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Articles from 2002 In July


Suppliers Tout Advances in Precision, Productivity

Originally Published MPMN July/August 2002

EQUIPMENT NEWS: Machining Equipment

Suppliers Tout Advances in Precision, Productivity

Ultrasonic equipment introduced for machining ceramics, silicone

Norbert Sparrow

Designed for machining materials such as glass and ceramics, a line of ultrasonic equipment from DMG America will make its U.S. debut at an upcoming trade show.

Suppliers of machining equipment for medical device applications are redoubling efforts to increase throughput without sacrificing accuracy or reliability. Equipment makers have developed a variety of technologies to achieve this goal. One firm is introducing ultrasonic machining equipment to the U.S. market, claiming that it is a productivity-boosting tool for the precise machining of ceramic, silicone, and glass materials. Another supplier has designed a grinding machine for the production of medical drills that replaces a four-step operation with a simultaneous process. These developments and related machining equipment news are covered in this section.

Linear-drive technology, ultrasound machining showcased

Specializing in the design and manufacture of metal-cutting machine tools, a company will present its range of linear-drive equipment at the International Manufacturing Technology Show in Chicago on September 4–11. Linear-drive technology substantially boosts machine productivity compared with that of equipment with conventional drives, according to DMG America. The firm will exhibit its newest generation of machining centers at the event and introduce its ultrasonic machining equipment.

A compact vertical machining center with a spindle that revolves at 12,000 rpm, a spiral chip conveyor, and a machine-bed flush mechanism will be displayed at the company stand. The firm will also showcase its new multispindle machines available with CNC-driven synchronous motors or ball-screw spindles. The multispindle machines are suited for processing 0.12–2.16-in.-diam parts.

In addition, the firm will present its ultrasonic machines in the United States for the first time. Designed to machine materials such as ceramics, glass, graphite, and precious stones, the DMS 35/50 line is said to represent a five-fold increase in productivity compared with other technologies. It achieves a surface roughness of <0.2 µm Ra. Ultrasonic equipment is suited for the precise machining of complex geometries and miniature products.

Grinding machine slashes cycle times

Rotary-transfer grinding equipment from Monnier + Zahner Ltd. machines medical drills in as fast as 45 seconds.

A recently developed rotary-transfer grinding machine for the production of medical drills reportedly achieves dramatic reductions in cycle time compared with conventional equipment. Disposable 315-mm-long drills ranging in diameter from 1 to 8 mm can be machined in as fast as 45 seconds, with most changeovers taking no more than 45 minutes, according to Monnier + Zahner Ltd.

Traditional five- and six-axis grinding machines require four operations to machine helicoidal drills: grinding the groove, grinding the back, start-grinding the centering point, and relief-grinding the cutting edge. The M 648 has four modular machining stations in a star shape and a loading station, enabling the four grinding operations and loading and unloading sequence to be done simultaneously.

The Swiss firm supplies about 35 machines to the medical market each year, as well as 15 to 20 machine tools. Thread-milling and thread-whirling machines for bone screws, milling machines for the production of self-cutting flutes, eight-spindle production centers for bone plates, and honing units for hip joints have been developed by the company.

Single-spindle units machine medical products with one setup

Single-spindle Swiss-type turning machines from Tornos Technologies U.S. Corp. feature a new cabinet design that eases user access to the work area.

A supplier of equipment that combines the speed and productivity of cam-style Swiss-type screw machines and the flexibility and precision of CNC equipment has redesigned some of its larger machines. The DECO 20a and 26a machines, supplied by Tornos Technologies U.S. Corp., have a new cabinet design and a pocket door that permits access to the work area from the top or bottom of the unit. In addition, a window just above the control unit puts the main spindle within easy reach and facilitates collet and guide-bushing changes.

Mechanical enhancements include a larger coolant tank, which now holds an additional 20 L of fluid, and fewer moving parts in the gripper and basin to limit positioning adjustments.

The accompanying software also has been upgraded. Accelerated program generation and data transfer, and more automated functions such as tool-collision monitoring and a geometry help screen are among the improvements.

The DECO 20a and 26a are available with up to 12 axes. The 20a has a 10,000-rpm spindle speed powered by a 5.5-kW motor, while the 26a machine attains speeds of 8000 rpm with a 7.5-kW motor. Both can be equipped with integrated bar loaders.

Tornos machines are routinely used for the machining of medical and dental implants and bone screws.

Drilling machine minimizes bore run-out

Specifically developed for medical device applications, a gun-type drilling machine practically eliminates bore run-out by rotating the tool and the workpiece in opposite directions. Drill depths that are more than 60x the diameter of the hole can be achieved. The drilling machines from TBT Automotive Div. ensure precise and reliable drilling even with difficult-to-machine materials such as titanium and stainless-steel alloys, according to the firm.

A high-pressure coolant system removes chips from holes as small as 0.032 in. diam. The coolant flows through the cutting tool at pressures up to 2500 psi, flushing out the chips, which flow with the coolant along the side of the tool and out of the bore.

During machining operations, the special drills a have burnishing effect on the bore surface. A surface with a roughness of better than 0.2-µm Ra can be achieved. Process monitoring systems prevent even small-diameter tools from breaking.

Machine is suited for finishing hip joints

A microfinishing machine is designed to correct surface imperfections and to impart a mirror finish to hip joints and other spherical surfaces. The SPH 150 machine from Nagel Precision Inc. has a four-position automatic tool changer that enables rough, semifinish, finish, and final-gloss finishing operations to be performed with a single chucking of the part. An automatic stone-dressing device ensures that the wheel contact area is narrow and constant to prevent distortion to the workpiece. An in-process size-control system maintains tolerances down to the micron level. The machine can be equipped with multiple spindles and automatic loading and unloading units to accommodate a range of production requirements.

Noncontact winding-angle detection improves process control

A microcoil, shown in the inset under a human hair next to Abraham Lincoln's nose on a penny, was produced on a Double Vision Coil Winder from Engineering By Design.

The use of a machine-vision system reportedly has improved the control accuracy of a company's line of coil winders by a factor of 100 compared with previous models. "This new winder has improved all process control variables to help device manufacturers make more consistent products with less waste," says Dale Henson, principal engineer and president of Engineering By Design. The machine's primary function is the production of coil stents and catheters, but it is suitable for a range of small-coil manufacturing operations.

Previous machine designs measured winding angles by feeding wire through a mechanical arm with an angle sensor. When measuring smaller wires, however, the sensor arm was prone to changing the wind angle as it came into contact with the wire. Deviations of as much as 2° were not uncommon. By integrating a noncontact machine-vision system, the new design attains wind-angle detection within 0.02°. "Maintaining a steady tension of 0.2 g and a wind angle of 0.1° makes it possible to produce a coil with 0.0004-in.-diam platinum wire," notes Henson.

In addition to enhanced process control, the Double Vision coil winder has a number of other built-in features to improve productivity. It offers menu-selectable variable, fixed-pitch, and tight-pitch winding capability with automatic mandrel and filament tensioning. Closed-loop tension and slack control enables winding speeds up to 6000 rpm., and by stacking two independent machines on one frame, the company has doubled the production capabilities without requiring additional floor space.

Digital drive boosts machining performance

A vertical high-speed center for machining graphite and metals is equipped with digital-drive technology to enhance performance even when working on complex 3-D projects. The BMC 12 TNC, which was recently introduced by Mikron Bostomatic Corp., also offers higher speeds and tighter tolerances than previous models and enhanced surface finishes.

A sealed cabinet and an integrated extraction system with a suction frame that efficiently removes dust from the point of machining make the equipment suitable for graphite machining. The use of linear guides and high-precision ball screws ensures accurate positioning and high stiffness, which are necessary to achieve the high feed rates and accelerations required to machine graphite.

Liquid-cooled spindle motors with hybrid ceramic bearings attain speeds up to 30,000 rpm. A permanently sealed grease-lubrication system prevents oil dripping from the spindle head, and a standard oil-mist lubrication system minimizes lubricant consumption while eliminating the handling and disposal of coolant emulsions.

Copyright ©2002 Medical Product Manufacturing News

Small and Mighty

Originally Published MPMN July/August 2002

PRODUCT UPDATE

Small and Mighty

Electronic components are becoming ever more efficient

Susan Wallace

The Pix-Tek surface-mount LEDs from Bivar Inc. have unique shapes.

The field of electronic components spans many types of products, from diodes to EMI and RFI shielding devices to crystals and oscillators. One of the things they all have in common is a trend toward a reduction in size accompanied by an increase in power. In this article, MPMN takes a look at some of the new electronic products that have been designed for medical device applications.

LEDs save space

Surface-mount LEDs feature pixel lenses that provide a wide viewing angle in a discrete configuration. Pix-Tek LEDs from Bivar Inc. are based on a patented technology that offers increased space and labor-saving economies over traditional through-hole mounting, while incorporating standard through-hole geometry that narrows the radiation patterns and eliminates light loss.

The 5-mm square and 5-mm round packages offer 50° and 25° viewing angles, respectively. They are available in many colors including RGB, white, and ultraviolet, with wavelengths from 400 to 600 nm.

The LEDs are suitable for moving message signs, general indication displays, and backlighting.

Switches last many cycles

A series of rocker switches satisfies most higher power ratings—up to 15 A at 125 V ac or 10 A at 250 V ac, as well as peak currents up to 150 A at 250 V ac for selected models. The 2600-series units from Apem Components Inc. also offer minimum electrical life of 10,000 cycles at full load.

The single- and double-pole models are available in on-on, on-off, and on-off-on electrical configurations, with two or three positions. Other specifications include initial contact resistance of 10 mΩ maximum, and dielectric strength of 2500 V rms/per minute between terminals and 3000 V rms between terminals and the metal mounting panel.

All models have a bezel size of 0.984 x 1.259 in. and project through a front panel 0.890 in. They snap fit into a 0.866 x 1.181-in panel cutout. Materials include a high-temperature plastic case, polyamide actuator and frame, and silver or silver-plated copper contacts. Terminal choices include ¼-in. solder lugs and quick connects or screw and clamp types.

Power inductors minimize board space

Surface-mount power inductors from Gowanda Electronics have been created to enable engineers to design circuitry with high current-handling capability and minimal board space.

The SMP 1812 series of surface-mount power inductors is targeted for use in dc/dc convertors and power supply applications in which high performance and small size are critical. The SMP 1812 inductors have an inductance from 1 to 330 µH, current ratings from 124 to 2018 mA, and saturation current from 129 to 2500 mA. An RF version of the series is also available.

Clock oscillators feature low voltage or low current

Apem's 2600-series rocker switches satisfy most higher power ratings.

Ultra-low-voltage and low-current HCMOS clock oscillators are suitable for applications in which a long sustainable battery life is a prime consideration. The ultra-low-voltage HCMOS clock from Raltron Electronics Corp. is available at 1.6 V and 20 mA, with a frequency range of 30 to 70 MHz. The low-current HCMOS clock features a supply current as low as 3.0 mA at 2.7 V or 3.3 V with an upper rating of 4.6 mA at 5 V. Its frequency range is from 4.0 to 30 MHz. Both clocks offer a low jitter specification of 1.0 picosecond rms and optional temperature ranges from 0° to 50°C to –20° to 80°C.

Standard frequency stability is ±50 ppm, and tighter tolerances are available. Both series come in a 5 x 7- mm package with a low profile height of 2.0 mm maximum.

Linear ac power sources are small but powerful

High-performance linear ac power sources have output ranges from 500 VA to 12 kVA in single-phase, split-phase, or three-phase mode. The AMX-series units from Pacific Power Source can produce high-quality, low-distortion output by combining a broad, 50-kHz small-signal bandwidth with a peak-to-rms-current ratio of 4–6:1. The instruments were designed to operate quietly and to use limited space efficiently, providing maximum power per cubic inch of rack space.

Some features of the power sources include output power with paralleled units up to 30 kVA, programmable or manual controllers, IEEE 488.2 or RS-232 with SCPI protocol, 6:1 peak current capability, continuous self-calibration, programmable output impedance, and programmable time- and cycle-based transients.

Single-board computer operates in extreme temperatures

A single-board computer is offered in an extended-temperature configuration. The VSBC-8 from VersaLogic Corp. has a 350-MHz Celeron cpu and operates at –40° to 85°C. The unit comes with PC/104-Plus expansion, AGP video with flat-panel support, 10/100 BaseT Ethernet, sound support, and up to 256 Mbyte of SDRAM.

On-board features include Opto 22–compatible digital input and output ports, four COM ports, and three extra timers.

The high-reliability design includes a cpu temperature sensor, latching input and output connectors, and a latching memory socket. Each board is subjected to a 48-hour burn-in, and 100% functional testing.

The computer is compatible with a wide range of popular operating systems.

RFI/EMI shielding gaskets feature snap-on mounting

Two variable-finger snap-on edge-mount gaskets offer RFI/EMI shielding effectiveness up to 100-dB attenuation. One side of the V-series Finger Stock BeCu gaskets from Tech-Etch Inc. hooks over the edge of a flange while fingers on the opposite side snap into slots. Each gasket is offered in five different finger, or slot, patterns.

Snap-on mounting provides fast, secure installation with high durability. No adhesive or fasteners are required. Featuring a no-snag design, the units are suitable for bidirectional applications, require only a low closing force, and close gaps as small as 0.01 in.

Copyright ©2002 Medical Product Manufacturing News

Spotlight on Precision Motion Control

Originally Published MPMN July/August 2002

SPOTLIGHT

Spotlight on Precision Motion Control

Brushless dc motors

High-performance brushless dc motors with built-in electronics are compact and offer quiet, efficient, and smooth operation. The BND12 and BND23 models have torque ratings from 1.7 to 22.0 oz-in. with speeds up to 12,000 rpm. Each frame size is available in different lengths with the integrated electronics optimized for each motor's operating parameters. The brushless configuration reduces maintenance and downtime. Northrop Grumman Poly-Scientific, 1213 N. Main St., Blacksburg, VA 24060.


SCARA robots

Horizontally articulated robots are designed for use in small assembly environments. The units feature standard cycle times of 0.35 second for the HS 350-mm and 450-mm units and 0.29 second for the HM 600-mm and 700-mm models. When compared with previous models, the products offer greater power with 2.6 times the applicable maximum moment of inertia. Denso Corp., 3900 Via Oro Ave., Long Beach, CA 90810.


Miniature drive systems

Coreless dc micromotors, precision gearheads, feedback devices, and drive electronics are available, as well as brushless and brush-type motors with diameters ranging from 1.9 to 44 mm The company's patented low-inertia system Faulhaber skew-wound rotor coil provides a fast start and stop and servoing response. The micromotors feature smooth operation with no cogging and low starting voltages for smooth acceleration and deceleration, low current consumption, compact size, and high operational lifetimes. They are available in a variety of semistandard and custom configurations. Micro Mo Electronics Inc., 14881 Evergreen Ave., Clearwater, FL 33762.


Assemblies

Assemblies are available for use in medical manufacturing automation for positioning or scanning. Precision BiSlide assemblies have dual 45° opposing "v" ways to provide high rigidity in all directions. The carriage moves on low-friction PTFE compound bearings, which are fully adjustable to customize preloading. Both manual and motor-driven units are available. A modular design and external base T-slots enable unlimited multiaxis configurations without adapter plates or brackets. Travel ranges from 5 to 80 in.; load capacity is 300 lb; and thrust load is 100 lb maximum. Repeatability is 0.0002 in.; straight line accuracy is 0.003 in. over the entire travel distance. Velmex Inc., 7550 State Rtes. 5 & 20, Bloomfield, NY 14469-9389.


Miniature step motors

Miniature step motors are available in several versions including a small, threaded-shaft linear actuator with either an R16 planetary gearbox, a B16 spur gearbox, or a 12-line magnetic encoder. The two-phase 24-step P110 measures 16 mm in diameter and 19 mm in length, with a holding torque rating of 7 mN.m. The product's disk-magnet technology enables a rotor inertia of 0.40 x 10–7 kg/m2 and the phase current can be boosted intermittently—up to 1.5 times nominal. A very low detent torque makes the unit suitable for microstep operation, and its high start and stop frequency helps avoid the need for ramped acceleration. Danaher Controls, Motion Components Div., 45 Hazelwood Dr., Amherst, NY 14228.


Robots

Two selectively compliant articulated robot arm products offer quick cycle times and fast motion. The TH250 and TH350 feature payloads of up to 3 kg and repeatability of ±0.01 mm. Both robots have built-in programmable logic controllers and can be programmed using a ladder sequence code. Ethernet, Device Net, or Profibus connectivity are available options. Toshiba Machine Co. America, 755 Greenleaf Ave., Elk Grove Village, IL 60007.


Encoders

A line of incremental and absolute encoders offers different mechanical interfaces, housing styles, resolutions, and electronic features. CoreTech encoders provide incremental counts from 1 to 8192. Absolute encoders offer resolution between 2 and 32,768 steps. Both encoder types are supplied in a variety of solid-shaft, hub-shaft, and hollow-shaft versions, and 2- and 2.5-in. and 60-mm housings. Stegmann, 7496 Webster St., P.O. Box 13596, Dayton, OH 45413-13596.


Slotless motors

Slotless, brushless dc motors are suitable for applications in which small package size, speed, and accuracy are critical. The motor design enables small-sized motors to produce high power outputs in high- or low-speed continuous duty operation. The motors' slotless stator winding and rotor construction provide zero cogging torque and vibration. The stator winding, made of high-density copper and positioned inside a toothless stator ring, creates no preferred rotor position and reduces audible noise. Frame sizes range from 1.4 to 5.8 in. diam. The motors achieve speeds to 50,000 rpm with torque constants to more than 600 oz-in. per amp. EADmotors, 1 Progress Dr., Dover, NH 03820.


Autoclavable brushless dc servomotors


(click to enlarge)

High-performance, fully autoclavable, slotless, brushless dc servomotors are suitable for medical and surgical applications. The highly efficient design of the motors offers reliability, very high power density, virtually no vibration, and no RFI or EMI noise. The units have high-quality stainless-steel components and are available in sizes as small as ½ in. Xtreme Energy Inc., 9543 International Ct. N., St. Petersburg, FL 33716.


Rare-earth magnet motor

A motor's patented rhombic moving coil design provides for long life, low electrical noise, fast acceleration, and high efficiency. Four versions of the RE-max 24-mm-diam motor are available, with metal or graphite brushes, single or double shafts, and power ranges from 6.5 to 11 W. Maximum continuous torque is up to 12.4 mNm. The motors weigh 71 g, and the length (excluding shaft) is 31.9 mm. Ambient temperature range is –30° to 85°C, and the maximum efficiency can attain 90%, depending on the winding. Other options include ball bearings, sleeve bearings, and terminals and leads. Maxon Precision Motors, 838 Mitten Rd., Burlingame, CA 94010.


Synchronized motion control

A motion, vision, and I/O system features a high-performance, software-only controller that offers 32 axes of synchronized motion control. The Automation 3200 uses a distributed control architecture that enables it to maintain performance independent of the number of axes being controlled. This is accomplished by avoiding the processing bottleneck caused by single-processor control architecture. Aerotech Inc., 101 Zeta Dr., Pittsburgh, PA 15238-2897.

Copyright ©2002 Medical Product Manufacturing News

Spotlight on Molding Services

Originally Published MPMN July/August 2002

SPOTLIGHT

Spotlight on Molding Services

Overmolding services

A company specializes in the production of close-tolerance, multiresin, multicolor, and two-shot overmolded parts and their assemblies. Also offering steel tool development and injection molding, the firm operates from facilities that are ISO 9002 certified. Process control equipment, vision camera systems, and robotic manufacturing devices ensure quality. Assembly, packaging, machining, welding, pad printing, and other value-added services are also offered. Scientific Molding Corp., 330 SMC Dr., Somerset, WI 54025.


Injection molding services

Injection molding services are available to produce components and assemblies for drug-delivery systems, diagnostic equipment, surgical instruments, blood-therapy devices, and IV disposables. The finished components are flexible and lightweight and can help to reduce device costs. Mold design and production services are also offered. American Technical Molding, 2052 W. 11th St., Upland, CA 91786.


Complex Injection Molding

Precision injection-molded parts with complex shapes are produced with tight tolerances. The components are constructed from a range of FDA-compliant materials, including polyetheretherketone, acrylonitrile butadiene styrene, polycarbonate, nylon, and acetal. Acceptable production quantities span from a single prototype to full production levels. An in-house tool room is available to provide quick turnaround times. Design engineering and material selection assistance services are also provided. Patrick Plastics Corp., 1300 Nagle Blvd., Batavia, IL 60510.


Molded components

A company offers injection molding of device components that require precision and consistency. Equipped with a Class 100,000 cleanroom, the firm performs detailed front-end analysis to ensure that the parts meet customer specifications. A variety of secondary services are also offered, including ultrasonic welding, hot stamping, machining, drilling, silk- screening, coating, and bar coding. Plastics Engineering & Development Inc., 2731 Loker Ave. W., Carlsbad, CA 92008.


Molded tanks

Portable batch tanks are rotationally molded in sizes of 15 to 250 L. The high-density polyethylene units can be specified with nonmetallic sanitary fittings, loose-fitting dust or bolt-on gasketed covers, and swivel, locking, or fixed casters. Tank stands are constructed from nonmetallic or stainless- or plated-steel materials. The company uses a nitrogen welding process to allow flexibility in the positioning of fittings and appurtenances. Terracon Corp., 5 Boynton Rd., Holliston, MA 01746.


Rapid molding process

Offering an alternative to investment, sand, and die-casting, a rapid molding process uses permanent graphite molds to produce electro-optical components from a zinc aluminum alloy. Approximately the same density as cast iron, this alloy is hard and strong and allows machining. Typical turnaround time from receipt of the finished CAD to shipping of the first article samples is 4 to 6 weeks. Finished parts have a lustrous finish that does not require treatment to prevent corrosion. Graphicast Inc., 36 Knight St., Jaffrey, NH 03452.


Injection-molded components

Featuring an in-house mold shop and a Class 1000 cleanroom, a company offers thermoplastics injection molding services. For fluoropolymer materials, the firm provides compression, automatic, and isostatic molding. Other manufacturing services include ultrasonic welding, heat staking, hot stamping, pad printing, and assembly. Folding, bending, shaping, and welding processes are available to insert nonmetallic materials into housing containers, support brackets, and fixtures. Amicon Plastics, 8500 Commerce Park Dr., Ste. 110, Houston, TX 77036.


Plastic tools and parts

Injection-molded plastic tools and parts can be supplied for a range of medical applications. Components requiring insert molding are produced using a vertical injection molding machine with a 25-tn hydraulic clamp, a 12-station rotary table, and 100 function timers. All of the company's machines are interfaced with manufacturing robots and real-time statistical process controls to ensure quality. The firm is ISO 9001 certified and features a Class 100,000 cleanroom. Inland Technologies Inc., 7851 Cherry Ave., Fontana, CA 92336.

Copyright ©2002 Medical Product Manufacturing News

Ink-Jet Printer Keeps Company in the Black

Originally Published MPMN July/August 2002

PROFILE

Ink-Jet Printer Keeps Company in the Black

Code-printing unit uses less ink to increase cost savings

Zachary Turke

The S.C.I.F.I. 3200 ink-jet printer from Matthews International Corp. is suited for small-character printing applications where ink efficiency is a primary concern.
(click to enlarge)

Containing collection tubes, needles, alcohol pads, gauze, and other elements, medical test kits from GBF Inc. (Greensboro, NC) provide paramedics with the tools for collecting blood and urine samples. These kits are supplied in a fold-and-tuck box that securely holds the components and also functions as the mailer in which the samples are returned to the lab for clinical analysis. To enable tracking in the event of a product recall, GBF prints a date code, lot number, and expiration date on the outside of this box. When it was discovered that the large amount of ink required by its ink-jet printing system was cutting into profit margins, however, GBF turned to Matthews International Corp. (Pittsburgh) for a more-efficient printing unit.

"The old printer they were using was costing them money, so they wanted a new system that could do the same job with less ink," says Matthews marketing communications manager Michelle Spaulding. "We examined their manufacturing operations and decided that the best solution was a S.C.I.F.I. 3200 small- character ink-jet printer," she adds. Compatible with high-speed automated production, this printer uses a photo eye to trigger the pressurized ink jets when a box is properly positioned. GBF uses the printer to code roughly 185,000 kits per month, and, according to Spaulding, this translates into significant ink savings. "With the old printer, they were spending $4000 on ink every five months," says Spaulding. "The S.C.I.F.I. 3200 unit requires only $500 worth of ink annually."

Suited for automated production lines, the printer offers a maximum print speed of 400 ft/min.
(click to enlarge)

But ink efficiency is not the printer's only benefit. Using a robust drop-on-demand valve technology, the printer also reduces maintenance demands as it does not require flushing for short shutdown periods. "Manufacturers can just turn the unit off on Friday night, and it will be ready for use when they return on Monday morning," explains Spaulding. Additionally, the printer offers OEMs a variety of programming options. "You can control the printer using a computer, a PLC, a Palm device running Windows CE software, a remote keyboard, a bar code reader, and a variety of other devices that attach through an RS-232 serial port," says Spaulding.

Suited for printing characters that range in size up to 4 in., the S.C.I.F.I. 3200 printer offers a maximum speed of 400 ft/min. The device is capable of printing logos, graphics, and bar code information, and comes equipped with Matthews's Mattcom software. Primarily supplied as a single-color unit, the printer can also be reconfigured to handle a variety of hues. According to Spaulding, GBF is so satisfied with the results of its new printing system that the firm is considering converting other printing operations to Matthews technology.

Copyright ©2002 Medical Product Manufacturing News

Bus Connector Accommodates Multiple Sensor Types

Originally Published MPMN July/August 2002

HOTLINE

Bus Connector Accommodates Multiple Sensor Types

Technology eases connection and removal

Replacing traditional parallel wiring systems, a digital bus connector from Burkert USA Inc. (Irvine, CA) is suited for use with flow, level, pressure, and temperature sensors. Carrying both power and data to multiple process points, the AS-interface connector uses two-wire construction to provide a necessary link to pumps and process valves. Read more...

 

Illuminator Maximizes Lamp Life

Fiber-optic device offers cool illumination

A fiber-optic illuminator from StockerYale (Salem, NH) offers a 400% increase in lamp life compared with conventional halogen fiber-optic systems. The Mille Luce Model 1000 provides a minimum of 1000 hours of shadow-free, glare-free cool illumination without any significant loss in light output. Read more...

 

Thin-Wall Polyolefin Heat-Shrink Tubing Is Optimized for Device Applications

Medical-grade tubing is flexible and strong

Extremely thin-walled heat-shrink tubing from Cobalt Polymers (Cloverdale, CA) is available in diameters from 0.010 to 0.360 in. Wall thicknesses range from 0.001 to 0.005 in. The tubing is available in shrink ratios of 2:1 and 4:1 and will recover to its specified dimension when exposed to temperatures of 290°F by means of a heat gun, hot box, or oven. Read more...

Copyright ©2002 Medical Product Manufacturing News

Quality Control Products Get Their Own Pavilion at MD&M East

Originally Published MPMN July/August 2002

INDUSTRY NEWS

Quality Control Products Get Their Own Pavilion at MD&M East

Susan Wallace

Quality control and testing and inspection products are used in virtually every phase of medical device manufacturing, from R&D to finished product and package testing. Last month, at MD&M East 2002 (New York City), manufacturers offering a full array of these critical testing and inspection products and services were featured in their own Quality Pavilion.

Suppliers exhibited optical and laser inspection equipment, materials-testing equipment, quality assurance testing equipment and services, product reliability technology, surface-measurement products, data-acquisition and -collection devices, and validation and ISO certification software, among other products.

Following is a wrap-up of some notable products and services introduced at the show.

Benchtop Tester

The SmartScope Quest 250 from Optical Gaging Products Inc. is a multisensor measurement system offering high accuracy.

A system is designed to test the tensile, compression, and flexural properties of medical devices and materials. The 3300-series instrument from Instron (Canton, MA; www.instron.com) includes a load frame with integrated control electronics, a load cell, surface-mount circuitry, and Series IX materials-testing software. A high-torque motor with closed- loop position control enables the system to constantly measure the test force being applied, ensuring complete accuracy and repeatability.

Column covers are fitted with T-slots to allow compatibility with various accessories, such as grips, fixtures, extensometers, and chambers. Safety features include ball-screw covers for long machine life and operator protection. The benchtop tester is available in a choice of colors.  

Real-Time X-Rays A desktop, real-time x-ray inspection system provides sufficient resolution and sensitivity to enable device manufacturers to detect subtle failures during production. The conveyorized MXRA system from Glenbrook Technologies (Randolph, NJ; www.glenbrooktech.com) is suitable for inspecting low-density products and materials such as catheters, injection-molded plastics, and silicones.

The company's camera technology can produce x-ray images using anode voltages as low as 15 kV to reveal voids in plastic moldings that would not be apparent using conventional real-time x-ray techniques. The high-sensitivity images are of high resolution, revealing defects as small as 0.001 in.

The system is currently being used by medical device manufacturers for 100% inspection of sealed products such as surgical staples, molded catheters, pacemakers, temperature sensors, and other inaccessible devices.

The MXRA system can be upgraded with image processors, video micrometers, andprinters.  

Video Measurements

An x-ray image taken with the MXRA system. The small image provides a close-up view of a defect in a molded catheter.

A benchtop, multisensor dimensional system offers high-accuracy video measurements with a continuously adjustable zoom lens. The SmartScope Quest 250 from Optical Gaging Products Inc. (Rochester, NY; www.ogpnet.com) integrates data from video, touch probe, and laser sensors to completely characterize a part. The touch probe is used to acquire data from areas not accessible by the optics and supports a variety of standard probe heads and styli.

"While the video and touch probe are ideal for dimensional measurements on a macro scale, the laser allows for surface profiling and scanning at a micro level," says Eric Gesner, the company's corporate product manager.

All sensors are calibrated to a common reference frame, and can be used interchangeably with the same measurement program. Parts that previously needed to be measured in separate setups on different machines can be measured completely on the SmartScopeQuest.

Document Management System Has New Capabilities

Software now offers complete change management and document control functionality within the 3-D, computer-aided design (CAD) process while enabling compliance with GMPs and FDA requirements. Document Control Systems (Salt Lake City; www.mastercontrol.com) has adapted its MasterControl 3D for SolidWorks to provide full revision control and audit trail tracking for every 3-D design component that meets and exceeds FDA's 21 CFR, Part 11 regulations for electronic signatures and recordkeeping.

The software is validation-ready with prewritten validation test plans for performing installation qualifications and operational qualifications. The company also offers on-site validation support for performance qualification to allow complete validation and 21 CFR, Part 11 compliance.

The software can manage any document, regardless of the application in which it was created, including word processing, spreadsheets, graphics, audio, video, and CAD. It provides the means to control the three main components created and manipulated during the 3-D CAD process: parts, drawings, and assemblies.

"This software is the only product currently available that will allow medical device companies to be Part 11 compliant for every aspect of their business related to documentation, especially with departments that are approving 3-D CAD drawings," says Brad Wright, the firm's president and CEO.

Copyright ©2002 Medical Product Manufacturing News

Advanced Semiconductor Engineering to Manufacture NanoMuscle Actuators

Originally Published MPMN July/August 2002

Advanced Semiconductor Engineering to Manufacture NanoMuscle Actuators

Zachary Turke

This piezoelectric motor developed by scientists at Pennsylvania State University measures 4 mm in length and 1.8 mm in diameter.
In a bid to meet customer demand for miniature motion technologies, NanoMuscle Inc. (Antioch, CA; www.nanomuscle.com) has licensed contract manufacturing services from Advanced Semiconductor Engineering (ASE) Inc. (Taipei; www.aseglobal.com). A semiconductor packaging and testing company, ASE will produce the NanoMuscle linear actuators at its newly expanded facilities in Korea. According to NanoMuscle CEO Rod MacGregor, the selection of ASE is a logical one. "They have proven experience in the manufacture, assembly, and testing of integrated circuits and modules," he says. "And their Korean manufacturing facilities are capable of producing millions of the high-quality actuators each month for delivery to our customers around the world."

NanoMuscle linear actuators provide silent motion in a miniature package to enable a new generation of medical devices. Replacing motors and solenoids, the actuators harness the power of shape-memory alloys to reduce bulk, noise, and cost. "Our actuators are about the size of a paper clip, and require about one-fifth the power of motors they replace," MacGregor says. Possible applications for the actuators include patient-side instrumentation, diagnostic assays, and implantable devices.

Copyright ©2002 Medical Product Manufacturing News

Miniature Motor May Enable Smaller-Diameter Catheters

Originally Published MPMN July/August 2002

Miniature Motor May Enable Smaller-Diameter Catheters

Zachary Turke

Advanced Semiconductor Engineering Inc. will manufacture miniature linear actuators for NanoMuscle Inc. at its Korean facilities.
Researchers working at Pennsylvania State University (State College, PA; www.psu.edu) have developed an ultrasonic piezoelectric motor that measures 4 mm long and 1.8 mm in diameter, dimensions that approximate those of a single grain of rice. Constructed of common materials to allow inexpensive mass production, each motor consists of a metal or plastic tube, two strips of lead zirconate tintanate, and a spring. The researchers stress that despite their small size, the motors are very powerful. "Our prototypes deliver a power output of 1 mN•m, just under the strength required to break the skin and draw blood," says professor of electrical engineering and team leader Kenju Uchino. An efficiency of 28% is cited as another benefit of the piezoelectric components. Most miniature electromagnetic motors offer an efficiency of 2%.

"Because the motors are so small and can be manufacturedinexpensively, they are ideal for narrow-diameter, disposable medical instruments," says Uchino when asked about potential applications for this novel technology. Catheters employed to break up kidney stones are just one example of these kinds of products. Currently, these catheters must have a diameter of at least 3 mm to accommodate the necessary motion control components. The Penn State motor would allow a diameter reduction of roughly 1 mm, making the catheter more comfortable to the patient while retaining sufficient power to eliminate the deposits. Because they are not electromagnetic, the motors could also be used in instrumentation for magnetic resonance imaging.

Copyright ©2002 Medical Product Manufacturing News

The Sum of All Fees? About $25 Million to Start

Originally Published MPMN July/August 2002

EDITOR'S PAGE

The Sum of All Fees? About $25 Million to Start

The device industry dodged a bullet at the end of May, according to Mark Leahey, director of federal affairs at the Medical Device Manufacturers Association (MDMA). That's how he characterizes the failed attempt to tag on a $25 million medical device user fee package to the bioterrorism bill passed by Congress.

Hammered out by rival industry association AdvaMed and FDA, the package was designed to shore up FDA's flagging resources and prevent a return to the device approval backlogs and delays of yore. Under the terms of the agreement, FDA's Center for Devices and Radiological Health would receive an additional $40 million for device review activities in the first year. User fees would account for about $25 million of the total amount, progressively increasing to approximately $35 million by 2007; levying of the fees would be contingent on a $15 million increase in appropriations.

"We came very close," says AdvaMed executive vice president of technical and regulatory affairs Jim Benson. A former member of FDA who played a key role in negotiating the package with the agency, Benson is confident that user fees will be signed into law in short order. "I have assurances from the bill's supporters that we will find another legislative vehicle and get it passed by this summer," he told MPMN. Leahey and MDMA reluctantly concur that the passage of a user fees bill has momentum. That doesn't mean, adds Leahey, that industry should blithely accept terms that impair a small company's ability to compete.

MDMA has been a staunch opponent of user fees in the past. "MDMA exists to protect the interests of the small innovative entrepreneurial sector of the industry," says Leahey. "We were among the first to recognize that FDA lacks the resources to keep up with innovative technologies, but we have traditionally viewed it as a government program that should be funded by the government." MDMA is willing to bend on this principle, he adds, if AdvaMed and FDA show similar flexibility.

"We don't have the budget surpluses we had in the 1990s, and it's clear that straight appropriations are not a viable solution in the current economic environment," acknowledges Leahey. Leahey and MDMA chairman Paul Touhey met with FDA officials recently to do a line-by-line review of the user fee proposal. MDMA has made two principal demands, says Leahey: a guarantee that FDA would forfeit user fees if it does not meet its performance goals, and an exemption for small companies. If a compromise cannot be reached on these issues, he says, MDMA cannot support the bill.

The current package allows firms with sales of less than $5 million to defer their user fee payment for one year. They may also petition for extensions, and, in some cases, obtain a waiver. "A company could request a waiver because it has developed a life-saving product that has a limited market," explains Benson. "It's comparable to the orphan product concept, but in the user fee package, the device doesn't have to be an orphan for the fee to be waived." MDMA wants the waiver to be extended to all companies under a certain size.

"The deferral has no teeth to it," says Leahey. "For example, a company I know of that is developing a high-tech device will apply for a PMA in the next year or two. We know it is going to need about four or five supplements three to four years [after it has been granted a PMA] before it has a marketable product," says Leahey. Under the current proposal, that firm would pay $125,000 to submit a PMA and $25,000 for a PMA supplement. It's important to remember, says Leahey, that having a "PMA doesn't mean you're going to realize sales within a year."

Small startups don't have the big machinery of larger companies to generate revenue, says Leahey, adding that FDA has been receptive to this argument. "We are moving toward a complete exemption for companies under a certain dollar figure in sales," he says, although no agreement has been reached on a specific threshold. "We want to craft a proposal that isn't overly burdensome to large companies, but that provides protection for the small innovative entrepreneurial sector of our industry," says Leahey.

Will FDA and AdvaMed bite the bullet?

Stay tuned.

Norbert Sparrow

Copyright ©2002 Medical Product Manufacturing News