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Articles from 1999 In April

Injecting New Life into Plastics Processing Equipment

An MD&DI April 1999 Column

Although room-sized systems still exist, equipment is becoming smaller, transportable, and capable of handling jobs of various demands.

Although many injection molding and plastics processing equipment companies will be the first to admit that, as an industry, they've lagged a bit behind those working with metals, change is definitely in the air. New machines are increasing the ease with which small or uneven-surfaced parts are produced, single machines can perform more functions than ever before, and technology is shifting from hydraulics to electric systems, as well as from analog to digital.

Realizing that the specific dimensions of whatever part is being molded is what determines the best setup in an injection molding machine, some manufacturers have gone overboard to provide options. Autojectors (Avilla, IN) has more than 30 different machines, which virtually guarantees that one of them will meet a customer's specfications. Just one of many options, the HCS-40 is ideal for molding inserts with long leads. Its horizontal two-station shuttle table is operated by a hydraulic cylinder and adjustable stops, and the shuttle system allows inserts to be loaded at one end of the table while parts are molded at the opposite end.


Led by the surge into microelectronics a few years ago, the trend toward miniaturization is a hot topic in injection molding. Everything seems to be preceded with micro—microsensors, micropumps, even microsurgical instruments. On the road to shrinking parts, however, technical problems need to be resolved. Cycle times are usually longer than necessary for such small parts because the sprue and runner sizes aren't always proportionately reduced to minimize material residence times and melt degradation. Longer cooling and heating cycles, meant for larger part sizes, also increase energy consumption. Standard machine ejector mechanisms can damage minute structures, develop electrostatic charges during the part ejection process, and fail quality standards because of the large sprue-to-part ratio.

The Microsystem's seven modules can mold parts weighing less than 0.1 g (Battenfeld; Meinerzhagen, Germany).

Battenfeld (Meinerzhagen, Germany) has introduced a new injection molding manufacturing cell designed to counteract these problems. The Microsystem 50/2 SE's plunger injection system has a diameter of 5 mm, and each of the seven modules is operated by the company's new Unilog B4 control system. The Microsystem can mold parts weighing less than 0.1 g while avoiding the typical problems outlined above. A rotary table clamp system, with one station for injection molding and a second for part ejection, has reduced cycle times by more than 50%. The two-axis handling system removes parts using suction cups that also help separate and orient them for optical quality control and packaging. Parts that do not fit the specifications are automatically discarded by the handling system.


Some machines don't get a complete technical overhaul, but are improvements nonetheless. Such is the case with the new Omega III ultrasonic welding series from Forward Technology Industries (Minneapolis), which is replacing the Omega II line. The three models, with varying degrees of complexity, are geared toward the fast, reliable assembly of thermoplastic parts. The MCA is the company's basic unit, and the MCS intermediate model now offers features that were previously available only on the most advanced model. The MCX offers extensive control and optimum adjustment for complex applications. The new modular design for all three welders allows the generator and controller to be placed in a number of locations on or around the welder.

"The new line will considerably increase the general capacity and flexibility of the machine," says Bryan Schaupp, ultrasonic product manager. Among the new performance features is an improved reactive welding system (RWS) exclusive to Forward Technology products. RWS provides the precise amount of ultrasonic energy necessary to complete the weld, regardless of the dimensional variations or irregularities of the part.

Husky Injection Molding Systems (Bolton, ON, Canada), in its new S-Series, has introduced a line of small-tonnage (60–160 tn) units that are well suited for high-end medical applications. The machines incorporate a number of features from the company's current E- and G-Series that have helped to simplify unit design, reduce maintenance, and decrease the incidence of part contamination.

New models don't always have entirely new technology but offer improved features, such as simplified programming and machine adjustment, a larger working area, a back-lit display screen, improved amplitude control, optical encoders, a power clamp, a foot-operated material hopper, and other features that reduce operator fatigue or simplify integration into an assembly line.


For some manufacturers, the ability to meet cleanroom specifications is of utmost importance. The Newbury Vertical injection molding machine by Van Dorn Demag Corp. (Strongsville, OH) offers a three-year, no-fluid-leak guarantee. Toggle clamps reduce the amount of oil in the processing environment, and a breather cap at the oil tank cap provides additional assurance of cleanroom compliance. The company's Ergotech 60 system reduces particle emissions by having only two dynamic seals and featuring a permanent lubrication system with a lubrication interval of three months.

Krauss-Maffei Corp. (Florence, KY) offers a line of machines for liquid injection molding, multicomponents, and thermoset processing. Its KM80 injection molding/cleanroom system features a clamp end that remains in the cleanroom during processing, sealing off the cleanroom during operation and maintenance with two additional metal plates. Casters supporting the hardwall cleanroom allow the unit to be rolled away from the clamp for mold change and maintenance.

The two-platen C-design offers speed, superior precision capability, and excellent repeatability, according to the company. The cantilevered clamping unit results in full accessibility, reduced footprint, and reduced energy consumption. The MC4F process control system is mounted on the machine and swivels for operation either inside or outside the cleanroom.


Molders who have tired of cleaning oil spills; replacing oil, water, and filters; and figuring out how to safely dispose of oil and water to meet environmental standards can make the move to fully electrical injection molding machines. Toshiba Machine Co.'s (Elk Grove Village, IL) initial machines, ranging from 45 to 250 tn, are billed as energy savers because the motors shut themselves off when a function is complete or the system is between cycles. Since each function is run by a separate motor, energy savings will vary depending on the process, but is expected to be more than 50% compared with traditional units. Ube Machinery Inc. (Ann Arbor, MI), which has produced electric machines for more than 10 years and has produced its third generation, believes that its servomotors save as much as 60 to 80% electrical use.

Barr Klaus, technical director of Cincinnati Milacron Inc. (Batavia, OH), says that although his company is already introducing their fourth generation of electrical machines, most users are just beginning to appreciate their advantages. "Our years of investment in this technology are paying off with increasing sales and enhanced market share in what we believe is the future direction of injection molding machinery," he explains. "The injection molding industry is just beginning the changeover from hydraulic to electric power that has already occurred in both machine tools and robots. Now we're being validated by both market acceptance and by competitors who are rushing out first designs."

Milacron's all-electric Roboshot injection molding machine makes liquid injection molded medical-grade parts. It features a water-cooled jacketed barrel and shot-off nozzle, as well as integrated mold-temperature control.

Last year, Cincinnati Milacron debuted the first electrically activated rotary mold on an all-electric machine. Klaus says that while there is an initial cost premium in this and other electric molders, operational cost savings quickly pay for the difference.

According to Toshiba and Ube, electric machine operation is more consistent than that of its traditional counterparts, and its part repeatability results in fewer rejected parts and less material scrap. The lack of hydraulic oil, and the water to cool it, provides a cleaner environment and eliminates leakage and the concern over oil recycling. Thus, maintenance and repairs are minimal. The elimination of hydraulic pumps reduces noise by 25%. Toshiba vice president Tim Glassburn says, "Our new line of electric machines will give our customers and 'not-yet customers' a whole new set of options from which to choose."

Boy Machines Inc. (Exton, PA) is also offering its customers the option of an electrical ejector system in its cleanroom machines to replace the standard hydraulic ejector. The electrical system increases the cleanliness of the operation and allows the machine to remain in operation during the clamping unit's movements.

The cleanroom features are met by installing a laminar-flow system on the hood of the clamping unit; stricter standards require that the freely overhanging clamping unit be segregated with its own enclosure and laminar-flow system. The rest of the machine remains outside of the cleanroom unit. The pump drive motor used for cleanroom applications is cooled by water instead of air, preventing air-turbulence contamination.

With Battenfeld's Microsystem, parts contamination is controlled by the cleanroom conditions inside the system enclosure. The servoelectric drive used in all machine functions is well suited for this environment, and its use allows a resolution 40 times that of conventional stroke-measuring devices used in hydraulic machines, leading to a better-controlled molding process. A final module places the parts in the proper orientation within blister packaging, protecting them from soiling and transport damage. If the parts are needed for another assembly process, they are already separated.

The ES Elject series from Nissei America Inc. (Anaheim, CA), ranging from 22 to 397 tn, is another line of electric injection molders. According to the company, the lack of hydraulic oil reduces each model's floor space by up to 15%. Also, the electrically driven actuators for injection, metering, mold opening and closing, and ejection can operate either individually or simultaneously, thus eliminating standby time.

Some owners of hydraulic injection molding systems have tried to upgrade to a partially electric system to avoid the cost of purchasing a new all-electric system. However, adding electric servos may decrease noise levels and save a bit of energy, but not improve process capability. Further changes won't do much to change the characteristics of the hydraulic system but can cost nearly as much as a new all-electric machine, so it's best not to scrimp when upgrading.

In fact, whereas many people are initially attracted to electrical systems because they hope to reduce energy costs and eliminate the hassles of recycling hydraulic oil, they are often pleased to discover that the best reason to turn to electrical systems is the increased quality and production they offer. Also, much less operator monitoring and system adjusting are needed.


At Herrmann Ultrasonics (Schaumburg, IL), welding technology development has focused on process improvement, both in terms of consistency and capability. The solution: switching their signal generators and controllers from analog to digital circuitry. According to Jim Meggesin, the operating performance of analog components is affected by variations in factors including temperature, humidity, aging, and manufacturing tolerances. "A good analog circuit design can minimize the impact of these variations," says Meggesin, "but a digital design can eliminate them altogether. Better data resolution provides more-precise and faster control for improved system performance. And fewer components means greater system reliability."

A side benefit to the digital in-process data is its availability for uses other than system control loops. Meggesin explains that the computers monitor the actual weld parameters in real time and can identify violations of the process control window and the corresponding bad parts. The data are available for export to SQA software where statistical data can automatically be obtained.

"The data are invaluable for both process development and quality assurance of production processes," says Meggesin. He adds that although the capability isn't new, the upgraded computers now operate in a Windows environment to make data collection easier. The precise data allows the computer to identify individual product stacks by acoustic signatures and automatically set the appropriate weld parameter. The plug-and-play utility reduces setup time and eliminates human error.


As with any other major purchase, it's necessary for companies to examine the many molding or assembly machines available before deciding what best meets current needs. It's also important to learn about what kind of support the manufacturer can offer in terms of maintenance, repair, and the ability to provide additional services as needs grow. However, with the many new options available, it certainly seems like now is a good time to start shopping.

Jennifer M. Sakurai is managing editor of MD&DI.

Several of the units described in this article will be exhibited at the Injection Molding & Plastics Processing Pavilion at MD&M East 99, to be held May 25–27 in New York City.

Copyright ©1999 Medical Device & Diagnostic Industry

Cover Products

Cover Products

Thermoelectric cooling semiconductor modules available in new configuration

A line of thermoelectric cooling semiconductor modules feature a porch configuration for easier installation and optimum solder contact. The 4-mm-wide ceramic porch extends between the positive and negative contacts, allowing for clean lead attachment and preventing accidental pellet contamination. Available in sizes of 40 x 44 or 30 x 34 mm, the Z-max modules are manufactured through a metallurgical process that produces a robust positive semiconductor chip, resulting in a temperature differential of 4°C. Applications include DNA thermocyclers, blood analyzers, blood reagent refrigeration units, therapy blankets, and devices without sufficient space for standard compression refrigeration. Tellurex Corp., 1248 Hastings St., Traverse City, MI 49686.

Company employs high-energy accelerators for electron-beam irradiation

A company provides gamma and electron-beam irradiation services to the healthcare products market. Its electron-beam facility in San Diego, CA, offers flexibility in processing, fast turnaround, and improved penetration through the use of two independently operated high-energy accelerators. The electron beam is bent 90°, maintaining tighter control of the beam energy. Applications include the sterilization of products and the cross-linking of polymers. SteriGenics International Inc., P.O. Box 5030, Fremont, CA 94537-5030.

Custom five-axis micromachining services for medical OEMs

An ISO 9002–certified company specializes in custom machining of miniature, submillimeter complex components. Using five-axis micro mills and eight-axis Swiss CNC machines, the company's capabilities include micro milling and grinding, CNC turning and milling, and micro laser cutting, drilling, and welding. Machined sizes of 0.5-mm OD, 0.13-mm ID, and 0.003-mm tolerances are achieved on titanium, stainless steel, brass, aluminum, engineered resins, and other materials. Services include micromachining prototype development and production for a variety of volumes, applications, and materials. Remmele Engineering Inc., Micro Machining Div., 17701 U.S. Highway 10, Big Lake, MN 55309-9430.

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Copyright ©1999 Medical Product Manufacturing News

Testing and Inspection

Testing and Inspection

Package-integrity test system

A package-integrity test system provides objective, nondestructive quality control for the sterile integrity of porous medical device packages. Suitable for use in package development, validation, and routine quality inspection on the production floor, the Sealcheck 210 system detects and reports the location of thin channel leaks. It features retrievable validation data and a graphic display. True Technology Inc., 143 California St., Newton, MA 02458.

Portable helium leak detector

Featuring an oil-free diaphragm and molecular drag pump, a portable helium leak detector works in cleanrooms, pharmaceutical manufacturing facilities, and other environments where contamination is a concern. Operation, calibration, and shutdown of the MS-40 Dry detector are fully automated, and the time from start-up to operation is less than 3 minutes. The unit's leak standard compensates for temperature, ensuring accurate measurements. The leak detector includes a 5-year warranty. Veeco Instruments Inc., Terminal Dr., Plainview, NY 11803.

Accelerated stress test system

For use on medical electronic products, an accelerated stress test system requires hours to reveal how a product will hold up during years of use. Stresses are placed on products through repetitive-shock vibration and temperature change rates that exceed 70°C per minute. The liquid-nitrogen-cooled chamber features high volume and adjustable air distribution to direct airflow rapidly over the product. Access to the internal chamber is provided through doors on the front and back of the unit. The vibration system uses a thermal isolation system to minimize thermal loading on the chamber. Up to 16 accelerometer and 8 thermocouple monitoring channels allow the user to see which stresses are being applied to the product, and the product test system electronically stimulates and monitors multiple product parameters while under stress. Thermotron Industries, 291 Kollen Park Dr., Holland, MI 49423.

Axial testing system

A system is suitable for testing medical devices and biomechanical constructs, characterizing biomaterial properties, and simulating biological forces and displacements. Designed to run fatigue cycles at frequencies up to 30 Hz, the 858 Mini Bionix II system can be purchased as an axial-only, an axial/torsional, or an axial/rotational system. It provides accurate testing under axial loads up to ±25 kN with standard displacements of ±50 mm. The system fits on a laboratory bench, and is available with a specially designed cart. MTS Systems Corp., 14000 Technology Dr., Eden Prairie, MN 55344-2290.

Capillary rheometer

Offering sophisticated material characterization, data analysis, and reporting capabilities, a benchtop capillary rheometer incorporates unique algorithms to allow the automatic determination of polymer-melt stability. For testing a wide range of materials, the LCR6000 benchtop rheometer uses a three-zone heater and an adaptive temperature-control algorithm to provide precise and uniform heat up to 430°C. Advanced electronics enable up to 45 shear-stress or shear-rate points to be obtained during each test. In addition, bidirectional communications enable test parameters to be downloaded from a PC. Dynisco Polymer Test, 115 Thousand Oaks Blvd., Morgantown, PA 19543-0709.

Leak tester

Featuring flexibility and simple setup and operation, a leak tester offers three inputs and three outputs to interface to PLCs or external devices. The Sentinel C-20 provides accurate measurement through an internal, NIST-traceable leak orifice for its automatic calibration routine. Inputs include a start and stop test and a programmable input, and outputs include accept, reject, and programmable output. The pressure-loss value, process drift correction, calculated leak rate, and accept/reject results are stored for up to 100 parts and can be easily viewed by the operator or output to a printer. Cincinnati Test Systems Inc., 5555 Dry Fork Rd., Cleves, OH 45002.

Seal-strength tester

An automated seal-strength package tester is available to produce quantitative data for compliance with the requirements of ISO 11607. The BT-1000 performs burst, creep, and creep-to-failure tests on porous and nonporous packages. Pouches, header bags, and lidded trays are among the package configurations that can be validated and controlled in the manufacturing process. The unit will also perform leak tests on seals for nonporous package materials such as foil or poly film packs. T.M. Electronics Inc., 330 Tacoma St., Worcester, MA 01605.

Lever-operated test stand

Capable of producing up to 750 lb of force, a lever-operated test stand allows for several years of repetitive testing. Measuring 6 x 8 x 26 in. and weighing 16 lb, the Model TSA stand can be supplied with an optional digital travel display and a horizontal or wall mounting kit. The rack-and-pinion mechanism allows for a total of 8½ in. of travel. Applications include material testing, sporing testing, peel testing, and product integrity testing. Mark-10 Corp., 458 W. John St., Hicksville, NY 11801.

Instrumented indentor

An instrumented indentor is one of five interchangeable platforms on a workstation used to measure mechanical strength. The indentor offers ranges from 1 g to 200 kg, and provides reports on hardness, elastic modulus, yield strength, maximum stress, and work-hardening constant. In addition, other platforms can be installed to measure tensile and flexural stress and strain, torque, adhesion, friction, and wear. The same platform can receive modules for five coating-adherence tests; three bonding-agent strength tests; torque, tear strength, and piercing tests; and microcircuit technology tests. Quad Group Inc., 1815 S. Lewis St., Spokane, WA 99224.

Testing and evaluating equipment

An engineering company produces testing equipment for medical device manufacturers. The company offers sharpness tests for needles and blades, leak tests, flow-rate measuring, product and methods development, and process validation. It specializes in the quality control of medical devices, including needles, syringes, catheters, and other products. Melab Medizintechnik und Labor GmbH, Gartenstr. 12, Fiolzheim 71292, Germany.

Universal testing systems

Powerful, compact benchtop testing machines determine tension, compression, shear, flexural, and other properties of metals, plastics, composites, rubber, wire, textiles, adhesives, ceramics, and other materials. S-series benchtop universal testing machines can also be used to analyze finished products, including IV tubing, hypodermic needles, latex gloves, scalpels, and other medical instruments. Five models of the machines are available. Machine features include a digital display of force and displacement during testing, a real-time autoranging graphic display, cyclic control of the force or strain extension between zero and a selected value, and storage and retrieval of test parameters. Tinius Olsen Testing Machine Company, Inc., P.O. Box 429, Easton Rd., Willow Grove, PA 19090-0429.

Air-leak tester

Featuring a main unit and up to four intelligent detector modules, a leak tester is capable of synchronous and asynchronous testing. The Model Q6000 air-leak tester's detector modules can be connected to the control unit from up to 100 ft away, and can store up to 10 programs each. Each gas box functions independently of the others, regardless of its power or operational status. Program editing or removal is password protected at the control unit. For each leak test, the system provides a graphic display of test status and pressure profiles. ITI Qualitek, 267 Boston Rd., North Billerica, MA 01862-2310.

Strain viewer

A large-field polariscope strain viewer is used for the quality control of all types of transparent polymers. Manufacturers can set up the unit horizontally or vertically to view the residual strains in their products. Quantitative measurement of retardation and birefringence can be obtained with an optional compensator. The SV-2000 unit's testing methods are nondestructive. Strainoptic Technologies Inc., 108 W. Montgomery Ave., North Wales, PA 19454.

Leak and flow tester

Combining simple operation and setup with several advanced features, a leak and flow tester allows users to customize test programs to meet specific requirements. The Sprint-1100 system includes a pressure-plot graphic display and data-logging capabilities for RS-232 and PC memory cards. In addition to its multiple testing capabilities, the system also performs statistical analysis of test results. At a single test station, users can test multiple components that have different configurations. Uson, 5215 Hollister, Houston, TX 77040.

Microbial air samplers

A line of lightweight, portable air samplers provide repeatable results in maintaining a contamination control monitoring program. The standard RCS centrifugal air sampler offers reliable results when simple monitoring is required. The RCS Plus samples 50 L of air per minute and functions in laminar-flow areas. Capable of sampling 100 L of air per minute, the RCS High Flow features removable components and includes an infrared remote control with a keypad and integrated display. All the samplers use Hycon agar media strips to ensure accurate results. Biotest Diagnostics Corp., 66 Ford Rd., Ste. 131, Denville, NJ 07834.

Pneumatic leak tester

Capable of testing parts of different sizes and changing internal volumes, a pneumatic leak tester minimizes the required cycle time for each part tested. The System 100 leak tester features a mass-flow test method, which provides a direct readout of leak rate regardless of the part's internal volume. The unit's plumbing pneumatics are contained in a compact manifold with pilot-operated valves, eliminating many fittings and connections and providing a leak-free system. The tester can operate on a stand-alone basis or can be integrated into a fully automated assembly. Phase One Instruments, Div. of Vacuum Instrument Corp., 3203 Plainfield Rd., Dayton, OH 45432.

Dual-channel leak detector

By simultaneously testing two parts or conducting different tests on the same part, a dual-channel leak tester enables manufacturing companies to use only one tester for multiple tasks. The unit features extended memory and retains more data than earlier models, saving up to 1000 test records for display. Measuring 6.54 x 12.63 x 15.75 in., the unit can be incorporated easily into automated assembly and test systems. Offering cycle times from 0.3 to 2 second on test-part volumes up to 25 cm3, the M-1075 leak detector has a sensing range of up to 80 cm3 per minute at test pressures up to 100 psig. The system offers PC or PLC compatibility for interfacing with machine controls, data highways, or host computers. Intertech Development Co., 7401 N. Linder Ave., Skokie, IL 60077.

Case inspection system

A compact, high-speed case inspection system detects missing, empty, or broken containers in opened or closed cases. The FT-100 system can also detect grossly underfilled containers and cases that have absorbed the spilled contents of a broken bottle. The inspection head houses a radiation source and detector system that measures the relative density of the case as it passes through the inspection zone. The system can inspect cardboard, paper, plastic, or wood cases on fixed- or variable-speed lines. Several tunnel widths are available, and the system can be installed on existing production lines with minimal modifications. Industrial Dynamics International Inc., 2927 Lomita Blvd., Torrance, CA 90505.

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Copyright ©1999 Medical Product Manufacturing News

Desktop Workstation Performs Small-Scale Laser Welding


Desktop Workstation Performs Small-Scale Laser Welding

Compact unit welds metallic parts and solder reflow

EQUILASERS INC. (Sunnyvale, CA) has introduced a self-contained laser station for spot welding, seam welding, wire welding, and reflow soldering. The system sits on a bench with a footprint of approximately 3 x 5 ft. At the workstation's core is the Equilaser EDW-15, a 15-W Nd:YAG laser welder.

Designed for R&D and production quantities, the Equilaser EDW-15 laser welding station conserves costly floor space and operates on 20-A, 110-V ac current.

The unit's high-magnification vision system uses an optical fiber and viewing assembly to focus the welding beam on a small spot while providing through-the-lens video monitoring of the workpiece. A step motor–driven lathe is included for precise circumferential welds. For processing that requires the presence of inert gas, the unit includes a gas-handling system with flow rate adjustment.

The workstation also includes a video system with a miniature high-resolution color camera and monitor. The camera lens configuration has a magnification of up to 80x with a spot size as small as 80 µm. The laser's power is up to 15 W, the peak power is up to 3 kW, the pulse-width adjustment is up to 10 milliseconds, and the spot size can be as small as 40 µm.

For more information, call Equilasers Inc. at 408/734-2700.

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Program Aids in Timely Equipment Calibration

Organizes, maintains, and retrieves records

TO ASSIST DEVICE COMPANIES with efficient management of GMP and other equipment calibration requirements, Blue Mountain Quality Resources (State College, PA) introduced Calibration Manager software for Windows. The system can help companies discover calibration problems early and prevent the use of uncalibrated equipment. In addition to providing automatic calculation of due dates and printing calibration schedule reports, the program also tracks histories and preventive maintenance.

The Equipment Master file feature has more than 50 fields to track specific information about each piece of equipment. Using the Equipment Master file, companies can schedule calibrations, assign calibration forms, track standards, designate calibration features, and quickly view the equipment history.

Calibration Manager tracks due dates and histories and prints calibration schedule reports.

The system's customizable report writer allows users to modify standard reports as needed; print reports to the screen, to a printer, to other software packages, and to HTML; and create and print calibration labels and bar coded labels. To ensure data integrity, the system employs passwords or security levels to limit access. Also, the system has a feature to track data changes by creating an audit trail.

For more information, call Blue Mountain Quality Resources, at 814/234-2417.

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Multipolymer Compound Exhibits Lipid Resistance

Suitable for injection molding a variety of medical devices

A TRANSPARENT, impact-modified, acrylic-based multipolymer compound manufactured by CYRO Industries (Rockaway, NJ) is resistant to lipids and PVC plasticizers. When sterilized at typical gamma irradiation levels, Cyrolite CG-97 does not show property deterioration and does not yellow but shifts to a permanent blue-green tint. The material can also be sterilized with EtO without adverse effects.

Developed for applications requiring chemical resistance to lipids and PVC plasticizers, Cyrolite CG-97 exhibits clarity after gamma radiation (85%).

Because the material can be processed at low temperatures, it is appropriate for use in thin-walled devices, applications with multicavities, and other difficult-to-fill parts, such as filter housings, luer locks, IV connectors, and accessories. Cyrolite CG-97 can be processed in all types of injection molding presses and is readily adaptable to tooling designed for styrene, vinyl, ABS, and polycarbonate.

For more information, call CYRO Industries at 973/442-6000.

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Copyright ©1999 Medical Product Manufacturing News

Plastics Processing to Be Highlighted at MD&M East

Plastics Processing to Be Highlighted at MD&M East

Exposition will showcase latest manufacturing technologies

This year's Medical Design & Manufacturing (MD&M) East 99 Exposition, May 25–27, will include an Injection Molding and Plastics Processing Pavilion, which will feature more than 100 of the medical industry's top providers of plastics-processing equipment, materials, and services.

In addition to resin suppliers, the pavilion will showcase injection molding equipment, extrusion lines, hot-runner systems, robotics, software, and test and inspection devices. Mold makers, custom assemblers, and processors of medical plastic, rubber, and silicone parts will also be participating in the pavilion.

The MD&M East Conference and Exposition will be held at the Jacob Javits Convention Center in New York City. Other featured pavilions will display packaging, labeling and bar coding, design software and rapid prototyping, medical electronics, in vitro diagnostics, and business expansion services. More than 700 suppliers and service providers will be exhibiting at the exposition. MD&M East is colocated with the Atlantic Design Engineering Show.

Product design and development firm Axiom (Charlotte, NC) will be displaying the BDProbeTec ET, an in vitro molecular diagnostic device, at the Injection Molding and Plastics Processing Pavilion. The device was developed through a design partnership between Axiom and Becton Dickinson Microbiology Systems (Sparks, MD).

Returning to MD&M East for its second year, the Medical Design Excellence Awards display will feature the finalist and winning devices for this annual medical product design and engineering competition.

The technical program will include courses on quality systems, process validation, designing effective devices, and materials and plastics processing. The Pharmaceutical and Medical Packaging Symposium will include three days of sessions focusing on validation and materials.

For more information, call 310/445-4200.

Motion Control Expo Slated for May

International Robots and Vision Show to colocate

The Cobo Convention Center in Detroit will be hosting the Motion Control Expo May 11–13. The expo will cover pneumatic, hydraulic, mechanical, and electrical motion control technologies. An executive-level conference track, "Automation: The Competitive Enterprise," will include tutorials and technical sessions on trends, techniques, and technologies. The American Institute of Motion Engineers will also be present and will sponsor technical courses during the expo.

Boy Machines Inc. will be showing its smallest-capacity cleanroom production injection molder at MD&M East. The 14.2-tn unit features fully closed loop microprocessor control.

Colocated with the Motion Control Expo, the International Robots and Vision Show will include 150 exhibitors and 100 conference presenters who will address improving product quality, decreasing manufacturing costs, increasing production uptime, and reducing scrap, rework, and product returns. For more information, call 800/331-5706.

Business & Acquisition News

Multinational testing laboratory NAMSA (Northwood, OH) is now being represented by Medical Engineering Technologies Ltd. in the United Kingdom. West Pharmaceutical Services (Lionville, PA) is the new name for The West Co. The new name reflects the integration of the firm's elastomer, metal, and plastic technologies into the next generation of healthcare product development. Bayer AG, Leverkusen, Germany, and DSM, Heelen, Netherlands, have reached an agreement under which Bayer will acquire DSM's global transparent sheet business. Meier Tool & Engineering Inc. has relocated to a 33,000-sq-ft facility at 875 Lund Blvd., Anola, MN. The expansion will allow the firm to offer increased production capabilities, as well as expand its design and tooling departments and rapid prototyping services. Contract electronic manufacturers SMT Dynamics and Blackfox Technology Group have combined to form Emsource LLC which will have facilities in Longmont, CO, and Anaheim, CA.

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Copyright ©1999 Medical Product Manufacturing News

The Digital Experience

The Digital Experience

A key component from Clare Micronix enabled General Electric to take ultrasound imaging to new depths.

Sally Lane, MPMN Senior Editor

As any music lover knows, the sound quality of a compact disc is generally superior to that of a cassette tape. This is because a compact disc relies on digital technology, while the cassette tape is based on analog technology. The advantage of digital technology is that once the "value" of the data being used is determined, it can be copied, stored, reproduced, or modified without degradation.

The same digital technology that has been used to improve everyday consumer items such as wristwatches and computers has also been applied to the healthcare industry. In particular, digital technology is being used in ultrasound machines to help them capture clearer real-time images.

Digital Technology

The key components in all digital products are an analog-to-digital convertor and a digital-to-analog convertor (DAC). Digital ultrasound technology would not be possible without the use of hundreds of application-specific integrated circuits (ASICs) that conduct these conversions. Since 1991, Clare Micronix Integrated Systems Inc. (Aliso Viejo, CA), a manufacturer of analog and mixed-signal solutions, has been developing digitally synthesized transmitter ASICs for General Electric, a manufacturer of ultrasound systems. Using Clare Micronix ASICs, GE was able to develop the LOGIQ 700 MR, the first fully digital 128-receive-channel digitally encoded ultrasound system.

The latest generation of GE ultrasound systems relies on hundreds of application-specific integrated circuits (ASICs) to provide clearer, digital images.

Building a Better Chip

In conventional systems, deep ultrasound penetration often means decreased resolution. To resolve this problem, "There were three primary functions GE needed on the chip," says Craig Stodart, a senior design engineer at Clare Micronix. GE needed the chip to operate at very high speeds of 10 nanoseconds, they needed a high-power chip, one that could produce a 12-V, 0.1-A pulse, and they needed a chip that was programmable. "These functions would allow GE to continuously modulate both the amplitude and the timing of the pulse being sent to the transducer to produce the ultrasound signal they wanted," Stodart says.

The result was the P5 transducer driver pulser chip. "Our chip is a mixed-signal chip—it has both analog and digital functions. The digital portion allows the chip to communicate with the channels in the ultrasound system, while the analog portion acts as the interface between the chip and the transducer sensor," Stodart explains. "The chip converts a set of image input values into controlled current pulses and sends them out to the ultrasound transducer."

How Ultrasound Works

To form an ultrasound image, an ultrasound waveform is transmitted and focused along a single beam, or vector, and the ultrasound energy reflected from a patient is collected and focused so that the received signal can be used to form a picture of an object. Once this single beam is collected, the ultrasound imager repeats the operation, collecting a series of beams that can be reconstructed into a two-dimensional image.

The ultrasound energy is controlled by applying time delays to each element of a multiple-element transducer. The sound waves, or signals, from the various elements must be delayed so that they all arrive at the focal point at the same moment. A similar beam formation must be done on reception. The precision with which all of these delays are done—whether on transmission or reception—determines the precision with which focusing can be done. Any miscalibration of the delays will result in image artifact.

"In the old systems, the only control you had over the transmitter was to turn it on and off," says Greg Lillegard, lead design engineer at GE. "These [P5] chips, instead of just allowing us to have on-off sort of controls, give us detailed control over the signal."

Prior to digital ultrasound, the returning electrical pulses were coordinated with analog circuitry, with a great deal of signal processing occurring before the image had been digitized. In the new ultrasound systems, a digital beam former digitizes the acoustic signal returning from the tissue immediately, before the time delays occur, so that the time delays and the summation that follow it can be done with digital electronics.

Digitizing the signal this early in the imaging chain helps guarantee signal integrity, permits much greater precision shaping the ultrasound beam, and gives the system a great deal of flexibility, allowing reprogramming of the size, shape, direction, and intensity of the beam.

The Reengineered ASIC

Each P5 chip in the LOGIQ 700 ultrasound system drives two channels. Each channel, which consists of a transmitter and a receiver, can be thought of as a tiny separate system providing data on a single location in the body, Lillegard says.

The ASIC Clare designed for GE can operate at speeds of 10 nanoseconds and produce a 12-V, 0.1-A pulse.

The chip, or transmitter, sends out a signal that travels to the transducer, which in turn emits a pulse that travels to the patient. The pulse hits the targeted site and emits a signal, or echo, that travels back to the transducer where it registers as an electrical pulse. This pulse, or signal, is then sent to the receiver where it is processed, Lillegard explains.

In order to provide larger-aperture images with uniform depth of field, more transmit-and-receive channels were necessary, as were the flexibility and speed to generate multiple focal zones that could be varied over depth while keeping the image focus uniform. "ASICs allow us to have more channels, and more channels give you a higher-fidelity image," Lillegard says. As a comparison, older ultrasound systems have 48 to 128 channels, whereas the new systems have 1024 acquisition channels.

The Design Process

For Clare Micronix engineers, the first step in designing the chip was to choose a process that would allow them to create an integrated circuit. "The process we chose was a 12-V, 4-GHz complementary IC process," Stodart says. Each chip contains a timing-control circuit, a high-power driver, which drives the pulse out to the ultrasound sensor, and a high-speed DAC.

Without the use of ASICs that combine several functions on one chip, such technology would not be possible because the number of chips needed to drive the machinery would be too cumbersome, Stodart says. "The idea behind the P5 transducer driver pulser chip was to take as much functionality as possible and put it on one chip," he says.

As for the future, Lillegard notes, "As more processing capability is built into systems, there will be more and more channels, and ASIC technology will continue to provide us with the capability to improve the ultrasound image."

MPMN is seeking success stories like this. If your company has one to share, please contact managing editor Karim Marouf at 11444 W. Olympic, Ste. 900, Los Angeles, CA 90064-1549; 310/445-4200 or e-mail

Return to the MPMN home page.

Copyright ©1999 Medical Product Manufacturing News

Changing the MenuA New Source for Business Information

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI April 1999 Column

Of all the sessions at the 1999 HIMA annual meeting, the final panel discussion was perhaps the most vibrant—a free-wheeling exchange that touched on business topics ranging from venture capital and IPOs to valuation and exit strategies, supply-chain issues, mergers and acquisitions, co-marketing possibilities, and other strategic alliances. Several panelists raised the subject of innovative cooperative ventures between large and small companies: for example, a big company buying a stake in an exciting new technology, or a small company making a deal to secure market access. There was much talk about lions and lambs turning in together, until one panelist reminded the audience of Woody Allen's commentary—that the lion may lie down with the lamb, but the lamb won't get much sleep.

The vigilance required to remain a viable partner as opposed to a lamb chop can be used to characterize the myriad pressures that smaller device companies—often referred to in these pages as the heart and soul of the industry—face in today's market. From constricted distribution channels to a retreat of investors spooked by the less-than-stellar performance of recent public offerings, the barriers that inhibit small companies from creating value and growing over time seem to be increasing. Even those companies that manage to get a compelling new product onto the market—the most difficult task of all—often succumb to capacity problems in striving to meet subsequent production and distribution demands.

For public companies, scrutiny is unrelenting, and the slightest misstep can have dire consequences. "You have to keep all your promises," said panelist Casey McGlynn, chairman of the life sciences group at Wilson, Sonsini, Goodrich & Rosati. "Companies have no leeway. If anything at all goes wrong—the least burp—the baby gets thrown out with the bathwater. Today's market is a very difficult place if you have insignificant revenues or miss your numbers."

Although the current state of the industry thus places a premium on specialized business skills, many device executives are more adept at designing a product modification or clinical trial than they are at putting together a competitive business plan. Because access to essential business information is so critical in today's complex and unforgiving environment, Canon Communications, publisher of MD&DI, has announced the creation of a new publication devoted exclusively to the business needs of top-level medical technology executives.

With its first issue scheduled to appear on June 15, Medical Device Executive Portfolio will offer in-depth business analysis and essential market strategies to 15,000 readers with direct responsibility for corporate planning and finance, marketing, business development, regulatory and legal affairs, management information systems, advertising, distribution, and sales. Feature articles in these areas will be supplemented by business resource guides to professional services in a variety of fields, including advertising and communications, financial planning, import/export support, intellectual properties, management consultation, recruitment services, technology transfer, reimbursement strategies, and many others.

For information about Medical Device Executive Portfolio, contact its editor, Steve Halasey, at 310/445-4274 or As always, MD&DI will continue to provide pertinent business information and industry analysis within the context of its wider coverage of all aspects of device development. But this new offering should add some serious muscle to a few lambs.

Jon Katz

Copyright ©1999 Medical Device & Diagnostic Industry

Global Harmonization and Mutual Recognition Efforts:Keeping Up The Pace

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI April 1999 Column


An executive specializing in international regulatory affairs assesses the current movement toward globalization and identifies key areas requiring the most urgent action.

In both the drug and device industries, we are seeing significant movement toward bringing international regulatory systems in line with one another. But many Americans continue to wonder whether we, as industry members and as a country, are ready to move along this road, and if so, how fast and how far should we go? What are the various tools we can use to reach the desired destination, and what is the role of each? Does any of this diminish the role of FDA in protecting the health of the American public?

My thoughts on these questions reflect the perspective of a company that operates in more than 120 countries, producing implantable, critical-care devices that are subject to the most stringent controls of a wide range of regulatory systems. They also reflect my observations regarding what is happening around the world in the broader context of healthcare delivery.

The first question that must be answered is whether there is solid justification for moving toward harmonization. For an answer, we must take stock of today's medical environment. First of all, medical technology manufacturers such as Medtronic are now developing products to meet the demands of patients and the medical community in a global medical marketplace. In addition, in all countries, the pressure to control healthcare costs is growing. Because the proliferation of divergent regulatory systems significantly slows the dissemination of new technology across borders and increases total healthcare costs, the world is naturally progressing toward globalized regulatory requirements.

If harmonization of medical device regulation is occurring naturally, the real issue thus becomes a question of where that process should be leading us. The end result must be able to keep unsafe medical devices off the market. But this doesn't mean that a system like FDA is needed. In fact, FDA-like regulatory systems are inappropriate and impossible in most countries, especially those in Asia. All developed nations are rapidly moving toward the same level of sophistication when it comes to the evaluation of medical devices, be they Class I, II, or III. The European Union (EU) has created a regulatory mechanism that ensures the highest level of safety for patients, while quickly moving beneficial products to the market. The EU has already established a very credible review system for medical devices through efforts such as basing the process on quality system standards, using the world-class, globally recognized ISO 9000 series of standards.

In fact, as countries update their regulatory procedures, most are following the lead of Europe. The EU is aggressively pursuing mutual recognition agreements (MRAs) with many non-EU partners, including Switzerland, Canada, Australia, and some Asian countries. Even without an MRA with the EU, some Asian countries, notably China, are unilaterally adopting an EU-style regulatory approach. The United States cannot remain insular; the world is moving ahead, and we cannot afford to be left behind.

I want to be clear that I believe we need a strong FDA that has the confidence of the American people. But I do not believe that globalization of medical device regulation—including both a move toward harmonization and the achievement of device MRAs—is in conflict with protecting the sovereignty of the United States or the ability of FDA to carry out its mission. We cannot reach our goal overnight, but we need to keep progressing, and FDA must continue to play an active role in the process. There are places we can start right now, and there are other areas that need enhanced industry support.

I'd like to suggest five such areas in which global harmonization efforts should be focused. They are:

  • Moving ahead quickly regarding an MRA with the EU, particularly on quality systems.
  • The acceptance of a universal data set for clinical trials.
  • The recognition of international performance standards.
  • Steady progress toward an MRA with the EU on product approvals done according to a manufacturer's own country's requirements by accredited third parties, starting with 510(k) devices.
  • The acceptance by regulatory authorities in Asia of a common dossier.

A brief review of these five areas will perhaps offer some justification for my thoughts. First, with regard to reaching an MRA for quality system standards, FDA deserves significant credit for progress made in this area. The agency's new quality system regulation (QSR), which replaces good manufacturing practices (GMPs), is nearly identical to ISO 13485/13488. Both are based on a quality system approach, a concept that did not exist when GMPs were first developed, and both ensure a higher degree of product quality than ever existed before. FDA's new QSIT inspection program is another positive development. The agency should continue to be open to new approaches and to learning, and not push its own system. Given these developments, the MRA and harmonization can move ahead quickly. Both efforts are important. The MRA can help the harmonization effort by bringing together FDA and the EU, including industry, resulting in confidence building, learning, and longer-term benefits.

I have emphasized the quality systems portion of the MRA, because it is so fundamental for worldwide harmonization and for assurance of device quality. Any new regulatory scheme should be established based on the ISO 9000 series, not on local testing, extensive dossiers, or local requirements that are out of step with international practice.

The second area for action is the need to move toward a universal data set that will satisfy worldwide clinical requirements. Two factors weigh strongly in favor of this goal. In the area of clinical research, most of what is being done in Europe is widely accepted in this country. In fact, European research now makes up the majority of papers presented at many leading medical conferences, and, most importantly, FDA routinely accepts clinical data from European trials in product approval submissions. The other factor is that any company involved today with developing a Class III product tries to create one set of data that can be used universally for all regulatory bodies—the only way to cost-effectively develop clinical data. However, in doing so, manufacturers often exceed the requirements of any one regulatory authority, and presenting the data differently in numerous submissions is not cost-effective.

We should begin discussions aimed at achieving a harmonized clinical philosophy under which the boundaries of clinical data collection are properly defined and agreed upon, including harmonization of clinical controls. Frankly, this means recognizing, as Europe and various nations have done, that certain data—most importantly, data on cost-effectiveness, relative effectiveness, and medical outcomes—should not be required as part of the product approval process unless explicit claims referring to such are being made. This kind of data is important and has an increasingly appropriate role in healthcare delivery, but not in product approval.

The third area requiring immediate action concerns the recognition of consensus performance standards. These standards—designed with the input of industry, government (including FDA), and medical professionals—represent state-of-the-art norms for ensuring the safety of medical devices. They are developed at both the international level, by groups such as the International Electrotechnical Commission and the International Organization for Standardization, as well as by groups like the European Committee for Standardization in Europe and AAMI, the American National Standards Institute, and the Underwriters Laboratories in the United States. The standards can be horizontal, applicable to all devices across the board, or vertical, covering only a specific device or type of technology.

Recognition of consensus standards is important because they ensure that products are evaluated according to the best possible criteria. Standards also produce a transparent system, under which manufacturers can know the relevant criteria during the product development process, which increases the efficiency of review. The rapid acceptance of the European regulatory system as an efficient and credible process can be traced in large part to its reliance on consensus standards, together with a procedure for company declarations of conformity.

Domestically, FDA deserves credit for its willingness to move forward, as with the QSR. One of the things to come out of FDA-reform discussions in the last Congress was an agreement by FDA, Congress, and industry that recognition of international standards makes sense and should be a part of any legislative reform. Here, again, FDA deserves credit for acting quickly in this area following passage of the FDA Modernization Act in late 1997. FDA has worked with the National Electrical Manufacturers Association on a pilot program under which FDA accepts certification of compliance with identified consensus standards, such as IEC 601-1 (the safety standard for electrical medical equipment), as part of the 510(k) process. This pilot program has reduced product review times by as much as 50%. Expanding recognition to the fullest extent possible, as FDA is now doing, is critical to moving toward true harmonization.

The fourth area I would like to examine is both an occasion to urge continued progress and a statement of the goal to which I believe we must aspire in our harmonization efforts. The ultimate objective must be a comprehensive MRA covering product approvals for 510(k) devices. The building blocks are already in place, or close to it. They include the acceptance of consensus performance standards, an agreement on quality system regulation, and the accreditation of third parties—including some European notified bodies—as part of FDA's pilot project for the performance of product review functions. These three elements would produce a U.S. system for device regulation closely mirroring that of Europe. Both systems could then ensure the highest degree of device safety, while at the same time providing better, more timely access to advanced therapies for the patients who need them.

A series of recent MRA discussions between the EU and FDA have provided opportunities to get this process on the proper footing. I believe these discussions should be aimed at producing an MRA that focuses on the points I have specified: mutual recognition of quality system regulation for all devices, adoption of consensus performance standards, and mutual recognition of approvals by third parties for 510(k) devices.

The final area I want to emphasize is the need for harmonization in Asia. The current situation in Asia is reminiscent of the messy regulatory landscape of Europe in the late 1980s. Each country is developing a unique approach to device regulation, comprising various mixtures of local testing, different data requirements, different products regulated, and, inevitably, too few staff. The result is a fast-growing problem of regulatory overkill, proliferation of divergent requirements, and product-introduction delays. And while there is no convenient organization such as the EC for Asia, HIMA has organized an Asian Harmonization Working Party consisting of regulatory authorities and area managers of U.S. companies. This group should now serve as a forum for discussion of Asian harmonization, including acceptance of a common dossier and ISO 9001 certificates. We can also work on this problem with the assistance of the U.S. government in regional organizations such as Asia Pacific Economic Cooperation (APEC).

The environment is right for efforts between government and industry to produce real progress in these areas. If this comes to pass, both patients and the enterprise of medical research will surely benefit.

Fred S. Halverson is vice president of international regulatory strategy and reimbursement policy at Medtronic Inc. (Minneapolis).

Copyright ©1999 Medical Device & Diagnostic Industry

Careful Study Marks Henney's First Months : Burlington "Will Be Missed Severely" : "Least-Burdensome" Device Rules Discussed : At Least Have a Plan, Says FDA : Few Takers for New 510(k) Paradigm : Could MedWatch Form Revision Hurt Y2K?

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI April 1999 Column

The new FDA commissioner plays it close to the vest while expressing a willingness to work with the industry.


  • Burlington "Will Be Missed Severely"
  • "Least-Burdensome" Device Rules Discussed
  • At Least Have a Plan, Says FDA
  • Few Takers for 510(k) Paradigm
  • Could MedWatch Form Revision Hurt Y2K?

In sharp contrast to her predecessor, who hit the deck running and quickly grasped all media opportunities to promote his agenda, new FDA commissioner Jane Henney has kept a low profile as she has carefully studied the state of the agency during her first few months in office.

Some of Henney's conduct is certainly due to native reserve and caution, but some has been forced on her by circumstance. She is rediscovering an FDA that has far fewer resources than the one she left in 1994, after serving as David Kessler's deputy for operations for two years. She has also found that all parts of the agency are fully engaged with implementing the FDA Modernization Act (FDAMA), which is her publicly stated top priority. And she has doubtless realized that FDA's command structure—in the political vacuum left by Kessler's departure—was "occupied" by the HHS Office of the Secretary, leaving it with less autonomy than top managers had been used to having when Kessler was there.

On top of all this, Henney's practical ability to effect immediate changes in the agency's top management has a new limitation with which Kessler never had to contend. The Treasury Employees Union has taken over the agency's career employees and must be negotiated with concerning all organizational and process-based planning.

As part of her refamiliarization with the agency, Henney in December visited FDA's Denver district office and then spoke with members of the local medical device industry, under the auspices of the Colorado Medical Device Association (CMDA), at a meeting held in the law offices of Chrisman, Bynum & Johnson in Boulder. During a 25-minute question-and-answer period, Henney hedged most of her responses by reiterating her need to gather more information. She was well equipped, however, to field a question about the industry's reported tendency to move R&D offshore to gain faster approvals—as, for example, Medtronic was said to have done with at least 15 products.

Henney replied that there was undoubtedly more to this offshore trend than the timeliness of the review process, citing two recent examples of devices that had been approved by FDA and marketed within a few months of submission.

To a question about FDA's budget, Henney noted that some parts of the agency were well funded by user fees whereas others were short of resources. She maintained that, before making any recommendations, she would have to study the matter further to see where additional resources were most urgently needed. Henney also begged off when asked about device reprocessing, saying she would check into this area to learn what was going on. And when asked by CMDA president Dick Hanson about the possibility of combining FDA and EU requirements to ease the burden on industry, Henney again said she needed time to catch up on the issue.

In general remarks to CMDA, the new commissioner expressed her willingness to continue FDA's cooperation with the medical device industry. She particularly noted the importance of carrying on the progress of the joint FDA-industry task force that has been working on the agency's grassroots regulatory partnership program.

CDRH director Bruce Burlington, who left the agency in mid-March, "will be missed severely," according to Health Industry Manufacturers Association executive vice president James Benson. Burlington, an 18-year FDA veteran, is leaving to head up regulatory affairs at Wyeth-Ayerst Pharmaceuticals in Philadelphia. He is credited with reorganizing FDA's generic drug program after it succumbed to scandal in the late 1980s, with leading internal efficiency efforts in the review of drugs and devices, and, as CDRH director since 1993, with cutting review backlogs and increasing productivity by 40%.

Benson commented that Burlington was sometimes accused of implementing a drug model for devices, but noted that, overall, "I don't think we were at odds," and called Burlington's term at CDRH "good for industry."

What is FDA expected to make of Congress's industry-cheered directive in FDAMA section 205 enjoining the agency to consider the "least-burdensome" means of assuring that medical devices are effective enough to go to market? Following a January 4 meeting requested by the device industry to discuss this provision of the law, CDRH's Office of Device Evaluation (ODE) is waiting to see if industry will produce a draft guidance document, as promised, before drafting one of its own.

"We had a very successful meeting," says ODE director Susan Alpert. "Many of the FDA people who were there listening told me they learned about industry concerns that they weren't sensitive to before. They know industry wants something that can be looked at, referred to, relied on, and discussed."

Alpert said that the specific design of a document was not discussed. She did mention one possibility: a flowchart that would raise questions FDA staff should consider in determining, first, what evidence is really needed for any particular device, and second, what is the least-burdensome way to obtain the evidence required to make a decision.

Alpert's assessment of the meeting was echoed by HIMA executive vice president James Benson and Medical Device Manufacturers Association (MDMA) executive director Stephen Northrup, both of whom said they believed the agency better understood industry concerns and showed a willingness to consider them.

Disagreement continues, however, over FDA's arm's-length policy of not sitting down with industry to work out the nuts and bolts together. The January 4 meeting, for instance, focused on industry concerns and the ways those concerns could be addressed, not on specific language that might go into a guidance document—even though, according to MDMA's Northrup, Alpert acknowledged the possibility of inconsistencies among individual reviewers as to what studies may actually be needed to make a determination concerning effectiveness for a particular device. Benson stated that he hopes commissioner Jane Henney will revisit this policy; Northrup also said he did not like the policy but that it was too late to do anything about it, since almost all materials that could have been discussed collaboratively if the policy had not been in place are now in the pipeline.

"We've done it this way because sometimes not everyone can get to the table for discussion for a variety of reasons," Alpert explained. "Our thinking has been that it's best if the agency puts something out in writing, and then everyone who is interested has equal access to it and equal opportunity to comment, to influence the decision, to have an impact."

Benson volunteered for HIMA to take the lead in forming a working group of all interested parties (except FDA) to discuss what could go into some form of guidance document and then to submit such a document to FDA. Alpert said the agency would be happy to receive such a draft "straw man" and would consider its contents during the creation of whatever will be produced. "If we hear that industry isn't going to produce something, then we will go forward and put our ideas down and put them out for comment," she continued.

While there seemed to be agreement on basic themes at the meeting, differences of opinion did arise. David Sampson, appearing on behalf of the Blue Cross/Blue Shield Association and its Technology Evaluation Center, cautioned against weakening current standards for premarket approval (PMA) devices and asserted that an industry-led task force is "not warranted or appropriate. FDA is the proper body to design process improvements should they be needed."

FDA, Sampson said, must "maintain and perhaps even strengthen its standards for evidence of clinical effectiveness to ensure that FDA-approved technologies provide clinical benefit to patients."

Northrup countered that industry does not desire to "weaken or subvert the gold standard of FDA or the high regard in which it is held around the world" but only wants FDA to require use of the least-burdensome means of meeting existing standards. Benson said he will invite Blue Cross/Blue Shield to participate in the working group if they are interested in contributing to a draft guidance document rather than in trying to prevent such a document from being developed.

After the meeting, Alpert commented that some industry representatives who spoke seemed to believe that standards could be changed or that the agency had to justify its requirement for particular types of trials. Her response, she said, was that the agency does not read the law that way.

Scottcare Corp. (Cleveland), manufacturer of the Tele-Rehab II cardiopulmonary monitoring system, received one of the few warning letters sent by FDA to companies not making progress in coming into compliance with the new quality system regulation. "The letter covered all design controls," Cincinnati district compliance officer Lawrence E. Boyd said. "They basically had nothing in place. They hadn't changed anything."

Boyd said that companies hoping to avoid warning letters more than six months after the new regulation took effect should at least have drafted procedures explaining what they will do to come into compliance. "They should have a plan to describe what they're going to do and specifications for how they will change a design if that's needed."

Why aren't device companies jumping at the chance to submit less rather than more data under CDRH's premarket notification (510(k)) paradigm? An internal agency task force has convened to find ways of jump-starting this innovative program, under which the center is accepting reduced-data "special" 510(k) device modification submissions bearing declarations of conformance to design controls and recognized standards. The paradigm also allows "abbreviated" 510(k) submissions for new devices with summary data and conformance declarations to recognized standards or an agency guidance.

One criticism CDRH has heard about its new program is that conformance to standards is required at the time of submission, something that may not be practical for certain devices.

CDRH's Office of Science and Technology director Harvey Rudolph agrees. He says that for certain products—like diagnostic imaging devices—FDA will probably allow manufacturers to simply certify that the devices will conform to standards once they come off the assembly line.

For years, the center has accepted 510(k)s for these types of products based entirely on the design of the device, and Rudolph says there are many other devices that can fit into this category. The details are still being worked out in the center, but Rudolph is confident that this approach will be adopted and should help with more paradigm submissions.

Center officials speculate that many in industry are still not aware of the paradigm program, and CDRH will look to increase its communications outreach, educating manufacturers on the benefits of abbreviated and special 510(k)s. Conformance to standards is also available to PMA application submitters as a result of FDAMA, Rudolph says.

Industry may be reluctant to test the new waters because of concerns that a submission could influence an FDA investigator to audit data related to the declaration of conformance. Rudolph says that whereas a few special 510(k)s were audited recently, most of the investigations were part of routine scheduled inspections. He doesn't expect conformance declarations to trigger an inspection—rather, the majority of audits will be tacked on to scheduled quality system inspections.

Rudolph anticipates an upswing in new paradigm submissions now that FDA has recognized additional standards. Although the first group of standards probably did not result in a significant reduction in submitted data, Rudolph says that the second group will definitely bring about substantial cuts. Submissions incorporating these latter standards will probably be seen beginning in about a month.

Because revisions to FDA's MedWatch Form 3500A, proposed by the agency last November, are not "critical" and would produce only marginal benefits, if any at all, FDA should defer the rule-making process until after industry has emerged from the Y2K crunch, HIMA urged in January 11 comments.

Many companies have invested in computerized versions of form 3500A that would require significant time and resources to modify to the new format, HIMA argued. The process would be further complicated by integrated computer links to other company operations. "For example, some companies have established a searchable database that will automatically retrieve information located in specific boxes of former 3500As that have been completed and submitted to FDA," the association said. The new format would make the databases useless.

HIMA gave another example, one involving computer programs that directly transfer complaint-handling system data to a computer-generated form 3500A. Significant reprogramming would be necessary, HIMA said, to maintain and validate this type of operation.

No changes should be made to the form until at least the year 2001, HIMA told FDA, adding that when changes are proposed they should be developed in consultation with stakeholders—the way form 3500A itself was developed.

In other comments on the proposed revisions, Schering-Plough Research Institute (Kenilworth, NJ) asserted that the changes are mostly cosmetic, conferring no obvious value added, and urged FDA not to proceed. The changes "will impose significant cost to industry to reprogram and revalidate existing systems that generate the computer facsimiles of the MedWatch form," wrote Barton L. Cobert, MD, the institute's senior director of medical and safety services.

Copyright ©1999 Medical Device & Diagnostic Industry

Pyrogenicity Testing; EtO Sterilization

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI April 1999 Column


Richard F. Wallin, DVM, PhD, is president of NAMSA (Northwood, OH) and lead author of a series on ISO 10993 that was published in MD&DI throughout 1998.

In the December 1998 article on ISO 10993-12, there is no mention of the test for pyrogenicity. Is this covered by ISO 10993 or a different standard?

ISO 10993 covers testing for pyrogenicity in the section dealing with systemic toxicity. However, a distinction must be made between pyrogen testing for lot release purposes and testing to satisfy biocompatibility requirements. Lot release tests help ensure that product headed for patient use is free of bacterial endotoxins. Medical devices that come in contact with water during manufacturing or processing may be subject to endotoxin contamination. The bacteria in water are the most common source of the endotoxins that cause fever when injected intravenously. The reagent Limulus amebocyte lysate (LAL) is commonly used for lot-to-lot medical device testing. However, ISO 10993 does not deal with lot-to-lot testing requirements but with the biocompatibility of materials.

For biocompatibility testing, material samples are prepared as described in the December article. It is common to extract at 70ºC for 24 hours using the specified surface or weight-to-volume ratios mentioned. The test ensures the absence of material-mediated pyrogenicity caused by various chemical extractables that, like bacterial endotoxins, cause a fever when a sufficient dose is injected intravenously. The rabbit pyrogen test is used for biocompatibility because rabbits respond to pyrogens regardless of their source, while LAL reagent is selectively sensitive to bacterial endotoxins. This test may, therefore, respond to the presence of bacterial endotoxins, but those results are not relevant to biocompatibility issues.

Paul J. Sordellini of Quality Solutions Inc. (Annandale, NJ) is a consultant serving the medical device industry.

I've read that the principle of "three in one" as it applies to a complete EtO sterilization cycle being done in one room reduces the time necessary for desorption from days to only 10 hours. Does this principle really exist?

First, desorption rates of EtO from medical devices depend on many factors, including packaging material and design. It's not realistic to claim that all medical devices can be successfully aerated in 10 hours, just as it's not accurate to say that all devices must undergo several days of aeration. Desorption times can be reduced by aerating at higher temperatures, aerating under vacuum, adding steam washes to the postevacuation phases, and in some cases by humidifying the aeration room. However, in each case, the aeration time must be determined empirically.

"Three-in-one" EtO sterilization consists of performing conditioning, gas sterilization, and aeration all within the same vacuum-pressure vessel, reducing product load movement, time, and labor requirements. Conditioning and aeration inside a sterilizer are accelerated when performed under vacuum as opposed to atmospheric pressure. However, this monopolizes use of the sterilizer for long periods of time, which can dramatically decrease the profitability for some facilities.

The three-in-one method was often used before the 1990s when many manufacturers had in-house sterilization operations that used inexpensive, nonflammable EtO/chlorofluorocarbon (CFC) blends. Gas sterilization hardware for use with nonflammable mixtures was also inexpensive, so several sterilizers could be placed in proximity to the manufacturing area.

When the 1987 Montreal Protocol led to the phasing out of CFCs, the industry was left with a prohibitively expensive new nonflammable sterilant blend (EtO/hydrochlorofluorocarbon) or pure EtO. Most manufacturers chose pure EtO and a new business formula took effect: pure EtO sterilizers were expensive; external preconditioning and aeration rooms were cheap. With pure EtO, sterilizer throughput determines the operation's profitability. By preconditioning and aerating externally, the loads-per-day capacity of the sterilizer is increased. A three-in-one operation can occupy a sterilizer for as long as three days per load. With the rare exception of low-volume, high-cost devices sterilized in-house, a three-in-one system may not be a profitable choice. Such an approach should only be used with products that allow dynamic environmental conditioning both to humidify the load and to force the removal of EtO after exposure.

Our mixture of EtO/CO2 is explosive. How can the danger of an explosion be eliminated?

EtO is explosive when its concentration in air exceeds 3% by volume. Nonflammable blends of 8.5% EtO with 91.5% CO2 require sterilizers rated for high positive pressures in order to achieve moderate concentrations. If the EtO/CO2 mixture contains more than 8.5% EtO, it should be treated in the same manner as pure EtO.

Sterilization systems for 100% EtO are expensive to set up but economical for routine use. The risk of explosion is eliminated by using specially rated hardware—nonsparking/intrinsically safe—to eliminate ignition sources. Prior to admitting EtO to the sterilizer, most of the air is displaced from the load by diluting it with an inert gas such as nitrogen or carbon dioxide. Each time the sterilizer is evacuated and backfilled with an inert diluent, the remaining amount of air decreases until the risk of flammability is eliminated. At the end of the process, inert gas again displaces the EtO before air is admitted to the sterilizer and the load removed. For more information on what equipment to use with 100% EtO, consult AAMI TIR No. 15-1997.

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