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Articles from 2004 In September


Creating Stronger Bonds

Originally Published MPMN September 2004

PRODUCT UPDATE

Creating Stronger Bonds

Adhesives fulfill a variety of needs in manufacturing medical devices

Melody Lee
Devcon's epoxy adhesive can replace welding or soldering processes.

Adhesives in the medical device industry continue to expand their capabilities and their range of use. They challenge existing bonding methods in medicine and in device assembly. Dispensing systems are also evolving to handle medical device needs. This article explores some of the advancements in adhesives used on devices and in assembly processes, and discusses trends in dispensing systems. 

Films and Coatings Provide Added Support

In June, industry research company The Freedonia Group (Cleveland) reported its predictions regarding demand for medical adhesives and sealants. The report says that, in the United States, the market will grow 7.5% per year through 2007. According to the study, the $1.3 billion market is driven by the use of adhesives with sutures and staples rather than bandages. The main cause for the growth points to the aging U.S. population. 

Coatings or layers of adhesives are often used on patient-contact devices such as sensors. According to Melinda Hopp, director of marketing for Adhesives Research Inc. (Glen Rock, PA), trends in this area include tight tolerances, optical properties, and biocompatibility. She cites how sensors are becoming quantitative in measurement outcomes. This means that materials used on the sensors, like the adhesives, need to have very specific tolerances. 

There is also a "demand for multifunctional adhesives that do more than adhere to or bond substrates together," Hopp says. An example of this is the company's ARflow products. The line includes coatings, pressure-sensitive adhesives, and heat-sealable tapes. The adhesives are active in bonding components and wicking biological fluids in in vitro diagnostic devices. Dual-coated tapes can have a hydrophilic coating on one side and a pressure-sensitive or heat-sealable coating on the other.

"The demand for these technologies is driven by the products' hydrophilic properties," says Hopp. "[This includes] the ability to reduce the surface tension of fluids. The adhesive coating provides several key benefits, including reduced analysis time and more-efficient transport of fluids with smaller sample volumes."
 
For films and tapes that are applied directly to skin, Scapa Medical (Windsor, CT) offers a high-molecular-weight, rubber-based product. The MG-series adhesive is applied to sensors and bandages that are placed on patients' skin. Made of a gelatinous thermoplastic material, the product acts like a solid adhesive and will not dry out. It can be used on a number of substrates including polyurethane films, nonwoven fabrics, and polyethylene and polyurethane foams. 

Adhesives Bond Surfaces Together

Adhesives offered by Master Bond Inc. can bond one surface to another during device assembly.

In addition to direct skin placement, adhesives can bond one surface to another in medical device assembly. "For devices made of plastics, welding and soldering are not options," says Walter Brenner, R&D manager for Master Bond Inc. (Hackensack, NJ). "Using adhesives also means that [the process is] nontoxic. You don't have traces of metal parts or contaminants that can enter the bloodstream and cause damage."

For a product that resists exposure to repeated sterilization, Master Bond Inc. produces a heat-cured epoxy adhesive. The two-part EP45HTMed can withstand long-term exposure to temperatures ranging from -80° to 500°F. Suitable for use in the assembly of reusable devices, the product adheres to metals, glass, ceramics, wood, plastics, and vulcanized rubber.

An epoxy offered by Devcon (Danvers, MA) avoids chemical hazards that may occur in welding or soldering processes. The company's electrically conductive adhesive can bond electrical components that could be damaged by a hot solder. The Syon Tru-Bond 206A epoxy mixes and pours easily, fills voids, and cures with minimal air entrapment. The material can be used in service temperatures from -65° to 200°F. 

Automation--The Future of Dispensing Systems?

According to Stephen Buchanan, president of Adhesive Packaging Specialties Inc. (Peabody, MA), the adhesive packaging segment of the medical market has gone from steady to strong in the past three years. That's good news for suppliers of adhesive packaging and dispensing systems that are continually improving their capabilities. 

Syringes by Adhesive Packaging Specialties Inc. provide on-demand mixing and dispensing. 

"The move that we see [in adhesive dispensing] is toward automation but with more application-specific equipment," says Jere Donohue, CEO of Integrated Dispensing Solutions (Agoura Hills, CA). "Any of our dispensers can also be mounted on a robot. It just becomes more economical as the price of robots keeps falling."

The company offers a number of systems, including air-free syringes, tube dispensers, pens, and multishot applicators. A full-featured digital shot meter provides up to six different time settings, easily recalled for sequential operation. Two valves may also be controlled with the unit, delivering same-size shots. The machine processes up to 900 units per minute. 

Another type of dispensing system is a syringe offered by Adhesive Packaging Specialties. Housing two-part reactive adhesives, sealants, or resins, the system mixes and dispenses a small amount at a time. The dual-style product provides on-demand mixing and dispensing in a controlled process. Premixed and frozen resin systems are ready for use once they are thawed. 

When using premixed syringes, "you get the same result each time," says Donna Bardell, sales manager for Adhesive Packaging Specialties. "If you mix it yourself, the ratio will be off every time. We precisely measure an entire batch and put it into the syringe all ready for use. The fumes are kept contained, the mixing is precise, and no guessing is involved. The waste is also minimal."

Copyright ©2004 Medical Product Manufacturing News

Assembly

Originally Published MPMN September 2004

Outsourcing Outlook

Assembly

Manufacturer Offers Assembly, Testing, and Packaging Services

A full-service contract manufacturer of medical devices provides assembly, testing, packaging, and sterilization services. The company offers cleanroom and noncleanroom assembly, testing, and packaging services for Class I, II, and III medical devices; IVDs; and electronic instrumentation. Process capabilities range from tubing sets to ultraprecision electromechanical devices with interface tolerances of 1/5 the thickness of a human hair. A full-service injection molding program, including mold design, fabrication, and cleanroom molding, is available. The company is ISO 13485 certified and FDA registered. Ventrex Inc., Ventura, CA www.ventrex.com 


Fabricator Adds

Custom Assembly and Packaging Services A supplier of die-cut and converted components has added custom assembly and packaging to its list of value-added services. These services can be customized to the specifications and requirements of each client. The company offers die-cutting of soft, semisoft, and thin rigid materials; multilayer laminating; and narrow-width slitting. Product design and prototyping are also available. Pacific Die Cut Industries, Hayward, CA www.pacificdiecut.com 



Assembly Capabilities Include Bonding Processes

A manufacturer for the medical device industry furnishes services such as assembly, product design, tooling and mold fabrication, and injection molding. Assembly capabilities include solvent and adhesive bonding, and automation for rapid assembly. Such services as the design and manufacture of assemblies and printing and component sourcing are also available. Class 10,000 and Class 100,000 cleanroom assembly services are offered. Injectech LLC, Ft. Collins, CO www.injectech.com 



Contract Manufacturer Uses Automation in Product Assembly

Assembly capabilities with a focus on automation are available from a provider of precision plastic-injection molding services. Complete or partial component assembly is offered in facilities compliant with industry standards. Cleanrooms are Class 100,000 certified. Additional services include product design and development, clinical trials, global manufacturing, and distribution. NyPro Medical Products Group, Clinton, MA www.nypro.com   


Name Change for Medical Assembly Provider

A maker of accessories for medical monitor manufacturers has changed its name. Axcesor, formerly known as Martech Assemblies, provides design, engineering, packaging, and assembly services. The company has 16,000 sq ft of manufacturing space in dedicated assembly cells and bench build stations. Four vertical injection molding presses offer custom insert molding in any volume in a choice of resins. A Class 100,000 cleanroom is biologically monitored for medical assembly, packaging, and electronic assembly. Axcesor Inc., Grafton, WI www.axcesor.com 


Company Specializes in Needle and Metal Components Assembly

A single-source manufacturer of needles and hypodermic products offers prototyping, manufacturing, assembly, and packaging services. Assembly services include manufacturing of OEM tubular components and assembly using various processes such as epoxy, laser, brazing, and soldering. Popper & Sons Inc., New Hyde Park, NY www.popperandsons.com 


Contract Assembly and Automation Services in Cleanroom Environment

Project management from product design support and prototyping through assembly, packaging, and sterilization is provided by an ISO 9000-compliant manufacturer. The company can design, develop, and build automated equipment for product assembly using its modular Class 100,000 cleanrooms. Inventory maintenance, distribution, and marketing support are also available. Integrated Biosciences Inc., Harrisburg, PA www.ibiosci.com 



Injection Molder Constructs a Class 10,000 Cleanroom

Cleanroom assembly is offered at an injection molding company. The cleanroom occupies 5300 sq ft in the company's 170,000-sq-ft facility and has received Class 10,000 operational certification. The room is equipped with three electric injection molding machines and can accommodate four additional machines. Assembly and postmolding operations can also be conducted inside the cleanroom. Cal-Mold Inc., Mira Loma, CA www.calmold.com 


Class II Device Manufacturer Expands Facility

An FDA-registered and ISO 9001/ISO 13488-certified contract manufacturer of Class II medical devices and electromedical assemblies has expanded its manufacturing plant in Costa Rica. The facility's 10,000-sq-ft expansion includes a larger controlled environment and Class 100,000 cleanrooms to accommodate demands for increased capacity. Production services include injection molding, metal stamping, welding, adhesives, curing, testing, printing, and packaging. Precision Concepts Costa Rica S.A., Alajuela, Costa Rica www.pc-cr.com 



Copyright ©2004 Medical Product Manufacturing News

Medical Device Companies Shine In Florida

Originally Published MPMN September 2004

Regional Focus

Medical Device Companies Shine In Florida 

Businesses take advantage of tax breaks, skilled labor, and global access.

What comes to mind first when you think of Florida? Vacations, beaches, warm weather, or Mickey Mouse? Or for you sports fans--the Heat, Magic, Marlins, Devil Rays, Buccanneers, Dolphins, or Jaguars? Then again, maybe your first thought was of the infamous hanging chads

It's true that all of those things represent Florida. But did you also know that the Sunshine State is home to the second largest number of medical device companies in the United States? There are 1021 FDA-registered companies in the state, according to Enterprise Florida, the state's economic development organization. 

More than 23,000 residents of Florida work in this sector. And they are compensated well. The average annual wage is $50,090, which is 40% higher than the state's average annual wage. 

All kinds of exciting medical breakthroughs are coming out of Florida. The state is home to Cordis, a Johnson & Johnson Co., the makers of the first drug-eluting stent approved by FDA. The Cypher sirolimus-eluting coronary stent combines a proven metal stent with an antirejection-type medication. The stent provides structural support to the artery while slowly releasing the sirolimus drug to limit normal tissue overgrowth.

And Largo, Florida-based Smith & Nephew is making strides in tissue engineering. The company has developed Dermagraft, a cryopreserved human fibroblast-derived dermal substitute. Made of fibroblasts derived from newborn foreskin tissue, an extracellular matrix, and a bioabsorbable scaffold, it is used to treat diabetic ulcers. 

So Why Florida?

There are many reasons companies settle in Florida, not the least of which is the lure of sun, surf, and fun. 

"Florida is a destination location that many of our customers are visiting on a regular basis, either for business or pleasure," says Ray Johnson, president of Doyen Medipharm (Lakeland, FL; www.doyenmedipharm.com). "As such, we are able to encourage a high frequency of visitors to our facility where we can most effectively demonstrate our manufactured equipment and contract manufacturing capabilities. The natural draw of the state has certainly been a competitive advantage for us (especially in the winter months)!"

Doyen Medipharm is a manufacturer of medical packaging machinery, and also provides contract packaging and gamma sterilization services.
Florida's natural charms may have enticed companies to go there, but the state has worked hard to ensure that they stay. They offer a number of perks for businesses. For example, Florida has no state personal income tax and no state-level property tax. It has no corporate income tax on limited partnerships. And there is no sales tax on purchases of raw materials incorporated into a final product for resale, including nonreusable containers or packaging.

In addition, the state of Florida offers specialized tax incentives and tax credits to medical device manufacturers. "The biomedical technology industry is one of the most viable, rapidly growing industry sectors in the world and Florida already has a place at the table," says Florida Governor Jeb Bush. "The [incentives] will elevate our ability to attract, retain, and grow this industry and continue to create high-wage, high-value jobs for Floridians."

The state's strategic geographic location is also key for foreign trade. For many years running, the state has held a commanding share of U.S. trade with Latin American and Caribbean nations, as well as between those regions and the rest of the world, according to Enterprise Florida. 
"Florida is a global gateway with access to Latin America and the Caribbean basin," says Diana Greenidge at component supplier Small Parts Inc. (Miami Lakes, FL; www.smallparts.com). The state has a large multilingual workforce that further benefits international business dealings. And almost 30 multinational medical device firms have their corporate headquarters in Florida.

There is also strong research and academic support of high-tech industries, such as medical devices. Florida universities are active in the development of vascular and cardiac devices, lasers, and nanotechnology. In fact, Scripps Research Institute is set to open a Florida facility in Palm Beach County. It will focus on biomedical research, technology development, and drug design. It is expected to be completed in 2006.

The medical device industry gets strong support from the Florida Medical Manufacturers' Consortium (FMMC). The organization was formed to further the interests of medical manufacturers throughout the state. According to the Maddux Business Report, its goals are to provide opportunities for industry members to assist each other, to interface with academic institutions, and to promote the mutual interests of the industry to the general public and governmental entities.

Although the medical device industry is growing statewide, there are specific regions with higher concentrations of device companies and their suppliers. One of the largest is the High-Tech Corridor.

The High-Tech Corridor

Florida's High-Tech Corridor stretches across a 21-county area in the central part of Florida. It is home to more than 181 medical and biomedical technology firms.

The Corridor starts on the west coast in the Tampa Bay region. According to a 2002 report by the FMMC, the medical manufacturing industry cluster is expected to have an economic impact of more than 40,000 jobs and more than $5 billion on the local economy in the seven-county Tampa Bay area. Medical device manufacturers dominate the industry.

OEM suppliers such as Intelligent Micro Patterning (St. Petersburg, FL; www.intelligentmp.com), Doyen Medipharm Inc., Oscor Inc. (Palm Harbor, FL; www.oscor.com), Halkey-Roberts Corp. (St. Petersburg, FL; www.halkey-roberts.com), and VLOC Inc. are located in the Tampa Bay area.

The High-Tech Corridor "allows us to have local access to experienced engineers, a broad selection of quality subsuppliers, and local availability of special services for part manufacturing such as plasma coating, titanium nitrate plating, rifle drilling, and sterilization services," says Doyen Medipharm's Ray Johnson.

On the other coast of central Florida is Volusia County. Besides being home to the world-famous Daytona Beach, it is a growing region for medical device manufacturers. "Actually, central Florida is becoming known among economists and analysts as a hotbed for technology," says Richard Michael, director of the Volusia County Department of Economic Development. "More than 25% of our manufacturing workforce is at work in medical technology." 

Command Medical Products (Ormond Beach, FL; www.commandmedical.com) and Hudson Tool & Die (Ormond Beach, FL; www.hudsontool.com) are just two suppliers that are located there.
 
"Our ability to communicate with other suppliers in the region is a main reason for locating here," says David Slick Sr., founder of Command Medical. 

And the county is actively seeking more medical manufacturers. It cites the state's economic incentives, a low cost of living, and more competitive labor costs as reasons to relocate there. 

Also, the area's colleges and universities have adapted their curricula to support new technologies and train technical personnel. For example, Bethune-Cookman College has graduated more than 200 students in the past 10 years in biomedical techniques. 

In the following pages, you'll find suppliers of products from pacemaker leads to polyimide tubing. Given all that the Sunshine State has to offer, it's likely that they will be joined by many more companies in the future.

Copyright ©2004 Medical Product Manufacturing News

Catheter and Stent Fabrication

Originally Published MPMN September 2004

SPOTLIGHT

Catheter and Stent Fabrication


Nylon tubing

Thermoplastic tubing made with polyamide and polyimide copolymer thermoplastics is available. Engineered resins such as nylon 6/6, 11, 12, and PEBA are also used in the manufacturing process. The tubing is available in a range of made-to-order sizes, properties, and extruded forms. These forms range from ultra-thin-wall tubing to long continuous lengths of precision lay-flat tubing. The company's capabilities include multilumen bump tubing used for precision minimally invasive surgical devices. Zeus Industrial Products Inc., Orangeburg, SC www.zeusinc.com 


Corrosion testing

A provider of electrochemistry, microscopy, and surface-analytical services can evaluate corrosion performance and surface conditions of stents and catheters. The company can perform ASTM F2129 testing for corrosion susceptibility of small implant devices, ASTM F746 testing for pitting or crevice corrosion of implant materials, or other electrochemical corrosion tests designed to customer specifications. Optical microscopy, metallographic microscopy, and scanning electron microscopy are all available. X-ray photoelectron spectroscopy can be used to quantitatively characterize the elemental and chemical nature of the surfaces of implantable devices, including surface oxides, stains, contamination, or surface treatments. Anderson Materials Evaluation Inc., Columbia, MD www.andersonmaterials.com 


Tubing assembly and production

A company offers equipment for the production and assembly of tubing. The Model 125B-1 tube cutter is designed to cut plastic, rubber, and elastomeric tubing from a minimum of 3 in. up to any length and up to 2 in. diam. A benchtop pneumatic press features two-handed, antitiedown start switches for operator safety. The Model 685H tube expander softens tubing without splitting the ends by using controlled heat; another tube expander comes with standard and 90° jaw sets. The company's solvent dispenser enables the uniform application of solvent to tubing parts without blocking tube passages. Lakeview Equipment Inc., Northbrook, IL www.lakeviewexpanders.com 


Contract catheter manufacturing

A company provides catheter design and engineering support for medical device OEMs. Tipping, drilling, neck-downs, custom injection molding, and assembly are all conducted within cleanroom environments. The company specializes in projects requiring complex shapes or designs. Process documentation and validation is conducted on all projects. MedConnection LLC, Phillipsburg, NJ www.medconnection.net 


Catheter-manufacturing systems

Precision instruments for catheter manufacturers are available. The PIRF II catheter-manufacturing system produces small-profile catheters by concentrating heat in areas as small as 1 mm for butt-weld applications and smaller for tipping applications. The PIRF III system features increased power over the PIRF II for multiple-part tipping and forming of large-profile catheters. Platforms are available for tipping up to four parts in one cycle. Both devices incorporate the company's patented temperature control systems. Sebra, Tucson, AZ www.sebra.com 


Laser cutting workstation

A fully enclosed CO2 laser desktop micromachining workstation is designed for cutting catheter tubes. Features include x-y and rotational axis using brushless servomotors, a gas-jet nozzle, vapor exhaust, an automatic door, stand-alone operation, and a Visual Basic front end for interfacing. The user can laser cut profiles in multilumen plastic catheter tubing that would not be possible by punching, drilling, or grinding. Flying Optic Lasers, Bonney Lake, WA www.flyingoptics.com 



Tube coiling and banding

An automatic tubing coiler measures, cuts, and bands together flexible tubing of various diameters. The portable Model 520 pulls tubing from a spool onto two adjustable posts, retaining its shape, then cuts coils 21- to 172-in.-long, assembling as many as 1800 units an hour. Connector fittings may be automatically installed in the tubing ends. Castle Engineering Company, Inc., Golden, CO www.castleeng.com 


Direct-drive rotary stage

A direct-drive rotary stage features a brushless motor and an integral pneumatic collet chuck. The ASR1100 rotary stage accepts ER16-series collets in multiple sizes, supporting tube diameters from 0.5 to 10 mm. The collet is retained with a threaded retaining cap that enables quick changeover to different tube diameters. Air pressures up to 40 psi are delivered through a frictionless, sealless rotary union to the collet assembly. The direct-drive brushless motor requires minimal maintenance and provides rapid acceleration. Aerotech Inc., Pittsburgh, PA www.aerotech.com 


Catheter laser bonder

Laser equipment is designed for proximal and distal catheter balloon bonding, soft-tip attachment, and shaft bonding. The bonder has four program types: manual, static, dynamic, and multistep. Laser power, movement, duration, travel speed, and spindle rotational speed are based on the program selected. 

The unit features dual precision spindles, a soft-touch clamp, a large through bore, and an in-line diode laser pointer. No programming experience is needed to operate the bonder. Maximum laser power is 10 W. Advanced Process Engineering, San Diego, CA www.ape-usa.net 


Microabrasive blasting

A company offers microabrasive blasting equipment to manufacturers of catheters and stents. Microabrasive blasting with sodium biocarbonate media is used in catheter manufacturing to remove polymer coatings from small selected areas and to remove PTFE coatings from catheter guidewires.

The use of other abrasive media to prepare surfaces for bonding and coating adhesion is another application. Blasting is also used by stent manufacturers to remove unwanted materials without altering device geometry, and to lightly texture stents prior to applying special coatings. Comco Inc., Burbank, CA www.comcoinc.com 


Catheter design and manufacturing

A company has developed several core technologies for the design and manufacture of catheters to deliver stents and other therapeutic devices. Current and previous design and manufacturing projects include PTCA, PTA, sizing, and valvuloplasty balloon catheters, ASD and PFO delivery catheters; infusion and microcatheters; debris-trapping catheters; and various urethral catheters. All design and manufacturing processes including extrusion, bonding, molding, and assembly are completed in-house. Minnesota MedTec Inc., Minneapolis, MN
www.minnesotamedtec.com 

Copyright ©2004 Medical Product Manufacturing News

Filters

Originally Published MPMN September 2004

SPOTLIGHT

Filters


Security filters


Defined surface characteristics and accurate mesh openings enable medical fabrics to act as security filters. Medifab products can also serve as wicking and spreading media in infusion and transfusion sets, arterial and cardiotomy blood filters, blood bags, and diagnostic test strips. The fabrics were developed to meet the processing and cleanliness requirements of the medical industry. They are routinely tested for endotoxins and hemolytic substances using USP Class VI, ISO 10993, and cytotoxicity test methods. The filters can be surface treated to enhance priming, wetting, and wicking properties. Sefar America Inc., Depew, NY www.sefar.com 



Woven synthetic materials

Medical fabrics are suitable for blood filtration in arterial, cardiotomy, and transfusion applications. The precision-woven synthetics can also be used in medical and diagnostic products, such as drug-infusion systems, flow-control devices, moisture barriers, biopsy bags, and electromagnetic and radio-frequency interference shielding. The filters materials can be fabricated into slit rolls, stamped parts, tubes, pleated elements, and bags. Ultrasonic cutting and welding, pleating, and laser and cold cutting are performed in a Class 10,000 cleanroom. Customers can choose from a variety of pore sizes, thicknesses, flow rates, and hydrophilic or hydrophobic finishes. SaatiTech Inc., Somers, NY www.saati.com 


Custom screens

A supplier of precision thin-metal parts offers burr-free and stress-free custom screens in a number of metal alloys. Materials include biocompatible alloys such as titanium and specialty stainless steels. According to the company, its screen production process offers low costs, fast delivery, and parts design flexibility. The tooling also enables medical device design engineers to create multiple versions of a certain part. Fotofab, Chicago, IL www.fotofab.com 


Porous metal media

Filters and other porous metal products are suited for a number of medical applications requiring efficiency, exact flow specifications, biocompatibility, high-temperature resistance, and resistance to aggressive chemicals. Working with customers in the medical industry, the company has designed products meeting the filtration and flow-control requirements of medical devices. Examples include biocompatible porous titanium filters, implantable devices, metal filters in test stands, spargers used in cell-culture processes, filters to prevent plugging in catheters, and precision flow restrictors for the delivery of gases in life-critical systems. According to the company, porous metal offers the advantage of withstanding aggressive and repeated sterilization regimes. Mott Corp., Farmington, CT www.mottcorp.com 


IV filter

A lightweight IV filter offers low-profile geometry for patient comfort andsmooth flow characteristics for easy priming and high-flow applications. The MediPure filter is designed for use in adult IV applications and is available in 0.2- and 1.2-µm and high-flow versions. The compact housing holds 12 cm2 of effective filtration area, and its alcohol- and lipid-resistant housing offers optic clarity even after gamma sterilization. The universal housing design can be purchased with tubing or socket ports to fit customer requirements. Filtertek, Hebron, IL www.filtertek.com   


Medical electronics filters

Miniature air filters are designed to fit medical electronics equipment in which a number of certifications and classifications are critical. The line consists of air filters of 25 sq in. or smaller and thicknesses of 1¼4 in. or smaller, suitable for electronics enclosures with limited space. Frame options include flex-frame and edge-to-edge designs. With flex-frames, the products can bend to fit cramped enclosures. Edge-to-edge versions maximize the flow of clean, cooling air along the interior chassis walls. The products meet UL 94HF-1 flammability resistance requirements and can be configured with electromagnetic interference-shielding capabilities. The company delivers free prototype air filters to customers within 5 working days. Universal Air Filter, Sauget, IL www.uaf.com 


In-line filter

An all-PTFE filter provides a highly inert flow path that protects laboratory equipment by trapping particulate matter. The product's housing is imprinted with a spoke-style pattern to distribute the fluid over the entire filter surface to ensure maximum productivity. Connection options are available to provide flexibility to the instrument designer, including male-female and female-female designs, plus a barbed version for 1/16-in.-ID soft-wall tubing. Designed with a replaceable element, the filter removes particulates from fluids that could otherwise damage laboratory pumps, valves, and mechanical liquid-handling devices. Unfiltered matter can create a grinding action resulting in premature wear, misalignment, deformation, fluid leakage, and equipment failure. Bio-Chem Valve Inc., Boonton, NJ www.bio-chemvalve.com 


Specialty medical fabrics

With expertise in vascular grafts, orthopedic implants, and filter media, a company offers medical fabrics with high temperature resistance, static protection, UV durability, and biomedical compatibility. The products have been used in woven grafts for medical endovascular implants. All R&D, manufacturing, and material storage are carried out in dedicated environmentally controlled rooms. Complete lot traceability is maintained for a minimum of 10 years. A design staff works with customers to develop a concept, define specifications, design the fabric, create the prototype, test for performance, and support commercialization. Offray Specialty Narrow Fabrics, Chester, NJ www.osnf.com  



Hollow-fiber production machines

A line of production machines are manufactured from Type 316 stainless steel and other medical-grade materials to produce fiber on a continuous basis. End uses for the fibers include the filtration of blood, water, other liquids, and gases. The company designed and built the blending kettles producing the dope that is extruded through an adjustable spinneret. The extruded fibers are deposited into a coagulation bath and conveyed through additional rinse baths. After being cleaned, they are passed through a drying oven and wound onto an autodoffing rewind. Automatic handling is also available. Chase Machine & Engineering Inc., West Warwick, RI www.chasemachine.com 

Copyright ©2004 Medical Product Manufacturing News

Machining for Small Parts

Originally Published MPMN September 2004

PROFILE

Machining for Small Parts

A supplier of micromachining products provides close tolerances

Susan Wallace

Molds from Guidant are machined with Makino equipment. The equipment can help companies decrease lead times.

Micromanufacturing in the medical field is becoming increasingly common. Intricate, high-tolerance, and high-quality parts, such as the leads that connect to life-saving devices such as implantable defibrillators and pacemakers are being designed ever smaller. Machines to manufacture them have a tough task to fulfill.

Guidant Corp. (St. Paul, MN; www.guidant.com) designs and develops cardiovascular medical products. It is experienced in micromanufacturing technology. This is particularly true at its Model Shop for Advanced Manufacturing Engineering in Cardiac Rhythm Management. The shop has grown at a rate of nearly 46%. It is expected to double in size over the next year.

The model shop's group leader, Susan M. Sackman, says the features and parts they are making in micromanufacturing require such tolerances as 0.0002 in., with absolutely no variance, over as much as a 6-in. flat piece of 420 stainless steel. 

To do this, "We have come to depend on vertical milling and sinker EDM machines that can give us the best tolerances possible," Sackman says. "We set out to acquire the best machines possible to meet our demands."

Guidant sent out some test samples to Makino (Mason, OH; www.makino.com) and a number of competitive machine manufacturers to mill and burn some molds. Sackman says the results were not even close.

"The machining industry is putting out great machines, but Makino definitely has distinct advantages over competitors, which makes the decision to buy machines a little bit easier," she says. "We also use high-speed machining for milling fixtures and support tools for general manufacturing production-line assembly devices."

"One thing that we strongly considered was whether the machine will be as effective and productive on our shop floor in two or five years as it is today. When you have an 8000 rpm machine, you are very limited. When you have a Makino that goes 30,000 rpm, like the V33, then your operation can really become efficient. And, because we primarily mill and use copper electrodes, the outstanding EDM part quality produced on the EDGE2S is outstanding--just awesome."

The company purchased two new V33 VMCs from Makino to cut copper electrodes for the EDGE2S Ram EDM machines, which are dedicated to burning lead fixture molds for various products. Guidant also uses the V33s to hard mill steel molds and also small, delicate ceramic leads. 

Sackman says, "We need machines like Makino that we can count on to hold tolerances, quality, and surface finishes. We just cannot get that micromanufacturing quality in older technology or other competitive equipment."

"Before we got the Makinos, a mold would historically take us 8 to 10 weeks to build. We are now building them in four," says Sackman. "We ship them to our different Guidant locations, where these molds are used to produce the tips of critical cardiovascular component leads that connect the human heart to our pacemaker or defibrillator devices."

Model maker Dave Sederberg says Guidant uses cooper electrodes in its processes due to the complexity of its products. "We need to burn to a high glaze surface finish, and we get phenomenal results and extreme accuracy with copper," says Sederberg. "The shapes that we are burning are very small and intricate, and with the V33 we can actually cut copper and get the high-shine mirror electrode finishes."

Sackman says that acquiring the Makino equipment was one of the main factors in decreasing the company's lead time, and enhancing its "work orders completed" formula. In 1999, Guidant's lead time was 30 days. Now they are down to 17.9. "This drastic cut is really a money saver for us," Sackman says.

Copyright ©2004 Medical Product Manufacturing News

On-line Platform TargetsUsers of Plastics 

Originally Published MPMN September 2004

E-News

On-line Platform Targets Users of Plastics 

www.omnexus.com 

Grant Wilson, Business Development, Medical 
EWI Inc.

In the world of on-line communities, the Omnexus Web site is where plastics suppliers meet the end-use industries. SpecialChem (Paris, France), an on-line innovation and solutions hub, expanded its coverage by acquiring the existing Omnexus platform from major plastics suppliers in December 2003. On June 11, the company launched a revamped version of the site. 

The new Omnexus site represents the end-use industries in which plastics are most employed. These include the automotive, packaging, medical, electronics, and telecommunications sectors. The site is now devoted to articles about the latest technologies, polymer profiles, and trend updates. 

Users can also access technical support from suppliers. More than 75,000 industry professionals are registered on the site, with 3000 new users added each month, according to Christophe Cabarry, founder of SpecialChem. With the added support, OEMs receive the help that they need while the suppliers open doors for extra business.

"OEMs are downsizing and have cut the product development resources," says Cabarry. "At the same time, suppliers of plastics and elastomers are reducing their technical support, which they used to offer customers for free."

In addition to support, Omnexus houses a variety of industry information. The site's innovation section organizes topics by applications, grades and materials, environment, and other categories. R&D data include patent details and papers relevant to specific industries. Materials are classified by common themes such as transparency, barrier and thermal properties, and adhesion. A global news service tracks market trends and industry events. "A team of experts scans the entire industry globally [to provide information to the site]," says Cabarry. "They spot the latest innovations from publications, conferences, patents, [and] press releases, and [keep tabs on] relationships among large producers and suppliers."

The site's polymer selector allows users to choose materials based on desired properties. A list of suitable polymers is created, showing a profile and cost index. Users can select from a list of properties to further narrow the choices, which are compared on a graphical chart. Strengths, limitations, applications, chemical resistance, and processibility are shown for each polymer.

For design advice, an on-line support feature connects the user with an expert. This area of the site focuses on metal replacement and transparency; a number of solutions already are available on-line. Data sheets identify needs and problems that medical engineers commonly face. 

"OEMs can use the new Omnexus to find inspiration for [product] innovations, and to keep up with trends," says Cabarry. "Most users are not experts in plastics. We can help them to accelerate development and innovation."

Melody Lee

Copyright ©2004 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN September 2004

E-News

My Favorite Bookmarks

Grant Wilson

Grant Wilson, Business Development, Medical 
EWI Inc.

Globalspec (www.globalspec.com) provides users with a simple search engine to find a wide range of engineering materials. Categories are included to help limit the scope of the search. The list of categories includes products, manufacturers, and service providers. Users can also search by material properties, patents, and standards.

Dogpile (www.dogpile.com) is a search engine with the best results from a number of top engines, including Google, Yahoo, and Ask Jeeves. When searching for detailed technical information, often this site seems to have the most "on-target" links without a lot of fine-tuning of the key words. New features on the site include tabs for Yellow and White Pages, and organized results.

Laser Institute of America (LIA; www.laserinstitute.org) is a professional membership society for fostering lasers, laser applications, and safety. Covering the medical industry, LIA serves laser users around the world. Its Web site is a great source for laser education, publications for laser applications, and materials processing. On-line forums include questions about medical lasers. Details about upcoming sponsored conferences and proceedings from past events are also given.

Design News (www.designnews.com) is an excellent resource for design engineers in just about any industry. A lot of design information is available on this site in a number of topics. The list includes electronics, engineering software and hardware, fluid power, motion control, joining and assembly, and materials. The site provides an easy registration process to subscribe to HTML newsletters that are sent twice each month. The e-mails contain specific new information on whichever of these particular topics is of most interest to you.

EWI Inc. (Columbus, OH; www.ewi.org) is a materials-joining engineering center, working with metals, polymers, ceramics, and glass. A wide range of joining technologies is used, from laser and ultrasonic welding to adhesives. The company covers the spectrum of technology and product development to manufacturing, including FEA and weld modeling.

Melody Lee

Copyright ©2004 Medical Product Manufacturing News

IN BRIEF

Originally Published MPMN September 2004

INDUSTRY NEWS

IN BRIEF 

Ampac Packaging LLC
(Cincinnati; www.ampaconline.com) and Kapak Corp. (Minneapolis; www.kapak.com) have announced a financial partnership agreement. Under the terms of the agreement, Kapak will continue to operate independently, but will be armed with a new influx of capital from Ampac. . . 

Specialty Coating Systems, a business unit of Cookson Electronics (Indianapolis, www.scscookson.com) has opened a new 17,000-sq-ft cleanroom in its worldwide headquarters. The cleanroom's design features ISO Class 7 and ISO Class 6 areas, and an ISO Class 5 area for component fixturing and examination. . . 

Xact Wire EDM (Waukesha, WI; www.exactedm.com) celebrates its 20th anniversary this year . . .

Universal Laser Systems Inc. (Scottsdale, AZ; www.ulsinc.com) has announced that one of its distributors, C.E.M., has moved to a larger facility in Santa Ana, CA. The new space is 2000 sq ft, and can accommodate one of Universal's XL series machines. . . 

Nusil Technology (Carpinteria, CA; www.nusilcom) will be expanding its headquarters and adding a new 70,000-sq-ft building to its 185,000-sq-ft research and manufacturing complex. The new building will house the shipping and packaging departments and the company's warehouse . . . 

The near-infrared absorbents used in the Clearweld process from Gentex Corp. (Carbondale, PA; www.gentexcorp.com) have been shown to meet the requirements of USP Class VI testing. . .

The MedTech Group Inc. (South Plainfield, NJ; www.medtech-grp.com) has opened a new 25,000-sq-ft facility in Costa Rica. . .

DSM Desotech Inc.
(New Castle, DE; www.dsmdesotech.com) and 3D Systems Corp. (Valencia, CA; www.3dsystems.com) have entered into a worldwide nonexclusive distribution agreement for stereolithography resin. Under the terms of the agreement, 3D Systems will distribute DSM Somos stereolithography resins.

Copyright ©2004 Medical Product Manufacturing News

New Fabrics Comfort and ProtectHealthcare Workers 

Originally Published MPMN September 2004

INDUSTRY NEWS

New Fabrics Comfort and Protect Healthcare Workers 

Corinne Litchfield

By combining softness and barrier properties in a new line of fabrics, Polymer Group Inc. (PGI) (Mooresville, NC; www.polymergroupinc.com) aims to provide healthcare workers with more comfort on the job, as well as high levels of protection. "MediSoft fabrics provide the high barrier protection of spun-melt materials combined with the softness, drapability, and breathability the industry demands," says CEO James L. Schaeffer. 

Concerns surrounding the potential of cross-infection have propelled the medical industry to develop fabrics with improved fluid barriers. This can be achieved by means of the spun-melt process, but garments made with these fabrics tend to be stiff and uncomfortable, particularly after extended use. "MediSoft fabrics give PGI the ability to offer the comfort and convenience of spun-lace fabrics with the protection and cost advantages of spun-melt 
technology," adds Schaeffer.

The company used two tests to evaluate fabric softness: Handle-O-Meter testing to measure the fabric's drapability by evaluating the combined effects of flexibility and surface friction, and the coefficient of friction to measure its softness. MediSoft fabrics exhibited a 50% increase in drapability and a 40% increase in softness over standard spun-melt fabrics used in medical applications, according to the company. The fabrics also exceeded the Association for the Advancement of Medical Instrumentation (AAMI) standards for Level III garments of 50 cm in hydroheads, a measurement of barrier properties. 

Introduced at the 2004 International Engineered Fabrics Conference and Expo (IDEA04), the fabrics are being evaluated by key global suppliers. The material is manufactured at the company's facility in Nanhai, China.

Copyright ©2004 Medical Product Manufacturing News