SPECIAL SECTION
In what has become an annual tradition, EMDM is proud to present this year-end roundup of companies and products that, in our and our readers’ estimation, made a notable contribution to the design and manufacture of medical devices.
The product and service descriptions reprised here were chosen because they generated the greatest number of requests for information from EMDM readers. In essence, each time a reader fills out one of the bound-in Reader Service cards or uses our online RequestLink system, he or she is casting a ballot for a company or product. With this issue, this year’s results are in.
The longer articles in this section that profile companies are more-subjective choices. They were selected by the readers and editors of EMDM because, in one way or another, they helped to advance medical technology. While this selection is by no means exhaustive, I think you will agree that the commitment to innovation shared by these companies deserves recognition.
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Tube expander and stripper
An expander and stripper for latex, silicone, and rubber tubing uses jaws to expand tubing, allowing for the insertion of a fitting. The user then removes the tubing from the jaws with the fitting inside. Standard expansion jaws, including straight jaws for tubing from 0.125 to 0.500 in. ID, are available. Units include a foot pedal, hand switch, regulator, and gauge. Specialized jaw sets and a free evaluation of expansion problems are offered. Lakeview Equipment Inc., Northbrook, IL, USA.
Drug-delivery polymers
Biodegradable polymers are used to convert medical devices and pharmaceutical products into drug-delivery systems. The proprietary SynBiosys drug-delivery technology involves giving the polymers properties that enable them to release well-controlled amounts of peptides and small-molecule drugs over periods of weeks to months. The polymers are offered in configurations suited to the route of administration and site of application; they come chiefly as drug-eluting coatings for stents or other medical devices and also as drug-releasing microspheres, implants, and gels for pharmaceutical applications. The patented technology is biocompatible and meets regulatory requirements. If desired, elastomeric characteristics are available on a custom basis. InnoCore Technologies, Groningen, Netherlands.
Sterile packaging
Packaging has been introduced that can withstand fast, aggressive sterilization cycles, thus reportedly boosting throughput by up to 50%. The packs may reduce material waste, require less inventory space, and eliminate the need for premade vented bags and preprinted product insert cards. The stackable packaging is processed by means of thermoform-fill-seal technology. Suitable for packaging multiple products, including surgical kits, tubing, catheters, dialysis aids, and implant materials, the product has been awarded the Institute of Packaging Professionals’ AmeriStar Award. Multivac, Wolfertschwenden, Germany.
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Plastic disposables moulding
An international development partner and supplier of injection-moulded plastic systems has 16 facilities and branches in Europe, Asia, and the United States and specializes in components for medical diagnostic systems such as a test cartridge recently developed for use in a fully automated diabetes analysis instrument. Offering expertise in problem solving as well as cleanroom manufacturing and subassembly capabilities, the company enhanced the functionality of the cartridge by optimizing a seal between that component and a soft part of the hub that would be effective both when at rest and when in motion. Its flexibility in mould design made possible the innovative sealing geometry that achieved the purpose. The company additionally was able to mould instrument windows that had the same optical clarity as cuvettes; this required adhering to required minimum tolerances. Microtiter plates, cuvettes, reaction vessels, pipette tips, and lancets for diabetics are among the products the firm has manufactured. Wilden AG, Regensburg, Germany.
Microplate-sealing tapes
A recently expanded selection of microplate-sealing tapes can be cut to specification and are suitable for bio-analysis, compound storage, general assays, genomics, or high-throughput screening. Possible tape materials include foil, polyolefin, clear polyester, and white polyester. The tapes can be integrated for use with automated lines. Custom and precut finished tapes are also available. G&L Precision Die Cutting, Amstelveen, Netherlands.
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Adhesive tape
A pressure-sensitive adhesive tape consists of permanent or removable mounting adhesive on double-coated polyester film. The adhesive brings a clean bond to medical devices for mounting foams, polycarbonates, and plastics to glass and other hard surfaces. The tape is resistant to both moisture and cockling and is polycoated to ensure flatness. It offers repositioning ability with minimal force required to remove it from most surfaces. The exposed side of the 0.5-mm polyester film is coated with 1 mm of a high-gloss, high-tack, moderate-peel, high-shear acrylic adhesive, while the liner side is coated with 1 mm of a low-peel, high-shear, removable acrylic adhesive. Adchem, Riverhead, NY, USA.
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Membrane pump
A miniature membrane pump uses a diaphragm design to achieve a flow rate of 6 L/min, a maximum vacuum of 650 mbar, and a maximum pressure of 1300 mbar. The pump can start operation against pressure and does not require oil or maintenance. Various motors, including brushless motors, are offered. According to the manufacturer, the pump has a long service life. Schwarzer Precision, Essen, Germany.
Steam sterilization monitor
Providing an integrated solution for steam sterilization monitoring, a stand-alone test device measures the physical parameters of the sterilization cycle. The electronic test system gives accurate temperature, pressure, and time measurements; includes an air-detection system; and serves as a completely computerized engineering tool for precise analysis. The system provides a leak-rate test, clear pass-fail reading, early warning indication, and sterilization parameter indication measurement. As an alternative to the traditional Bowie-Dick test pack, it offers superheated-steam determination capabilities, electronic graphic analysis with printouts, and the creation of an electronic data archive using PC software. Other system features include software-based diagnostics; an efficient, cost-saving method for checking the calibration of sterilizer instruments; calculation of the dilution factor for air removal; and calculation of the total energy input of the sterilization process expressed as a function of microbial lethality. The monitor is designed to eliminate subjective test result interpretation and the possibility of inconclusive results. 3M Health Care Ltd., Loughborough, Leics, UK.
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Moulding compound
A company offers a clear, tear-resistant, and conformable moulding compound for hearing-aid shell and ear-piece fabrication. After curing with exposure to UV or visible light, the product delivers a tear strength of 145 lb/in. and a modulus of 740 psi. Despite its durability, the compound is designed to remain soft and comfortable in the ear canal. The formulation complies with ISO 10993 standards and resists chemicals naturally found in the human ear. Henkel Loctite, Munich, Germany.
Titanium stock
An extensive inventory of titanium bar, billet, plate, sheet, and wire is available to manufacturers of such implantable medical devices as hip and knee joints, bone screws, trauma plates, and dental implants. All materials are 100% traceable from melt source through mill processing. The supplier ships orders of standard mill shapes promptly, and can process custom parts to very close tolerances. Small-diameter medical bar and rod can be brought to tolerances of H9 to suit especially demanding requirements. Materials available for surgical implants are unalloyed titanium (specified to ASTM F67-95), wrought titanium 6AL-4V extra-low-interstitial alloy (ASTM F136-98), and wrought titanium 6AL-4V alloy (ASTM F1472-99). Complete chemical and mechanical property test reports accompany each shipment. Titanium Industries, Birmingham, UK.
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Solid-state relays
A family of solid-state relays provide thermal performance and reliability in a range of applications. Solid-state relays use direct-bonded copper to operate at low temperatures and achieve long life expectancy. Fewer solder joints in the path of the load current reduce overall heat dissipation and improve reliability. The epoxy-free design eliminates expansion and contraction stress on internal components and the risk of catastrophic failure in the event of a load problem. The DBC substrate carries the SCR die mounts directly onto the heat sink instead of the circuitry housing, providing a 40% increase in heat-transfer efficiency when compared with the first-generation product. Crouzet, Basingstoke, Hants, UK.
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Multisensor chip
A chip constructed for biosensor applications in the life sciences combines several platinum thin-film structures, such as temperature sensors, heaters, and electrodes, on a single platform substrate. The sensors and heaters ensure precise control of temperature, while the electrodes are capable of detecting the presence of adherent cells and the morphological changes in them. The Multi-Sensor-Platform chip can be customized to suit application requirements. In addition, it can be converted into a gas sensor by means of the application of a gas-sensitive layer. The platform chip is suitable for lab-on-a-chip applications, such as polymerase chain reaction, that require precise temperature sensing and heating. Heraeus Sensor Technology, Hanau, Germany.
Metallic materials catalogue
An updated products bulletin on stainless steel, nickel alloy, and titanium alloy strip and wire is available. The 20-page colour publication illustrates manufacturing operations the company uses to produce strip and wire. Detailed application information and chemistries are provided on 60 of the more than 100 alloys in the company’s typical inventory. Tables cover the grades, diameters, and cross sections available in wire products, and the range of gauges, tolerances, finishes, temper widths, and edge conditions available in strip form. Ulbrich Stainless Steels and Special Metals, North Haven, CT, USA.
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Antimicrobial gels
Unlike first-aid dressings that absorb blood and wound fluids and primarily protect against external contamination, antimicrobial gels keep wounds moist and kill bacteria on contact. Eliminating the need for preservatives or antimicrobial agents such as silver, the gels provide a skin-friendly environment that is antimicrobial to a broad spectrum of germ species, including C. albicans, A. niger, P. aeruginosa, S. aureus, and E. coli. The dressings are available in a range of sizes from 75 × 45 mm up to 200 × 200 mm. They are backed with a breathable polyurethane bacterial barrier in adhesive-bordered and nonbordered versions. First Water Ltd., Ramsbury, Wilts, UK.
Metallic materials
A manufacturer can process a variety of alloys to suit individual applications and ensure complete traceability by processing alloys from the melting stage. The company’s shape-memory and superelastic alloys are available in an array of bar, strip, wire, and tubing forms. Materials include elastic wire, superelastic wire, radiopaque-cored superelastic wire, and nickel-free superelastic titanium alloy. The company is certified to ISO 9001 and ISO 14000. Furukawa Electric Europe Ltd., London, UK.
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Wound-care products
Differentiating dressings and plasters by incorporating a printed logo can help device OEMs to stand out from the crowd of “me-too” products. A firm offers a range of services to help its customers brand products with a minimum of fuss. The one-stop-shop concept includes everything from artwork generation to delivery of the finished product. High-resolution flexographic printing capabilities in widths up to 1.6 m complement the firm’s existing expertise in film and foam manufacture, lamination, adhesive coating, and slitting. Logos, grids, text, and other data can be printed in a single colour on substrates including clear and colour films. A choice of US FDA–approved printed colours is available. The company supplies a range of advanced flexible components to specialist manufacturers in the wound-care, ostomy, and medical device sectors. Ultrathin polyurethane films and polyurethane or polyethylene foams, complex laminates, and conductive substrates are available. Intelicoat, Wrexham, Clwyd, UK.
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Valves and pumps
Liquid and miniature solenoid valves, electronic pressure controllers, and miniature diaphragm pumps are suited for use with medical and analytical instrumentation. Two- and three-way valves feature package widths as small as 8 mm and a variety of port styles for manifold and tube connection. Pneutronic valves offer flow rates up to 35 slm. Electronic pressure controllers can provide closed-loop proportional control for critical air and gas flows. Compact, high-performance diaphragm pumps for air samplers, gas monitors, and portable medical instruments are also available. The high-efficiency pumps feature flow rates up to 65 slm with operating pressures up to 1.5 bar and a vacuum of up to 22 in. Hg. Sensortechnics GmbH, Puchheim, Germany.
Medical-grade silicone
A grade of silicone can withstand UV rays, harsh chemicals, and temperatures from –50° to 200°C. The material has shape-memory properties and can be moulded in complex geometries with thin walls. Recently approved for medical applications, the self-bonding silicone can be comoulded with several common thermoplastics and can bond chemically without the need for primers. The colour of the material can be altered with a range of pigments that includes radiopaque and self-bleeding additives. Medical Rubber AB, Hörby, Sweden.
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RFID software
A radio-frequency ID (RFID) label–printing package features a 64-05 RFID label printer that, while printing, jumps over bumps made by embedded RFID chips. As a result, there is less likelihood of costly label waste caused by chips damaged during the printing process. Another feature of the system is near-edge printing technology, which provides precise control for printing bar codes, text, and graphics, and a detect-and-deflect process. This process identifies labels with faulty RFID chips, marks them with an x, and then reprints the information on the next label. The starter kit also includes 500 Class 1 RFID carton and pallet labels, an optional interrogator with two antennas, demonstration software, on-site setup assistance, training services, and 12 months of technical support. In addition, the kit comes with label management software, which uses Windows drivers to control printer functions. Avery Dennison Deutschland GmbH, Eching, Germany.
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Contract manufacturing services
A provider of custom, disposable, sterile medical device and pharmaceutical packaging has increased its bag-manufacturing capability with the integration of RF welding technology. Commonly used to weld PVC and polyurethanes, the procedure can also join nylon, PET, EVA, and ABS polymers. The company can also develop multiple-chamber bags and offers peelable-seal technology using thermal welding techniques. Contract manufacturing of custom components such as ports and saddles is also offered. The company is certified to ISO 13845 and registered with US FDA. Medisize, Hillegom, Netherlands.
Spinal needles
A line of spinal anaesthesiology needles is av
ailable from a specialist manufacturer of metal tubular medical device components. The needles feature either pencil-point tips with lateral openings cut close to the tip or Quincke-type tips with a short cutting bevel. Offered in gauges of 19 through 27, each in blade lengths of 70, 90, and 110 mm, they are also available in combination with an introducer. Thin-walled tubes with a relatively large inner diameter offer advantages with respect to cerebrospinal fluid reflux. In addition, a highly transparent hub helps facilitate control of reflux; stylet hubs are colour coded for quick, easy identification of needle size. The needles can be delivered sterilized in custom packaging or in bulk. Süddeutsche Feinmechanik GmbH, Wächtersbach, Germany.
Zone-coated lids
A company produces zone-coated lids that achieve maximum porosity and eliminate the need to coat the entire lid surface with adhesive. The lids feature the company’s proprietary hot-melt adhesive coating, which is nontoxic. To minimize exposure of the device to the adhesive, the coating is applied only to a controlled area along the package flange. The adhesive will not flake during handling and cause product contamination. Oliver Products International, Venray, Netherlands.
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Tuohy-Borst adapters
Large-bore adapters feature a side port and threaded flare connector. Available in 0–13 and 7–17 French sizes, the adapters are compatible with the company’s existing product line; the side port allows easy access to the fluid path. The products have a tapered silicone gasket to provide a tight seal with an adjustable, easy-to-control cap, and a clear polycarbonate body. The manufacturer has achieved ISO 9001:2000 compliance. Qosina, Edgewood, NY, USA.
Pressure-sensitive adhesive tapes
Pressure-sensitive adhesive (PSA) tapes are skin friendly and electrically conductive. Suited for attaching medical devices to patients’ skin, the adhesive facilitates bonding to a variety of skin types, yet tapes can be easily removed. The combination of high bond strength and stable conductivity enables use of the tapes for electrical interconnection in devices such as electrodes and defibrillators. Applications include wound-care products, biofeedback monitors, and in vitro diagnostics. The adhesive is available on a number of tape constructions to support long-term wear. The company also offers a family of electrically conductive PSA systems that incorporate a patented homogeneous conductive adhesive. Adhesives Research Ireland Ltd., Limerick, Ireland.
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UV power meter
Designed to measure and display the UV output irradiance emitted from a UV light source, a power meter features a compact sensor head. The C9386 can measure the intensity of a UV-spot light source, as well as the energy transmitted to light-cured glue and ink. The meter has a portable control unit and is suited for measuring light irradiated on components in high-density arrays. Hamamatsu, Herrsching am Ammersee, Germany.
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Flexible epoxy
An ultraflexible epoxy provides thermal shock and vibration resistance, sound absorption, and adhesion to dissimilar substrates. The Duralco 4538 formulation cures at room temperature without odour and will not gum up or soften at elevated temperatures. The epoxy seals glass ports to brass housings and withstands thermal cycling from –100° to 300°F without cracking; bonds treated Teflon housings to ceramic bushings and ceramic magnets to a variety of difficult surfaces, including plastic holders, Zytel 101, and Vitrex; and encapsulates delicate electronic components for use in severe thermal shock applications. By adjusting the mix ratio of resin to hardener, users can tailor the epoxy to satisfy many different requirements. The product is available in pint kits, gallon kits, and premeasured packages. Cotronics Corp., Brooklyn, NY, USA.
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Brushless dc motors
Brushless dc motors with integrated drive electronics feature a new speed command function. Separate inputs for voltage levels enable control of the motors’ speed at a constant torque. The firm has also expanded the motors’ operating temperature range to –25° to 85°C. Equipped with neodymium magnets, the motors achieve from 1.8- to 28-mN•m continuous-output torque, depending on the model. They are available in voltages from 9 to 24 V. Because of electronic commutation technology, service life of the motors is limited only by the associated bearings and electronic components. Minimotor S.A., Croglio, Switzerland.
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Cyanoacrylate dispenser
A company offers a dispenser that uses precisely timed pulses of air to consistently deliver cyanoacrylate. An alternative to squeeze bottles, hand syringes, and other manual applicators, the dispenser has a 0–1-bar pressure regulator. A microprocessor-based digital timer that operates to four decimal places enables accurate deposit size. A syringe reservoir is used to dispense the cyanoacrylate, and can be held as a pen or mounted on an optional arm for hands-free operation. The dispenser is backed by a 10-year no-fault warranty. EFD International, Dunstable, Beds, UK.
Tubing
A range of seamless, cold-drawn tubing includes OD dimensions from 0.3 to 50.8 mm. Long-coiled forms are available in addition to straight lengths of tubing precision cut to customer requirements. Applications include implants, stents, and endoscopic devices. Tube surfaces are refined by means of passivation, polishing, or electropolishing processes. Outer surfaces can be finished to 0.1 µm and inner surfaces to 0.2 µm. Fine Tubes Ltd., Plymouth, UK.
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Fluoropolymer manifold
A custom perfluoroalkoxy (PFA) manifold for use in fluid-handling instrumentation is designed to resist corrosion and heat in aggressive chemistry applications better than other materials can. The manifold’s multilayer construction involves a proprietary bonding process that uses no solvents, adhesives, or gaskets to connect fluid paths and chambers. Integrated fluid paths minimize connections and solution volumes and eliminate leak points. The translucent PFA allows the channel contents to be viewed. PFA combines properties of PTFE and FEP, but continuous-use testing shows that it outperforms both of those materials. The plug-and-play manifold can include surface-mount valves, pumps, sensors, fittings, and other components. Eastern Plastics Inc., Bristol, CT, USA.
Biomaterials
A company that offers a range of biomaterials produces coloured and radiopaque silicone elastomers suitable for short- and long-term implants. Biodegradable polymers from the polyglycolic and polylactic families also can be processed, and traditional thermoplastic polymers can be moulded or extruded for a variety of medical applications. The firm also processes titanium, stainless steel, shape-memory alloys, and other metals. In order to improve the mechanical and biological characteristics of implants, surface and thermal treatments can be applied to the materials. These include vacuum overhardening, mechanical and electrolytic polishing, electrolytic oxidation, and galvanization. A range of composite materials can be manufactured to meet customer specifications, and the firm can design and manufacture ceramic, ruby, sapphire, and aluminium oxide parts for medical applications. Statice Biomaterials, Besançon, France.
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Cables
Special cables and cable systems are manufactured to custom specifications. ECG cables, camera cables for use in dental equipment, endoscope cables, and hybrid coaxial and energy cables are available. The company’s products can withstand high and low temperatures and sterilization. Cable diameters range from 0.1 to 100 mm, and all of the products can be supplied as prefinished plug-and-play systems designed according to customer specifications. The company is certified to ISO 9001. Ernst & Engbring, Oer-Erkenschwick, Germany.
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Solenoid valve
An ultraminiature solenoid valve, claimed by the manufacturer to be the world’s smallest, exhibits high-performance flow-switching characteristics. Measuring 0.12 in. in diameter by 0.4 in. in length and weighing 300 mg, the magnetically latched, two-way Series 120 valve needs only a 1-millisecond pulse to switch the state (+5 V dc to open, –5 V dc to close) and is well suited for compact battery-powered pneumatic applications, including lab-on-a-chip and other power-sensitive OEM flow-switching devices. The tiny, quiet valve is capable of generating airflow of 1 slm at 5 psid. It is rated for pressures of vacuum through 15 psig, with a maximum differential pressure of 5 psi. Lee Products Ltd., Gerrards Cross, Bucks, UK.
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DEHP-free tubing
Designed for critical medical applications, DEHP-free tubing is reportedly the only product of its kind for extracorporeal membrane oxygenation and other demanding procedures. The tubing is suited for use with dialysis and peristaltic pumps, and with blood and IV solutions. Tygon S-95-E tubing withstands EtO and gamma sterilization and resists chemicals. It has been subjected to rigorous testing to ensure spallation is minimal when it is used with peristaltic pumps. Tygon S-95-E meets ISO 10993, USP Class VI, and European Pharmacopoeia criteria. Saint-Gobain PPL Gessil, Saint-Quentin Fallavier, France.
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Silicone products
A supplier of silicone products for medical applications offers a comprehensive range of standard products such as ballon catheters, gastro tubes, wound drains, and tubing. USP Class VI and long-term implantable materials are routinely processed. The company provides cutting, punching, printing, and coating services, and it supplies finished sterile products such as catheters and wound drains. Foley and suprapubic catheters, as well as products in customer-specific configurations, are available. In addition to extrusion, the firm provides balloon moulding and dipping services. Two-layer balloons can be mounted on PVC shafts. The company also has expertise in embedding antimicrobial and other protective agents into catheters. Its quality systems are certified to ISO 9001 and ISO 13485. Contract manufacturing is also available. Degania Silicone Europe, Regensburg, Germany.
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Assembly system
A flexible assembly system suitable for medical device manufacture can perform a range of tasks while conserving cleanroom space. Measuring 22 m in length, the Spaceline system comprises 13–54 directly driven, synchronized automatic stations. Powered by a twin drive, the system is reportedly the first linear-transfer assembly line to combine the flexibility of a servomotor with the speed, efficiency, and reliability of a cam drive. Additionally, the machine uses a precision index for cross-transferring pallets, thereby saving space and providing additional space for workstations when compared with other assembly machines. The system is compliant with US 21 CFR Part 11, and is now being used to assemble insulin pens at the rate of 520 parts per minute, insulin pen cannulae at 900 parts per minute, and IVD cartridges at 120 pieces per minute. Other applications include tube coiling, solvent dosing, and packaging. sortimat Technology, Winnenden, Germany.
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Heater, sensor design kits
Two design kits are available to teach engineers about a company’s flexible heaters and noninvasive sensor products. The heaters prototype design kit includes 12 flexible heaters of various shapes and sizes in polyimide and silicone rubber insulation, a 100-ž platinum resistance temperature detector (RTD) sensor, pressure-sensitive adhesive, and silicone RTV adhesive. An accompanying booklet features a start-up guide, technical specifications, application ideas, and white papers on prototyping techniques and other topics. The noninvasive sensors kit comes with five thermal-ribbon, thermal-tab, and bolt-on RTDs. The RTDs allow engineers to accurately gauge temperatures in places where they would otherwise have to drill or tap a sensor. Minco, Minneapolis, MN, USA.
Nitinol products
Nitinol as well as stainless steel, magnesium, and cobalt and titanium alloys are processed for medical applications by a firm that manufactures products to customer specifications. The company’s biocompatible nitinol reportedly has 10 times the elastic ductility of steel and resists buckling. To satisfy OEM demands, the firm has developed a technique that enables the production of large, thin-walled nitinol tubes with extremely narrow ID and OD tolerances. EUROFLEX GmbH, Pforzheim, Germany.
