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Articles from 2004 In October


First Time Exhibitors

Originally Published MPMN October 2004

MD&M Minneapolis

First Time Exhibitors

Acsion Reaches Out to Engineers and OEMs

“Ready for prime time” is the way account executive Lu Ann Sidney describes the feeling at Acsion (Pinawa, MB, Canada) about being a first-time exhibitor at MD&M Minneapolis. At the show, Acsion will let attendees know about its contract sterilization services and E-beam accelerator. The company would like to reach out to quality assurance professionals who make decisions about sterilization vendors, but also wants to educate the medical device industry about material-selection issues. “We want to reach engineers in the early stages of designing and make sure they consider designing products for E-beam sterilization,” says Sidney.

Acsion was formed in 1998 out of a Canadian national laboratory and grew to provide repair services to the aerospace industry and radiation sterilization services to the healthcare industry. Its national lab roots give the company a personalized service, as well as materials-testing and analytical capabilities. Acsion provides bioburden reduction and cross-linking services to the medical products industry, in addition to E-beam sterilization. Validation, expert advice, and consultation are all additional services the company offers.

There is a demand for E-beam sterilization and limited access to linear accelerators. Acsion meets that demand with its new, state-of-the-art accelerator. As the business grows, the company may move in the direction of also providing assembly or packaging services.

The company is working hard these days to make its presence known at shows such as MD&M and others in Medical Alley. It hopes to create more business opportunities with its traditional customers, and also make contact with OEMs for potential partnerships to provide full services. “The Minneapolis–St. Paul area has been overlooked for a long time and the base of technical expertise is unbelievable,” according to Sidney. “There is plenty of opportunity and Acsion sees that.”
www.acsion.com
Booth #853

Micro Control Is Ready to Assist with Electronic Manufacturing Services

It’s impressive to be able to offer quality contract electronic manufacturing with fast turnaround to the medical device industry. Micro Control Co. (Minneapolis) goes above and beyond to also offer design and assembly services. The company prides itself on vertical integration; mechanical and electronic engineers work beside manufacturers in the in-house machine and sheet-metal shops to meet customers’ needs with full services and high standards of quality.

Started in 1972 by the present owner, Micro Control provided test equipment for memory boards and devices to the electronics industry. The company continues to offer test equipment and burn-in systems for the semiconductor industry, but expanded in 1994 to offer contract electronic manufacturing services to other markets. Micro Control’s capabilities include high-speed surface-mount, through-hole, and mixed technologies; BGA placement with x-ray inspection; BGA rework; mechanical/box build; and large, high-density printed circuit boards.

“We have customers for whom we manufacture circuit boards for prototyping of implantable equipment, and we deal a lot with prototypes for medical usage of circuit boards,” says manager of electronics manufacturing Rafael Iglesias, “but we’d like to show the community that we have the capacity to assist anyone.”

The ISO 9001:2000–compliant company chose to educate MD&M attendees about its electronic manufacturing services because of its desire to continue expanding its client base. Micro Control exhibits at other trade shows throughout the year, but wants MD&M Minneapolis visitors to know it is a local company and everything needed to complete manufacturing jobs is locally obtained.
www.microcontrol.com
Booth #649

Air Squared Showcases Scroll Compressors for a New Audience

Manufacturer Air Squared (Hamilton, OH) has been attending trade shows for about five years, including the MD&M East and West shows, in an effort to meet new customers. In addition to its Ohio offices, the company has manufacturing facilities in Broomfield, Colorado. An interest in increasing exposure in the Midwest has led to its presence at the MD&M Minneapolis show.

Air Squared makes scroll-type air compressors, vacuum pumps, and expanders, primarily for medical OEMs. The scroll design enables clean, oil-free compressed air, high efficiency, and low noise for medical applications such as ventilators, portable oxygen concentrators, nebulizers, and dialysis equipment. The company began custom designing and licensing scroll technology for the medical industry in 1991, branching out 10 years later to accommodate its customers by manufacturing scroll devices. Visitors to Air Squared’s MD&M Minneapolis booth can view its scroll compressors and vacuum pumps.

According to president Robert Shaffer, Air Squared is most proud of its small, efficient scroll compressors. “Scroll compressors become more difficult to manufacture as they get smaller,” he explains. “Air Squared has developed proprietary technology that enables us to make a small, efficient compressor at a competitive cost.”

Air Squared has contracted for the development of small, injection-molded compressors for medical applications. Future initiatives include expanding into other areas such as fuel cells. Manufacturing capabilities will broaden as its clientele base grows. The company owns eight patents and has applied for two more. It is currently preparing two patents covering scroll improvements that make the scroll cost-competitive and practical to manufacture.
www.airsquared.com
Booth #1751

Sanbor Medical Plans for Growth with New Facilities and Certifications

Before establishing its medical division a year ago, Sanbor Corp. was primarily focused on serving the appliance, automotive, and electronics industries. But increasing sales prompted the company to form Sanbor Medical (Allentown, PA). “Sales to medical device manufacturers have grown to about 10% of the company’s business over the past 10 years,” says Joseph F. Horvath, vice president of sales and marketing. The division is now geared up and ready to grow.

Sanbor Medical is a fully integrated manufacturer, with design and production capabilities for custom cable and cable assemblies, printed circuit board assembly, injection and insert molding, and system assembly and subassembly. The division is ISO 9000 certified, and is pursuing ISO 13485 certification. In November, Sanbor will move production from its current facility in Xiamen, China, to a new 130,000-sq-ft location nearby. It plans to install a Class 100,000 cleanroom production area and seek FDA registration for the facility.

Though its production facility is in China, Sanbor Medical is a U.S. corporation. So while products are made offshore, “our liabilities and customer accountability are here in the United States,” says Horvath. Numerous levels of IP confidentiality are built into the Sanbor system for the protection of the customer. The company has U.S.-based engineering, project management, sales, customer service, logistics (with a Los Angeles distribution center), and accounting functions.

The division’s goal is to grow to be 25 to 30% of Sanbor Corp.’s total business. “We see a lot of opportunity for Sanbor Medical in certain niches within the market,” says Horvath. In addition to electronic circuitry, its smart cables incorporate a number of molded components within the assembly. “With 17 molding lines and an experienced group of plastics engineers, we have built an extensive capability in the manufacturing of precision molded parts,” Horvath says.

The first trade shows for the division were MD&M East in June and OEM New England in September. At MD&M Minneapolis it will showcase custom cable assemblies, smart cables, molded components, printed circuit board assemblies, and subassemblies.
www.sanbor.com
Booth #849

FMEA Software Makers Promise One-Study ROI

Though they are being increasingly embraced by device makers as a valuable way to maintain product quality, failure modes and effects analysis (FMEA) studies are grueling and time-consuming work. And up until two years ago, medical device engineers had nothing beyond spreadsheets to help them get that work done. “At the time, there wasn’t really anything out there supporting medical manufacturers,” says Mark Chambers, senior manager of the reliability division of Dyadem International Ltd. (Toronto, ON, Canada).

Dyadem entered the medical market in early 2001 with the launch of its FMEA For Medical Devices 5 software, a tool designed specifically for medical device FMEA. The studies, an ongoing process carried out through the lifetime of a product, help define process control plans and record and prioritize continuous improvements.

This has been the company’s first year attending medical trade shows, including MD&M East and MD&M West. At MD&M Minneapolis, Dyadem will showcase the newest version of its product, FMEA For Medical Devices 6, launched a year ago. New features in the upgrade include electronic records and signature capability, and linking of supporting documents. “Sales are up 140%, compared with the first year we launched the product,” says Chambers.

The software can reduce FMEA time by 65%, and pays for itself after the first study. “Do one study with the software, and you’ll see your return on investment very quickly,” Chambers says. FMEA6 is also intuitive and easy to learn. According to Chambers, 80% of its users don’t require training, but he adds that the company maintains a full dedicated client-care group to assist users. FMEA6 has templates to cover several standards and processes—including ISO standards, EN standards, MIL-STD-1629A, 510(k) premarket notification, and FDA quality system requirements—but users can also easily customize their own templates.
FMEA6 is more expensive than competing products, but the customization features, reporting capabilities, ease of use, library of generic failure-mode information, and ability to integrate with third-party products make it the best product on the market, Chambers insists. “We challenge anyone to find a better product than ours.” www.dyadem.com
Booth #656

Titanium Stamping Is Business as Usual for Okay Industries

Some of the country’s biggest players in the medical device industry are located in the Midwest, which is why Okay Industries (New Britain, CT) is looking forward to being a first-time exhibitor at the MD&M Minneapolis trade show. Business development manager Jason M. Howey cites the company’s expertise in stamping titanium as the main reason MD&M Minneapolis visitors will be interested in visiting the Okay booth.

Titanium components will be on display, and representatives will be on hand to discuss the company’s stamping knowledge and its assembly and subassembly services. Okay’s trademarked process of prototyping a component “mirrors the production process, so there are no worries,” Howey explains. “It’s prototyped the way it’s going to be made in production, so there are no headaches.”

The ISO 9002– and QS 9000–certified company has an experienced engineering and research and design staff, as well as state-of-the-art equipment for prototyping and production. Okay prides itself on focusing on the initial design phases but offers full services through production. It also boasts a trademarked application for converting components into low-cost metal stamping, and a proprietary process for grinding surgical scissors and knife edges. Stamping press sizes up to 800 tn can be used to produce components for implantable devices and surgical stapling devices, in addition to surgical cutting instruments, drug-delivery devices, and other laparoscopic, endoscopic, and arthroscopic applications.

Okay Industries was originally known as B. Jahn Manufacturing. Founded in 1911, it was one of the largest tool and die shops on the East Coast. It has been serving the medical device industry since 1977 and is now based out of a 100,000-sq-ft facility, housing 135 employees. Planning for future endeavors, Howey says the company is looking more at assembly and titanium expertise for some products that are machined.
www.okayind.com
Booth #1635

Despite Name Changes, Moog Components Group’s Product Quality Remains Consistent

As a division of Moog Inc., Moog Components Group (Blacksburg, VA) has only been around about a year. But that doesn’t mean it is a new company. “Our company has been in business for more than 50 years,” says Paul Murphy, group sales manager of commercial products. “We’re not a new kid on the block.” However, because the division has been through a variety of corporate owners in recent years—including acquisitions by Northrop Grumman in 2001 and Moog Inc. in 2003—maintaining an industry reputation is a challenge.

Building name recognition for the division, formerly known as Poly-Scientific, is one reason behind a new focus on industry-specific shows, Murphy says. Exhibiting at the National Design Engineering Show, part of National Manufacturing Week in Chicago, has become less productive. “We’ve seen a steady drop in attendance for more broad-based shows,” says Murphy. “The quality and quantity of our leads has deteriorated.”

Because medical is the largest and fastest-growing market for Moog Components’s products—including slip rings and fractional horsepower brushless dc motors—industry shows are a better fit. Murphy says many of the company’s regular customers are present at the MD&M West show, where they have been exhibiting for three years. That show, along with MD&M East and MD&M Minneapolis, will be the anchor of the company’s trade show activities going forward. “Our primary market focus for the commercial side of the business is the medical market,” Murphy says.

At MD&M Minneapolis, Moog Components Group will showcase product expansions. These include digital drives using the latest digital signal-processing technology available, and motors with improved efficiency. “We find that in many medical applications, the efficiency is very critical to promote the longest battery life,” Murphy says. The company will also display its new miniature slip ring capsule, which has a through-bore that allows passage of cables through the center to facilitate mounting of the slip ring in a device.
www.moog.com
Booth #850

Asahi Intecc USA Offers Custom Wire Manufacturing

In 1976, a wire manufacturer for industrial products opened its doors in Japan. Today, Asahi Intecc USA Inc. (Newport Beach, CA) has a reputation as one of the main suppliers of wire to the medical industry and boasts ISO 9001, ISO 13485, and EN 46001 quality management system certification. With more than 1300 employees in Japan, Thailand, and the United States, Asahi Intecc has been serving the needs of the medical device market for 10 years.

One of the keys to the company’s success is being able to offer high-volume, full services in wire manufacturing. Asahi Intecc obtained FDA registration for its Japan and Thailand facilities in order to export raw materials to its U.S. location. This process cuts down on costs for the company and allows the U.S. facility to take care of making the finished product to customer specifications, as well as packaging and sterilization.

On exhibit at the MD&M Minneapolis trade show will be the company’s most popular product, ACTONE cable tube, a stainless-steel cable with a hollow structure. The cable offers flexibility, kink-resistance, softness, and high torque transmission. Asahi Intecc also manufactures precision wire, miniature wire, miniature coil, torque transmission wire, torque transmission coil, braid-reinforced catheter tubing, and custom devices. The manufacturer has complete control over each wire’s mechanical properties, including tensile strength and elongation. Nitinol ties will also be on display at MD&M.

Yoshi Terai, the company’s president, found the Anaheim and New York MD&M trade shows to be rewarding experiences, and is looking forward to the Minneapolis show for the city’s large medical market and potential customer base.
www.asahi-intecc.com
Booth #830

CNC Machine Tools Are Second Nature for Haas Automation

No stranger to trade shows, Haas Automation (Oxnard, CA) makes its debut at MD&M Minneapolis this year in an effort to reach out to the Midwest market for CNC machine tools. The largest manufacturer of such machine tools in the United States, Haas provides milling and turning machines used to shape metal and other materials for medical device parts. The ISO 9000:2001–certified company hopes to meet medical device and contract manufacturers who have a design Haas can turn into a finished product.

Haas will partner with its Minneapolis distributors to present a total of five machines at the MD&M show, as well as educate attendees about the rest of its product line. On display will be the TM-1 vertical machining center, a fully CNC machine without enclosure. The toolroom-series machine has built-in software with intuitive milling and turning, allowing novice medical companies to make a smooth transition from manual to CNC processes. Other machines on display are targeted at companies already familiar with CNC who need high volume and quick production. Two new machines are very small versions of milling machines already in existence. The machines are small enough for customers to place in an office facility with limited space.

Started in 1983, Haas Automation is a relatively young company in terms of machine tool standards. Spawned from owner and CEO Haas’s design of a product to increase production in his machine shop, the company began to manufacture products and expanded from there. Its 820,000 (and growing) employees take pride in having found a niche in an old market and commanding and maintaining a 40% market share in the United States, as well as having customers around the world. Haas is heavily targeting the medical industry lately to develop more niche-type products that meet the needs of specific device manufacturers.
www.haascnc.com
Booth #1539

Copyright ©2004 Medical Product Manufacturing News

When the Pressure Is On

Originally Published MPMN October 2004

PRODUCT UPDATE

When the Pressure Is On

Pressure sensors and transducers used in lifesaving applications must meet demanding requirements

Susan Wallace

FOP-MIV pressure sensors from Fiso Technologies Inc. are ultrasmall in order to fit within the tight physical diameters of a catheter.

Devices that measure various pressures in the human body have to be absolutely accurate. This means that all their components, but especially built-in pressure sensors, have to be able to withstand even harsh circumstances. The sensors have to perform even when overwhelmed by electro-magnetic interference from other equipment. To fit within the tight physical dimensions of a catheter, they have to be ultrasmall. If they are to be used in single-use products, they also need to be cost-effective.

FISO Technologies Inc. (Quebec, PC, Canada) has introduced fiber-optic pressure sensors that it says can meet all of these requirements. The company’s FOP-MIV units are suitable for minimally invasive pressure-sensing applications such as blood pressure monitoring, and intracranial and intrauterine urodynamic testing.

The sensors are based on the combination of micromechanical systems and Fabry-Perot interferometer technologies. The sensing element is a silicon diaphragm manufactured using processes derived from the semiconductor industry. The diaphragm forms a recessed cavity to be bonded on top of a glass capillary. A lead fiber-optic cable is pigtailed to the capillary.

The inner surface of the diaphragm and the surface of the glass substrate are coated with dielectric multilayer mirrors treated to partially reflect light. The space separating the mirrors forms a Fabry-Perot interferometer. Light reflected in the interferometer is wavelength-modulated in accordance with the cavity length.

As pressure rises, the diaphragm deflects and comes closer to the bottom mirror. The optical spectrum reflected by the interferometer is unique for each cavity length.

A white-light correlator is a spatially distributed Fabry-Perot cavity in which the cavity length varies along the lateral position. The conversion of the optical signal into an electronic representation is completed by a combination of a Fizeau interferometer and a linear CCD array. Light is transmitted maximally at the exact location along the Fizeau interferometer where its spacing equals the cavity length of the sensor. The interferometer makes a spontaneous correlation of the signal for all spacing values of the cavity.

Further processing detects the maximum peak response obtained by a pixel-decoded photodetector and determines precisely the absolute cavity.

The signal conditioner is designed to be integrated into an existing system, or can be externally interfaced to a monitor.
The company believes its fiber-optic technology has several advantages over liquid-filled, piezoelectric, or intensity-backed optical sensors. One of these is intrinsic immunity. Because of the optical nature of the sensors and transmission line, a monitoring system can deliver high-fidelity pressure measurements even in the presence of strong electromagnetic, microwave, or radio-frequency fields.

The sensors’ ultraminiature size is also an advantage. They are small enough to fit inside a needle or at the tip of a catheter. The nominal diameter is of 0.55 mm.
Fiber-optic units from Fiso Technologies Inc. can be integrated into a variety of minimally invasive pressure-sensing applications.

Insensitivity to light loss is another benefit. In case of light loss due to fiber bending, cable length, or light-source fluctuations, the light signal detected by the CCD array may vary but the position of the maximum peak is maintained.

No calibration is needed. An optical intelligent connector allows the user to change one sensor to another as a plug-and-play procedure. The intelligent connector has a top-mounted EEPROM that contains all the calibration parameters of each sensor.

Transducer Is Suitable for Process Systems

A pressure transducer uses CVD strain gauge technology. The Model 512 from Setra Systems Inc. (Boxborough, MA) has a thick diaphragm to withstand pressure spikes, shock, and vibration caused by the harsh physical and environmental conditions of industrial applications.

The Model 512 pressure transducer withstands pressure spikes, shock, and vibration caused by the harsh conditions of industrial applications.


The unit’s design is resistant to aging and virtually insensitive to thermal transients and pressure cycling. Users can expect less than 0.2% drift per year.

The Model 512 offers 0.5% full-scale accuracy, a compensated temperature range of –5° to 180°F, and gauge or compound pressure ranges from –14.7 to 6000 psi. The transducer’s proof pressure specification is 43 full scale, with less than a 1.0% zero shift. All wetted parts are constructed of corrosion-resistant 17–4-pH stainless steel.

A variety of voltage or current outputs are available over almost any pressure range. Choices of pressure fitting and cable electrical termination are offered, enabling the unit to be custom configured to any OEM application.

Force Sensor Measures Blockages in Tubing

A thin-film force sensor from SMD Sensors (Meriden, CT) is used in ambulatory infusion pumps to measure occlusions in silicone or PVC tubes. The tube with associated fittings is known as a disposable set. The SMD100 sensor is pressed against the outside of the tube and detects an increase in force as downstream blockage causes pressure in the tube to increase.

An advantage of the sensor is that it can be used with an inexpensive standard tube, reducing the cost of the disposable set, thereby saving money. The SMD100 is made using a 10,000-W bridge, giving 1-mV output per volt on input power. It is available in custom shapes for different placements.

Copyright ©2004 Medical Product Manufacturing News

Sterilization

Originally Published MPMN October 2004

Outsourcing Outlook

Sterilization

Company Offers EtO Sterilization Services

EtO sterilization services are available from a ISO 13488-certified company. Its 30,000-sq-ft facility allows for quick order processing and delivery. The company also performs sterility testing on customer products. Long Island Sterilization, Hauppauge, NY
www.devicelink.com/company98/co/ 206/20669.html


Support Services Are Available

A range of services, from process selection and cycle development through performance qualification and certification, are available from a sterilization contractor. Validations for EtO, VHP, moist heat, dry heat, E-beam and gamma irradiation, and aseptic processing are offered. The company provides process selection
and customized protocol development to meet current AAMI and ISO standards, as well as consultation services. Sterilization Validation Services, Oceanside, CA www.svs.com


Contractor Provides Three Types of Sterilization

A contract sterilization service provider offers gamma, EtO, and E-beam sterilization. The company's technical support team assists customers in all phases of the sterilization design process, including product development, materials testing, protocol generation, and sterility validation. There are 16 facilities available for sterilization services. Steris Isomedix Services, Mentor, OH www.isomedix.com


Contract Sterilization Services Are Offered Globally

Sterilization and laboratory services are offered worldwide by a firm with expertise in gamma, EtO, and E-beam technologies. With more than 1000 employees in 38 facilities around the globe, the company offers customized distribution and sterilization services, equipment, and technical advice.

Many of the company's EtO sterilizers have been fitted with microwave spectrometers. These devices monitor the EtO gas concentration and in-chamber humidity during the sterilization process. Spectrometers are reliable and easy to calibrate; most importantly, they provide the measurement capability to allow the elimination of biological indicators in routine processes, according to the company. This reportedly accelerates product release. Sterigenics, Oak Brook, IL
www.sterigenics.com


Assembly and Packaging Services Supplier Also Provides EtO Sterilization

Low-cost and high-quality assembly, packaging, and EtO sterilization services are offered in state-of-the-art Class 10,000 and Class 100,000 cleanrooms. The Istanbul-based firm is certified to ISO 9001, ISO 13485, and EN 550. "Apart from our regular manufacturing activities, we also offer contract sterilization services to third parties," says general manager Utku Oguz. "Our sterilization system is revalidated every year. Also, we are the only company in Turkey to have completed the software validations that are required by the new ISO 13485 standard."

In the Class 100,000 cleanroom, the company currently manufactures surgical sutures and carries out suture-needle attachment operations. Daily packaging capacity for IV infusion sets is 120,000. Sterile Health Products Inc., Istanbul, Turkey www.steril.com


Packaging, Lab Testing, and Sterilization Are Available On-Site

Medical device sterilization, including custom packaging and laboratory services and all necessary validation support, is available to customers nationwide. The company will accept projects ranging from processing only to complete turnkey services. Three facilities are equipped to complete all services on-site.
Centurion Sterilization Services, Howell, MI www.centurionsterile.com

Copyright ©2004 Medical Product Manufacturing News

Microtechnology

Originally Published MPMN October 2004

SPOTLIGHT

Microtechnology

Optocouplers

Two types of optocouplers are available for use in implantable applications. The photovoltaic and phototransistor optocouplers provide gate drive voltage and effective isolation in small surface-mount packages. The 52464 photovoltaic optocoupler consists of an LED and photovoltaic detector in a 125-mil-package and supplies dc voltage for driving field-effect transistors (FETs) and/or insulated gate bipolar transistors (IGBTs). The 52465 phototransistor optocoupler comes in a 95-mil-square package size and has an LED and a phototransistor that provides optical isolation. Both components can be attached with epoxy or solder and are suitable for hybrids or COB applications. Micropac Industries Inc., Garland, TX www.micropac.com



Precision metal parts

Precision metal parts as small as 1 mm diam are produced using CNC machines. Many metals can be cut and machined using the company’s twin-spindle CNC micromachining center. Twin-spindle machines eliminate all secondary operations and handling. Machining operations such as turning, milling, drilling, and deburring are accomplished within the machine for accuracy and control. MicroGroup, Medway, MA www.microgroup.com




Data acquisition system-on-chip

A versatile single-chip data acquisition chain consists of a programmable gain/offset-amplifying, high-resolution analog-to-digital convertor (ADC), a 120-segment LCD driver, and a communications interface. The XE88LC02 chip enables ultra-low-power miniature medical and metering devices to be built with a minimum of external parts. The programmable 16-plus-10-bits chip uses less than 2 µA in real-time clock mode and a typical 300 µA/MIPS in sustained computing mode. It connects directly to any type of resistive sensor and is easily calibrated. Xemics S.A., Neuchâtel, Switzerland www.xemics.com





DNA capture media

A fibrous media can be bonded into shapes to fit pipette tips, spin columns, and microtiter wells. The DNA capture media uses a dual approach
to DNA isolation. The fiber has a natural affinity with DNA, and the bonded fiber structure functions as a size-exclusion filter. Media performance can be enhanced by using pendant amine or carboxyl groups on the fiber to attach cross-linking chemistries. Filtrona Fibertec, Colonial Heights, VA www.filtronafibertec.com



Optical encoder

A compact, 1/2-in. optical encoder requires minimal behind-panel space. The Series 62S component features a minimum life expectancy of 1 million rotational cycles; 8,12,16, 20, 24, 32 detent positions; and an optional integral push button. If needed, the company will customize the switch, including terminations, shaft and bushing configurations, and resolutions. The encoder is suitable for applications where behind-the-panel space is limited. Grayhill Inc., La Grange, IL www.grayhill.com 


Microsolenoid valve and ceramic pumps

A microsolenoid two-way valve is designed for the dispensing or metering of fluids in small package sizes. The Geronimo valve uses a microdiaphragm to isolate the fluid path and provide a durable seal. Specially created for high-density manifolding applications, the valve features a low internal volume and a diameter of 0.25 in. The company’s series of small ceramic pumps are self-priming and are factory-set for a fixed volume of 10 to 1000 µl per solenoid actuation. The pumps have a low internal volume and a Cv range of less than 1%. An all-ceramic plunger and seal add resilience to the products. Kloehn Ltd., Las Vegas, NV www.kloehn.com


 


Instrument controller

A C-programmable embedded instrument controller with a built-in, touchscreen-operated GUI can be used in OEM applications such as robotics, portable data acquisition systems, and scientific instruments. The controller features a high-contrast, 128 ¥ 240- pixel display with a touchscreen overlay, up to 1 MB Flash and 512 K RAM, and precoded device drivers. The unit uses a real-time, multitasking operating system. It commands eight 8-bit A/D lines, eight digital I/O lines including timer-controlled and PWM channels, and two RS-232/485 ports. Mosaic Industries Inc., Newark, CA www.mosaic-industries.com


Turning center

A turning center can micromachine complex parts in a single setup for fast production and high accuracy. The Deco 13a features 10 independent axes of motion, software that can program multiple axes of movement with a macro program, and several rotating tool positions. The single-spindle automatic machine accommodates part diameters from 13 mm, making it suitable for a variety of small medical implants and bone screws. Users can enhance machine performance by opting for 12 axes with two additional spindles. Tornos, Brookfield, CT www.tornos.ch


Miniature linear guides

Two series of miniature stainless-steel linear guides are available. The guides incorporate molded resin in the ball slider recirculation circuits in order to enhance motion smoothness and minimize slide weight, metal-to-metal noise levels, and dust generation. Offered in five accuracy grades, the guides can be supplied with a fine clearance or slight preload based on the customer’s application. NSK Precision America Inc., Addison, IL www.nskprecision.com


Miniature brakes and clutches

Miniature slip brakes and clutches are typically used for manufacturing wire-reinforced small tubing used in clearing heart artery blockages, manufacturing wire stents, and testing small motors. The brakes are typically used for load simulation and unwind (payout) tensioning of films and wire. Clutches are used for rewind tensioning and torque limiting. The magnetic particle brake B5DZ has a torque range of 0.05 to 1 oz-in. The company’s magnetic particle clutch C5D has a torque range of 0.2 to 5 oz-in. Hysteresis brakes as small as 0.12 to 5 oz-in. are also available. Independent of slip speed, torque is varied from near zero to rated torque by varying input current. Long life, even under constant slip, is assured with the company’s patented magnetic seals. Placid Industries Inc., Lake Placid, NY www.placidindustries.com

Copyright ©2004 Medical Product Manufacturing News

Disposables

Originally Published MPMN October 2004

SPOTLIGHT

Disposables


IV fluid control


Product design and development is available from a provider of IV fluid control technology. Projects are followed from concept to market by developing required technologies and devising strategic business solutions. The company specializes in one-way and bidirectional check valves as well as needleless access systems. Manufacturing is performed in Class 100,000 cleanrooms. Nypro Medical Products Group, Clinton, MA www.npmedical.com



Flexible catheter systems

A maker of custom medical devices and components manufactures complex disposables for a catheter system used for high- and pulsed-dose cancer treatments. The treatment needle assembly can be removed between patient treatments. The catheter buttons and needle assemblies are marked with channel numbers for quick, accurate reconnection to the system’s afterloaders. The system design reduces the chance of catheter kinking. Medisize, Hillegom, Netherlands www.medisize.com



Liquid dispenser

Cleaning validation of a liquid-dispensing system is simplified with peristaltic pump technology. Disposing of the entire fluid path eliminates cross-contamination between production runs. For each production batch, a new, sterile, disposable tube is used. In most cases, product changeovers and validation can be accomplished in less than 5 minutes. The company’s liquid-filling technology is suitable for pilot lot manufacturing as well as large-scale filling operations. Flexicon America Inc., Burlington, VT www.flexiconamerica.com




Adhesive materials and manufacturing

Three adhesive coating lines produce a variety of single- and double-coated pressure-sensitive materials. Typical materials include woven and nonwoven fabrics, plastic and breathable films, foams, foils, and paper. Adhesion characteristics can be targeted to meet specific product performance requirements. The company also offers slitting, sheeting, die-cutting, and packaging services. Kapco, Kent, OH www.kapco.com



Miniature screened orifice

Consistent, uniform flow is an essential requirement of medical fluid-handling systems and components. A miniature screened orifice is designed for these types of critical flow control applications. The orifice is preinstalled in a male-to-female luer adaptor and features an integral safety screen that protects the device from contamination. Designed for both liquid and gas media, the orifice is available in 18 standard flow rates. Each part is 100% tested with either water or nitrogen to ensure 5% flow-rate tolerances. The orifice is made from stainless steel and the luer adaptor is made of medical-grade polypropylene. The Lee Co., Westbrook, CT www.theleeco.com   


Needle-free valves

Needle-free valves feature a flush, swabbable top to minimize contamination. Made of latex-free materials, the SmartSite valves comprise only three parts and have a straight fluid-path design similar to a standard injection port. The streamlined design makes the valves cost-effective to manufacture. SmartSite technology can be adapted to most IV administration applications. Uses include infusion pump sets, heparin and saline locks, extension sets, vial access pins, vial adapters, and bag spikes. Alaris Medical Systems, San Diego, CA www.alarismed.com



 


Disposable tubing and molded fittings

Extruded, corrugated, and collapsible plastic tubing and injection-molded fittings are available from a manufacturer. Production and assembly services are also offered. Visitors to the company’s Web site can view images of its product lines and request samples. GlobalMed Inc., Trenton, ON, Canada www.globalmedinc.com






Die-cutting, laminating, and slitting services

A manufacturer specializes in precision die-cutting, laminating, slitting, rewinding, assembly, and printing. Custom fabrications are built to customer specifications. The company can convert different materials, including medical-grade tapes and films, foils, papers, and hydrogels. Assistance in materials selection and design is also offered. Pepin Manufacturing Inc., Lake City, MN www.pepinmfg.com



Copyright ©2004 Medical Product Manufacturing News

Bringing It All In House

Originally Published MPMN October 2004

PROFILE

Bringing It All In House

Microblasting technology helps pacing-lead manufacturer integrate molding and machining processess

Joyce Laird

Oscar Inc. uses a microblasting device supplied by Comco Inc. to deburr small parts, retexture the inner surface of molds, and clean extrusion dies.

Oscor Inc. (Palm Harbor, FL; www.oscor.com) has been in the business of manufacturing pacing leads in a variety of shapes and lengths for 26 years. It also produces associated parts and the transvenous introducer systems that are used to place cardiac pacing leads. In addition to self-branded product lines, the firm has rapidly expanding lines of OEM products.

A pacing lead carries the electrical signals between a pacemaker and a human heart. Complementary parts include tips, coverings, and fixation devices such as small, flexible silicone tines that attach the lead directly to the heart muscle. Such tines can be as small as 7 French (2.3 mm).

In 2003, the firm decided to bring all manufacturing processes in-house to improve quality control and reduce lead times. By integrating manufacturing capabilities that had been outsourced, the company eliminated fluctuations in quality and production delays that were restricting its ability to respond quickly to the rapidly growing OEM market.

Two key processes brought in-house required adding a machining and mold-making division to the company. Ernest DeBella, manager of operations for these divisions, was put in charge of integrating them into the company’s overall production flow. “We have two thermoplastic and four silicone molders,” explains DeBella. “We also have two extrusion lines, and four Swiss-style lathes for making metal parts. Our machining facility makes the metallic portions that we overmold into electrical connectors, and we have a shop that makes the molds," says DeBella.

Microblasting technology cleans and textures small parts without altering their surface dimensions.


Several aspects of mold making caused DeBella concern. The mold’s inner surface must have a precise texture that allows the material to flow and permits the formed part to be released easily. Through repeated use, the surface tends to become smooth, causing material to stick to it. Reconditioning is required to solve this problem. The extruders also need to be torn down and cleaned of residue periodically to keep the equipment from “gumming up” and to meet quality control specifications.

“The sizes we're working with and the accuracy required leave no room for error,” says DeBella. “We’ll take a 1-mm-diam pin that is 5 mm long and overmold it with silicone. To do this, you need a shutoff mold. By that, I mean the cavity has to end against that pin. That requires hitting numbers very, very closely on each pin. We’re talking about minute standard deviations,” says DeBella. “Surface retexturing can’t cause a deviation in the mold dimensions,” he adds.

Blasting Ahead

DeBella did his research on the Internet and learned about the use of microblasting technology in the mold making and machining industries. A refined version of sandblasting, microblasting is designed to clean, texture, deburr, or otherwise process very small parts and hard-to-reach areas with extreme accuracy. The variety of abrasive media that are available and the capability to adjust the blast pressure offer users a great degree of process control. Micro-blasting can achieve precise close-tolerance cleaning and texturing without altering the part’s surface dimensions.

Consisting of a control unit and work chamber, this compact equipment blasts a jet of dry air and abrasive media through the nozzle of a pencil-like stylus. Nozzle openings can range from 0.018 to 0.060 in.

Pacing leads, introducer systems, and associated parts are manufactured by Florida-based Oscor Inc.

DeBella tested various vendors’ equipment by sending the companies samples and evaluating the results. Ultimately, a microblaster designed and built by Comco Inc. (Burbank, CA; www.comcoinc.com) carried the day. “We now have a Comco MicroBlaster model MB1000-1 and are using 25-µm glass-bead abrasive media. We set our air pressure at 60 psi, and it gets the job done perfectly,” says DeBella.

Although Oscor purchased the unit specifically for mold cleaning and texturing, the firm soon discovered that it had other applications. “We also found that we could clean our extrusion dies with it,” says DeBella. “We frequently change plastics between runs. That requires a teardown of the extrusion lines. The pin and die set is pulled and the crosshead is disassembled. We burn old residue off in a furnace and then blast it with glass beads to completely clean it off,” he explains. “We are also using the blaster to deburr parts in the machine shop,” adds DeBella. “It has turned out to be a great tool with a lot of versatility.”

Oscor's standard line includes more than 20 different leads, plus associated introducers and related products. The OEM side is growing daily, and many large, long-term OEM projects are in process. It comes down to manufacturing in the tens of thousands of units using costly FDA– compliant materials such as implantable silicone, 316 L stainless steel, titanium, and platinum meridian. Tolerances are very tight, and all production machines are top of the line. Keeping that equipment and its working assemblies in good condition ensures a perfect product every time.

Copyright ©2004 Medical Product Manufacturing News

Polymer Library Offers Database of Journals and Data Sheets

Originally Published MPMN October 2004

E-News

Polymer Library Offers Database of Journals and Data Sheets

www.polymerlibrary.com (click to go to site)

Melody Lee

A virtual Polymer Library by Rapra Technology (Shrewsbury, Shropshire, UK) recently changed its interface to enable easy searching and displaying of results. The revamped site also allows account details to be more closely monitored. The new system displays purchase history for up to 14 months.

The library contains more than 820,000 records on the rubber, plastics, and adhesives industries. According to the site, about 35,000 records are added each year. Using only already published material, the Web site lists information from journals, reports, and data sheets. Topics include properties and testing, raw materials, and market statistics. Available in a number of languages, the site’s contents come from around the world including North America, Europe, and Asia.

New users can sign up for free trial access. As a subscriber, a number of options are available. The price of viewing abstracts varies with the plan, and unlimited viewings for an unlimited number of members is also an option.

Copyright ©2004 Medical Product Manufacturing News

Selection Center Matches Users’ Needs with Sensors

Originally Published MPMN October 2004

E-News

Selection Center Matches Users’ Needs with Sensors

www.balluff.com/bmf (click to go to site).
Melody Lee

Balluff Inc. (Florence, KY) added a pneumatic cylinder sensor selection center to its Web site. The application matches one of the company’s sensors with mounting hardware. Information on more than 500 pneumatic cylinders from other manufacturers is given.

“An on-line database allows a user to find the correct sensor and associated bracket, based on the cylinder type,” says Shannon Deye, the company’s marketing communications manager. “The center makes the process of matching a sensor to a cylinder transparent. A data sheet [is printed out] and offers the user a chance to
e-mail an RFQ.”

Information is available on sensor features, such as housing and connector options, output, and operating voltage. The company’s sensor family consists of six designs and a full line of related bracketry, cables, and connectors.

Copyright ©2004 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN October 2004

E-News

My Favorite Bookmarks

Paul Lum
Paul Lum, Member of Technical Staff,
Pelikan Technologies Inc.


The Web site for the Institute of Physics (www.iop.org) is tied to advanced topics in technology. The institute is a professional body promoting an interest in physics among all age groups. The site is a great place to begin searching for articles on physics and related topics, such as nanotechnology. Users can meet with others in their areas of specialty through community events posted on-line.

Medscape (www.medscape.com), associated with WebMD, contains a great deal of information on current news and developments in medicine. The Medscape updates or alerts are an excellent resource for staying on top of weekly developments. A resource center breaks the site’s contents into more than 60 categories for easy access. Registered users can participate in discussion boards.

The U.S. Department of Health and Human Services’ National Institutes of Health (www.nih.gov) site is great for finding facts on science and medicine. MedlinePlus, an on-line database, allows you to search topics on virtually anything dealing with medicine. A news section highlights issues such as health and medical research.

Bloodgas.org (www.bloodgas.org) is an excellent source for point-of-care testing, blood gas measurement, or related topics. Experts and healthcare professionals provide most of the site’s content. The main sections cover technology, quality assurance, point-of-care testing, and neonatalogy.

Optics.org (www.optics.org) is an updated resource on the latest developments in optics applications. The main page directs users to links such as new products, patent highlights, events, and a buyer’s guide. After reading feature articles, users can leave comments to share with others.

Pelikan Technologies (Palo Alto, CA; www.pelikantechnologies.com) addresses the key barriers of pain and ease of use in diabetic measurements. The company develops products that will significantly improve glucose monitoring, leading to improved compliance and better long-term disease management.

Melody Lee

Copyright ©2004 Medical Product Manufacturing News

In Brief

Originally Published MPMN October 2004

INDUSTRY NEWS

In Brief
Susan Wallace

Medical device outsourcing firm Precision Medical Products Inc. (Denver, PA; www.pmp.net) has purchased the operating assets of Hershner Enterprises Inc. (Shrewsbury, PA), a company trading as Specialized Precision Injection Molding. . . Curtiss-Wright Controls Inc. (Gastonia, NC; www.cwcontrols.com) has agreed to acquire the assets of Synergy Microsystems Inc. (San Diego, CA; www.synergymicro.com) for $49 million. . . The Protomold Company, Inc. (Maple Plain, MN; www.protomold.com) has been named a Deloitte & Touche 2004 Minnesota Technology Fast 50 winner. The list ranks the fastest-growing Minnesota-based technology companies, measured by revenue growth over a five-year period. . . Polytec PI Inc., a provider of laser-based measurement systems, has reorganized to become Polytec Inc. (Tustin, CA; www.polytec.com), completing the separation of Polytec and PI’s North American operations. . . Indigo Systems (Goleta, CA; www.indigosystems.com) has changed the name of its miniature infrared camera from Omega to ThermoVision Micron. . . Microphoto Inc. (Roseville, MI; www.microphoto.net) has announced the completion of a 3000-sq-ft metal-etching facility and will begin another phase of expansion in the near future. . . Nypro Inc. (Clinton, MA; www.nypro.com) will create new applications for hook fasteners, using patented technology by Inter-Mold Corp. (Naples, FL; www.inter-mold.com) that allows a one-step injection molding of fasteners directly into plastic parts. . . Precision Wire Components (Portland, OR; www.pwcwire.com) expanded into a 40,000-sq-ft manufacturing plant to mark its eighth-year anniversary. . . Rice Lake Weighing Systems (Rice Lake, WI; www.rlws.com) has purchased the assets of Powell All-Steel Scales (Jasper, AL; www.powellscales.com), a manufacturer of heavy-capacity scale equipment. . . GE Inspection Technologies (Huerth, Germany; www.geinspectiontechnologies.com) has opened its China Application Center in Shanghai, bringing its total number of centers to eight worldwide.

Copyright ©2004 Medical Product Manufacturing News