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Articles from 2002 In January


Site Provides Testing and Certification Service Information

Originally Published MPMN January/February 2002

E-NEWS

Site Provides Testing and Certification Service Information

An updated Web site offers users on-line access to testing and certification information. Located at www.etlsemko.com, the site includes a resource library with instant access to standards updates, white papers, case studies, articles, press releases, and other information. In addition to customized information, users can submit queries to ETL Semko (Boxborough, MA), which will be answered within 24 hours. A product directory allows users to search the company's database by proprietary marks.

According to marketing director Nancy Medas, "the redesign of our Web site created an interactive tool that provides fast, anywhere access to general conformity-assessment information, and immediate responses to industry-specific questions and requests."

Katherine Sweeny

Copyright ©2002 Medical Product Manufacturing News

Acrylics Web Portal Launched

Originally Published MPMN January/February 2002

E-NEWS

Acrylics Web Portal Launched

www.cyro.com

Acrylics queries can be answered quickly and accurately at a new Web site for medical device design engineers, medical packagers, injection molders, processors, and other specifiers. Available at www. cyro.com, the site's E'crylic Central Web portal includes four components: the Tech-Knowlogy Center, Distributor Corner, a new supply-chain management capability called E'ssistance, and the company site for Cyro Industries (New York City).

The TechKnowlogy Center offers a Web database developed by acrylic molding and extrusion, compound, and sheet experts. Users have immediate access to FAQs, technical information, fabrication tips, physical properties, and other data. They can also send questions on-line to Cyro's technical service center that will be answered within 24 hours. The site offers free membership, which includes a folder to keep track of previously answered queries and other information. Members can also choose to receive updated product information and enhancements via e-mail.

The E'ssistance feature enables ordering of regularly stocked acrylic items and indirect supplies, as well as maintenance, repair, and operations. The distribution section gives the company's distributors real-time access to information about orders, inventory, and availability of products. The company's home page provides information about products, distributors, market applications, material safety, and company news.

Katherine Sweeny

Copyright ©2002 Medical Product Manufacturing News

K 2001: Living in a Material World

Originally Published MPMN January/February 2002

PRODUCT UPDATE

K 2001: Living in a Material World

Polymers that promise device OEMs cost and performance benefits debuted at the international plastics and rubber show

Every three years, the K show occupies the massive fairgrounds in Düsseldorf, Germany, turning the city into the de facto plastics capital of the world. From raw materials and processing equipment to contract manufacturers, exhibitors cover the spectrum of activities directly or peripherally related to the plastics and rubber industry. Although visitor attendance at the 2001 show took an understandable dip for the first time in decades, exhibitors were not deterred and squeezed into every nook and cranny of the 17 halls. In fact, if the show organizers had not announced that attendance was down by 12% compared to the 1998 show, it's doubtful that anyone would have noticed.

Although automotive products and consumer goods were among the most visible applications on display, numerous suppliers of materials, equipment, and services that cater to the device industry were present. Several of them chose K 2001 as a platform to introduce products suited for the medical market; they will be profiled in MPMN as the technologies become available to North American customers. In this section, we focus on exhibitors who introduced materials that may lower production costs or improve the performance of medical products.


Nova presents a clear alternative to premium-priced materials

A clear impact-modified SMMA copolymer from Nova Chemicals, Zylar delivers toughness and clarity at a lower total molding cost than polycarbonate.

Designing and manufacturing a new device is a little like bringing up your first child. You coddle it, sparing no effort or expense to ensure its safety. After a couple of panicked visits to the emergency room that prompt the physician to chuckle and comment, "first-time parents, eh?" you learn that you might be trying too hard. In the product design world, that's called overengineering. According to Greg Wilkinson, business director for the NAS and Zylar families of materials at Nova Chemicals Inc., it's quite common, and often unnecessary.

"In the early stages of a product's life cycle, the tendency is to overengineer the device. Later on, OEMs often will take a second look at their devices and realize they don't need all of that strength . . . that they're using aerospace technology where it really isn't required," says Wilkinson. When they reach that point, Wilkinson hopes they will keep Zylar in mind.

A clear, impact-modified SMMA copolymer with enhanced stiffness and heat-deflection temperature, Zylar reportedly delivers toughness and clarity at a lower total molding cost than acrylic, polycarbonate, or clear ABS resins. The Zylar 94-568 formulation was introduced during the K 2001 show by Nova at an off-site location.

"Zylar 94-568 is designed for applications where impact resistance and elongation strength are needed and stiffness is essential," says Wilkinson. It represents an attractive alternative material for manufacturers of mature products seeking cost-efficiencies, he adds. "It doesn't have all of the strength of polycarbonate, but it may have enough to satisfy your needs."

Because it processes like a styrenic, Zylar is easier to work with than polycarbonate and thus reduces utility costs and cycle times, according to Wilkinson. The material is alcohol resistant and withstands gamma and EtO sterilization. Parts made of the material can be solvent welded. Current applications include Yankauer suction wands and IV components.

The company also announced during the show that the material had successfully completed ISO 10993 testing. "By meeting the ISO standard, Nova can help OEMs accelerate the approval process," stresses Wilkinson.


Nylon's flow qualities ease processing

Orthopedic devices may benefit from a semicrystalline nylon introduced by Rhodia Inc. The material's performance characteristics match those of other polyamides but it is easier to process, according to the firm.

The core applications of a semicrystalline nylon introduced by Rhodia Inc. are in the automotive sector, but it may also have a bright future in medical devices. Orthopedic devices, in particular, are under serious consideration, according to Philippe Guinot, strategy and business development director at Rhodia Engineering Plastics.

"The Technyl Star material's flow characteristics result in substantial processing advantages," says Guinot, who cites reduced mold-fill times, lower processing temperatures, and the ability to use smaller presses as some of the benefits. This family of polymers is based on a proprietary polymerization and compounding technology that engenders a nonlinear structure in the polymeric chain.

In addition to its processing characteristics, Technyl Star achieves high mechanical and thermal properties at room and elevated temperatures. "The performance characteristics match other polyamides and high-performance polymers," points out Guinot, "but it is much easier to process." The material's chemical and physical properties, he adds, minimize roughness in the surface finish even with highly filled grades. Consequently, Technyl Star is well positioned for applications in which strength and surface aesthetics are required.

The device sector shows promise, says Guinot, who nevertheless cautions that "Rhodia will only consider nonimplantable products that do not come in contact with body fluids." A device manufacturer is evaluating the material, he adds, but it is too early in the process to mention any specifics.

"As with any new application, we are exploring how we can bring a functional value to our customers and, ultimately, to the end-user. In this case, we can bring down the overall production costs and reduce the weight of the final device," says Guinot.


Interest heats up for thermally conductive TPEs

As power densities increase, conventional plastic products become prone to overheating, thus causing component failure. Thermally conductive plastics can solve this problem while enhancing design flexibility. Cool Polymers Inc. introduced some recent medical applications of the materials at K 2001.

Among other products, the company exhibited a temperature monitor the size of a watch battery that incorporates a thermally conductive liquid crystalline polymer. The monitor acts like a heat pipe, conducting body heat at rates up to 50 W/meter Kelvin to a sensor that sends the data via a wireless connection to a computerized monitoring system.

The company also showed an integrated high-torque motor and driver suited for use in medical equipment. The component is aimed at designers who want the simplicity of onboard electronics without the expense of an indexer on each axis. The part uses a thermally conductive polycarbonate to draw heat away from the controller and dissipate it into the surrounding air.

Thermally conductive materials can be formulated with most base thermoplastics. They feature a low coefficient of thermal expansion and contribute to a reduction or elimination of additional parts and assembly processes. The materials are available in electrically insulative and conductive grades and meet UL flammability requirements; some grades are also suitable for EMI and RFI shielding applications.


New TPE exhibits array of benefits

Based on proprietary technology, a new thermoplastic elastomer combines the high-temperature performance of silicone rubber with the melt reprocessing characteristics and thermal and chemical resistance of engineering thermoplastics. At K 2001, Dow Corning Corp. announced that it is in the early stages of commercializing the thermoplastic silicone vulcanizate (TPSiV) material. "We have begun sampling limited quantities to customers who contributed in the development of TPSiV," says Kevin Murphy, Dow Corning's global portfolio leader for thermoplastics.

In addition to the attributes mentioned above, the material's benefits include its compatibility with injection molding, extrusion, and blow molding processes and its ability to bond with a variety of substrates. Its silky feel is achieved without the use of plasticizers, and the material is available in durometers ranging from 50 Shore A to 60 Shore D.

"Initially, we will be going into automotive applications," notes Murphy, "but we are seriously looking at the medical market as well." The material's properties, along with its cost, make it "a natural for this sector," he adds.

Norbert Sparrow

Copyright ©2002 Medical Product Manufacturing News

Inspection and Testing Systems Offer Custom Capabilities and Heightened Sensitivity

Originally Published MPMN January/February 2002

EQUIPMENT NEWS: Testing and Inspection Equipment

Inspection and Testing Systems Offer Custom Capabilities and Heightened Sensitivity

Systems are suitable for devices, materials, and packaging

To achieve the level of precision necessary in the manufacture of medical devices, OEMs employ inspection and testing machines to detect flaws in their products and weed out defective ones. These machines have become more essential and more technologically advanced as safety and quality requirements have become more stringent. Following is a sampling of some recent developments in inspection and testing equipment, including a vision system that offers high-end features at a reduced cost, a custom-designed inspection system with a reagent dispenser, and a material tester with an enhanced electronics package.


Machine vision system provides scalability, versatility

A stand-alone system is designed to simplify machine vision procedures on the factory floor. Visionscape Express, from RVSI Acuity CiMatrix, is suitable for inspection, assembly verification, gauging, and automatic identification applications. It supports two cameras in its standard configuration and can expand to four-camera operation. A variety of cameras and integrated imagers can be interfaced to combine cameras, lenses, and lighting in a single system. A frame grabber and a vision accelerator, both with an analog interface, and a vision accelerator with a digital camera interface are some of the optional accessories available. All configurations feature I/O capabilities including dedicated triggers and strobe outputs for available channels. Ten opto-isolated digital I/O ports are wired directly to terminals on the back of the system. For expanded capabilities, an optional external opto-isolated I/O board provides 24 digital I/O points and 8 analog outputs. A custom vision ASIC is designed to accelerate low-level vision algorithms for enhanced throughput. "Visionscape Express offers the power, flexibility, and scalability of a high-end system," says machine vision product manager Greg Hallerman. "It can adapt to demanding applications as inspection requirements grow."


Vision inspection systems are highly customizable

Omron Electronics' F160 integrates two cameras into a microprocessor-based system to reduce inspection time.

A machine vision sensor system combines dual cameras and high-speed processing to deliver faster capture and image processing speeds than traditional systems. Provided by Omron Electronics LLC, the system has two cameras with eight user-selectable shutter speeds and an interactive lighting interface. A variable box measurement for area and defect inspection ensures that the F160 system uses optimal measurement regions. The regions can be set to change automatically when performing inspections for objects of varying sizes, such as surface-mount components. Flash-RAM memory cards allow expansion of memory capacity to handle multiple product lines. The system's high-speed setting allows 5000-item-per-minute inspection. Character recognition software enables the F160 to recognize many types of characters, adapt to fluctuations in character shape and size, and discriminate between similar characters. Customization features include a selection of compact camera options, operating menus, and symbol and text colors.

Kuntz's Membrane Striation machine combines a vision inspection system with a reagent dispenser.

While the F160 has many customization options, the Membrane Striation machine from Kuntz Mfg. Co., Inc., is a completely custom-made vision inspection system. Designed for use with rapid diagnostic test kits, this system also features a reagent dispenser and is capable of inspecting and reject marking up to 100 lines, which are dispensed simultaneously and continually at a rate of approximately 20 ft/min. It is a reel-to-reel system that offers integrated drying as well as in-line inspection of line presence, quality, line-to-line distance, and positioning on the membrane. The system can also inspect lamination placement and assemblies. An internal camera takes overlapping shots of the moving web; these images are instantaneously compared with predefined inspection tools and, if not satisfactory, are marked downstream. "Integrating vision inspection with automated systems helps guarantee that no bad parts are allowed to continue through the manufacturing process," says sales and marketing manager Anita Jul Brown. "Vision inspection features are suitable for any type of medical dispensing application in which parts need to be held within critical reference points."

The nonspray dispense method creates crisp lines that can be placed closely together. A built-in light meter measures light degradation, allowing the camera to compensate for basic light deviations. Preferred methods of reject marking used with medical devices, including disposable felt pen marking, laser marking, and ink-jet marking, can be employed on the system. On web machines, speeds of 25 m/min can be achieved, and speeds of 800 parts per minute are reached on assembly machines. The type of reagents used depends on the type of diagnostic test that is being created.


Testers suitable for a variety of biomaterials, polymers, and gels

Mach-1 material testers from Biosyntech Canada offer different models for a range of testing requirements.

Designed to test the mechanical and electrical properties of a variety of materials, a line of testers provides micromechanical evaluation and in vitro simulations. The Mach-1 systems from Biosyntech Canada Inc. can test biomaterials and biological tissues, pharmaceuticals, and a range of polymers and gels including adhesives, elastomers, films, foams, hydrogels, latex, pastes, and sponges. The A Class systems provide precision measurement, force, and displacement control for small and soft samples, and can perform tension, compression, dynamic, static, and creep testing. Class V systems are versatile, upgradable, and designed for multiaxis testing including compression, tension, shear, and torsion testing. E Class systems offer low force and static testing in compression. Intended for testing in controlled environmental applications, the Mach-1 systems are suitable for long-term living specimen studies of gels, cell cultures, and tissues. Contract testing services are also available.


Upgraded electronics package boosts performance of material testing platform

Material testing systems with an upgraded electronics package from Instron Corp. enable accurate data capture of events that happen quickly, such as the insertion of a needle.

A system suited for testing metals, biomaterials, microelectronics, adhesives, and composites incorporates an enhanced electronics package that permits accelerated performance and accurate data capture in applications with rapidly changing loads. The 5800-series material testers were introduced by Instron Corp. at the recent Medical Design & Manufacturing (MD&M) Exposition in Minneapolis.

"The system has a 5-kHz data acquisition rate and expanded bandwidth compared with previous systems," notes product manager Jim Ritchey. "It allows you to capture data on events that happen extremely quickly, such as the insertion of a needle, or where there are rapid changes in load, as in peel-tear tests." Ritchey also cites the system's open architecture as a key benefit. "We have a broad array of software available, but it doesn't cover every conceivable test. The open architecture enables the user to perform nonstandard applications," he explains.

The 5800-series load frames are available in floor, table, and single-column configurations; optional material testing accessories include extensometry devices, high-temperature furnaces, environmental chambers, load cells, grips, and fixtures. Optional applications software includes the Merlin suite for static and cyclic tests and the FastTrack suite for fracture toughness and simulation procedures. The system's versatility and adaptability to changing requirements give it an edge in the marketplace, according to Ritchey.


Leak detectors capable of finding microscopic defects

A custom-manufactured leak-detection system is tested, calibrated, and certified in an FDA-registered design lab. The IntelliScan MT-160 from I.C. Technologies Inc. can locate and display microscopic pinholes, pores, cracks, and fissures in deep-drawn foil, lidding foil, PVC, and other nontransparent lid and base materials. Each defect's relative position is displayed in real time on the front panel. The system features a noncontact design that allows full-speed scanning of whole surfaces at industry-level resolutions. It can find defects as small as 10 µm at speeds of more than 100 in./sec. Several outputs allow quick reaction to and rejection of the package or material. The triple-microprocessor design incorporates a 48-point internal self-monitoring circuitry and microprocessor program. Capable of inspecting different types of packaging including filled sealed pouches, cups, trays, and bottles, a leak tester with easy-to-change tooling can handle a variety of materials. Supplied by Packaging Technologies & Inspection LLC, the 225 machine is a turnkey system offering simplified inspection. Suitable for flexible and rigid containers and packages, it performs nondestructive testing at sensitivities down to <25 µm. An operator interface touch screen is used for data collection. A self-teach feature reduces setup and operator training time by automatically setting the reject, pressure, and testing criteria from the initial test samples, with minimal input by the operator. Reject values are fine-tuned and automatically adjusted. The testing procedure involves enclosing the product in a customized cavity, monitoring fill time and absolute vacuum, measuring the differential vacuum change, and comparing the results to learned reject criteria. A vacuum decay testing system has microcomponents that offer increased sensitivity.


Leak testers feature ISO 9000-certified parts

A series of leak testers, which are suitable for elastic or rigid devices, allows easy programming of operating conditions. The P-Test series testers from Tecnoideal s.r.l. have resolutions of 1 mmHg or 1 mm H20, depending on the model. Components used in the systems are either approved by a notified body or supplied by an ISO 9000-certified firm. The P-Test series is intended for air pressure decay leak testing of medical devices such as blood lines, infusion and transfusion sets, bags, filters, oxygenators, heat exchangers, reservoirs, stopcocks, and related products. The hardware has been redesigned to prevent damage caused by short circuits or power surges. Flash EPROM programming improves project management and offers a variety of programming options. A pneumatic circuit is designed to withstand hundreds of thousands of test cycles. The testers can be used on production lines as well as in quality assurance and R&D departments.

Katherine Sweeny

Copyright ©2002 Medical Product Manufacturing News

Spotlight on Switches, Signals, and Connectors

Originally Published MPMN January/February 2002

Spotlight on Switches, Signals, and Connectors

Surface-mount connectors

Single- and double-row surface-mount connectors use modular spring-loaded contacts on a 0.100-in. grid. The contacts are available in seven heights, from 0.177 to 0.295 in. A precision-machined piston, machined base, and gold-plated components ensure a minimum 40,000-cycle life. The low-resistance, high-current contacts are rated at 2 A continuous, 3 A peak. High-temperature thermoplastic insulators are suitable for all surface-mount processes. Mill-Max Mfg. Corp., 190 Pine Hollow Rd., Oyster Bay, NY, 11771.


Tactile dome switches

Tactile dome switches feature a hole in the center, which enables a designer to place an LED directly behind the dome rather than off to one side. The result is a more intense lighting effect. The BL-series units are four-legged momentary switch contacts that, when used in conjunction with a PC board or membrane, become normally open tactile switches. The domes come in standard sizes of 10, 12, and 14 mm, and custom sizes can be specified. All domes are made of stainless steel, with nickel, silver, or gold plating available as options. The tactile domes have a contact life that exceeds 1 million cycles, and an operating temperature range from –45° to 100°C. They are SPST and have a switching voltage of 0.1 to 50 V dc, a switching current of 0.005 to 100 mA dc, and a switching capacity of 1 W. Snaptron Inc., 2468 E. 9th St., Loveland, CO, 80537.


Flexible jumpers

Flexible jumpers can be used as interconnection devices for board-to-board, board-to-display, board-to-connector, board-to-sensor, or any other application requiring flexibility. No artwork or special tooling is required. The jumpers can be manufactured on any pitch down to 0.010 in. (or 0.005-in.-diam wire with 0.005-in. spaces) with any material as conductors from 20 to 40 AWG round, stranded, or flat. The dielectric is polyimide H film, making the products suitable for wave, IR, vapor-phase, or hot-air soldering. Elmec Manufacturing, 4127 Avenida de la Plata, Oceanside, CA 92056.


Status indicators

Color machine-status indicators offer four colors in a single stack. The LME-Q and LMS-Q are available with a 300-mm pole that can be cut to any size to accommodate any application. The pole-mount version comes with a top-mounting bracket and the LME tower has optional flashing capabilities and two alarm circuits. An audible alarm is adjustable to 90 dBm and is available with a direct mount. All quad-color towers are available in three quad-color combinations. Patlite Corp., 3860 Del Amo Blvd., #401, Torrance, CA 90503.


Tension transducers

An integrated interface and amplifier that outputs a 10-V dc signal proportional to tension is offered as an option for idler roll tension transducer pairs. Transducers fitted with the unit are powered by 24 V dc. Because the company's standard strain-gauge tension transducers provide a 250-mV dc output signal, which is not directly usable by many customers, a separate electronics package, usually a transducer interface circuit card, has been required to condition the transducer pair's output to make it usable. With the development of the 10-V output option, it is no longer necessary to install the extra transducer interface and amplifier card. Dover Flexo Electronics Inc., 217 Pickering Rd., Rochester, NH 03867.


Light-emitting diodes

Light-emitting diodes in blue, white, and green colors enable design engineers to create aesthetically dynamic variations on their front-panel designs with multiple colors and increased illumination intensity. Super Bright LEDs are single element and rated at a forward peak current of 30 mA. The continuous forward current is 20 mA and the reverse peak voltage is 5 V. The LED circuit is independent of the switch operation. To produce an even, full-face, brilliant illumination, the units are installed in switches with white diffusers and clear caps. They are available on push-button switches ranging from subminiature to standard in size, and with electrical ratings of 0.4 VA to 5 A. NKK Switches, 7850 E. Gelding Dr., Scottsdale, AZ 85260.


Push-button switches

Push-button switches use an elastomer membrane seal between the actuator and the switch body and a flat front-panel seal. The IB and IS series provide sealing protection to specification IP67, as well as salt-spray resistance to IEC specification 512-6, test 11f. The compact models with a behind-the-panel depth of only 13 mm also feature ergonomically sculptured bezels with seven cosmetic actuator-color selections. Contact ratings are 400 mA at 32 V ac, 100 mA at 50 V dc, or 125 mA at 125 V ac. Initial contact resistance is 50 m(omega). Electrical life is 500,000 cycles minimum at full load, and mechanical life is 1 million cycles. Apem Components Inc., 63 Neck Rd., Haverhill, MA, 01835.


Encoders

A line of precision medical-grade mechanical encoders features easily modifiable shafts, bushings, and switching schemes. They are available with an integrated push-button switch in the spindle or shaft direction, and have 30 pulses per rotation. Life expectancy exceeds 100,000 rotations. Elma Electronic Inc., 44350 Grimmer Blvd., Fremont, CA 94538.


Low-profile power-supply connectors

Power-supply connectors compliant with a communications link that connects industrial devices to a network are supplied in five positions and in 5.08-mm pitch. Suitable for factory automation networks, HR31 connectors have through-hole-type headers that come in both straight and right-angle versions. Either solder or gold plating is available—gold-plated contacts increase mating and unmating cycles to 1000 times. The products are provided with removable contacts for quick and easy contact replacement. A 10.2-mm height allows for high-density mounting. Two forms of locking are provided—both a simple snap lock and permanently attached self-aligning screws (on plug) and threaded inserts (on receptacle) ensure engagement of both assemblies. Hirose Electric (USA) Inc., 2688 Westhills Ct., Simi Valley, CA 93065.


Visual interface connectors

Digital visual interface connectors are available with two different PCB layouts. Both come standard with board locks and 4-40 riveted threaded inserts, and one has additional plastic pegs. Both types are reflow compatible and available in black or white thermoplastic. The contact material is copper alloy with 30-µm gold plating. The connectors conform to the Digital Display Working Group DVI standard and are available as right-angle sockets in both digital and digital/analog. Kycon Inc., 1810 Little Orchard St., San Jose, CA 95125.



Miniature plastic connectors

Miniature plastic connectors are equipped with up to 19 gold-plated contacts in a sleek impact-resistant ½-in.-diam plastic housing. The 4032 series of connectors are offered sealed to IP68 and are fully submersible. The patented SureGrip TM plug body can be securely gripped, even with wet hands or gloves. Other features include a push-pull positive locking mechanism and an easy-to-use, self-aligning keyway. Color-coding options are offered for easy identification. Fischer Connectors, 115 Perimeter Center Pl., Atlanta, GA 30346.

Copyright ©2002 Medical Product Manufacturing News

Miniature Electroformed Housings Help Camera Probes Get Big Picture

Originally Published MPMN January/February 2002

PROFILE

Miniature Electroformed Housings Help Camera Probes Get Big Picture

Tight-tolerance casings allow smaller size and improved focus

These miniature bellows were also electroformed by Servometer.

The use of camera probes has increased greatly over the past decade with the rise of minimally invasive surgery and other advanced procedures. Packed with sensors and fiber-optic light bundles, these instruments allow the real-time imaging of otherwise-inaccessible surfaces and cavities. As with most medical products, however, there has been market demand for further miniaturization, which can create new challenges for manufacturers.

A case in point is the dilemma faced by an East Coast manufacturer that had been successfully producing probes with 0.48-in.-diam machined housings for years. When the market required a reduced diameter size, the company found it had difficulty manufacturing the component by conventional methods.

The device manufacturer "needed a housing that had a diameter of 0.196 in. and a tight wall-thickness tolerance to hold the camera firmly in place," explains Paul Hazlitt, director of engineering for Servometer (Cedar Grove, NJ), an electroforming firm. "When the camera bundle was more than 0.250 in. in diameter, it was possible to machine the part with a tolerance of ±0.001 in. But with a smaller-diameter probe, that variation was too wide."

As uniform wall thickness is essential to the proper functioning of the camera, the manufacturer of the probe was forced to examine new production methods. When both accuracy and shape factors ruled out stamping, the company contacted Servometer to investigate electroforming.

This diagram shows the miniature camera housing that was electroformed by Servometer. The tight-tolerance wall thickness allows the camera to be held firmly in place.

"Electroforming is a precise process that can produce intricate parts with little variation, so we didn't have a problem producing the part with a tolerance of ±0.0005 in.," says Hazlitt. Manufactured from nickel, the Servometer housing operates in a temperature range of –25° to 125°C and protects the camera from moisture and chemicals, allowing the probe to be used in harsh environments.

Servometer estimates that it was able to produce prototype retainers for the company in about two weeks. Importantly, this production method allows for even further miniaturization. "We can maintain the required tolerance with part diameters as small as 0.030 in.," says Hazlitt.

After successful ISO and USP Class VI testing, the camera probe company adopted Servometer's electroformed housing as the standard casing for cameras with diameters smaller than 0.25 in. Though electroformed components cost slightly more than other units, the company notes that the reliably tight tolerance allows technicians to spend less time inspecting, testing, and adjusting the cameras once they are inserted.

A reduction in the number of rejected components and a zero field failure rate are also cited as cost-offsetting factors. According to Servometer, the electroforming process could bring similar benefits to a range of other products. "This process is also suited for instrumentation components, flexible couplings, and surgical devices," says Hazlitt.

Zachary Turke

Copyright ©2002 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN January/February 2002

E-NEWS

My Favorite Bookmarks

Damon Black,
Product Development Engineer

Advanced Neuromodulation Systems

The Internet is a powerful tool for people developing medical products. In this new column, MPMN asks design engineers what sites they have bookmarked in their Web browsers that are helpful to them in this process. This month, Damon Black, a product development engineer with Advanced Neuromodulation Systems (Plano, TX; www.ans-medical.com), shares a few of his favorite sites.

Damon Black

"GE Polymerland (www. gepolymerland.com) is a site that can really help to streamline the materials selection process. With information on more than 30,000 resins, the page incorporates a wizard that asks project-specific questions to help narrow down the company's offerings to a short list of suitable plastics. For each listing, the company includes a material safety datasheet and discusses processing parameters and other issues, like biocompatibility and sterilization capability.

Medical Device Link (www.devicelink.com) is by far my most frequently visited Web site for medical device news and information. I usually browse it once or twice a week with my first cup of coffee to keep up on everything from corporate partnerings to product launches. The site also features a searchable database that lists suppliers for almost any part or service related to device development. Among other criteria, you can search the listings by company, product, and location.

The United States Patent and Trademark Office (www.uspto.gov) site is an invaluable tool when developing new ideas. It allows users to browse patent grants and applications by a variety of factors, including inventor, issue date, and assignee—an extremely useful feature for keeping tabs on competitors. Not only are there listings for current patents, but the page also contains information on expired grants and pending applications. Best of all, the listings are available in full-image or full-text versions that are free to download or print.

The Center for Devices and Radiological Health (www.fda.gov/cdrh) Web site is a vital link in the process for getting FDA approval to market just about any medical device. It contains detailed information on a range of pre- and postmarket issues such as 510(k) regulations, device classification, and third-party review. I also use the page to look up negative-use incidences for existing devices that are similar to the ones I am working to develop. Most records are available as both text and pdf files."

Advanced Neuromodulation Systems designs, develops, and manufactures implantable systems used to manage chronic intractable pain and other central nervous system disorders. The company offers a variety of pulse-generator and radio-frequency neurostimulators, including the Renew RF unit.

Zachary Turke

Copyright ©2002 Medical Product Manufacturing News

In Brief

Originally Published MPMN January/February 2002

INDUSTRY NEWS

In Brief

Klöckner Pentaplast of America Inc. (Gordonsville, VA) has announced the acquisition of Witt Plastics (Greenville, OH), a custom extruder of high-impact polystyrene and polypropylene films....Coated and adhesive product supplier Medco Labs (Cleveland) has formed a consumer products division. The company "intends to develop private-label, joint-venture, and proprietary branded product opportunities...to provide manufacturers with line extensions of existing branded products...with state-of-the-art transdermal technology," says marketing director Elizabeth Littman....NAMSA (Northwood, OH) has acquired Cole Industrial Laboratories LLC (Toledo, OH), which manufactures GroPro Plus growth promotion indicator organisms....Trace Laboratories (Palatine, IL) recently received accreditation by the American Association for Laboratory Accreditation (Frederick, MD) for EMC testing. The company has been shown to be competent to perform a range of EMC tests including radiated and conducted tests, as well as ESD and transient testing....UTI Corp. (Collegeville, PA) has announced its acquisition of Micro-Guide Inc. (Tehachapi, CA), a provider of precision-ground microminiature wire products. This new division will complement the capabilities of another of its companies, Star Guide (Arvada, CO), a supplier of ground and formed wire components....Nellcor (Pleasanton, CA), a division of Tyco Healthcare (Irvine, CA), has extended its partnership with Medical Data Electronics (MDE; Arleta, CA). The agreement allows MDE to integrate Nellcor's pulse oximetry technology into its Escort Prism and Prism SE portable bedside monitors....BP Amoco Polymers Inc. (Alpharetta, GA) is expanding its sulfone polymers plant in Marietta, OH, and its sulfone monomer plant in Augusta, GA....Genencor International Inc. (Rochester, NY) and Dow Corning Corp. (Midland, MI) have announced a strategic alliance to create a new silicone biotechnology platform. The alliance intends to create biologically medicated, silicone-based products for the life sciences and personal-care markets....Compressed-air drying and filtration equipment provider Van Air Inc. (Lake City, PA) has acquired certain assets of LifeStream International Inc. (The Woodlands, TX), a cardiopulmonary products supplier. The Surgimedics division of Van Air will manufacture and sell a line of smoke evacuation systems and filtration accessories for laser and electrosurgical applications....Pemstar Inc. (Rochester, MN) and Given Imaging (Norcross, GA) have expanded their agreements for Pemstar to build and operate production lines for Given Imaging's M2A capsule, which contains a miniaturized video camera. Pemstar will deliver the first semiautomated production line for the M2A.

Katherine Sweeny

Copyright ©2002 Medical Product Manufacturing News

Sunrise Labs Pursues International Markets from New Facility

Originally Published MPMN January/February 2002

INDUSTRY NEWS

Sunrise Labs Pursues International Markets from New Facility

Software and electronics design engineering firm Sunrise Labs Inc. (Manchester, NH; www.sunriselabs.com) has relocated to an expanded facility in Manchester, NH. Located 10 minutes from the Manchester Airport, the new headquarters facilitates the company's bid to enter the international market. "A lot of our clients have international parent companies," explains sales and marketing vice president John MacGilvary. "With more than four times the space of our previous building, this new facility has allowed us to increase our design capabilities to service these larger corporations."

Sunrise Labs is a full-service design engineering company offering systems engineering, user-interface design, prototype fabrication, manufacturing introduction and support, and other services. The company has participated in the development of patient monitors, surgical lasers, image readers, and mammography systems.

Zachary Turke

Copyright ©2002 Medical Product Manufacturing News

Digital Imaging Technology Extends Depth of Field

Originally Published MPMN January/February 2002

INDUSTRY NEWS

Digital Imaging Technology Extends Depth of Field

 
The image on the top shows a leaf under normal magnification conditions. Viewed using Wavefront Coding technology from CDM Optics Inc., the image on the bottom shows the same leaf with a depth of field that is roughly 10 times greater.

An imaging system uses digital signal processing to extend depth of field without a reduction of light levels. Pioneered by CDM Optics Inc. (Boulder, CO; www.cdm-optics.com), Wavefront Coding technology increases the viewable depth of an image by as much as 1500%. "This system is unique because it keeps both the back- and foreground in crisp focus," says CEO R. C. Mercure. "For the first time, users can have a clear view of the whole sample rather than having to focus on individual elements."

The system uses a generalized aspheric optic element placed near the aperture stop of an optical instrument to produce these results. Capable of being incorporated onto existing lens surfaces or added as a separate unit, this element encodes the images with a well-defined blur that is insensitive to misfocusing. Digital signal processing is later used to decode this sampled image, resulting in a picture with an extended depth of field and a reduction in focus-related aberrations.

The Wavefront Coding process is suited for use with microscopes, endoscopes, laparoscopes, orthoscopes, and miniature cameras. The developer says it is particularly useful in applications where the sample moves or is too wide to be completely viewed in a single frame, or where the operator requires depth cues to indicate position. Because it allows the use of plastic elements, the system also reduces costs when compared with some glass-based instruments.

CDM Optics has formed a partnership with Carl Zeiss Group (Thornwood, NY; www.zeiss. com) to jointly develop and market this product. "This agreement underscores our commitment to the optics industry and enhances the system's credibility," says Mercure.

Zachary Turke

Copyright ©2002 Medical Product Manufacturing News