PRODUCT UPDATE

Metals Companies Sharpen Their Competitive Edge

Lori Bryan

By addressing a wide rangeof issues from processing capability to cost containment, metal fabricators and suppliers are bolstering their niche in the device industry.

Staying competitive in a growing industry is a challenge that metal fabricators and suppliers contend with daily. "We are being faced with an increasing number of competitors," says Paul Dorrington, sales and marketing manager for Sandvik Metinox (Holbrook, Sheffield, UK). "And in terms of the medical market," he adds, "of course, we are dealing with the demand for extremely high-quality products and services." As the millennium approaches, companies like metals supplier Sandvik Metinox are helping to ensure their continued livelihood by making product improvements, advancing metals technology, reducing costs, and widening market access, to name but a few strategies.

"High precision," says Clemens Meyer-Kobbe, doctor of mechanical engineering at MeKo Laser Material Processing GmbH (Sarstedt, Germany), "sets our company apart from other metal fabricators." According to Meyer-Kobbe, very few companies worldwide can achieve accuracy of ±5 µm—a capability that the firm is proud to offer its customers. Known for expertise in high-precision laser material processing, the company has developed laser machines that ensure stents are cut burr-free with the highest possible degree of accuracy. The company also offers 100% final inspection, employing high-tech microscopes and other mechanical measuring instruments to attain high measuring accuracy. Such efforts are critical, says Meyer-Kobbe, as the market grows globally and quality standards multiply and become increasingly stringent.

Other metals companies too are honing their processing capabilities. Advances in automated inspection and sorting capabilities at Metal Cutting Corp. (Cedar Grove, NJ, USA) enable the company to offer its customers tight tolerances and high-volume product to the highest quality standards. Deep-drilling technology available from Burri S.A. (Moutier, Switzerland) involves a unique attachment on the company's machines that produces very small, deep drills with possible dimensions of 1.5 x 90 mm. And at Metal Injection Mouldings Ltd. (Altrincham, Cheshire, UK), a relatively new process called metal injection moulding (MIM) is the primary focus. "The challenges are generic," says director/general manager Andy Hayward, "whether we are fabricating for the medical market or otherwise. We are working to improve the range of alloys available, to better our processing ability to produce tight tolerances, and to reduce costs across the board."

For Memry Corp. (Brookfield, CT, USA), being cost-competitive has everything to do with product design. "We're a significant processor of nitinol with a highly skilled and diverse staff," says product marketing manager Jim Radcliffe. "We have to be cost-competitive, so we strive to come up with good, cost-competitive designs." According to Radcliffe, the company often discovers through its R&D process new and innovative ways to heat-treat, cut, shape, form, and grind the material. The company also uses a wide range of computer technologies including CAD.

Accessing the Worldwide Market

Titanium International Ltd. (Birmingham, UK) supplies a full range of titanium worldwide from its UK facility and service centres in Düsseldorf, Paris, and Singapore. Being a global presence has always been a key strategy at the company, which supplies plates, sheets, bars, and tubes in a wide range of grades for the fabrication of industrial, medical, and aerospace products. To achieve and maintain a market leader position, says Roger Hopper, the company is committed to having "the widest range of off-the-shelf titanium available in Europe." He estimates that the value of the material in stock approaches 4.5 million pounds sterling. The company also is equipped with several cutting machines to produce client-specified cut lengths. Characterized by a high strength-to-weight ratio, low modulus, and resistance to bodily fluids, titanium is suited for the manufacture of trauma plates, bone screws, artificial joints, and various surgical instruments.

Other metal fabricators and suppliers are carving out their niche, or at least beginning to, in the global marketplace. "We are in the process of getting ISO 9000 and CE certifications so that we can sell in Europe," says Jon A. Austin, new product development manager for DS Mfg. Inc. (Ventura, CA, USA), a manufacturer of metal surgical devices. The company reportedly has one customer in the UK and a potential client in France.

"We have to broaden our horizons," adds Peter v.d. Biggelaar, manager of engineering at Van Geel Hermus (Venray, Netherlands). Because the equipment produced by the company is not made entirely of sheet metal, the firm has to network with other suppliers that can deliver the plastic parts, the aluminium die-cast parts, and so forth. "We are trying to deliver a total concept from engineering to just-in-time delivery of parts," says Biggelaar, "so opening up a network in which we are still the one contact that the customer comes to is a challenge."

Research Key to Industry Prosperity

Also working to strengthen the position of the industry is the Netherlands Institute for Metals Research (NIMR; Delft, Netherlands). Opened officially in April of last year, the NIMR reportedly brings together the resources of the Dutch government with key corporate partners and addresses research issues in metals science, engineering, and production. Researchers reportedly focus on such areas as welding, fibre-metal laminates, corrosion, powder metallurgy, laser technology, and coatings. Those seeking more information may visit the institute's Web site.

Device manufacturers looking for metal fabrication services or materials might begin by contacting one of the fabricators or suppliers detailed in this section. Each is dedicated to the improvement of metals technology for the medical marketplace.

DS Mfg. Inc.

A full-service manufacturer of dental and surgical components and subassemblies in stainless steel, titanium, and other alloys provides its customers with innovative, cost-efficient product solutions. DS Mfg. Inc. (Ventura, CA, USA) develops a broad range of products including medical devices and subassemblies, surgical saw blades, broaches, burrs, drills, rasps, bone plates, formed wire products, and implant components.

"We have recently [installed] additional burr-grinding capacity, including a five-axis CNC burr grinder with autoload and autotouch probe features," says new product development manager Jon A. Austin. The new equipment, he says, will enable the company to greatly reduce lead times for its customers.

Among the firm's capabilities are laser cutting and welding, metal stamping, CNC milling and turning, resistance welding, five-axis CNC grinding, passivation, and electropolishing. The full-line contract metal fabricator provides R&D engineering and design assistance, ensuring its customers complete confidentiality. Engineers utilize 3-D Surf CAM for programming, and AutoCAD software for design and development.

An ongoing project at the firm, says Austin, is the fabrication of instruments for coronary bypass surgery.

Burri S.A.

A subcontractor machines 1–30-mm-diam complex, precise turned parts from such materials as steel and stainless steel, titanium, aluminium, and brass and copper alloys. Production equipment utilized by Burri S.A. (Moutier, Switzerland) includes CAM-driven single spindles up to 20 mm, multispindles up to 30 mm, CNC automatic screw machines and lathes, machining centres and rotary transfer machines, CNC milling machines, high-production turning machines, and CNC grinders. The company has developed machines specifically for the high-speed turning of contacts used in integrated circuit bases, and currently is developing secondary-operation machines for the machining of components for coaxial connectors.

Among its capabilities, the company offers deep- drilling services to its customers, says marketing director Jean-Paul Müller. Not all metal fabricators have this technology, says Müller, which is used to produce long holes in long metal or titanium parts. "If we have to make a long part with a hole inside, the challenge lies in producing a long hole," he says. "Drilling a 1.5-mm hole on an 80-mm length, for example, requires a special drilling attachment." Because the tooling is very fragile, he says, the operator must have the expertise to handle it successfully, to prevent tool damage, and to guarantee a surface roughness that is acceptable on the product.

The ISO 9002–certified company works with most customers on a ship-to-stock contract basis.

Memry Corp.

In addition to high-capacity processing of nitinol wire, strip, and tube materials, a company also provides specialized forming, secondary operations, and cleanroom subassemblies engineered to meet customer requirements. Memry Corp. (Brookfield, CT, USA) has recently launched a line of nitinol strip products for use in permanent implants, minimally invasive medical devices, and other medical applications. Formed shapes made from the nitinol strip are suited for use in snares, retrieval baskets, and orthodontic appliances, while nitinol-strip coils can be formed into self-expanding and body-temperature-responsive stents for the treatment of cardiovascular, urological, and gastrointestinal diseases.

The highly flexible, kink-resistant nitinol material can reportedly withstand up to 10 times more strain than stainless steel without permanently deforming. "Not only can we process nitinol," emphasizes product marketing manager Jim Radcliffe, "but we can also form it and make components." The company's greatest asset, says Radcliffe, is its knowledge of how to work the material. "We often find through our R&D process new applications, new ways to heat-treat the material, as well as to cut it, shape it, form it, and grind it. So, when we talk about innovating or adding new capabilities, [discussions revolve around] how we can best work with the material."

To help accelerate its customers' new product development efforts, the company offers 18 standard sizes of narrow and wide nitinol strip available for immediate delivery. Nitinol strip can be supplied in either a cold-worked or superelastic condition depending on the customer's requirements. Starting thickness for the standard strip is 0.002 in. with a maximum width of 0.200 in. The firm also produces standard nitinol wire diameters starting at 0.005 in., and nitinol tubing with ODs starting at 0.012 in. Products are manufactured in an ISO 9001–certified facility to meet rigid alloy composition, dimensional, and mechanical product specifications.

Sandvik Metinox

Medical implant steels are supplied to device manufacturers for a broad range of uses including the manufacture of hip and knee joints, pins, screws, and plates for trauma surgery. Formerly called Metinox Steel Ltd., Sandvik Metinox (Holbrook, Sheffield, UK) is the worldwide distributor of Sandvik Bioline TM steels, which are manufactured from high-purity stainless steels. Products are available in profiles and bar, wire, strip, and tube forms.

According to sales and marketing manager Paul Dorrington, the company has recently released a new material called Sandvik Bioline High N. "The new material is a nitrogen-alloyed 316 material that conforms to ISO 5832 part 9," says Dorrington. Commercially available in Europe, the steel is reportedly cleaner—an improvement over standard 316 LVM.

Owned by Swedish steel maker AB Sandvik Steel, the company offers total process and quality control from steel melting to finished product. Extensive R&D facilities are available for the development of new materials and product improvements.

Metal Cutting Corp.

A company with more than 30 years' experience serving the medical industry uses abrasive-wheel cutting techniques to produce burr-free metal parts. Metal Cutting Corp. (Cedar Grove, NJ, USA) reportedly can achieve length and diameter tolerances in the micron range, parallelism and flatness of less than a micron, squareness in the minutes, and surfaces as smooth as 1 µin.

According to executive vice president Joshua S. Jablons, the company has made significant advances in its automated inspection and sorting capabilities. "Our niche," says Jablons, "is that we provide very tight tolerances and dimensional sorting capabilities." The firm employs camera vision technology with parallel processors, and laser and LVDT dimensional sorting devices. Multistage ultrasonic cleaning equipment and a cleanroom environment enable the company's staff to hold 5-µm total dimensional tolerances in sorting, and to supply a high-volume product at the highest standards of cleanliness.

Capabilities include cutting, grinding, lapping, and polishing of small-diameter metal tubes, wires, and rods. All metals, including stainless steels, cobalt alloys, NiTi and all titanium grades, and precious and refractory metals, are processed for catheters, stents, radiopaque markers, cardiac pacing, diagnostic probes, electrodes, and minimally invasive device applications. In-house operations include proprietary rotary abrasive cutting, double-disk grinding, centreless grinding, wire straightening, and barrel, vibratory, and centrifugal polishing.

Zappa Rinaldo snc

Finished mechanical parts in ferrous and nonferrous metals are produced according to customer drawings and specifications. Metal parts supplied by Zappa Rinaldo snc (Monza, MI, Italy) are used in such products as medical and pneumatic systems, equipment, and tooling.

The company entrusts all necessary preliminary operations such as die-casting and moulding, and any supplementary treatments including glass-bead peening, sandblasting, heat and chemical treatments, and laser marking, to an organized network of specialized external suppliers. A constant-temperature room and efficient quality control system enable the firm to provide its clients with minimal working tolerances. A punctual delivery service to both national and international companies is offered.

MeKo Laser Material Processing GmbH

A specialist in high-precision laser processing cuts materials for the medical industry. "We are cutting stainless steel, copper, brass, aluminium, titanium, tantalum, NiTi—all types of materials," says Dr.-Ing. Clemens Meyer-Kobbe, specialist in mechanical engineering at MeKo (Sarstedt, Germany). Complex geometries (flat or tube) and miniature workpieces are laser cut with an accuracy of 0.005 mm.

Stent cutting, says Meyer-Kobbe, is one of the firm's most sought-after capabilities. Specially developed laser machines ensure that stents are cut burr-free with the highest possible accuracy. Heat treating and polishing of the stents is available upon customer request. A 100% final inspection guarantees product quality. "We inspect our finished products," says Meyer-Kobbe. "We invest a lot of money in special microscopes and other mechanical measuring instruments in order to achieve a higher measuring accuracy."

The ISO 9002–certified company also offers laser and conventional welding and various postprocessing operations, including bending, ultrasonic finishing, electropolishing, heat treating, and milling.

Van Geel Hermus

Traditionally a sheet-metal workshop, a company also offers its ability to engineer and produce parts for the medical industry. "Over time," says Peter v.d. Biggelaar, manager of engineering at Van Geel Hermus (Venray, Netherlands), "we have seen that our customers want a service that [begins] at the outset of the process with development and engineering." According to Biggelaar, the company has been providing this type of service for a couple of years. "We are trying to start with the customer and the [knowledge] of the specs and function they want," says Biggelaar, "instead of making the parts according to the drawings that the customer has made."

Currently the company is working for firms that manufacture ultrasound equipment. "For these firms," says Biggelaar, "we are building trolleys upon which ultrasound scanners and electronics are mounted." Three-dimensional laser-welded assemblies such as complex modular constructions and casing assemblies are specialties as well.

Materials processed by the company include steel, stainless steel, and aluminium. Hydraulic presses up to 630 t, CNC punching systems, 3-D CAD/CAM systems, robotic laser systems, and laser cutters are among the equipment employed.

Metal Injection Mouldings Ltd.

A manufacturing technique, metal injection moulding (MIM) combines the technologies of powder metallurgy and injection moulding for the production of high-integrity metal parts in complex shapes. Benefits of the process, which is carried out by Metal Injection Mouldings Ltd. (Altrincham, Cheshire, UK), include close tolerances, smooth surface finish, and finely reproduced detail. Components can be manufactured in a wide range of metals including low-alloy steels, stainless steels, tool steels, magnetic alloys, and bronze. "We are one of two companies in the UK that can perform MIM," says director/general manager Andy Hayward, "so the demand for our services is rather high."

The company has had several contracts with medical companies that called for the MIM of simple mechanical parts. One project involved the development of metal jaws for a minimally invasive surgical device for Gyrus Medical (St. Mellons, Cardiff, UK). An engineering and design consultancy firm, Gripgold Product Design Ltd. (Felpham Village, W Sussex, UK), was hired to design the mechanisms, which had to be durable and capable of withstanding repeated sterilization. "The driving force for us," says Roger Virgo, managing director at Gripgold, "was not just to come up with a mechanical design that worked well, but to devise a cost-effective design as well." For such reasons, says Virgo, Gripgold chose to promote MIM for the Gyrus project.

Depending on size and component design, accuracy generally ranges from ±0.02 mm for a 4-mm dimension to ±0.2 mm for a 40-mm dimension. Surface treatments can be applied by such conventional methods as polishing, grinding, plating, and case hardening.

Titanium
International Ltd.

Because of its high strength-to-weight ratio, low modulus, and resistance to bodily fluids, titanium is well suited for the fabrication of medical implants. The material also exhibits better corrosion resistance than stainless steel, adds Roger Hopper of Titanium International Ltd. (Birmingham, UK), whose company reportedly stocks the most extensive range of off-the-shelf titanium in Europe. According to Hopper, the inventory of material alone is worth 4.5 million pounds sterling.

"Few companies have titanium plates in stock," says Hopper, "and even fewer have the sawing
machines to produce cut lengths like we do." The company can supply the material in the form of bars, plates, sheets, and precision-ground wire in a wide array of grades or in commercially pure titanium. Typical applications include trauma plates, dental fixtures, bone screws, and artificial joints. Increasingly, titanium is specified for surgical instruments, according to Hopper, and Titanium International is ready to meet this demand with stocks of Ti-6Al-4V sheet, small bar, and wire.

Certified to ISO 9001 and ISO 9002, Titanium International distributes a full range of titanium products from its headquarters in Birmingham. Service centres are located in Düsseldorf, Germany, and Paris.

Star Guide Corp.

Precision wire components are fabricated in diameters from 0.05 mm for manufacturers of guidewires, catheters, pacemakers, and other medical devices. Typical components manufactured by Star Guide Corp. (Arvada, CO, USA) include stylets, guidewire cores, mandrels, and lead wire components. Among the company's production capabilities are precision centreless grinding of fine-diameter wire, wire straightening and cutting, single- and multistrand coil winding, microwelding, wire forming, and coatings including PTFE and parylene. Expertise in handling stainless steel, MP35N, nickel-titanium, platinum, and other alloys is offered. The firm's ISO 9002–certified facility has been enlarged for increased subassembly production capacity. Employing welding, brazing, and joining technologies, the company can assemble precision wire parts for several applications.

Bartels Mikrotechnik GmbH

A company uses excimer lasers to produce microstructures in various materials including metal. Capabilities of Bartels Mikrotechnik GmbH (Dortmund, Germany) range from the production of simple holes to complex 3-D structures. The company can build the technical and industrial equipment necessary to meet customer needs. Among the services offered are pilot production, quality control procedures, configuration of product lines for customer-owned facilities, and feasibility studies including the development of processes for special applications.