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Articles from 2003 In September


Reflecting on the Golden State

Originally Published MPMN September 2003

EDITOR'S PAGE

Reflecting on the Golden State


California is known as the Golden State for many reasons. It has golden beaches, golden poppy fields, and more than a few golden people. It shines with the glitter of Tinseltown and the mythical endless summer. Celebrities and former presidents call it home, and the rest of the nation seems to be fascinated with its every facet.

So when the editors of MPMN chose to focus on Southern California in this issue--a decision that was made in 2002--we knew the state would be in the news in some way. However, recent happenings have exceeded our expectations.

Next month, for the first time in the history of the state, its citizens will decide whether to recall their governor. Candidates seeking to replace him have been talking a lot about how bad the economy is. Maybe that's true.

But seemingly not for the medical device industry. Biotechnology-related businesses in the state have continued to expand during the recent economic downturn. And, in 2002, California led the nation in the number of firms in three areas of biotechnology: medical biotechnology, medical devices, and agricultural biotechnology. Close to a third of all biotech companies in the United States are located in the state.

Even better, these industries are projected to grow by more than 30% from 2000 to 2010. This is expected to add an estimated 219,000 new jobs. The medical instruments sector in the state currently employs 52,000. It is projected to grow by more than 10% to 58,000 jobs in 2010.

Obviously, medical device manufacturers see the appeal of doing business in California. More than 5500, or a little more than 20% of the country's medical device establishments are in the state. The reasons are clear. The area is blessed with a moderate climate and easy access to skilled labor. And it is strategically positioned on the Pacific Rim. 

Because Southern California contributes so much to the nation's medical device industry, MPMN's editors decided to devote a special section in this issue to the region. It has long been known for its innovations in medical technology, a tradition that continues. 

For example, San Diego-based Apex Medical Technologies has developed a new curing process for synthetic polyisoprene latex. The process uses organic peroxides that do not rely on any accelerators. Because accelerators are usually the cause of allergies in the end-user, this problem is eliminated.

Another company, Photobit Corp. (Pasadena, CA), is a supplier of CMOS image sensors. The company recently created a sensor that is embedded in a capsule meant to be swallowed by a patient to explore the gastrointestinal tract. It transmits color video signals as it travels through the stomach and small bowel.

New companies are also sprouting up in Southern California. They are developing technologies that are attracting serious money from venture capitalists. Orquis Medical Corp. (Lake Forest, CA) makes minimally invasive devices aimed at treating congestive heart failure. NuVasive Inc. (San Diego) offers an intraoperative nerve guidance system that enables a surgeon to navigate past nerves while advancing cannula to access the spine. The company's surgical navigator uses radiographic imaging to help a surgeon accurately guide cannulae and surgical instruments to targeted areas of the spine.

Clearly, Southern California has a lot to offer the medical device community. For the rest of the story, turn to page 40 for a feature article and supplier profiles.

Susan Wallace
, Managing Editor

Copyright ©2003 Medical Product Manufacturing News

System Integrates Manufacturing and Regulatory Controls

Originally Published MPMN September 2003

INDUSTRY NEWS

System Integrates Manufacturing and Regulatory Controls

Laura Angela Bagnetto

A system that integrates corrective action programs and manufacturing controls has been developed for companies in regulated industries. The fruit of an alliance between Camstar Systems Inc. (Campbell, CA; www.camstar.com) and Pilgrim Software Inc. (Tampa, FL; www.pilgrimsoftware.com), the product seeks to speed reaction times.

Marketed under the Camstar name, the system addresses manufacturing, quality control, and regulatory issues in compliance with 21 CFR Part 11. One of its key features is the integration of real-time detection and response, notably in respect to the handling of corrective and preventive action (CAPA) procedures.

"The system will register a nonconforming event and open up a CAPA report," says Rob Rudder, vice president of business development at Camstar. Everything comes to a halt until the problem is resolved. A role-defined alarm alerts the appropriate person, whether it is the machine operator, quality assurance manager, or someone at the corporate level. "That is what this system is all about," says Rudder. "It delivers information to the right person so that he or she can react quickly."

Alerts can be sent via e-mail or to a pager or PDA. Most companies opt for e-mail, according to Rudder. The alerts can be viewed on the company's intranet to foster "collaboration in working out a solution," says Rudder. Managers are also able to monitor progress and response times.

Camstar and Pilgrim both embed .net and xml Web services in their applications. This made it easy to blend the functionality of both systems while providing a common user experience. The resulting product reportedly can help device OEMs improve quality, increase yields, and speed new products' time to market while achieving regulatory compliance.


Copyright ©2003 Medical Product Manufacturing News

Partnership Focuses on R&D of Polymer Nanocomposites

Originally Published MPMN September 2003

INDUSTRY NEWS

Partnership Focuses on R&D of Polymer Nanocomposites
PNC-Tech members study some of the latest nanocomposite samples.

Melody Lee

The National Research Council Industrial Materials Institute (NRC-IMI; Boucherville, QC, Canada, www.cnrc-nrc.gc.ca) has launched an R&D initiative in partnership with 13 major companies. Known as PNC-Tech, the initiative plans to invest $300,000 a year in R&D focused on the development of polymer nanocomposites, which are plastic-based materials. 

The list of partnering companies ranges from manufacturers of compounds and polymers to end-users, and is expected to increase to include other companies and universities. Companies investing in the partnership will benefit from the research as they move to incorporate these high-performance materials in next-generation products.

"Nanotechnologies will play an important role in tomorrow's manufacturing industries," says Allan Rock, minister of industry and minister responsible for the National Research Council.

Polymer nanocomposites are plastic materials mixed with small amounts of clay, named as such because the clay must be mixed into the plastic at a nanometric scale. Specifically, a few molecules of clay are sandwiched between minuscule layers of plastics or polymers, resulting in a new material that adopts many properties including strength, resistance to permeability, and heat stability.

The processing, behavior, and performance of polymer nanocomposites are all areas that will be covered in the initial research being funded by PNC-Tech. Nanoparticle surface modification routes for specific applications will be studied, as well as the development of the melt blending process. 

"The partners decide the topic and goals of the research program, and the institute does the work," says Blaise Labrecque, business officer for NRC-IMI. "Once the research is performed internally, the results must be kept confidential for two years, but the partners can use the information on a privileged basis for R&D."


Copyright ©2003 Medical Product Manufacturing News

New Facilities Help Speed Up Services for OEMs

Originally Published MPMN September 2003

INDUSTRY NEWS

New Facilities Help Speed Up Services for OEMs
Coastal Life Technologies' new cleanroom and distribution center will increase its production and service capabilities.

Susan Wallace

Contract manufacturer Coastal Life Technologies Inc. (CLT; San Antonio, TX; www. cltsa.com) recently celebrated the completion of a new cleanroom and distribution center. The company says the new facilities will increase the level of its production and service capabilities.

The FDA-registered and ISO/EN-certified company has numerous employees with vast knowledge of the medical device manufacturing industry. This allows for rapid response to a variety of customer requirements from private labeling to cleanroom assembly and packaging, engineering, sterilization, and distribution services.

The company is dedicated to creating partnerships that enable the company to be a "one-stop" solution for servicing OEMs in a timely and cost-effective manner.


Copyright ©2003 Medical Product Manufacturing News

A Software Application Enables Compliancein Revenue Execution

Originally Published MPMN September 2003

INDUSTRY NEWS

A Software Application Enables Compliance in Revenue Execution

Rita Emmanouilidou

A software suite is designed to help medical device manufacturers manage their revenue execution processes. Revenue Execution version 4.0 from Model N (South San Francisco, CA; www.modeln.com) captures all the stages of the process, from pricing strategies to compliance tracking. "Revenue and profit are the most critical drivers of company value," says Zack Rinat, CEO and founder of Model N. "Automating the process provides the opportunity to unlock company value."

Traditional revenue tracking systems involve the use of spreadsheets and off-line databases. However, these are not shared by all users. Therefore, they cannot be kept completely up-to-date. Moreover, certain procedures--such as the calculation of payments for incentives--are manual, and therefore prone to error. Most importantly, companies may risk audit and legal exposure because of the difficulty of complying with government pricing information requirements. Pricing changes alone have an enormous impact on a company's overall financial health. Medical device manufacturing and supply firms are particularly susceptible to erosion of pricing because of constantly evolving contracts and multiple levels of government regulation.

Model N software acts as an internal control mechanism, ensuring complete transparency and access to the most up-to-date information. First, it captures a company's pricing strategy in a centrally located system. All information is accessible by sales and customer support teams. The suite also automates the contract management process, including internal approvals, renewals, and expirations. Customers' compliance with contract terms, as well as the company's compliance with government pricing rules can both be monitored through the system. The software also automates the setup and tracking of settlement processes such as those for incentive rebates. 

"The new Model N software suite supports the cross-departmental processes required for strong revenue execution," says Rinat. He adds, "Perhaps most importantly, it provides critical visibility into compliance--both customers' compliance to deal terms and a company's compliance to government regulations around pricing."

Copyright ©2003 Medical Product Manufacturing News

NPE Exhibitors Eye Medical Device Applications

Originally Published MPMN September 2003

INDUSTRY NEWS

NPE Exhibitors Eye Medical Device Applications

Mediflex compounds for tubing extrusion and other medical applications were introduced by Star Thermoplastic Elastomers at the recent NPE show.

Norbert Sparrow

Hammered by rising oil prices and knee-deep in a soggy economy, the plastics industry did not anticipate a blockbuster NPE show in Chicago this year. Some openly wondered how bad it was going to be. Although attendance contracted by almost 30% compared to the record set in 2000, the number of exhibitors, down only 4%, barely took a hit. More important, the exhibitors I spoke with were fairly upbeat. Of course, most of my appointments were with suppliers for whom the medical device industry is a key customer. They have good reason to be optimistic.

According to a recent report on the medical device plastics market, demand for resins will grow by more than 4% annually over the next five years. By 2008, medical technology companies will consume almost 2.9 billion lb of resin, according to Business Communications Company, Inc. With growth industries hard to come by, it should be no surprise that NPE exhibitors were eager to highlight products with medical applications. Here are a few that caught my attention.

Building a Better Antimicrobial

The Specialty Elastomers Business of Milliken Chemical (Spartanburg, SC; www.millikenchemical.com) chose NPE to launch its nonleaching antimicrobial heat-cured rubber compounds. The Elastoguard materials reportedly address some of the deficiencies of "traditional antimicrobial materials that come from an organic base," according to Scott McDowell, marketing analyst and planner for Milliken's coated products and elastomers business. One drawback of organic-based products is the tendency of chemicals to leach from the matrix material, leaving parts of the surface unprotected. In addition, "the chemicals tend to degrade at processing temperatures over 250°C," says McDowell.

The biocide used in Elastoguard compounds permeates the entire rubber part. The proprietary Alphasan silver-sodium-zirconium-phosphate ion-exchange resin provides complete protection without zones of inhibition or noninhibition. Nor will the biocide degrade over time, says the company. In fact, its performance is enhanced during use as abrasion of the rubber causes more of the agent to reach the surface. The resin is thermally stable, and can tolerate temperatures greater than 800°C, according to McDowell.

Potential uses for elastomeric products with the silver-based biocide include seals, gaskets, O-rings, casters, diaphragms, liners, and tubing. Wound-care products and catheters are also among its medical applications.

A couple of companies introduced new lines of thermoplastic materials suited for medical applications. Star Thermoplastic Elastomers (Chicago; www.starthermoplastics.com) unveiled its Mediflex compounds, which are available in grades ranging from 8 Shore A to 60 Shore D. Suited for a variety of medical products, the materials are nonallergenic and recyclable, and can be specified colored, translucent, or clear. They contain no carbamates or potentially hazardous extractables.

New antimicrobial 
materials from the Specialty Elastomers Business of Milliken Chemical are suited for the manufacture of gaskets, seals, O-rings, and numerous other medical device components.

Thermoplastic polyurethanes (TPUs) that are based on a new high moisture vapor transmission (HMVT) technology were among the featured products from Noveon (Cleveland; www.estane. com). The Estane high-heat and ultra HMVT formulations are suited for a number of breathable medical applications such as apparel and wound-care products.

"The technology involves a different chemistry than we used in the past," says new business development manager Susan Hemphill. "It creates a monolithic barrier in film or coated form," she adds, keeping out water and other fluids while allowing moisture vapor to move about freely. Micropores or perforations are not needed. In addition, the chemistry allows manufacturers to "dial in" the material's breathability for specific product applications.

The high-heat HMVT TPU is designed for processors requiring high thermal performance. Increasing the thermal behavior of a breathable product broadens the processing conversion options, notes the firm. Also based on the company's Estane TPU technology, the Ultra HMVT TPU reportedly provides a 50% improvement in moisture vapor transmission over the firm's conventional HMVT materials.

Equipment News

A supplier of plastics-joining equipment employing various technologies, Branson Ultrasonics Corp. (Danbury,NJ; www.bransonultrasonics.com) exhibited its new infrared assembly method (IRAM) laser systems. Operating in simultaneous and scanning modes, the IRAM systems are designed for demanding customers that need a "perfect weld with no flash or particulates and fast cycle times," says marketing director Sylvio Mainolfi. The modular welders are available in 100-, 125-, and 750-W versions. Laser IRAM equipment can be integrated into automated systems, achieving a throughput of 20 to 30 parts per minute, depending on the application. Branson demonstrated the unit at NPE using the Clearweld process developed by Gentex. The process allows clear and colored plastics to be laser welded without the use of opaque materials. (To find out more about this technology, see the Hotline section in the May 2002 issue of MPMN or go to www.devicelink.com/mpmn.)

On a smaller scale, Plastec North America Inc. (Miami; www.plastec-moditec.com) displayed what it describes as the smallest slow-speed granulator on the market. Developed by Moditec in France and distributed in North America by Plastec, the 25-rpm granulator is available with 5.27 ¥ 4.5- or 5.27 ¥ 7-in. cutting chambers. Medical device molding applications and other processes that involve small sprues and runners are among the target markets for the machine, according to Plastec vice president Ernesto J. Sosa.


Copyright ©2003 Medical Product Manufacturing News

Filters Meet the Changing Demands of the Industry

Originally Published MPMN September 2003

PRODUCT UPDATE

Filters Meet the Changing Demands of the Industry 

When it comes to the filters used in the medical device industry, size and material matter. The dimensions of a pore could literally mean life or death, depending on the purpose of the filter. Whether the goal is combatting an outbreak of a contagious disease or just perfecting an existing line of filters, manufacturers continually seek new solutions. Following are a few examples of recent filter developments that may be of interest to MPMN readers.

Melody Lee

Pall Medical's breathing filters reduce the risk of contamination in ventilator circuits.

Breathing filters prevent viral and bacterial contamination 

When infectious diseases threaten hospitals, the use of high-efficiency filters such as Pall Medical's BB25A, Ultipor 100, and BB50T may prevent the transmission of contaminants to patients and healthcare workers. The three breathing-system filters have been validated with a microbial removal rating of 99.999% to block liquids such as tracheal discharge and saliva when faced with a monodispersed challenge of a host of pathogens. The products are used with ventilators, anesthesia machines, and manual-resuscitation bags, preventing contaminated secretions from passing into the ventilator circuit. 

"Breathing-circuit filters that combine a reliable hydrophobic barrier and high levels of viral and bacterial retention offer the best option to protect therapeutic equipment and minimize exposure of patients and healthcare workers to infectious respiratory secretions," says Judy Angelbeck, senior vice president of Pall Medical. 

With an internal volume of 85 ml, the Ultipor 100 is a 15-mm-diam flexible tube with the options of a protective cap to replace conventional catheter mounts, a CO2-monitoring port with a luer lock, or a tethered cap. Constructed with pleated hydrophobic resin and bonded inorganic chemical fibers, the filter is resistant to water and nebulized medication droplets.

The BB25A is a small-volume anesthesia filter, made of materials free of natural rubber latex. With a volume of 35 ml, the product offers a CO2-monitoring port for filtration protection and retains heat and humidity for anesthesia patients. The BB50T removes ribavirin, pentadimine, histamine, and methacholine exhaust to protect the hospital staff and the environment from bacteria. 

PEEK polymer fits filtration and separation applications 

PEEK fabrics from Sefar America Inc. offer small pore sizes to resist a wide range of inorganic and organic chemicals.

A PEEK monofilament fabric introduced by Sefar America Inc. is suitable for drying applications where temperature resistance, light weight, flexibility, and performance in chemically corrosive environments are required. With pore sizes starting at 10 µm, the fabric's thickness is as low as 60 µm with basis weights of 0.8 oz/sq yd and up. The product's fibers are as small as 30 µm in diameter, with up to 600 of the threads woven into each inch of the material. 

The PEEK polymer, available for filtration and separation applications, "can be at 450° to 500°F, and is resistant to a wide range of inorganic and organic chemicals," according to Rick Gaiser, Sefar America's manager of market development. "This fabric's high mechanical strength makes it a very durable fiber for wear resistance and dimensional stability at high temperatures." 
Gaiser explains that PEEK fabrics have a 200°F temperature advantage over nylon 6/6, and higher elongation compared with polyphenylene sulfide fiber, enabling better impact recovery. The material is available as roll goods for customer fabrication or as fabricated components.

Diagnostic membranes offer a variety of flow rates for assays

Backed nitrocellulose membranes by Millipore Corp. enable flexibility in the optimization of immunoassay selectivity and sensitivity.

A complete line of nitrocellulose membranes is offered for lateral-flow diagnostic assays. The membranes feature a smooth surface quality to enhance the consistency of reagent striping. The backed nitrocellulose Hi-Flow Plus membranes by Millipore Corp. offer capillary flow rates ranging from 65 to 240 seconds/4 cm to allow flexibility in the optimization of immunoassay selectivity and sensitivity. To avoid interfering with assay performance, the product is directly cast onto a clear polyester backing with a thickness of either 2 or 4 mil, reducing any occurrences of an adhesive migrating into the membrane substrate in a finished test strip. 

Hi-Flow Plus 120 has a nominal flow time of 120 seconds across 4 cm of membrane, while Hi-Flow Plus 180's nominal flow time measures 180 seconds across 4 cm. Both comply with an average flow time variance of 11% and a thickness variance of 6%. Three other products in the Hi-Flow Plus line feature lateral flow times of 75, 90, and 135 seconds across 4 cm of membrane, respectively. Hi-Flow Plus 65 is suitable for tests where speed is critical, the analyte is plentiful, and sensitivity is not a concern. On the other hand, Hi-Flow Plus 240 is appropriate for slower tests with limited analyte and necessity for high sensitivity. 

Before shipment, each 100-m master roll is sampled in six areas across the head and tail end, inspected for surface quality, and tested for capillary flow rate and thickness. The tests are done on the actual roll sent to the customer, rather than on edges trimmed off during casting.

Copyright ©2003 Medical Product Manufacturing News

Extrusion and Tube Processing

Originally Published MPMN September 2003

EQUIPMENT NEWS

Extrusion and Tube Processing
Tube expansion is facilitated with Lakeview Equipment's Model 685H hot-jaw tubing expander.

Tube Expander Eliminates Split Ends

For difficult-to-expand tubing, Lakeview Equipment Inc.'s tube expander facilitates the expansion without splitting the ends. The Model 685H hot-jaw tubing expander features a threaded stop, permitting the width to be adjusted to customer requirements. With tip heat controllable up to 350°F, the unit is suitable for vinyl, Teflon, polyurethane, and polyethylene tubing. 

Standard jaws are available from 1¼16 to 3¼8 in., with other sizes and configurations customizable. Operated on 60 Hz and at 60-100 psi, the expander's assembly includes a foot pedal with a regulator and air gauge.
Lakeview Equipment Inc., 3382 Commercial Ave., North Brook, IL 60062.


Portable Tubing Coiler Offers Automatic Assembly

Castle Engineering Co.'s 
Model 520 coiler measures, cuts, and bands tubing. 

A tubing coiler's automatic features improve the process of measuring, cutting, and banding together various diameters of flexible tubing. The Model 520 tubing coiler from Castle Engineering Co. pulls the tubing from a spool onto two adjustable posts, retains the shape, and cuts the coiled assembly from the machine. With the capability to produce coils measuring from 21 to 172 in. in length, the machine assembles up to 1800 units per hour. The machine is portable, requiring 115 V electrical power and an 80-psi air supply. Customers can also choose to have connector fittings automatically installed into the tubing ends. 
Castle Engineering Co., 400 Corporate Cir., Unit N, Golden, CO 80401.


Extruders Are Redesigned for Improved Functionality

Welex Inc. introduces Mark I extruders for medical tubing production. 

Welex Inc. reformed its line of Mark I extruders to meet global market requirements, adding more functions to the medical tubing and custom profile extrusion equipment. Ac vector drives are now standard, reducing maintenance and improving energy efficiency. Operator controls have also been updated with communication outputs available for programmable logic controller integration. Single-bolt quick-release clamps have been added to the products to enable quick die, screw, and screen changes. Feed-hopper sampling chutes and shut-off slides have also been updated. The extruders are available in sizes ranging from 11¼4 to 31¼2 in. 
Welex Inc., 850 Jolly Rd., Blue Bell, PA 19422.
 

Tube Sealer Creates Hermetic End Seals

The K1 plastic-tube sealer by 
Stapla Ultrasonics Corp. hermetically end-seals thermoplastic and laminate tubes.

With an operating frequency of 20 kHz and generator output of 3000 W, Stapla Ultrasonics Corp.'s K1 plastic-tube sealer produces clean, wrinkle-free seals for thermoplastic and laminate tubes. The sealer operates using only one button, which sets all the relevant welding parameters. Once the data are programmed, the system automatically maintains the preset information. 

Designed for production environments, the product can be installed on filling stations and connected to external control units. The sealer incorporates the company's technology originally developed for its K1 high-precision ultrasonic plastic welder. 
Stapla Ultrasonics Corp., 375 Ballardvale St., Wilmington, MA 01876.


Precision System Laser Cuts Stents

The StarCut laser system by Rofin-Sinar Inc. precisely cuts stents.

A laser cutting system developed by Rofin-Sinar Inc. provides precise cutting for the delicate process of manufacturing intracoronary stents. Used for alleviating vasoconstriction and angioplasty, the stents created by the StarCut cutting system exhibit widths of less than 20 µm with nearly dross-free edge quality. No internal water cooling is needed in the tube. 

Operated by CNC, the Class I system is capable of cutting complex geometries from a thin-walled steel tube measuring 1.0-10.0 mm diam. A precision of contour within 5 µm is achieved, and the system reaches a cutting speed up to 50 mm/sec. 
Rofin-Sinar Inc., 40984 Concept Dr., Plymouth, MI 48170.


Extrusion Bump Puller Enables Programmable Control

Engineering by Design's extrusion bump puller produces plastic tubes. 

A new puller from Engineering by Design works with existing extruders to automatically form plastic tubing with diameter changes such as bulges, bumps, balloons, or tapers while compensating for process variations. The unit incorporates a new design featuring a menu-selectable base and programmable logic controller-based alphanumeric touch screen. Extruded plastic tubes can be precisely sized by varying pull speed and extrusion die air pressure. After the profile is formed, it is measured, and the speed and pressure are automatically adjusted as needed. The bump extrusion puller cuts any length with a bump process speed of 250 ft/min, and is capable of noncontact measurements in 0.06-in. increments at 30 ft/min. The bump profile control includes base and bump diameter, bump length, and taper transitions. With measurements sensed by a laser micrometer or vision camera, the puller is suitable for products with outside diameters ranging in size from 0.02-0.38 in. 
Engineering by Design, 2123-D Bering Dr., San Jose, CA 95131.


In-Line Tubing Dies Offer Customized Tooling Capabilities

Engineering by Design's extrusion bump puller produces plastic tubes. 

A new series of in-line tubing dies from Guill Tool & Engineering Company, Inc., is designed for polymer or rubber hose or pipe extrusion ranging from 0.005-8.0 in. in diameter. The Series 900 is capable of achieving concentricity, reducing the amount of material usage. With the option of running one to five layers simultaneously, the product's in-line- designed heads reduce spider lines and allow room for more air. The series's adjustable die holder and cartridge-style ball assembly does not require the loosening of retaining screws to make adjustments. Its positive seal system also eliminates leakage between deflectors, self-aligns to decrease operator error, and is adaptable to a variety of specific extruder-layout configurations. 
Guill Tool & Engineering Company, Inc., 10 Pike St., West Warwick, RI 02893.

The Series 900 in-line dies from Guill Tool & Engineering Company, Inc., enable tooling for polymer or rubber applications. 

Lasag's Model KLS 246 pulsed Nd:YAG laser incorporates CNC motion controllers and precision lasers. 

Catheter-Tipping Equipment Delivers RF Energy

Sebra adds the PIRF III system to its line of catheter manufacturing equipment. 

With the release of a catheter-manufacturing equipment line, Sebra offers a new option for tipping, welding, and flaring. Using closed-loop temperature control, PIRF III delivers heat to multiple-cavity molds suitable for high-volume production of urinary and tracheal catheters. Using technology that incorporates electronic and mechanical components, the product provides energy for each cycle. 
Sebra, 100 N. Tucson Blvd., Tucson, AZ 85716.
Schoolhouse Rd., Souderton, PA 18964.


Motion Controllers Increase Lasers' Flexibility

Lasag Industrial's CNC motion controllers are matched with precision lasers to enable flexibility in medical device design. The KLS 246 pulsed Nd:YAG lasers feature a modular design, a gold-ellipse optical cavity, small beam size, and no-contact processing.
Suitable for cutting, welding, drilling, marking, and removing of materials, the product offers a conventional or fiber beam delivery with up to six outputs. The laser's power ranges from 15-250 W. It has a pulse length of 0.012-20.0 milliseconds, pulse repetition maximum of 1000-5000 Hz, and pulse energy maximum of 0.18-50 J. 
Lasag Industrial, 601 Campus Dr., Ste. B-5, Arlington Height, IL 60004.


Copyright ©2003 Medical Product Manufacturing News

A Climate of Innovation

Originally Published MPMN September 2003

REGIONAL FOCUS

A Climate of Innovation

Device OEMs and associated suppliers have made Southern California a medical technology hub

Norbert Sparrow

It has not been a good year for California, to put it lightly. A record budget deficit aggravated by legislative inertia and a governor running for his political life have taken some of the luster off the Golden State. But there are plenty of economic bright spots in the world's fifth largest economy, one of which is the healthcare industry.

California currently is home to more than 5500 registered medical device manufacturers. That represents a little more than 20% of the national total, according to figures compiled by the FDA Center for Devices and Radiological Health's Division of Small Manufacturers Assistance. Two of the state's three medical device manufacturing clusters are located in Southern California (the San Francisco Bay area is the state's third pole).

Not only is the device industry an economic force in the region, it is a font of innovation. Biomedical companies in Southern California invested more than $852 million developing new products for unmet medical needs in 2000, according to the California Healthcare Institute, an industry mouthpiece. On average, biomedical firms invest four times more in R&D than other high-tech companies, reports the institute. A facility opened by Siemens Hearing Instruments near Los Angeles to support an emerging technology, described below, is one example of a company building for the future.

The spirit of innovation thrives not only in Southern California's device industry, but also among the many suppliers of products and services that vie for its business. A small sampling of these firms are profiled in this section. 

Siemens Finds a Place in the Sun

Siemens Hearing Instruments recently moved into a new 28,000-sq-ft facility near Los Angeles to meet growing demand for its products.

Siemens Hearing Instruments has operated a production facility in Cerritos, near Los Angeles, for more than a decade. When the company needed to find a larger plant to accommodate its growing business needs, one of its top priorities was to source a facility in the immediate vicinity. "Employee retention was a key factor" in deciding where to look, says operations manager Dave Anderson. "Each of our digitally manufactured hearing aids is, in fact, a custom product. Fabricating them is more of an art form than a science," explains Anderson, and turning a technician into an artisan requires substantial training. Siemens did not want to risk losing its human resources by making an ill-considered relocation.

In January, the staff moved into a brand new facility in La Mirada, just three miles away from the old plant. The 28,000-sq-ft building was designed from the ground up to accommodate the company's unique laser manufacturing process and to meet future expansion needs. It is Siemens's largest satellite facility, serving the western United States, and the first to have been designed to integrate the company's proprietary manufacturing process.

The Laser Accurate Scan Replication (LasR) shell manufacturing process was introduced by Siemens at the 2001 American Academy of Audiology conference. The system's software combined with laser scanning and manufacturing technology produces highly accurate impressions of the ear canal, resulting in better-fitting hearing aids than can be obtained with conventional methods. "I do believe we are the first company to use this technology in a production environment," says Anderson. "Until now, it has been used mostly in R&D." Anderson credits the Southern California-based supplier of the production equipment for helping to "push the machines to the limit. It has been a good partnership," he adds. "The firm works very closely with us to make sure that everything happens when it needs to."

A quality inspection being done on catheters treated with the Lubrilast coating from AST Products.

The LasR process uses laser scans of the ear canal to produce a "point cloud" 3-D image of the impression. The raw data are then used to create a surface over the virtual impression. Vent and receiver holes can be easily positioned, as needed. Guided by the 3-D rendered data, a laser sinters the polymer powder into a shell. Surface treatments texture the biocompatible material to resemble natural skin. Snug and securely fitting completely-in-the-canal, mini-canal, and half-shell hearing instruments can be made in this manner. Digital technology promises further advances, says Anderson, for which the La Mirada facility is already equipped.
Since the impression data are scanned and stored in a database, identical shells can be recreated on demand. "And in the not-very-distant future, doctors will be able to scan a patient's ear and send the information electronically to our production facility," says Anderson. "Physical impressions will become a thing of the past."

A Commitment to Safety

Like Siemens, Alaris Medical Systems is a medical device manufacturer. Unlike many OEMs, however, Alaris also supplies its technology on a contract basis to other device manufacturers.

To help eliminate needlestick injuries, Alaris has developed a needle-free valve and platform technology that can be adapted to a host of healthcare applications. The SmartSite Needle-Free system (described on page 43) is but one way in which the company advances the causes of innovation and safety in the medical device arena. The Alaris Center for Medication Safety and Clinical Improvement at the company's global headquarters in San Diego is also a key element in the firm's campaign to promote best practices for medication safety.

The Alaris Center for Medication 
Safety and Clinical Improvement 
is equipped with a simulated operating suite and patient recovery room where healthcare professionals can test procedures.

Centerpieces of the sleekly designed suite are the simulated patient recovery and operating rooms. These fully equipped sites afford clinicians a hands-on opportunity to test various technologies and share best practices with colleagues in a simulated clinical setting. The center also includes mock nursing and pharmaceutical stations.

The Alaris center also hosts a number of events on the theme of medication safety. The use of technology to address administration errors was the subject of a roundtable discussion in 2002 that attracted leading national figures. More recently, the center convened a group of experts to discuss the use of bar coding to improve patient safety at the point of care.

Medication errors are a leading cause of morbidity in hospitals, noted Alaris OEM sales manager Bob Tolliver during an interview with MPMN. Case studies and statistics presented at the meeting made a compelling case for the use of bar coding to combat this trend. According to one participant, the use of bar coding led to a projected 87% annual reduction in medication errors in a single unit. Referencing the vaunted supply chain management of the world's number-one retailer, Tolliver asked, "If Wal-Mart can do it, why can't hospitals?"

The Alaris center also offers an array of consulting, evaluation, and training services for healthcare professionals. Nurses, in particular, may benefit from the NurseSmart program. Sophisticated analytical tools such as failure mode and effects analysis, as well as continuous quality improvement concepts, can be applied to nursing practices by trained Alaris Medical Systems staff.

Several other Southern California- based suppliers are featured in the following pages. From a firm that has issued a manifesto of scientific molding principles to a company that has developed an accelerator-free curing process to neutralize the presence of allergens in latex, they all share a firm commitment to providing device OEMs with creative solutions for their products and manufacturing needs.

Regional Focus Products & Services

Metal Fabrication Services

Precision machining of parts measuring 0.20 to 1.250 in. diam is offered by a company that recently moved into a new facility. "The move has positioned us to better accommodate the evolving needs of our clients," says Mark Deischter of Micro Precision Swiss. By optimizing its in-house capabilities, the firm can now satisfy customer requests for the full-service manufacture of components and assemblies, he adds.

The new facility houses an array of seven-axis CNC grinders, laser welding and marking equipment, and electrochemical marking systems. Stainless steel, titanium, PEEK, and Ultem are among the materials processed. The company has begun to explore processing platinum, as well.

An electronic MRP system ensures traceability of the materials and components throughout the production process. The company is certified to ISO 9002, EN 46002, and AS 9100.

Micro Precision Swiss
30331 Esperanza, Rancho Santa Margarita, CA 92688

Automation Equipment

Flawless product assembly performed in a compliant, validated manner is a necessity in the medical device sector. "Absolute quality is a huge driver in this industry," says Erik Poulsen, general manager at Ismeca USA Inc. That quest, he adds, is leading many device OEMs to Ismeca's door.

Headquartered in Switzerland, Ismeca has broad experience developing automation systems for the medical device, electronics, and semiconductor industries. One of the company's key strengths, according to Poulsen, is its ability to design systems that fully comply with the device industry's regulatory requirements. "We support the process with [extensive] documentation," he says, "That's part of our added value." Inspection and test systems, HEPA filters, and other accessories are routinely built into the systems to satisfy customer requirements, he notes.

Having full development and production facilities in the United States and Europe has been a boon to customers with multiple sites, adds Poulsen. Systems can be built in parallel in compliance with U.S. and EU regulations for companies with production facilities on both continents.

Ismeca offers a number of automation technologies that range from a single continuous process to individual cells to processes linked via synchronous or asynchronous methods. Production flexibility and the availability of modular plug-and-play configurations are among the most popular features of the automation systems.

The firm has developed units for the automated assembly of insulin pens, safety syringes, diagnostic kits, and a range of single-use devices.

Ismeca USA Inc.
2365 Oak Ridge Way, Vista, CA 92081

Digital Dispenser

A servo-driven automated dispensing system for precision processes has been introduced by a company that specializes in automated manufacturing solutions. The dispenser comes with powerful proprietary software and an easy-to-use graphical user interface that enables intuitive programming and control. The Champion 6809 can be configured to match exacting application requirements from dots to underfills with a placement accuracy within 3 µm, according to Creative Automation Co.

Designed for subnanoliter processes, the device dispenses dot diameters and bead widths down to 75 µm. Volumes can be less than 0.5 nl, and the positive-displacement pump can achieve up to 90,000 deposits per hour. Volumetric efficiency is ensured regardless of deposit size, viscosity, or temperature.

The unit comes standard with a three-axis brushless servomotor drive, x- and y-axis linear encoders, z-axis rotary encoder, Windows-style software, and an LCD. Numerous optional features are available.

Creative Automation Co.
11641 Pendleton St., Sun Valley, CA 91352

Machining Services

A job shop near San Diego manufactures Swiss-type machined parts from stainless steel, titanium, aluminum, alloys, and plastics for the medical device and dental industries. Jeropa Swiss Precision Inc. specializes in the production of miniature, complex components in small to medium runs, according to senior vice president Rosemarie Paroz. The company is registered with FDA as a contract manufacturer.

The facility is equipped with an array of 2-, 4-, 5-, and 8-axis CNC screw machines, as well as drilling, tapping, milling, turning, thread-rolling, reaming, honing, and broaching equipment for secondary operations. The turning capacity ranges from 0.015 to 11¼16 in. diam, with a maximum chucking diameter of 3.00 in. One of the more unusual pieces of equipment on the shop floor is the Skylab 20-24, a universal machine for secondary operations invented by company founder and president Jean-Louis Paroz.

A versatile machine that can drill, tap, mill, and slot, the Skylab 20-24 is where it all began for Jeropa, says Rosemarie Paroz. Her husband initially went into business selling the machine, until he realized that putting it to work on a contract basis would be more profitable. The company made a name for itself fabricating dental anchors; its reputation as a meticulous manufacturer of intricate small parts soon spread to other OEMs. Today, the medical and dental device industries represent 60% of the firm's business.

Jeropa Swiss Precision Inc.
950 Borra Pl., Escondido, CA 92029

Testing Equipment

Crescent Design hit the jackpot when it introduced its signature hydraulic burst and leak tester (HBLT) to the medical device market in 1994. Having a background in video poker and blackjack machines apparently helped.

In the early days, Crescent Design president Steve Royce and his partner Jay Sarno designed video machines for the gaming industry. Business declined after a while, "but that's really where our expertise in user interfaces comes from," says Royce. "You're dealing with people who may have had a bit to drink, so you have to make the interface as intuitive and obvious as you possibly can." Device OEMs presumably are a sober lot, but the HBLT's ease of use has been partly responsible for the product's success. The willingness of the Crescent Design team to listen to--and act on--customer requests has also been a significant factor.

"We started with a 1000-psi model," says Royce. "Pretty soon, someone called asking if we had a 1200 psi. We didn't, so we went to work on one." Currently, the company has five models available, with a sixth ready for rollout and a seventh in development. The company is putting considerable effort into adding peripherals that "empower users to do more with their testers," says Royce.

Other recent activities at Crescent Design include the development of software that will automatically time the deflation of a balloon inside a vein, an automated guidewire coiner, and a "smart" manifold that adds 10 outputs to the HBLT. Royce welcomes custom projects that test his firm's engineering mettle. "We build on what we've learned," he says, and the company's lean, nimble infrastructure enables it to solve customer problems in an effective manner. "Constant improvement and increasing our capabilities is how we compete," stresses Royce.

Crescent Design
9932 Mesa Rim Rd., Ste. B, San Diego, CA 92121

Robotics

"The medical device market is underserved by suppliers of robotic assembly equipment," says Michael Ferrara, director of factory automation robotics at Epson Robots. Naturally, his company is eager to fill that gap.

Epson Robots celebrates its 20th anniversary this year. Reaching that milestone is an indication of the firm's commitment to its customers and markets, and its ability to develop the products that people want. "There have been numerous boom-and-bust cycles in the past 20 years," notes Ferrara. "But Epson Robots was here when you woke up this morning and we will be here tomorrow." A single-minded focus on ease of use and flexibility has contributed greatly to the company's longevity, he adds.

The firm's EZ Modules, for example, can be configured by the user as 1-, 2-, 3-, or 4-axis robots. They come standard with a RC420 controller and user-friendly RC+ programming software; an RC520 controller is available for controlling multiple EZ Modules or a combination of modules and SCARA robots. ActiveX controls, conveyer tracking, Ethernet I/Os, force sensors, auditing systems, and vision guides can be easily integrated using the RC+ programming software.

The firm's robotic systems are typically used to package syringes, assemble biological test kits, load medical analyzers, test asthma inhalers, and dispense genetic materials.

Epson Robots
18300 Central Ave., Carson, CA 90746

Sterilization Systems

A just-in-time sterilization system is designed to use low-temperature hydrogen peroxide gas plasma to safely and rapidly sterilize most medical devices. Advanced Sterilization Products, a Johnson & Johnson Co., developed the Sterrad 200 GMP for industrial markets. The 7.3-cu-ft-capacity unit allows manufacturers of low-volume, high-cost products to "exercise control over their supply chain," says Mike Valentine, director, scientific and industrial business. "Sterrad allows you to deal with the process yourself. You're not at the mercy of a contract sterilizer who may tell you that you'll have to wait until he finishes another job." Control also allows a reduction of inventory. "Many companies today are metrics-driven, focused on just-in-time manufacturing and inventory reduction," says Valentine. "Using the Sterrad system, you can sterilize product on Monday and ship it Tuesday."

Although it may have been a concern in the past, process validation is no longer an issue, notes Valentine. "ISO 14937 sets out guidelines for sterility assurance levels of nontraditional methodologies, and FDA knows our products because they have 510(k) approval. I wouldn't have said this three or four years ago, but there is now a clear template and path to achieve regulatory approval using our sterilization process," stresses Valentine.

The company provides extensive validation assistance and regulatory and technical support to its customers. "We will test the product and packaging in-house. Within three days, we can tell a potential customer if we can sterilize the product," says Valentine. "Then we get to work on cycle development to match throughput expectations. That's redone on-site, and that all becomes part of the validation package. The instrument we provide is preprogrammed for plug-and-play operation," adds Valentine.

Advanced Sterilization Products
33 Technology Dr., Irvine, CA 92618

Needle-Free Valves

A study conducted in 1990 concluded that more than 800,000 hospital workers had a needlestick injury each year. Alarmingly, a significant number of those incidents involved exposure to HIV-contaminated blood. Needle-free valves developed by Alaris Medical Systems Inc. are among a generation of devices designed to help prevent those types of accidents.

The SmartSite needle-free valves feature a flush, swabbable top to minimize contamination. Made of latex-free materials, the valves have a straight fluid-path design similar to a standard injection port. Unlike competing products that may have as many as seven components, the SmartSite valves comprise only three parts. "Simplicity means repeatability," notes OEM sales manager Bob Tolliver. The streamlined design makes the valves cost-effective to manufacture, he adds. The technology has been recognized by the Medical Design Excellence Awards, an annual program organized by Canon Communications llc, which also publishes this magazine. In particular, jurors applauded the simple and reliable design and the innovative manner in which the product addresses safety concerns.

One of the strengths of Alaris, according to Tolliver, is its status as both an OEM supplier to medical device manufacturers and a direct supplier to hospitals. "Our logo goes on every product we make, regardless of whether it's for our use or produced for a client," says Tolliver. "We partner with our customers and stand firmly behind our products." The company has a vigorous quality control program, he adds. A fully automated system subjects each valve to 100% flow testing.

"SmartSite technology can be adapted to most IV administration applications," says Tolliver. Typical uses include infusion pump sets, heparin and saline locks, extension sets, vial access pins, vial adapters, and bag spikes.

The company also has substantial R&D resources available for product and process development. "Our focus is on high-volume, low-cost, high-quality disposables," says Janice McCampbell, director, engineering, disposable products. Concurrent engineering, a phased design and development process that allows for customization, and an emphasis on design for manufacture are among the department's procedures, she adds. Virtual engineering through the use of failure mode and effects analysis (FMEA) and other tools also plays a key role in product development. McCampbell cites a recent development project. "The device was designed with a single vent, which caused some stress issues. Using FMEA, we found that doubling the number of vents would solve the problem." That change saved the client a "huge amount in tooling costs. It's one example of what we can contribute by partnering with other OEMs," says McCampbell.

Alaris Medical Systems
10221 Wateridge Cir., San Diego, CA 92121-2772

Liquid Silicone Rubber Molding

A newly developed series of liquid silicone rubbers (LSRs) feature rapid cure rates and 5 to 8% compression sets after 4 hours at 200°C. The resistance to deformation is described as a boon to designers of medical parts such as seals, diaphragm pumps, valves, and catheters, according to Hi-Tech Rubber Inc. The firm's medical device tech team developed the LSRs in collaboration with material processors.

The contract molding company reports that the LSR products are available in a hardness range of 23 Shore A to 60 durometer and with a tensile strength of 1233-1421 psi. Elongation varies from 460 to 750%, depending on the LSR's durometer. The materials can be processed using a variety of molding applications. Cycle times can be shortened by molding using an automatic cold-runner technology.

Hi-Tech Rubber offers multiple processes and materials suited for the manufacture of elastomeric components used in medical devices. Prototype to high-volume production quantities can be accommodated.

Hi-Tech Rubber Inc.
3191 E. La Palma Ave., Anaheim, CA 92806

IV Components

Multipurpose vial adapters in three styles and sizes have been added to a company's product line. Latex-free and conforming with ISO 594, the KippMed vial adapter developed by Porex Medical Products Inc. enables a single adapter to be used with vials of varying sizes. Other features include a low insertion force and a design that allows maximum fluid withdrawal with minimal waste.
The adapter can be used with or without a needle-free access connector for multiple dosing. In addition, the device has the smallest fluid residual volume currently available, according to marketing manager Janice Tarwater.

The vial adapter joins the company's KippMed product line, which comprises proprietary medical products as well as standard IV luer connectors and caps. The firm specializes in the design and manufacture of precision complex plastic-injection tooling and custom molding of tight-tolerance medical devices. The ability to take a product from concept to prototype to full production, thus potentially reducing time to market, is described as one of the company's key strengths.

Porex Medical Products
930 Wanamaker Ave., Ontario, CA 91761

Molding Services

Scientific molding is not a new concept, Charles A. Brewer III readily admits. But C. Brewer Co. is really doing it, not just paying lip service, he stresses.

A third-generation mold maker and CEO of the firm since 1996, Brewer posits an understanding of the "four pillars" of the molding process as a prerequisite to achieving consistent success. By establishing fixed values for the four most important variables of the process--time, temperature, pressure, and cooling--the company can provide documented data to support the production of optimized tooling. "We see ourselves as a 911 service," says Brewer. "Customers routinely come to us with what might be characterized as a sick mold. We believe there is one optimal molding process, and it's our job to discern the problem and to fix it."

The company's forte is precision molding, specifically parts with tight tolerances that are used in the medical, biomedical, and electronics sectors. By combining mold making, molding, and assembly services under one roof, the firm offers customers the convenience of single sourcing. More than 40 Nissei machines ranging from 40 to 350 t are on-site, including all-electric machines in a Class 100,000 cleanroom.

To continue to meet and, indeed, exceed customer demands related to product quality and delivery times, the company maintains a large engineering staff and invests substantially in leading-edge technologies. Brewer cites the use of cavity-pressure-monitoring tools as one example. "A pressure transducer gets you close to exactly what's happening inside the cavity," he says. "It's one tool that we use to advance scientific process optimization." The next step in the company's evolution, he adds, is the introduction of a six-sigma molding process. "We have the tooling in place to achieve that," says Brewer. "It won't happen tomorrow, but it's coming."

C. Brewer Co.
3630 Miraloma Ave., Anaheim, CA 92806

Heat Sealing Equipment

Process control capabilities are among the priorities of medical device OEMs when they are sourcing equipment. As industry demands have evolved, so has the line of heat sealing equipment supplied by Belco Packaging Systems, notes Thomas A. Milisk, vice president, sales and marketing.

"We offer single- and dual-station tray sealers in four platen sizes at four levels of process control," says Milisk. Constant-heat bar and pouch sealers with two levels of process control capabilities are also available, he adds. The firm recently introduced tabletop tray and pouch sealers, configured for aseptic packaging. A unique feature of this equipment, according to Milisk, is that the machine itself can be sterilized by autoclave.

For tertiary packaging needs, the company supplies shrink packaging machines for form-fill-seal applications, infinite-length side sealers, automatic and semiautomatic L-bar sealers, shrink tunnels, and industrial blister sealers. The machines are available in a range of sizes and throughput capabilities.

Belco Packaging Systems
910 S. Mountain Ave., Monrovia, CA 91016

Dip Molding Services

A company that was founded in 1985 to develop dip-molded devices using advanced polymers in lieu of natural rubber latex provides a range of materials expertise to device OEMs. "We think of ourselves as an extension of our customer's R&D department," says Mark McGlothlin, president of Apex Medical Technologies. He adds that about half of the company's business currently involves materials consulting, licensing agreements, and related projects, with contract dip molding accounting for the rest.

The company's proprietary dip molding process uses synthetic elastomers to fabricate thin-walled components for the medical device industry. The firm has collaborated with many device OEMs from concept to final production to bring products such as catheter balloons, stent and probe covers, and tissue-removal sacks to market. Although polyurethane is the material of choice, a number of other thermoplastic elastomers have been used where high elongation values are desirable. For applications requiring low creep properties, synthetic polyisoprene latex has been processed.

"We developed synthetic polyisoprene latex to respond to customer requests for a material that acted like natural rubber," says McGlothlin. Dip-molded components made from this material have low modulus and tensile set properties, and high resiliency and ultimate elongation, he notes, but without the biocompatibility issues that plague natural latex rubber. "It does not contain proteins, thus preventing Type I allergies, and the absence of accelerators and nitrosamines virtually eliminates Type IV allergy concerns," says McGlothlin.

The company has recently adapted the curing process developed for synthetic polyisoprene latex to silicone. Dip-molded silicone latex products have the potential to compete with conventional liquid-injection-molded products, adds McGlothlin. Not only does the process achieve better material properties, according to McGlothlin, but the tooling costs are substantially lower.

Apex Medical Technologies Inc.
10064 Mesa Ridge Ct., Ste. 202,
San Diego, CA 92121


Copyright ©2003 Medical Product Manufacturing News

Adhesives and PSAs

Originally Published MPMN September 2003

SPOTLIGHT

Adhesives and PSAs

UV-curable sealant

An adhesive and sealant adhering to the USP Class VI protocol is a single-component urethane formulation, featuring physical strength, elongation properties, and abrasion resistance. The optically clear UV15X-6 is suitable for use in bonding to clear plastics such as polycarbonates and acrylic resins, and cures on demand when exposed to UV light. The cure is not affected by air or moisture. Master Bond Inc., 154 Hobart St., Hackensack, NJ 07601.


Pressure-sensitive tapes

A U.S.-based pharmaceutical company offers a range of medical-grade pressure-sensitive tapes featuring polyethylene and polyurethane qualities. Scantape and Scanfoam are suitable for conversion onto medical devices, and are coated on nonwovens, films, foams, and fabrics. Common uses include surgical products, diagnostic devices, electrodes, intravenous devices, and allergy-testing devices. The products are tailored to customer requirements and specifications. Alpharma Inc., One Executive Dr., Fort Lee, NJ 07024.



Tapes and sleeves

Cohesive tapes and sleeves enable the securing of products without adhesive residue. The tapes are offered in rolls ranging in width from 1¼2 to 1 in., and larger, with lengths varying from 500 to 2000 ft. The latex-free products can be sterilized using EtO, gamma, or steam methods, and are available in white, natural, or custom printed. The sleeves are used to encircle tubing sets or other medical devices that need to be contained for packaging. They are made of kraft paper with cohesive material applied to each end. S-Y-M Products Co., P.O. Box 112160, Stamford, CT 06911.
.


Rubber-based transfer adhesive

A rubber-based transfer adhesive 
was designed specifically for the expanded polystrene (EPS) foam packaging market. According to the company, the adhesive provides a cost-effective solution to EPS foam fabricators requiring a pressure-sensitive adhesive in their design cycle. The 6801-P has a thickness of 1 mil and features a plastic liner engineered for the wire-cutting process. It is supplied in 50-in. widths to accommodate the standard 48-in. EPS block stock. Adchem Corp., 1852 Old Country Rd., Riverhead, NY 11901.


Pressure-sensitive film

A double-coated pressure-sensitive adhesive film is specifically designed for use in surgical drape fabrication. The Bioflex Rx895S is a 3-mil matte polyethylene film carrier coated on its exposed side with 1.75 mil of a rubber pressure-sensitive adhesive. The liner side of the film is coated with 1 mil of an acrylic pressure-sensitive substance. With the ability to adhere to a variety of nonwoven and film substrates, the product conforms to curved areas of the body. Scapa Medical, 111 Great Pond Dr., Windsor, CT 06095.



Electrically conductive adhesive

AA two-component, solvent-resistant ink, coating, and adhesive is available for screen-printing circuit lines. The electrically conductive 118-09A/B is flexible and can be cured at low temperatures. In addition to low ohmic contact to indium and tin oxide sputtered glass and polyester, the product also is suitable for adhesion to Kapton, Mylar, polycarbonate, and other substrates. Applications include EMI and RFI shielding of polyimide flexible circuits, membrane switches, and electrical attachments for surface-mounted devices. Creative Materials Inc., 141 Middlesex Rd., Tyngsboro, MA 01879.


Epoxy bonds

Fast-curing epoxy adhesives that require no fixturing are available in three formulations. They are suited for OEM assembly applications and repairs, and have the ability to withstand dry temperatures of -40° to 200°F. The 5 Minute epoxy bonds metals, fabrics, ceramics, glass, wood, and concrete, with a mixed viscosity of 10,000 cP, dielectric strength of 490 V/mil, and an adhesive tensile shear strength of 2500 psi. The 5 Minute epoxy gel is thixotropic and nonsagging, with a working time of 3-6 minutes at room temperature and adhesive tensile shear strength of 2500 psi. The One Minute epoxy gel bonds to metals, glass, fiberglass, and ceramics, with shear strength of 1600 psi. Devcon, 30 Endicott St., Danvers, MA 01923.


UV flood systems

A manufacturer of advanced adhesive-curing products has introduced two UV flood lamp systems. Both can be used for lab evaluation and benchtop assembly. Cure Zone 2 has a curing area of 8 ¥ 8 in., emits 80 MW/cm2, and provides cool curing for sensitive substrates. With the ability to accommodate large parts, the product is suited for curing adhesive between mating glass and plastic parts. Cure Zone HO2 has a curing area of 5 ¥ 5 in.; it emits 120 MW/cm2 and rapidly cures UV adhesives, coatings, and potting materials. The units allow complete viewing of the curing process, which averages 1-5 seconds with a moderate-intensity light source. Dymax Corp., 51 Greenwoods Rd., Torrington, CT 06790.


Wound-care products

A full range of production capabilities for private-label manufacturing of wound-care products is available. Bordered gauze, composites, foam, hydrocolloids, nonadherent pads, sheet hydrogel, thin film, and wound-closure strips are among the list of options. The products are manufactured in a controlled environment under ISO 9001:2000 and FDA regulations using a variety of die-cutting, lamination, and assembly techniques. PCI Technology, 8181 Eastpoint Dr., Ste. 500, Dallas, TX 75227.


Custom-engineered tapes

Custom-engineered tapes are formulated with the appropriate combination of materials, thickness, flexibility, adhesion, and release characteristics to fit specific customer applications and needs. The products' properties include resistance to heat, moisture, and UV light, along with permanent adhesion or residue-free release. The tapes can bond with dissimilar materials including foams and sponges and coincide with a process such as die- or kiss-cutting. Master rolls of 54 or 60 in. are available. Tyco Adhesives, 1400 Providence Hwy., Norwood, MA 02062.


Custom backings and adhesives

AA contract manufacturer fabricates diagnostic and wound-care products, surgical drapes, and 3M-branded microplate sealing tapes. The company's specialty components contain active ingredients and custom backings and adhesives. Its capabilities include tight-tolerance slitting, laminating, spool traverse winding, in-line packaging, and flexographic printing. M & C Specialties, 90 James Way, Southampton, PA 18966.




Copyright ©2003 Medical Product Manufacturing News