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Articles from 2005 In June


Originally Published MPMN June 2005

MD&M East


Welcome to the Medical Design & Manufacturing (MD&M) East 2005 trade show! Held June 13–15, 2005, at the Jacob K. Javits Convention Center in New York City, it promises to be bigger than ever. More than 1500 companies will be exhibiting their products and services, and 30,000 buyers are expected to participate.

New this year is the Automation Technology Expo (ATX). ATX will feature the latest technological advances in custom automation and assembly, robotics, control software, motors, drives, and motion control. The ATX show will be colocated with MD&M East, EastPack, PLASTEC East, and Atlantic Design & Manufacturing.

Conference sessions will run concurrently. Program content is 90% new to MD&M East, and was carefully developed in response to industry input.

MPMN has devoted the next several pages to in-depth coverage of the show. Read on for a sneak peek at the products and services you’ll be seeing there. A conference guide and a look at some companies exhibiting for the very first time are also included.


Aztec Tool’s Capabilities Are Far from Being Ancient History

Corinne Litchfield

The name of a business can suggest many things. Traits such as quality, reliability, and skill are among the traits that customers expect from a business. So when it came to selecting a name for Aztec Tool (Edgewood, NY), the company looked no further than the ancient civilization known for its skilled craftsmanship and toolmaking abilities. Founded in 1977, the firm first established itself as a toolmaker in the cosmetic industry and then expanded into product design and injection molding. The company has been involved with medical manufacturing for the last 10–12 years, according to general manager Harry Herz.

The MD&M East show will be Aztec Tool’s first foray into the medical manufacturing trade show arena. “We go to the show every year for tooling and design systems,” says Herz. “This year we decided it was time to really start promoting ourselves. We want more local customers and since the show caters to a local trade, this is the best bang for the buck.”

The company will be showcasing its tooling and product design capabilities. Samples of injection-molded products will also be on display at the show. However, Herz confesses that the real showpiece for Aztec Tool is its employees. “Our people are the key to our business,” he adds. After hearing lots of positive feedback from show exhibitors in previous years, the company hopes to leave MD&M East with a few good client leads.

Firm Moves behind the Booth

Analee Zelaya

In the past, representatives of Endoscopy Support Services Inc. (ESS; Brewster, NY) walked the halls of the Medical Design & Manufacturing (MD&M) shows as observers. General manager James Burns says that he found the shows “useful for helping [ESS] find items, products, and pieces to make products.”

Burns will be on the exhibitor side of the MD&M East Show booth for the first time this year, and looks forward to companies selecting ESS’s services. These include quickly repairing endoscopic equipment and accessories such as flexible and rigid endoscopes, light sources, and endoscopy video equipment, which may have been deemed incapable of being fixed. The repair cost reportedly is more affordable than what the manufacturer of the equipment charges.

Burns also notes that, at the show, ESS would like to make contacts with large manufacturers wanting to sell ESS’s products under their brand names. Interested companies will choose from equipment ranging from software for image and video capturing to racks, cabinets, and endoscopic carts and trolleys.

The i-Cap software installs on either a laptop or desktop computer, along with the accessories that are included. Once the software is connected to a firm’s video output device, snapshots and videos of a procedure are taken. These images then can be organized by patient ID and reports generated in Microsoft Word. In addition, the firm offers endoscopic carts that are preassembled and a version that requires assembly because it is “flat packed,” according to Burns. Since the flat-pack cart is not bulky, its shipping costs are economical. The company’s Web site includes a link to its on-line carts store, from where a free catalog can be requested.

Innergy Power Gets All Charged Up for New York

Corinne Litchfield

After a positive experience at the MD&M West show this past January, Innergy Power (Scotts Valley, CA) decided to hedge its bets and exhibit at the MD&M East show. “We talked to other vendors [at the West show] who told us they generated more leads at the East shows,” says CEO Darrell Musick. “We figured if we got just as many leads at East that we did at West, it would be worth it.”

As a designer and manufacturer of batteries for more than 10 years, Innergy Power has maintained a presence within the medical device industry. The company’s batteries are based upon its patented ThinLine planar-case design, combined with thin-metal-film technology. By integrating these features, the company is able to produce thin, flat, lightweight sealed-lead batteries with performance comparable to that of nickel–cadmium and nickel–metal hydride batteries.

Innergy Power’s latest product, solar energy modules, will be on display at MD&M East. According to Musick, an international aid supplier recently included the modules in kits to be used in tsunami relief efforts. “We provided our 20-W solar modules in a binder-style format, complete with a zippered carrying case, to the supplier,” Musick explains. “The modules fold out for use, and include an adapter cord that allows users to plug the battery into a car’s cigarette lighter.” The module can be used to operate or recharge a 12-V device.

He’s particularly excited about the company’s hybrid unit, which will also be displayed at the show. The hybrid unit runs off of solar panels during daylight and uses battery power at night. “It has some interesting possibilities for medical manufacturing,” adds Musick. The company hopes to explore possible medical device applications for both products at the East show.

It’s All in the Family for Sandvik Coromant

Corinne Litchfield

It’s been said that imitation is the sincerest form of flattery. For Sandvik Coromant (Fair Lawn, NJ), the desire to mimic its sister companies has influenced the tooling maker to exhibit at MD&M East. Offering cutting tools for machining metals such as stainless steel and titanium, the company also makes tools for plastics machining.

Sandvik Coromant has been expanding its role in the medical device industry in recent years. According to business development manager Steve Piscopo, the Sandvik engineering group, especially sister company Sandvik Bioline, has been marketing itself more aggressively to the medical device industry. “We’ve been paying attention to what they are doing,” he says. In fact, it was Sandvik Bioline’s experience with medical manufacturing that encouraged the firm to expand its reach into the field. “There’s a good connection between medical manufacturing and Swiss machining,” he says.
Sandvik Coromant’s first appearance on the MD&M show circuit was in Minneapolis in 2004. Again, it was Sandvik Bioline’s success with MD&M shows that encouraged the company to participate. “We looked to see what they were doing to help us figure out how to position ourselves,” says Piscopo.

The company’s focus at MD&M East will be on small-part machining. “We’ve also got a broad product offering for threading, milling, drilling, turning, boring, and parting off,” adds Piscopo. Future plans include adding more services and equipment to its medical manufacturing capabilities.

Company Breathes New Life into Already-Deployed Products

Analee Zelaya

Designing, manufacturing, and deploying a medical device get the ball rolling, but the opportunities for revenue do not end there.

While working as a product manager at Johnson & Johnson, Shannon James Tillman saw the opening for an aftermarket niche where programs and services optimized the value of products after they had been deployed to the field. In August 2000, Millstone Medical Outsourcing (Fall River, MA), which is positioned in the postmanufacturing area of medical devices, was founded with Tillman as president and CEO. The firm now features Johnson & Johnson on its client roster, along with other major orthopedic device makers like Stryker.

Since its inception, the ISO 13485:1996–certified firm has seen an average 90% growth every year. Yet despite having worked with leading orthopedics companies, many of which are based in the eastern United States, Tillman still considers Millstone Medical “the best-kept secret” in the industry. To change this perception, the firm will make its inaugural appearance at a trade show, having chosen the MD&M East Show. Through this medium, Tillman will tell medical device manufacturers that the firm is “saving leading orthopedic OEMs millions of dollars every year by allowing them to avoid the costs of new products, and helping them to better account for and utilize what they have already deployed in the field.”

The company’s core capabilities include reprocessing, repackaging, and field-inventory auditing. Each year Millstone Medical’s field auditing department carries out more than 1200 physical inventories of products consigned to field sales locations across the United States. Financial reporting and presentation; organizational evaluations; and physical counting at hospitals, distributor offices, and regional warehouses are performed. Millstone Medical also provides loaner kit expediting, advanced inspection, ultrasonic cleaning, assembly and packaging, and distribution services. The firm handles products ranging from adhesion barrier polymer delivery systems to spinal pedicle screw implant assemblies. Other capabilities include label production, heat sealing, tubing, manual and automated polybagging, shrink-wrapping, syringe and powder filling, sterilization management, and Class 10,000 clean processing in a nearly 4000-sq-ft controlled environment.

Clients can monitor their products through production on Millstone Medical’s customized on-line inventory management system, which can be accessed worldwide via the Internet.

No Friction in Business Is Key for Firm

Analee Zelaya

Chances are that people associate Bose Corp. with the speakers in their living rooms or noise-canceling headphones. They might not have heard that Bose also manufactures advanced testing equipment for the medical device and engineered materials industries via its business unit, EnduraTEC Systems Group (ESG; Minnetonka, MN).

Bose and EnduraTEC forged a relationship in 1999 when Bose provided patented moving-magnet ElectroForce linear actuators for integration into EnduraTEC’s 9000-series stent/graft testers. The ElectroForce technology, which achieves frequencies of up to 60 Hz, enables precise and extremely fast material-testing protocols to be performed. Evidently liking the achievements of the collaboration, Bose purchased the materials-testing assets of the then-15-year-old EnduraTec in May 2004. It also resolved “to grow the company through broader exposure within the [medical device and engineered materials] industries,” according to the company’s general manager, Ed Moriarty. Exhibiting at the MD&M shows fits into that strategy.

Prior to its acquisition by Bose, ESG had exhibited at the MD&M West and Minneapolis shows. Moriarty notes that the firm had “positive” experiences and was “pleased with the type of response [generated] from customers.” By participating at this year’s East show for the first time, ESG will complete the MD&M trifecta. Moriarty adds: “We may not have been reaching all of the potential customers. We want to ensure that we are reaching customers who are likely to attend only one of the shows to further broaden our exposure.”

At the show, ESG plans to display its test instruments, including the smallest system that the firm supplies. The ElectroForce 3100-series is suitable for tissue mechanics research, bioMEMS evaluation and testing, and durability testing of medical devices. Featuring a friction-free moving-magnet flexure design that replaces traditional bearings, the machines provide durable and precise testing. This is possible because no static friction is created, which occurs and must be overcome when servopneumatic or servohydraulic systems are employed. In addition, this line of products is said to curtail the costs of energy and maintenance. The equipment requires no sound isolation and can be used in a cleanroom. In addition, ESG will showcase the largest version of its stent/graft tester, the ElectroForce Series 9150. This machine can test a stent measuring 18 to 42 mm in diameter.

Moriarty says, “Bose plans to continue to invest in this market.” It’s probably a safe bet, then, that the company will continue to make noise at future MD&M trade shows.

It’s a Neighborhood Block Party at Medivative Technologies

Corinne Litchfield

Here’s a riddle: Why did the contract manufacturer cross the street? In the case of Medivative Technologies (Indianapolis), a provider of contract manufacturing and process engineering services, it was to establish itself in the medical device industry.

Founded in 2002 as an offshoot of Aircom Manufacturing, Medivative is literally across the street from its parent company. “We had several medical OEMs coming to [Aircom] for cleanroom injection molding services,” says vice president of business development Ty Whitacre. “There’s a lot of future growth in medical manufacturing, so it was only logical to move in that direction.”

With capabilities ranging from product design to distribution, Medivative feels it has a distinct advantage over other contract manufacturers. In fact, the company’s foundation is built upon Aircom’s 45 years of experience in sheet-metal fabrication and plastic-injection molding. “Because Aircom has such a long history with both metal and plastic, we’re able to solve problems from a manufacturing standpoint that other companies might not be able to address,” states Whitacre. “We have a lot of years of experience, even though we’re young,” adds plant manager Tim Franklin.

Medivative attended the MD&M Minneapolis show in 2004 and decided to exhibit at MD&M East 2005 in order to take advantage of the location. “We have a lot of contacts and salespeople on the East Coast,” says Whitacre. “In my experience, the quality of sales leads that come out of the show have always been very high,” he adds. The company will be showcasing its capabilities in full-service contract manufacturing and medical device development at the show.

Manufacturer of Plastic Components Reaches Out to OEMs, Contract Houses

Caitlin Cook

The most brilliantly conceived products require components that will serve specific needs, translating innovative ideas into product realities. Jerry Zawada, medical segment manager for Busak+Shamban (Fort Wayne, IN), looks forward to proving to potential customers at MD&M East that his company speaks their language. No time could be more appropriate than the firm’s first opportunity to exhibit at a medical device show in the United States. “MD&M East is one of the largest shows in the country, and has proximity to both the U.S. pharmaceutical and medical device industries,” says Zawada.

“We offer a wide variety of sealing and bearing components made from elastomers, thermoplastics, and PTFEs,” Zawada comments. “They’d typically be used in things like blood separators, bone drills, catheters, syringe pumps, oxygen concentrators, and even hospital beds.” Zawada also adds that a recent addition to the company’s product line may hit just the right note in appealing to OEMs looking for performance and cost-effectiveness. “Our line of thermoplastic bearings and bushings is unique because they’re [made of] plastic instead of steel,” minimizing both weight and costs, he says. “They can be used in both durable and nondurable (disposable) applications.” Also to be showcased at the event are spring-energized PTFE seals that are suitable for high-speed rotary applications, including pumps, centrifuges, and bone drills.

In addition to components, Busak+Shamban manufactures plastic materials. The company hopes that a line of perfluoroelastomers called Isolast will strengthen its solid OEM base. “Perfluoros are used a lot in this industry because they have a wide temperature range and fluid compatibility,” remarks Zawada. “They’ve been used for things like high-performance liquid chromatographs and also in O-ring form in a number of liquid-handling devices.”

Company representatives are looking to strengthen their OEM customer base while reaching out to contract houses. “We’re interested in generating concrete leads that would take us into next-generation products,” says Zawada. “Our goal is to be considered a preferred supplier, one-stop shop, and the answer to tough problems and everyday needs.”

Endoscopy Firm Makes Its Debut at MD&M East

Susan Wallace

An endoscope and endoscope parts manufacturer chose MD&M East as its very first trade show ever. IEC-Innovative Endoscopy Components LLC (Sunrise, FL) says MD&M East is the perfect venue to showcase its product line. The company offers mechanical-, optical-, and injection-molded polymer and electronic items to the medical device industry.

“MD&M has become an international medical device show that attracts visitors from all countries due to its excellent location in New York City, with a tremendous growing amount of visitors,” says the company’s managing director, Gerald Goigitzer. “We also go there to meet some of our customers that we never had the chance to meet in person.”

The company started out six years ago as the U.S. sales office for a German endoscope and endoscope parts manufacturer, Rudolf Innoview GmbH. Initially they only provided three different items, but many models of each. Now they stock almost 500 items ranging from optical endoscope objectives and lenses to insertion tubes and parts for the flexible repair industry, arthroscopic shaver blades, and parts for orthopedic power tools.

Firm Chooses MD&M East for Its First Trade Show

Susan Wallace

About four years ago, Rob Connelly visited the MD&M East show. “I was amazed at everything they had,” he says. “Almost anything that you could imagine for the medical device industry was there.”

Apparently he never forgot the experience because when he started up FineLine Prototyping (Raleigh, NC) he choose MD&M East as the new company’s very first trade show. About 60% of the company’s business is in medical devices, so he says the show is perfect for them.

The core service offered at FineLine is the prototyping of three-dimensional objects using stereolithography (SL) technology. High-resolution SL is the company’s specialty. A high-resolution SL part build uses a 0.003 to 0.004-in.-diam laser beam and/or a layer thickness less than 0.004 in.

Building parts with the smaller laser-beam diameter results in parts with sharp corners and the thinnest possible walls. Thin layers reduce the cleanup required to smooth out contours or to polish tooling masters. This build style results in accurate, high- quality parts, according to the company.

Another service available is SLArmor. Exclusively from FineLine, this technology finishes off an advanced ceramic-filled epoxy material from DSM Somos—ProtoTool 20L—with a metal coating that gives parts the look, feel, and strength of metal, but without the weight. Reportedly, the composite nature of the process gives SLArmor a greater strength-to-weight ratio than many metals.

The company also offers FMF, a microfluidic fabrication process, that it says offers shortened development time for microfluidic devices of all shapes and sizes. It is a modified form of high-resolution stereolithography that allows the creation of any three-dimensional object through a process of stacking two-dimensional layers of 50-µm thickness. If the ultimate objective is to injection mold a microfluidic product, the FMF process enables designing and testing of most features. This process eliminates the constraints created by the limitations of conventional or mask-less photolithography.

Copyright ©2005 Medical Product Manufacturing News

The Cutting Edge of Laser Processing

Originally Published MPMN June 2005


The Cutting Edge of Laser Processing

Machines and technologies make an imprint on various substances

Analee Zelaya

Equipment for direct part marking is available on a rental basis from Laser Depot.
It’s no secret that people appreciate choices. And the laser processing industry offers many options for medical device manufacturers. Most companies provide services or equipment for sale, but a new trend is also emerging. Renting equipment is becoming an alternative to temporarily outsourced services.

The machines create markings on a variety of materials, including metals, such as stainless steel and gold, and plastics, ceramics, and coatings. And in a field where smaller is better, the sizes and thicknesses that can be achieved keep shrinking. Read on for an in-depth look at some recent happenings in the world of laser processing.

Laser Produces Fine Markings on Precious Metals and Plastics

A designer and manufacturer offers resistance welding and reflow soldering power supplies, heads, monitors, and accessories for both large-scale and fine-spot applications that require precision metal joining. Unitek Miyachi Corp. (Monrovia, CA) has introduced a diode-pumped solid-state laser marker that produces fine markings on precious metals and plastics. The Model LMV1000G is specifically designed for high-speed precision marking applications. Complementing the company’s existing marker products, the equipment offers a 532-nm wavelength laser output suitable for clear marking. The output reportedly also expands the types of materials that can be economically laser marked. For example, machine- and human-readable marks on gold-plated electronic components can be performed without removal of any of the gold. As a result, the corrosion resistance and electrical properties of the plating are maintained.

The laser marker uses Vanadate technology, Nd:YV04, an alternative to Nd:YAG. The lasing medium and the end-pumping technology offer many advantages, including high peak-power density, short Q-switch pulse durations, and good beam quality. Small spot sizes, fine line thicknesses, and small character or feature sizes are then possible to achieve. In addition, the device produces linewidths as small as 20 µm, character sizes down to 100 µm, and data matrix codes with 20-µm cell sizes, using standard-length lenses. This enables working distances to remain practical. Application development support is provided at no extra charge.

Company Rents Fiber Laser Marking Systems

Laser Depot, a div. of Precision Technology Group (Lake Mary, FL), offers an alternative to temporarily outsourced laser marking services that is suitable for direct part marking and part identification. The firm has introduced rental equipment that is reportedly easy to use and completely maintenance-free.

Incorporating fiber laser technology, the FiberTower Mini and handheld fiber laser marking system are offered at a monthly rental charge. The compact systems plug into a 100-V ac outlet for quick start-up, producing high-quality marks on production parts. They are suitable for marking metals, plastics, ceramics, and coatings. The company also offers rent-to-buy options.

Automated Laser Processing Is Provided for Shops of All Sizes

Engraving and cutting systems from Universal Laser Systems render metal-marking compounds unnecessary.

Laser processing can be automated in shops of all sizes with modular, sized-to-fit systems that enable hands-off conversion of raw materials into cut parts. Cincinnati Inc. (Cincinnati, OH) offers the Modular Material Handling Systems (MMHS) that optimize material flow and laser burn time. This enables long periods of unattended operation. The firm engineers, manufactures, and services the systems.

Individual shops can choose from four base systems and a variety of options to suit their needs. Systems can be configured for basic automated loading and unloading with a single laser, such as System 1. Full automation of high-volume production, employing material storage towers to serve multiple lasers that run complex mixes of parts and materials, can also be achieved. Customers can also customize automated sheet- and part-handling to their existing floor space and processing needs. Expansion and modification can be accommodated as laser activity grows and changes.

The basic MMHS-1 system consists of one or more stack carts, a sheet handler, gantry sheet transporter, unload cart or station, and Web-enabled PC control with user-friendly touch screen operation. The system removes the top sheet of raw material from a stack and transports it on the overhead gantry to the dual-pallet laser. Then, the sheet is placed on the open pallet while the previous job is being cut. When that job is finished, the pallets switch positions. At this point, the overhead gantry removes the finished nest of parts and strips them onto an unload station or parts cart. It subsequently returns to the sheet handler for the next sheet.

The sheet handler separates a single sheet from a stack of raw material using three different technologies: a mechanical peeler, fanning magnet, or air knife. This ensures that only a single sheet of material is processed. A sheet-thickness gauge verifies the correct material thickness before placing the sheet on the gantry. A vacuum lift system uses suction cups that are divided into five programmable zones to accommodate different sheet sizes.

Servodriven components are said to provide accurate and reliable performance, eliminating the need for limit switches, which can be failure prone. Remote operation and diagnostics are performed with the cell controller.

Metal-Marking Compounds Are Eliminated during the Engraving and Cutting Process

LPKF’s ProtoLaser 100 structuring system for printed circuit board prototyping cuts and drills, and needs no chemicals.

Universal Laser Systems Inc. (ULS; Scottsdale, AZ) offers air-cooled CO2 laser engraving and cutting systems, including a variety of computer-controlled machines. These are used for marking medical devices and making labels for medical equipment. Engraving fields can range from 16 ¥ 12 to 48 ¥ 24 in., power can range from 25 to 210 W to handle multiple laser processing applications.

ULS also provides high power density focusing optics, systems that mark metals such as stainless steel. Metal-marking compounds that are normally required when marking metals with a low-powered CO2 laser source are not needed.

The firm holds U.S. and international patents in laser technology, including one for a configuration approach that allows customers to select the platform, a laser cartridge or multiple cartridges, and accessories.

Laser Uses Milling, Drilling, and Contour Routing Techniques

An easy-to-use, self-contained laser structuring system for printed circuit board (PCB) prototyping combines a laser with the milling, drilling, and contour routing capabilities of the manufacturer’s advanced PCB plotter. The ProtoLaser 100 offered by LPKF Laser & Electronics (Wilsonville, OR) produces radio-frequency and microwave boards using a range of materials such as FR4 and PTFE-based substrates. The equipment also is used for structuring, cutting, and drilling.

The laser technology isolates the circuits from the copper layer and removes noncontacting copper between them. Therefore, boards can be structured at speeds to 1 sq in./min, with circuit paths as small as 2 mil. The 1-mil laser beam delivers sharp artwork definition, especially in corners. Since the plotter milling tools change automatically, the system runs unattended.

An optical fiducial recognition system in the laser and milling heads ensures that the laser-structured area of the PCB is precisely aligned with the mechanically milled area. The equipment requires no chemicals or external chilling systems. An integrated dust-extraction system removes all laser- and milling-generated debris, making it safe to operate in different work environments. The company’s CAM software automatically manages all tool parameters, and also the interaction between the laser and mechanical machining.

Copyright ©2005 Medical Product Manufacturing News

Outsourcing Outlook: Sterilization Company Specializes

Originally Published MPMN June 2005

Outsourcing Outlook


Sterilization Company Specializes in Small Loads

A company specializes in the sterilization of small loads for medical device manufacturers. A range of temperatures from 20° to 50°C is available, and 100% ethylene oxide is used. There is no chamber pressurization that may damage specialty or sensitive products. Items or devices from 0.1 to 15 cu ft can be sterilized. The company uses both chemical and biological indicators, provides validation services, and offers quick turnaround times.
Andersen Scientific Inc., Haw River, NC

Customized Sterilization Service Offered

Medical device sterilization, including custom packaging and laboratory services and all necessary validation support, is available to customers nationwide. The company can provide as little as simply processing cycles or as much as complete turnkey validation. Each facility is ISO 13488 certified and complies with EN 550 and all applicable FDA requirements. Centurion Sterilization Services, Howell, MI

Company Expands Its Sterilization Services

An autoclave sterilization firm has expanded its services by installing a clean-steam autoclave. The Finn Aqua autoclave has a capacity of 260 cu ft. Features include flexibility in time, temperature, and pressure capabilities. The company also offers flexible-packaging sterilization, as well as validation services. Cytosol OEM, Lenoir, NC

Irradiator Processes Small and Large Runs

A provider of gamma sterilization uses an irradiator that can deliver a dose as low as 0.5 kGy for any density. The irradiator can process both large and small runs in temperature-controlled environments. It is suitable for AAMI validations and materials testing. The company uses a Kodak BioMax alanine dosimetry system. Same-day and overnight processing are available. CFC Logistics, Quakertown, PA

E-Beam Sterilization Facility Offers One-Step Process

A one-step process combines sterilization and improvements in product performance, extending wear, temperature, pressure, and chemical resistance. Packaged medical devices are sterilized and treated without the use of chemicals or additives. The degree of treatment is controlled by the dose level required to sterilize the product or to deliver the desired performance. A permanent cross-linking of the plastic material occurs during sterilization. This causes an improvement in tensile and impact strength, thermal stability, permeability of oxygen and other environmental gases, and resistance to solvents, chemicals, and abrasion. The process enables medical-device designers of molded parts, tubing, woven and nonwoven materials, and other biomedical products to substitute less costly materials and to reduce the size of their products while improving their performance. E-Beam Services, Cranbury, NJ

Copyright ©2005 Medical Product Manufacturing News

Metal Fabrication

Originally Published MPMN June 2005


Metal Fabrication

Materials processing

Advanced materials processes such as laser welding, cutting, drilling, and engraving are among a contract firm’s specialties, as well as wire EDM, EDM hole drilling, and conventional machining. Secondary process capabilities include high-quality finishing services. Accumet Laser, Cranston, RI

Laboratory services

Process development
A company works with medical device manufacturers to develop new laser-based processes and turn the processes into turnkey production equipment. Past projects included surgical tool and device marking and texturing, dental drill-bit depth gauge marking, and pacemaker cathode cutting. Control Micro Systems, Winter Park, FL

Quick-turnaround metal fabrication

Precision metal parts can be delivered in 24 hours with chemical etching. Working with more than 50 metal alloys, the company uses the photochemical machining process to produce custom, precision metal parts in an environmentally friendly manner. Typical applications range from fine-mesh screens to electrical contacts, heat sinks to lead frames, and connector housings to RF/EMI shields. Fotofab, Chicago, IL

Precision-machined components

An ISO 9001:2000–certified manufacturer of precision-machined components and assemblies for medical implants, orthopedic instruments, and devices offers products for joint replacement, fracture management, and spine, hand, and extremity procedures. The company uses CNC milling up to 5 axes, CNC turning, CNC Swiss screw machining up to 12-axis, CNC wire EDM, and assemblies. Specialty services include prototypes, product launching, and project management. Marox, Holyoke, MA

Die-cutting services

A company specializing in die-cutting services offers products such as thermal- transfer materials, EMI laminates and gaskets, electrical insulators, gaskets and seals, and screens and filters. Formed plastic covers made from polycarbonate, polypropylene, and acrylic are also available. Additional capabilities include water-jet cutting, CNC routing, stamping, and laminating. Orion Industries Inc., Ayer, MA

Machined metal fabrication

A supplier has expertise in machined metal fabrication. Capabilities include multiaxis CNC Swiss turning, wire and plunge EDM, five-axis machining, deburring, precision cleaning and finishing, and resistance and laser welding. Other services such as molding engineering-grade thermoplastic and elastomeric materials, micromolding, liquid silicone–injection molding, product design and engineering, in-house CAD/CAM-based tooling design and fabrication, insert molding, overmolding, and white room molding are also available. The firm has a dedicated R&D and prototyping department Donatelle, New Brighton, MN

Contract wire EDM services

A company supplying contract wire EDM services has 24 wire EMD machines and five high-speed small-hole machines in its fully equipped facility. Inspection equipment includes video systems with resolution to four-millionths and reverse engineering capabilities. Prototype through production runs can be accommodated. Xact Wire EDM Corp., Waukesha, WI

Sheet-metal fabrication

Full-service product conceptualization, design, and manufacturing of metal stampings, enclosures, precision-machined parts, and buss bars are available. Both prototyping and volume production are offered. The company’s design services division helps customers develop and design products with deference to critical considerations for product integrity, functionality, manufacturability, and cost. Quality Tool Inc., Minneapolis, MN

Automated machining

Automated machining services are offered using two horizontal CNC mills with 32 pallets. The machines can run 24 hours a day, 7 days a week. With this service, setups are eliminated and lead times are shortened. Other services such as CNC machining, Swiss machining, and assembly are also offered. Moseys Production Machinists, Anaheim, CA

Copyright ©2005 Medical Product Manufacturing News

Testing & Inspection: Wireless data logger

Originally Published MPMN June 2005


Testing & Inspection

Wireless data logger

A wireless data logger measures and monitors temperature from 32° to 300°F and pressure from 0.40 to 300 psi. The PicoVACQ PT has dimensions of 0.6 in. in diam and 1.4 in. in height, and can be placed inside a product or directly in sterilizers, pouches, bottles, or any other type of packaging. The unit can record up to four measurements per second and start recording either from a temperature threshold or a time. The device is suitable for obtaining reports of thermal validation or control, testing equipment, and verifying sterilizers. TMI USA, Dulles, VA

Laboratory services

A company’s services include more than 400 microbiological and analytical tests. Specialties include microbiology tests, sterilization validation, lot-release tests, biocompatibility tests, organism identification, and filter validation. Within a 62,000-sq-ft facility, 80 laboratories are maintained as well as a custom-built 3000-sq-ft sterility testing cleanroom suite. Nelson Laboratories, Salt Lake City, UT

Chemical and microbiological analysis

Chemical and microbiological analytical services are offered by a company with a large laboratory capacity, extensive technical expertise and experience, and a multiple-shift staff. Services include drug substance and drug product stability testing, commercial product release testing, stability storage testing, plastic and glass container testing, and analytical method development and validation. Lancaster Laboratories, Lancaster, PA

Thermal imaging service

Hourly thermal imaging is available as part of a company’s yield improvement services. Thermal imaging is a noncontact method for measuring temperature. Many parts can be in one scene, even those in motion. More than 1 million temperature measurements can be taken each second at 0.1°C sensitivity. The technique is a fast way to find the root cause of defects in drying, bonding, lasing, dipping, molding, and other temperature-sensitive processes. The service requires no change to existing production protocols. Elastic Design LLC, San Bruno, CA

Luer testing

Testing of luer products is performed according to ISO 594, EN 1707, and ISO 10555 standards. Physical tests include gauging, ease of assembly, unscrewing torque, overriding torque, air and liquid leakage, separation force, and stress cracking. Melab GmbH, Leonberg, Germany

Troubleshooting tool

A stand-alone troubleshooting tool is designed for control system testing and maintenance. Suitable for use in medical product manufacturing, the Crakker enables evaluation of programmable logic controllers, relay logic, and document control systems. The unit records timing, transitions, and status of up to 16 input and output points in real-time speeds, without altering or reprogramming a validated system. Logic Beach Inc., La Mesa, CA

Performance and safety testing

A comprehensive range of performance and safety testing services are available. The company’s capabilities include chemical and physical testing to ensure biocompatibility and material characterization. Fast turnaround and complete confidentiality are ensured. Akron Rubber Development Laboratory Inc., Akron, OH

Safety testing

A company tests finished devices, components, or raw materials to determine their safety. A customized master specification is offered in order to develop the most accurate test method for a product. Tests include bioburden analyses such as aerobic, anaerobic, and spore former assays. Cleanroom certifications are also available, as well EtO residual analysis to ensure monitoring compliance in accordance with many standards. On-site environmental monitoring determines the efficacy of air filtration systems and the impact on medical devices in the manufacturing process. Dynatec Scientific Laboratory, El Paso, TX

Low-force dynamic test systems

A family of dynamic mechanical test systems features a 20-kHz servocontroller capable of single- or multiple-axis control and data acquisition for material, component, and device tests. The Dyna-Myte units expand the bandwidth of mechanical-properties testing beyond the firm’s 100Q and 100R tensile, tear, compression, and peel testers to include fatigue, cyclic, and dynamic-properties tests. Systems are configured from a wide range of dynamic actuators from 50 to 3000 N, with travel from 12 to 300 mm, and include load cells and strain sensors, LVDTs, and encoders to measure and control mechanical stress and strain at frequencies to 100 Hz. Test Resources Inc., Shakopee, MN

Copyright ©2005 Medical Product Manufacturing News

Manufacturer Finds Better Results under Pressure

Originally Published MPMN June 2005


Manufacturer Finds Better Results under Pressure

Pressure-formed thermoplastic alloy improves performance and appearance of medical imaging instrument

The SKYLight system was redesigned using panels made from Kydex T, a thermoplastic alloy.

Sometimes even the most innovative and advanced equipment can benefit from a slight redesign. In the case of one company, seeking out new manufacturing methods led to a more aesthetically pleasing product, as well as more cost-effective materials.
The SKYLight nuclear diagnostic imaging system from Philips Medical Systems (Milpitas, CA; is a gantry-free camera that features an open-floor design, allowing imaging of a patient in any position on any bed. The system also enables imaging of two patients simultaneously.

The original design used painted and textured fiberglass panels, which soon proved to be labor-intensive. “There were some variations from part to part with the fiberglass panels,” says Brent Shannon, mechanical engineer at Philips Medical Systems. “We found we had to deal with each part on an individual basis, which was time-consuming.” The company’s concerns with the inconsistencies, as well as a desire to reduce costs, led it to conclude that a new type of paneling was needed.

To find solutions to these challenges, Philips consulted pressure former Specialty Manufacturing Inc. (SMI; San Diego; for design assistance, a material recommendation, and production of the thermoplastic enclosure system. SMI evaluated several thermoplastic sheet materials, recounts Haydn Forward, SMI’s vice president, including ABS, an ABS/ polycarbonate alloy, and an ABS/ PVC combination.

Kydex T, a proprietary alloy from Kleerdex Co. LLC (Bloomsburg, PA;, was ultimately specified. “The material carries a UL Std. 94V-0/5V fire rating and, and based on our history with it, provides the formability, toughness, and color qualities required by the SKYLight application,” says Forward. “With impact resistance of 15 ft-lb/in., it also offers significantly better protection against impact from wheelchairs and gurneys than other thermoplastic materials we considered,” he adds.

Specialty Manufacturing Inc. pressure-formed the panels
to thicknesses ranging from 0.0187 to 0.250 in.

Formability and repeatability of the sheet were critical because the enclosure panels were redesigned with precise tongue-and-groove connections to simplify assembly. The snap-fit capability requires only 16 fasteners to secure all 36 parts comprising the enclosure. The tolerance of the tongue-and-groove connections is measured in thousandths of an inch, explains Forward. The tabs and receiving slots of the connections are formed into the panels during processing and maintain tolerances within 0.015 in.

The integrity of the tongue-and-groove connections also relies on the polymer’s memory of to maintain the shape of the part after the tabs and slots engage. “A key to this design is the natural memory of the thermoplastic sheet in achieving a snap-fit,” says Jack Schrieffer, engineering manager at SMI. “The stiffness and predictability of Kydex T sheet in this regard are crucial to the success of the novel design,” he adds.

Because the SKYLight instrument is produced in limited quantities, with part production typically in the hundreds per year, color consistency is also of special concern. “Philips must be able to mix and match components as necessary, whether for new units or as replacements, with no variation in color,” says Schrieffer. “Consistency of the Kydex T sheet enables us to offer the repeatability associated with a precision color house.” Forward explains that appearance also hinges on the ability of the thermoplastic sheet to accurately reproduce the acid-etched texture of the aluminum pressure-forming molds, and that the sheet reproduces mold finish with no part-to-part variation, even among deep-drawn parts.

The parts that SMI pressure-forms range in size to 30 sq in., with draws up to 9 in. Sheet thicknesses range from 0.187 to 0.250 in., depending on part size, shape, and rigidity.

Schrieffer explains that pressure- forming is an effective way to produce tight-tolerance parts in low volumes. “The sheer size of these parts would make injection molding a difficult and cost-prohibitive option,” he adds, “especially considering the large number of different parts and relatively low annual volume. We are able to achieve the appearance and fit of an injection-molded part with shorter lead times and lower tooling costs by using pressure-forming.”

Schrieffer also adds that pressure- forming enables the use of undercuts, which are critical to the tongue-and-groove design. Since there are no restrictions on the core-and-cavity interface with a female-cavity-only pressure-forming tool, it is easier to incorporate undercuts than it is in injection molding tools, which use costly collapsible cores to achieve the same result. With single-sided-aluminum pressure-forming tools, design changes can also be made faster and at significantly lower cost.

Multiaxis CNC equipment is used to trim pressure-formed parts. “A design change can often be accomplished by a simple CNC programming change, such as adjusting a height cut or an opening dimension. This makes pressure-forming even more attractive from cost and time-to- market viewpoints,” says Schrieffer.

SMI precisely controls heating of the sheet as an important element of the overall process parameters. “We know we can count on the consistency of each sheet of Kydex to react the same to our heating profile to yield repeatable results. The material is not only predictable, it provides an excellent balance of physical properties and formability required for this application,” says Schrieffer.

SMI received the Multi-Part Assembly Award in 2004 for the Philips SKYLight pressure-formed enclosure from The Society of Plastics Engineers Thermoforming Division.

Copyright ©2005 Medical Product Manufacturing News

Free Course May Improve Workforce

Originally Published MPMN June 2005


Free Course May Improve Workforce

Analee Zelaya

Click to go to site.

Automated Learning Corp. (ALC; Kanata, ON, Canada), an e-learning company that focuses on workforce skills, is offering a free on-line training course, titled Going Lean: Introduction to Lean Concepts. The interactive multimedia program that deals with improving workplace performance expires December 1, 2005. Topics that will be covered include the advantages of going lean, eight kinds of waste, the obstacles to transformation, and the metrics of lean manufacturing. Becoming a truly lean organization and being completely and fully functional will also be reviewed. Interested individuals can register on the firm’s Web site.

The firm provides customized consulting and training solutions as well as other off-the-shelf courses on areas such as safety and ESD.

Copyright ©2005 Medical Product Manufacturing News

Portal Provides Guide to Technologies

Originally Published MPMN June 2005


Portal Provides Guide to Technologies

Analee Zelaya

Click to go to site.

A supplier of technology-based systems for curing and surface-treatment processes produces precision dispensing equipment that applies adhesives, sealants, and coatings to products during manufacturing. Nordson Corp. (Westlake, OH), along with such high-technology subsidiaries as Asymtek, EFD, and March Plasma Systems, has developed liquid and powder dispensing, plasma surface treatment, solder assembly, fluid-jetting, nanofiber, and ultraviolet curing products. The company’s Life Sciences group has launched a Web portal that highlights the coordination of these technologies. The group focuses on delivering process efficiencies and cost savings to the biotechnology, medical device, and medical electronics industries.

The site’s users can access technical papers and trade show information, gain access to lab capabilities, and explore the firm’s new applications. They also can register to have a Nordson representative visit their facilities to provide a dispensing seminar.

“Nordson systems bring higher quality, speed, and increased efficiency to a wide range of life sciences applications,” says Nancy Gleason, manager of the Nordson Life Sciences group. “Our new portal site provides manufacturers with easy access to comprehensive information from all the Nordson companies that serve life sciences, and allows them to browse for application-specific technologies.”

Copyright ©2005 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN June 2005


My Favorite Bookmarks

Larry Pope,
Vice President of Corporate Quality and Regulatory Affairs

Larry Pope

If you need help in creating meaningful data presentations, check out the Web site for Edward Tufte, professor emeritus at Yale University ( He offers a one-day course on data presentation, and there’s an on-line forum where you can ask questions and get feedback on information design. You can also take a look at some of his artwork and sculpture.

Clinivation ( offers documentation templates for policies and procedures in your quality system. This is a good place to start when you are having a difficult time creating a new form or procedure.

The Regulatory Affairs Professionals Society (RAPS) is a member organization that creates and upholds ethical standards, and offers credentialing and education to regulatory affairs personnel within the health product sector. Its Web site ( provides articles and notices relevant to the profession. The site also includes information on educational opportunities and RAPS certification programs.

The American National Standards Institute (ANSI) Web site ( provides information on current standards activities. The Electronic Standards Store on its site is my source for the standards that we use.

When you need to figure out how many millimeters make up a mile, try ( This site offers a variety of programs to convert from one type of measurement units to another. Conversions for a variety of measurements, from metric to U.S. avoirdupois, are possible. You can even calculate conversions using ancient Greek and Roman systems of measurement.

Trivirix (Durham, NC; is a contract manufacturer exclusively focused on the design, manufacture, and support of electronic and electromechanical medical and life science equipment. Specializing in moderate-volume, high-mix manufacturing, the company has facilities in the United States and Europe..

Corinne Litchfield

Copyright ©2005 Medical Product Manufacturing News

In Brief

Originally Published MPMN June 2005


In Brief

Colortronic North America ( has recently moved its headquarters to Flint, MI. Its production capabilities will move to the new ACS Group facility in New Berlin, WI. . . Unitek Miyachi Corp. (Monrovia, CA; has changed its name to Miyachi Unitek Corp. . . GSI Lumonics Inc. (Northville, MI; has opened two regional sales offices in mainland China. One is in Shanghai, the other is in Beijing. . . Makino Inc. (Fountain Valley, CA; has opened a California Tech Center in greater Los Angeles to serve as a West coast regional sales, service, and applications support facility. . . Precision Associates Inc. (Minneapolis; is celebrating its 50th year in business . . .

Copyright ©2005 Medical Product Manufacturing News