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Articles from 1998 In October


Products Featured on the October 1998 issue of MPMN

Products Featured on the October 1998 issue of MPMN

Diffusion bonding eliminates the need for adhesives

Using diffusion bonding, a company produces plastic assemblies without the use of adhesives. When heat and pressure are applied, the polymer chains of two adjoining thermoplastic layers diffuse into one another, creating a hermetic seal. Benefits of the process include the ability to create dense, 3-D assemblies of fluid and pneumatic circuits with a hermetic seal; to incorporate internal components such as check valves, reservoirs, or electrodes; and to increase reliability by eliminating external tubing. Eastern Plastics Inc., P.O. Box 9188, Bristol, CT 06010-9188.


Board-mountable pressure transducer integrates easily into OEM systems

A manufacturer of high-accuracy electronic instrumentation offers a line of board-mountable pressure transducers. The Model 210 series is designed for easy integration into OEM systems, and uses the company's patented variable-capacitance sensing technology. The transducers feature advanced signal conditioning, high-level output, RFI immunity, and rugged construction. Setra Systems Inc., 159 Swanson Rd., Mail Stop 14-26, Boxborough, MA 01719.


Single-source supplier offers injection-molded products

An FDA-registered contract manufacturing company offers high-quality injection-molded products and services to the medical industry. The company's capabilities include part development and design, rapid prototyping, precision high-speed mold design and construction, mold sampling and process development, cleanroom injection molding and assembly, automated assembly equipment design and construction, and process validation and statistical process control. Infinity Plastics, 6020 Nicolle St., Bldg. D, Ventura, CA 93003-7676.

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99% Inspiration

EDITOR'S PAGE

99% Inspiration

Inspiration—and products engineered under its influence—is the theme for the 1999 Medical Design Excellence Awards. When MPMN's publisher Canon Communications launched the engineering and design competition last year, designers, engineers, marketers, and CEOs from global device corporations and entrepreneurial start-ups shared enthusiastic stories of what inspired them to create their new medical products.

Through overseeing the awards program, I learned a lot about teamwork, how companies stimulate innovative thinking, and how ideas for the next generation of medical devices make it from sketch to working prototype to mass production.

Stuart Karten, whose Marina del Rey, CA, industrial design firm received an award for designing a speech processor and its accessories for Advanced Bionics (Sylmar, CA), says that since his firm works for a variety of industries it often brings ideas from consumer products into medical device design. "When we designed the speech processor, we wanted to walk the line between the seriousness of a medical product and the appeal of a consumer electronic product," Karten says. "We looked at a lot of body-worn electronic products such as Walkmans and we also examined medical products and combined details of both."

To stimulate creative thinking, Karten and his staff venture out on monthly field trips to hike or view art or architecture. "Often we look at nature for inspiration. When we developed a concept for a cable system, the design team used the human nervous system for inspiration," Karten says. "We also hold group brainstorming sessions to generate as many directions as possible for analysis."

For Karl Leinsing of Alaris Medical Systems (Creedmoor, NC), the challenge of designing a competitive disposable needlefree system inspired him to develop the award-winning SmartSite needlefree valve. He says that part of the impetus for submitting the device into the competition was to promote Alaris Medical Systems' new identity resulting from the merger of IVAC and IMED. He also felt that the innovative design of his invention deserved recognition and wanted to promote its existence in the market. "In its recent quarterly report, Alaris attributed the SmartSite valve as a key contributor to the company's growth," Leinsing says. In addition, he reports that demand for the product is such that Alaris is working to double its production capacity.

I hope you'll submit the product of your inspiration to the 1999 Medical Design Excellence Awards. To receive the competition rules and entry form, you can call the 24-hour fax-on-demand number at 800/588-8527 to receive it via fax, visit Medical Device Link at http://www.devicelink.com/awards to download the form, or call me at 310/392-5509, ext. 197.

Amy Allen
amy.allen@cancom.com

Machining Equipment



Machining Equipment

Pneumatic cutter

A pneumatic jumbo cutter is designed to cut round material up to 1 in. diam and flat material up to 3.34 in. wide. The JC 3985's powerful feed belts can transport material at a rate of 16 to 195 ft/min, pulling wire directly from a spool or drum. It can also be integrated with the manufacturer's PF 2000 electric demand prefeed, which accommodates larger spools and provides greater feeding control. The cutter, providing 150 lb of pull force and a cutting force of 600 lb, processes wire, steel cable, metal strips, tubing, and sleeving. Schleuniger Inc., 87 Colin Dr., Manchester, NH 03103.


EDM system

A special-purpose EDM system can drill holes ranging from 0.012 to 0.118 in. diam through any conductive material using ordinary tap water as a dielectric. The HS-1 DrillMan features cutting depths up to 200x hole diam and penetration rates as fast as 1 in. in 30 seconds. The machine's applications range from start holes for wire EDM jobs to production jobs, such as safety wire holes. Multiple holes can be accurately positioned using the edge-find feature from a reference surface, and the x-y digital readout enables accurate hole spacing. Hansvedt Industries Inc., P.O. Box 6099, Urbana, IL 61801.


Automatic lathes

Single-spindle automatic lathes feature a parallel numerical control (PNC) system and TB-Deco software. The PNC technology replaces mechanical cams by creating electronic paths to the individual tool holders, all controlled by a clock. The TB-Deco software, run on Windows, controls all aspects of machining and can be programmed on any PC. Three different models (20, 10, and 7 mm) of the Deco 2000 series are offered in four different axial configurations. Specifications for the 20-mm version include maximum workpiece lengths of 200 mm, headstock spindle speeds up to 10,000 rpm, and a 5.5-hp motor. Tornos Technologies U.S. Corp., 70 Pocono Rd., Brookfield, CT 06804.


Machining system

A machining center can be configured with a variety of main and auxiliary spindles, fourth axes, and productivity and precision enhancing options to meet specific machining needs. With axes travels of x = 32 in., y = 16 in., and z = 20 in., the BostoMatic 32 is suitable for machining small to medium-sized precision parts. The machine's control has a processing speed of up to 1100 five-axis blocks per second for hesitation-free contouring at feed rates up to 450 in./min (787-in./min rapid transverse) on even the most data-intensive part programs. Boston Digital Corp., 125 Fortune Blvd., Milford, MA 01757.


Grinding system

Geared for high-level production and accuracy, a centerless abrasive belt grinding system is offered with numerous advantages over bonded wheel grinding. The Model 1212 heavy-duty, high-precision system is designed for the sizing and finishing of a variety of cylindrical parts, and features high stock removal and feed rates, constant grinding surface speed, cool operation, and no in-process wheel dressing. The grinding and tool-polishing belts can be quickly and easily changed in a 2-minute operation. Acme Manufacturing Co., 650 W. 12 Mile Rd., Madison Heights, MI 48071.


Laser micromachining equipment

Micromachining equipment based on solid-state laser technology is designed for micromachining ceramics, semiconductor materials, and polymers with spot sizes less than 25 µm. Typical applications of the Impressario series are microcutting, microetching, high-speed microdrilling, micromilling, and microtrimming of materials with a resolution of less than 10 µm. The micromachining tools are available in both traditional arc lamp and diode-pumped versions. The exact wavelength and cavity design will be a function of the specific micromachining application. Resonetics Inc., 4 Bud Way #21, Nashua, NH 03063.


Fineblanking system

Integrated finish and cleaning systems make automated cellular fineblanking possible, even for flexible manufacturing environments. The single-fluid systems perform deburring, surface and edge finishing, cleaning, cooling, drying, and rust protection of fineblanked parts, all in a continuous process. They allow the efficiencies of complete, automated cellular processing—from coil to finished fineblanked parts—while producing different part configurations in flexible batch sizes and schedules. Feintool Cincinnati Inc., 11280 Cornell Park Dr., Cincinnati, OH 45242.


Electric spindle

An electric-powered, 2000–40,000-rpm spindle system is made for 1/8-in. and smaller end-milling and drilling-plus-microslitting, chamfering, and grinding on retrofitted CNC and transfer machines. The Astro-E400 system consists of a 210-W brushless dc micromotor; a straight 1.181-in.-diam spindle; and a power unit that controls speed, motor cooling air, forward and reverse operation, sequence of operations, and other functions. An integral sequence control system permits one power unit to control the operation of three different micromotor spindles using 24-V commands downloaded from host CNC machines. Integral electronic sensors provide torque feedback from the cutting tool to the power unit to maintain constant cutting speed under varying loads, plus an automatic motor stop to prevent overloads. NSK America Corp., 700 Cooper Ct., Ste. B, Schaumburg, IL 60173.


CNC cylindrical grinder

Designed to meet the rigorous demands and exacting requirements of high-production grinding, a CNC cylindrical grinder features a 24-in. wheel and a 25-hp wheel-head motor, allowing for aggressive stock-removal rates and improved cycle times. Other features of the Model 324S include a straight wheel head, 16-in. swing, 32-in.-between-centers distance, GE Fanuc 18TB CNC control, and vibration-damping base design. Weldon Machine Tool Inc., 1800 W. King St., York, PA 17404.

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Compact Displays Feature High Resolution



Electronics

Combined Rocker Switch and Circuit Breaker Protects from Water Splashes

Suitable for patient monitoring instrumentation and other equipment

E-T-A CIRCUIT BREAKERS (Mt. Prospect, IL) has introduced a combined rocker switch and CBE (circuit breaker for equipment) to offer full protection from water splashes. The Model 3130 CBE is especially suitable for medical electronics applications where the equipment may be exposed to water or damp conditions, such as during cleaning or sterilization.

The unit is designed for both reliable protection and aesthetic appeal. It conforms to IP65, an IEC standard definition that indicates the degree of protection against water ingress. Specific applications include patient monitoring devices, heart pumps, hospital beds, and paramedic equipment.

Combining a switch and circuit protection in one compact unit, the single-pole version weighs only 0.6 oz. It uses less space and incurs lower product costs than if separate components are used.

The Model 3130 is the first component of this type designed especially for external snap-in panel mounting. Rocker switch illumination is optional. The versatile circuit breaker can withstand temperatures from –30° to 60°C and has undergone extensive testing in a variety of situations.

For more information, contact E-T-A Circuit Breakers at 847/827-7600.

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Display Technology

Compact Displays Feature High Resolution

Use thin-film technology

TWO COLOR DISPLAYS suitable for medical instrumentation are distinguished by their small size and by the high resolution they provide. The screens, available in 1.8- or 2.5-in. sizes, use thin-film technology (TFT).

The Models TFT-18DM and TFT-25DM feature 160 x 234-pixel resolution and an analog RGB interface. They measure only 51 x 39 x 13 mm and 68 x 55 x 13 mm, respectively. Both displays come with a CCFL backlight and are available as full monitors with inverter and control circuitry.

Power consumption is 0.90 W for the TFT-18DM and 0.97 W for the TFT-25DM. Both use an external dc/dc converter/inverter. The manufacturer, Purdy Electronics (Sunnyvale, CA), says that the TFT technology provides the displays with high contrast, good response, and an optimal viewing angle. Due to their small size, they are suitable for handheld medical instruments and diagnostic devices.

For more information, call Purdy Electronics Corp. at 408/523-8230.

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Disposables

Needlefree Injector Offers Comfort and Safety in Home-Use Applications

Designed to be used by OEMs in developing self-care products

MERIDIAN MEDICAL TECHNOLOGIES INC. (Columbia, MD) has introduced a needlefree disposable injector. The prefilled injector is meant to be used by manufacturers in the development of products that can be self-administered by patients.

"The Intraject system provides patients with a new level of convenience, comfort, and safety, while also reducing total healthcare costs by eliminating the need for office visits for injections," says James H. Miller, Meridian's CEO. Miller notes that the injector offers significant new product development opportunities for existing medications, as well as a practical means of administering the growing array of new pharmaceuticals and biologicals that require injection.

About half the size of a fountain pen, the inexpensive disposable device is fast and easy to use, and causes virtually no pain, according to Meridian. The patient simply removes the safety seal and presses the injector against an arm or thigh. A precise dosage of medication is automatically injected through the skin within 50 milliseconds as compressed nitrogen expands to activate the system.

According to Gerald Wannarka, Meridian's vice president of technology, "The availability of improved technology for self-administration of injectable drugs should significantly improve patient compliance, as well as provide added flexibility in the development of dosage regimes. We believe that the Intraject system has the potential to displace a significant portion of the conventional needle syringe market."

For more information, call Meridian at 410/309-6830.

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Medical Design Awards Issues Call for Entries



Medical Design Awards Issues Call for Entries

Annual competition honors innovative medical products

Medical product designers, engineers, and manufacturers are invited to submit entries to the second annual Medical Design Excellence Awards. The product design and engineering competition, sponsored by MPMN's publisher Canon Communications, seeks to recognize innovative medical products that advance the state of the art and improve health care. "We were impressed by the quality of the entries submitted to the 1998 Medical Design Excellence Awards," says Canon Communications' president Bill Cobert. "The finalist and winner products selected by the 1998 jury showcased cutting-edge technologies and creative engineering solutions in a wide range of healthcare disciplines. We are looking forward to seeing the entries in the 1999 competition."

The deadline for submitting entries is February 8, 1999. To be eligible, products must be commercially available by the deadline date. Winners will be published in Medical Product Manufacturing News and will be displayed during Medical Design & Manufacturing East 99 in New York City, May 25–27, 1999. The Industrial Designers Society of America (IDSA; Great Falls, VA) is endorsing and administering the program.

To receive competition rules and entry forms, call Canon Communications at 310/392-5509 or IDSA at 703/759-0100, call the 24-hour fax-on-demand line at 800/588-8527 to receive the materials via fax, or visit Medical Device Link on-line at http://www.devicelink.com/awards to download the information.

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Industrial Design Competition Winners Selected

Medical category showcases emerging technologies

A diverse array of medical devices received top honors in the 1998 Industrial Design Excellence Awards (IDEA), an annual competition sponsored by the Industrial Designers Society of America (Great Falls, VA). In the medical and scientific category, the IDEA gold winners are:

  • Access home monitoring system designed by Anderson Design (Plainville, CT) and Corometrics Medical Systems (Wallingford, CT).
  • Stifneck Select collar designed by Laerdal Medical Corp. (Wappingers Falls, NY) and IDEO Product Development (Lexington, MA).
  • Senso CIC hearing aid designed by WIDEX ApS (Vaerloese, Denmark).

Laerdal Medical's Stifneck Select collar won an IDEA gold award for its user-friendliness, adjustability, and reusability.

The competition's silver winners are:

  • Sequoia ultrasound system designed by Lunar Design (Palo Alto, CA) and Acuson Corp. (Mountain View, CA).
  • Select modular patient-monitoring system designed by Hauser Inc. (Westlake Village, CA) for Johnson & Johnson Medical (Tampa, FL).
  • FirstPICC central catheter designed by Becton Dickinson (Sandy, UT).
  • DynaMyte augmentative communicator designed by Sentient Systems (Pittsburgh), Daedalus Design (Pittsburgh), and LSB Technology (Clairton, PA).
  • Automatic pressure-tracking adiabatic calorimeter designed by Arthur D. Little Inc. (Cambridge, MA).

The DynaMyte augmentative communicator for people with speech, language, learning, or physical disabilities was designed for easy operation and durability.

The annual IDEA competition recognized a total of 126 winners in 47 subcategories. To view the winning designs, visit IDSA's Web site at http://www.idsa.org.

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Packaging Professionals to Meet in November

Pack Expo 98 to highlight packaging technologies

Repositioning traditional products for new growth is the topic of the keynote address at Pack Expo 98, scheduled for November 8–12 at McCormick Place in Chicago. The trade show, sponsored by the Packaging Machinery Manufacturers Institute (PMMI; Arlington, VA), will showcase packaging and packaging-related converting machinery as well as materials.

Morning sessions will focus on retail packaging trends and the state of the U.S. and Canadian packaging machinery industry. For more information, visit http://www.packexpo.com or call 703/243-8555.

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Substantial Growth Anticipated for European Disposables Market

Infusion and related supplies contribute to growth

The European market for disposable medical supplies is forecast to increase more than 6% annually, reaching $46 billion in 2002, according to a recent report. "Disposable Medical Supplies: Europe," published by The Freedonia Group (Cleveland), identifies angioplasty catheters, DNA test kits, transdermal hormone replacement and nicotine patches, and daily contact lenses as product areas expected to contribute to this healthy growth.

The firm expects European demand for infusion and related administration supplies to increase 6.3% annually, reaching $9.5 billion in 2002. With shorter hospital stays and increased self-care, growth is anticipated in the alternative-site markets for IV sets, oxygen supplies, prefilled inhalers, and transdermal patches. Improvements in oral drugs and nutritionals will soften the European demand for hypodermic devices, IV catheters, and enteral feeding supplies, the report stated.

Another growth area within the European market for medical disposables is medical kits and trays, which is achieving an annual gain of 6.7% from the 1997 level and is expected to reach $9.5 billion in 2002. The report is available for $3800 from The Freedonia Group (440/684-9600 or http://www.freedoniagroup.com).

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Suppliers and Manufacturers to Convene at OEMBoston

Event features collocated OEMed and OEM Electronics

On October 14–15, thousands of medical and electronic manufacturing professionals will converge on the Bayside Expo Center in Boston to see the latest technology, products, and services.

The third annual OEMed will feature products and services from hundreds of companies—a comprehensive display of the raw materials, equipment, components, and services used in the production of medical devices. A Medical Electronics Pavilion will showcase subsystems such as BGA, COB, CSP, and flip-chip packaging, as well as LEDs, LCDs, EPROMs, power supplies, solid-state sensors, connectors, and fiber optics.

In addition to the OEMed show, OEMBoston will also feature the collocated OEM Electronics show. OEM Electronics will feature more than 100 national and regional exhibitors showcasing the latest electronic products and services.

For more information contact Sophia Washam of Canon Communications at 310/392-5509, ext. 210; visit www.devicelink.com/expo; or call the 24-hour, toll-free fax-on-demand line at 888/462-7060.

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Business and Acquisition News

Lumonics (Kanata, ON, Canada) acquired Meteor Optics (Glendale, AZ), a designer of fiber optics for high-power industrial lasers. Meteor Optics will become Lumonics' Phoenix operations. CAD/CAM/CAE system provider Matra Datavision (Les Ulis, France) signed an agreement to transfer the customers of its current plastics simulation product Euclid Quantum to C-MOLD (Louisville, KY) software. The transfer will include the provision of implementation, training, and customer support services. Phoenix Health Care Products (Milwaukee) has been licensed by DuPont (Wilmington, DE) to provide a new 1025B Tyvek for desiccant packaging. 3M (St. Paul, MN) is offering a sampling program to allow companies to try its hydrofluoroether fluids as an alternative to chlorofluorocarbons and other cleaning substances. For information, call 800/906-6886. PGI Nonwovens, a division of Polymer Group Inc. (Mooresville, NC), secured proprietary worldwide distribution rights to Halar ECTFE, produced from a melt-processable fluoropolymer developed and manufactured by Ausimont USA Inc. (Thorofare, NJ). Plastic Molding Technology (Seymour, CT) was presented with the Connecticut Award for Excellence from the State of Connecticut's assessment and performance recognition program. Minnesota Tool and Die Works relocated from Maple Grove to a larger facility in Ramsey, MN.

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Hypertronics Corp.

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

Manufacturer Replaces CFC with Environmentally Friendly Vapor Degreaser



Manufacturer Replaces CFC with Environmentally Friendly Vapor Degreaser

Global concerns about depleting the ozone layer have forced industry to find alternatives to chlorofluorocarbons (CFCs) in manufacturing. For Cardiac Control Systems (Palm Coast, FL), a manufacturer of cardiac pacing systems and components, finding a CFC substitute for degreasing parts was critical.

Prior to the phaseout of CFC solvents, Cardiac Control Systems operated a small vapor degreaser using CFC-113 to remove light fingerprints and soils from component parts and packaging material. The company used the system to clean components made from stainless steel, titanium, silicone, polyethylene, PTFE, and other materials. Parts such as gold ribbon conductors that are to be spot welded are cleaned during production, and even polybags used to hold parts are cleaned to remove dust and particulate matter.

Searching for the Optimal Method

The company began researching alternatives to CFC cleaning in 1996, initially adopting a two-fluid advanced vapor degreasing (AVD) process while continuing the search for a single-fluid system. Although the AVD process worked well, it required that parts be immersed into the cleaning fluid. Also, the method's operating temperature was too high for some parts that were cleaned during manufacturing.


Cardiac Control Systems Inc. uses 3M's HFE-7100 to clean various components. The fluid is an alternative to ozone-depleting cleaners.

With the assistance of Petroferm Inc. (Fernandina Beach, FL), a cleaning specialist and supplier of cleaning solvents, and 3M (St. Paul, MN), Cardiac Control Systems decided to test a single-fluid vapor degreasing process using 3M's HFE-7100. The hydrofluoroether (HFE) is listed in the Environmental Protection Agency's New Alternatives Policy as acceptable without restrictions for use as an alternative to ozone-depleting substances.

After Petroferm tested the cleaning process on sample parts, Cardiac Control Systems began gathering the extensive data necessary to validate the process and confirm its effectiveness. Once Cardiac Control Systems determined that the process was suitable, the firm decided to use an MLR-120 cleaning unit (Baron-Blakeslee; Long Beach, CA) and installed the system in its cleanroom production area. The unit, modified by Ultronix (Hatfield, PA), was previously fitted with an additional freeboard and a second set of refrigerant coils to minimize vapor loss.

How the Process Works

Many of Cardiac Control Systems' parts cleaned in the vapor degreaser are tiny metal components. "With the AVD process, parts were placed in the degreaser's liquid boil sump, which requires that these components be contained in covered mesh baskets to prevent displacement by liquid flow," says Robert Consiglio, mechanical engineer, Cardiac Control Systems. "When the HFE method is used, parts are placed in a vapor zone instead of being immersed in a fluid, so the parts can be placed in open trays for the 1-minute cleaning cycle." After the parts are placed into the system for cleaning, vapor condenses on them. The condensate drains away contaminants and then evaporates and condenses on cleaning coils as the cleaned parts are withdrawn. Contaminant residue is filtered out of the fluid, which continuously recycles from liquid to vapor. A spray wand inside the cleaning unit can be used on surfaces that require slightly more aggressive cleaning actions.

Benefits of HFE Cleaning

Cardiac Control Systems found that the properties of the HFE fluid offered a number of improvements over CFCs. The boiling point of CFC-113 is 48°C, whereas 3M's HFE-7100 boils at 60°C. The higher temperature reduces emissive losses and aids in solvent action. The viscosity of the 3M fluid is 0.61 cps at 25°C compared to 0.68 for CFC-113, and its surface tension is 13.6 dyne/cm at 25°C compared to 17.3 for the CFC solvent.

The density of the HFE fluid, combined with its low viscosity and surface tension, allows it to penetrate and clean components with complex surface features. The low surface tension of the fluid allows for fast wetting of low-energy substrates, while low viscosity aids in the penetration of tight and complex geometries. This action is necessary for adequate cleaning, and it reduces fluid loss when the parts are removed from the degreasing unit.

The fluid's very low heat of vaporization leads to relatively rapid drying and minimizes liquid dragout from the system. The fluid has a shortened atmospheric lifetime and lower global-warming potential than CFCs and many fluorinated compounds. It is also low in toxicity, which complements its effectiveness as a solvent.

Implementing the System

Training the unit operators to use the degreasing system efficiently was important, Consiglio says. "In order to minimize fluid loss, operators need to raise the parts baskets slowly after the cleaning cycle so that the fluid evaporates and recondenses fully on cooling coils rather than being brought out of the freeboard area," he says. A sliding cover over the two sumps is moved into place whenever the system is not in operation to prevent air turbulence from drawing out the denser cleaning vapor.

Cardiac Control Systems is also using the cleaning system instead of oven drying to remove water droplets from production equipment parts that are periodically washed in a water process. "Moisture is displaced by the condenser vapor and is ultimately removed from the system via the water separator," Consiglio says. "This vapor drying process saves both time and energy compared to oven drying."

Maintenance of the new cleaning system is minimal, Consiglio says. "Fluid disposal is not an issue because continuous filtration removes particulates from the operating fluid. The distillation process occurring in the machine ensures that clean fluid is constantly available for cleaning," he says. Because the HFE molecule is thermally and hydrolytically stable, it can be recirculated continuously in the cleaning system without deterioration.

"The cost of cleaning with the single-fluid 3M HFE process is comparable to earlier processes, and its performance is as good or better," says Consiglio. "Parts cleaned in the new system are free of contaminants and residue, and they meet our stringent requirements."

MPMN is actively seeking success stories like this. If your company has one to tell, please contact managing editor Karim Marouf at 3340 Ocean Park Blvd., Ste. 1000, Santa Monica, CA 90405; 310/392-5509 or E-mail karim.marouf@cancom.com

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Resins and Compounds



Resins and Compounds


TPV elastomers

Supplied in injection molding and extrusion grades, novel thermoplastic vulcanizates (TPVs) offer enhanced performance characteristics as well as the strength and elasticity of conventional TPVs. Because they absorb less moisture than standard formulations, Uniprene 7010 compounds reduce or eliminate predrying requirements. They can also be colored more readily since they exhibit less yellowness in their uncolored state. The compounds provide superior elastic recovery, especially at elevated temperatures. Tecknor Apex Plastics Div., 505 Central Ave., Pawtucket, RI 02861.


HMVT resins

Monolithic, high-moisture-vapor-transmission (HMVT) products allow medical textiles to achieve good breathability and barrier protection in a wide range of applications. Available for use in medical apparel and wound dressings, Estane HMVT products provide greater MVT properties, improved abrasion resistance, and better low-temperature flexibility compared to other materials, according to the manufacturer. Compared to microporous-based products, the Estane resins offer greater pliability and softness, a feature that provides the end-user with increased comfort and pleasing aesthetics. BF Goodrich Specialty Plastics, 9911 Brecksville Rd., Cleveland, OH 44141.


Medical-grade polypropylene

Radiation-stable resins exhibit virtually no discoloration or degradation after intense radiation exposure, whether by gamma, E-beam, or other high-energy sources. In addition to a complete line of injection molding grades, the PP Gamma resin line includes film and fiber grades. All are autoclavable. Gamma-10 Plastics Inc., P.O. Box 177, Minneapolis, MN 55364.


Medical urethanes

A line of medical urethanes are formulated expressly for catheters. As a benefit to medical product OEMs, ready-to-use compounds have been formulated from base resins that have already been approved for medical applications. Specifications of the Fostathane urethanes include a durometer range of Shore 80A to 75D using test method ASTM D2240. The transparent compounds are available in a wide range of popular colors. Radiopaque fillers can be added for special applications. Foster Corp., P.O. Box 997, Dayville, CT 06241.


Bovine-free PVC

Available with vegetable-derived stabilizers and lubricants, medical-grade PVC extrusion and molding compounds offer superior clarity, heat stability, and melt viscosity compared with compounds containing animal-fat microingredients. Extrusion-grade, gamma-sterilized samples of the material also exhibit a reduction in discoloration compared with traditional PVC compounds. The bovine-free resins are suitable for uses that include Class VI radiation-resistant tubing, fittings and connectors, films, drip chambers, and oxygen therapy equipment. AlphaGary Corp., P.O. Box 808, Leominster, MA 01453.


PVC compounds

Advanced medical-grade PVC compounds now offer the gasket and diaphragm market good physical properties as well as ease of handling during manufacture. Unlike conventional PVC compounds, Flexchem compounds have a unique rheology that enables them to be extruded into narrow tapes that can be fed into auxiliary punching equipment and handled via automated robotics. This type of thin-film production is well suited for medical applications calling for consistent thickness and flatness. Unichem Products, a Div. of Colorite Polymers, 101 Railroad Ave., Ridgefield, NJ 07657.


Thermoplastic compounds

Thermoplastic compounds are available in small or large batch sizes. Custom color matching is available from either the Pantone selection or as a match to a specific supplied sample. Compounds available include fluoropolymers, polyurethanes, polyolefins, Pebax, and polyamides. Radiopaque fillers are blended to customer specifications and are available in barium sulfate, bismuth subcarbonate, bismuth trioxide, bismuth oxychloride, tungsten, and titanium dioxide. All materials contain consistent lot-to-lot characteristics and are provided with a full certification concerning the base resin, additive percentages, and lot traceability. Fluortek Inc., 12 McFadden Rd., Easton, PA 18045.


Lipid-resistant polycarbonate resin

A highly transparent, lipid-resistant polycarbonate resin helps alleviate cracking in high-stress applications where there is contact with intravenous fluid products, particularly lipid emulsions. Makrolon DP1-1805 is also sterilizable by radiation, EtO, and steam autoclaving, and it meets FDA biocompatibility requirements. According to the manufacturer, it is easier to process than similar resins. Bayer Polymers Div., 100 Bayer Rd., Pittsburgh, PA 15205.


Crystalline polymers

Representing the basis for an entirely new family of materials, Questra crystalline polymers are a range of high-performance engineering resins synthesized from styrene monomers using metallocene catalysts. The resins provide innovative options for product designers and manufacturers seeking a mix of value and performance properties in an engineering thermoplastic. The crystalline polymers have a melting point of 270°C and a glass transition temperature of 100°C. Dow Plastics, P.O. Box 1206, Midland, MI 48641.


Opaque resins

Custom-compounded thermoplastics are available for the medical device industry. To produce resins that are opaque to x-rays, barium sulfate, bismuth compounds, and elemental tungsten are added. Other polymer additives included colors, lubricants, antioxidants, UV stabilizers, and more. Alloys or blends of polymers are routinely made. New England Urethane, 105 Sackett Point Rd., North Haven, CT 06473.

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Treatment Enhances Cutting Blades



Treatment Enhances Cutting Blades

Coating lengthens blade life for medical manufacturer.

Cutting rubber smoothly and consistently can sometimes be a troublesome project for medical device manufacturers. Abrasive additives in rubber compounds can erode the sharpness of a cutting blade, while rubber residue on a blade's surfaces can cause drag and friction. In short periods of time, rubber can dramatically wear down an edge's sharpness.

As a manufacturer of rubber strips for ECG electrodes, ConMed Corp. (Utica, NY) understands the problems that cutting blades can encounter with rubber. ConMed's small, one-time-use rubber strips are manufactured to hold the lead wires in place on a patient during an ECG test. These rubber strips are manufactured by slicing ribbons of rubber into 1- to 2-in.-long, clean, even pieces. As the company discovered, though, these rubber ribbons can wreak havoc on untreated cutting blades, forcing repeated blade changeovers to maintain a clean, effective cut. To correct the problem, the company turned to General Magnaplate Corp.'s (Linden, NJ) Goldenedge reactive ion deposition surface enhancement, which dramatically increased the durability and sharpness of its blades.

The Goldenedge surface treatment helps cutting edges resist wear and abrasion while lengthening service life.

In 1993, ConMed purchased Andover Medical Corp. and incorporated its product line into ConMed's new ECG manufacturing division. Using Andover's leftover supply of cutting blades, ConMed's productivity levels matched expectations and production went smoothly. But manufacturing problems arose when the old supply of blades ran low and ConMed ordered a new batch. The company found that these replacement blades wore out so quickly that it had to stop all production once or twice daily to replace them. Production costs jumped as wasted downtime began to add up with the frequent blade changeovers.

ConMed reported the problem to the blade manufacturer, but found that the new batch of blades was manufactured to the same specifications as earlier batches. Eager to find the problem, ConMed manufacturing engineer John Saltamach began looking through Andover's old records for hints at what might be going wrong. There, he discovered the source of the problem: previously, the blades had been sent to General Magnaplate Corp. to be treated with a coating enhancement.

This coating was General Magnaplate's Goldenedge surface treatment, an ultrahard, microthin, enhanced titanium nitride that can be applied to the cutting edges of blades, knives, slicers, and other sharp-edged devices. The coating resists wear and abrasion while lengthening service life by up to 20 times in some cases. And, unlike chemical vapor deposition processes that require temperatures as high as 1800°F (hot enough to produce excessive distortion and warping in the metal), Goldenedge's physical vapor deposition process employs temperatures as low as 400°F. As a result, this process can coat a variety of materials without causing a loss of hardness, affecting metallurgical properties, or distorting the substrate.

Goldenedge can be applied in controlled thickness levels to within ±0.000015 in., preventing dulling even on angles as small as 7°–9°. As General Magnaplate corporate vice president Walter Alina notes, "Normally with titanium nitride, you'd put 2 to 5 microns on a surface. But if you have a very razor-sharp edge and want to maintain that, you'd have to cut way back on the metal's thickness. So we just deposit a micron, maybe a little bit more, and that's it." Goldenedge also has an extremely fine grain structure that results in a low coefficient of friction. As Alina says, "This coating is about as uniform as you can get. Our proprietary system provides for deposition of a very fine molecule. We take a great deal of care to build up a very thin coat."

With Goldenedge once again applied to its cutting blades, ConMed found that its production line ran with its original level of efficiency. Now, instead of changing blades one to three times during an eight-hour shift, the enhanced blades last well into a second shift. Says ConMed's Saltamach, "There was a dramatic difference between the coated and the uncoated blades. The Goldenedge blades worked like a charm. And their extra life is an important factor in keeping our costs down."

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Implementing Training Programs for Software Quality Assurance Engineers

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI October 1998 Column

SQAE TRAINING

Given their potential to reduce software failures, well-trained SQAEs are essential for devices that rely on software.

Software quality assurance engineers (SQAEs) play a key role in ensuring the safety and efficacy of device software and ultimately the devices themselves. As FDA begins to examine the software design process and quality system software more closely, the need for well-trained SQAEs becomes critical for product quality. A necessary but often overlooked aspect of producing well-trained SQAEs is the implementation of a training program to guarantee adequate and consistent development methods and design controls for product and quality system software. Training can also benefit new SQAE hires who may not have significant experience in the medical device industry or who may not understand the company's established development methods and relevant quality system requirements. This article focuses on some of the key elements necessary in implementing a successful software quality assurance training program.

CHOOSING A TRAINER AND ASSESSING TRAINING NEEDS

Most successful trainers exhibit common traits, such as mastery of and enthusiasm for their subject, patience, flexibility, and a willingness to explain their rationale for decisions. In some ways, successful trainers serve as mentors for new hires in that they help guide the direction a new hire takes in the company. The most important aspect of selecting a technical trainer is choosing someone who wants to train a new hire and whose personality is compatible with the particular trainee. Trainers may have undergone a similar training program earlier in their own careers, or they may have been certified as an SQAE trainer by their company through a train-the-trainer initiative. In some companies, the trainer may simply be the most experienced individual in the company. To be successful, a training program needs both genuinely interested trainers and support from corporate management.

Figure 1. Decision tree for assessing training needs.

To meet training goals and use time efficiently, it is important for the trainer to assess the individual's training needs. The trainer must determine whether the trainee is new to software quality assurance, new to the medical device industry, or new to a particular area of the medical device industry (e.g., pacemaker manufacturing). Regardless of the SQA-related experience level, training must be provided on the company's procedures for design controls, document controls, and other key aspects of the quality system. Figure 1 represents a decision tree for assessing the training needs of an individual.

PHASES OF THE TRAINING PROGRAM

A senior SQAE trainer should be assigned to each new SQAE trainee. This trainer should not only execute assigned portions of the formal training plan, but also support the new SQAE for at least six months. The training program should consist of an overall syllabus (i.e., body of knowledge), with a training plan created for each individual. This involves tailoring the syllabus to each trainee's needs and prioritizing the skills training based on the individual's experience and target assignments. If one-on-one training is not an option, the alternative would be to group new hires under a general training plan with one trainer for the group. This approach is less desirable because trainees do not receive as much individual attention, and the plan is not tailored to each person's specific needs. Instead of training when each individual is hired, the company waits until it has enough employees to form a training group. This could result in potential negative corporate impacts based on work performed by new hires as they wait for other employees to join the company so that a training group can be formed.

The training plan should begin within the first two weeks of the trainee's employment and span at least eight weeks. Individuals who lack software quality assurance experience and medical device industry exposure may require more than eight weeks. For those companies that can't afford to make this commitment, other options include requiring more experience of SQAE hires, using alternative training media (e.g., computer-based training, videotapes), relying on new hires to self-train in their off-hours, or outsourcing the software quality assurance tasks.

These options, however, are less desirable and pose greater risks to the company because they lead to inconsistent software development approaches. Without an adequate training program, manufactured devices may not meet specified requirements or may carry a high number of latent defects. Furthermore, compliance with established design control procedures may not be apparent or may be lacking entirely. In companies that tend to cut corners by failing to implement a training program, a development team may look for the answer to each query by approaching every member of the SQAE team independently, rephrasing the same question in the hopes of finding an easy answer.

The individualized training plan combines reading, lectures, and hands-on execution of tasks in the following phases:

  • Assigned trainer gives lectures, combined with hands-on examples/exercises. New employee orientation, such as safety program training and quality manual training, also takes place.
  • Assisted hands-on execution of tasks (shadowing trainer) with the goal of significant exposure to the job.
  • Trainer and manager assess trainee's readiness to work alone on individual tasks and assignments.
  • New SQAE works alone with question and answer follow-up sessions held with trainer. The trainer reviews each assignment before it is considered complete. The goal of this phase is to begin introducing the trainee into the company's workflow.
  • Trainer and manager decide whether or not the employee will begin working independently. This phase consists of assessing the trainee's progress in the SQAE domain and determining whether or not the training plan has succeeded.
  • New SQAE works alone. At this point, the intensive training is complete, and the trainee is an independent SQAE. On-going assessment of the SQAE's effectiveness becomes part of the com- pany's standard performance appraisal process.

SAMPLE TRAINING PLAN

The following sample training plan is designed for trainees who are new to the company and the medical device industry and have a minimum of two years' experience as SQAEs. These sessions complement lectures and assisted hands-on execution of tasks.

SESSION 1: SQAE Introduction

  • Introduction to SQA personnel and management and discussion of QA organization chart.
  • Description of overall company function, products, and types of software.
  • Overview of company software development process and standards.
  • Overview of company software quality process and standards.
  • Overview of typical software development deliverables and software quality deliverables.

SESSION 2: SQA Interfaces

  • History of SQA at the company.
  • Relationship and level of involvement of SQA with different software groups.
  • Indication of software groups new SQAE will work with.
  • Organization chart, indicating the key software contributors and their roles and relationships, etc.

SESSION 3: Relevant Corporate Standards

  • Train on industry standardsand application of these standards to the company.
  • Train on certification-based standards, if appropriate.

SESSION 4: Design Controls

  • Address company requirements for product development and maintenance, with specific focus on software.
  • Step through the product development process.
  • Step through the software development process.

SESSION 5: Configuration Management (CM)

  • Address company requirements for configuration management, with specific focus on software.
  • Step through the product configuration process.
  • Step through the software configuration process.
  • Demonstrate the system by selecting one or more software documents/specifications from the repository and pointing out the control mechanisms. Do the same with one or more software releases.

SESSION 6: Software-Related Standard Operating Procedures

  • Step through specific software development, software quality, and software CM procedures and practices, explaining how each implements and complies with the higher-level policies and standards.
  • Step through the sample planning documents, indicating how each implements the company standards and procedures.

SESSION 7: Assisted Hands-On Task Review

  • Using the audit checklists created in the homework assignment for session 6, execute an informal audit of one or more software development areas and the CM function for those areas. Discuss findings.

ORGANIZATIONAL FLEXIBILITY

Time is the single most important issue facing the SQAE manager who decides to implement a training program. Since the most effective SQAE trainers are typically the senior SQAEs, the company usually desires close to 100% of their time to be spent on key development projects. For the training plan to succeed, expectations for the trainer's project support time must be scaled back until the assigned trainee has graduated.

INDEPENDENT PROGRESS REVIEW

To ensure that the training plan is working, periodic review of the trainee's progress is helpful. This can be provided by a senior SQAE, the SQAE manager, or a knowledgeable, unbiased third party. The goal of the progress review is to identify any weak areas and ascertain whether the trainee has successfully completed the topics assigned by the trainer. If new areas of concern are noted during the progress review, the manager and trainer should modify the training plan to address these concerns. Ideally, this review coincides with a probationary performance review, if required by the company. Also, the employee's progress, including completion of the training plan, should be documented for the personnel record.

CAREER GOALS FOR THE SQAE TEAM

A competent SQAE team serves both corporate and individual objectives. The development of safer, more-effective devices benefits the company; meanwhile individuals become more valuable to the industry, resulting in their increased recognition and compensation. The short-term goal for any new SQAE should be to establish expertise by completing the training plan.

The easiest way to demonstrate competency is to pursue professional certification. At present, one of the most widely recognized certifications for SQAEs is the American Society for Quality's certification in software quality engineering (CSQE). (For further information, contact the American Society for Quality at 800/248-1946.) The CSQE, or a similar certification program, should become a goal for each member of the SQAE team. A new SQAE's long-term goals should include achieving a level of competency that leads to a role as a process improvement advocate, a trainer for a new SQAE, or both.

HOMEWORK FOR SAMPLE TRAINING PLAN

The following homework assignments correspond to the lecture sessions described in the sample training plan (above).

SESSION 1: Read company software development and software quality policy/standards.

SESSION 2: If company is certified (or pursuing certification) to any industry standards, such as ISO 9001, and if the new employee is unfamiliar with these standards, the trainee should read them thoroughly before the next session. Otherwise, the trainee should reread the company software development and quality policies/standards and document any questions. The trainee should also read the GMPs and relevant reviewer guidance.

SESSION 3: No homework.

SESSION 4: Read company standards and high-level procedures for configuration management.

SESSION 5: Read detailed software development and quality procedures, practices, etc. Also read a sample project plan, software development plan, software quality plan, and software CM plan (preferably from one of the projects/departments to be supported by this new SQAE).

SESSION 6: Create sample audit checklists against one software development procedure and one software CM procedure.

SESSION 7: No homework.

RECENT EXPERIENCE

In the past three years, two device companies have adopted a training plan similar to the one described here and achieved excellent results. Initially, the time investment seemed overwhelming; however, the performance level of trained individuals who completed their training plan has been outstanding. Furthermore, the consistency in overall SQAE methodology throughout these organizations improved significantly after implementing the training program.

Trainers and trainees who completed the training plan gained significant benefits. The trainers gained satisfaction in watching the development of their assigned trainees and developed a good working relationship with them. Trainees were quickly made to feel a part of the team and established a base on which to make future decisions concerning device software.

The successful outcome of implementing a formalized SQAE training program has more than paid for the initial investment made by the two domestic device manufacturers referred to above. The lessons learned in implementing this approach follow:

  • Training progresses at a different rate for each individual. Overall experience, industry experience, formal education, device knowledge, and enthusiasm all play a role in determining the right amount of time to dedicate to any specific topic.
  • Not every good SQAE is a good trainer. Serving as a trainer requires a solid command of the subject, interest in training, and infinite patience.
  • The SQAE manager needs to monitor the relationship between the trainer and trainee; strong personality conflicts or insufficient interest/patience on the part of the trainer is counterproductive. The manager should be prepared to intervene and assign a new trainer if necessary.
  • Upon completion of each individual's training program, the sponsoring department should consider marking the event as a cause for celebration. Acknowledging the trainer's efforts is critical in keeping trainers motivated.

MEDICAL DEVICE TECHNOLOGY TRAINING PLAN

Specific technical training on the company's medical device(s) should be conducted concurrently with the general SQA lectures.

SESSION 1: Current Device Introduction

  • Introduction to device(s) currently in production.
  • Tour of manufacturing facility (if colocated with R&D).
SESSION 2: Device Retrospective Review
  • Introduction to device(s) no longer in production but still in active use by the user community.
SESSION 3: Introduction to Device Technology
  • Review of device design for a given current product.
SESSION 4: Current Device Software Review (Part I)
  • Review of software design and code for product introduced in Session 3.
SESSION 5: Current Device Software Review (Part II)
  • Review of software design, code, and test protocols for another device (i.e., other than the Session 3-4 device).
SESSION 6: Support Software Review
  • Review of software design, code, and test protocols for selected production control or quality system support software.

CONCLUSION

Establishing a formal SQAE training program benefits both the company and the individual. A thorough body of knowledge is established for the SQAEs, and a process for attaining that body of knowledge is defined. In addition, a training program establishes consistent SQA methods throughout the company, which reduces overall corporate risks during product development. By implementing a training program, the company increases each SQAE's value, resulting in safer, more-effective devices.

A well-structured training program can provide a solid first step toward employees attaining certification. Professional certification efficiently answers third- party auditors' questions about SQAEs adequate job knowledge and moves the auditor on to other topics. Thus, if certified professionals cannot be found during the hiring process, the company should encourage new employees and support their efforts to attain certification.

The onset of regulated design controls necessitates a strong device development methodology. Software quality assurance plays a key role for every device that relies on software control, as well as for those quality system elements that rely on software. Without a solid training program, software quality assurance engineers may not be adequately equipped to implement effective medical device software design controls.

Tammy M. Pelnik is vice president of The St. Vrain Group, Inc. (Boulder, CO), and a certified quality manager. Gayla J. Suddarth is a quality manager with Tanning Technology Corp. (Denver) and a certified software quality engineer.


Copyright ©1998 Medical Device & Diagnostic Industry