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Articles from 1999 In May


Cover Products

Medical Product Manufacturing News

Cover Products

Burr-free manufacturing produces thin-wall medical tubing

Using burr-free manufacturing techniques, a company produces small-diameter metal tubes, wires, and rods. Any metal can be used to create catheters, stents, radiopaque markers, cardiac pacing devices, diagnostic probes, electrodes, and other minimally invasive device applications. Fabrication capabilities encompass rotary abrasive cutting; double-disk and centerless grinding; lapping; barrel, vibratory, and centrifugal polishing; and wire straightening. Multistage ultrasonic cleaning, camera vision inspection, and automated dimensional sorting ensure that length and diameter tolerances are in the microns, parallelism and flatness are less than a micron, squareness is in the minutes, and surface finishes are as smooth as 1 µin. Metal Cutting Corp., 59 Village Park Rd., Cedar Grove, NJ 07009.



Medical-grade dressing is hypoallergenic and breathable

For wounds requiring regular monitoring, a company provides a dressing made of clear urethane film. The hypoallergenic acrylic adhesive is pattern-coated on the film for breathability and a high moisture-vapor transmission rate, giving wounds improved exposure to the air without increased danger from contaminants. The adhesive film conforms to irregular surfaces and is easily removed from skin. Scapa Tapes, 111 Great Pond Dr., Windsor, CT 06095.



Light-emitting diodes have increased irradiance levels

A manufacturer of optoelectronic measuring equipment offers a new line of light-emitting diodes. The IPL 10630 self-monitoring emitters are a marked improvement over previous versions, with irradiance levels increased by three times for the blue LED and eight times for the green LED. Joining these for the first time is a broad-spectrum white LED. The hermetically sealed devices reject electrical noise in difficult environments. The emitters operate from a single- or dual-rail power source, allowing compatibility with logic circuits or voltage comparators. Integrated Photomatrix Inc., 4282 Reynolds Dr., Hilliard, OH 43026.



Copyright ©1999 Medical Product Manufacturing News

Dispensing equipment



Dispensing equipment

Programmable unit

A digital programmable liquid dispenser offers high-speed dispense control with the ability to cycle up to 900 times per minute. Up to six time settings can be programmed between 0.01 and 99.99 seconds and can be shown on an LED. The DD305 unit provides a repeat accuracy of 0.1%, an adjustable vacuum feature to control fluid drips between dispense cycles, and consistent deposition of materials. Microprocessor-based control, a 24-V-dc filtered and regulated power supply, an automatic and manual mode switch with LED indicator, and a dual-regulated air outlet are features of the unit. I & J Fisnar Inc., 2-07 Banta Pl., Fair Lawn, NJ 07410-3002.


Dispensing modules

A company provides custom dispensers for medical device manufacturing and secondary medical dispensing applications. Applications include automated dispensing of lubricants for aerosol drug-delivery systems and dispensing 50-nl volumes of liquids. Modules and options include 1-, 2-, and 3-axis Cartesian motion modules; a selection of dispensing pumps and valves; height sensors; heated tips and tables; and the company's True Volume piston positive-displacement pump. Creative Automation Co., 11641 Pendleton St., Sun Valley, CA 91352.


Sealant applicator

In as little as two seconds, a machine can apply liquid sealant to threaded valves and fittings to prevent leaks. The ECSII, designed to operate from a vertical axis rather than a horizontal position, uses gravity to help feed a consistent bead of sealant without a messy overflow. The system automates liquid sealant application with batch processing. A palm valve that activates the system with only 4 oz of pressure is designed to reduce the risk of repetitive-motion injuries. Federal Process Corp., Advanced Adhesives and Sealants Div., 24400 Highpoint Rd., Cleveland, OH 44122.


Adhesive dispenser

Designed as an alternative to solvent dispensing, a UV-curable adhesive dispenser offers repeatable and quick dispensing onto PVC, ABS, and other medical polymers. The UVAD's custom bushings dispense adhesive on internal or external surfaces of medical tubing or components. The system was designed to minimize environmental contamination and prevent wasting of adhesive. TechnoMed Inc., 59 Stiles Rd., Salem, NH 03079.


Dispensing workstations

A variety of standard dispensing workstations are available for medical equipment manufacturing. The work cells can be designed with pinch tube valves that can accommodate volumes down to 0.00002 cm3 or programmable and adjustable positive-displacement valves for volumes ranging from 0.001 to 50 cm3. A z-lift can also be included to provide one axis of motion by moving the dispense valve to the part or the part to the dispense valve. Dispensing and motion are controlled by a foot switch, panel switch, or part sensors that trigger the controller. Time, cycle speed, cycle sequencing, system pressure, material feed pressure, and dispense volumes are all adjustable. Dispensit, a unit of Liquid Control, 6896 Hillsdale Ct., Indianapolis, IN 46250.


Tabletop system

A low-cost tabletop dispensing system features integrated start, stop, and e-stop buttons with a thumbwheel program selector and an integral air lockout/tagout device. The Z-300 system incorporates closed-loop servo drives for both x- and y-axis motion and a pneumatic slide for z-axis movement. With a 300 x 300-mm work area, the system can be used for a variety of fluid dispensing, filling, and assembly applications. Pressurized syringe, cartridge, or bulk material feeding can be accommodated. Zmation Inc., 14811 N.E. Airport Way, Ste. 200, Portland, OR 97230.


Cyanoacrylate systems

Operated in timed or manual mode, dispensing systems accurately dispense a variety of cyanoacrylate materials. The systems are available in handheld (System 230) and fixtured (System 240) models. Because of their replaceable diaphragms, the valves are cost- effective and can produce more
than 300,000 cycles. Kahnetics Dispensing Systems, 2260 S. Vista Ave., Bloomington, CA 92316.


Small-volume liquid dispensing

A dispensing system features a rotary reciprocating ceramic dispense head that achieves 0.1% repeatability. The Microspense AP allows the user to calibrate the system to a specific setting and then to automatically adjust displacement to maximum for priming and maintenance modes. The unit can then return to its calibrated setting without operator involvement. The pump head design also includes improved fluidic sealing components that are appropriate for clean-in-place applications IVEK Corp., 10 Fairbanks Rd., North Springfield, VT 05150.


Filler and dispenser

A volumetric liquid filler and dispenser fills free-flowing to low-viscosity liquids in volumes ranging from 0.5 ml to 5 L. The GEN Pro/Fill 1000 system offers accurate filling, fast changeover, and clean-in-place capabilities. An optional Coriolis net mass-flow meter allows the filler to be operated in either a net weight or volumetric mode. Standard configurations include a semiautomatic benchtop system and a fully automatic high-speed filling system. Other configurations include units for form-fill-seal machines and custom-designed systems. Oden Corp., 255 Great Arrow Ave., Buffalo, NY 14207-3024.


Automatic dispenser

An automatic dispenser applies UV-curable adhesives in accurate, repeatable amounts. The 1500XL system combines the speed and accuracy of an air-powered fluid dispenser with barrels and tips specifically designed to apply UV-curable adhesives. Adhesive is loaded into a handheld barrel reservoir that is fitted with a precision tip and connected to the dispenser by a lightweight air line. Clear barrels and tips contain a UV-blocking additive that allows the adhesive level to be monitored without the risk of premature curing. A microprocessor-based timer permits dispense time to be adjusted in increments as little as 0.001 seconds. EFD, 977 Waterman Ave., East Providence, RI 02914-1378.


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Copyright ©1999 Medical Product Manufacturing News

Injection Molding and Plastics Processing



Injection Molding and Plastics Processing

The use of medical disposables is expected to escalate because of their promise of decreasing costs and improving efficiency. As a result, the demand for molding and plastics processing services and equipment is expected to grow. With the continuing consolidation of device companies, more manufacturers are acquiring smaller-tonnage equipment to run in-house or are outsourcing services ranging from mold and tool design to complete molding, assembly, and packaging. Reflecting that trend, a number of the industry's leading equipment and service providers will be participating in the Injection Molding and Plastics Processing Pavilion at the Medical Design & Manufacturing Exposition in New York City, May 25–27, 1999. Here is a preview of some of the equipment and services at the pavilion.


Small-Tonnage Machines Feature Hydromechanical Clamp Mechanism

Complement manufacturer's existing line of high-end molders

HUSKY INJECTION MOLDING SYSTEMS (Bolton, ON, Canada) has introduced a line of small-tonnage machines with 60-, 90-, 120-, and 160-t clamping force. The individual clamps can be matched with a range of reciprocating-screw injection units with screw and barrel sizes extending from 18 to 65 mm.

Husky's small-tonnage machines feature an injection unit design that does not require a quill to drive the screw.

The S-series units incorporate many of the features found on Husky's E- and G-series machines. A hydromechanical clamp has a bayonet-style locking mechanism attached to the clamp piston. This design eliminates the shut-height adjustment on the tie bars and reduces the maintenance required. The Reflex clamp platen design ensures parallelism between the mold-mounting surfaces, and the rigid base design supports the moving platen weight as it rides on linear bearings, independent of the tie bars. Because tie bar grease is eliminated, the potential for part contamination is reduced.

For more information, contact Husky Injection Molding Systems Ltd., 905/951-5000.

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Ultrasonic Welders Assemble Thermoplastic Parts

Three different model designs are available

A LINE OF ULTRASONIC WELDERS has been redesigned to offer improvements over the previous line. The Omega III–series welders from Forward Technology Industries (Minneapolis) have a modular design, allowing users to place the generator and controller in various positions on the welder.

The Omega III–series ultrasonic welders offer modularity and flexibility.

The Omega III line consists of three models—the MCA, MCS, and MCX. The MCA is the company's most basic unit, and can be relied upon to deliver fast, reliable assembly. The MCS is an intermediate model with features previously offered only on Forward's top-end machine. The company's most sophisticated welder, the MCX, offers extensive control and optimum adjustment for the most complex applications.

For more information, contact Forward Technology Industries Inc. at 612/559-1785.

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Design, Prototyping, and Manufacturing Services

For a wide range of injection-molded medical devices

WITH A WORLDWIDE INVENTORY of more than 680 machines, Moll Medical Div. (Knoxville, TN) has the ability to mold precision components in Class 100,000 cleanrooms and to assemble products in Class 10,000 cleanrooms. Moll specializes in design assistance, mold design and construction, cleanroom manufacturing and assembly, high-speed assembly, sterile packaging, advanced molding technology, and the provision of FDA documentation.

Moll Medical Div. has 27 facilities across North America and Europe.

Moll also offers rapid prototyping services and stereolithography capabilities, which enable engineers to move from design to scale prototype in a short time. The rapid turnaround, in addition to assistance with FDA documentation, enables customers to get products to market as quickly as possible.

With 27 facilities in six countries, Moll can supply any part of the world with precision injection-molded plastic components and assemblies. The company specializes in scrub brushes, IV bags, drug-delivery systems, surgical devices, and Class I, II, and III medical devices.

For more information, contact Moll Medical Div. at 877/275-6655.

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Extrusion Processing for Medical-Grade Films

Systems can be configured for coating and laminating

DESIGNED FOR PILOT, RESEARCH, and production extrusion of medical-grade films and coatings, extrusion, lamination, and coating systems from Davis-Standard (Pawcatuck, CT) are available in web sizes up to 39 in. The equipment is capable of the material development of medical-grade films, and can be configured for various coating and lamination applications.

Davis-Standard laboratory coating and lamination system for medical-grade films.

The systems feature tension-controlled unwinders and winders, which can handle delicate and stretch materials that require low tension. Butt-splice technology enables the machines to perform automatic web changeovers of two-layered structures while maintaining the continuity of each layer.

For more information, contact Davis-Standard Corp. at 860/599-1010.

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Injection Molder Makes Thermoplastic Components

Capabilities include engineering, mold construction

FOR RAPID PART PRODUCTION, Hi-Tech Mold & Tool Inc. (Pittsfield, MA) provides a single source for part design, mold construction, and injection molding and assembly. To accommodate considerable growth, Hi-Tech recently moved to a facility custom built for plastics processing.

In addition to application development, material selection, and product design and production, Hi-Tech's engineering services include failure analysis, testing, and plastics education and training. For mold construction, the company offers prototypes to full production-ready molds that have up to a 6000-lb mold weight.

For more information, contact Hi-Tech Mold & Tool Inc. at 413/443-9184.

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Overmolding and Insert Molding for Medical Devices

Injection molders have control validation systems

HORIZONTAL AND VERTICAL injection molding machines from Van Dorn Demag Corp. (Strongsville, OH) support a wide range of medical applications, including overmolding and insert molding. The Newbury vertical machine performs overmolding of instrument and electrical connections, while the Ergotech Modular horizontal machine handles most injection molding applications.

The 30-tn Newbury Vertical uses a toggle-clamp configuration to minimize the amount of oil in the processing environment. It features stainless-steel gate and table guarding, premium filtration, and a drawer magnet to catch particles. The 60-tn Ergotech Modular machine has two dynamic seals, which reduce particle emissions, and a permanent centralized lubrication system.

Van Dorn Demag's 30-tn Newbury Vertical machine performs overmolding for plastic medical equipment.

To meet the medical manufacturing industry's regulations, the systems feature process monitoring and machine-level statistical process control. The machines have the ability to monitor 32 parameters and to log and print documentation.

For more information, contact Van Dorn Demag Corp. at 440/876-6231.

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Sprueless Mold Technology

Company builds 128-cavity hotrunner molds for maximum productivity

SPECIALIZING IN HIGH-TECH injection molds for disposable medical and laboratory applications, Tanner Formenbau AG (Feuerthalen, Switzerland) has recently added hotrunner molds for pipette tips to its range of services. The technology produces tight tolerances, which is important for providing an accurate fit between the core and capturing sleeve so that the pipette tip is free of flashes.

Tanner Formenbau's 32-cavity injection mold for pipette tips produces extremely close tolerances.

For needle protectors, the firm offers hotrunner multitip nozzles in many standard sizes. The high-grade tooling steels for the inserts and stainless-steel mold bases are designed for long life. Operators can exchange component-shaping inserts without a time-consuming takedown of the mold. The inserts and mold bases are designed for efficient cooling, permitting fast cycles. The firm also develops molds for needle holders, plungers, syringe barrels, and laboratory products such as tissue culture flasks, petri dishes, and microtest plates.

For more information, contact Tanner Formenbau AG at +41 52 6474646.

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All-Electric Molding Machines Lower Energy Consumption

Molders provide consistency in operation and part repeatability

HIGH-PRECISION toggle-type machines from Toshiba Machine Co. (Elk Grove Village, IL) use servo-drive electric motors for operating accuracy in all machine functions. Each operation of the EC60 uses a separate motor, which shuts down when its specific function is complete. In addition, with no oil reservoirs to cool, water usage is reduced by 70% when compared with that of nonelectric machines. These two factors contribute to an energy-usage reduction that exceeds 50% over nonelectric or partially electric molding machines.

The all-electric Toshiba EC60 offers an energy-usage reduction of 50% over nonelectric machines.

The all-electric machines, available in sizes ranging from 45 to 250 tn, also have fewer working parts and require less maintenance than do nonelectric machines. In addition, users benefit from less time spent on preventive maintenance or oil-leak cleaning.

For more information, contact Toshiba Machine Co. at 800/275-8373.

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3-D CAD is Instrumental in Design of In Vitro Device

Partnership produces ergonomic features and a cost-effective design

WORKING AGAINST TIGHT TIME constraints, Axiom (Charlotte, NC) and Becton Dickinson Microbiology Systems (Sparks, MD) worked together to develop a clinical instrument for the in vitro molecular diagnosis of infectious diseases. Using 3-D CAD systems to create the plastic design for part and tooling considerations, Axiom's engineers designed the overall appearance and ergonomic features of the BDProbeTec ET system.

Designed by Axiom, Becton Dickinson's BDProbeTec Et system has ergonomic features and is easy to maintain.

"It was important to provide easy operator service access while maintaining the integrity of the internal environment in different compartments of the instrument," said Tim Rothwell, Axiom's design manager.

This was accomplished with a cost-effective design and by using the minimum number of components.

For the molding process, Axiom used gas-assist injection molding, which could include tall boss features and thick sections for structure without damaging the molding cosmetics or creating excessive part weight.

The design program also included the prototyping of 60 preproduction units for beta unit tests. These functional prototypes, developed using liquid-resin casting technology, were useful in debugging the design, generating early market feedback, and meeting time lines.

For more information, contact Axiom at 704/398-0887.

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Molding Machines Meet Cleanroom Requirements

Three models with a variety of configuration choices available

BOY MACHINES INC. (Exton, PA) offers a line of cleanroom injection molding machines that meet cleanroom requirements in a number of ways. The machines are available in capacities from 14.2 to 88 tn, and feature a choice of Procan 2, Procan CT,
or Dipronic solid-state microprocessor control.

The injection molding machines from Boy Machines Inc. can meet any cleanroom requirements.

Boy's injection molders can have a laminar-flow system installed on the hood of the clamping unit to meet high standards. For compliance with even higher standards, the machine's overhanging clamping unit can be segregated with its own clean enclosure and laminar-flow system.

For more information, contact Boy Machines Inc., 610/363-0163.

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Cleanroom Molding and Assembly

Company provides quality control and specialized manufacturing services

USING STATE-OF-THE-ART computer analysis and a full staff of design engineers, Courtesy Corp. (Buffalo Grove, IL) provides quality assurance in tooling and cleanroom molding and assembly. With CAE and CAD/CAM technology, Courtesy offers a complete line of services and support, from concept development to finished products. Interchangeable, close-tolerance components are manufactured for optimum performance with minimum maintenance.

Equipped with 132 closed-loop molding machines, Courtesy's Class 100,000 cleanroom features robotics, digital mold temperature controllers, and automated material-handling systems. Quality control functions are consolidated in a fully equipped inspection, measurement, and test laboratory, where statistical process control analysis is performed to ensure that all requirements are met.

For more information, contact Courtesy Corp. at 847/541-7900.

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Injection Molder Handles Liquid Silicone

A 110-tn unit offers cleanroom capabilities and energy efficiency

FEATURING A JACKETED, water-cooled barrel and a shutoff nozzle, Milacron's (Batavia, OH) injection molding machine molds liquid silicone medical-grade parts. Capable of injection repeatability of ±0.0005 in., the Roboshot All-Electric has an integrated mold temperature control. In addition, the 110-tn machine offers cleanroom capability and low energy usage.

For more information, contact Milacron at 513/841-8100.

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Machine Produces Injection-Molded Microparts

Molds parts with weights less than 0.1 g

BATTENFELD (Meinerzhagen, Germany) has developed an injection molding machine for microparts that is capable of reducing cycle times by more than 50%. The Microsystem machine features a Unilog B4 control system and a plunger injector with a diameter of 5 mm. The high-precision sensor housing consists of polycarbonate and weighs 0.002 g.

Normally, cycle times for producing microparts are high because of the disproportionate sizes of the sprue and runner, which can account for more than 90% of the unit's weight. With the Microsystem, these problems are overcome. It uses a rotary-table clamp system, which has one station for injection and another for part ejection, designed to keep the parts separate and correctly oriented for quality control and packaging.

Battenfeld avoids contamination of the molded parts by maintaining cleanroom conditions inside the system enclosure. The molding machine uses electric servo drives for all functions, providing higher resolution than conventional stroke-measuring devices can.

For more information, contact Battenfeld at +43 2252 404415.

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Cleanroom Injection Molding Machine Provides Flexibility

Clamp-end remains in cleanroom during processing

OFFERING SPEED and high precision and repeatability capabilities, Krauss-Maffei Corp.'s (Florence, KY) C-design cleanroom injection molding machine is designed for standard and specialized applications. The KM80's clamping unit is fitted with two metal plates that seal off the cleanroom during processing and maintenance. The machine is on casters, enabling it to be rolled away from the clamp for mold changing and maintenance.

Krauss-Maffei's cleanroom injection molding unit offers accessibility and a small footprint.

The KM80 is available from 30 to 800 tn and features a cantilevered clamping unit, which provides a small footprint and promotes low energy consumption. The unit's process control system is mounted directly on the machine.

For more information, contact Krauss-Maffei Corp. at 606/283-0299.



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Copyright ©1999 Medical Product Manufacturing News

New Treatment for Obstructive Sleep Apnea Employs Radio-Frequency Energy



New Treatment for Obstructive Sleep Apnea Employs Radio-Frequency Energy

Treatment Made Possible by Device Constructed of Innovative Plastic

By Karim Marouf, MPMN Managing Editor

Habitual snoring, obstructive sleep apnea, and other upper-airway disturbances affect millions of people. Whereas existing therapies using lasers or traditional surgical techniques to remove tissue can be expensive, painful, and debilitating to the patient, a minimally invasive procedure developed by Somnus Medical Technologies Inc. (Sunnyvale, CA) uses radio-frequency thermal ablation to treat the disorder.

To perform the procedure, the physician uses a tiny electrode on the Somnoplasty instrument to transmit low levels of radio-frequency energy to create molecular friction in subsurface tissue. Within a few weeks, the treated tissue is resorbed by the body, while soft tissue is tightened and the size of the structure, typically the uvula, is decreased. Perceived levels of snoring are then significantly reduced.

Designing the instrument was a challenge taken on by a Somnus design team led by Ben Nordell. The device was to consist of a disposable catheter-based tip, made of ABS, and a reusable main body, which had to be made of a plastic that could withstand repeated sterilization. Since the handheld device would have to survive being dropped by a physician, the plastic used for the body had to be impact resistant. Certainly many plastics can provide this feature, but it was a challenge to find one that would maintain its strength after repeated sterilization cycles.

The main body of the Somnoplasty instrument was made using Radel R, a plastic that retains its impact resistance after repeated steam sterilization.

The design team first consulted a study group consisting of several doctors who specialized in the field of sleep disorders. The team learned that the device would usually undergo steam sterilization. Since boiler additives such as morpholine, used to stop corrosion in the steam sterilization system, can degrade plastics, the device needed to be made from a chemically resistant material.

Making the device out of stainless steel, which would have been sturdy and sterilizable but also heavy and expensive, was never seriously considered. Explains Nordell, "With these new engineering plastics, you can do a great deal that you couldn't have before, so it is no longer necessary to use."

The device designers looked into various plastics, including several from Amoco Polymers Inc. (Alpharetta, GA), part of the BP Amoco Group. One that stood out above the rest was Radel R polyphenylsulfone. "Radel R is suitable for any device that sees repeated sterilization and needs to maintain its impact strength," explains Daryl Brace, public relations manager for Amoco. "Many polymers become brittle, but Radel R has excellent hydrolytic stability, so it can withstand numerous steam sterilization cycles and still maintain its physical properties." Previous applications for Radel R have included surgical instrument trays and laboratory animal cages.

Radel R thus fit the design team's criteria for impact strength, sterilizability, and chemical resistance. A less critical, but still important feature, was that since surgeons are accustomed to using high-quality stainless-steel equipment, the material had to both look and feel right to them. Stephen Rudy, ex­vice president of marketing for Somnus, says, "We would repeatedly go out and hand materials to surgeons and ask, 'How does this feel?' Any materials that they didn't like got knocked off the list." Nordell affirms, "We wanted something with a sturdy feel to it. It was very important to project that impression."

It will be no surprise to design engineers that one of the greatest challenges that Somnus's team had to overcome was pressure to develop the device quickly. The project from start-up to molding the parts took less than a year. "There were a lot of confining issues that we had to work through," says Nordell. One was designing a simple but very durable and resilient latch mechanism between the disposable and reusable parts. A snap fit was the solution.

Another challenge was creating prototypes to analyze the appropriateness of the material. Nordell says, "We didn't have a whole lot of money to spend on prototype tooling. To prove out the concept and verify its sterilizability, we purchased these materials and did 3-D machining on all the parts prior to even releasing tooling." Here the team discovered another benefit of Radel R--that it is easy to machine.

Molding Radel R did present some challenges. "The flow characteristics and the setup parameters necessary to get a flawless part were a tough chase," says Nordell. "But we worked with Amoco very closely, and they provided the technical expertise to our molder to dictate how the material should be run, and eventually it worked very well."

Brace emphasizes that Amoco specializes in working closely with both its clients and its clients' molders. "The whole idea of providing a package of services is that we help from design to finished part. We provide advice on tool design, how to process the polymer, how to detail the component, what kind of radiuses to put in, and how to maximize impact resistance."

The finished device is the first of its kind approved by FDA to treat sleep apnea. Because of it, a lot of people will sleep a little easier, and the designers at Somnus can be proud of that accomplishment.

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 karim.marouf@cancom.com.

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Copyright ©1999 Medical Product Manufacturing News

Molding Services



Molding Services


Silicone molding

An FDA-registered facility uses liquid injection molding, transfer molding, and compression molding to produce components for medical devices. Medical- and implant-grade silicones are used exclusively. The company's quality system is certified to ISO 9001 and EN 46001. Recently it has also expanded its molding and mold-making capabilities by acquiring additional equipment. Helix Medical Inc., 1110 Mark Ave., Carpenteria, CA 93013


Medical component molding

Using closed-loop microprocessor-controlled equipment, a company molds a variety of engineering resins such as ABS, PPS, PSU, LCP, PBT, and thermoplastic rubber 24 hours a day in a clean environment. Medical components are produced in its ISO 9000–compliant plant using in-house CAD/CAM mold making, electronic data transfer to support customer orders, and SPC to monitor molded part quality. Tolerances are typically held to ±0.001 in. from multicavity production molds. Plastic Molding Technology Inc., Silvermine Industrial Park, 92 Cogwheel Ln., Seymour, CT 06483.


Book mold tooling

A company offers custom book mold tooling that is used to insert mold medical devices requiring critical tolerances. This design allows secure placement of delicate inserts such as cannulae, tubing, wires, or filter membranes into the mold on a horizontal surface. Once inserts are in place the top mold half is gently closed around them, preventing damage and ensuring proper alignment in the mold during the clamping and injection cycle. Multiple book molds used in conjunction with a rotary table insert molding machine provide maximum production capacity and flexibility by allowing parts to cure in the mold while indexing. The company also provides mold sampling and first-article approval, initial start-up production, and long-term or backup contract insert molding. Aberdeen Technologies Inc., P.O. Box 163, Wheaton, IL 60189-0163.


Specialty medical components

Close-tolerance components are produced by a company using thermoplastic or thermoset injection processes. Material capabilities range from general commodity-grade resins to high-performance plastics. On-site precision molding and tool making, extensive press capabilities, secondary services, quality control, and engineering assistance are all provided. Sanlar Inc., 1655 W. 20th St., Erie, PA 16502.


Liquid-resin casting

When injection molding quality is needed but low production volumes make it difficult to justify the tooling costs, liquid-resin casting may be a suitable alternative for producing complex parts. A provider of this process states that the tooling for liquid-resin casting is typically 10 to 25% of the cost of injection molding tooling. Manufacturers can quickly move from design to market with lead times ranging from 2 to 6 weeks—and even less if a model is available. Nontraditional mold media, such as flexible silicone, allow parts to be made with molded in O-ring grooves or other undercuts, as well as textures and threads, thus eliminating the need for expensive secondary processes. Polymer Design Corp., 180 Pleasant St., Rockland, MA 02370.


Injection molding and manufacturing services

A manufacturing-driven custom injection molder offers customers an on-site engineering design center in which design, engineering, mold development, and manufacturing are brought together as integrated services, rather than independent steps. Its engineering and technical team can significantly influence projects in the earliest development stages, assisting customers in design and concept before and during the blueprint phase. S&W Plastics Inc., 10206 Crosstown Cir., Eden Prairie, MN 55344.


Liquid-silicone injection molding

An FDA-registered and ISO 9001–certified manufacturer of disposable medical devices offers liquid-silicone injection molding. This molding process is suitable for molding complex design configurations that require close tolerances, square inside corners, sealing, and O-ring grooves. Implantable-grade silicones are also available. According to the company, silicone elastomers produce high-quality results economically, efficiently, and flash free. Burron OEM Div., B. Braun Medical Inc., P.O. Box 4027, Bethlehem, PA 18018-0027.


Full-service molder

A company provides all the processing disciplines of a full-service ISO 9002–compliant injection molder, a fully outfitted CNC mold manufacturer for building prototype or production injection molds, and a complete full-service industrial design group to engineer and test new products. All of these offerings are available in one facility and are available as a package or separately so that customers can choose only what they need. Tech Inc., P.O. Box 476, Merrimack, NH 03054.


Molding and assembly

An injection molder offers broad material-processing capabilities ranging from engineering polymers and LIM silicones to commodity resins. The company's press capacity ranges from 50 to 300 tn. Additional services available include Class 100,000 assembly, ultrasonic welding, packaging for sterilization, product distribution, regulatory assistance, prototyping, product engineering, and mold procurement. New part designs are subjected to mold-flow simulations to identify process limitations and to reduce lead times. Atrion Medical Inc., 1426 Curt Francis Rd., Arab, AL 35016.


Prototypes and short-run parts

A company provides prototype and short-run injection-molded plastic parts. Molds are constructed from aluminum or steel per exact specifications of design drawings. Cores are hand operated to ensure that the molds will be low cost. Parts can be produced from such materials as Delrin, nylons, and polycarbonates, as well as acrylics and ABS. The molder does not charge for any mold setups because the mold is in the machine and ready for any quantity in less than 15 minutes. Plastic Metal Design & Manufacturing, 23162 La Cadena Dr., Laguna Hills, CA 92653.


Molding and manufacturing services

A company offers molding and contract manufacturing of medical, dental, and surgical instruments, devices, and implants. Services include design engineering, prototyping, and production. Plastic mold design and injection molding, as well as ultraprecise CNC and Swiss machining, contract assembly, packaging, and sterilization, are all available. Specialized Medical Devices, P.O. Box 1704, Lancaster, PA 17608-1704.

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Copyright ©1999 Medical Product Manufacturing News

Machining



Machining


Micromachining Services

A company provides micromachining for surgical and implantable medical devices. A streamlined production environment facilitates production of holes and details measuring 0.0005 in. or less, wall sections of less than 0.002 in., and parts with a 0.020-in. overall dimension in titanium, stainless steel, and hardened metals. In addition, the company offers prototyping, from proof of concept to the production process, in only a few days. Remmele Engineering Inc., Micro Machining Div. 17701 U.S. Hwy 10, Big Lake, MN 55309.


Precision plastic machining

With expertise in annealing and preshrinking materials to maintain close tolerances and minimal stress, a company provides precision machining of all plastic materials. CNC milling and turning centers, automatic screw machine products, vacuum forming, strip-heat bending, and assembly services are available. In addition, the company maintains quality control procedures in accordance with MIL-I-45208A. Coordinate-measuring machines are linked to a computer and provide tolerance computation, statistical analysis, contour verification, and 2- or 3-D measurements. Space Age Plastic Fabricators Inc., 4519 White Plains Rd., Bronx, NY 10470.


Precision medical components

Precision components, parts, and assemblies are available from a precision machining company. A six-axis machine and a state-of-the-art shop-control system are among several capabilities that enable the company to produce medical components with tight tolerances. Therapeutic catheters, infusion components, orthofixation devices, bone screws, dental implants and screws, and products for minimally invasive surgery are available. AeroMed Inc., 2342 N. Penn Rd., Hatfield, PA 19440.


Full-service machining

Products ranging from simple monitoring devices to critical-care instruments are designed and manufactured by a company with full-service machining capabilities. CNC, EDM, and screw machining are among the services provided at the company's state-of-the-art facilities. The company handles polyurethane, PVC, nylon, polycarbonate, polysulfone, silicone, and other medical-grade polymers. Insert molding, injection molding, and wire extrusion services are also available. CEA Technologies Inc., 1735 Merchants Ct., Colorado Springs, CO 80916.


Surgical instrument manufacturing

A company designs and manufactures handheld surgical instruments. With the support of several highly qualified engineers, the company provides devices for endoscopic, ophthalmic, ENT, and orthopedic surgery. The company offers rapid prototyping and standard production capabilities. Optics Technology Inc., 3800 Monroe Ave., Pittsford, NY 14534.


Single-source precision machining

A supplier to manufacturers of medical instruments for arthroscopic, endoscopic, orthopedic, and cardiac surgery is a one-stop source for machining and fabricating operations. The company specializes in Class III medical devices. Facilities include many nontraditional machines, including laser and EDM technology, in addition to more traditional equipment, such as VMC and CNC turning machines. Spectrum Manufacturing, 140 E. Hintz Rd., Wheeling IL 60090.


Precise parts manufacturing

Specializing in ultraprecision machining to standard, miniature, and subminiature levels, a company employs advanced programming and production equipment in the manufacturing of precise parts in high volumes. An environmentally controlled manufacturing facility has 13 Swiss turning centers, 16 CNC wire electrical-discharge machines, 17 plunge-type electrical-discharge machines, 9 CNC mills and lathes, and a range of conventional machines. In addition, the company has 25 advanced laser units for making intricate cutouts and patterns in thin metals. Norman Noble Inc., 1650 Collamer Rd., Highland Heights, OH 44110.


CNC machining services

Chemical, thermal, and mechanical polishing are provided by a company that specializes in CNC machining of components for the medical device industry. The company focuses on accuracy, fine finish, and on-time delivery. To ensure dimensional stability, annealing and stress-relieving capabilities are provided. The company's fabrication and assembly facilities offer close-tolerance work and small-hole drilling. Microcomponents are also available. Connecticut Plastics, 1268 Old Colony Rd., Wallingford, CT 06492.


Components for minimally invasive surgery

A company works with manufacturers to resolve R&D, technical, and production issues for surgical instruments. Products offered include guidewires, core wires, trocars, cannulae, bone drills, straight-cut wire, mandrels, dilators, stylets, and probes. Materials processed include 304 stainless steel, nitinol, titanium, brass, aluminum, and plastics. New England Precision Grinding Inc., 469-B Fortune Blvd., Milford, MA 01757.


Precision micromachining

A company provides precision micromachining of complex plastic, titanium, platinum, and stainless-steel components that require tight tolerances. A full engineering staff offers flexible, high-volume production and a fast turnaround for prototypes. Ultraclean facilities are equipped to serve the cardiovascular, neurological, orthopedic, dental, and drug-delivery markets. The company's equipment includes five Swiss lathes with full c-axis capability, CNC machining centers, slant- and gang-style lathes, and video inspection equipment. C-Axis, 800 Tower Dr., Hamel, MN 55340.


Turnkey machining

A company provides turnkey machining services from the prototype stage to production. Specializing in the machining of tubular components from stainless steel, brass, aluminum, and other alloys, the company uses state-of-the-art equipment. Burr-free cutting and grinding, CNC machining, EDM, and close-tolerance bending, cutting, flaring, and swaging are provided. The company is ISO 9001 certified. Popper & Sons Inc., P.O. Box 128, New Hyde Park, NY 11040-0134.


Medical products machining

CNC Swiss screw machining and EDM manufacturing capabilities are offered by a company with more than 150 years of metal manufacturing experience. A medical products machining operation has been upgraded to satisfy a wide range of machining needs, including Swiss screw machining, milling, laser welding, die-sink EDM, microblasting, passivation, radiopaque marker-band cutting, and powder and sputter coating. Platinum and platinum iridium alloys, gold, stainless steel, titanium, MP35N, and other specialty materials can be used to produce machine parts. Johnson Matthey Inc., 1401 King Rd., West Chester, PA 19380.


Nd:YAG laser drilling

Capable of high-speed laser microvia drilling through dielectric and copper, a tripled Nd:YAG laser drilling system eliminates the need to pre-etch copper vias. The Model 5100 laser system drills vias with diameters under 25 µm and allows higher registration accuracy in underlayers. In addition to the Nd:YAG laser system, the company has CO2 and excimer laser drilling technology available for prototypes, small lots, and volume production. All processing is performed in a Class 10,000 cleanroom. Solder mask removal, flexible-circuit dielectric material removal, and medical device fabrication services are also available. PhotoMachining Inc., 4 Industrial Dr., Unit 40, Pelham, NH 03076.

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Copyright ©1999 Medical Product Manufacturing News

Part Analyst, Cheerleader, and Visionary, Ron Sparks is Scoping Out the Future

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI May 1999 Column

Listening to Ron Sparks, newly appointed president of Smith & Nephew's endoscopy division (Andover, MA), it's easy to understand why he is often recruited to implement a new program, promote sales, or turn around a faltering concept. His enthusiasm and energy are top-notch, and one quickly figures out that he's the type who, when the door gets shut in his face, finds a window to crawl through.

Ron Sparks compares his role to that of a magnet pulling together diverse ideas.

Fresh out of the University of Massachusetts (UMass) management program, Sparks worked on a series of jobs, some in other industries, before he joined Smith & Nephew 16 years ago. "Without equivocation, this is the most exciting business that I've ever been part of," says Sparks. "The medical industry is great because you have the opportunity to help patients who are ill—to be in a position to help people with products and services. The marketplace is fast paced, fast growing, and it demands a lot of the people in it. But the level of reward goes far beyond that of a run-of-the-mill business."

Although Smith & Nephew is fourth in the endoscopy market behind Olympus, Ethicon, and U.S. Surgical, Sparks explains that the others are heavily specialized, whereas Smith & Nephew is the only company to have developed the means to access and repair a wide variety of tissue and organ systems.

New technology excites Sparks, and this sentiment is echoed in the division's strategic intent statement. "The statement shows who we think we want to be," he says. "We want to be the first choice of surgeons worldwide, but for surgical techniques or strategies, not products." Projects that intrigue Sparks include a hand-assisted laparoscopic procedure in which "the hand part allows a surgeon to bring the tissue to the instrument rather than the other way around," he explains. "Traditional laparoscopic systems are not intuitive, visibility is often difficult, and it is easy for a surgeon to nick the patient and hard to stop the bleeding." The Hand Port is not yet approved in the United States, although clinical trial results may change that in the third or fourth quarter this year. Until then, use is limited to the United Kingdom, Germany, and Spain.

Improvements in what Sparks calls access technology have physicians excited as well. An orthopedic surgeon recently invited Sparks to look through a scope. Thinking that he already was familiar with the scope in question, Sparks wasn't overly eager at the outset but admits to being amazed at finding the resolution sharp enough to see red corpuscles traveling through blood vessels.

Drug delivery is undergoing a metamorphosis of its own. For example, an antiinflammatory delivered in a microencapsulated form can be released directly at the affected site rather than being administered through an IV and traveling throughout the body.

Since late 1995, Smith & Nephew has maintained a multimillion dollar partnership with UMass to continue its research efforts to develop improved surgical equipment and procedures. "For academic research—the thinking-out-of-the-box environment that we need—the university setting is the right place," says Sparks.

Smith & Nephew provides funding for the program, the university provides the space for lab work, and the surgeons and engineers work together every day. "It's a great program," Sparks says. "I can't say enough about it. The program helps a company like Smith & Nephew distinguish itself as a great company because it helps the evolution of surgical products and techniques." The first device to develop from that relationship allows surgeons to tie sutures with one hand by pulling a triggerlike mechanism.

Sparks describes his role as that of a chief visionary. "I'm the coach; I don't touch the football, but I stand on the sidelines and cheer when the team executes a great play," he explains. "I try to provide the answer to the question that asks what we're trying to accomplish. And I remember that every customer is three people—the user, the purchaser, and the payer."

In an effort to break down corporate walls, Sparks has an open-door policy that he hopes promotes a seamless company. "I don't want anyone to ever say, 'I did everything I was supposed to do, and then so-and-so messed it up,'" he explains. "I'd rather just analyze the situation and figure out what went wrong and why, not whose fault it was.

"At the same time, I have to look into the future, to get the headlights to shine out as far as they can. I constantly ask what's going to make something obsolete. My favorite quote is: 'The best way to figure out the future is to invent it.'"

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


Copyright ©1999 Medical Device & Diagnostic Industry

Casting an Interactive Web: Henney Seeks Real-Time Input from Industry

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI May 1999 Column

Will new media help implement FDAMA's mandate for engagement and interaction between FDA and device companies? A recent event tests a powerful mechanism for dialogue.

Marshall McLuhan's dictum from the 1960s that "the medium is the message" is being validated to an extravagant degree in the Internet Age. From chat rooms to the stock valuations of Web-based enterprises, the allure, promise, and underlying symbolism of the medium itself have become as important as the actual content offered.

The same could be said about the recent FDA happening—to use another sixties tag—that took place on April 28. Billed as "an interactive satellite teleconference/Webcast" and held in conjunction with regional public meetings, the event featured commissioner Jane Henney and a lineup of her chief deputies doing essentially what the session title announced: "Talking With Stakeholders About FDA Modernization." The purpose of the gathering was "to discuss the agency's progress in implementing FDAMA and to seek additional input on specific FDAMA performance targets."

A small studio audience included representatives from various industry and professional organizations, but the real audience comprised the numberless participants at their PCs who were urged to phone or fax in their questions. And although a range of topics was addressed, the real subject seemed to be the medium and format of the presentation, which exemplified FDAMA's mandate for engagement and interaction. Despite the intermittent technical distractions—
participants moving as if underwater, words and lips out of synch—the transforming image was that of the FDA commissioner available to any interrogator across the country. It was only a few short years ago, one remembers, that FDA issued a six-page memorandum telling its reviewers how to stop talking with industry on the phone.

Henney did say some intriguing things, several of which are likely to raise industry eyebrows. In her lobbying for an "adequately resourced" agency, she emphasized the erosion of "core program" funding, even with modest budget increases the last few years and an 18% raise slated for 2000. (According to Henney, for example, key scientific personnel at FDA have not been able to attend relevant professional meetings for three or four years.) Citing the "very successful experiment" of drug user fees, she noted the "opportunity" for user fees for devices, contingent upon industry and Congressional support and a firm tie-in to specific performance goals. While acknowledging that manufacturers were "not wildly enthusiastic" about user fees, Henney explained that the fees were simply another "way of giving [device companies] the resources they need." The fact that these resources for industry would have to be purchased with resources from industry somehow got lost in the soothing rhetoric.

In response to a question about regulatory harmonization and the globalization of today's market, Henney brought up another "key opportunity" not likely to be at the top of industry's wish list: that of "exporting FDA's high standards worldwide." And she was frank in lamenting the headache for the agency caused by the FDAMA provision requiring the "least burdensome" means of establishing device effectiveness. She would have been "a happier camper," Henney told a caller, had wording like "most reasonable"—with its overtones of cooperation—been used instead.

The commissioner appeared committed to perpetuating subsequent on-line exchanges during the implementation of FDAMA, pledging to carefully evaluate the usefulness of the teleconference and to budget for similar events in the future. Her hope is clearly that the new medium itself can help fulfill both the letter and spirit of the new law.

Jon Katz

jon.katz@cancom.com


Copyright ©1999 Medical Device & Diagnostic Industry

FDA/Industry Partnerships: Moving toward More Equitable Enforcement

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI May 1999 Column

Reversing what was often an adversarial relationship, FDA has worked with representatives of the device industry to implement changes designed to improve the agency's inspection and enforcement policies.

Medical device companies see themselves as innovators in the diagnosis, cure, or treatment of disease or injury. Their success depends on providing patients early access to their technically advanced, safe, and effective devices. FDA officials see themselves as the guardians of the public health. Their mandate is to foster the introduction of new technology and to ensure that the devices designed to diagnose, cure, or treat disease or injuries do not inadvertently cause harm. One of the ways FDA accomplishes its mandate is through the inspection of device manufacturers. During the past few years, many FDA officials in the Office of Regulatory Affairs (ORA) and the Center for Devices and Radiological Health (CDRH) have begun to view industry as a partner rather than an adversary. Working with device manufacturers, FDA has implemented many changes that have improved the effectiveness of FDA inspections and made the enforcement process more equitable. These efforts need to continue, so that the industry will view the inspection process as facilitating rather than impeding timely patient access to safe and effective products.

FDA ENFORCEMENT IN THE EARLY 1990s

In November 1990, David Kessler became the Commissioner of Food and Drugs. In speeches, he repeatedly stated that FDA enforcement "needed to be taken up a notch." Under Kessler's mandate, officials in CDRH's Office of Compliance—believing that medical device manufacturers did not take FDA seriously—instituted a program under which companies who had systemic problems with their good manufacturing practices were placed on a reference list. Being on the list precluded the companies from having their 510(k) applications cleared. When the program was implemented, the medical device industry was incensed.

The Health Industry Manufacturers Association (HIMA) filed a citizen petition asserting that the agency lacked the statutory authority to link 510(k) clearance with compliance with GMP requirements. HIMA also objected to the difficulties companies had in determining whether or not they were on the list, and in getting themselves off the list. Over time, Ron Johnson, director at CDRH's Office of Compliance, and Marge Hoban, chief of the center's Field Programs Branch, remedied many of the problems. Eventually, due in large part to the reengineering efforts of Phil Phillips, deputy director for policy at CDRH's Office for Device Evaluation, FDA eliminated the reference list for Class I and Class II products.

Another Kessler initiative was to decentralize the power for enforcement actions and delegate to officials in FDA district offices the authority to send warning letters. The district officials were instructed not to be predictable in their enforcement actions. They were to go into a firm, spot regulatory violations, and then go on to find different regulatory violations in other companies. These initiatives caused companies to be suspicious of FDA because they were fearful of unpredictable and inconsistent regulatory actions.

STIMULI TO CHANGE

In 1994, HIMA polled the industry regarding its concerns about FDA enforcement policies and developed recommendations to improve the inspection process. In meetings with officials from FDA's Office of Regulatory Affairs and CDRH, HIMA suggested items such as:

  • Conducting preannounced inspections.
  • Annotating the FDA 483 with completed or promised corrective actions.
  • Requiring that annotations be put in context (e.g., the investigator examined 50 complaints and found that 3 had not been reported as MDRs).
  • Issuing closeout letters after completion of inspections.

A group of FDA officials received similar input from the Medical Device Industry Initiatives Grassroots Task Force, an industry group consisting of representatives of national and regional medical device associations.

Cognizant of its diminishing budgetary resources and of the reasonableness of the suggestions presented, FDA in 1996 implemented a pilot program that included the items noted above. The agency subsequently surveyed the investigators and the companies being inspected, and found that most respondents in both groups believed that the pilot program improved the efficiency of inspections and the quality of communication between the investigator and the company. The program was so successful that, in March 1997, the features of the program became part of FDA's standard operating procedures for conducting medical device inspections. In addition, the program is currently being implemented on a pilot basis in other FDA centers.

To solicit additional ideas on how to further improve the inspection process, FDA throughout 1996 and 1997 met with industry officials in various cities, including Dallas, Nashville, Boston, Atlanta, Charlotte, and Orlando. Some of the suggestions coming out of these meetings included:

  • Conducting joint training for industry and FDA investigators on the new quality system requirements.
  • Providing the establishment inspection reports (EIRs) automatically to companies after their facilities have been inspected.
  • Excluding from warning letters items that have been corrected or for which corrections have been promised.
  • Increasing the time for companies to respond to FDA 483 observations, and acknowledging their responses in the warning letter.

FDA RESPONSE TO INDUSTRY SUGGESTIONS

Joint Training. In response to the industry suggestion on joint training, FDA's southwest regional office conducted joint training for FDA and industry personnel on how to comply with the MDR requirements. FDA also worked with the Food and Drug Law Institute and with national and regional device associations to present periodic teleconferences on FDA requirements for members of the industry and FDA officials. Additionally, the agency conducted joint training on how to comply with the design control portion of the new quality system regulation.

Establishment Inspection Reports. FDA has instituted a program under which it automatically provides EIRs to companies after their FDA inspections. This program has proven to be very successful, with companies better able to understand FDA's conclusions about their firm's state of compliance.

Warning Letter Pilot. Prompted by the industry's pressing concerns regarding the impact that warning letters have on corporate image and stock price, a committee of the Medical Device Industry Initiatives Grassroots Task Force, working with FDA officials, designed an 18-month pilot program. Its purpose was to preclude FDA from sending warning letters to companies who had corrected or were in the process of correcting deficiencies.

The way the program works is as follows. As of March 29, 1999, after a domestic device investigation, a company with a good record of compliance with FDA requirements will be given 15 working days to respond to deficiencies that would have previously triggered a warning letter. If the response is deemed to be satisfactory, then a warning letter will not be issued. Instead, FDA will issue a postinspectional notification letter. The letter will state that while the inspection found quality system deficiencies which, if not corrected, would warrant a warning letter, the company's written response has satisfied FDA that the company has taken or will take appropriate corrective actions. If, at a later time, FDA observes that the deviations from the quality system regulation have not been remedied, the agency may take regulatory action (seizure, injunction, and civil penalties) without notice.

The program also addresses situations that would have warranted a warning letter for failure to submit a 510(k) application or for labeling violations. Under this program, companies, in most instances, will receive an untitled letter within 30 working days of the FDA inspection. Companies will have 15 working days to respond to FDA. CDRH will then have 30 working days to consider the firm's response. If the firm's response is satisfactory, FDA will send a postinspectional letter similar to the one discussed above. Ernest Malachowski, chief operating officer of Chrisman Bynum & Johnson (Boulder, CO) and a member of the committee that designed the pilot program, says that "The changes provide the device industry with the opportunity to make corrections—and perhaps forego the receipt of a warning letter—without diminshing the agency's authority."

Inspection Evaluation Survey. For many years, industry has made various allegations about the lack of uniformity in FDA inspections. In an attempt to get accurate data, a committee of the Medical Device Industry Initiatives Grassroots Task Force, in cooperation with University of California, Irvine (UCI) Center for Statistical Consulting, designed a medical device inspection evaluation survey to provide a mechanism by which industry can provide anonymous feedback to ORA and members of the public regarding the FDA inspection process. The survey, which began on March 1, 1999, will be conducted as a pilot program for one year.

The FDA contact for the program is Denise Dion, medical device expert investigator, who coordinated the internal distribution of the surveys to the FDA districts. Dion sees the process working in the following manner. Upon completion of an FDA inspection, the investigator will fill out the top portion of the survey that contains background information about the company and the devices it manufactures, the name of the investigator, the FDA district, whether or not a 483 was issued, and the reason for the inspection. After completing the form, the investigator will give it to an official at the firm that is being inspected, and ask him or her to complete it and return it in the stamped envelope to UCI.

Data will be entered and analyzed at UCI, with specifics about companies and investigators kept confidential. Questions asked in the evaluation include the following:

  • Was there enough advance notification?
  • Was it necessary to reschedule the inspection?
  • Was there adequate communication during the inspection?
  • Was a 483 issued?
  • Were corrective actions promised, and were they annotated on the 483?
  • Were the observations on the 483 appropriate?
  • How did the inspection compare with past inspections?

UCI will analyze the data at the end of six months and again at the end of one year. To show trends in satisfaction and perceived problems, a comparison of the responses both nationally and by individual districts will be made. The analysis will also consider:

  • The length of the inspection as a function of the type of inspection (preapproval, quality system, or other).
  • Whether a 483 was issued.
  • Whether there were interruptions.
  • Whether any problems were perceived with the inspection.

Once the analysis is completed, the results will be widely disseminated and placed on the Web sites of FDA, HIMA, the Association of Diagnostic Manufacturers, the American Society for Quality, and the Medical Device Manufacturers Association. Lauren Andersen, president and CEO of Andersen Products (Haw River, NC) and a member of the committee that developed the survey, states that "The survey's success depends on the willingness of companies to complete it and on the candor of their responses. With good participation, this program can encourage objectivity and consistency in FDA's field operations."

QUALITY SYSTEM INSPECTION TECHNIQUE (QSIT)

For years, members of the industry complained that FDA investigators inspecting their companies focused on individual deviations from the GMP regulations rather than on whether their company had a quality system in place that was designed to manufacture safe and effective products. In 1998, a group of FDA and industry officials developed recommendations to address these concerns.

Based on the group's recommendations, a CDRH team led by Tim Wells developed a new systems approach for FDA inspections, which they called the quality system inspection technique (QSIT). QSIT is based on the premise that the quality system regulation has seven major subsystems whose requirements intersect. The subsystems are:

  • Management controls.
  • Design controls.
  • Corrective and preventive actions.
  • Production and process controls.
  • Record/document/change controls.
  • Material controls.
  • Facility controls.

During an initial inspection, an FDA investigator will examine whether the company has the first four subsystems in place, and whether it is manufacturing products under the procedures required by those subsystems. If a company has an inspection following which no official action is indicated, subsequent inspections will be more limited.

FDA recently conducted a study of inspections using the QSIT approach in the agency's Los Angeles, Minneapolis, and Denver districts. Responses indicated that both industry officials and FDA investigators believed that QSIT inspections were efficient and focused, and provided assurance that companies had systems in place that would produce safe and effective medical devices.

Because of the QSIT study's success, FDA will implement inspections under QSIT in all districts during the first quarter of 2000. More information on QSIT is available on FDA's Web site.

FDA INSPECTION REQUIREMENTS

The Federal Food, Drug, and Cosmetic Act requires FDA to inspect nonexempt Class II and Class III device manufacturers every two years to ensure that they are manufacturing safe and effective products. According to the agency's plan for statutory compliance under the FDA Modernization Act, FDA is complying with its biennial inspection requirements at a level of 28%. Whether the failure of FDA to visit firms makes those companies lax is open to question. Eve Ross, counsel for W.L. Gore & Associates (Newark, DE), speaks for many companies when she says, "We don't follow good quality practices because of FDA. Good quality is good business." Nonetheless, Los Angeles FDA compliance director Tom Sawyer states that "The FDA inspection process, in which the investigator is able to link his or her observations to the regulations, provides an important insight to firm managers intent upon complying with the law and putting high-quality products into commerce."

Today we live in a global economy, and many firms do business in Europe. According to Ken Kopesky, director of corporate compliance and audit at Medtronic Inc. (Minneapolis), "Every year, notified bodies come in and inspect our manufacturing facilities for compliance with the quality system provisions of EN ISO 9001 or 9002 and EN 46001 or 46002." Most U.S. firms believe that they would save resources if FDA would recognize the inspections by these notified bodies. Michael Gropp, chief compliance officer at Guidant Corp. (Indianapolis), states that "The situation will become more acute as authorities from other countries also develop their own quality system requirements and expectations for audits." Kim Trautman, FDA's GMP expert, says that although FDA does support the concept of eventual mutual recognition of CGMP inspections between major device markets, "full achievement of this goal is still in the future."

CONCLUSION

FDA officials partnering with industry to examine inspections and enforcement in a new light have made tremendous progress in making the process of initiating regulatory action more equitable. Wayne Barlow, CEO of Wescor Inc. (Logan, UT) and chairman of the Medical Device Industry Initiatives Grassroots Task Force, says that "the agency is operating in a more user-friendly mode than at any time during the previous decade."

When FDA Commissioner Jane Henney met with the task force in December 1998, she complimented the group on its accomplishments and challenged it to be creative in developing more initiatives that will further improve the process. One of these future challenges is for FDA to continue its involvement in ongoing initiatives to harmonize its requirements with those of the European Union and other international regulatory agencies. Such a measure would go a long way in promoting a view of the FDA regulatory process as benefiting timely patient access to safe and effective products.

Nancy Singer is special counsel at HIMA, a medical device industry trade association based in Washington, DC.


Copyright ©1999 Medical Device & Diagnostic Industry

File Closes on Document Leak: Final investigation leaves key questions unresolved.

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI May 1999 Column

FDA is proposing a device reclassification that relies on data from PMAs approved at least six years ago. The use of such data is permitted in FDAMA section 216, which replaces a never-used provision from the 1990 Safe Medical Devices Act called the "four-of-a-kind" rule.

The four-of-a-kind rule allowed FDA to rely on data after four of the same kind of PMAs submitted after 1990 were approved. However, the rule was never really implemented, because agreement could not be reached on what "of the same kind" meant, according to CDRH scientific reviewer John Baxley. The current case represents the first time FDA will rely on this type of data, whose use is being proposed in the reclassification of extracorporeal shock-wave lithotripter devices from Class III to Class II (see the February 8, 1999, Federal Register).

Baxley sees this six-year-old-data provision as benefiting new PMAs for which a history of related approvals exists. For example, a new PMA candidate could do some sort of bench testing and feasibility testing (either animal or clinical testing), and then apprise FDA of the long history of use of the type of device.

FDA could then evaluate the bench testing and see whether the new device conforms to currently approved devices. If so, says Baxley, FDA could apply the knowledge on success rates, risks, and complications from the other PMAs to this new device. "This would speed review and approvals," he says.

Makers of already-marketed but unapproved devices for in vitro fertilization and other "assisted reproduction procedures" were in February given 60 days to submit 510(k)s for each device, to register their facilities and products, and to establish that they are in compliance with the QSR and all other regulations. Continued marketing is permitted until CDRH makes a "substantially equivalent" determination, but devices that do not qualify must be removed from the market pending approval of a PMA, according to the Center.

FDA says it is purchasing a Diasensor 1000 noninvasive blood glucose monitor from Biocontrol Technology Inc. (Pittsburgh) in order to "understand its behavior and the behavior of other types of remote sensing technology," according to FDA public affairs specialist Sharon Snider. Biocontrol failed at least twice to gain FDA clearance of its device in 1996.

The company says FDA will not use the monitor in the type of clinical investigation that would support market authorization, but rather to gain knowledge of the functioning of such devices over their full range of performance.

Scientific and engineering personnel from the company are to hold a seminar to educate agency staff on the use and maintenance of the device. A home-use instrument that eliminates the need for finger pricks, the Diasensor 1000 is not approved for sale in the Unites States but is being sold in the 15-nation European Union.

The Health Industry Manufacturers Association plans to work to see that FDA adopts a dispute resolution procedure that gives industry the opportunity to present its case in a scientific dispute to a third party who can "make a decision and come close to requiring the agency to adhere to that decision." HIMA executive vice president for technology and regulatory affairs James S. Benson says that something like binding arbitration is the kind of approach the organization would like to see.

"Such disputes only come up in a very small percentage of cases," Benson says, "but when they do hit, they can really hurt companies. There needs to be a clear-cut mechanism to address these disputes."

FDA has delegated responsibility for handling disputes to its centers, Benson says, and it is HIMA's understanding that a draft guidance will be issued shortly. "If that guidance meets our needs, that will be fine. But if it doesn't, we will be submitting comments and will consider whether we should approach some people in Congress to ask if they believe what the agency did was adequate."

Another HIMA initiative for 1999 is to establish a database on consensus standards that companies can meet and then file compliance reports to FDA in lieu of submitting test data. "There's a multitude of consensus standards out there," Benson said. "The idea of the database is to be able to improve communications by letting people know what standards are available and who they can talk to in various companies and organizations about standards they've used." Benson said the database could be maintained by a third party or kept on HIMA's Web site.

A series of meetings with CBER officials has also been undertaken with the goal of improving communications between industry and that center's regulators. "We've had very good meetings with some of the people who are regulating devices for CBER," Benson reports. "We've mapped out steps for improved communications. They are willing to set up vehicles to get a better handle on the review process. Since there are no user fees supporting device review, it often ends up on the bottom of the heap. We know CBER is trying to turn this situation around and get some management controls in place."

Benson notes that HIMA has "done the same kind of things on some issues with CDRH and it has worked very well. Good things happen when you are able to sit down around the table and work through issues."

In a joint advisory dated February 22 with CDC and OSHA, CDRH warned health practitioners of the risk of injury or infection due to accidental breakage of glass capillary (blood collection) tubes. The advisory—which follows the death from AIDS of a physician who contracted the disease from a broken tube—urges use of safer products, such as tubes not made of glass or those wrapped in puncture-resistant film.


Copyright ©1999 Medical Device & Diagnostic Industry