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Articles from 2001 In March

EDITOR'S PAGE Safe Sourcing: To Build a Beautiful Relationship, Ask the Right Questions

Originally Published MDDI March 2001


Safe Sourcing: To Build a Beautiful Relationship, Ask the Right Questions

Few would dispute that outsourcing can be an effective tool for OEMs seeking to contain costs and speed time to market. Choosing a partner, however, is not simple. You know the obvious questions to ask: Does the company have appropriate quality systems in place? Is it able to cost-effectively manage the project? Is the firm financially stable? But there are a host of seemingly secondary issues that, if neglected, could result in a rocky relationship with your supplier. A session on outsourcing at MD&M West in January focused on this aspect. I spoke with panelist Douglas Stockdale, a principal at DS Consultants (Rancho Santa Margarita, CA), regarding some of the elements to consider when mapping an outsourcing strategy.

Striking up a relationship with a supplier is like "hiring a person on your staff," says Stockdale. "Except that it's a very big person. Companies have personalities. That can affect how your partnership goes, because you are absorbing them into the organization," he notes. Latent corporate culture clashes aren't always weighted very heavily in what Stockdale calls the decision matrix. It's an oversight that some companies live to regret. Perhaps the firm you are contracting with isn't forthcoming with information and needs constant prodding to provide project updates. Conversely, some companies will flood you with more information than you need or want. It's not always easy to assess these types of things, says Stockdale, but it's well worth the effort. Broach the subject with your potential partner's references, he suggests.

Stockdale also stresses the use of a fact-based approach to decision making. That may seem elementary, but he has seen countless examples of companies relying on subjective data to reach a decision. "OEMs may choose a supplier because they have worked with him in the past, and they will simply assume that he can handle a new technology without really looking into it," he says. Or a company may base its decision on a glowing recommendation it has received from someone. Upon closer inspection, the company may discover that two or three key engineers who were responsible for much of the core work have left the firm, says Stockdale.

He also places stock in drafting what-if scenarios, a virtue he learned the hard way. "I was involved in one outsourcing project where the supplier had the capacity to fulfill the OEM's obligations, but what we didn't know was that it was committing the same types of capacity resources to another very big client," he recalls. "We both said yes, and the next thing I know I'm having trouble with my delivery schedule." Scenario analyses allow you to clarify many of the hidden issues that might affect outcomes. "You determine the probabilities, stack them up, and ask yourself, 'Does this make sense?'"

Along the same lines, don't stop thinking about tomorrow, to borrow a phrase. OEMs sometimes neglect to take into account future needs, notes Stockdale. "Do the suppliers you are considering have the capacity to grow with you?" he asks. And if they do, ask if they are considering making commitments to other clients that could jeopardize their ability to meet your potential demands, Stockdale reiterates.

The bottom line is that it pays to do your homework. Applying a methodical approach to the sourcing process at the outset can prevent problems from erupting the morning after when you can least afford them.

Norbert Sparrow
[email protected]

Copyright ©2001 Medical Product Manufacturing News


Ascension Technology Launches Medical Industry Initiative

Ascension Technology Launches Medical Industry Initiative

A significant shift in research and development accompanies Ascension Technology Corp.'s (Burlington, VT) new company initiative targeting medical applications for motion-tracking devices. Its units are already in use in three-dimensional ultrasounds, image-guided procedures, and medical training simulators. The firm's engineering-driven effort comes in response to the medical OEM community's large need for position trackers. According to Jack Scully, vice-president of sales and marketing, the transition is natural because "we have the magnetic-tracking technology and resources" needed to fill the growing demand for instruments that "instantly track the position and orientation of probes," even inside the body. As part of the initiative, existing devices are being redesigned to meet the medical industry's stringent regulations and high-performance requirements.

The development of three new products coincides with this initiative. The 3D-BIRD orientation tracker provides instant tracking and can be used in headsets. The laserBIRD optical tracker uses light energy to track sensors in environments unsuited for magnetic, inertial, or acoustic devices. An environmental analyzer scans for interference and allows adjustment for peak performance of magnetic tracking devices. Retaining its commitment to the markets it has served in the past, Ascension will continue production of tracking devices for animation, virtual prototyping, simulation, and biomechanics.

Zachary Turke

Klöckner to Focus on Global Films Exclusively

Klöckner to Focus on Global Films Exclusively

In order to focus on its global films business, Klöckner-Werke AG (Duisburg, Germany) will divest all nonfilm activities, including packaging machinery, filling equipment, and other interests.

In order to concentrate on the global films market, Klöckner will no longer sell packaging or other machinery.

"Klöckner will expand its participation in film markets globally via internal expansions, new products, and select acquisitions. This announcement reinforces a strategic initiative we began in 1995 with the acquisition of Hoeschst AG's Kalle division," says Tom Goeke, president of Klöckner Pentaplast of America Inc. (Gordonsville, VA).

The company produces rigid film and sheet, including vinyl, polyester, Barex, and barrier films used in a variety of packaging, printing, and technical applications. Further additions to the Klöckner Pentaplast film group include Roxan GmbH (Germany), Aerni Leuch AG (Switzerland), Stanley Smith Ltd. (UK), and ARCOR (Argentina). In addition, the company has opened several facilities internationally. According to Goeke, the global operations of the company have shown an average annual growth rate of 30% during the last five years since the strategy to focus on films was initiated.

Life-Emitting Diodes: LEDs Promote Healing

Life-Emitting Diodes: LEDs Promote Healing

Light-emitting diodes (LEDs) designed for plant-growth research aboard the space shuttle are being put to a new use in Wisconsin: accelerating wound healing in cancer patients. Scientists at the Medical College of Wisconsin have discovered that repeated application of special LEDs speeds recovery from burns, ulcers, and oral sores caused by chemotherapy and radiation. Though the exact reasons for this outcome are not known, speculation suggests that the near-infrared light emitted by LEDs boosts cell energy. Whatever the reason, recovery has been so dramatic in some cases that patients who would previously have required intravenous feeding were able to eat solid foods.

The Medical College treatment uses a portable flat LED array that measures just 3.5 x 4.5 in. The unit is placed outside a patient's cheek for one minute a day. Quickly and painlessly, the light passes through the cheek to the inside of the mouth where it works to heal the painful sores associated with cancer treatments. Used consistently, the lights improve ingestion and help prevent further sores. There is some evidence that these LEDs may also reduce the risk of infection.

This unexpected application of NASA technology came after Ronald Ignatius, owner of Quantum Devices (Barneveld, WI), read about a brain-cancer surgery technique using drugs stimulated by laser lights. The wavelength of light emitted by the laser probes was roughly the same as the LEDs Ignatius had already designed for space research. Only a slight alteration was needed to make the arrays suitable for stimulating a benzoporphyrin derivative, a photodynamic drug. Because the technology was originally designed for use in space, the LEDs are small and light, making them cheaper and easier to use than conventional laser systems, which have large cooling systems.

SPOTLIGHT: Switches and Connectors

Originally Published MPMN March 2001

SPOTLIGHT: Switches and Connectors

Pressure and vacuum switches

Precision snap-acting switches react to pressure or vacuum and send signals to electronic control systems. The switches feature miniature size, low differential, adjustable settings, various mountings, and good repeatability. They are single pole, double throw for normally open, normally closed, and common terminals. The standard rating is 15 A, and 0.1- to 25-A versions are also available. Adjustment ranges from 0.5 to 100 psi, or 2 to 28 in./Hg. Air Logic Pneumatic Components & Systems, 5102 Douglas Ave., Racine, WI 53402.

Nanominiature connectors

Nanominiature connectors with a 0.025-in. pitch are made of standard materials including PPS or LCP insulators and BeCu male contacts rated at 1 A. Optional anodized aluminum shells are available for enhanced durability and additional mounting flexibility. Both standard and custom configurations are suitable for applications in the medical and other high-tech industries. Omnetics Connector Corp., 7260 Commerce Cir. E., Minneapolis, MN 55432.

Modular connector system

An interconnect system affords the opportunity to combine both power and signal functions. The Compodre system includes internal pods that can accept any combination of the manufacturer's Mini-Fit and Micro-Fit connectors. The system saves space and offers a cost-effective method to customize interconnects. It requires no tools for assembly, and polarized pods help prevent improper assembly. Molex Inc., 2222 Wellington Ct., Lisle, IL 60532.

DIN connectors

Fully shielded and watertight, a series of circular DIN connectors are IP 67 rated. Ten different pin combinations allow the connectors to be used in medical instrumentation and measurement, control, and communications systems. Available options include in-line cable-to-cable connectors, panel-mounted versions with solder contacts, and panel-mounted PCB connectors. Other connectors are available with IP 40 ratings and current capacities of 5 A. Lumberg Inc., 14121 Justice Rd., Midlothian, VA 23113.

High-density differential connectors

A high-density differential connector series supports data transfer up to 5 Gb/sec with less than 3% forward crosstalk at a 100-picosecond-pulse rise time (four pairs switching). According to the manufacturer, the Micro Giga connectors offer designers a better cost-performance ratio in high-speed systems than fiber-optic or coax interconnects. The connector series is initially available as a board-to-board, surface-mount plug and socket with a stacking height of 8 mm. The contact pitch is 0.75 mm with a 0.5-mm pitch between leads. Fujitsu Takamisawa America Inc., 250 E. Caribbean Dr., Sunnyvale, CA 94089.

Circular connectors

Circular connectors feature the Hypertac contact, which permits more than 100,000 duty cycles with no performance degradation. The units feature environmental seals, self-alignment, and two to five contact positions. A mated pair is securely held with a dual-latch system that is cam-released with a simple 30° twist and pull. All mating surfaces are finished in gold, nickel, or copper for good contact performance. IEH Corp., 140 58th St., 8E, Brooklyn, NY 11220.

Power cords

Medical-grade power cords feature solid, nickel-plated pins and crimped connections. The UL-listed and CSA-certified plugs have reinforced plug bases and semirigid PVC molding that provides good strain relief. Connectors are double insulated with floating phosphor-bronze contacts. Plugs and connectors are available clear or color matched. Feller US Corp., 68 Veronica Ave., Unit 5, Somerset, NJ 08873.

Circular connector

A 1- to 12-pin miniature circular connector is suited for handheld computer systems and medical instrumentation used in nonsterile environments. With preloaded PCB connectors, the Minicon component has a unisex shell that accepts male and female inserts. The rugged unit is secured by a push/pull locking system. Polarizing guides are constructed completely of metal. A chuck-type strain relief is standard, with additional strain reliefs available to handle a variety of cables. PC receptacles and environment-specific models can also be obtained. Neutrik USA, 195 Lehigh Ave., Lakewood, NJ 08701.

Bayonet connector

A high-density circular bayonet connector can be mated with MIL-C-26482 series-1 products. Constructed with a single-piece molded thermoplastic shell and insulator, the Sealok connector offers cost savings over some units with traditional metal housings. Contacts are two pieces, stamped and formed with a stainless-steel retention clip. Gold or tin plating is available for wire sizes of 20/22 and 24/26 AWG. All units feature metal coupling nuts. FCI Interconnections Group, 25 Grumbacher Rd., York, PA 17402.

Tactile switch

Accommodating design variations, a tactile switch uses a right-angle bracket for secure mounting. The 10-mm JB-series switch is constructed with a rubber seal that allows automated soldering and washing while preventing contact contamination. With a maximum power level of 125 mA at 24 V dc, the product is available in standard or high-operating-force versions. Dome contacts ensure crisp feedback and long product life. A choice of button or snap-on-cap actuators is offered. NKK Switches, 7850 E. Gelding Dr., Scottsdale, AZ 85620-3420.

Membrane switch

Low-profile membrane switches provide reliable input for medical and laboratory instrumentation. A proprietary sealing process keeps the units free from moisture ingress caused by cleaning materials. The seals are also resistant to harsh chemicals. Switches are produced to customer specifications. Silver Cloud Mfg., 525 Orange St., Millville, NJ 08332-5002.

Copyright ©2001 Medical Product Manufacturing News

Beyond 2001

Originally Published MPMN March 2001

Beyond 2001

A survey of some of the emerging technologies that are reshaping the development and manufacture of medical devices

Robots share the operating room with surgeons wearing retinal scanning displays. Internet-enabled active implants transmit patient data 24/7 to a network, where physicians and technical personnel remotely monitor device performance and patient status. And the cost of microchips plummets, as conductive plastics and a simplified processing technique enable the use of integrated circuits in a host of new devices. These are just some of the startling developments in store for the medical industry in the years ahead. Read on for a glimpse of the shape of things to come, compiled by the MPMN editorial staff.

Nomad shares a vision for the future

Retinal scanning displays developed by Microvision (Bothell, WA) may look like something out of M:I-2, but these visors that superimpose images and data on the user's field of vision have applications in the real world. Chris Thero, product manager, explains how the company's Nomad device, currently in beta form, can be used during spinal surgery.

A hands-free display allows the user to superimpose monitor feeds over real-world images.
"The surgeon has to place these pedicle screws, and to do so he must look up from the patient at a monitor to see where they should go. Using Nomad, preoperative images can be taken showing where the screws need to be, and these images can be superimposed right on the patient," says Thero.

Microvision has developed a technology that sends a computer or video signal into drive electronics that "talk" to the light sources, according to Thero. The beam is scanned on a small mirror that rocks in horizontal and vertical directions and scans the pixels onto a see-through optical viewer. "A beam splitter sends some of that light directly to the user's eye and some to the external world," she explains. "Basically, it gets scanned to the eye without panels or microdisplays. There's no screen, if you will."

Beta prototypes currently in use display only monochrome red, but Microvision also has full-color systems in alpha prototype mode. The latter are being tested at Wallace Kettering Neuroscience Institute for use in image-guided surgery. Other applications under serious investigation involve assisting people with low vision. "We have just begun a clinical trial at the Veterans Administration hospital near Stanford University, where we are looking at how Nomad can help people suffering from severe low vision to read," says Richard Duval, medical segment marketing manager.

Although Microvision markets its technology in product form to clinics, the company is interested in exploring partnerships with other medical technology companies "where we can augment what they are already offering," notes Duval. "In fact, that is our ideal business model."

Plastic microchips may enable new breed of devices

Modern plastics may soon replace silicon as the main component of semiconductors, allowing even inexpensive devices to contain microchips. These conductive plastics will significantly lower the costs of integrated circuits by eliminating the expensive process of forging circuits from ultrapure silicon crystals using lithography. While the price of silicon has decreased considerably, even simple silicon devices still sell for around a dollar. State-of-the-art silicon devices cost up to 100 times that much.

The oligothiophenes and polythiophenes used to make plastic microchips eliminate many of these cost concerns. Though processing methods are still being developed, these conductive materials will likely be applied in liquid form directly to a substrate using methods similar to silk-screen, ink-jet, or offset printing. Though all of these methods show promise, there are many problems still to be worked out. For example, ink-jet printers currently achieve resolutions of only 25 µm, well shy of the 0.2 µm needed for the most modern circuits. Other challenges include developing a way of applying several types of chemicals simultaneously.

When these problems are resolved, scientists see broad technical ramifications for the medical community. In addition to a price reduction in products that already use conventional microchips, it would become cost-effective to incorporate integrated circuits in a range of new devices .

Possible products could include bandages with circuits to measure saturation and temperature, or to detect the presence of bacteria. Another application, being developed by Xerox (Stamford, CT), involves the production of large flat-panel digital image sensors. Bob Street, a researcher for the company, says that "printed plastic transistors offer a next-generation technology [necessary] to reduce the costs" of these devices by eliminating the amorphous-silicon transistors currently used. While no one can say when plastic microchips will become a viable technology, Street predicts that image sensors using them will become available within five to 10 years.

The Internet links doctors and patients

With new technologies like Universal Plug and Play, a networking architecture that can connect PCs, intelligent appliances, and wireless devices, and the Bluetooth standard for wireless technology that allows networking without cables, medical device manufacturers should expect the industry to become Internet-focused in the near future. According to Edward Steinfeld, embedded computing marketing consultant for Automata International Marketing (Westford, MA), "wireless technology, regardless of which technology is used, is a must in current plans for new medical instruments. Every instrument can be networked, and most can have handheld consoles transmitting via radio frequency to the main instrument or to a small server/receiver on a local network."

An example of an end-use product that has integrated Internet-based technology is a new wireless device and network that allows doctors to monitor patients hundreds of miles away, and to collect cardiological data. Medtronic (Minneapolis) plans to build a secure network linking patients who have its implanted pacemakers and defibrillators to their doctors and other healthcare services. The company's Chronicle pacemakers and defibrillators will send data to the network that doctors can access. The networking system will include transmitters that can read a patient's heart device remotely, with plans to include portable and wireless devices down the line. Doctors will be able to compile data remotely from electrocardiograms, check how the device is working, and see whether a patient is taking his or her medication. The doctor can then reprogram the device over the Internet or call the patient in for a visit.

The amazing world of micromachines

A working car the size of a grain of rice. . . .A million microminiature mirrors, fitted on an area the size of a postage stamp. . . .Electric motors narrower than a human hair spinning at 350,000 rpm . . . .These are all examples of the amazing world of micromachines. The medical industry is one of the pioneers mapping this technological frontier.

A gear-drive chain and linkages are shown with a grain of pollen and red blood cells.
More than 600 organizations are working on microelectromechanical systems (MEMS), for which the global market is expected to reach $20 billion by 2002. The first widely used MEMS were the simple accelerometers used in automobile airbags. During sudden deceleration, the silicon sensor bends far enough to complete a microcircuit that activates the vehicle's airbag.

A similar sensor was developed for disposable blood pressure devices, which greatly reduced costs by replacing a much larger and more expensive instrument. But this simple 2-D microdevice only points the way toward the 3-D MEMS that are being developed for the medical industry.

These MEMS often sound like something taken from the film Fantastic Voyage. For example, this technology could enable the development of "smart pills." Powered by tiny motors, smart pills could serve as drug-delivery devices by cruising through a diabetic's bloodstream and automatically releasing insulin when sensing a rise in blood sugar. Using tiny blades, a MEMS device could also be used to cut through arterial plaque or to search for and destroy infected cells.

Microfluidic devices, already in use and likely to become popular with pharmaceutical researchers, are like laboratories on a chip. Chemical reactions take place inside the fluid passages that have been micromachined into the devices.

The production of such sophisticated MEMS-based devices is one of the biggest hurdles that engineers are trying to overcome. The huge differences in scale between a micromachine's parts and the tooling present enormous obstacles. When parts are being assembled with tiny tweezers, they may either leap away unpredictably or cling to the tweezers due to static electricity.

Building a microminiature robot to perform assembly operations may be a solution, but then the question becomes, How do you build the microrobot itself? Engineers have found a solution by creating "factories on chips." Thousands of cilia covering a surface the size of a conventional computer chip can move objects in any direction (up, down, left, right), drop them into specific slots, and even recognize and toss out defective parts. The microminiature factories are still in development, but considering the amazing leaps in technology that we've made in the last decade, engineers may soon be able to turn science fiction fantasies into everyday reality.

Robots invade the OR

Industrial robots that conform to Class 1 cleanroom requirements are core components of an automated cell that mills patients' femurs to prepare them for the insertion of hip prostheses. Orto Maquet (Rastatt, Germany), a manufacturer of operating tables that has marketed the cell thus far in Germany and France, specified the RX 90 CR robots, developed by Staubli (Horgen, Switzerland), for this application primarily because of their precision and repeatability.

Surgical robots outperform humans in bone milling.
"Maquet claims that the robots drill the bone to an accuracy of 0.1 mm," says Jean-Luc Burquier, group division manager, robotics, at Staubli's production unit in Faverges, France. "A surgeon typically achieves an accuracy of 1 to 2 mm, making a robot 10 to 20 times more accurate than its human counterpart." The machines' extraordinary precision results in less bleeding during the procedure and accelerates rehabilitation, which goes a long way toward allaying any misgivings the patient may have of being operated on by a robot, adds Burquier.

The RX 90 robots attracted the attention of Maquet engineers at the mammoth annual manufacturing trade show in Hannover, Germany. "They are made of stainless steel and smooth polyurethane, making them suitable for use in Class 1 environments," notes Burquier. In addition, all of the cables and motors are embedded inside the arm, and the robots have a compact footprint. "We worked with Maquet for a couple of years to adapt the robots to their specifications, and to incorporate additional safety features required by the application," adds Burquier.

The first operation using computer-assisted surgical planning and robotics (CASPAR) was conducted in 1997 in Germany. Maquet is currently exploring other applications, adds Burquier, and has achieved two world firsts: the replacement of cruciate knee ligaments in 1999, and the insertion of a tricompartment knee prosthesis. French and German hospitals are using CASPAR, and the cell will soon be installed in hospitals in Belgium and Italy. The company is seeking approval from FDA to market the device in the United States.

Testers Offer Less Bulk, More Versatility

Originally Published MDDI March 2001

EQUIPMENT NEWS: Testing Equipment
Testers Offer Less Bulk, More Versatility

Multitesting devices gain in popularity

Designed with portability in mind, the Rigel 266 electrical safety tester from Seaward Electronic Ltd. measures 310 x 210 x 80 mm and weighs just 4 kg. The safety tester is smaller and lighter than similar devices on the market, according to Paul Millican, a Seaward design engineer who led the Rigel 266 development project. To keep product size to a minimum, Millican and his team grouped many connections that would normally be on the tester itself into a flying-lead arrangement. The Rigel also features microprocessor-based technology that's more compact than the combination of switching relays and logic circuitry found in larger benchtop testers.

The Rigel 266 electrical safety tester developed by Seaward Electronic Ltd. combines leakage-test functions with appliance-testing capabilities.
The unit is designed specifically to perform electromedical safety tests on Class I and II equipment during the manufacturing process. The 266 features soft key and rotary switch operation, and offers a large 7.5 x 10-cm LCD that helps to reduce errors in usage and reading results.

The 266 also offers the ability to perform more than one type of test, combining leakage-test functions with appliance-testing capabilities. "It basically means that you don't have to spend money on two testers to check your piece of medical equipment," Millican says. The 266 can carry out load, insulation, IEC lead, ground continuity, ground leakage, enclosure leakage, patient leakage, and patient auxiliary current tests. The device offers true RMS leakage measurements, automatic testing of single-fault conditions, and 16-A testing capability.

Multiple functionality is also one of the features of the Guardian 6100, developed by QuadTech Inc., which performs five electrical safety tests. It carries out ac hipot tests from 50 to 5000 V and dc hipot tests from 50 to 6000 V. Current-trip levels for the ac and dc hipot testing functions can be programmed over ranges of 1 µA to 40 mA ac and 0.1 µA to 20 mA dc, providing flexibility in testing a wide range of devices.

Five electrical safety tests can be carried out using the Guardian 6100 from QuadTech Inc.
In addition to these tests, the device performs ground bond tests (which verify the integrity of a product's ground system) to 30 A, and takes insulation resistance measurements from 100 kW to 50 GW. The insulation resistance test calculates and displays a product's insulation resistance value in ohms at any programmed test voltage between 50 and 1000 V dc.

The instrument's fifth function is taking line and ground leakage measurements from 0.1 µA to 9.999 mA. Ground leakage current tests measure the current flowing through a product's line-cord ground connector. During these tests, the unit can monitor line voltage, current, or power consumption.

Any combination of these five tests, up to a total of 10, can be run automatically in sequence from a single start command. An overall go/no-go indication is provided based on programmed limits, and any failed measurement results are clearly indicated.

Jim Richards, marketing engineer for QuadTech, cites several advantages of multitest devices such as the 6100. In addition to cost savings, the devices offer greater test efficiency. "If you were doing five tests and had to have five test stations, that would take a lot longer," Richards explains. "You have to move a product [to a station], connect it, do a test, then move it to another station, connect it, do another test," and so on. With all the testers combined into one, only one test hookup is required, which greatly streamlines the process.

Multifunction testers also simplify maintenance. "You only have to calibrate one unit, as opposed to two or three," Richards says. "If you have to take one unit off the production line, it's more efficient than having to take two or three units off the line." There's only one reason for buying a single-test unit, adds Richards: "If you're doing just one test and want to do it as inexpensively as possible."

Tester detects mechanical and electronic failure modes

A vibration machine has been developed specifically for failure-mode verification testing (FMVT). Made by Entela Inc., the FMVT Machine is a six-axis, pneumatically actuated device capable of activating repeatable failure modes in an array of electromechanical components and systems.

With a uniform random frequency range of 2 to 5000 Hz and total displacement of 4 in., the FMVT Machine can reveal inherent design weaknesses that may not be detected by traditional testing methods. By subjecting a device to a combination of stress-inducing environments, the machine can produce multiple failure modes in as little as one day.

The machine is suitable for users of various levels of expertise. "The controls are simple, allowing quick setup," notes Alexander Porter, Entela's engineering development manager and the inventor of the FMVT Machine. "But a layered menu system allows advanced users to fine-tune the behavior of the machine."

During a recent test, the machine was able to trigger both mechanical and electrical failure in an ECG unit, Entela reports. Conventional air-hammer vibration machines normally produce a higher frequency range, which triggers only electronic failure. By producing mechanical failures as well, the FMVT Machine provides more data to design engineers and expedites the redesign process, according to the firm.

Force testers offer up to 500-lb capacities

Suited for cost-effective low- and medium-force testing, economical digital force gauges offer capacities up to 500 lb in nine different force ranges. The units supplied by Com-Ten Industries achieve 0.2% full scale accuracy; when combined with the company's E-Z test stand, they can perform accurate tensile and compression tests on spring, crimp, foam, peel, and crush applications. The compact stand features a revolving, reversible hand crank and has an optional digital travel display.

Digital force gauges from Com-Ten are suited for low- and medium-force testing.   A crimp pull tester from Mark-10 Corp. incorporates a removable base plate to facilitate connection to a computer, data collector, or printer.

A variety of digital and mechanical force and torque gauges are supplied by Shimpo Instruments for use in testing blister packs, implants, couplings, tubing, and minimally invasive surgical instruments. The instruments' measurement capacities range from mere grams to 500 lb. Higher ranges will soon be available, according to the firm. The all-metal gauges are calibrated to NIST standards.

When connected to Loadmeter software, the company's FGV digital force gauge and programmable test stand can test a product quickly and evaluate and incorporate data into an overall quality assurance program. The DFS and DRI digital gauges feature 100-sample memory, onboard statistics calculation, high and low set points, variable units of measure, and peak hold with user-determined display speed. Used in conjunction with interchangeable load cells and torque sensors, the DRI can double as a force or torque tester and torque calibrator.

A crimp pull tester developed by Mark-10 Corp. consists of the company's Model TSB test stand, Series BG digital force gauge, and fixtures for wire terminal testing. A removable base plate contains a grid of tapped holes to mount the fixtures, which can be connected to computers, data collectors, and printers for SPC or further processing. Go/no-go signals are generated for quick results. The device measures 4 x 8.5 x 19 in., weighs 18 lb, and accommodates 8.5 in. of travel. The durable tester is designed for many years of use in laboratory and industrial environments.

Leak testers attain heightened sensitivity levels

A turnkey inspection system with micrometer-level testing sensitivity comes with a software tutorial that reduces setup and training time and enhances accuracy and consistency. Developed by PTI Packaging Technologies & Inspection LLC, the P-325 is suited for the inspection of filled and sealed bottles, blisters, IV bags, vials and ampules, and related products.

Hydraulic burst and leak testers supplied by Crescent Design are suited for destructive and nondestructive component and device testing.
The leak tester is fitted with a high-resolution differential vacuum transducer in addition to an absolute vacuum transducer. High-vacuum miniature components make possible the unit's elevated sensitivity level, according to the firm, and because the parts are commercially available, the tester is easy to validate.

A semiautomatic leak tester developed by Phase 1 Instruments is designed to perform fast and accurate tests on catheters and other small parts, using air or nitrogen. The Model 11 tester operates according to the mass-flow leak detection technique. Constant pressure is maintained to the test part by a pressure regulator; any makeup air that may be required is measured by a sensitive mass flowmeter. Test results are indicated on a readout in cubic centimeters per minute.

Offering leak detection down to 1 µm, the P-325 from PTI Packaging Technologies & Inspection LLC is suited for the inspection of filled and sealed, flexible or rigid packaging.
The company also offers a digital leak check for on-site calibration and verification of calibrated leak orifices and leak-test units. The 20-cm3/min full-scale device is compatible with vacuum, compressed-air, and nitrogen applications. It connects to the outlet of a calibrated leak orifice or adjustable metering valve and provides a direct leak-rate readout to enable traceable calibration verification.
Carleton Technologies Inc. has developed a nonporous-package tester.
A hydraulic burst and leak tester manufactured by Crescent Design is suited for the destructive and nondestructive testing of valves and luer fittings, chromatography valves, pressure switches, liquid filters, tubing, angioplasty balloons and catheters, and related devices. The tabletop HBLT tester features 0–1800-psi capability, programmable test profiles, and field-programmable software. Pressure display units are selectable, and calibration can be performed without removing the cover of the SPC-compatible tester.
Video metrology systems from RAM Optical Instrumentation Inc. provide precise measurement and parts positioning during the manufacturing process.
A leak tester from Phase 1 Instruments uses the mass-flow leak detection technique to test catheters and other small parts.

A company that supplies a line of testing modules, fixtures, and ancillary equipment for package testing has developed a nonporous-package tester. Test-A-Pack F100-2700-2, offered by Carleton Technologies Inc., verifies the integrity of nonporous flexible packaging.

The unit consists of a digital control console and a package test chamber. The console automatically regulates the vacuum source while presenting test data on the screen. By adding water to the test chamber for submersion testing, users can determine the precise location
of a leak.

PROFILE: Better Vision System Boosts Inhaler Box Output

Originally Published MPMN March 2001

PROFILE: Better Vision System Boosts Inhaler Box Output

With a new pair of eyes watching a once-troublesome production process, an inhaler maker is getting more accurate inspections and fewer false rejects.

At the U.S. facility of Bespak plc, a UK-based manufacturer of drug-delivery devices, a machine vision system measures the dimensions of orifices in injection-molded plastic inserts that are assembled into inhaler boxes. To meet customer specifications, the vision system is supposed to reject orifices that don't fall within a ±0.002-in.-diam tolerance. The system also checks to make sure that the orifices are no more than 20% oval (i.e., that there is no more than a 20% difference between any two diametric measurements of the same orifice).

Automated assembly of the inhalers is performed at the Bespak facility in Apex, NC.

But Bespak's eight-year-old vision system wasn't up to the job. The system couldn't pass the most basic validation tests or meet the company's repeatability and reliability testing requirements. "Our internal requirement was no more than 20% variability in performance, and our ultimate goal was to achieve less than 10%," explains Jim Gallion, manager of manufacturing engineering at Bespak's facility, located in Apex, NC. "With that system we were struggling to get below 30–40% variability, which was leading to an excessive amount of falsely rejected products."

A Better Alternative

Gallion and his colleagues investigated other alternatives. After evaluating several products, they settled on a Checkpoint 900 vision system from Cognex Corp. (Natick, MA). The vision system includes a Pentium-equipped computer with a Checkpoint 900 PC plug-in card, two Sony CCD cameras, and a remote-controlled Fostec fiber-optic light source.

In Bespak's plant, inhalers are assembled by an automated machine. The machine takes inserts from feeder bowls and places them two at a time on a rotary indexing table. The table indexes the parts into the view of the two vision cameras, which are mounted side by side. Motion stops while each camera captures an image of the part in its line of view. Extreme magnification is necessary to get high-quality images of the tiny orifices, which measure approximately 0.02 in. diam.

Extreme magnification is required to capture images of the 0.02-in.-diam orifices in the inhaler box inserts.

Image data goes to the Checkpoint card, which uses PatMax geometric pattern matching software to determine the exact position of the orifices. This is no easy task, due in part to the size of the orifices and in part to machine vibration. "Even slight vibration can shake the field of view and cause the pattern's position to vary," explains Joe Grove, a Bespak manufacturing engineer. But with its rapid-reset CCD cameras and high-speed processor, the vision system can capture high-resolution images of a vibrating target, Grove reports.

When the system receives an image, it checks the orifice diameter using Checkpoint's Edge and Arc Gauge tools. These tools acquire 72 radial points, which are used to calculate an average diameter. The system also uses the radial points to determine whether the shape of the orifice meets the oval-shape specifications. The entire inspection process takes less than a second.

Light Concerns

During inspection, the Fostec light illuminates the orifice from the inside. If light intensity diminishes, "the vision system is not able to detect the crisp, well-defined edge of the orifice, which affects the accuracy and reliability of the results," Grove says.

To maintain adequate light intensity, Grove came up with a data-carrying loop. A key component of the loop is Checkpoint's Light Meter tool, which assigns a "light value" to each image the system captures. This value is transferred from Checkpoint software to Visual Basic through bridging software called Checkpoint Communication, or CPComm. The transfer is necessary because, unlike the Checkpoint software, Visual Basic can be used to communicate with the Fostec light. If the light value is too low, the system sends a Visual Basic message to the light source to boost intensity. Then the light meter checks the intensity again. If it's still too low, another Visual Basic message is dispatched to the light. The process is repeated until the proper intensity level is reached. "This is a pretty high-level feedback loop that solves the major problem with vision, which is lighting variation," Gallion says.

When the vision system spots a defect, it's logged in a database. Defective parts are dropped in a reject bin. Parts that pass inspection are placed on an offload conveyor, which carries them to a packaging station.

During the inspection process, a special graphical user interface appears on a 17-in. monitor built into the assembly machine. Developed by Bespak engineers, the interface displays the parts being inspected and keeps a running tally of the number of rejects. By hiding Checkpoint's more complex features, the interface makes it easier for plant personnel to operate, test, and calibrate the system.

Passing the Test

Since it was installed and validated last year, the new vision system has been inspecting more than 20,000 inserts a day. "The Checkpoint system [has] proved capable of measuring the inserts within strict tolerances," Gallion reports. "And it passed the original validation tests and many others with flying colors."

The machine vision system inspects more than 20,000 inserts daily.

According to Bespak, the system has been very reliable, producing fewer false rejects and less scrap than its predecessor. The system has also reduced variability to well below Bespak's target of 10%. Even with tighter-than-normal tolerances, variability now ranges between 3 and 4%. According to Gallion, variability that low "is completely unheard of for automatic vision inspection at these speeds."

Encouraged by this experience, Bespak has much bigger plans for the Checkpoint vision system. "We will use this everywhere," says Gallion, adding that his company plans to use vision data to make process adjustments that will prevent the manufacture of faulty parts. "This is where we see the world going."

William Leventon

Copyright ©2001 Medical Product Manufacturing News

Advances in Surface Treatment Technology

Originally Published MPMN March 2001


Advances in Surface Treatment Technology

A variety of techniques can render devices bondable, radiopaque, lubricious, or antimicrobial.

Implantable or invasive devices must be compatible with the human body as well as cost-effective for the manufacturer. While some materials such as plastics and fluoropolymers may be inexpensive in terms of production costs, in their untreated form they may not be suitable for interaction with the human body. The application of certain surface treatment techniques can provide the desired properties for these devices without raising the cost prohibitively. A sampling of suitable surface modification methods follows. Please see page 56 for a Buyers Guide listing of surface modification providers with complete contact information.

Portable plasma systems are suitable for ambient-air use

Although silicone and fluoropolymers are inexpensive and highly moldable, they are not naturally wettable and pose problems for medical device manufacturers if bonding or adhesion is required. Plasma, an electrically conductive ionized gas, can raise the surface energy of a material to provide adequate surface activation for enhanced wetting and adhesive bonding. The recent trend in plasma treatment has been to make surface treatment equipment smaller and portable in order to provide precise control of the plasma stream in any environment.

Tri-Star Technologies (El Segundo, CA) has developed the PT2000P Plasma Station, a portable benchtop unit that prepares nonconductive surfaces for the application of adhesives and lubricious or other specialized coatings. The unit features a flexible interface between the plasma generator and plasma delivery head. Detachable heads in many sizes and configurations can be customized to treat 60-µm to 5-in. exterior areas and can be attached to a conveyor, indexing table, or robotic assemblies, or used as a handheld device.

According to Tri-Star president Alex Kerner, the system "does not require a vacuum chamber or cleanroom of its own. It works in an open, ambient environment at atmospheric pressure and room temperature, making it much more user-friendly than systems needing special environments."

The PT2000P is equipped with a digital plasma exposure meter, a plasma intensity regulator that sets voltage parameters and determines plasma current, a gas-flow regulator, and other controls that allow users to determine and adjust plasma energy. The unit plugs into a regular 110- or 120-V outlet, is cleanroom-compatible, and uses argon gas or other mixes of gases.

The PlasmaPen offered by Metroline/IPC can be used for spot treatment in ambient environments.

Like the PT2000P, the PlasmaPen from Metroline/IPC (Corona, CA) functions in the ambient environment. The PlasmaPen can be run manually or by robot, and requires only a standard 120-V outlet connection and a compressed-air-system connection. The unit uses compressed air or other gases to treat a range of materials including plastics, metals, and glass. When it is activated, gas flows through the pen and is ejected out of the nozzle. Applications include surface cleaning, surface modification, and localized treatment of catheters. The plasma treatment can be combined with other chemicals to give more properties to materials. Options include an internal pump that eliminates the need for compressed air, multiple plasma jets that operate in parallel, and variable power level and gas flow. "Plasma has been a great technical solution, but hard to justify economically," says vice president of sales and marketing Blake Thompson. "The PlasmaPen dramatically reduces costs by being usable for in-line production and spot treatment of small assemblies without engendering the cost of disposing of wet chemicals."

Radiopaque coatings provide accurate invasive device positioning

When using invasive devices like catheters, guidewires, and stents, it is critical that the physician knows exactly where the device is once it is inserted into the body. The addition of metallic radiopaque markers on these devices allows them to be seen on x-ray film or on a fluoroscope. Spire Corp. (Bedford, MA) has developed a system of attaching radiopaque markers through the use of ion-beam-assisted deposition.

The Ion-Sight process involves a combination of evaporation and concurrent ion-beam bombardment in a high-vacuum environment. Ion bombardment intermixes coating and substrate atoms to create very dense, adherent film structures. Gold, silver, or platinum films can be applied to polymers, metals, and ceramics to provide radiopaque markers suitable for use on catheters, guidewires, stents, and vascular grafts.

Polymerization improves effectiveness of invasive devices

Invasive and extracorporeal devices that come in contact with body fluids often require surface treatment to make them lubricious and biocompatible. Untreated, these devices can cause bacterial infections, blood clots, and other complications. STS Biopolymers Inc. (Henrietta, NY) recently developed two surface modification techniques designed to increase the effectiveness and improve the surface quality of catheters and other in-dwelling medical devices.

Graft-Coat, a reverse-phase graft polymerization technology, allows a variety of polymer layers to be permanently bonded to difficult-to-coat surfaces such as silicone, latex, polyethylene, and fluoropolymers. "The major advantage of Graft-Coat surface modification is the chemistry of attaching free radicals to a substrate that allows monomers to covalently bond and polymerize onto the surface within an aqueous medium to create the desired polymer surface," says Richard Whitbourne, chairman of STS Biopolymers. "A benefit of this technology is the ability to coat medical device surfaces, including catheter lumens and odd-shaped geometries, without the use of plasma, or gamma or UV radiation."

Graft-Coat technology can be used to improve the existing surfaces of devices and to incorporate a range of pharmaceutical agents such as antimicrobials, anticancer drugs, and other substances individually or in combination with the coating. Incorporated drugs are delivered at high concentrations at the device surface, with low systemic concentrations. Varying hydrophilic properties reduce friction and increase the physician's ability to control the device, reducing the risk of patient trauma and complications.

Some catheters and other in-dwelling medical devices may activate the body's coagulation and inflammatory system, causing what is known as thrombosis, when they come into contact with the patient's blood. To prevent thrombosis, device manufacturers can utilize the anticlotting activity of heparin polymer surface coatings.

A common treatment for invasive medical devices is the use of a heparin benzalkonium (HBAK) complex. Benzalkonium allows HBAK to adhere to device surfaces, but is sufficiently soluble in blood that, upon presentation to vasculature, it is quickly washed away. STS Biopolymers has developed heparin-containing Medi-Coat polymer coatings for use on implants and in-dwelling catheters to render them hemocompatible for sustained periods. The Medi-Coat system consists of an inert biocompatible polymer matrix used to entrap heparin complexes on the surfaces of medical devices. The polymer coating acts as a reservoir for the heparin complex, releasing the agent slowly over time upon exposure to blood to increase the duration of anticoagulant activity. A high local heparin concentration at the device surface results in prolonged antithrombogenic protection from less than one hour to more than two weeks, while maintaining low systemic concentration levels.

Silver-based antimicrobial treatment suited for long-term in-dwelling devices

Also for use in catheters and other invasive devices is an antimicrobial compound developed by Agion Technologies Inc. (Wakefield, MA). Its effectiveness has been demonstrated in laboratories against a range of nosocomial, airborne, and waterborne bacteria; yeast; fungi; and molds. The compound is composed of silver ions bonded to a naturally occurring, completely inert ceramic material that releases the silver at a slow and steady rate. Ambient moisture in the air causes low-level release that maintains an antimicrobial surface. As humidity increases and the environment becomes more suited for bacterial growth, more silver is released, up to a maximum release rate. Even under very wet conditions, the silver releases very slowly, ensuring long-term protection. Silver kills microbes by interacting with multiple binding sites on the microbes' surfaces that are unlike the binding sites used by organic antibiotics, reducing the likelihood of bacteria becoming resistant to the compound. The Agion compound does not cause discoloration in products, tolerates high temperatures used in manufacturing, and is effective against a broad spectrum of bacteria. Potential uses include wound care, heart valves, pacemaker leads, suture rings, feeding tubes, orthopedic implants, small-joint replacements, and catheters of all types.

Katherine Sweeny

Copyright ©2001 Medical Product Manufacturing News

Avery Dennison Specialty Tape Division Establishes Medical Group

Originally Published MDDI March 2001


Avery Dennison Specialty Tape Division Establishes Medical Group

A press conference held at the Medical Design & Manufacturing (MD&M) West show in Anaheim, CA, on January 8 announced the formation of Avery Dennison Medical. The new group is part of Avery Dennison's Specialty Tape Div. (Mentor, OH).

The medical group will operate as a full-time supplier of base materials for various applications.

"The healthcare industry is constantly looking for new products that will improve wound-care management and patient comfort," said Jef Smets, vice president of Avery Dennison's Specialty Tape Div. "We see an opportunity to leverage our technology base and medical industry partnerships to lead growth in this promising area."

The medical group has been established to operate as a full-line supplier of base materials used in various medical device applications including ostomy, wound care, electromedical, surgical supplies, and diagnostic products. Expanded capabilities include contract manufacturing. The company will not sell products under its own name.

According to Avery Dennison, the demand for wound-care management products is expanding at 15 to 20% annually. Key factors driving this growth are an overall worldwide population base that is older and living longer, as well as a rapid development of and demand for lifestyle drugs directed at solving obesity, arthritis, and impotence, among other conditions.

Karim Marouf