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Originally Published EMDM November 2003

Top 40

The best products and services of the year

The Year’s Best and Brightest

The readers have spoken. Of the hundreds of product and service announcements published by EMDM during the past year, the 40 articles reprised in this section were the overwhelming favourites among medical device OEMs. The products and services were selected based on responses tabulated through our reader service programme. EMDM extends its congratulations to the laureates of the 2003 Top 40.

Microtubes and catheters

Specialized microtubes and microcomponents are developed and manufactured by one of the few firms in Europe that extrudes miniature tubing. The company supplies special single-lumen, multilumen, multilayer, reinforced, coextruded, and radiopaque tubes. The company can also perform assembly; hole-punching; caulking; connection; flanging and flaring; drilling; punching; ink marking, serigraphy, and tampography; bonding; radial forming; tapering; forming; welding; insert moulding; and tip heat shrinking. Other capabilities include the production of three-layer tubing using a different material for each layer, and the design, prototyping and production of catheters. Enki S.r.l., Mirandola (MO), Italy.

Antimicrobial finishes

Antimicrobial finishes enable textile manufacturers to respond to hygiene, infection, and bacterial-growth concerns in the medical industry. A range of antimicrobial treatments based on an active agent called PHMB are available for both product preservation and hygienic effects. The antimicrobial agent binds to the product, making it effective and safe, according to the company. The Vanquish range of broad-spectrum antifungals, antibacterials, and antialgals is suited for plastics, sealants, and adhesives. The products are registered with the US Environmental Protection Agency. Reputex, an antimicrobial and antifungal agent, is designed for use with textiles, while Proxel and Vantocil IB are available for a wide range of applications including polymer emulsions, paints, adhesives, sealants, and general wet-state preservation. Avecia Protection & Hygiene, Blackley, Manchester, UK.

Miniature gear pumps

Combining expertise in mobile hydraulics and silicon-based microsystem engineering, a specialty manufacturer produces miniature annular gear pumps. The robust miniaturized fluidic actuators offer high-volume flow and dosing accuracy in such applications as high-precision dosing pumps, implantable pumps, and other custom fluidic systems. The mzr-pump series provides particularly high performance in a very small package, with rotor sizes ranging from 1 to 18 mm and flow rates between 50 µl/min and 5 L/min being achievable even at high pressures. The high-precision finishing of these devices ensures dosing accuracy within 0.5% with 1 µl of water. The manufacturer supplies all of the components required for complete microfluidic systems and can provide assistance in developing and integrating systems. HNP Mikrosysteme GmbH, Parchim, Germany.

Miniature motor 

A piezoelectric micromotor that combines power, nanoscale resolution, and speed in a compact package also boasts a simple, robust design. It is a cost-effective alternative to conventional electromagnetic linear motion systems, according to the company. Pump systems used in insulin delivery and anaesthetic devices would also benefit. Constructed in a single piece with four movable appendages, the Piezo Legs motor operates without gears or a mechanical transmission. Applying voltage to the motor sets in motion a synchronized forward or backward movement of each pair of legs, allowing the motor to “walk” up to several centimetres per second with a resolution down to 10 nanometres. It can lift up to 1000 times its weight and attains 10 N of pulling force without the use of drive screws, gears, or other mechanical subassemblies. The motor’s motion mechanism is composed of thin piezoceramic layers sandwiched between conductive materials. More than 100 layers can be stacked on top of one other, allowing the motor to run exclusively on battery power. Movement is fine-tuned and each leg is fitted with a wear-resistant sole to minimize wear. The backlash-free motor operation is suitable for micromanipulation in surgical and laboratory instruments. PiezoMotor Uppsala AB, Uppsala, Sweden.

MEMS-based sensors

Liquid-flow sensors for integration with glucose-monitoring, drug-delivery, dialysis, and infusion devices use microelectromechanical systems (MEMS) technology to measure and control minute quantities of fluids. Two versions of the sensor, which uses a thermal-based technology to measure flow rates down to 0.05 µl/min, have been introduced: an isolated model fitted with a tube to separate the fluid from the sensor and a nonisolated version in which the fluid comes into direct contact with the sensor. Both models are small in size, do not retain contaminants, condensates or liquids, and are suitable for use in disposable products. By employing a mechanical bypass design, the sensor can also measure liquid flows exceeding 10 L/min. Honeywell Sensing and Control, Offenbach, Germany.

Tube cutter

A versatile tube-cutting machine cuts plastic, rubber, and elastomeric tubing with diameters as large as 2 in. in any amount longer than 3 in. A single unit of the Model 125B-1 medical tube cutter can be used to cut tubing of different diameters and to make cuts of different lengths by means of interchangeable bushing sets sized to the customer’s specifications. Two tubes of any diameter up to 3¼4 in. may be cut simultaneously as long as material composition, material hardness, and wall thickness permit. The hand-fed 7-lb, 6 ¥ 27-in. machine is intended for limited production runs. The tube cutter is pneumatically operated at up to 100 psi via finger switch or foot pedal. Blade ram speed is adjustable. A counter, additional bushing sets, and extra blades are available from the manufacturer, that also offers complimentary evaluation of tube- cutting requirements. The blade and bushing sets can be replaced quickly and easily. Lakeview Equipment Inc., Northbrook, IL, USA.

Complex parts

A company has developed a direct-manufacture process to design and produce intricate metal and ceramic components. The technique is suited for creating small quantities of complex ceramic and metal components in short amounts of time. Parts are crafted from 3-D computer models using ceramic or metal powders. With the help of a temporary plastic binder substance, the materials are easy to form, cut, and merge into complex shapes. They can be converted overnight into solid, leak-free ceramic or metal units by simply removing the binder and consolidating the powder by sintering. The company has developed intricate components for clients, including a metal manifold that contains 4500 channels inside a 75 ¥ 75 ¥ 19-mm block, and a high-temperature flow nozzle created by laser cutting and laminating thin sheets of ceramic tape. Testable, functional ceramic and metal prototypes with mechanical properties comparable to production devices can be provided. The fabrication process is suited for components that are complex, difficult to manufacture, or that manipulate fluids and gases internally, such as biomedical sensors or analytical instrumentation. Cam-Lem Inc., Cleveland, OH, USA.

Antimicrobial adhesives

Adhesives, coatings, and potting materials incorporate minute silver-powder particles to prevent contamination. Adhesives with two different concentrations of the silver additives were tested by exposing them to Staphylococcus epidermis. The test showed that a bacteriostatic adhesive delayed the bacteria’s proliferation, while a germicidal adhesive neutralized the pathogen. The properties of the Vitralit Biobond adhesives can be modified to meet customer-specified applications. The company also offers a range of UV- and visible-light curing adhesives for joining stainless-steel cannulae to hubs and syringes, high-speed adhesives for bonding latex balloons to catheters, and dispensing equipment and UV lamps. All of the company’s adhesives meet USP Class VI guidelines and are certified to ISO 10993. Panacol-Elosol GmbH, Oberursel, Germany.

Self-monitoring sensor

A gas detector uses infrared beams to monitor EtO concentrations in sterilization chambers that process pharmaceutical powders, pellets, pills, and packages. The device shows EtO concentrations over the entire sterilization cycle. 

The self-monitoring sensor can be factory installed on new chambers or retrofitted to existing units. Measuring 2.5 in. diam and 3 in. long, the device sits flush on the chamber’s sidewall. Using infrared beams, the unit has no lenses or mirrors that can collect dust or require alignment. Self-correcting electronics ensure reliable, long-term operation, according to the company. Sensor Electronics, Minneapolis, MN, USA.

Magnetoresistive switches

Switches can be operated through materials up to 60-mm-thick walls without the need to drill holes. Freemount Top switches, which can be either rotary or push button, are mounted horizontally or vertically on one side of a panel with the control electronics on the other side. The mechanism allows the switches to work through plastics, marble, wood, glass, sheet stainless steel, and granite. The switches make use of giant magnetoresistive technology and can accommodate various substrate thicknesses. Because their actuators are entirely passive, the switches are suitable for use in hazardous environments or in situations where electromagnetic compatibility is a concern. Sealing problems are avoided, as no holes need to be made in the panel. Other functions, such as timers, can be incorporated into the switches. The advantages of this switching technology include security (the button can be removed when not in use) and self-calibration, which prevents the switch from having to be custom made for every application. Easy installation is possible using self-adhesive mounts, which are resistant to most liquids and gases. The switches can also be custom labelled to carry the name or logo of the product being controlled. Possible medical applications include placement in control panels. Herga Electric, Bury St. Edmunds, Suffolk, UK.

Contract services

A recently introduced catheter tubing system is marketed to PTCA catheter manufacturers. The EZ Glide Flexi combines the strength, trackability, and pushability of metal tubing with the easy handling and smooth finish of plastic tubing, according to the company. Its spiral shape and smooth surface provide physicians with fast, reliable performance. The tubing can be adapted to suit a range of applications, and is available in a variety of colours. The company manufactures all the metal and plastic components used in PTCA catheters, and provides full in-house assembly. The company also supplies metal and plastic hypotubes, stents, wires, balloons, extrusions, and fully assembled components on a contract basis. Creganna Medical Devices, Galway, Ireland.

Switch-mode power supplies

A recently introduced family of universal switch-mode power supplies is geared to OEMs that manufacture ultrasound equipment, breast pumps, regulators, and related instruments. The MW125 power supplies are available in nine models, ranging from 21 to 48 W with input voltages from 100 to 250 V ac. The desktop model measures 3.92 ¥ 2.58 ¥ 1.61 in., while device-mounted models are 1.61 ¥ 2.58 ¥ 3.92 in. The components comply with CE marking guidelines, and they can be supplied in a variety of medical device–mounted configurations specific to the North American, Japanese, European, and UK markets. They comply with global safety standards. Ault Inc., Minneapolis, MN, USA.

Spirometry filters

An antibacterial and antiviral filter can be designed to the specifications of pulmonary specialists and reduces the risk of contamination during respiratory tests. The spirometry filter features high efficiency in bacterial and viral filtration, low airflow resistance, adequate filtering surface area, low interior volume, and a mouthpiece with a medium-sized diameter. The filter’s antibacterial and antiviral properties eliminate the need for frequent cleanings and sterilization. The filter can be adapted for use with all leading respiratory function testing equipment. The unit’s technical specifications have been verified by independent tests. Mada, Milan, Italy.

Contract manufacturing services

Contract manufacturing services are available from a company that assembles, packages, and sterilizes products for laboratory analysis, cardiology, heart surgery, intensive care, haemodialysis, haemofiltration, infusion, and other fields. The company manufactures medical devices to customer specifications, including finished products in bulk, finished products that are packaged and labelled with the CE mark, and OEM semifinished products and accessories. Services from product development and prototype construction to manufacturing and distribution are available. In addition to its OEM activities, the company is also moving toward the development of its own finished products, and signs noncompetition agreements with its OEM clients to avoid any conflict of interest. Probio S.r.l., Mirandola (MO), Italy.

Medical nonwoven tape

An embossed medical nonwoven tape offers the bidirectional tearability generally associated with perforated plastic tapes and the comfort and extended-wear capabilities of microporous tapes. The 9914 tape combines rayon, polyester, and thermoplastic fibres; an embossing process enhances bidirectional tearing properties and increases the tape’s conformability. Designed to present a clean, professional appearance during wear, the surface of the nonwoven material is engineered not to fluff up. The adhesive’s hypoallergenic formula provides enhanced skin adhesion compared with traditional microporous tapes, according to the company. Available with or without a protective paper release liner, the EtO- and gamma-sterilizable tape has broad “stick-to-skin” applications. Sports medicine tapes, island dressings, and electrode backing applications are among the product’s primary uses. 3M Medical Specialties, Bracknell, Berks, UK.

Metal fabrication

A metal fabricator machines titanium and stainless steel for the medical industry. The company offers custom turning services using advanced Swiss CNC machining tools and quality-testing devices. Its production department uses single-spindle turning machines with 10 controlled axes. The machines feature high-pressure deep-boring systems, as well as internal and external thread-milling devices. Parts for implants, orthopaedics, traumatology, dentistry, and maxillofacial surgery can be produced. The firm is certified to ISO 9002 and EN 46002. Carniaflex S.r.l., Paluzza (UD), Italy.

Surface treatments

Inadequate coverage is a shortcoming of some surface treatments that may pose a problem for certain applications. Parylene is a gas-deposited polymer that is conformal and has uniform thickness. It doesn’t have any voids, pinholes, or low-coverage areas, according to the company. The material’s benefits include barrier properties and reliability. The barrier qualities help prevent penetration from moisture, chemicals, gases, and biofluids. The thin, transparent polymer film seals the surface microporosity of biomedical components, including stents, catheters, guidewires, pacemakers, artificial prostheses, mandrels, endoscopic seals, and silicone rubber devices. Specialty Coating Systems, Indianapolis, IN, USA.


Medical disposables

A company specializes in the design and manufacture of medical disposables, and supplies OEM components, subassemblies, and custom finished devices to the medical sector. The product line includes latex and latex-free components, as well as a range of infusion bags, including some made from PVC-free materials. Tubing extrusion, coextrusion, and sterilization services are available. The firm is certified to ISO 9001 and EN 46001. Services include plastic component design for the medical and biopharmaceutical industries using a broad range of USP Class VI materials. A recent addition to the product line is a patented, all-in-one, PVC-free, steam-sterilizable bag that is supplied with an infusion set for a total infusion solution. Also available are product lines for plasmapheresis, peritoneal dialysis, and haemofiltration. Haemotronic S.p.A., Mirandola (MO), Italy.

Custom medical devices

A company manufactures medical devices, such as postoperative drainage systems and custom packs for extracorporeal circulation, as well as components for haematology, neurosurgery, radiology, and intensive therapy. Other product lines include specialized devices for diagnostic imaging. Pilot lines of custom devices and components can be produced, by means of a benchtop injection moulding machine. An on-site Class 10,000 cleanroom houses the assembly lines, with an additional small cleanroom for quality control testing. In addition to its OEM services, the company manufactures finished products under its own label and sells them directly to hospitals. Sidam s.a.s, Mirandola (MO), Italy.

IV filters

Filters, vents, and flow control devices are manufactured for use in disposable blood therapy, IV, and enteral feeding sets. Catheter vents, spike vents, transducer protectors, vented IV bacterial filters, check valves, transfer filters, and needleless connectors are provided by the ISO 9001–certified company. Filtertek S.A., Newcastle West, Co. Limerick, Ireland.

Air filters

A range of air filters is available that includes bacterial and viral filters. HME, HMEF, CPAP and BIPAP, and suction and vent filters are also supplied. The filters attain bacterial efficiencies of 99.99999% for use in anaesthesia, drug therapy, spirometry, and many specialized medical applications. Air Safety Ltd., Morecamb, Lancs, UK.

Thread-milling machine

Precision equipment has been developed for milling medical screws. The thread-milling machine incorporates CNC technology to ease programming and resetting operations. The machine can process workpieces measuring 1.5 to 100 mm diam; a system for the production of 1.5–13-mm-diam screws is also available. Monnier & Zahner AG, Safnern, Switzerland.


Low-pressure balloons

Thermoformable polyurethane film enables the manufacture of low-pressure balloons with big bodies and small necks in nonlatex materials. Offered in 1:10, 1:15, and 1:20 neck-to-body ratios, and variations in between, the balloons can be produced in any size or configuration, including conical, pear, triangular, and cylindrical shapes. A proprietary welding process renders the seams practically invisible, and the technology ensures that the seams are stronger than the materials used. Films with built-in properties for drug delivery and other applications are also available. The US FDA– registered company offers full contract packaging and assembly services, and it specializes in taking OEM projects from concept to final production. Polyzen Inc., Cary, NC, USA.

Pouch-making machine

A company supplies a range of fully featured and versatile four-side-seal pouch-making machines. The smallest is designed for short production runs or small-volume production. The range can be easily validated for sterile production and works well with all thermal and cold sealing materials. Options allow for different pack and printing configurations. Pack length is software controlled and can be changed in seconds. Typical production rates are 20 cycles per minute. Medical Engineering Technologies Ltd., Folkestone, Kent, UK.

Solenoid valves

A series of completely sealed solenoid valves is designed for analytical equipment, chip-manufacturing equipment, and other precision ultra-high-purity electronic production equipment requiring all-welded components. Series-50 valves are available in a two-way normally closed configuration in many ac and dc voltages. They are made entirely of Type 430F stainless steel and have either 1¼8- or 1¼4-in.-OD stainless-steel welded tubing as port connections. Their sleeve assemblies can be attached via threads and elastomeric seals or, in the most critical applications, by direct welding of the body to the sleeve assembly. Grommet- or conduit-style housings are standard. Options include three-way operation, quiet-running diode-rectified coils, and other features to meet requirements for continuous operation at maximum rated pressures. Peter Paul Electronics Company, Inc., New Britain, CT, USA.

Micromechanical parts

Semifinished and finished micromechanical parts are manufactured from gold, silver, platinum, palladium, titanium, and other materials on a custom basis for medical device OEMs. The close-tolerance, high-purity components can be manufactured in prototype to full production quantities. The company is certified to ISO 9001 and is a US FDA–registered contract manufacturer. CM Medical, Cendres & Métaux S.A., Bienne, Switzerland.

Miniature medical cable

Customized wire and cable for the medical industry are offered in highly flexible microminiature sizes suitable for implantable applications. The supplier can insulate a conductor 0.002 in. in diameter with a 1.5-mil layer of Teflon to produce an ultraflexible insulated wire no more than 0.005 in. thick. Multiples of such conductors are used to make very small reusable or disposable medical cables. Cables are offered in a wide range of conductor and insulation materials and include nonelectrical components such as extruded lumens, fibre optics, tubing, and strength members. Laser gauging and digital micrometer measurement are used in conjunction with statistical process control methods to maintain manufacturing tolerances. Calmont Wire and Cable Inc., Santa Ana, CA, USA.

Insulation resistance meter

A handheld, battery-operated meter adapts to a wide variety of preventive maintenance and diagnostic testing applications, including checking the insulation resistance of wiring, communication cables, motors, appliances, and other electronic products and controls. The meter offers the capabilities of resistance and continuity checks, as well as ac and dc voltage measurements. The handheld unit provides accurate insulation resistance measurements below 2000 ž. Voltage measurements are possible up to 1000 V. A zero-offset adjustment provides automatic removal of lead resistance for optimum accuracy at low resistance. Incorporating these functions into one compact unit eliminates the need for multiple instruments. The meter offers user-friendly operating features such as a rotary switch for selection of test type, a large test button to initiate measurement, and backlighting for a clear indication of results in poor lighting conditions. The unit is fully compliant with IEC and EN safety standards and includes a number of important safety features, such as audible and visible warnings when high voltage is applied, an automatic shutdown feature, and test leads with alligator clips and probes. Clare Instruments, Tampa, FL, USA.

Rotary pouch sealer with bar code scanner

A validatable rotary pouch sealer is offered with a bar code scanner option. Bar codes indicating expiry dates, batch numbers, and operator names are created using Windows software and can be printed on the pouch using the sealer’s integrated printer. In addition, bar codes specifying the machine settings for a given production run can be printed on a sheet of paper that the operator can then simply enter into the system using the attached scanner. The company offers a range of continuous heat sealers for medical applications, including models with a stainless-steel cover plate, digital temperature control, and adjustable alarms that alert the user when pressure and speed parameters are not being met. The firm is certified to ISO 9001 and its products are designed and built in accordance with CE marking guidelines. Audion Elektro B.V., Weesp, Netherlands.

Laser system

A laser system is suited for the microwelding of metals and semiconductors, as well as for the microdrilling of ceramics and glass. In the standard version, the laser energy is supplied by a quartz-glass fibre and focused to a 100-µm spot. A more-specialized model is equipped with thinner fibres and higher-quality optics, and allows focusing down to a 50-µm spot. The system can also be supplied with a second fibre output for simultaneous setting of two welding points of equal energy. 

A red pilot laser is provided for easier orientation. The system can be controlled by a small separate operator console, or by a PC via a serial interface. Canlas Laser Processing GmbH, Berlin, Germany.

Surface treatment and coatings

Coatings and surface treatments are applied to medical devices so as to optimize biocompatibility and mechanical performance without affecting properties of the bulk material. Lubricious hydrogel coatings; antimicrobial, controlled-drug-release, and nonthrombogenic coatings; thin hydrophilic coatings; and plasma-enhanced conformal parylene coatings can be applied to a variety of catheters, cannulae, guidewires, blades, tubes, stents, and other invasive and blood-contacting devices. Also, plastic, metal, and ceramic surfaces can be modified to achieve desired chemical characteristics. Substrates that can be coated include aluminium, nitinol, stainless steel, titanium, gold, platinum, glass, latex, silicone, and a wide range of polymeric plastics. Coating formulations are water based, and processing techniques involve no solvents. In addition to performing contract coating in a facility that meets GMP and ISO 9001 standards, the service provider produces and sells systems for surface treatment and surface analysis. AST Products Inc., Billerica, MA, USA.

Temperature monitors

Temperature-sensitive tags affixed to products being shipped or stored reveal at a glance whether the tagged goods have been exposed to temperatures out of the desired range. WarmMark time-temperature tags also measure and indicate the length of time of the unwanted exposure. An out-of-range temperature exposure is revealed when a red-dyed chemical in a pad melts; the chemical migrates down a track strip until the temperature returns within range, colouring the tag’s circular windows at a controlled rate. Tags are available with response ranges covering –18° to 37°C, and accuracy within 1°C of the response temperature is guaranteed. Requiring no special storage themselves, the tags are activated when a barrier film strip is removed. They are applied to the product by a pressure-sensitive adhesive backing that is exposed when a release liner is removed. Introtech B.V., Loenen, Netherlands.

Porous plastic parts

Using primarily the sintering technique of manufacturing, a specialty company makes porous parts from plastic for use in filtration, separation, fluidization, and other applications. Parts are constructed of Cellpor, a customizable sintering material that can have pores ranging in size from 3 to 500 µm. The recyclable, environmentally friendly material exhibits high resistance to chemicals, high flexural strength, and good consistency, and can be engineered to be hydrophobic or hydrophilic. In-house capabilities of the manufacturer include CAD/CAM, laboratory testing that includes pore measuring, production, quality control, and dispatch and end control. 

An extensive assortment of standard products is kept in stock. The ISO 9001–certified firm also can provide cost-efficient fabrication of small series as well as high production volumes. Esters Sintering Technique, Aachen, Germany.

USP Class VI thermoplastic elastomer

A soft thermoplastic elastomer (TPE) compound designed as an alternative to latex and other thermoset rubbers associated with allergic reactions in healthcare workers and patients has been approved for applications requiring USP Class VI certification. Dynaflex G2706, which is made of Kraton polymer, contains no nitrosamines, phthalates, or polyvinyl chloride. With a hardness of 29 Shore A, the TPE provides a soft touch and rubbery feel to such products as US FDA–approved medical tubing, syringe tips and bulbs, gaskets and seals, O-rings, sheets, elastic bands, and personal-care products. The naturally translucent compound displays good tensile strength and very good elongation and resilience, and it can be coloured easily. It can be injection moulded and extruded, either alone or blended with other compounds, and it adheres well when overmoulded onto polypropylene. Scrap is fully recyclable. GLS Corp., McHenry, IL, USA.

Silicone components

A contract manufacturer of silicone rubber components for the medical device industry offers capabilities in design consultation, low- to high-volume production, assembly, and testing. In addition to moulding components by means of the quick, precise, and clean liquid-injection moulding process, the company provides insert and transfer moulding services. Extrusion abilities range from single-lumen tubing in 0.006–1.50-in. IDs to coextrusions with stripes and wires, and tubes with as many as 22 lumens or even more. Assembly and subassembly operations are conducted in a clean environment and encompass slitting, punching, trimming, bevelling, tipping, bonding, marking, skiving, and cuffing. Materials assistance, engineering support, prototyping, raw-materials testing, in-process inspection, end-product testing, and Class 100,000 cleanroom production are available to all customers. Silicone components can be combined with customer-specified nonsilicone parts to make complete devices. Vesta Inc., Franklin, WI, USA.

Polypropylene nonwovens

Polypropylene polymers are spunbonded into a family of nonwoven materials having a wide variety of weights and colours and tailored for many different end-uses. The product range includes composite fabrics, spun-dyed webs, multilayer webs, microfibres, fine filaments, and melt-blown nonwovens. Available in web widths of 160 to 340 cm and weights of 14 to 180 g/m2, the nonwovens can be treated to exhibit very good water repellency, resistance to ultraviolet radiation, and other properties. Finished fabrics are packaged in rolls, labelled, and distributed to converters and manufacturers. The supplier has a technology and development centre staffed by chemists and process engineers, and equipped with a pilot production line for new-product trials, on- and off-line quality control of customization processes, and short production runs. The company partners with customers in developing custom projects and new applications. ATEX S.r.l., Settala (MI), Italy.

Elastomeric valves

Duckbill valves, umbrella valves, combination duckbill-umbrella valves, and cross-slit valves made of biocompatible silicone, fluorosilicone, fluoroelastomer, and other elastomeric materials are available to OEMs for integration into a wide variety of medical devices. The components can be used as one-way valves, metering valves, pressure-relief valves, or introducer valves. Applications include intravenous therapy, anaesthesia, enteral nutrition, haemodialysis, urology, ventilation, vascular surgery and endosurgery, wound drainage, diagnostics, and more. The manufacturer develops and distributes worldwide a range of miniature self-actuating valves and elastomeric valve components. Besides offering standard components that are described in a catalogue, the company can provide design assistance in developing custom valves to suit specific needs. Minivalve International, Oldenzaal, Netherlands.

Plastic products

A plastisol dipping process allows for products to be smooth and seamless. The controlled manufacturing line can produce intricate pieces, either ultraclear or colour-coded to medical specifications. Products supplied include multilumen tubing, cannulae, catheters, tubes, balloons, masks, connectors, stirrups, and suture boots. Piper Plastics Corp., Copiague, NY, USA.

Silicone tubing

Medical- and implant-grade silicone tubing can be custom manufactured to meet precise specifications. Made of both restricted and unrestricted raw material, silicone tubing is available with standard outside diameters of 0.94–15.88 mm and corresponding inner diameters of 0.51–9.53 mm. Tubes are provided in 15-m coils as standard and have a durometer of 50 Shore A. All manufacturing is conducted in a Class 10,000 cleanroom. Seurat S.A.S., Montrouge, France.

Micromotors

Flat micromotors no larger than a small coin and weighing 1 g can achieve speeds up to 60,000 rpm in medical equipment applications and in robotic machinery and positioning-system drives. If high speed is not required, the versatile precision motors can be reduced through a variety of gear variations to produce torques as high as 34 mN·m. A lithographically structured coil developed by the manufacturer is behind the flatness of the motors, while hard and soft magnetic materials are used to build up the magnetic field. A wide range of standard micromotors is supplemented by custom options and by a selection of gear components. Mymotors & Actuators GmbH, Wendelsheim, Germany. 

Copyright ©2003 European Medical Device Manufacturer