Medical Device Link.

PRODUCT UPDATE

GCP

A manufacturer of blades and cutting tools of many types operates a medical blade division that specializes in honing individual knife edges or continuous band steel for the manufacture of sterilizable single-use and reusable surgical blades and related items. ISO 9002:2000– and EN 46002:1996–certified GCP (La Monnerie-le-Montel, France) produces ultrasharp and precise razor edges for ophthalmologic, oral, and endoscopic surgery applications. Using specially designed equipment, it can produce compound bevels by means of a multistep process. Either standard ground bevels or finely polished edges can be supplied, according to the customer’s requirement, and the products carry the CE mark.
Microscopes and measuring devices linked to a computer ensure consistent, repeatable blade quality. Measurements of both edge sharpness and dimensional integrity are recorded. Subsequently, a visual inspection by means of binocular microscopes is performed to discover any imperfections not detectable by measuring techniques. Critical blades are inspected individually.

The company has in-house injection moulding capabilities as well, which are used in the production of complete blade assemblies. For dust control, injection moulding facilities are isolated from the Class 10,000 cleanroom in which instrument cleaning, electropolishing, assembly, and packaging are performed.

Maillefer Instruments

Instruments for dental implantation applications, along with a full line of surgical instruments, are manufactured by a company offering Swiss precision in machining. Maillefer Instruments (Ballaigues, Switzerland) provides services from design through production and finishing. Its OEM instruments, machined from stainless steel, titanium, and other materials, include twist drills, burrs, reamers, taps, trephines, craniotomes, screwdrivers, and various other tools and accessories.

The company’s research and development capacity is not limited to machined products but extends to the creation of its own production equipment. Equipped with more than 800 machines, the firm has a reputation as a leading regional machine manufacturer.

LNS Group

An automatic bar feed for high-volume precision machining applications allows users to cut bar stock up to 12 ft at maximum spindle speeds without generating dangerous vibrations. LNS Group (Orvin, Switzerland) has incorporated both hydrostatic and hydrodynamic principles in creating the Hydrobar Sprint 555. The former makes it possible to limit vibration, which extends tool life and leads to more-precise surface finishes on machined parts. The hydrodynamic principle enables a wide range of bar-stock diameters, from 5 to 55 mm, to be accommodated, minimizes the number of guide channels necessary, and allows the few changeovers that are required to be completed in 2–8 minutes.

The bar feed’s hydrostatic feature involves a patented self-opening bearing block designed to let the user run round bar stock at a lathe’s maximum speed without remnant retraction. With respect to hydrodynamics, an automatic front rest prevents bar vibrations from being transferred to the machine cutting area and adjusts automatically to the bar and pusher diameters when the operator inputs bar-stock diameter at the menu-driven remote control. A quick-release system for changing the guide elements allows quick changeover without tools. Servo-driven torque and speed adjustments occur automatically.

STI Laser Industries Ltd.

An expert in medical and optical device micromachining offers its services as an engineering and manufacturing platform for new product development. From conceptual design through series production, STI Laser Industries Ltd. (Or Aqiva, Israel) provides knowledge-supported competence and fast turnaround. It is staffed with material and laser processing specialists, mechanical engineers, and quality inspectors with a background in medical parts inspection. The company collaborates with established and start-up medical device industry enterprises and is open to a variety of business arrangements, including joint ventures.

The service provider can perform engineering design review, high-precision laser cutting and welding of miniature parts with complex geometry, and such postprocessing operations as ultrasonic cleaning, heat-treating, passivation, and electropolishing. It machines a wide range of raw materials, including Type 316 LVM stainless steel, nickel titanium alloys, cobalt chromium alloys, titanium, platinum, gold, tantalum, and other biocompatible metals.

Certified to ISO 9001:2000 and ISO 13485 and compliant with good manufacturing practices, the company follows very strict quality control, using advanced optical microscopes for high-precision measurement.

Veslatec Oy

A manufacturer of precision machined and micromachined components for medical, electrical, and process equipment uses lasers to cut, weld, drill, and label products. Veslatec Oy (Vaasa, Finland) conducts active research and equipment development in the fields of microcutting and fine detail structuring. The company uses high-frequency ultrashort-pulse lasers for drilling fine filters, structuring sliding surfaces, and manufacturing medical implants, sensors, and nozzles; Nd:YAG lasers are used for machining and labelling.

The new high-frequency laser technology offers faster processing than is possible with conventional YAG lasers, as well as producing a better cut quality and smaller details and removing the need for finishing processes. Ultrashort-pulse lasers, delivering high energy for very brief periods, minimize shock effects and thus do not distort microscale features. In addition, the heat-affected zone is small, microcracking does not occur, and the laser beam penetrates the material completely.

The ISO 9001:2000– and ISO 14001:1996– certified company can perform micromachining with ultrashort-pulse lasers on all sorts of materials economically. The technology supports the development of products that employ new materials and include finely detailed features.

New England Precision Grinding Inc.

A precision manufacturer of small wire products and supplier of wire-based materials and services to medical device OEMs offers an extensive array of in-house services, including burr-free cutting, bending, and grinding. Custom capabilities available from New England Precision Grinding Inc. (Holliston, MA, USA) include taper, form, and step grinding; centreless grinding; coining; end rounding; grit and bead blasting; laser marking; and wire forming. Electropolishing, passivation, and coating services are offered to give wire components the desired surface appearance and characteristics. Production using sophisticated equipment is supported by the manufacturer’s competence in component design, engineering, and rapid prototyping.

Automated precision grinding machines are employed for the cost-efficient production of a variety of intricate wire and tubing designs in Type 304 stainless steel, nitinol, and custom materials. Wire products can be given four-facet diamond, back-bevel, stepped trocar, or barrel tips, or barb, lancet, Franseen, or arrowhead points. Tolerances within 0.0001 in., tip sharpness of better than 0.00005 in., surface finishes of less than 6 rms, and ground diameters as small as 0.005 in. are standard specifications.

In addition to stock wire for medical applications, the supplier can provide custom products engineered to realize customers’ concepts in trocars, stepped and shaped mandrels, core pins, dilators, cannulae, paddled wires, snares, core wires, stylets, K-wires, bone drills, probes, needles, and hypotube components.

Hurco Europe Ltd.

A manufacturer of a wide range of machine tools equips its machines with sophisticated controls that offer the flexibility of a choice between conversational shop-floor programming and numerically controlled (NC) programming. The Max and UltiMax controls with which the machining centres and lathes from Hurco Europe Ltd. (High Wycombe, Bucks, UK) are provided are designed to be easy to learn and to use, thanks to their basic conversational format. The user supplies the necessary geometric information from which the machine then calculates any unknown points of intersection. The machine reads DXF files directly into the control.

Conversational rotary programming is standard on all TM-series lathes and VM-, VMX-, VMXHS-, and VTX/HTX-series machining centres, but powerful NC capability with high-speed profiling options is available for complex three-dimensional machining. This flexibility and ease of use facilitates the quick generation of one-offs, small batches, and trial components.

Max controls are easy to program, with interactive graphics making the cutter path and part geometry very clear and providing automatic scaling and unlimited views of the part to be machined. High-speed digital processing makes available sufficient power and memory for handling the most complex functions. The UltiMax also is ergonomically designed and equipped with a colour touch screen monitor, but its display is distinguished by having two panels, the right showing a model of the part which the operator can touch to edit, and the left delivering the portion of the code corresponding to the element to be edited.

Kern Micro- und Feinwerktechnik GmbH & Co. KG

Precision high-speed machining is the specialty of a machine manufacturer headquartered in Murnau-Westried, Germany, that has developed a machining centre that features a positioning scatter of just ±0.3 mm according to VDI/DGQ 3441. This high level of accuracy is guaranteed through the entire 500 × 500-mm x-y travel of the Pyramid Nano computer numerically controlled machine from Kern Micro- und Feinwerktechnik GmbH & Co. KG. The centre is equipped with hydrostatic drives and guides. Heat-generating elements lie outside the machine; by design, all critical parts of the system are continuously cooled to a stable temperature.

The 7-t machine has a symmetrical body built from Armorith polymer concrete reinforced with steel bars for maximum rigidity and stiffness and virtually total vibration absorption. Its hydrostatic drives avoid the cogging effect associated with linear drives and also consume considerably less power. An automatic workpiece changer with 20 pockets allows fully automatic unmanned high-precision machining.

The Pyramid Nano comes with two alternative spindles, a 6.4-kW version running at 500–50,000 rpm and equipped with an HSK-25 toolholder, and an 11-kW, HSK-40 version offering speeds of 200–36,000 rpm. The tool magazine can be expanded from 32 to 96 stations in the first case or from 25 to 75 stations in the second case without changing external machine dimensions. A trunnion-style head with direct torque drives provides fourth- and fifth-axis machining capability.

Misumi UK Ltd.

More than 70,000 catalogued factory automation components are available from a global manufacturer whose worldwide subsidiaries use just-in-time and kaizen techniques to meet clients’ needs for fast delivery. Misumi UK Ltd. (Staines, Middx, UK) supplies both standard and custom components for linear and rotary motion control, positioning, and general machine mechanics. Designers in need of a not yet existing component can submit a drawing or simply consult the company’s sales engineers and a suitable mechanical component will be developed to fulfill the machine requirement.

Precision components can be specified by material, dimensions, surface treatment, or special machining requirements. Stainless-steel components meet the strict guidelines of medical device manufacturing and cleanroom environments; in addition, such components can be specified with enhanced seals, special materials of construction, or oil-free or low-grease designs. For example, end-machined ball screws can be specified as to length in millimetres, the need for key grooves to be added to the ends, and whether cleanroom-appropriate low-particulating lubricant is necessary. These ball screws are offered precision ground with C3, C5, or C7 lead accuracies and precision rolled with C7 or C10 lead accuracies.

The catalogue of components is online, as well as being available in print form. At the online portal, components compatible with all industry-standard computer-aided design (CAD) packages can be specified and then inserted directly into the customer’s chosen CAD system.