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Articles from 2002 In October


Company Adopts Global Vision to Capture Greater Share

Originally Published MPMN October 2002

INDUSTRY NEWS

Company Adopts Global Vision to Capture Greater Share

Norbert Sparrow
United Plastics Group has Class 10,000 and Class 100,000 cleanrooms available for medical device OEMs.

Lean manufacturing practices, a commitment to constant improvement, and a global reach are not novel concepts, but they have not been seriously embraced by suppliers of molding services. At least that's the belief of United Plastics Group (UPG; Westmont, IL; www.unitedplasticsgroup.com), which is applying those principles to its molding and assembly facilities worldwide. By doing so, UPG hopes to increase its share of the medical device molding market.

A supplier of injection molding and assembly services with 11 facilities in the United States, the United Kingdom, Mexico, and, most recently, China, UPG currently does about 11% of its business with device OEMs. It wants to see that activity grow 25 to 40% in the next 12 months, according to Richard Harris, vice president of finance and CFO. The company's aggressive efforts to streamline its business and manufacturing practices are designed to make that forecast a bottom-line reality.

"Lean manufacturing is nothing new," admits Harris, "but we are introducing that model into the molding services industry. It is still possible to become a global leader by applying these principles," he explains, because few companies in this sector have ever attempted it. The benefits to the medical device and other industries are a reduction in costs combined with an improvement in quality, he adds.

UPG has a solid foundation to attract the business of device OEMs, notes global business director Brian VanderLaan. The company's resources include an FDA-registered facility in Fremont, CA; Class 10,000 and Class 100,000 cleanrooms; and proven expertise in the fabrication of a range of medical equipment. UPG has experience manufacturing complex handheld electromedical devices and assembling blood glucose meters, diagnostic, and respiratory devices.

An array of 10- to 100-t presses enables the firm to mold a range of part sizes; pad printing, EMI and RFI solutions, and assembly processes, including sonic and vibration welding, are also available.

By introducing lean manufacturing practices and GE-developed six sigma processes to its 11 facilities, UPG is adding production efficiencies and cost reductions to those manufacturing resources. The use of multiskilled teams to reduce product-flow and setup times while minimizing waste has increased "productivity by as much as 138%," claims Chuck Villa, executive vice president, business development. "That allows us to offer engineered products at commodity prices," adds VanderLaan.

The firm also recently inaugurated a technology and development center at its plant in Anaheim, CA. Established to assist customers with product design and quality issues, the center is equipped with Intelligent Qualitative Control processing software, cavity pressure sensing technology, and high-speed CNC milling machines. It also has rapid prototyping and in-house tooling capabilities.

The objective of the tech center and, indeed, all of the systems that the company is putting in place, stresses Villa, is to help customers accelerate their products' time to market and to reduce costs.

Copyright ©2002 Medical Product Manufacturing News

Alcoa Acquires Custom Thermoforming Services

Originally Published MPMN October 2002

INDUSTRY NEWS

Alcoa Acquires Custom Thermoforming Services

Alcoa Flexible Packaging now supplies custom thermoformed packaging for medical device applications.

Custom thermoforming services for medical products are now available from Alcoa Flexible Packaging (Richmond, VA; www.alcoa.com) as a result of its acquisition of Ivex Packaging Corp. in July. The firm can provide thermoformed packaging for medical devices; diagnostic, procedural, and dental kits; implant trays; and home healthcare products.

The state-of-the-art thermoforming equipment allows Alcoa to produce complex designs to precise specifications in a broad range of materials. The custom capabilities "complement the flexible packaging product offerings and increase the scope of packaging options that we can offer our strategic growth markets,"says flexible packaging president Elizabeth A. Fessenden.

The company supplies extrusion and adhesive laminated pouch materials, overwraps and liner stock, blister lidding foil, shrink film, and a host of other packaging materials to the medical and other industries.

Copyright ©2002 Medical Product Manufacturing News

MSI Moves into New Facilities, Launches Marker-Band Swaging Line

Originally Published MPMN October 2002

INDUSTRY NEWS

MSI Moves into New Facilities, Launches Marker-Band Swaging Line

Susan Wallace

MSI’s new manufacturing facilitiesdouble the company’s workspace.

To celebrate the opening of its new facilities and the launching of a line of marker-band swaging equipment, Machine Solutions Inc. (MSI; Flagstaff, AZ; www.machinesolutions.org) held an Open House event on August 19, 2002. The new facilities double the company's workspace. Nearly 7000 sq ft is divided into a contract manufacturing work area, an equipment demonstration and evolution space, and a dedicated manufacturing area for custom or proprietary projects, as well as office space for the company's 17 employees.

The company supplies stent crimping, catheter balloon pleating and folding, and marker-band swaging equipment to the medical device
industry and has customers in the United States, Europe, the Middle East, and Asia.

Domestic customers include Boston Scientific Scimed, (Natick, MA; bostonscientific.com), Guidant (Indianapolis; www.guidant.com), Cordis, a Johnson & Johnson Co., (Miami; www. cordis. com), and Medtronic (Minneapolis; www. medtronic.com).

Marker-band swaging equipment, the company's latest product offering, is set to be launched in the fourth quarter of 2002, according to company sources. "This line could keep the company busy for the next 10 years," says company cofounder Dan Kasprzyk. Marker bands are components of a stent that enable the surgeon to locate the device on an x-ray.
Kasprzyk added that MSI's future plans include introducing or extending one new product line per quarter, building intellectual property, and continuing to convert the
operations of its four largest customers.

Copyright ©2002 Medical Product Manufacturing News

Machining Firm Adds Laser R&D Lab

Originally Published MPMN October 2002

INDUSTRY NEWS

Machining Firm Adds Laser R&D Lab

Norbert Sparrow
The addition of a laser R&D department will help Norman Noble Inc. to offer customers innovative machining solutions.

A supplier of micromachining services recently established a laser machining research and development department. The lab's mission is to optimize the capabilities of the laser machining center at Norman Noble Inc. (Highland Heights, OH; www.nnoble.com) and to help develop novel processes to solve customer problems.

The company operates one of the largest laser machining centers in the world, according to Jeff Miller, laser R&D manager. "We know that the full potential of this process is limited only by our experience," says Miller. A full-time R&D department will help to achieve the company's goal of "meeting every laser machining challenge." Several proprietary processes developed at the center already have benefited customers faced with challenges in micromachining subminiature components, according to the company.

Equipped with five proprietary laser systems, the lab is located in a restricted area adjacent to the laser production department. The proximity to the manufacturing site is designed to enable immediate hands-on project assistance as required. Production problems that may arise are immediately addressed, minimizing downtime.

Lab personnel routinely design tooling and develop, test, and refine project parameters. The company has also engaged in extensive in-house testing and experimentation on a wide range of metals, plastics, acrylics, and quartz to further its knowledge of laser processing capabilities.

In addition to lasers, Norman Noble is equipped with EDM and Swiss automatic equipment, multispindle lathes, and water-jet and high-speed CNC milling machines. Cleanroom assembly and packaging, as well as finishing services through partner company Electrolizing Corp. of Ohio, are available. The company targets its microprecision machining services to the medical, aerospace, and other industries.

Copyright ©2002 Medical Product Manufacturing News

Plastic Lift Tray Features Reduced Weight

Originally Published MPMN October 2002

INDUSTRY NEWS

Plastic Lift Tray Features Reduced Weight

Zachary Turke

This plastic lift tray from Meese Orbitron Dunne Co. offers a 39% weight reduction from some steel and aluminum units.
Weighing only 14 lb, a one-piece plastic lift tray with molded-in inserts from Meese Orbitron Dunne Co. (Saddle Brook, NJ; www.modroto.com) replaces steel and aluminum units. Offering a 39% weight reduction from some previous metal designs, the plastic tray serves as the top section of a hydraulic lift, creating a stable platform for installing MRI machines, heart monitors, laboratory apparatus, and other sensitive medical equipment. The unit accommodates loads up to 500 lb and is designed to be visually appealing.

Measuring 2 x 3 ft, the tray is rotationally molded of polyethylene to ensure durability and wear resistance. This one-step foaming process simultaneously blends the resin with foam pellets and blowing agents to build in rigidity and stiffness during the standard molding cycle. Because it eliminates the secondary injection of urethane, it also reduces environmental concerns and allows a lower per-unit cost.

Copyright ©2002 Medical Product Manufacturing News

Terahertz Waves May Offer New Sensing Option

Originally Published MPMN October 2002

INDUSTRY NEWS

Terahertz Waves May Offer New Sensing Option

Zachary Turke

The image on the left is a photographic picture of a human tooth. The image on the right
is the same tooth as viewed
using a terahertz sensor from Teraview Ltd. The pink area indicates a cavity.

Capable of penetrating through clothes and human tissue, terahertz waves may provide healthcare professionals with the newest option for detecting cancer and other maladies. Emitted naturally by all objects, these waves are similar to infrared radiation but are much harder to detect, something that has complicated their use in commercial products. But all this may be changing. Working under the name Star Tiger (Oxford, UK; www.startiger. org), a consortium of scientists has developed a photonic bandgap material that reflects rather than absorbs these weak waves to ensure that as many as possible reach detecting units. The group produced its first prototype in August 2002 and hopes to soon develop a device that can create a terahertz image of a human hand within 30 seconds.

Teraview Ltd. (Cambridge, UK; www.teraview.co.uk) is also working to develop a medical terahertz sensor, but is taking a different approach. Instead of using naturally emitting signals, this company uses laser technology to intensify these signals to detectable levels. The firm hopes to offer its first commercial product, a cancer detection unit, in the fourth quarter of 2002 and thinks it will offer many benefits over previous technologies. "Our sensors are nonionizing, so they're completely safe," explains Teraview business development manager Paul Smith. "And unlike x-ray units, they give researchers both imaging and spectral information." Teraview also plans to develop terahertz sensors for noninvasive blood glucose monitoring, drug research, and dental applications.

Copyright ©2002 Medical Product Manufacturing News

Antimicrobial Wound Dressing Introduced

Originally Published MPMN October 2002

INDUSTRY NEWS

Antimicrobial Wound Dressing Introduced

Kelly Donoghue


A medical foam for wound dressings is shown with and without an antimicrobial additive developed by Milliken Chemical.

A silver-ion material that prevents bacterial contamination has been used as an additive in a medical foam for wound dressings. Developed by Lendell Manufacturing Inc. (LMI; St. Charles, MI; www.lendell.com), Microbisan is the first absorbent dressing to contain antimicrobial Alphasan from Milliken Chemical (Spartanburg, SC; www.milliken.com).

LMI and Milliken jointly developed the product, according to Phil Sheridan, LMI technical and research director. The antimicrobial is added to the foam by means of a polyurethane production process that completely disperses the additive throughout the finished product. The antimicrobial in the foam keeps the wound free of bacterial contamination as the dressing absorbs wound fluids. Alphasan is effective over long periods, continuing to work even when dressings are infrequently changed.

A zirconium phosphate–based ceramic ion-exchange resin containing silver, Alphasan is effective against a range of microorganisms that can cause odor, discoloration, biofilm formation, and other undesirable effects. The material is widely used in Europe, Japan, and the United States, and it is approved by FDA for contact applications.

Copyright ©2002 Medical Product Manufacturing News

Biosensors on the Inside Track

Originally Published MPMN October 2002

EDITOR'S PAGE

Biosensors on the Inside Track

When researchers first began toying with the idea of implanting biosensors in the human body, the technology's potential fired up imaginations. One day, some suggested, these silent sentinels would patrol our inner organs for symptoms of disease and even begin treatment. We're not there yet, and significant technological hurdles remain, but there are encouraging signs that these types of devices may in some limited form treat disease and monitor our health from within. In an article in the August 9 issue of Science magazine, Robert R. Service reports on recent advances and some remarkable developments that may lie ahead.

It should come as no surprise that blood glucose monitoring is the "killer app" of biosensor technology. "Diabetes now afflicts some 16 million Americans," writes Service. "The test strips for analyzing those drops of blood are a $2 billion-a-year business." It stands to reason that a device that can measure glucose levels without finger sticks has the potential to capture a huge market share. According to a study on the U.S. market for biosensors and bioelectronics published this month by Business Communications Company, Inc., "pioneering biosensor devices" such as those measuring glucose levels will propel market growth for these components in the otherwise sluggish medical analysis sector.

The key challenge faced by developers of implantable biosensors, writes Service, is the body's natural immune response to the presence of artificial material. One solution developed by Medtronic Minimed, the diabetes management business of Medtronic, is a tiny enzyme-based sensor that is implanted under the skin for up to three days. Although a step in the right direction, the device's limitations—notably that a new sensor must be inserted every few days—makes it less than ideal from the user's point of view, according to Service. A more promising alternative was presented by the same company at the annual meeting of the American Diabetes Association (ADA) in San Francisco. At the June event, Medtronic Minimed announced research results indicating that "a medical device mimicking the human pancreas is closer to becoming a reality."

The tests, conducted in Montpellier, France, involved the implantation of a long-term glucose sensor and insulin pump in patients for six months. The sensor measures glucose levels using an enzyme-based electrochemical technology and is connected to the insulin pump via an abdominal lead. Patients program the pump to deliver insulin using a handheld remote programmer. Weekly glucose readings taken by the sensor during the six months compared favorably with the results of at least six daily finger sticks, according to researchers.

Two closed-loop experiments, in which continuous glucose data from the sensor was used to automatically regulate insulin delivery from the implantable pump, also showed positive results. A system that continuously records glucose levels and delivers insulin automatically without patient intervention—an artificial pancreas, in sum—may well be within reach. To find out more about this study, go to the newsroom at www.medtronic.com.

In situ sensing is achieving breakthroughs in other areas, as well. One development cited by Service involves tiny pressure sensors that can be implanted during spinal surgery, when neighboring vertebrae are fused together. Micromechanics expert Shuvo Roy at Ohio's Cleveland Clinic Hospital launched the project in the hopes of eliminating unnecessary follow-up surgery.

After treating patients having problems with the spongy disks that separate the bones in the spine, doctors routinely conduct ultrasound tests to ensure that the vertebrae are fused properly. In about 15% of cases, writes Service, those readings are incorrect and consequently another surgery is performed. To prevent this, Roy has produced a microelectromechanical sensor that monitors the load being carried by the bones in the spine. Ultimately, Roy hopes to reduce the size of the sensors to a cubic millimeter and implant them with a syringe.

As Service notes in his article, we may be a long way from Fantastic Voyage or the totally invaded body . . . but perhaps we're not so far from the first brief excursions.

Norbert Sparrow

Copyright ©2002 Medical Product Manufacturing News

Packaging Machinery Enables More Efficient Production

Originally Published MPMN October 2002

PRODUCT UPDATE

Packaging Machinery Enables More Efficient Production

Advances in technology provide flexibility and speed

Susan Wallace

Just as there are constant advances in medical device technologies, frequent enhancements are taking place in the packaging of those devices. All of the products described below are designed to speed up packaging and make the process more cost-effective.

To locate other companies supplying packaging equipment, please refer to the the packaging directory.

Sealing Mechanisms Offer Flexibility

The WF2H case former from Wexxar Packaging Machinery Ltd. seals with either hot-melt glue or pressure-sensitive tape.

A convertible case former offers the option of switching sealing mechanisms from hot-melt glue to pressure-sensitive tape with a drop-in cartridge that can be set up and ready to use in minutes. The Model WF2H from Wexxar Packaging Machinery Ltd. is suitable for any application that requires corrugated case and tray forming and sealing.

According to the company, using one machine to provide both types of closures enables packagers to boost productivity through increased equipment utilization. Having the versatility to satisfy either preference can be an effective way to keep costs down while broadening capabilities to meet customer needs.

The WF2 incorporates patented pin and dome positive case-opening technology. This technology provides forming reliability because it can handle all weights and plies of board construction and is equally forgiving of quality variations in corrugated packaging.

Pouch Feeder Accurately Inserts and Counts

The Model OT from Palace Packaging Machines provides accurate inserting and counting of loose bulk pouches.

A pouch feeder handles loose bulk quantities of filled pouches of product, counting and inserting the pouches into containers at the same time. The Model OT feeder from Palace Packaging Machines Inc. can either be used as a stand-alone unit or be incorporated into a packaging line. It accommodates pouches filled with dry or powdered liquid, individual pieces such as hardware or medical kit components, and liquid or viscous products.

According to the company, counting and inserting pouches from loose bulk provides a significant advantage over feeding systems in which pouches are cut from a roll, because there is no risk of a slit or opened pouch that spills its contents into the container or onto the factory floor. The unit handles filled pouches in sizes up to 4 x 6 in., and can be customized to feed from 1 to 20 lanes, with a per-lane feed rate of up to 150 per minute. It can be attached to cartoners, baggers, buckey conveyors, and tray thermoformers.

Combination Machine Saves Space

A thermoformer and cartoner combination saves time and space, as well as provides product protection and safety during production. The CP600-P3000 from Klockner Medipak has a large-capacity bottom foil reel and the ability to change reels and splice while in operation. This eliminates delays due to material changeovers.

An air-controlled, segregated dosing area offers product protection while enabling access from both front and back of the machine. The transaction from packaging to cartoning occurs within the same safety guarded area at high-speed accuracy that ensures meeting tight production schedules.

Machine Offers Sterile Seal Validation

The Integri-Seal from Circle Packaging Machinery Inc. offers complete validation.

A horizontal form/fill/seal machine from Circle Packaging Machine Inc. features a seal-validation system that includes a touch screen display monitoring speed, single-point temperature, and single-point pressure during normal operation and at process setup. All electrical components are Allen Bradley.

The Integri-Seal unit is offered in single- and dual-lane configurations. Other features include rapid changeover, a long-dwell traveling cross seal with temperature control via the touch screen, and the capability to print out operation parameters with date and time identification.

Thermal Printer Eliminates the Need for Text, Graphics, and Bar Code Labels

The Thermal Printmaster from About Packaging Robotics Inc. is suitable for Tyvek and other flexible packaging materials.

A machine can print directly on packages at rates from 4 to 10 in./sec. The Thermal Printmaster from About Packaging Robotics Inc. can handle items that are 1.5 to 10 in. wide and provide a maximum print width of 8.5 in. The 300-dpi near-edge printer gives users the appearance of preprinted pouches and the flexiblity of on-demand product identification. The unit is suitable for Tyvek and other flexible packaging materials.

The ribbon-saving technology results in approximately 10 mm of unused ribbon per impression. The tabletop printer features a rugged steel printing platform, high-resolution print capability, excellent copy registration, and a stepper motor–driven infeed to ensure positive automatic feed of a wide range of varnished, polished, or porous flat products.

Copyright ©2002 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN October 2002

E-NEWS

My Favorite Bookmarks

Nate Davies
Account Manager
JL White Technical Sales Inc.

Zachary Turke

Nate Davies

Biotech Resources Web Project (http://biotech.icmb.utexas.edu) is a great site for biology and chemistry information. Designed for everyone from high school students to professional researchers, the page hosts a comprehensive biotechnology dictionary that comes in handy for looking up unfamiliar terms. There's even an acronym database where you can enter initials that are constantly cropping up in medical literature and the page will tell you what they stand for.

Environmental Chemistry ( www.environmentalchemistry.com) contains more information than you'll ever need, but what I come here for most is an on-line version of the periodic table. The site's table is set up just like its paper equivalent, but clicking on any element takes you to a page of detailed substance-specific information. Among other items, this information includes electron diagrams, atomic structure notes, descriptions of chemical and physical properties, regulatory and health concerns, and even a brief history.

Plastics.com (www.plastics.com) is a site that helps to make sense of the vast number of engineering polymers available today. I have to work with a variety of these materials as part of my job, and this page gives me figures on hardness, elongation, radiation, chemical resistance, and other factors. The registration process is a bit on the long side, but once you've completed it, you can search the site's database by polymer name or property.

Nate Davies Plastics Database (www.jlwhite.com/plastics.xls) is my own plastics resource. Originally, it was just for my personal use, but I got so many customer requests for information on different kinds of plastics that I decided to publish it on the Web. I've been updating it for the last four years with relevant data, and I think it serves as a good starting place for people wondering what materials are out there.

JL White Technical Sales Inc., a div. of Scivex (Santa Clara, CA; www.jlwhite. com), is a manufacturers' representative specializing in advanced materials, electromechanical products, and machined and molded components. The company provides technical sales, customer support, and engineering services.

Copyright ©2002 Medical Product Manufacturing News