mouth. In charge of promoting the advanced materials and engineering, health, and agro-food sectors within the Agence Régionale de Developpement d'Auvergne, Auroy sometimes wishes the slogan had not struck such a resonant chord with the public. While she is an ardent supporter of the region's culinary creations, the focus on cheese does tend to distract people from recognizing Auvergne's other achievements, not the least of which involves a tradition of medical innovation.

One example that Auroy cites is the internationally recognized work of Maurice Bruhat in the field of endoscopy. "In the 1970s, almost 80% of all endoscopic procedures in France were performed in Clermont-Ferrand under his supervision," she says. In 1991, Bruhat founded the International Centre of Endoscopic Surgery (CICE) in Clermont-Ferrand, which trains hundreds of surgeons each year from around the world in the latest procedures. The CICE is also dedicated to advancing the state of the art in endoscopic surgery through extensive R&D in partnership with local universities and industry. It was largely because of Bruhat's reputation that the manufacturer of endoscopic instruments Karl Storz GmbH (Tuttlingen, Germany) set up a facility at the nearby Bioparc just outside Vichy, adds Auroy.

To promote regional expertise in medical manufacturing within France as well as internationally, AxE Biomed was founded in 1995. Grouping both regional manufacturers of medical equipment and qualified subcontractors, the association has grown from the initial 11 members to 24 today. In addition to its promotional efforts, the association supports research through the establishment of working groups on such issues as hospital hygiene, to investigate the prevention of nosocomial infections, and on biomaterials. The latter group has brought together area manufacturers and researchers to discuss the medical use of titanium alloys and ceramics, and to spearhead a study of corrosion on metal surgical instruments. This study is currently under way in partnership with Clermont-Ferrand's university hospital, adds Auroy.

"There is a tremendous amount of synergy present within AxE Biomed," says association president Franck Vaudoit, whose company Auvergne Techniques de Pointe (Clermont-Ferrand) supplies water-jet cutting and laser marking services. Customers contracting the services of one member company routinely find that they can source a supplier of another needed service within the association, says Vaudoit. Internal networking has also led to the emergence of new business opportunities within the group. A recent example is Vichy Bio Materials (VBM; Vichy), a joint venture of founding AxE Biomed members Vichy Medical Product (Vichy) and Forécreu Biométal (Commentry) to develop and market products made from resorbable materials.

Bioresorbable Products Supplied to OEMs

Launched in September, VBM offers a dedicated site for the manufacture of orthopaedic implants made from synthetic bioresorbable materials. In addition to cleanroom manufacturing procedures that follow US FDA cGMP guidelines, the company supplies mold design, packaging, and prototyping services. Quality testing is performed in accordance with EN 46002, and the firm offers assistance in setting up clinical trials and obtaining the CE mark. Demand for resorbable implants is growing at a rapid pace, according to G. Phillipe Planche, one of the VBM shareholders and sales manager at Vichy Medical Product.

"Resorbable materials can eliminate a second surgical procedure," says Planche. "But another advantage they have over rigid metal implants, which may weaken the bone, is that the materials degrade while the bone regains its strength."

VBM's objective is to make these products available to companies that may not have the resources for the R&D and capital investment this type of technology requires. While several US companies and a handful of European ones are currently offering this technology, Forécreu president François Ory adds that VBM is the only independent firm in Europe supplying these products to companies in the orthopaedic and traumatology sectors.

For Forécreu and Vichy Medical Product, this project represents a convergence of their companies' expertise. Forécreu supplies cannulated stainless-steel bars and implant-grade cannulated stainless-steel and titanium bars to device manufacturers worldwide through sales offices in the United Kingdom, Germany, Italy, the United States, and Japan. Its materials are used in the manufacture of medical and dental instruments as well as bone screws, intramedullary nails, and related implants. The company has built its reputation on metallurgical savoir faire and a medical materials focus, says Ory, and the capability to perform extensive biomechanical tests that are traditionally conducted by the purchaser.

Vichy Medical Product specializes in injection moulding and assembly in Class 10,000 and Class 100,000 cleanrooms that can attain Class 100 conditions with the use of a laminar-flow hood. The company is equipped with eight injection moulding machines with clamping forces ranging from 25 to 250 tn and routinely processes such materials as polyethylene, polyurethane, and PEEK.

Liquid Silicone Rubber on the Rise

Also a supplier of moulding services, CVA (Saint-Vidal) has prospered since its founding in 1961 thanks to a sustained demand for the rubber nipples used in baby bottles, pacifiers, and related devices. The company has captured 60% of the national market, making it the leader in France, and exports to more than 25 countries. Indeed, baby-care products represented 90% of the company's output as recently as 1990, when CVA decided that it was time to diversify.

"When we began substituting silicone for natural rubber, we also initiated a strategy of diversification," says marketing director Dominique Dupard. "Expanding our presence as a supplier to the medical device industry seemed like the best way to move forward," he says, "since we were already producing some paramedical products."

Silicone, and in particular liquid silicone rubber (LSR), represented a real opportunity for the company to begin diversifying its production, says Dupard. "The overwhelming advantage of liquid silicone rubber over natural rubber," he says, "resides in its ease of conversion." Processing natural rubber is a labour-intensive activity that is difficult to industrialize, explains Dupard. "LSR, on the other hand, acts more like a thermoplastic elastomer. It allows for maximum automation, and cycle times can be reduced by as much as 50% compared to rubber."

Because of its cost, LSR has not been the material of choice for medical consumables in France and elsewhere, adds Dupard, but that may be changing. "It is perceived to be an expensive material, especially in France, where demand for LSR lags far behind Germany or Italy, he says. The drop in price and the advent of fast-curing LSR has contributed to opening up new markets and will eventually correct the perception that it is a "haut-de-gamme material."

For CVA, one market that holds great promise for LSR is the medical device sector, and it is aggressively pursuing a strategy to position the company as a global supplier of moulded LSR medical components. Medical-related business currently accounts for 10% of the company's earnings; according to Dupard, that will grow to 15% in 1999 and 20–25% shortly thereafter. To that end, CVA is investing heavily in its infrastructure.

The company currently owns eight presses, including one 85-tn press in a controlled environment that attains Class 100 status, processing LSR 24 hours a day. Several additional presses are on order. They will be housed in a new facility equipped with a cleanroom, CNC and electroerosion machines, a metrology lab, and a design bureau. To further show the company's commitment to the device industry, CVA is also integrating tooling design. "That will enable us to be even more competitive and to guarantee confidentiality," says Dupard.

Package Deal Proves Popular with Device Manufacturers

Lending an attentive ear to the wishes of device manufacturers has helped Cartolux (Peschadoires) gain significant market share as a supplier of packaging services. The company was founded by the great grandfather of current managing director François Berry in 1927, but it didn't begin targeting the medical device industry until five years ago. Today, about 35% of Cartolux's business comes from device manufacturers. Berry attributes this rapid rise to the complete packaging solutions offered by his firm.

"Initially, we were thermoforming relatively simple packaging for surgical instruments," says Berry. It soon became apparent to him that manufacturers were really looking for a company that could provide a full array of packaging services. "So we began to make blisters, to cut the Tyvek and foam, and produce the secondary packaging, as well. We've integrated everything into a Class 10,000 cleanroom, which can be supplemented with laminar-flow hoods," explains Berry. The philosophy of the company has evolved in the process, he adds. "We strive to be a partner of our clients, not simply a supplier of services," says Berry.

Cartolux has several proprietary models of blister packs that can be rapidly modified to accommodate a client's product. "Not only do we offer fast turnaround, but the client can save a considerable amount of money because there are no tooling costs," says Berry.

Since 1998, Cartolux also manufactures thermoformed Radel handling trays that withstand sterilization temperatures up to 200°C.

Allez les Bleus . . . d'Auvergne

The expertise of these and other companies profiled in the accompanying section should dispel the notion that Auvergne is first and foremost a tantalizing cheese tray. Having said that, should you find yourself in the region sourcing a supplier, take my advice and don't pass up the opportunity to sample a bleu d'Auvergne, Chaumes, or Cantal. Chances are your host will insist that you do so anyway. Consider it one of the fringe benefits of business-to-business transactions in Auvergne.

Products & Services from Auvergne

Moulded components

An injection moulding firm produces trocars, lancets, and related devices in Class 10,000 and Class 100,000 cleanrooms. A laminar-flow station can be used when Class 100 conditions are required. Materials processed include polyethylene, polyurethane, and PEEK as well as resorbable formulations. The company, which is equipped with eight 25–250-tn injection moulding machines, can accommodate small- and large-volume production runs. Mould design and prototyping services can be provided. The company is in the process of obtaining ISO 9002 certification. Vichy Medical Product, Vichy.

Thermoforming

In addition to a broad range of standard blister packs for implants, catheters, and related medical products, a company specializes in the design and manufacture of custom packs. Product and tooling design is performed in-house to facilitate rapid turnarounds. A Class 10,000 cleanroom is on-site; medical-grade PETG is processed using an Illig thermoforming machine specifically designed for cleanroom applications. The company, which was recently certified to ISO 9001, exercises rigorous quality control. To ensure that no dust has settled on the material during calendering, for example, products are individually checked for dark spots and other flaws. The company also provides welding and printing services. Velfor-Plast, Saint-Pal-en-Chalençon.

Liquid silicone rubber components

Liquid silicone rubber components are moulded on an 85-tn press in a clean environment that attains Class 100 conditions. To ensure that all products comply with relevant standards, an integrated laboratory inspects incoming raw materials, conducts systematic quality control at each step of the manufacturing process, and inspects the finished products. In addition to liquid silicone rubber, natural and thermoplastic rubber is processed. The ISO 9002–compliant facility recently achieved EN 46002 certification. The company will soon open a new facility that will house a cleanroom and seven additional presses, including a 160-tn dual-injection moulding machine designed for thermoplastic and TPE processing. The new plant will also include a design bureau, metrology lab, CNC machines, and electrical-discharge equipment. CVA, Saint-Vidal.

Packaging services

Specializing in the manufacture of thermoformed packaging, a company supplies blister packs, cut and printed Tyvek, sterilizable foam cut to client specifications, and secondary plastic or cardboard packaging. The facility is equipped with a Class 10,000 cleanroom. Materials typically processed include polycarbonate, PETG, and PPSU. The company is constantly adding to its standard range of packaging, enabling it to offer clients rapid and cost-effective packaging solutions. In addition to thermoforming equipment, the 5200-m² plant is equipped with cutting machines and welding stations. It recently acquired automated equipment designed to cut foam in a sterile environment. Contract printing services can also be provided. The firm, which is certified to ISO 9002, is a supplier of thermoformed packaging to leading national manufacturers of orthopaedic products. Cartolux, Peschadoires.

Water-jet cutting, laser marking services

A supplier of contract services offers water-jet cutting and laser marking services to device manufacturers. Water-jet cutting is a cold, nonpolluting process that will not affect the material in a thermal or tensile manner. Titanium, stainless steel, nickel, nickel-chrome, and nickel-chrome-cobalt are among the metals and alloys that are routinely processed; depending on the material, thicknesses up to 250 mm can be accommodated. The company also offers laser marking services for implants and medical instruments. Auvergne Techniques de Pointe, Clermont-Ferrand.

Cannulated bars

Stainless-steel and titanium-alloy cannulated bars are designed, manufactured, and marketed for use in surgical instruments and implants. Screws, intramedullary nails, and other osteosynthetic implants are among the items routinely manufactured at the production site. Manufacturing processes include forging, rolling, extrusion, cold and hot drawing, thermal processing, and finishing operations. An on-site laboratory performs biomechanical testing and metallurgical analyses. Forécreu Biométal, Commentry.

Resorbable implants

A recently formed company develops and manufactures orthopaedic implants from resorbable materials. Manufacturing services are performed in a cleanroom facility under US FDA cGMP guidelines and quality testing is conducted in accordance with EN 46002. The firm also provides mould design and prototyping services and assists clients in establishing clinical trials and compiling documentation to obtain the CE mark. Vichy Bio Materials, Vichy.