3F Electronics Company, Ltd.

Providing services as a development partner, a contract manufacturer offers capabilities in the R&D, manufacturing, and servicing of advanced medical electronic equipment. Its product range comprises the clinical areas of monitoring, ultrasonic detection, and auxiliary treatment. The company has established strong platforms in breakthrough product development, production of complete solutions, logistical support, and sales. Among its many product launches are a multiparameter adult, pediatric, and neonatal patient monitor, a multifunctional cardio-analysis system, a transcranial Doppler system, and an ultrasonic cardio-output detector.

Acnis International

A supplier of metals based in France provides a wide array of semi-produced products in titanium and titanium alloys for medical applications such as implants and surgical tools. The firm also offers stainless steels, cobalt chromium, and specialty steels. Available shapes include bars, sheets, and wires.

AOK Tooling Ltd.

A one-stop contract services provider handles product R&D, tooling design, tooling fabrication, molding, product assembly, and global customer service. Equipped with several sets of computer-aided design and manufacturing software, the company has accumulated experience in the design of components, die-casting tooling, plastics tooling, and metal press tooling. The manufacturing facility in Shenzhen houses CNC machining centers, electrical-discharge machines, grinding machines, lathes, milling machines, drilling machines, and 31 molding machines to handle the toolmaking and component-molding workload. The firm also has offices in Hong Kong, the United States, and the Netherlands.

Arjo Wiggins S.A.S.

A range of medical papers offering high bacterial barrier and enhanced sealing and peeling properties can all be sterilized by means of autoclaving, EtO gas, and irradiation. Basic product lines include direct-sealing papers and base papers that can be converted via any kind of coating. Arjopeel is a reinforced paper designed for puncture-resistant and bulky packaging and can be given specific peel properties to suit the customer’s application. The CE marked Sterisheet range, which complies with ISO EN 11607 Part 1, EN 868 Parts 1 and 2, and the European Medical Devices Directive, provides a very good bacterial barrier, controlled permeability, good strength, and fluid repellency. These papers serve to protect medical and surgical instruments organized in trays for use, can be used as sterile covers, or may be converted into drapes for covering patients in the operating theater.

Tough, durable Makrolon medical-grade polycarbonates are biocompatible materials suitable for molding medical device components that may be sterilized once or multiple times. Applicable for both device construction and device packaging, these technically advanced resins meet US FDA–modified ISO 10993-1 requirements. The lightweight plastics are virtually unbreakable, transparent, impact resistant even at low temperatures, and highly resistant to heat. The manufacturer also offers non-medical-grade Makrolon- and Apec-brand polycarbonates for other high-tech applications.

Branson Ultrasonics (Asia Pacific) Company, Ltd.

A series of ultrasonic assembly systems equipped with full digital control feature high levels of performance, process control, and user-friendliness, including Chinese, Korean, and Japanese setup languages. Suitable for manual, semiautomated, and fully automatic assembly operations, the 2000X series is available with power outputs of 400–4000 W and in frequencies of 20, 30, and 40 kHz. A VGA color touch screen interface ensures ease of use, while digital controls with a 1-millisecond sampling rate provide for accurate, repeatable welding. Process control features include closed-loop amplitude control, real-time graphing, and control modes based on time, energy, peak power, collapse, and absolute distance. Communication capabilities include Ethernet and software-based remote setup and diagnostics.

CAN in Automation (CiA) e.V.

An internationally standardized communication protocol is available to manufacturers of complex medical devices equipped with controller-area network (CAN) controllers, such as computer tomographs, angiograph scanners, magnetic resonators, and the like, to replace proprietary higher-level protocols and thus enable the equipment to interoperate. The CANopen protocol has already been used in the development of device communication profiles for x-ray collimators and dosimeters, while an application profile for contrast media injectors and electrocardiogram devices has enabled manufacturers to design devices that can communicate in plug-and-play fashion. Such device and application profiles define data to be communicated among devices in a network, along with the services and protocols with which they are transferred. The protocol facilitates integration of equipment made by different companies. Additionally, it allows device manufacturers to concentrate entirely on developing their products, and not on a variety of communication protocols.

Ceramaret S.A.

Medical and dental device components are made from the advanced ceramic materials such as alumina, zirconia, and ZTA by a long-time specialist in the field of hard materials. Insulators for endoscopes and electrosurgical devices, dental abutments, and blades are among the parts it produces. In addition, the company manufactures pistons, valves, and various other components for high-pressure pumps and precision dispensers. Certified to ISO 9001:2000 and ISO 14001:2004, it strives always to keep pace with the leading edge of developments in ceramic technology.

Colder Products Co.

A fluid-delivery-system coupling made of ABS plastic with stainless-steel springs and EPDM O-ring seals features a nonspill design that minimizes the potential exposure of users to biohazards in medical, biopharmaceutical, and chemical applications. The NS4 ABS–series connection is intended to bring the benefits of nonspill performance to medical equipment used in applications requiring medical-grade quality and gamma sterilizability. Its nonspill shutoff valve that ensures operator safety also allows for quick single-handed connection and disconnection. The coupling serves as a durable, lightweight, compact, and economical substitute for metal spill-resistant couplings, ball valves, and fittings.

Colpitt B.V.

A company engineers and manufactures custom production systems for manufacturers of medical disposable components. It can supply machines for all levels of automation. The equipment is widely used to produce medical bags for blood, IV solution, dialysis, drug, nutrition, and other applications. A Shanghai office specializes in supplying infusion bags for the pharmaceutical industry and transfusion and disposal bags for medical applications. The Chinese firm represents many European and U. S. manufacturers of advanced machinery, materials, and components.

Crump Group Inc.

A cross-sectional scanning inspection system is a turnkey solution that can capture the most complex internal and external geometry of small injection-molded parts. Suitable for use in first-article inspection, reverse engineering, failure analysis, and tooling qualification, the CSS 300 system combines the manufacturer’s cross-sectional scanning technology with its Spec. Check inspection software. The manufacturer is an innovating specialist in three-dimensional inspection systems, software, and services. Its industrial metrology systems have been designed for use in medical device manufacturing, electronics, injection molding, and other industries.

Doceram Engineered Ceramics Company, Ltd.

Engineered ceramics and high-precision ceramic components for medical and dental applications are offered by a specialist company. Products include high-precision dispensing pumps made of aluminum oxide, ZTA, or zirconium oxide; wear-, heat-, and acid-resistant equipment parts that need no oil lubrication; ceramic drilling heads and screwing tools for fitting dental implants; abutments for dental implants; and semifinished parts for crowns and bridges. High-performance ceramics will add extra value in medical technology applications, but at least as important may be the assurance of part quality.

Dynatek Laboratories

A second-generation coating durability tester for evaluating the durability of coatings on drug-eluting and other coated stents features additional capabilities designed to accommodate a wider variety of devices and testing techniques. The CDT2 instrument allows for a larger range of sample lengths and diameters and for complicated sample designs, such as bent or bifurcated devices, making possible the testing of larger peripheral vascular stents and complex coronary and peripheral stents. The redesigned tester accepts the use of laser micrometers for sample measurement, allows vertical or horizontal testing, and provides internal loop heating for enhanced temperature control. Deployment access ports are available to provide for direct stent deployment into the premounted sample vessels, thus enabling the tester to be used for both acute- and chronic-phase coating durability testing. The user controls the testing speed, temperature, pressures, and flow rates, and can set up alarms to ensure that proper conditions are maintained throughout the test.

A materials supplier provides medical OEMs with products as varied as plastics for nonimplantable devices and rigid and flexible medical packaging, and pharmaceutical coatings. Its copolyesters are free of orthophthalate plasticizers, bisphenol-A, and halogens. The various copolyesters, Eastalloy blends, and cellulosics available for device manufacturing provide a wide range of properties and flexibility in sterilization options. All medical-grade resins are supplied with full characterization, including technical data, ISO 10993 Part 1 biocompatibility test reports, USP Class VI test reports, and U.S. drug or device master file authorizations. The company’s comprehensive application development and strong technical support can help OEMs bring new applications to market quickly.

An aseptic valve is designed to dispense accurate shots of fluid in sterile liquid-filling operations while also minimizing contamination risk. Typical uses of the 754V-SS valve include filling drug vials and dispensing saline into contact lens packages. To ensure sterility and simplify cleaning, the fluid path of the device is smooth and free of areas in which bacteria or contaminating materials could collect. Wetted parts are manufactured from US FDA–compliant Type 316L stainless steel and PTFE, making the valve suitable for clean-in-place and sterilize-in-place processes. The low-maintenance design, reliable performance, and dispensing accuracy of the device are intended to minimize downtime and thus enhance productivity.

A specialist manufacturer of wires, guidewires, and formed wire products supplies the OEM market with tailor-made solutions. The ISO 13485– and Directive 93/42/EEC Annex II–certified manufacturer offers precision coated and uncoated guidewires 0.012–0.094 in. in diameter for percutaneous transluminal coronary angioplasty and other applications. Nitinol wire baskets, snares, and hypotubes also are produced by the company. Wires can be given biocompatible coatings of PTFE or hydrophilic materials and can be precoated or spray-coated. High-precision grinding is an in-house capability.

A custom manufacturer produces high-grade semifinished products, components, and actuators from a variety of materials to customer specifications. Items having a diverse range of dimensions and specified properties are made from various types of nitinol; stainless steels, including nickel-free alloys; cobalt-based alloys; titanium alloys; tantalum; platinum alloys; resorbable alloys; and other materials. Offering services as a strategic partner, the company has a quality management system certified to DIN EN ISO 9001 and DIN EN ISO 13485:2003.

Farlow’s Scientific Glassblowing Inc.

Molds, capture tubes, and tipping dies made of precision-blown glass are supplied to catheter manufacturers by a company whose aim is to provide economical alternatives to conventional fabrication tooling and equipment. Products are supported with full engineering and design services to help customers meet special requirements. The full range of tooling components manufactured from clear, smooth, and dimensionally accurate glass includes balloon molds, capture tubes and sleeves, tipping dies and forming tips, and custom dip molds. The tooling has a smooth inner finish, fire-polished ends, and ceramic labels and can be heated by means of hot air, electricity, and infrared or radio-frequency radiation. Also available from the supplier are balloon-forming machines designed to accommodate its glass molds.

A company specializes in low-pressure plasma technology for surface-treating medical devices. Plasma treatment can activate a device surface in preparation for gluing, bonding, coating, or printing, or can modify it to make it more hydrophobic, hydrophilic, or biocompatible through the deposition of a coating via plasma polymerization. The dry technology is environmentally friendly and cost-effective. The treatment is typically applied to stents, guidewires, nonwovens for filters, device plastics, catheters, syringes, and microtiter plates and other diagnostic devices. The service provider can perform the treatment on a subcontracting basis. It can also supply standard and custom plasma equipment to customers wishing to treat their own devices in-house, making available its application laboratory for testing and demonstrations.

Precision grinding machines for the forming of such medical devices as guidewires are manufactured by an ISO 9001:2000–certified specialist company that also provides contract grinding services. The CAM.2 CNC grinding system can produce wires with tapers, flats, hexes, and virtually any shape required, and is able to grind wire down to 0.0203 mm in diameter. Also manufactured are conventional centerless grinders with full automation for the production of multitaper guidewires. The company supports its machines with its own gauging equipment for measuring wires produced on the systems. Its R&D center runs process optimization trials with the customer’s product in order to ensure that the equipment ultimately delivered performs as required, and a prototype development function establishes feasibility.

GlobTek (Shanghai) Company, Ltd.

A series of CE marked wall-plug-in blade power supplies for medical and information technology equipment applications are designed to meet requirements for China, Korea (Class II), North America, Europe, the UK, and Australia, and are compliant with the European RoHS directive. The GTM41060 series, offering a maximum of 24 W of continuous output power with a constant-current option, features double-reinforced insulation and is housed in an impact-resistant nonvented polycarbonate upper and lower case with thermal conduction cooling. Regulated output voltage can be 5 to 48 V dc controlled in increments of 0.1 V. The supplies provide regulated output with very low ripple and include built-in protection against overcurrent, overvoltage, short circuit, and thermal excess. They meet all applicable safety agency requirements and comply with EMI/RFI regulations and EMC directives. Modified and custom designs are available.

GVS S.p.A.

The GVS Group manufactures injection-moulded plastic filters for application in the automotive, medical, pharmaceutical, and industrial sectors. The two most important products currently marketed in China are the Speedflow IV filters and the Easydrop IV flow regulators.

Ismeca Komax Systems Rockford

Custom-engineered assembly systems for the production of medical devices use a full range of machine and software platforms and can incorporate semiautomatic or fully automatic linear, rotary, or pallet-based configurations that are controlled either by programmable logic control or by an industrial personal computer. Most projects include synchronous cam-driven cells designed to work under cleanroom conditions, but pneumatic or numerical control–based systems that satisfy lower output rates also can be supplied. Small systems through complete lines can be constructed, all designed with a full understanding of the assembly processes involved in assembling and testing the client’s product. Such complex production processes as needle feeding, catheter tip forming, ultrasonic welding, and vision inspection are integrated seamlessly into a dedicated production line. The manufacturer provides U.S. FDA validation services.

Platinum, nitinol, and specialty metals are machined, drawn, rolled, and formed to customer specifications by a global company whose high-volume ramp-up capacity enables it to react quickly to critical challenges faced by medical device manufacturers worldwide. The product range includes nitinol tube, wire, and ultrathin sheet manufactured to the highest six-sigma standards. Additionally, the supplier offers a just-developed economical radiopaque alternative to platinum called Biomed.

Since 1980, Kahle Automation S.r.l. has focused solely on the manufacture of assembly machines for medical devices. The company’s product line includes custom-made automation equipment for IV supplies, safety devices, catheters, blood collection supplies, syringes needles, tubing and related devices, refillable syringes, and other pharmaceutical devices.

Since 1980, Kahle Automation S.r.l. has focused solely on the manufacture of assembly machines for medical devices. The company’s product line includes custom-made automation equipment for IV supplies, safety devices, catheters, blood collection supplies, syringes needles, tubing and related devices, refillable syringes, and other pharmaceutical devices.

A specialist in the design, development, and manufacture of medical guidewires offers both 510(k)-approved diagnostic and interventional OEM guidewires and collaborative development services for customer-specific designs. Designs for a wide variety of peripheral and coronary applications are available, as are several coating and material-enhancement options. The company’s product portfolio comprises uncoated and PTFE-, silicone-, and hydrophilic-coated guidewires, stylets, core wires, unifilar coils, multifilar coils, torque coils, and implantable components used in cardiac rhythm management and neurostimulation leads. Core production competencies include coil winding, grinding, device assembly, coating, precision machining, and full-service design and development. The company provides outsourcing services as well, ranging from concept development prototyping to scale-up manufacturing to dock-to-stock supply chain management.

Machine Solutions Inc.

Equipment for blowing and forming catheter balloons from extruded plastic tubing is available for R&D and high-volume manufacturing applications. Accommodating glass, metal, and tubular molds, the machinery is designed to provide short cycle times and promote uniformity. Special heating controls offer flexibility in process development, allowing for spot heating along the mold length, uniform heating of the entire mold, or a combination of these. Simultaneous adjustable tube tensioning and stretching makes possible balloons having optimal wall and shaft thicknesses. The equipment features an operator-friendly user interface and a robust and repeatable process.

Maide Technological Manufacturing Company, Ltd.

A company is dedicated to the development, production, and sales of automated assembly machines for medical devices and extruding equipment for medical tubing. Fully computerized high precision extruders and high speed tubing cutters are among its most popular products. The company’s goal is to deliver high quality products and optimal customer service.

A custom manufacturer produces home-care medical device components such as manual and powered wheelchairs, shower chairs, low-pressure pumps and mattress systems, walking aids, and other devices. The company possesses skills in bending, welding, polishing, and surface finishing and uses advanced technology. It welcomes OEM orders.

MeKo Laser Material Processing

A contract manufacturer specializes in supplying the medical device industry with high-precision material processing services. The ISO 13485:2003–certified company employs laser technologies to cut steel, aluminum, copper, ceramics, nitinol, magnetic alloys, and other materials to tolerances as fine as ±0.0002 in., and to drill holes with diameters as small as 0.0001 in. Its laser welding capabilities include the vacuum-tight welding and joining of dissimilar materials. In addition to performing these basic functions with state-of-the-art CO2 and Nd:YAG lasers, the company provides such postprocessing operations as electropolishing, annealing, surface finishing, and bending. A speciality is the precision cutting of stents, which can be delivered to customers worldwide overnight.

Minco, Singapore

A manufacturer of flexible heaters, temperature controllers, sensors, and other system control components has issued a free design guide for engineers needing to integrate efficient flexible heaters into their advanced designs. The guide covers the process all the way from initial concept to final application and includes a repeatable design process checklist that can be used whenever the need for heater integration arises. It includes information on how flexible heaters work, on choosing a heater for prototyping, and on determining the best long-term heating solution. Also, it contains detailed information on hundreds of stock and standard heaters available for experimentation and proof-of-concept testing, along with temperature sensor and controller options that can make a complete thermal regulation system. A complementary flexible heater prototype design kit is available for purchase.

Miyachi Unitek Corp.

A family of fiber laser welders consists of two models that employ proprietary fiber laser technology developed entirely in-house to offer very good beam quality and stability. Offering 100 and 300 W of continuous-wave (CW) output power respectively, the LF-100A and LF-300A lasers are designed to provide world-class performance and reliability in manufacturing applications. The basis of their performance capability is their innovative laser diode pumping and resonator technology. These features, along with built-in time- and energy-sharing beam distribution options, user-replaceable output fibers, modulated and CW power profiles, visible-aiming laser output, built-in integration with scanning weld heads, and compact fixed-focus heads, enable the instruments to satisfy the requirements of advanced manufacturers for laser-welding process capability, control, and performance.

Morgan Advanced Ceramics

A larger 36-mm ceramic-on-ceramic bearing now extends the range of a line of femoral heads and acetabular cups for use in hip replacement surgery. Designed to provide better stability in the artificial joint and a smaller chance of dislocation, the larger-diameter devices offer the same durability as other HIP Vitox/alumina joint components available in sizes down to 28 mm diam. They offer greater system strength as well, making the likelihood of product fracture less. In addition, the larger-sized devices feature a range of offsets to ±5 mm, as compared with ±3.5 mm for 28-mm-diam components, giving surgeons more options and greater flexibility during surgical procedures. Their material of construction is a purpose-developed bioceramic that displays very low wear rates in comparison to those of metal or polyethylene hip implants.

NCM Hersbit Chemical Company, Ltd.

Fine chemicals, coating and ink ingredients, plastics and fiber reinforcing materials, and construction materials are distributed in China by a representative of foreign manufacturers. The midsized enterprise runs a distribution network that covers all of China’s important economic regions. Its partners and suppliers include Arkema, BASF, DuPont, Dow, Eastman, ExxonMobil, AES, Ensinger, RTP, Solutia, and Victrex, among others. The company holds itself to the quality management standard specified in ISO 9001.

Machines for plastic injection molding with clamping forces up to 8000 kN are offered for manufacturing applications involving high-precision articles such as medical components, optical disks, and electronic components. SynErgy machines are designed for speed, precision, reliability, user-friendliness, and operational efficiency. The all-electric Elion range, with clamping forces of 500–1750 kN, adds innovative features to the attributes of the manufacturer’s classic machines. Each axis is specifically designed for the all-electric drive system, with the machine construction being heavily influenced by expressed customer requirements. The Swiss-based machine manufacturer offers Asian customers consultancy and training through its Chinese subsidiary, which includes a showroom demonstrating all of the machines in action.

A project focused on supporting medical device manufacturers in Fukushima Prefecture in north central Japan consists of medical equipment study meetings, seminars and consultation on compliance with the national Pharmaceutical Affairs Law, forums and exhibitions designed to expand sales opportunities for companies from the region, and financial assistance for joint R&D ventures between business and academic entities in the field of medical devices. The Fukushima Next Generation Medical Industry Integration Project helps companies using advanced manufacturing technologies such as precision processes to participate in the global medical device market. Besides the Japanese medical device manufacturers operating in the prefecture, existing resources include factories owned by large multinational device makers and universities that conduct R&D relating to medical technology. An annual regional trade fair, Medical Creation Fukushima, offers manufacturers an opportunity to sell technologies and products and also to solicit needed suppliers.

Noveon Asia Pacific Ltd.

A producer of thermoplastic polyurethanes (TPUs) offers in China aliphatic grades of TPU suitable for medical device manufacture. Biocompatible Thermedics aliphatic TPU provides softness combined with strength and very good physical properties, making it well suited for the production of catheters and related devices. Offering an advantage for patient comfort, polyurethanes generally have the ability to soften in the body, with direct water contact, and as temperature rises from 23° to 37°C. The company supplies a full range of Thermedics-brand resins and polymers, including radiopaque materials.

NuSil Technology

A manufacturer of silicone compounds for healthcare product and other applications offers pigmented masterbatches for liquid silicone rubber (LSR) formulations. Designed for use with silicone elastomers meeting USP Class VI biological testing requirements, the products are available in an unrestricted version suitable for long-term implantation and a restricted version that may be considered for applications involving implantation for less than 30 days and external uses. Supplied as pigment mixed with functional polymer rather than as powder, the masterbatches present a user-friendly solid-liquid mass that is easy to add to elastomer systems. They have a consistency similar to that of many LSRs. One formulation contains 50% barium sulfate by weight, and the other consists of 50% titanium dioxide.

A global contract manufacturing enterprise is organized to deliver competitive advantage to its clients in the drug-delivery, diagnostics, and general medical/surgical markets by providing innovative and fully integrated plastic components. The company offers more than 35 years of healthcare industry experience, proven program management and regulatory systems, extensive technical resources, and a commitment to providing a high level of customer service. It provides a full range of services, from product and mold design and tool building through supply chain management.

An easy-to-operate medical connector designed for such applications as test equipment and magnetic resonance imaging systems offers a lifetime of at least 100,000 mating cycles, secure locking, and a minimal claim on panel space. The nonmagnetic MAC connector has a plastic insulating body with many of the insert configurations available, and includes crimpable, removable contacts for power, data signal, radio-frequency signal, fluidic, fiber-optic, and other connections in a frame customizable to suit the application. Unit spacing is 2.54 mm or a multiple of that distance. Guide pins and guide bushings prevent misconnection.

Optical Gaging Products Inc.

A benchtop multisensor dimensional measurement system uses advanced video imaging technology to measure manufactured parts automatically without contact. The SmartScope ZIP 250 benefits from a redesign and updating that makes the versatile computer numerically controlled system more capable than before. Offering a standard x-y-z measurement volume of 250 ´ 150 ´ 200 mm, with 300 mm in the x-axis an option, the stable, accurate system has a fast stage speed for maximum throughput and short cycles. Other features include an autocalibrating 7:1 zoom lens, a new camera, and multiple all-light-emitting-diode illuminators. The true multisensor instrument supports sensor technologies for the full three-dimensional measurement of edges, surfaces, and complex contours, and can be configured with a touch probe for accessing part features that are recessed or difficult to image.

Optinova AB

A precision extruder of tubing for medical applications has developed a program of enhanced supply of tubing for the manufacture of intravenous catheters. The ICM tubing concept consists of a range of specially designed tubing accompanied by a package of technical support that adds value for customers. This has been extended with the introduction of the ICM-5 commodity concept, which involves an offering of gauge-by-gauge standardized tubing designed in accordance with applicable ISO standards and produced from FEP fluoropolymer resin with radiopaque barium sulfate stripes in the wall. The new commodity package provides the advantages of quick shipment from stock, competitive pricing even in smaller quantities, and a range of dimensions commonly used in IV catheters, and includes technical support, application tips, and recommendations.

A developer and manufacturer of OEM porous plastic materials serves a wide variety of healthcare industry customers with a broad range of standard and custom materials and processing capabilities. Development engineers working in state-of-the-art facilities are equipped to address any filtration, wicking, venting, diffusion, or media support application. The porous medical materials and filters can be supplied in unique dimensional shapes and in a wide selection of polymers to deliver the requisite accuracy, precision, and reliability cost-effectively. The company has expanded its offering of proprietary manufacturing processes to be able to provide such innovative and integrated diagnostic and medical device products as sample and absorbent pads, lateral-flow and conjugate-release materials, sample wicks, pipette and fluid-collection filters, and arterial and catheter vents.

Portescap

An aluminum housing that maximizes heat dissipation for higher output torque and low power consumption is a key feature of a hybrid stepper motor designed to offer high-level motion control performance in medical instrument, linear positioning stage, and electronics assembly applications. The h3 stepper motor uses a neodymium magnet to deliver high torque density for the package size. It runs quietly and with little resonance across the entire speed range, thus countering disadvantages common with stepper motor systems. Large bearings enable the motor to handle increased side and radial loads effectively. The enhanced version of this unit delivers as much as 40% more torque than the standard version.

A PTFE-lined, braid-reinforced catheter with varying hardness in the outer layer can provide variable flexibility from proximal to distal end. The outer layers can be colored, clear or filled with radiopaque materials. The braid pattern can also be varied along the shaft to provide additional flexibility. It can be used to provide a delivery system–type guide catheter that has variable stiffness along the shaft to the distal end, along with clear or radiopaque distal tips. The PTFE liner contributes a highly lubricious inner surface. The shaft can be braided with round single- or double-ended wire or flat or ribbon wire of different tensile strengths. Outer jacket materials are commonly nylon or nylon copolymers such as Pebax. The PTFE-lined shaft assemblies can be made with polyurethane materials, as well.

A company specializing in interventional medical devices provide OEMs assistance at all stages of product development, from concept, design, prototyping, to process optimization and technology transfer. Products developed include coronary drug-eluting stents, peripheral vascular stents, arterial filters, aortic stent grafts, interventional neurology devices, and balloon catheters. The firm can also help manufacturers upgrade manufacturing process, design innovative products, and cut production costs. At the show, it will showcase the manufacturing equipment for which it serves as a distributor in China, such as stent fatigue testers, laser balloon welders, and laser cutters.

Providence Enterprise Ltd.

A full-service contract manufacturer is dedicated to the production of highly engineered finished goods and electromechanical assemblies for the medical device, healthcare product, and other industries. The vertically integrated company provides all aspects of design and production under one roof, including the creation of mold tooling, both for use in-house and for export. With a manufacturing space more than 500,000 sq ft in extent and sales and administrative offices in Hong Kong, Germany, and the United States, the contractor carries certifications to ISO 9001, ISO 13485, TS 16949, and UL 746 and is a U.S. FDA–registered manufacturer.

Raumedic AG

Braided tubing developed especially for use in high-pressure applications includes a size designed for angiography. Catalog article 874216 has an inner wall and outer jacket of polyurethane and is reinforced with polyester. Measuring 3.60 mm OD and 1.85 mm ID, the tube is transparent, offers a high level of kink resistance, and has a burst pressure of 1200 psi determined by test at 23°C ± 2°C. It can be sterilized by ethylene oxide. The braided tubing is available in other sizes suitable for applications in neurology and cardiology, as well as for stent catheters, electrophysiology catheters, PTCA guiding catheters, and kink-resistant catheter tubing.

A pair of connecting elements for fluid-transport systems in medical equipment and biotechnology applications are manufactured, assembled, and packaged under cleanroom conditions using exclusively high-purity plastics conforming to USP Class VI and US FDA requirements. The POM and PSU polymers used in the RectuMed-series couplings are resistant to acidic and basic liquids over the wide temperature range of –20° to 80°C in the case of the smaller RectuMed XS and –20° to 140°C for the RectuMed M. The lightweight, ergonomically designed devices offer high safety in operation, very good strength, and a smooth flow path with no dead spaces. The single-use XS, with its nominal diameter of 2.7 mm and operational pressure rating of 0–4.5 bar, can be EtO sterilized and is suitable for patient-side applications. The 7-mm-diam RectuMed M, with the same operational pressure rating, is fitted with platinum-cured silicone O-rings and a sleeve with integrated spring-locking claws, and is designed for applications where safety and hygiene take a high priority.

Renolit Netherland B.V. produces medical-grade semifinished plastic products, specializing in PVC, PP, EVA, and custom-made formulations. Sold under the brand name Solmed®, these products have been used for more than 35 years by medical device manufacturers and pharmaceutical companies.

RTP Co.

A global specialist in thermoplastics compounding has published a white paper on the selection of materials for medical applications that may be requested via the company’s Web site. The document is designed to make the compounder’s expertise in polymer selection readily available to potential customers so that they can enter into materials selection for a project with greater understanding and ease. The literature helps design engineers to focus on application requirements and material properties in tandem in order to maximize the likelihood of the best compound for the application being formulated. The publisher operates eight manufacturing facilities on three continents, producing custom compounds from more than 60 engineering resin systems.

Sealed Air Nelipak

Specialty base and top-web flexible packaging materials for terminally sterilized medical devices include films that can be sealed to paper, Tyvek, or other films and that are suitable for thermoforming, flow packs, or overwrapping. The supplier specializes in providing materials that provide high performance in terms of processability, barrier control, and gauge reduction. An affiliated company specializes in designing and producing thermoformed packaging and lidding material for packaging medical devices and pharmaceuticals. It has in-house design, prototyping, and tooling departments and offers controlled production operations in Class 10,000 (ISO Class 7) cleanrooms for thermoforming and contract packaging. This company additionally builds blister sealing machines.

An ISO 9001–certified manufacturer of temperature sensors for the global medical device industry has entered the China market in addition to serving customers in North and South America, Europe, and Japan. The devices have been used as components in incubators, esophageal sensors, thermodilution catheters, and other medical devices.

A manufacturer of nonwoven medical disposable products mainly produces masks, bed sheets, pillow covers, drapes, and the like. Masks are manufactured in a variety of colors in 1-, 2-, 3-, and 4-layer overhead- and ear-loop-style and surgical versions. The company can produce nonwoven disposables to suit customer requirements, as well.

Advanced systems for applying drug-eluting coatings to stents are based on ultrasonic spray technology. They include a benchtop laboratory system that can be configured with either of two types of ultrasonic nozzle. The MicroMist nozzle produces a very thin, straight spray pattern having a diameter of 0.010–0.030 in., while the AccuMist nozzle generates a somewhat wider, 0.070- to 0.250-in.-diam, bow-shaped pattern. Both emit a highly precise, repeatable, and controllable low-velocity spray, with minimal overspray. Delivery rates range from 0.3 to 100 ml/hr. The system incorporates a programmable stent movement and rotation device located in an easy-to-access spray area that facilitates manual loading and unloading of stents in a controlled environment.

Single machining centers equipped to perform both milling and turning operations offer manufacturers of such demanding medical device components as joint implants a cost-effective means of meeting customer requirements for these components. The centers are capable not only of very high precision and the utilization of a large number of tools in machining the implant, but they are suited for making the tools specifically required to carry out this machining. They can machine completely from the bar either identical or different parts in succession without a new setup; milling and tuning on one center in a maximum of two chuckings maximizes workpiece quality while saving time. The machines can handle hard, tenacious titanium in bars 5 to 80 mm in diameter and up to 800 mm long, and can be automated for the purpose.

A provider of sterilization services is building an ethylene oxide (EtO) processing facility in Shanghai, which is expected to be completed later this year. The new plant will feature 32 euro-pallet sterilizers. At 2.4 m in height, the trailer-size sterilization chambers are designed to coordinate with sea container capacity, thereby maximizing production lot sizes and reducing cost. High-performance pallet-handling capabilities will further optimize process time and control. The company will employ its single-day, single-chamber CyclEOne processing technology, including parametric product release, which significantly reduces the time and cost associated with traditional EtO sterilization. With the capacity to process 180,000 pallets a year, the new facility will feature advanced technology to minimize emissions. It will also offer a microbiological and analytical laboratory staffed by experts and operating in full accord with global industry standards.

A global supplier of custom and standard packaging systems designed to protect pharmaceutical, diagnostic, veterinary, and over-the-counter drug products has established a plant in Changshu, Jiangsu, that begins operation this year. The company’s products include printed polypropylene tubes and stoppers with desiccant; patented 2AP material; desiccant packets and tablets; and humidity indicator cards, among others.

A global contract manufacturing company operates ISO 9002– and QS-9000-certified and US FDA–, GMP-, and UL-approved facilities in the United States and China. Its service capabilities include high-speed and two-shot molding, gas-assist molding, and complete assembly. The company can provide direct drop-shipping. Production facilities contain Class 100,000 and Class 10,000 molding and Class 10,000 assembly areas. Projects are handled by teams focused on only that customer in order to ensure the customer’s satisfaction.

An Irish-owned company with operations in Ireland and China provides integrated OEM manufacturing, outsourcing, trading, supply-chain management, and consulting services to manufacturing enterprises in various industries. The company’s intention is to be a low-cost value-added partner, whether the project is a single component, a small modification to an existing product, or full development of a new product. Its manufacturing capabilities include injection molding, injection blow molding, extrusion, cleanroom and noncleanroom assembly, and packaging. These are complemented by competence in product and packaging design, R&D, prototyping, sterilization, quality control, regulatory affairs, full project management, and cost optimization.

Tornos S.A. Shanghai Representative Office

A turning machine manufacturer has developed automatic lathes suitable for meeting the small-parts turning requirements of medical device manufacturers, particularly those specializing in implantable devices. The upgradable Deco machines are equipped to perform internal- and external-thread whirling and high-pressure deep drilling on complex components. They can be custom designed or adapted to special application requirements, but they are based on standardized elements to the extent possible, so as to minimize cost. System capabilities include fast machining rates, the ability to perform multiple operations, and part finishing (the removal of burrs). In high-pressure drilling, the lathes can drill difficult-to-machine materials to depths 50 times the diameter of the hole, which can be as small as 0.8 mm.

A US-based supplier of custom rolled strip, foil, and flat and shaped-wire products operates a service center in Hong Kong that supplements its representative office in Shanghai in service to the company’s Asian customer base. The 1000-m2 facility stocks a full array of titanium, nickel, and cobalt alloys and stainless steels, and offers finishing capabilities. It has room for expansion. The company provides medical device and other manufacturers with engineered materials that feature extremely precise tolerances and difficult-to-achieve properties.

Value Plastics Inc.

Plastic luer and bayonet-style panel-mount connectors are offered as an economical alternative to tubing connectors made of metal. Male luer connectors of the MLRLB series are designed to provide versatility in meeting permanent-mounting challenges in panels 1.6 to 3.2 mm thick, and fit flexible tubing of 1.6, 2.4, and 3.2 mm ID. Made of nylon or USP Class VI polypropylene, they use a snap-on male luer-lock thread to facilitate color coding and ensure a secure connection. Nylon BPMB-series bayonet connectors mate to the manufacturer’s BPF-series quick-connect fittings, offering finger-touch convenience in a wide range of applications and accommodating flexible tubing of 3.2, 4.0, and 4.8 mm ID. Also available is an addition to a line of female-luer panel-mount connectors with hose barb ends, the nylon or polypropylene FTLLBMLRL, which is designed to connect female luers to male luers through a panel 1.6 to 3.2 mm thick.

Vincent Medical Manufacturing Company, Ltd.

An outsource services provider offers a full range of capabilities to medical device companies, including transfer of the entire production line. From prototype development to trial runs and full-scale production, the company provides extensive engineering and manufacturing support services. It controls every stage of the process, including prototyping, mold building, injection molding, assembly, packaging, validation, EtO sterilization, cutting and sewing operations, logistics, and supply chain management. Turnkey manufacturing is carried out in a wholly owned 30,000-m2 facility in China that includes a Class 100,000 cleanroom for injection molding and assembly. The U.S. FDA–registered factory is certified to ISO 9001:2000, ISO 13485:2003, EN 550, and ISO 11135.

A compact two-axis video measurement system is well suited for the quality inspection of medical device components, offering high-accuracy performance and ease of use. The Merlin 300 provides very high repeatability and reproducibility; thus, no matter how many different people may be using the system, an accurate reading can be expected for the same component part each time it is inspected. Because little training is required, the system is virtually plug-and-play. It includes a dedicated Quadra-Chek 300 video microprocessor offering touch screen technology with video edge detection for fast measurement and high throughput, and a contrast teach facility enables the operator to easily determine the component edge, thus enhancing accuracy. Other key system features are its robust 150 ´ 100-mm x-y measuring stage, high-resolution charge-coupled-device and high-numerical-aperture objective lenses, and dimmable light-emitting diodes for surface and substage illumination.

Vitalo Group

A developer of high-end thermoformed precision packaging and thermoformed technical components has been able to create a replacement material for the EPS foam widely used in packaging for the distribution of blood collection tubes. The upcoming regulatory obligation on manufacturers to send packaging materials back to the producer has stimulated a demand for tray materials that produce a smaller recycling volume, to which the packaging specialist’s design team responded with an alternative that uses less material yet retains the outer dimensions of the standard 100-tube EPS tray as well as its necessary rigidity. The new design, which was extensively sampled and tested, resists deformation of the tray when it is filled with tubes and then shrink-wrapped with foil. The ISO 9001–certified packaging supplier offers in-house design, tooling, and production capabilities.

Wilden AG

A European-headquartered global injection molding company that manufactures individual medical device components, complex assemblies, and finished products on a contract basis in ISO 9001/9002– and ISO 13485–certified facilities is equipped to perform nondestructive material testing by means of 3-D x-ray computed tomography. The inspection equipment is used for both product development and production quality assurance. It gives the plastics processor the capability to analyze the interior features and walls of components made from light metal, plastic, or ceramic, as well as exterior elements, and determine the presence or absence of imperfections, bubbles, or variations in wall thickness. This reliable, fast, and cost-efficient method of material testing enables the company to provide thorough quality inspection as early as the prototype stage, thus helping to shorten the product development period and make dimensional measurement easier. The injection molder maintains a manufacturing area of about 60,000 m 2, of which 12,000 m 2 is dedicated to cleanroom production.

Zeus Industrial Products Inc.

A specialist in precision fluoropolymer extrusion has expanded its capabilities in tube flaring and flanging. A more consistent flare and 100% yield are promised to customers, which should translate to savings in time and cost. The supplier’s dedicated in-house capabilities allow for rapid prototyping and quick turnaround. Putting millions of flanges and flares every year onto nearly every kind of polymer tubing it manufactures, the company offers such options as covering stents, connecting fittings, and facilitating access for leads.

Product Previews for the 2008 show will be posted in June, 2008. Please bookmark url and return then for expo hall product previews.

Nothing contained on this Web site shall be construed as a contract, joint venture or other relationship between CANON COMMUNICATIONS LLC and any exhibitor, attendee, or other person or entity, or create an express or implied obligation that may be reasonably relied upon or result in liability against CANON COMMUNICATIONS LLC.