The following selection includes products and services that will be offered by a range of exhibitors at MD&M West, February 12–14, 2013.
Precision Wire and Tube Bending
Specializing in prototyping and the use of custom tooling for material machining and forming, Marshall Manufacturing Co. offers services in automated and robotic precision wire and tube bending. Tubes 0.050 to 0.500 in. in diameter and wire in diameters of 0.050 to 0.375 in. can be formed. The ISO 13485–certified company assists clients with decisions about the materials and processes that will lead to the achievement of the best form, function, and manufacturability for any medical part. Using such techniques as electrical-discharge machining, flaring, swaging, and laser machining, the company manufactures parts from premachined wire and tubing. Premachining operations include precision cutoff, turning, and milling of special tips, such as trocar, bullet, barbed, pencil, and other types. These operations can also produce cross holes, grooves, and slots, all with precise tolerances. Premachined parts can be bent to orient their machined features on each end to a precise final destination using customized separators and indexing.
Marshall Manufacturing Co.
Lactoprene SMC7, a lactide-based bioabsorbable polymer, is part of a suite of proprietary customized polymers from Poly-Med Inc. The material maintains an extended mass-loss profile of one to two years based on the final device construct and enables constructs to retain strength for much longer than typical glycolide-based absorbable materials, according to the manufacturer. A copolymer composed of FDA-accepted monomers, it has a long shelf life and can be extruded into a variety of constructions. The material is used in such medical devices and applications as sutures, meshes, and coatings that are best made from a longer-term absorbable material.
Product Design Services
Specializing in product design services, Precision Tool & Die focuses on creating practical device solutions that take into account the client’s requirements for production speed, efficiency, and economics. The company offers such services as concept generation, design input, design planning, analytical study and design refinement, 3-D drawings, prototyping, cost estimations, and design review. Capabilities in plastic injection molding, mold design, mold manufacturing, prototyping, short- and long-run production, contract assembly, and value-added services for medical device manufacturers are all offered at a single location.
Precision Tool & Die
Designed to support medical device packaging productivity in short-run production and laboratory and resealing applications, the Aergo 1M one-station heat-sealing machine from Sonoco Alloyd has a single manually operated nesting tray that slides out for loading and in for sealing. The tray features a sealing area measuring 12 × 18.5 in. Precise, reliable seals can be produced with a single 3.9-kW heater platen that provides operating temperatures up to 550°F. Standard machine features include a dual-readout digital temperature controller, a digital timer for heat-seal dwell contact, a digital cycle counter, and design elements that promote operator safety and convenience. Available with an array of accessories and options, the system can be delivered in a cleanroom-compatible version. The 600-lb machine can be mounted on a cart for mobility. Volume capacity ranges between 1000 and 2000 packages per shift.
Booths #604, 5039
Machined Fluidic Components
Swiss Productions Inc. manufactures screw-machined parts for fluidic systems. Capable of machining plastic or metal components in prototype quantities to long runs, the company operates a facility equipped with more than 50 screw machines that can produce components ranging in size from 2.5 in. in diameter down to syringe tips measuring 0.019 in. in diameter. Capabilities include the production of Teflon and ultra-high-molecular-weight syringe tips for premium-quality syringes, the creation of precision sealing surfaces, and the maintenance of tight tolerances to ensure seal integrity. In addition to plastic and metal medical syringes, the service provider machines valve and pump components, PEEK and CTFE connectors, and more.
Swiss Productions Inc.
A line of hydrophobic vacuum protection filters designed to help guard suction systems against bacterial, viral, and biohazardous contamination and preserve system performance have BFE and VFE ratings above 99.999%. Available from the developer AG Industries in several sizes and port configurations, the specialty filters additionally provide low pressure resistance. The manufacturer offers custom systems in addition to standard suction filters. Its vertically integrated manufacturing capabilities facilitate custom filter design, with variously configured housings, end fittings, and filter media being strategically combined to satisfy the customer’s specific flow and filtration requirements. Durable construction from hypoallergenic materials makes these vacuum filters suitable for use in aspirators, equipment for negative-wound-pressure therapy, and gas sampling systems.
Tube Measuring System
An integrated QC system for accurately measuring the critical dimensions of plastic medical tubes and tubular products consists of the UltraScan ultrasonic gauge, AccuScan laser-based scanner, LaserSpeed noncontact encoder, DataPro process controller and data management system, and BenchMike system for measuring tubing cut lengths. Beta LaserMike supplies the system to manufacturers of IV components, catheters, and similar products that need to maintain a high level of production control to meet stringent industry requirements for product quality and safety. Measuring the wall thickness and concentricity of medical tubes with precision, the ultrasonic gauge is equipped with patented technology for automatically setting up measurement parameters and efficiently tracking product variations. The laser scanner measures product diameter and ovality, the encoder measures product length and speed, the process controller monitors system gauges, and the tabletop measures cut tubing.
Precision Ceramic Parts
Ceramaret S.A. manufactures precision components for medical devices and analytical instruments from very hard high-purity ceramics, including 99.9%-pure alumina and TZP zirconia. It also employs 96%- and 99.7%-pure alumina and zirconia-toughened alumina. Suited for use as insulators, flow-control components, blades, feed-throughs, and other parts, the materials are inert, biocompatible, and insulative and resist high temperatures and aggressive solvents. The 99.9% alumina and TZP zirconia meet applicable international standards for implantable devices. The manufacturer uses single- and double-effect pressing, cold isostatic pressing, and hot isostatic pressing techniques to form parts with near net shape from compacted ceramic powder. It produces parts in-house, from generation of the powder to the finished component. CNC machining, centerless grinding, lapping, and honing are offered for secondary processing.
Secure, leak-free SnapQuik connectors offer a safe option for small-bore connection of medical tubing in air-driven devices and other applications. Developed by Colder Products Co., these fluid connectors are designed to provide a more-reliable alternative to luer fittings. By not mating with standard luer fittings, they reduce the chance of misconnections that can lead to patient injury or death. Featuring a streamlined exterior and a special internal-latching mechanism that makes them easy to clean, the connectors reduce the risk of dirt buildup and thus help minimize the potential for patient infection. The connection produces an audible click, and disconnection is effected quickly and simply using a breakaway latch mechanism. Designed for 3⁄32- and 1⁄8-in. tubing, the connectors deliver high-flow fluid transfer in a small profile. They are suited for such applications as air-inflated cuffs, surgical devices, and monitoring equipment.
Colder Products Co.
ST. PAUL, MN
Bluetooth Serial-Port Modules
The dual-mode OBS421 Bluetooth serial-port module and single-mode OLS425 and OLS426 Bluetooth low-energy serial-port modules from medical wireless system supplier connectBlue Inc. are self-sufficient Bluetooth low-energy modules with the UART interface. All three products are a complete embedded stack and are suited for replacing serial cables or accessing Bluetooth low-energy UART devices through the manufacturer’s low-energy serial-port service. The single-mode modules offer a long battery lifetime, and the dual-mode module provides compatibility support for both low-energy Bluetooth and Classic Bluetooth. The OLS426 module is interchangeable with Classic Bluetooth modules made by the same company.
The EasyReach cleaning tool has been designed by Contec Inc. for use in cleaning and disinfecting isolators, laminar-airflow hoods, cabinets, and gloveboxes. Made from lightweight stainless steel and featuring a 360° pivoting mop head, the autoclavable product enables users to swab walls, corners, ceilings, and otherhard-to-reach areas single-handedly and with minimal effort. The cleaning tool can be used with a variety of sterile, presaturated, and nonsterile disposable cleaning pads available from the supplier. It works with a quick-connecting mop system consisting of a 7.5-in. stainless-steel mop-head frame and a choice of several complementary handles. One available handle is 16 in. long and made of stainless steel. Two others—one in anodized aluminum and one in stainless steel—are also 16 in. long but can extend to a potential length of 30 in.
Digital Pressure Sensors
Digital ultra-low-pressure sensors in ranges down to 25 Pa full scale use a special compensation technology to achieve long-term offset stabilities better than 0.1% in measuring air and gases. Supplied by First Sensor AG, these Sensortechnics LDE flow-based differential-pressuresensors include a microcontroller for precision digital-signal conditioning and can attain high levels of accuracy. They are offered with a digital SPI bus and analog output. The sensors are based on a sensitive thermal mass-flow-measuring principle and provide high-resolution signals. Because the flow channel and sensing elements are integrated within the silicon sensor chip, gas flows in very low volume. This design effectively immunizes the sensors against dust contamination and humidity and allows the use of long connecting tubes and input filters without loss of their calibrated accuracy, the company says.
First Sensor AG
OEM Dispensers and Pumps
Fluid Metering Inc. supplies precision low-flow dispensers and metering pumps with a valveless, one-moving-part design to the medical device OEM market. The OEM line of products for use in medical diagnostic and analytical instrumentation includes fixed- and variable-displacementoptions. Standard models are available in a range of output volumes from 500 nl per dispense to 1.28 µl per revolution. Custom models can be designed to meet specific application requirements. Performance capabilities include flow coefficients of 0.5% or better and ±1% accuracy, along with good chemical resistance. The manufacturer offers stepper control kits ranging in sophistication from basic Quick Start control to advanced programmable stepper development for precision fluid control.
Fluid Metering Inc.
Booths #2283, 2383
Multiple-Channel Liquid Dispenser
Available from IVEK, the Multiplex multiple-channel dispensing system for sterile filling applications is able to deliver liquid volumes ranging from less than a μl up to 4 ml in a single stroke. The three-piece positive-displacement ceramic pump modules are engineered to eliminate particulate contamination while exhibiting high accuracy and repeatability. Designed to be hard and abrasion resistant, they keep the dispensing system from showing wear even after hundreds of millions of cycles, according to the company. Each piston-cylinder set has a ceramic rotary valve that is separately controlled, allowing the pumps to be individual enabled or disabled. The pumps are easily removed from the actuator for cleaning or autoclaving. Applications include sterile filling, syringe filling, and form-fill-seal systems.
NORTH SPRINGFIELD, VT
Hemostasis Valve Y-Connector
Qosina catalog item 80448, a one-handed hemostasis valve y-connector that allows independent manipulation of several guidewires, is offered with two wire-lock adapters, item numbers 80449 and 80450. These adapters work in conjunction with the valve in applications involving multiple guidewires. With the single-handedcontrol-lever action, light fingertip pressure enables users to lock and release the connectors, leaving the valve open, semiopen, or closed. A solid click clearly identifies the valve position through tactile as well as acoustic feedback. The connector housing, made from polycarbonate and polyoxymethylene, exhibits both high clarity and resistance to extreme temperature. Aiding in the control of backflow, the silicone valve fits guidewires measuring 0.118 in. and smaller in diameter.
Designed for use in applications in which long lead length, small size, or consistency of tip size are important, E300-series miniature and microsize thermistors from Quality Thermistor Inc. are incorporated in catheters, skin temperature monitors, and hypodermic and other housings. The tips of these thermistors measure 0.023, 0.031, and 0.037 in. in diameter. Their leads are solid nickel or copper, with polyesterimide or polyurethane insulation, and are sized at 32 or 38 AWG. The overall part length ranges from 3 to 36 in. The series operates at temperatures between 0° and 70°C, features a typical time constant in still air of 3 to 4 seconds, and has a typical dissipation constant of 0.2 to 1 mW/°C in still air, depending on the model. RoHS compliant, these resistors are available in point-matched and interchangeable tolerances.
Quality Thermistor Inc.
Biomedical Textile Engineering Services
Secant Medical Inc. offers custom engineering services to manufacturers of cardiovascular, neurovascular, orthopedic, and other types of medical implants. The company partners with OEM development teams to design and manufacture components made from advanced polymeric, metallic, and resorbable biomaterials such as polyesters, polyethylenes, polylactides, polyglycolides, polyaryletherketones, stainless steel, nitinol, and titanium. It can shape implantable medical fabrics—including low-profile options—into planar, tubular, or complex component structures that exhibit specified functional behaviors and performance characteristics. Helping device manufacturers design biomedical textiles that satisfy custom requirements, the company provides services that involve biomaterials research, engineering collaboration, custom product design, prototyping, and advanced manufacturing.
Secant Medical Inc.
Balloon Catheter Coating System
Offered by Sono-Tek Corp., the fully enclosed and programmable MediCoat BCC system is used for coating common sizes and types of balloon-mounted catheters with drugs for delivery during in vivo medical procedures such as angioplasty. Fitted with either MicroMist or AccuMist ultrasonic atomizing nozzles, the system generates a low-velocity soft spray and uniform micron-sized droplets to ensure good adherence to balloon surfaces without any overspray, cracking, or peeling of the coating. The subsequent drying procedure is automated, according to coating requirements. Ultrasonic spray technology enables thin functional coatings to be created reliably and repeatably at low flow rates and with good control of spray characteristics.
Ultrasonic Air-Bubble Sensors
Compact Sonocheck ABD07 clamp-on ultrasonic sensors for quick, reliable contactless air-and gas-bubble detection in liquid-filled tubes are supplied by Sonotec Ultraschallsensorik Halle GmbH to manufacturers of miniaturized and portable medical devices. Measuring 25.40 × 19 mm and 15.75 mm high, the minisensors offer performance comparable to much larger conventional air bubble detectors, according to the manufacturer. Bubble-size sensitivity and other parameters can be specified by the user. The manufacturer can also produce custom devices as necessary. Equipped with a programmable microcontroller, the sensors additionally perform liquid-level monitoring and full-empty detection. Their measurement cycle is 200 microseconds, typical response time is 1 millisecond, and guaranteed detection capability extends down to bubbles sized at one-third of any tube’s inner diameter.
Contract Injection Molding
Sunny Medical Device (Shenzhen) Company, Ltd., supplies OEM, ODM, and customized medical devices and assembly components on a contract basis to customers worldwide. Specializing in such interventional cardiology and radiology devices as balloon inflators, guidewires, angiographic needles, manifolds and stopcocks, pressure lines, hemostasis y-valve kits, angiographic control syringes, pressure transducer kits, heparin caps, and stoppers for guide catheters, the company offers capabilities in plastic injection molding, assembly, packaging, and EtO sterilization. It offers custom versions of the enumerated devices and of others as well. The service provider can develop new molds based on customer samples. All production procedures are conducted under conditions certified to ISO 13485, and all finished products are CE certified. Both sterile and nonsterile products are available on an OEM basis.
Sunny Medical Device (Shenzhen) Company, Ltd.
The fully automated Accu-Lase V200 laser-processing system, part of the line of low-maintenance catheter and guidewire processing equipment supplied by Syneo, is designed to optimize users’ process capability in the production cutting of polyimide tubing, the making of complex holes, and the marking of polymer components. Pioneering a new generation of machine technology from the manufacturer, the system embodies proprietary motion control and handling knowledge combined with precision laser-based material processing methodology for catheters and guidewires. To help customers incorporate laser technology into their manufacturing processes, the equipment company offers comprehensive laser technology support services in accordance with Six Sigma; education and training, maintenance, service calls, and repair services are available.
WEST PALM BEACH, FL
Wound-Care Components, Adhesives
Vancive Medical Technologies provides components and systems for developers, manufacturers, and converters of temporary adherent medical devices. Products include the InteliShield DEHP-free barrier film for ostomy applications, the BeneHold securement and wound-care solutions platform, a thin absorbent skin adhesive (TASA) platform, and pressure-sensitive adhesives in single- and double-coated, self-wound, and transfer tape constructions. The multicomponent plastic barrier film is made without PVC, PVDC, or plasticizers and with an optional nonleaching antimicrobial inner surface. The wound-care platform includes thin, conformable dressings that manage lightly to moderately exuding chronic and acute wounds, and the securement components and finished products include medical-tape strips and a tube-fixation device. The TASA platform delivers fluid-handling performance that supports extended wear time for dressings.
Vancive Medical Technologies
Pumps for Surgical Ablation
The OEM pumps in the 400RXMD family have been specifically designed by Watson-Marlow Pumps Group for the surgical ablation market. The pumps are suited for equipment employing radio-frequency ablation. They can also be used to pump cooling fluid for precise temperature control in surgical systems for the treatment of cardiac arrhythmia, cancer, and other procedures. The pumps are offered in a range of precision pressure settings to suit specific applications, feature a mechanism engineered to improve flow accuracy as compared with that of a predecessor line, and have a tube holder that ensures correct positioning of a newly loaded tube each time the safety lid is closed. Available in 10 variants, the pumps provide flows up to 500 ml/min at 550 rpm and deliver pressures up to 8 bar. The offer of two stepper motors and one brushless-motor option enables pump users to set pressure, flow, and rotation direction.
Watson-Marlow Pumps Group
Conductive Pad-Printing Ink
AG-1074 silver conductive ink for pad-printing high-definition fine-line traces in hard-to-print areas of electronic medical devices is offered by Conductive Compounds Inc. Providing design engineers with flexibility in creating circuits, the ink is designed to print well in recessed areas of hard-plastic device substrates and on raised surfaces, unlike screen printing and other conventional printing processes that cannot access contoured surfaces, according to the manufacturer. Solvents can be adjusted for compatibility with specific substrates or medical-grade silicone pads. The ink also enables design engineers to incorporate electronic circuit traces into molded parts more easily.
Conductive Compounds Inc.
Donaldson Company, Inc., provides filter vents made with proprietary Tetratex expanded-PTFE membranes for a variety of medical device applications, such as devices requiring acoustic and protective vents, drainage bags, IV-administration sets, ostomy bags, urine bags, and device packaging. The vents are hydrophobic, toxicity-tested to USP Class VI standards, clean and nonshedding, chemically inert, and thermally stable. They feature high particulate and bacterial removal rates and high rates of airflow, and are designed to minimize extractables. Oleophobic and acoustically transparent materials are optionally available. Equipped with design and filtration-material expertise, the manufacturer offers custom systems that are easily integrated into the customer’s device or application.
Donaldson Company, Inc.
Automatic Tubing Cutter
The Model WC601B benchtop automatic rotary-blade cutter is engineered to cut flexible tubing and sleeving to a programmed length and number of pieces easily and accurately without crushing processed material. Manufactured by the Eraser Company, Inc., the unit is suited for processing tubing to tight specifications. The minimum cut length is 0.100 in. while the maximum tube size accommodated is 0.500 in. OD. Ten variable feed rates allow the operator to choose the best rate for a given material in order to optimize productivity and cut-length repeatability and accuracy. A batching feature enables users to program all variables for as many as 99 different frequently run jobs, and a kitting feature allows users to cut multiple pieces of different lengths within a single batch.
The Eraser Company, Inc.
Ultrasonic Punching and Welding Machine
The HiQ MPW ultrasonic punching and weld-sealing machine has been designed by Herrmann Ultrasonics to save medical device manufacturers material and steps in the production of plastic components with integrated filter membranes. Supplied as a manual workstation or integrated into an automation line, the modular system can punch and weld at the same time. In a single step, the unit transports the membrane by conveyor, punches the membrane contour, and welds the membrane onto the part in a weld cycle time of less than 2 seconds. Downstream optical quality control is not needed because the system has its own vacuum monitor to check whether the membrane is correctly punched and positioned. The machine control features gentle conveyor transport with a splice check to minimize other sources of error and thus production downtime.
Herrmann Ultrasonics Inc.
Cariflex IR latex, a synthetic latex alternative to natural rubber for surgical gloves, medical bandages, catheters, tube connectors and other applications requiring high levels of purity, user protection and comfort, and product quality, exhibits the high tensile strength and tear resistance of natural rubber without the impurities that cause discoloration, odor, and allergic reactions. Kraton Performance Polymers Inc. produces the versatile polyisoprene material in a precisely controlled environment in solid and latex forms, without employing organic solvents. The latex version it supplies is able to be processed by manufacturers on production lines designed for natural rubber when process parameters have been adapted. Used in gloves, the latex not only provides protection against reactions to rubber proteins, but also can enhance comfort and minimize hand fatigue.
Kraton Performance Polymers Inc.
Digital Temperature Sensor
Suitable for many electronic systems, the Model TSYS01 digital temperature sensor from Measurement Specialties Inc. encapsulates a temperature sensing chip and a 24-bit analog-to-digital convertor in a QFN16 package. Its technology provides onboard factory calibration coefficients that deliver accurate temperature information accompanied by high measurement resolution. For enhanced application-specific performance, the manufacturer can perform custom calibration upon request. The sensor draws less than 12.5 μA during normal operation and under 0.14 μA in standby mode. Because of its small size, expansive operating temperature range of –40° to 125°C, and ±0.1°C accuracy, it can serve as a replacement for thermistors. Integration with microcontrollers is achieved via an I2C or SPI interface.
Measurement Specialties Inc.
Self-Sealing Porous Media
Porex Corp., a specialist in sintered porous plastic components for medical device applications, makes sintered self-sealing porous media capable ofblocking a range of polar organic solvents and acidic solutions. These porous self-sealing media have high gas permeability and good bacterial filtration capability. Additionally, the media can be manufactured with an indicator that changes color when it is exposed to a liquid. They are offered to help support the prevention of contamination and infection, especially in fluid-management applications.
High-Purity TPV Elastomers
Teknor Apex Co. has added two high-hardness grades to its Medalist MD-200 series of thermoplastic vulcanizate (TPV) elastomers: compound MD-240 at 87 Shore A and MD-245 at 43 Shore D. The latter grade has a durometer roughly equivalent to 93 Shore A. Designed and qualified to replace rubber in medical device applications, the line of resilient, high-purity, nonhygroscopic compounds now includes grades ranging in Shore A durometer from an ultrasoft 15 to the newly introduced hard compounds. Their rubber-like properties include low long-term compression set, high fatigue resistance, prolonged flex life, stability at high temperatures, abrasion resistance, and long-term sealability. Suitable for extrusion, injection-molding, and blow-molding processes, the hard grades can be used for the production of peristaltic tubes; collection and drainage tubes; vial, cap, and plug stoppers; seals and gaskets; device handles; ergonomic soft grips; valves; and diaphragms.
Teknor Apex Co.
The technical service organization TÜV SÜD America Inc. is a large-scale medical device notified body and testing laboratory. The company provides a suite of services that includes CE-marking and CB Scheme, as well as electrical, electromagnetic-compatibility, functional safety, and biocompatibility testing. It serves as a notified body for the EU Medical Devices Directive, Active Implantable Medical Devices Directive, and In Vitro Diagnostic Directive. In addition, the organization provides FDA 510(k) reviews and third-party inspections and certifies medical device manufacturing enterprises to ISO 9001, ISO 14001, ISO 13485, and CMDCAS standards.
TÜV SÜD America Inc.
With recently added manufacturing capacity, electronics manufacturing services provider Valtronic offers medical device industry customers expanded capabilities in surface-mount (SMT) manufacturing, assembly, and testing. The larger and more-efficient SMT area is equipped with 12 SMT machines. In addition, a larger cleanroom is now available for sensitive products. Flow-based production cells are in place for projects of all types, with IPC-A-610 inspectors assigned to each of them to ensure that quality standards are met through every step of the manufacturing process.