Product Preview

The following products and services are among those that will be highlighted at the upcoming Medical Design & Manufacturing (MD&M) Minnesota conference and exposition November 2–4, 1998.

For the conference schedule and a list of exhibitors.

Metal Injection Molding

High-strength, complex stainless-steel components produced via metal injection molding (MIM) have material properties approaching those of wrought stainless. Three-dimensional shape configurations available with MIM extend the miniaturization possibilities for metal components beyond those available with such metalworking processes as machining and investment casting. The economical process has been used, for example, to mold laparoscopic surgical devices from 17-4PH stainless steel. The company offers design assistance that includes extensive finite element analysis, as well as prototyping and production services. Kinetics Inc., Booth 310

Thermal-Bonded Tubing

Bonded tubing produced by means of heat rather than solvents exhibits a clean, strong bond that is consistent throughout the tubing's entire length. Thermal-bonded tubing can be peeled apart without leaving residue and without the integrity of the tubing wall being affected. The manufacturer, a specialty extruder and provider of contract services, is able to bond tubings of different durometers, sizes, and configurations. All tubing is customized to meet specifications. Sunlite Plastics, Booth 646

Adhesive Dispenser

Cosmetic defects in adhesive application can be eliminated with use of a dispenser that employs a timed air pulse and adjustable vacuum for precise control. The Model 1500XL dispenser makes clean, accurate placement of cyanoacrylates, epoxies, solvents, and sealants easy. A teach function facilitates setting of time and air pressure. The operator then simply places the dispense tip in position and presses an electric foot pedal to make accurate, repeatable dots or neat, controlled beads. The adjustable vacuum control exerts a constant negative pressure during application, preventing adhesive from dripping and damaging part surfaces. EFD Inc., Booth 336

Laser Job Shop

Microprecision laser processing is performed at Nd:YAG laser workstations. The service is especially well suited for microwelding, spot welding, and fine cutting and drilling jobs. Pulse shaping and accurate metal joining require no filler material. Precision laser welding involves no heat distortion or filler materials and produces high yield strength. Stations with an average power of 250 W are capable of welding penetration of as much as 2 mm, cutting rates up to 1.5 m/min, and cutting and drilling depths of as much as 6 mm. Additional laser services include high-powered cutting and drilling, heat-treating, and marking. The company also offers water-jet job-shop processing. LAI Midwest Inc.,Booth 565

Polyurethane Resins

Five families of polyurethane resins are designated as medical-grade biomaterials. Available in a durometer range of 75 Shore A to 75 Shore D, Tecoflex, Tecothane, and Carbothane can be used in both extrusion and injection molding applications. Tecophilic is a hydrophilic polyurethane formulated to absorb considerable amounts of water. Rugged injection-molded components can be made from Tecoplast, an 80 Shore D polyurethane. The biocompatibility and biostability of these resins were established by USP Class VI, MEM elution, and other tests, including postimplantation examination. Thermedics Inc., Booth 354

Filters

A line of filtration devices includes a large variety of 25-mm filters. Newly introduced housing sizes measure 3, 13, and 18 mm. Octagonal 25-mm housings and new spike products for chemotherapy are also featured. Custom filter devices can be engineered and manufactured to suit the specific needs of an application. A variety of in-stock media, connectors, and housing options are available, along with special-order items, making it possible to create a custom filter from a combination of components at off-the-shelf prices. Die-cut, pleated, seamed, and potted filter products are offered. Effective filtration areas range from 1 to 2600 cm². Private-label manufacturing is available. Arbor Technologies Inc., Booth 604

Brushless Motor

Measuring 0.75 in. diam by 1.38 in. long, a brushless dc motor with integrated electronics features operation based on the principle of sensorless feedback. Design advantages include no-load current draws of 0.05–0.1 A, a weight of just 1.3 oz, two-wire construction for ease of installation, and, because it connects directly to a dc power source, no need for supplemental electronic drivers or controllers. The 1935-series motor provides smooth motion, quiet operation, and a potential dynamic speed range of 100–15,000 rpm with speed varying linearly with supply voltage. The addition of an optional wire permits access to a tachometer feedback signal. Service life typically ranges between 20,000 and 30,000 hours. Micro Mo Electronics Inc., Booth 1022

Syringe

The new design of a 1.25-cm³ syringe features an integral molded luer-lock collar and a smooth transition from the outside diameter to the rear of the barrel. The crosshair plunger gives the syringe enhanced integrity and stability. Available in natural and black polypropylene, the syringe can be custom printed. The ISO 9001–certified manufacturer specializes in disposable medical devices. Burron OEM Div., B. Braun Medical Inc., Booth 419

Cleanroom Molding

A custom injection molding company has a business unit that specializes in the production of high-volume plastic injection-molded components in a Class 100,000 cleanroom environment. The cleanroom molding unit has plans to build a new 36,000-sq-ft facility which will accommodate more automation systems and thus increase efficiencies and production capacity. The parent company has 17 business units located in Wisconsin; design centers in California, Massachusetts, and North Carolina; and a manufacturing facility in Idaho. It serves OEMs in the medical, electronics, industrial, and other markets. Phillips Plastics Corp., Booth 1200

Multichip Modules/Hybrids

Multichip modules/hybrid circuits and PC boards and systems are custom designed and manufactured for use in pacemakers, drug pumps, hearing aids, neural stimulators, muscle stimulators, implantable defibrillators, cochlear implants, and other medical devices. OEM products for EEG and sleep-disorder equipment are also offered. Advanced automated assembly techniques are used in manufacturing, and prototyping services support both small- and large-scale production. Complete engineering design and production capabilities for low-power analog, high-speed digital, fiber-optic, high-voltage, and high-power applications are available. Products are traceable down to the single component or process level. Teledyne Electronic Technologies, Booth 1210

Digital Machine Vision

Using a patent-pending two-way digital serial communications network, a completely digital machine vision system offers high levels of inspection speed and accuracy in real-time manufacturing environments. Digital Serial Link technology enables the Passport DSL system to provide noise-free simultaneous image acquisition and data transfer over long distances without degradation, at bidirectional communication speeds of 330 MByte/sec. Up to 16 DSL 6000 digital cameras and/or analog cameras can be connected to the remote processor via twisted-pair cable. A proprietary PCI-based host board and the FlashFind pattern-recognition hardware accelerator together capture and process inspection data at unprecedented speeds, the vendor claims. Passport DSL operates in a Windows environment. PPT Vision Inc., Booth 369

Spot-Curing System

With exposure control by spot intensity or time completely automated, a microprocessor-controlled UV/visible light curing system offers a repeatable process with optimized cures. Changeable filters allow users of the Novacure system to tailor output for wavelength-specific applications and to protect sensitive substrates. The system can provide up to 20,000 mW/cm² of curing power. A built-in radiometer that ensures system integrity is easily removed for calibration to NIST standards. The Novacure monitors itself and reports internal calibrations, lamp hours, intensity, and exposures by date and time. Additional PC software for data downloading supports validated processes. A range of optical accessories help overcome access difficulties in bonding. EFOS Inc., Booth 408

Miniature Connector

A miniature electrical connector designed to facilitate the charging and downloading of bar code scanners and handheld terminals provides more than 15,000 mating cycles with outstanding repeatability. The KS10 connector has up to 10 contacts rated at 2.5 A continuous, with crimp and printed-circuit terminals. The compact device features a D-style polycarbonate housing that provides polarity assurance. Plug styling permits back-molding to the cable after crimping and inserting the pins. The receptacle has straight dip solder tails for flex strip or PCB use. Two rows of pins are set on a 0.083-in. grid with staggered spacing. Contacts provide an average 1 oz of insertion force per contact, with less than 0.8 m(omega) of contact resistance and virtual immunity to shock and vibration. Hypertronics Corp., Booth 1232

Contract Die-Cutting/Converting

A contract manufacturer specializes in custom die-cutting and converting, island placements, printing, and multiple laminations. Another capability is the mixing and extrusion of hydrocolloids. Typical products include wound-care dressings, kit components, diagnostic devices, electrode subassemblies, and transdermal and hydrogel products. The FDA-registered, ISO 9001–certified company follows GMPs and customer specifications. It can take the customer's project all the way from R&D to finished product when requested. SMI Div. of Sohn Mfg. Inc., Booth 228

Tubing Set Assemblies

Straight and coiled tubing set assemblies are produced for use in such medical applications as contrast injection, pressure monitoring, gas sampling, drug delivery, IV administration, and general fluid and gas transmission. A complete range of standard products is available. In addition, custom tubing assemblies can be manufactured to meet specific requirements. R-Group International, Booth 266

Sterile Packaging Material

Formed by bonding very fine high-density polyethylene fibers together with heat and pressure, a tough, durable sheet product has physical characteristics that suit it well for use in sterile packaging. Tyvek spunbonded olefin is strong, low-linting, opaque, and very resistant to water, chemicals, and abrasion. It provides an excellent microbial barrier. The olefin outperforms medical-grade papers in tests of puncture, tear, and tensile strength. It generates virtually no airborne particles when the package is peeled open. Tyvek retains its properties when exposed to EtO, gamma radiation, and electron-beam sterilization processes, as well as steam sterilization under controlled conditions. DuPont Tyvek, Booth 259

Miniature Heating Elements

A line of heaters includes sizes as small as 0.25 x 0.25 in. for fitting inside electronic components. Polyimide Thermofoil heaters mount directly to the component via self-stick adhesive or can be clamped beneath. They have power ratings up to 50 W/sq in. and operate at temperatures between –200° and 200°C. All models have UL recognition and meet NASA standards for vacuum outgassing. Standard electrical termination is 12-in. lead wires, with solder pads and flex circuits available as custom options. The heaters can be ordered with temperature-sensitive elements for use with the Heaterstat sensorless solid-state temperature controller. Applications include temperature stabilization of crystal oscillators, thermal stress testing of integrated circuits, and simulation of heat-emitting components for performance evaluation of cooling systems. Minco Products Inc., Booth 551

Printed Flexible Circuits

Supporting iontophoretic and electrophoretic delivery and monitoring for diagnostic, clinical, and related biomedical systems, printed flexible circuitry reliably generates the very low voltage conductivity that facilitates system interfacing. Conductor traces and dielectric spacers are precisely configured to achieve the degree of accuracy necessary to optimize bioelectronic signal generation and reactivity. Intricate die- and laser cutting produce registrations in the range of ±0.002 in. EDI-activated laser shaping provides fully functional component prototypes. The ISO 9001–certified manufacturer has more than 25 years of experience in the R&D, printing, and processing of conductive inks and membrane technology. Topflight Corp., Membrane Switch Div., Booth 1101

Wire Braider

A horizontal 16-carrier fine-wire braider comes complete with a belt puller that is controlled via "intelligent motion control." Braid angle or pick density can be changed on the fly. The unit has been designed to overbraid rigid mandrels. The complete line of wire-braiding equipment includes models with 3 to 144 carriers. Steeger USA Inc., Booth 558

Regulatory Databases

Access to comprehensive electronic databases containing medical device regulations, standards, and guidelines is available by subscription. Offered in CD-ROM and Internet versions, the libraries are useful to R&D engineers designing medical devices and to regulatory affairs professionals needing to keep up with both U.S. regulations and European directives related to CE marking. The libraries also reveal industry trends and decribe the requirements for entering Japanese medical device and pharmaceutical markets. Subscribers receive free industry news feeds, daily Federal Register updates, and unlimited toll-free technical support. IHS Health Information, Booth 1301

Miniature Clamps

A line of miniature clamps for precision medical applications effectively close tubes and hoses as small as 0.098 in. diam. Made of stainless steel or zinc-plated carbon steel, the clamps are compatible with medical-grade hose and tubing. Ear clamps for space-restricted applications have an ear-and-dimple design that allows the hose to breathe without leakage. Oetiker Inc., Booth 1318

Implantable Titanium

Titanium in the form of bar, billet, sheet, and wire is available internationally for use in implantable orthopedic devices such as hip and knee joints, bone screws, and trauma plates as well as dental implants. The biocompatible material is supplied with complete reports of chemical and mechanical property tests. Inventory is 100% traceable, from mill processing through melt source. Orders for standard mill shapes are shipped immediately. Custom parts can be cut to very close tolerances. Besides offering biocompatibility, flexibility, light weight, and high strength, titanium is compatible with conditions created under magnetic resonance imaging and computer tomography. Titanium Industries, Booth 1004

Consulting Services

Regulatory, clinical, and quality assurance consulting services are provided to medical device and in vitro diagnostic product manufacturers and suppliers worldwide. In the regulatory area, consultants offer help with the development of worldwide regulatory strategies; FDA submissions, including 510(k)s, IDEs, and PMAs; postmarket surveillance; and FDA liaison. Clinical services include the design, management, and monitoring of clinical studies; data processing; statistical analysis; and site audits. Also offered are quality system regulation and ISO quality system development and implementation; audits and training; supplier programs; and quality engineering services, including validation. Expertise in CE marking, design dossiers, and EN 540 conformance is offered to clients needing assistance with EU directives, as are authorized representative services and notified body liaison. Medical Device Consultants Inc., Booth 1115

Surface Modification

Drug delivery from medical device surfaces is facilitated by a surface modification technology. The PhotoLink process provides a covalently bound cross-linked polymeric matrix on the device surface which acts as a reservoir to hold unbound antimicrobial or therapeutic agents that can be released at a controlled rate. The coatings can be customized to deliver a variety of drugs over periods ranging from minutes to weeks. PhotoLink technology can be used on a large variety of surfaces, including plastics, metals, and glass, to achieve other surface-enhancing characteristics as well; lubricity, hemocompatibility, wettability, infection resistance, directed cell response, and DNA immobilization are also improved or attainable. SurModics Inc., Booth 230

Catheter-Manufacturing Equipment

A briefcase-sized catheter-manufacturing system provides fast, precise, and repeatable control of heating time, cooling time, and insertion pressure. The PIRF system can be used to tip, add neckdowns, and weld thermoplastics into finished catheters, easily shaping such materials as polyethylene, fluoropolymers, PVC, polypropylene, and polyurethane. With a proprietary process precisely controlling mold temperature during heating, the system maintains high quality levels and maximizes production yields. The CE-marked equipment meets international standards for safety and emissions. SEBRA, Booth 111

Interconnect Systems

A company that designs, develops, and manufactures interconnect systems for medical monitoring applications provides a complete range of cables, connectors, and lead wires for virtually all domestic and international manufacturers of vital-signs monitors. The TronoMate patient cable and lead wire system, designed for interchangeability, represents one product family that has achieved CE-marking status. The system includes fully shielded ECG cables wired for various monitors; standard individually replaceable, color-coded, shielded lead wires; and accessories that facilitate quick connections and attach the cable to garments or bedsheets. It was designed to comply with AAMI EC-53 1995 standards. The company also offers a line of chart papers and monitoring and diagnostic electrodes. Tronomed Inc., Booth 1106

Braid-Reinforced Tubing

Close-tolerance tubes in various configurations can be wire reinforced by means of a controlled braiding operation. The process utilizes single- or double-ended wires of various materials including stainless steel, beryllium copper, silver, and polymer monofilaments; diameters are as small as 0.002 in. Braiding is offered in a variety of picks per inch and can be applied over many thermoplastic substrates. The braid reinforcement is offered by a custom manufacturer of single- and multilumen small-diameter tubing that meets customer specifications. The engineering resins used as tubing material can be compounded with barium, bismuth, and tungsten for radiopacity. In-house tool design and manufacturing ensure quick turnaround. Precision Extrusion Inc., Booth 205

Rotary Heat Sealers

A versatile line of validatable continuous rotary heat sealing machines includes tabletop, stand-alone, and completely conveyorized models. With add-on options such as trimmers, printers, embossers, conveyors, and more, MPS 6300- and 6700-series heat sealers can accommodate virtually any flexible sealing application. Air-pressurized heating and cooling bars, a digital tachometer, a digital PID autotune controller, audio alarms, an external thermocouple, and reverse feed are features that enable sealing parameters to be validated. The easy-to-use systems are designed to minimize production downtime. Emplex Systems Inc., Booth 169

Close-Tolerance Machining

A contract manufacturer can custom machine individual components or complete assemblies to specification. Capabilities include close-tolerance prototype to production Swiss turning to ±0.0002 in., CNC machining, and CNC milling of precision components. High-performance turning and machining can be applied to components measuring from 1/8 to 8 in. diam. Materials machined include stainless steel, medium carbon steel, plastics, nylon, aluminum, and brass. In-house computer-integrated manufacturing capacity extends from tooling and fixture design to component parts. The single-source contractor also performs machining of investment castings, sand and die castings, and permanent molded castings. Criterion Instrument, Booth 255

Coils/Wire Forms

A line of precision coils and wire forms for medical uses includes multifilar implant coils for pacemaker and defibrillator leads, catheter and guidewire coils, and coils with variable initial tension. Coils can be manufactured with diameters as small as 0.003 in. and with round or shaped medical-grade materials including coated wires. Statistical process control is employed to minimize process variation. High levels of consistency and low levels of scrap result in high-value coils and wire forms. Custom-designed machines are built to manufacture production volumes within eight weeks. Quick-turnaround prototyping is also provided. Vadnais Technologies Corp., Booth 462

Rapid Prototyping

A full-spectrum service bureau specializes in rapid prototyping. The firm offers rapid prototypes ranging from stereolithography (SLA) models and cast-metal prototypes to cast-urethane and short-run injection-molded parts. The use of an SLA 5000 stereolithography machine enables the quick generation of inexpensive prototypes for medical device manufacturing clients. Vista Technologies, Booth 569

Switch-Testing Station

A displacement-force test station is capable of measuring contact resistance continuously during testing. The Model 921A testing device tests all sorts of membrane switches, including polydomes, metal domes, and elastomer and conventional keypads, as well as conventional electromechanical switches and virtually any component requiring accurate measurement of displacement force. Governed by Windows-based control and analysis software for storing, viewing, and printing test results, the station features operator-programmable touch force, displacement range, and test speed; interchangeable force sensors; and optional electrical resistance channels. It operates in three modes, and can be integrated into an automated production line. In engineering mode, the test station can provide up to 5000 data points per test, with displacement resolution of 0.0001 in. Tricor Systems Inc., Booth 730

Contract Sterilization

A provider of contract sterilization services to health-care product manufacturers specializes in 100% ethylene oxide processing, which it offers at several facilities nationwide. The company offers parametric release and can monitor relative humidity throughout the sterilization cycle. This technology allows processed product to be shipped to market immediately following aeration, thus eliminating the costs of biological indicators and sterility testing. All types of products can be sterilized with minimal turnaround time, in chambers measuring 1–26 pallets in size. The ISO 9002–certified contractor uses processes fully compliant with ANSI/AAMI/ISO 11135. Cosmed Group Inc., Booth 209

Electrosurgical Instruments

A manufacturer of precision medical instruments and components produces Class III electrosurgical instruments that are biocompatible and engineered for reuse after autoclaving. Devices are available nonsterile in bulk. A featured product is the LLETZ Loop molded electrode, available in seven loop sizes, whose molded construction encapsulates a 0.008-in. tungsten wire-loop cutting element. Stainless-steel blades as well as ball, needle, and other configurations are available. The manufacturer provides turnkey design, development, and production of all types of medical device components, including those requiring exotic metals or complex manufacturing techniques. InstruMed, div. of National Wire & Stamping, Booth 345

Packaging Film

A nylon-based forming film for use in medical packaging provides high material yield at a low cost per package without compromising package integrity. Thin-gauge PerfecFlex Ice is made from coextruded high-performance polyethylene and nylon resins by means of a technique that imparts to the film superior mechanical strength and abrasion and puncture resistance as well as good formability. Uniform gauge control provides consistent machinability. The clear, durable film is EtO, electron-beam, and gamma irradiation sterilizable. It is well suited for use with the manufacturer's coated Tyvek, PerfeCraft coated papers, and PerfecFlex barrier-film top web. Perfecseal, Booth 660

Foot Switch

Offering a choice of SPDT, DPDT, or two-stage operation, a lightweight foot switch provides precision foot control. The 3.6-oz Aquiline switch is made of durable reinforced polymeric material that will not rust or corrode. Its nonskid basepad and raised treadle ribs ensure consistent performance. The switch can be modified for IP68 operation. An integrated adjustable strain-relief clamp accommodates cords 0.250 to 0.400 in. in diameter. Full or twin foot guards are available for configurations using multiple switches. Linemaster Switch Corp., Booth 1024

Seal Design Guide

A comprehensive resource manual of sealing technology is offered by a company that designs and manufactures seals and sealing devices. The seal design guide is available as a 180-plus-page book or as an interactive CD-ROM for both IBM and Mac platforms. The guide provides information on basic O-ring design, seal types and gland design, critical operating-environment factors, material selection, applications for special elastomers, and troubleshooting. It features listings for the large inventory of standard-sized and nonstandard O-rings available from the manufacturer. Apple Rubber Products Inc., Booth 469

Contract Assembly and Packaging

A company offers contract manufacturing services ranging from prototyping to packaging. Medical and electronic assembly, pouch and tray packaging, and EtO and gamma sterilization are provided. Small or large runs are accepted; absolute traceability is part of the service. The company has cleanroom capabilities ranging from Class 10,000 to Class 10. LumiLife Corp., Booth 542

Check Valve

A USP Class VI–certified three-way check valve is designed for administering patient liquids via an infusion pump or syringe. The valve operates once a syringe is connected to the female luer lock side of the assembly. Fluid is then aspirated into the syringe from a container while the male luer lock connection on the patient side is closed. Fluid is transferred into the patient from the filled syringe while the tube side of the apparatus is closed. The actions of aspiration and injection can both be performed without removal of the syringe from the female luer lock connection. The three-way valve is assembled and tested in a Class 100,000 cleanroom under ISO 9001 quality assurance. It can be sterilized via EtO or gamma irradiation. Filtertek Inc., Booth 349

Nitinol Components

Innovative high-performance medical components and devices can be manufactured from nitinol in accordance with customer specifications. Products are made from both superelastic and thermally activated nickel titanium, stainless steel, and other high-performance materials. In consultation with clients, the ISO 9001– and CE mark–certified manufacturer provides services in product definition, design development and verification, preproduction, and manufacturing, including satisfying demanding requirements in grinding, polishing, spring forming, and other processes. The company has developed numerous Class I, Class II, and Class III devices. FlexMedics, Booth 309

Hydrocolloid

A special hydrocolloid adhesive formulation is designed to offer enhanced dynamic absorption and saturation potential in wound-care applications. H2410 hydrocolloid contains no animal products, an advantage in device approval. Manufactured in a Class 10,000 cleanroom, the fully integrated product is available in 18- and 39-mil thicknesses on rolls of transfer tape or 1-mil polyurethane film laminate with poly-coated liners. Avery Dennison Specialty Tape Div., Booth 146

Custom Machining

Precision custom-machined parts are produced to customer specifications. Tolerances can be maintained at ±0.002 mm for hundreds or thousands of parts. A quality control facility ensures the accuracy of every part. Serving industry worldwide, the company delivers parts on time from its four facilities. Design problems are welcome. American Micro Products Inc., Booth 168

Heater/RTD

A miniature resistance heater and a resistance temperature detector (RTD) are situated together on a single combination part which is available in various configurations and sizes. With separate etched circuits, both heater and RTD are made from thin metallic foils and laminated to thin, heat-resistant plastic substrates in a variety of shapes. Narrow lines and spaces as small as 0.001 in. are etched to provide electrically conductive traces in the foil. JP Technologies Inc., Booth 249

Irradiation Services

A provider of contract gamma and electron-beam sterilization services has 13 facilities nationwide. The company also offers consultative services based on its 20 years of sterilization business experience. Its SteriPro technical assistance program is designed to help medical device manufacturers with the development, validation, and ongoing sterilization management of a sterile product. Four different service packages and a custom option are available. The company offers a conversion assistance program for manufacturers changing over from EtO to radiation processing. SteriGenics International Inc., Booth 136

Replacement Biopsy Channels

A company specializing in the custom extrusion of PTFE, polyurethane, nylon, and other fluoropolymers with precision-controlled profiles offers a line of replacement biopsy channels. The endoscopic working channels have a PTFE inner layer and are supported with a polyurethane-encapsulated stainless-steel spring, making them highly durable and flexible. The ISO 9002–certified manufacturer also produces single- and multilumen tubing, optical fiber, wire sheathing, extruded sheets, and rod components. International Polymer Engineering, Booth 207

Springs

A full-service company manufactures custom springs and wire forms for medical, electrical, and precision specialty customers worldwide. Products are made from round wire 0.006 to 0.250 in. in diameter. Except for plating, all operations are performed in-house in accordance with ISO procedures and under full statistical process control with supervision by the manufacturer's own personnel. Cook Spring Company, Inc., Booth 144

Pouch Sealers

A line of packaging machines for medical pouch sealing is supplied worldwide by a company specializing in custom-engineered equipment. The floor-standing 552 MED pouch band sealer and MED VAC feature alarm-activated controls that respond when seal parameters escape a preset range. Seal temperature, time, and pressure can be preset via digital controls with LED readouts. An external connection makes machine calibration and validation possible. The standard MED VAC comes with jaw widths from 18 to 54 in. and lets the operator heat one or both jaws during the seal cycle. The tabletop PT Medical is a nonvacuum impulse model designed for space-limited or budget-conscious packagers needing the seal integrity of a medical sealer. Packaging Aids Corp., Booth 449

Video Measuring Systems

A line of automated video measuring systems has been optimized for accurate high-volume part inspection by the addition of a laser autofocus feature that enhances repeatability and increases the rate of throughput. The photodiode laser has a focusing cycle of milliseconds, increasing speed and reliability in collecting z-measurement data on 3-D parts. Even when taking advantage of the autofocus feature, users of the Veritas video measuring system still benefit from the system's long working distance for large-part inspection. The easy-to-use Veritas system consists of a measuring microscope with zoom optics (10:1 ratio), a stage, an integral CCD camera, Windows-based measurement software, and a video monitor. Video edge-detection capabilities and a three-axis computerized numerical control (CNC) system are standard. Nikon Inc., Booth 512

Surface Coatings

Advanced medical device surface treatments developed, manufactured, and applied by a service provider include lubricious, biocompatible, antithrombogenic, antimicrobial, antiinflammatory, and ultrasound echogenic coatings. The company develops custom coatings with one or more of these properties. The coatings can be formulated for short-, intermediate-, or long-term effects. Plasma pretreating service is also available. Coatings can be used on such devices as catheters, guidewires, dilators, cannulae, gastroenteral feeding tubes, blood filters, and stents. The company also sells biological indicators and provides packaging, EtO and steam sterilization, and testing services. STS Biopolymers Inc., Booth 530

Contract Manufacturing

Turnkey manufacturing services for medical devices and subassemblies are offered on a contract basis in a Class 100,000 cleanroom environment. The company uses 40 years of experience in managing complex projects from design through assembly to tailor each project to best satisfy the customer's specific requirements. Capabilities include 24-hour, 7-day-a-week production, design for assembly, and integrated manufacturing systems. To ensure performance and product reliability, the manufacturer complies with numerous international standards and FDA GMPs. The facility has been awarded ISO 9002 and UL quality certifications. UFE Inc., Booth 105

Catheter Assembly System

An IV-catheter assembly system is a complete integrated assembly line consisting of four machines that automatically assemble the components, form the tip, and perform full inspection of the product. The four indexing chassis are integrated by means of completely automated flexible rack-and-pallet systems that transfer both individual components and racks of multiple components to facilitate accrual of subassemblies for intermachine feeding of the components. This arrangement allows one machine to shut down without affecting operation of the rest of the line. The assembly system is designed to occupy minimal floor space and can produce 1800–5400 parts per hour. Final assembled product can be automatically loaded directly into a packaging machine. Kahle Engineering Corp., Booth 1026

Leak Tester

A pressure-decay leak-testing instrument utilizes an internal NIST-traceable leak orifice for automatic calibration to ensure accurate measurement. The flexible, economical Sentinel C-20 is simple to set up and operate. It offers three inputs and three outputs for interfacing to PLCs or external devices; this I/O capability allows the instrument to perform simple leak-testing functions or interface with a PLC-operated system. A single reject point can be programmed for reject/accept or accept/reject evaluation. The device can store the pressure-loss value, process-drift correction, calculated leak rate, and accept/reject result for up to 100 parts. Test parameters and results can be output to a printer or computer via an RS-232 port. Baillie Sales & Engineering Inc., Booth 612

Pressure Diaphragm

Designed for large-volume OEM and custom applications in pressure sensors, pressure transmitters, and medical equipment, a thin-film pressure diaphragm machined from 17-4PH stainless steel is available in a pressure range of 100–10,000 psi. The PT75 can withstand temperatures up to 350°F, displays good long-term stability, and features a compact outline. It also has a bridge resistance of 5000 (omega) and burst pressure of 300% of full scale. The manufacturer offers a line of load cells, pressure sensors, and force sensors. Revere Transducers, Booth 1009

DOE Software

A Windows-based statistical design of experiments program helps engineers, scientists, researchers, and quality professionals determine the critical factors that can affect products and processes. Version 5 of Design-Ease software for Windows generates simple yet powerful two-level factorial designs; solutions can be found in its statistical and graphical outputs. It offers rotating 3-D plots and interactive 2-D graphics. The software comes with free technical and statistical support and an illustrated tutorial. Stat-Ease Inc., Booth 447

Custom Silicone Fabrication

A custom manufacturer of silicone and elastomeric medical products specializes in millable injection and liquid injection molding. Its extrusion specialties include peristaltic pump tubing, coextruded tubing, tapes, and profiles. The ISO 9002–certified company offers services in design engineering, custom formulating and compounding, in-house tooling design, and secondary operations. All manufacturing is done in a Class 100,000 cleanroom. The R&D department has a dedicated extruder for fast response on prototypes and first-article production runs. Mox-Med Inc., Booth 114