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
