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Articles from 1998 In June


Products Featured on the June 1998 issue of MPMN

Products Featured on the June 1998 issue of MPMN

Luer-activated valve prevents needle-stick injuries

Designed to promote safe fluid delivery through needleless access systems, a capless luer-activated valve works with most standard syringes and is compatible with most drugs. Activated when coupled with most standard luer-lock and luer-slip syringes, the bidirectional LAV XL has a double-seal design that prevents leakage, protecting clinicians from blood contact. The valve can withstand gamma sterilization and can be cleaned with sterile swabbing, eliminating the need for a cap. The housing is molded from a Class VI clear polycarbonate, and the gland is made of a nonlatex material. Stand-alone and Y-site versions are available. NP Medical Inc., 101 Union St., Clinton, MA 01510.



Rotary unit designed for circular-pattern dispensing

Materials can be dispensed in a circular pattern onto parts such as sensors, connectors, batteries, and gages. A rotary dispensing table has two rotating platforms that enable dispensing on two items simultaneously. Key features of the RT404-2A table include variable speed, adjustable rotation speed, 2-in. vertical travel, and adjustable time-set between cycles. Rotation can be varied from 0° to 810°. Single-platform styles and adjustable z-axis models are also available. I & J Fisnar Inc., 2-07 Banta Pl., Fair Lawn, NJ 07410.



Connectors meet international safety standards

A variety of single- and multipin connectors can be provided with tinsel or stranded wire for maximum strength, flexibility, and durability. The TouchProof connector systems are designed to meet harmonized international standard EN 60601-1. For applications requiring multiple connections in a small package, a 1-mm, two-position straight connector and a 1-mm, three-position circular connector are offered. A 1.5-mm connector features a single molded plug with female receptacle and panel-mount jack. The connectors are suitable for applications suchas high-tech cochlear implants and TENS units. Plastics One Inc., 6591 Merriman Rd., Roanoke, VA 24018.


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Editor's Page

Editor's Page

A Hard Lesson in Materials Science

There is no doubt that the medical device industry's understanding of materials science has reached a mature status. During the past 30 years, much has been studied and documented about how materials behave, interact with the human body, and change when processed or combined with additives.

Materials suppliers have contributed to this basic knowledge through extensive publishing and the creation of databases, and device companies have devoted significant energy toward determining which processing technologies make the most of a material's properties.

Despite this wealth of information, materials science remains imperfect and incomplete. Materials still have the power to surprise us, sometimes in unfortunate ways. Such was the case in a recent, well-publicized situation where a much-tested hospital sterilization system created unanticipated and toxic by-products on certain medical instruments.

Materials science has become so sophisticated that it is in danger of being taken for granted. If medical device suppliers don't wish to confront nasty surprises down the road, they must continually question their assumptions about materials. Moreover, they must make every effort to understand materials themselves.

Recently Richard Wallin, president and CEO of the biological safety testing firm NAMSA, expressed surprise at the fact that some companies know very little about the materials they are using. "We still get samples labeled 'white plastic' to be tested, which implies that these are relatively uncharacterized materials. It's not of value to perform testing unless you understand the identity of the test sample and the reasons why the tests are necessary, and how to interpret the results." This information can—and should—be known by the manufacturer.

His point is well made: Without knowing the material's properties, extensive testing may not prove useful. Also, with compressed product development schedules, it's not always feasible to undergo exhaustive testing of every potential material. On the other hand, adequate measures must be taken to ensure that product safety is not sacrificed in the name of shorter time to market.

One way for medical device companies to achieve this balance—safety versus immediately accessible new technology—is to accept the responsibility of developing a thorough understanding of the materials they use.

Amy Allen

amy.allen@cancom.com

WELDING AND SEALING



WELDING AND SEALING

Plastics assembly system

An ultrasonic plastics assembly system incorporates a generator, process controller, and multiplexer network in one unit. The Dynamic Process Controller (DPC) uses a powerful 32-bit RISC microprocessor that allows the user to program and regulate all assembly cycle parameters that affect ultrasonic plastics assembly—time, energy, distance, peak power, force, velocity, frequency, and amplitude. The DPC samples the cycle parameters 1000 times per second to provide greater accuracy, consistency, and control during plastics assembly processes; it can process more data in less time, making assembly more efficient and reliable. Dukane Corp., Ultrasonics Div., 2900 Dukane Dr., St. Charles, IL 60174.


Microarc welding

A power supply designed for plasma and tungsten inert gas (TIG) welding provides an affordable alternative to laser or E-beam welding systems. The Plasmafix P&T power supply offers low amperage capabilities to 0.1 for plasma welding and 0.6 for TIG welding. It can be used for welding ball ends on wire, small-diameter wire rounding, precision component assembly, and medical instrumentation welding applications. The manufacturer also offers a range of welding peripherals and custom-designed systems. Process Welding Systems, 601 Swan Dr., Smyrna, TN 37167.


RF sealers

PLC-controlled radio-frequency sealers with automatic power control monitor and adjust the power settings for both the 360° tube seal and the perimeter seal in real time. The operator interface features preprogrammed job settings based on historical records and the ability to download production results to a PC for documentation purposes. On-screen diagnostic message capability is also built into the system. Cosmos Electronic Machine Corp., 140 Schmitt Blvd., Farmingdale, NY 11735.


RF generators

A company provides a family of small, versatile RF generators that power either handheld or bench-mounted pneumatic sealing and welding heads. The generators can easily and efficiently seal or weld tubing, luers, fittings, hubs, and bags, or can be used in custom applications. The operator can control RF power and dwell time either automatically by computer or manually via the easily accessible front panel. The tube sealer or welder is suitable for closed plastic systems for medical and biologic processes including synthetic cell and tissue processing and research, therapeutic blood processing units, sterile water or intravenous systems, and culture media processing. Each RF generator is configured with interchangeable plug-in generator and sealing head modules that take just minutes to replace. SEBRA, 500 N. Tucson Blvd., Tucson, AZ 85716.


Ultrasonic welders

A new line of ultrasonic welders features an expanded reactive welding system that supplies the exact amount of ultrasonic energy to finish the weld, regardless of dimensional variations of the part or welding mode used. The most sophisticated model in the Omega III series, the MCX offers the quality management and precision required for medical device welding applications. It features a large display screen and can weld using four different modes: constant time, where the actual weld cycle time is programmed into the MCX and is consistent each time; constant height, where a constant stack height is maintained from part to part; constant travel, where the actual melt travel is measured and kept constant, allowing for part variations; and constant energy, where the welder supplies exactly the same power to each weld. Additional features include simplified programming and machine adjustment, a large work area around the application, good amplitude control, and an optical encoder. A proportional valve allows trigger, weld, and cooling pressure to be controlled separately during the weld cycle, reducing weld time and increasing weld integrity. The MCX is available with welding frequencies of 20 or 30 kHz and power supplies ranging from 800 to 3000 W. Forward Technologies Industries Inc., 13500 County Rd. 6, Minneapolis, MN 55441.


Custom welding systems

A company builds custom systems for welding devices such as catheter guidewires, orthoscopic cutting tools, implantable battery devices, heart valves, biopsy needles, and other sensitive, precision devices. The quality-conscious contract welding division accepts long or short production runs. A free evaluation of a customer's sample application is offered. Weldlogic Inc., 2550 Azurite Cir., Newbury Park, CA 91320.


Power supply

A power supply/controller is capable of welding tubing and thin-wall pipe. The Model 207 machine produces welds that meet or exceed the requirements of medical device applications. Up to 100 different welding schedules can be stored in its memory for rapid access. High-integrity, sanitary welds are easily reproduced at the touch of a button. The microprocessor-controlled power supply is available in 100- or 150-A versions with a two-year warranty. Arc Machines Inc., 10280 Glenoaks Blvd., Pacoima, CA 91331.


Ultrasonic horns

A company designs and builds specialty medical ultrasonic horns and fixtures. The ATC line of 35- and 40-kHz tungsten carbide–faced horns are suitable for medical applications that require repeatable weld performance—such as small or delicate parts—over long production runs. The horns demonstrate longevity on abrasive materials for small-weld-surface applications. The Acoustical Tooling Co., 8408 Wilmette Ave., Darien, IL 60561.


RF welding machinery

RF welding machinery with built-in turntable systems can process pre-die-cut, silk-screened, foil-stamped, and roll-fed materials. The systems are flexible and modular, featuring automatic feeders that can be moved to different turntable positions or moved to another turntable. This flexibility provides labor savings and increases capacity. Safe and easy to operate by one person, the welding systems are fully tested before leaving the factory. Technicians are available to train operators and maintenance personnel. Hall Dielectric Machinery Company, Inc., 420 Bryant Blvd., Rock Hill, SC 29732.


Desktop laser welder

A compact, self-contained laser system is designed for precision welding and micromachining. The EDW-15 is half the weight and practically half the size of comparable systems, according to the manufacturer, making it suitable for desktop welding. Running on 115-V-ac wall current, the system delivers 15-W output and requires no external cooling. The application-specific fiber-optic delivery system (available in either 200 or 365 µm) allows highly precise microprocessing on a very small scale. The user-friendly welder comes equipped with a microprocessor-based control unit with a large, easy-to-read LCD. Variable pulse widths from 0.2 to 10 ms are achievable in single shot, burst, and repeat rates. Accurate application of the laser beam is facilitated by a visible light aiming feature. The workstation and related accessories include a focusing head, gas-handling system, viewing optics, and computer-controlled translation stages. Typical applications include spot welding for hard disk suspension, electrical contacts, and relay armatures; seam welding for pacemaker housings and electronic packages; and reflow soldering of flexible circuit boards. Equilasers Inc., 536 Weddell Dr., Ste. 6, Sunnyvale, CA 94089.

Electroconductive Textile Provides Uniform Heat Distribution



Heating Elements

Electroconductive Textile Provides Uniform Heat Distribution

Material regulates its temperature

DEVELOPERS OF PATIENT-WARMING products now have an alternative way to deliver and maintain heat. When combined with simple circuitry, a carbonized, conductive woven textile provides even heat dissipation and maintains its set temperature within ±0.2°C. Developed by Gorix Ltd. (Birkdale, Southport, UK), Gorix eliminates the problem of hot and cold spots that can occur with wire-matrix element heating. The uniform distribution and dissipation of heat from the surface allows the material to be used in close contact with the object being heated.

Potential uses for Gorix include patient bedding, wound care, solution-warming, patient-comfort, and circulatory-care products. Because the material is x-ray opaque, it may be used as a heating element in operating tables or alpine recovery stretchers. Warming blood and tissue samples with Gorix heating elements is under research.

Commenting about promising medical uses of Gorix, its inventor Robert Rix says, "It is especially well suited for applications where temperature management is critical—infant incubators is a good example—or where precise control is needed. The material could be used to produce a low-voltage heated mattress for geriatrics, for instance. Also, it could be encapsulated to make it waterproof."

The material is made from a polymeric fiber that is baked at a low temperature and then woven and baked again. After this initial process, the material can be laminated or encapsulated within other materials. It can be activated by low voltage and can draw power from sources such as standard wall outlets and rechargeable battery packs.

Another prime characteristic of the material is a linear change in resistivity as a response to temperature change. This means that the hotter Gorix gets, the lower its electrical resistance becomes and the easier it is for current to flow within the material. This capability enables it to be used as a heating element and as a temperature sensor. When employed in a baby incubator, for example, the Gorix material can act as a virtually self-regulating temperature management system.

The product was recently selected as one of four winners of the Millennium Product Award. Modernistic Inc. (St. Paul, MN) will act as an approved converter of the Gorix product in the United States.

For more information, contact Modernistic Inc. at 612/291-7650.

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Inspection

Image Acquisition Systems Cut Inspection Costs

Updated software package simplifies setup and operation

HIGH-SPEED INSPECTION systems employ photoelectric sensors and Windows-based software to provide the features of a machine vision system at less than half the usual price, according to the manufacturer.

SmartImage sensor systems use CCD technology to capture product images and transfer the pixel data to the RAM (random-access memory) of the system's embedded processor. Once the data is in RAM, the system uses FrameWork 1.3 software to compare the image information to predetermined criteria established during inspection setup.

System developer DVT Corp. (Norcross, GA) upgraded FrameWork 1.3 to deliver vital feedback for statistical process control and motion control. The FrameWork Windows-based interface employs a point-and-click matrix to streamline logic control.

The sensors provide information such as target trajectories, fiducial locations, critical measurements, and bar code identification. These operations can be combined with inspections, and all data can be output to SPC software packages for analysis.

For more information, contact DVT Corp. at 770/449-4960.

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Packaging

Packaging Film Exhibits Great Strength with Less Weight

While thinner than conventional film, it is up to 250% stronger

HIGH STRENGTH, LIGHT WEIGHT, and durability are key features of a linear low-density polyethylene (LLDPE) film for medical packaging. When produced at a 3-mil gauge, ShieLLD film demonstrates 150% more impact strength than 4-mil conventional LLDPE film, according to Philadelphia-based manufacturer Perfecseal. At 4 mil, the film's impact strength is 238% more than other types of 4-mil LLDPE, with 250% greater tear strength, according to Perfecseal.

By using 3-mil ShieLLD film in place of 4-mil conventional LLDPE, device manufacturers can use less material per package and thereby reduce overall packaging and decrease freight costs. "Downgauging from a 4-mil conventional film to 3-mil ShieLLD automatically results in cost savings because ShieLLD yields 25% more packaging material," says Terry Collins, product manager, converting, for Perfecseal.

The resins are manufactured using a new catalyst technology for narrow or controlled molecular weight distribution of the polyethylene polymer, resulting in greater strength properties in the finished film. Because conventional film extrusion machinery is not capable of processing this new resin, Perfecseal has invested in specialized equipment, manufacturing processes, and technical expertise to effectively process it into blown film.

Uses for ShieLLD films include header bag packaging for large, bulky devices or heavy trays containing a variety of supplies and instrumentation.

For more information, contact Perfecseal at 215/673-4500.

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New Applications Expand Market for Biodegradable Polymers



New Applications Expand Market for Biodegradable Polymers

The environmentally friendly materials offer many advantages

In recent years, biodegradable polymers have offered scientists a possible solution to the waste-disposal problems associated with traditional petroleum-based plastics. But while biopolymer research has continued at an accelerated pace, the plastics industry and even some environmentalists have been slow to accept these materials, and, consequently, the growth of the biopolymer market has been relatively slow. Now, however, innovative new biomedical applications, including artificial skin, heart valves, and other organs grown on biopolymer scaffolding, are creating major opportunities for new product development and the commercial exploitation of these materials. Biopolymers—plastics derived from natural materials—offer a number of advantages over synthetic, oil-based plastics. They are biodegradable, and therefore environmentally friendly, as well as biocompatible, which makes them a suitable alternative to compounds such as silicone in medical applications. In addition to the development of biopolymer-based processes for growing artificial organs, scientists have successfully used biopolymers to create "drugs" that never enter the bloodstream, antibacterial coatings for medical devices, a microsponge technology that releases medical ingredients slowly over time, a collagen plug that revolutionizes postoperative care, and therapies based on hyaluranon, a specially tailored visco-elastic biopolymer. While only a handful of firms have taken the lead in bringing biopolymer-based products to market, the field for commercial exploitation of these applications is wide open, according to the new edition of a study focusing on the biopolymer field. Biopolymers: Sophisticated Materials with Growing Market Potential, published by Technical Insights (Englewood, NJ), gives corporate strategists and R&D executives a solid understanding of biopolymers, and helps them pinpoint potentially profitable applications and take the right steps to exploit opportunities in licensing, partnering, and codeveloping. For more information on the study, contact Technical Insights at 201/568-4744.


Technological Breakthroughs Spur Growth in Patient Monitoring Markets

Market is forecast to generate $11.34 billion in 2004

The increasing use of computer-based systems and open-architecture designs, combined with the exploration of minimally and noninvasive procedures, has led to steady growth in patient monitoring markets. World Patient Monitoring Equipment Markets, a study by Frost & Sullivan (Mountain View, CA), an international marketing consulting company that monitors the medical industry, takes a close look at these rapidly growing markets, which generated sales of $5.31 billion in 1997. The advent of managed care and the increase of similar cost-cutting programs around the globe have altered not only manufacturers' clients, but the criteria for a successful sale as well. Vendors must now secure contracts with hospital purchasing groups that are under pressure to cut costs while maintaining or improving the quality of hospital care. This shift goes beyond directing marketing and sales efforts to the proper channels. It forces manufacturers to prove that their new products are as cost-effective as they are convenient. "No longer is new equipment bought just because it has better technology," said Mahpara Burney, medical analyst at Frost & Sullivan. "Manufacturers have to justify the price by demonstrating that the new features added to their products actually benefit the patient and present cost savings for the facility." Managed care is also shifting patient care from traditional hospital settings to alternate-care sites such as homes, rehabilitation centers, and nursing homes. While patients may not require intensive therapy and monitoring in these facilities, they do require some basic level of monitoring. Growth in these alternate-care facilities will shape which new products are introduced. Blood glucose monitors continue to be the largest patient monitoring market item, producing $2.1 billion in sales in 1997. In this competitive market, manufacturers are constantly improving their monitors by introducing smaller blood-sample requirements and adding such user-friendly features as voice prompts and extended memories. Since only about 15% of the world's more than 110 million diabetics monitor their blood glucose levels daily, manufacturers are hopeful that new features will help expand the market. The multiparameter monitoring equipment market forms the second-largest segment of revenues in the world patient monitoring equipment market, accounting for $1.4 billion in 1997. Telemetry and networking capabilities are two new features driving growth, but, more importantly, manufacturers are taking advantage of new sales opportunities in step-down facilities, the transport market, and outpatient care sites. For more information, contact Frost & Sullivan at 650/237-4384.


PEXCO Receives ISO 9002 Certification

Company produces tubing and catheters

PEXCO has received domestic and European ISO 9002 certification. The company produces a variety of precision tubing and catheters for the medical device market using a wide range of thermoplastic materials. Its Northborough, MA, facility employs 75 and features a fully equipped design and development center, a computerized production facility, and mobile Class 10,000 cleanrooms. For more information, contact PEXCO at 508/393-2553.


Perfecseal Establishes Prototype Center

Center will fabricate 3-D packaging prototypes

"All too often, packaging is an afterthought when introducing a new product," says Rich Craig, technical service manager of Perfecseal's new prototype center. "Then suddenly the pressure is on to develop a package as quickly as possible. This can lead to real problems down the line." Loacted in Philadelphia, the prototype center is to be used as a resource to customers for designing optimum new product packaging. The service can help customers make decisions about material selection, package configuration and size, aesthetics, and design. Perfecseal will fabricate a single, 3-D prototype package for use in focus groups, marketing presentations, or new product demonstrations. Customers can bring in their medical devices and let Perfecseal engineers help build packages around them. According to Craig, this kind of process allows customers to get a new product to market quickly and cost-effectively. He says, "The wrong package can be a disaster in many ways, such as in loss of sterile barriers. This is especially true when someone tries to make do with off-the-shelf packaging." A second prototype center, Radicel, is under development at the company's plant in Londonderry, Ireland, to serve overseas customers. For more information, contact Perfecseal at 800/999-7626.


Stretch Film Manufacturing Council Formed

Will create voluntary standards for the industry

The Flexible Packaging Association (FPA; Washington, DC) today announced the formation of the Stretch Film Manufacturing Council. The council, which is a subset of FPA, is composed of companies representing over 50% of the stretch film industry. The council's initial mission will be to create voluntary standards for the industry and develop statistical benchmarks for its members.

"This is the first time that this industry has come together to create a working council that benefits the stretch film manufacturing industry," says Glenn E. Braswell, president of FPA. "We at FPA are proud to be part of this groundbreaking endeavor."

The stretch film industry in the United States comprises 27 companies, employs approximately 1000 people, and generates sales of nearly $1 billion annually. FPA is the world's largest trade association representing manufacturers and suppliers of flexible packaging. The $17-billion industry employs 87,000 people in the United States and serves a broad array of markets, from food to pharmaceuticals to medical supplies.

For more information, contact FPA at 202/842-3880.

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Ultraprecise Machining Is Used to Make Imaging System Subassembly



Ultraprecise Machining Is Used to Make Imaging System Subassembly

Technological advances are the springboard from which the medical product industry develops new and more-refined diagnostic tools. But, as Analogic Corp. (Peabody, MA) discovered, those advances sometimes push beyond the scope of current manufacturing resources. And sometimes, good old-fashioned teamwork is the key to a solution.

Analogic has been a pioneer in medical imaging technology since 1975. As a developer of computed tomography (CT) systems and subsystems, the company introduced a lightweight, low-power mobile CT unit, a breakthrough that helps bring diagnostic imaging to trauma centers, intensive-care units, and surgical theaters in the United States, and new markets around the world. Analogic is also one of the leading suppliers of MRI power systems and ultrasound diagnostic medical imaging systems.


Using CNC machining technology, engineers at Lemco-Miller were able to achieve tolerances of 0.0004 in.

In 1995, Analogic began production of a new proprietary medical imaging subassembly for an OEM partner. The new imaging system would represent a breakthrough in price and performance in its category, and the subassembly would be a key factor in accomplishing those goals. The subassembly consisted of plates that would require precisely machined slots.

Analogic's specifications for the subassembly called for machining tolerances of 0.0004 in.—about 11 times smaller than a strand of hair. But Analogic's engineers found that this exacting level of precision exceeded the machining capabilities of its existing machine shop suppliers, who lacked the in-house engineering resources necessary to meet these requirements.

Requiring tolerances as tight as 0.0004 in., the specs were pushing the envelope of the computer numerical control (CNC) machining technology that most machine shops use. Analogic needed to find a supplier—or more specifically, a partner in the process—that could manage this level of precision and affect dynamic programming changes that addressed the statistical variability in machining a part from lot to lot.

Forming an Intercompany Engineering Team

The search for a partner that could augment Analogic's in-house engineering capabilities led the company to Lemco-Miller Corp. (Danvers, MA). One of the first machining facilities to become ISO 9002 certified, Lemco-Miller had assembled a strong manufacturing team headed by Glenn Currie and had acquired a reputation for its experience in CNC applications.

"We knew this project posed significant challenges, but we also recognized the strength of the resources that both our companies could bring to the project," says David Miller, Sr., CEO of Lemco-Miller.

Analogic and Lemco-Miller formed an intercompany engineering team to tackle the significant technical hurdles ahead. "If, as they say, two heads are better than one, we had 10 of the best heads in the business working together," says David Miller, Jr., director of operations and marketing for Lemco-Miller. "And, as it turned out, we needed every resource to deal with the level of precision these component parts required."

Usually, Analogic defines the specs and the supplier makes the product, but, in this case, technical personnel from both Analogic and Lemco-Miller stepped up to the plate together to make it happen.

The 10-person team immediately set a series of benchmarks to keep the project moving forward. The timeline allowed two months to create sample parts that would meet Analogic's specifications. The team also estimated that two dozen iterations would be needed just to get to that point. However, before work could begin, the team needed to tackle the software limitations of the CNC machines.

Technical Hurdles

"In CNC machining, the software issues command logic telling the machine to go to specific locations to perform the machining function. However, with this project, we had to go into the actual source codes—the programming—and create constant corrections based on statistical variability of how the machine produced the slots in the subassembly," says Currie.

This required a sophisticated understanding of how to maneuver the 3-D offset correction to a fixed point theoretically based on a dimension in a drawing. Software changes were implemented after an intensive week-long process. The team then put the program on-line and began making the first few iterations of the subassembly, performing adjustments along the way.

Lemco-Miller's engineers had to manage the wide range of variables that can affect the machining process. Because of the tight tolerances, and the need for repeatability, the team designed special fixturing to hold the metal in a restrained state during machining. Lemco-Miller's facility maintained a stable environment on the production floor to eliminate variations in temperature and humidity that could distort the readings.

"A wide range of factors—from the type of fixture used to the ambient temperature on the production floor to the temperature of the machine itself, even the blade sharpness—can affect the accuracy," says Currie. "And when you're talking about tolerances of 0.0004 in., if you change one thing, it's very easy to miss the mark. That's where repeatability becomes an issue, in addition to just getting the original settings right. We really had to be resourceful since we were charting unexplored territory beyond existing CNC technology."

For the inspection process, Analogic produced a powerful video microscope called Micro-Vu that amplifies the view to a factor of 200* and displays the image on a video screen. Lemco-Miller then generated a graph that allows the inspector to compare the actual positioning of the slots with a theoretical location. By enabling the operator to see down to that level of precision and be sure the coordinates line up precisely, Lemco-Miller ensured that the correct tolerances were achieved. The Micro-Vu was located at Lemco-Miller's facility, enabling adjustments to be made immediately on-site.

Overall, the teamwork paid off with greater efficiency than the participants had anticipated. Programming changes were implemented in a week. Eight weeks were required to develop the first production volumes of extremely precise components, but the number of iterations needed was only half of what had been expected. From the initial team meeting to actual production and assembly, just four months elapsed.

Another benefit of the partnership is that Analogic and Lemco-Miller both gear their operations around a just-in-time delivery environment. Analogic does not maintain an inventory stockpile, but takes regular deliveries of small lots that are integrated into its demand flow, right on the production and assembly floor. "It's been a natural process for us to produce and deliver small weekly lots that match Analogic's demand forecast," says Miller Jr.

Making Teamwork Count

"We learned a lot about the synergy that a value-engineering team creates," Currie says. "For the concept to really work, both parties need to enter into a true working partnership, be patient, and commit to an open relationship that allows an honest, free dialogue focused on solving the problem at hand."

Analogic has embarked on yet another system that builds on the existing technology but provides more-sophisticated capabilities. Lemco-Miller is also working on this new model, which poses an even greater level of difficulty than the first.

"It's a new challenge," says Miller Jr. "But with the advances we've made together and the open dialogue that exists, we have every reason to expect continued success with this new generation of high-precision instrumentation."

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Transfer and filter devices



Filters & Filtration Materials



Transfer and filter devices

An FDA-registered, ISO 9001—certified manufacturer of disposable medical devices offers a complete line of transfer and filter devices for a variety of fluid-transfer applications. The line includes the Mini-Spike dispensing pin for preparing and dispensing diluent or additive from multidose rubber-stopped vials and the Micro Chemo pin with a 0.2-µm hydrophobic air-venting filter that prevents exposure to toxic fumes during drug reconstitution. Other products include filter needles, vented needles, double-ended transfer needles, air-venting filters, hydrophilic in-line cone filters, and filter hubs in a variety of configurations. Burron OEM Div., B. Braun Medical Inc., P.O. Box 4027, Bethlehem, PA 18018.


Filter converting

Porous PTFE and Pall membrane are typical materials that a company converts to filters for sensitive medical applications. The company has a Class 1000 cleanroom and a temperature-controlled, low-humidity dry room for particularly sensitive medical applications. The company also provides slitting, laminating, and sheeting services. G&L Precision Die Cutting Inc., 1766 Junction Ave., San Jose, CA 95112.


IV filters

A worldwide manufacturer offers a complete line of IV filters and devices for adult and pediatric applications. The filters are available in 0.2- and 1.2-µm pore sizes. Unique requirements can be satisfied with custom-designed products. Other products include blood filters, lab and diagnostic filters, and respiratory filters, as well as other devices. The filters are manufactured in Class 100,000 cleanrooms in an ISO 9000—certified facility. Filtertek Inc., 11411 Price Rd., Hebron, IL 60034.


PTFE membranes

PTFE membranes are available from a company's broad range of hydrophobic and oleophobic media. The PTFE membranes are microporous and repel low-surface-tension liquids while venting gases. Because it is an effective barrier to microbes and particulate matter with high titer reductions, the product is suitable for use in a variety of medical applications, such as transducer protectors, IV vents, suction canister vents, urine bag vents, and package vents. Pall Corp., 25 Harbor Dr., Port Washington, NY 11050.


Snap-fit IV vents

A company offers a hydrophobic/oleophobic vent medium for snap-fit IV vents. The FiltaVent OGF 20 offers high bacteriological efficiency with low pressure drop. It is a suitable choice for water and fat/lipid—based IV vent applications and further expands the company's range of vents and other medical media. Whatman International, 6 Just Rd., Fairfield, NJ 07004.


Filter assemblies

Plastic filter assemblies are available in a variety of materials, sizes, and element efficiencies. Completely disposable filters and adsorbers consist of permanently welded housings with encapsulated microfiber elements or granular adsorption material with integral inlet and outlet filter pads. The 700 series of plastic housings can be used for coalescing, particulate, and liquid filtration. An added benefit is the use of the manufacturer's standard borosilicate microfiber elements, which offer good filtration efficiency at very low pressure drops and, being greater than 90% void volume, give long service life. United Filtration Systems Inc., 34062 James J. Pompo Dr., Fraser, MI 48026.


Filter media

A company offers a variety of filter materials including glass-microfiber, cellulose, synthetic, laminated, and composite media. Versatile finishing capabilities include custom converting of rolls, sheets, and die-cuts as well as laminating and packaging. Materials can be designed to meet specific requirements. Ahlstrom Filtration Inc., 122 W. Butler St., P.O. Box A, Mt. Holly Springs, PA 17065.


Filter materials

Custom-fabricated components and roll goods are made with precision-woven medical fabrics. Fabric performance is enhanced with special custom coatings and plasma treating. The company's products are suitable for use in medical filters. Saati Tech Inc., P.O, Box 543, Somers, NY 10589.


Hydrophilic filters

A company offers a complete line of filters for in-line filtration of IV solutions. The filters have a 0.22- or 1.2-µm polythersulfone membrane and can be supplied with luer-lock or luer-slip connectors. The filters can be used in pediatric patient infusions, epidural procedures, and lipid filtration. All have high flow rates, low drug binding, and microbial retention. DirectMed Inc., 11 Lowell Rd., Port Washington, NY 11050.


Solid support/filtration media

Many diagnostic kits and analytical testing devices use a paper or membrane product as an integral component. Such widely used supports include pure nitrocellulose membranes, 903 specimen collection paper for the absorption and testing of blood and other liquid samples, modified cellulosics, and a wide range of qualitative and quantitative filter papers. A company's media, designed to address the requirements of solid-phase technology and new product production, are available as experimental samples. Laminated and impregnated supports, glass fiber filters, and other solid-phase media and filters are available on request for evaluation and testing. Schleicher & Schuell, P.O. Box 2012, Keene, NH 03431.


IV filter

A filter removes microorganisms and particles larger than 1.2 µm from total nutrient admixture (TNA) emulsions with lipids. The filter has a polyethersulfone membrane for compatibility with TNA emulsions. It features a superhydrophobic vent for air elimination, and it can be sterilized by EtO, gamma, or E-beam. Millipore Corp., 80 Ashby Rd., Bedford, MA 01730.


Microfilter

Suitable for a variety of low-pressure air and low- to high-vacuum applications, a microfilter can use a variety of filter media, from 500 to less than 0.1 µm, including virus removal capability. The Hydrocheck features a large 25.8-cm2 effective filter area and allows high airflow with low resistance. Hydrophobic properties allow free passage of air while stopping fluids. Graduated hose barb connections (0.250—0.375 in.) are standard. The high-clarity plastic housing allows users to verify filter integrity, the presence of contamination, and when it's time to change the filter. Performance Systematix Inc., 8196 Broadmoor Ave. S.E., Caledonia, MI 49316.


Laminates for medical venting

A company provides ePTFE laminates for medical venting applications. The Gore-Tex laminates can be incorporated into transducer protectors, IV filters and spike vents, urine and ostomy bags, respiratory filters, and suction canisters. The company assists in determining the appropriate laminate for specific applications. W.L. Gore & Associates Inc., P.O. Box 1550, Elkton, MD 21922.

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Animation Simulates User Interface



Animation Simulates User Interface

Multimedia simulation offers cost-effective alternative to 3-D prototypes

Once the concept and underlying technology of a new medical product has been worked out, developing a user-interface prototype can be costly and time-consuming. This was the problem facing Indigo Medical (Palo Alto, CA). After designing a urological surgery laser, the company wanted to know what the interface would be like to use, but did not want to build an expensive prototype.

At the time of the product's development, Indigo was a start-up company with a tight design and development budget. In order to minimize overhead costs, the company hired San Francisco—based Bridge Design to handle some of its outsourced design and development efforts. With a goal of bringing the product to market quickly, the two companies worked together to develop a new design tool. Using multimedia and graphics software, the tool creates animated versions of a product's controls and of its display, while also showing the effects of these controls on the procedure or diagnostic technique.


Using multimedia and graphics software, San Francisco—based Bridge Design developed a demo of a user interface for Indigo's urological surgery device, pictured here.

"The increasing sophistication of today's product features is often accompanied by large software overhead," explains Horst Adam, former president of Indigo Medical. "That's why it was important to test out ideas with simple tools, such as Bridge Design's multimedia device, before committing to more costly and highly regulated final software."

Bridge Design president Bill Evans says, "Potential users were not interested in reading the usual dry interface specifications. They needed to focus on how the product could help them do their jobs better."

The demo that was developed for Indigo can be viewed on Bridge Design's Web site (http://www.bridgedesign.com). The urological surgery device delivers a laser to a fiber tip. During operation of the controls, the view through the endoscope is animated. A marker aiming beam flashes during setup. When the laser is fired, the beam comes on continuously. This is all done by simple animation of a fiber top with and without a red glow surrounding it. The software in the demo simply switches the view back and forth to give the impression of certain functions. A third area shows the operation of a footswitch, and animation shows it being depressed, with the main controls responding accordingly.

Demos developed by Bridge Design offer many benefits, including the opportunity to test whether users will like the planned features. They can also be expanded to include a competitor comparison. Demos are self-running, require only a color laptop, and are easy to distribute on floppy disk, CD-ROM, or over the Internet.

This multimedia tool had important benefits for Indigo's design process. As explained by Adam, it confirmed the functioning of the interface of complex products early in the design cycle—before big commitments to hardware and software were made. It also gave engineers a tight specification from which to write software, design hardware, and expose minor bugs. And, once the product was ready for market, the demo could be used as a sales tool that highlights the product's features, or it could be used to train users.

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Premier's Innovation Institute: To Play, Must You Pay?

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI June 1998 Column

This new GPO's program may put the squeeze on both large and small manufacturers.

Today, cost containment and consolidation rule the health-care world. Group purchasing organizations (GPOs), like Premier, strive to work with a limited number of suppliers in an effort to curtail costs. Several months ago Repertoire quoted Lynn Detlor, president of Premier Purchasing Partners in San Diego, as saying, "The cost of doing business with 400 or 500 vendors is not possible. We're not going to build a huge infrastructure. We won't deal with everyone in the industry." In fact, a new Premier program could further limit the number of suppliers with which the company does do business.

The Premier Innovation Institute, launched in February, aims to accelerate the introduction of innovative products and technology within the GPO. Institute-supported national experts will evaluate products and their use across the continuum of care. Those products that meet the criteria of superior clinical outcomes, cost savings, and safety after testing will then be marketed to the GPO's 1800-member hospital and health-care facilities. Success will be measured by how quickly and widespread new innovations are adopted.

Established as a freestanding, nonprofit corporation, the Institute will be managed by Premier, product tester Health Care Concepts (Austin, TX), and 10 to 15 participating companies—which is where critics of the program find a sticking point. Those vendors that sign on as partners must pay $1 million for each of two years. In return, the Institute will conduct one specific market penetration study per year for these companies, then market the results to its members.

What if your company can't afford the $1 million—per-year fee? Premier's senior vice president of corporate communications, Pat Poston, assures smaller companies that "the Institute will seek innovations from all sources to be evaluated."

The program has drawn its share of skepticism. Some say the fact that the Institute is funded by the same vendors whose products are being tested at the least raises the appearance of impropriety and calls into question the objectivity of the studies.

Others fear that smaller companies will get shut out of contracts. As one critic of this program—Ted Tyson, a business and marketing consultant based in Buffalo Grove, IL—told me recently: "Not many companies can afford this payment. If you want to be a major supplier, it's pay and play. In the guise of creating an institute that will assess value, Premier is coercing major suppliers into supporting another profit center for Premier and developing a way to increase its influence over the medical device industry."

Tyson continues, "If small medical device companies won't be able to do business with groups like Premier, which controls $8 billion to $10 billion of health- care purchases in the United States each year, it will stifle the very innovation Premier is striving to stimulate."

In addition to potentially knocking smaller companies out of contract contention, the new program also lends itself to the perception that it will favor one supplier over another. While Alan Weinstein, who is president of both Premier and the Institute, says "no study will result automatically in a group purchasing contract," one wonders if a new product given the Institute's thumbs-up could displace one already under contract.

While seeking to deliver new technologies to patients more rapidly is an admirable goal, Premier's methods may raise some questions for both industry members and providers alike. Both groups should consider the implications carefully before drawing a conclusion.

Stacey L. Bell


Copyright ©1998 Medical Device & Diagnostic Industry

Making Science a Priority in Device Testing

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI June 1998 Column

INSIDE MD&DI

Industry talks a lot about trying to avoid unnecessary testing," says Dick Wallin, the coauthor of this month's article on ISO 10993-10. The 10993 standards, he says, offer "a great opportunity for materials characterization testing to provide the solution. Once you know a material's properties, you can fix a formula, establish specifications, and then monitor manufacturing so the next time you test a product it's not because five years have passed, it's because something has changed."

ISO 10993, which addresses the biological evaluation of medical devices, has been in development for the past 10 years by Technical Committee 194 of the International Organization for Standardization (ISO) and numerous working groups. Wallin (pictured left) and his colleagues at NAMSA (Northwood, OH) have helped draft and review a number of the documents. ISO 10993 consists of several standards, including those on materials characterization, systemic effects, cytotoxicity, sample preparation, and the focus of this month's article, irritation. A 12-part series on the standards began appearing in MD&DI in January and will continue into early 1999.

"Part I, the introduction to the standards, is probably of greatest importance to the medical device industry," says Wallin. "It sets the stage for the other sections and sets forth principles for the testing of devices. In the past, the medical device industry and even regulators overlooked the importance of characterizing the chemical, physical, and toxicological properties of materials."

Increasingly, manufacturers must be prepared to answer the question, "What effects will a device—and the materials contained within that device—have on a patient over time?" Wallin and coauthor Paul Upman describe the methods used to detect contact hazards from device-released chemicals that may produce skin, mucosal, and eye irritation.

One reason why Wallin is writing this series of articles on ISO 10993 relates to the complexity of the standards and the tests. "ISO 10993 is probably the best-developed set of standards on this topic around. Some of the parts contain an extraordinary amount of detail. You could give a test outlined in these standards to a technician in any country in the world and get the same results. However, there's a huge discrepancy in the amount of direction provided for tests in other sections. In this series, we'll be able to provide concise information on the ISO biocompatibility approach as well as discuss some of the testing approaches we've taken in some areas where ISO direction is lacking."

Wallin has been involved in materials testing since he started his career at Baxter in the late 1960s. In the years before the Medical Device Amendments were passed, manufacturers simply set their own protocols for product testing and for ensuring that their products were safe.

In 1977, Wallin joined NAMSA as scientific director to expand his materials testing to devices for the entire industry. "It was a good time to broaden my testing opportunities," Wallin says. "The Medical Device Amendments and GLPs had just been passed, and I wanted the chance to do for the industry what I'd been doing for just one company." Wallin is now NAMSA's president, CEO, and chairman of the board.

Meetings continue to be held to refine and finalize the standards, and Wallin believes ISO 10993 will leave a lasting impact. "I'd like to believe this standard will move the industry from an empirical approach to device testing to a more scientific approach. Just as manufacturers follow the GMPs in manufacturing devices, they should now follow ISO 10993 in streamlining their testing processes."


Copyright ©1998 Medical Device & Diagnostic Industry