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Articles from 1998 In November


Coating Process Creates Permanent Slick, Dry Surface



Surface Modification

Coating Process Creates Permanent Slick, Dry Surface

The coefficient of friction of natural and synthetic elastomeric materials can be reduced

MANUFACTURERS AND USERS of plastic and rubber components can create a bonded slick, dry surface using a new coating process. Developed by Coating Technologies Inc. (Scotch Plains, NJ), the biocompatible LubriCoat coating reduces the friction on the surface of any synthetic or natural elastomeric material. The process creates a coating that does not crack, peel, or flake off; adds no significant weight; and will not affect the tensile strength, elasticity, compression, or durometer of the material it is applied to. LubriCoat can be used on parts such as seals, tubing, valves, and O-rings, eliminating the need to spray them with silicone.

The coating process is performed in a continuous batch operation. Prior to application of the coating, the elastomer surface is cleaned and specially prepared for bonding. The LubriCoat polymer is then applied, cured, and inspected. Fast, automated batch changeovers accommodate a variety of different component sizes and shapes.

Coating Technologies provides a contract coating service. For large production output, or for products that require greater control and monitoring, a custom turnkey package is available for in-house use.

For more information, call Coating Technologies at 908/654-5300.

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Imaging

Microminiature Camera Compatible with a Variety of Heads

Applications include endoscopy and microscopy

SUITABLE FOR ENDOSCOPY and microscopy, the IK-M43A microminiature camera by Toshiba (Irvine, CA) is compatible with 1/2- and 1/4-in. camera heads, as well as with standard C-mount lenses, without the use of an adapter.

The camera outputs S-video and composite (NTSC) signals and features a 410,000-pixel CCD image sensor, a newly designed microlens for enhanced low-light sensitivity, and 470-line resolution. Digital signal processing enhances image quality. An RS-232 interface allows PC control of the camera's CCU.

Other features include automatic tracking of white balance, an auto shutter mode that controls light from 1/60 to 1/50,000 of a second, and simultaneous Y/C and composite outputs.

For more information, call Toshiba at 708/482-0972.

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Testing Instruments

Dual-Channel Leak Tester Simultaneously Tests Two Parts

Allows higher production rates

A DUAL-CHANNEL leak-testing instrument increases productivity by simultaneously testing two parts or conducting different tests on the same part. The tester operates at high production-line speeds.

The new unit, made by InterTech Development Co. (Skokie, IL), is an enhanced version of the manufacturer's computerized M-1075 leak detector. It features extended memory, saving up to 1000 test records for display, printout, or downloading. In addition, it can perform statistical calculations on stored data to report mean, standard deviation, and mean ±3 standard deviation for statistical process control and other quality management programs.

The leak tester's design combines mass-flow sensing technology with microprocessor control for direct measurement of leakage rates, providing fast test cycle times of 0.3 to 2 seconds on test-part volumes ranging up to 25 cm3. This technology gives the new model a sensing range of up to 80 sccm and test pressures up to 100 psig. These features support a variety of applications involving products or components that must reliably contain a liquid, gas, or vacuum.

For more information, call InterTech Development Co. at 847/679-3377.

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Jury Named for Medical Design Awards



Jury Named for Medical Design Awards

MPMN publisher, Canon Communications (Santa Monica, CA), announced the jury for the 1999 Medical Design Excellence Awards. The eight-member panel will select the winning products for the annual medical product design and engineering competition.

The members of the 1999 jury are Kent Ritzel, Metaphase Design Group (St. Louis, MO); Christoph Böninger, Siemens Design & Messe GmbH (Munich, Germany); Michael Wiklund, American Institutes for Research (Concord, MA); Betsy Goodrich, Manta Product Development (Cambridge, MA); Sohrab Vossoughi, Ziba Design (Portland, OR); Bob Hall, GVO (Palo Alto, CA); Matt Duncan, Morphix Design, Newport Beach, CA); and John Gosbee, MD, Center for Applied Medical Informatics, Michigan State University Kalamazoo Center for Medical Studies (Kalamazoo, MI).

Products must be commercially available by the deadline date of February 8, 1999 in order to be eligible. Competition rules and entry forms are available through the 24-hour fax-on-demand line at 800/588-8527, by visiting www.devicelink.com/awards, or by calling Canon Communications at 310/392-5509.

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Bayer Expands with New Texas Facility

Growth includes $80 million capacity increase

As part of a plan to invest $9 billion in its U.S. operations by the year 2000, Bayer Corp. is opening a new facility at its Baytown, TX, site to strengthen its plastics and polyurethanes business. The new construction includes a $140 million MDI (diphenylmethane diisocyanate) plant and an $80 million expansion to increase the firm's polycarbonate capacity. The increase in polycarbonate will include both lipid-resistant and non-lipid-resistant grades, and will improve U.S. manufacturers' access to the materials.

Recent investments at the Baytown site include $500 million for infrastructure and other raw materials facilities for the manufacture of isocyanates, $150 million for a bisphenol A plant, and $140 million for dinitrotoluene and toluene diamine expansion.

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AAMI Issues EtO Guidances

Documents assist with sterilization procedures

Two new guidances for manufacturers using the ANSI/AAMI/ISO 11135 or 10993-7 standards are available from the Association for the Advancement of Medical Instrumentation (AAMI). TIR 15, "EtO Sterilization Equipment/Process Consideration," includes guidance on determining minimum product load temperature before preconditioning and on calculating relative humidity and EtO concentration in the load or sterilization chamber. TIR 19, "Guidance for 10993-7," includes a two-page flowchart illustrating decision points in the standard and the alternatives that are available at each point. Both guidances are available as individual documents and will appear together in AAMI's updated collection of 16 standards and reports, Sterilization, Part 3: Industrial Process Control. For information, call AAMI at 800/332-2264.

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Business News

Control products and systems company Spectrum Control Inc. (Erie, PA) has acquired most of the assets of Republic Electronics Corp., a maker of ceramic capacitors. Wire and cable manufacturer Tensolite Co. (St. Augustine, FL) has renamed VEMCO, a cable assembly company it recently acquired, Tensolite Interconnect Systems (Williston, VT). Plastic Molding Technology (Seymour, CT) has formed a joint venture company, Esoplast sro, with ESOX, (Bratislava, Slovakia) to provide insert- and injection-molded components. DDL Electronics Inc. (Newbury Park, CA) has announced that its wholly owned subsidiary SMTEK Corp. has signed a long-term partnership agreement with Haas Automation Inc. (Oxnard, CA) for the manufacture of custom electronic assemblies. Bonding equipment manufacturer Palomar Technologies (Vista, CA) has acquired Toddco General Inc. (Poway, CA). Toddco will combine with Palomar's welder product line group to form a new entity, MicroJoin Inc., which will be located at Toddco's former headquarters. ITW Electronic Component Packaging Systems (Arlington, TX) has acquired CariTech Inc. (Hudson, WI), a manufacturer of carrier tape products for the integrated circuit device market. Kalle Pentaplast GmbH (Montabaur, Germany) is expanding its product line to include rigid films based on COC raw materials. The films will be marketed by Ticona GmbH (Frankfurt, Germany) under the name Topas. Cincinnati Milacron (Batavia, OH) has signed a definitive agreement to buy Johnson Controls' plastics machinery division (Manchester, MI) for approximately $210 million. Accu-Sort Systems (Telford, PA) has acquired Visolux Accu-Sort (Stahnsdorf, Germany) to form Accu-Sort/Europe GmbH (ASE) to serve the European market for automatic identification systems.

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Prototype Wins Physicians' Approval



Prototype Wins Physicians' Approval

For the first time, military surgeons have performed arthroscopic surgeries in the field, thanks to a headset featuring miniature color display technology developed by Honeywell (Minneapolis) under sponsorship from the Defense Advanced Research Projects Agency (DARPA). The video headset's successful development and early acceptance in the field were due in large part to user research employing realistic prototypes of the device. The prototypes were assembled from parts fabricated using fused deposition modeling (FDM) technology and stereolithography (SLA).

Honeywell's new device replaces cumbersome CRT monitors, making it easier for surgeons to conduct minimally invasive surgeries in limited-space environments. The miniature color display is mounted on a headset and is used to view video images of a patient's internal geometry.

The headset can be adjusted for comfort and optimal viewing.

Investing in R&D

Honeywell's Technology Center (Minneapolis) develops and evaluates advanced technologies, processes, and product and service concepts for military and commercial settings. The U.S. government approached the center's display group with a concept for a high-resolution miniature display. While the display was initially developed for pilots and soldiers, the group identified the headset concept as a potential application.

A New Video Endoscopic Tool

Surgeons use video endoscopes for minimally invasive surgical procedures such as arthroscopy and laparoscopy. The endoscope has a miniature camera that transmits an electronic image to a CRT monitor. The monitor is often located several feet away from the operating table, requiring the surgeon to look away from the patient to view the image. Constantly turning one's head is awkward, and looking in the opposite direction of the procedure also can be disorienting.

A functional prototype of a stereoscopic head-mounted viewer, designed to replace CRT monitors, helped potential users recognize its value.



Military surgeons face additional challenges. As equipped as combat-support hospitals are, the medical team is still limited in the types of procedures it can perform because of weight and volume restrictions on equipment that is transported to a field location. The CRT monitors used for endoscopic procedures are large, heavy, and fragile, making them nearly impossible to transport. Thus, the U.S. military currently flies soldiers back to military hospitals for endoscopic surgery.

Honeywell research scientists identified miniature head-mounted display technology as a solution for both ease-of-use and portability problems. After the technology was under development for about one year, the Technology Center brought in Logica, a Minneapolis engineering and industrial design firm, to help design and prototype the device.

Logica and Honeywell designed the 28-oz headset so that surgeons could adjust it for both comfort and optimal viewing. Two miniature color displays are mounted directly in front of the eyes. The video display electronics are contained in a small pack worn by the surgeon.

Conducting Focus Group Research

To obtain feedback on the device, Honeywell and Logica sought input from potential users. In planning for focus group testing, one of the challenges Honeywell and Logica faced was the quality of the color and resolution of the image. Because the miniature color display technology was still in development during initial focus group testing, its image quality was not as high as that of the traditional CRT monitors the surgeons were accustomed to.

The designers were concerned that a low-quality image would bias the surgeons' perception of the entire technology, so they conducted early focus groups without prototypes. "Without a prototype, we quickly learned we could not get meaningful feedback on our design," says Scott Nelson, staff scientist at the Honeywell Technology Center. "It wasn't until 1995 that the miniature display resolution was anywhere near the quality of the CRT. Once we passed that milestone, we needed prototypes, but we couldn't justify tooling costs for focus group research. That's when we turned to Logica."

Choosing the Right RP Technology

About one year after the initial discussions with users, more focus groups were conducted--this time using functional prototypes with parts created using FDM and SLA. When selecting a rapid prototyping technology, "we look at the complexity and the size of the part," says Dan Cunagin, Logica vice president of engineering. "We use the Stratasys FDM system because we like its ABS material properties. It's easy to finish, it's strong, and it approximates injection-molded plastic."

Using FDM, Logica was able to develop 3-D parts from CAD-generated solid models. Stratasys QuickSlice software mathematically slices the conceptual model into horizontal layers, and then the FDM equipment extrudes thermoplastic material by layers to produce the 3-D object.

Several factors influenced Logica's decision to use FDM for portions of the headset assembly: the strength and heat-resistant properties of ABS, quick turnaround, and ease of modification. "By using FDM technology, we get our parts in hours versus a week or two," Nelson says, "and they are much closer representations to the actual CAD file."

According to Cunagin, machined parts would have been less representative of production parts than rapid prototyped parts. "If we want the surgeons to give us input, we need to provide them with a prototype that looks as much like a real product as possible," Cunagin says. "With any wearable product, the design becomes very sensitive. If the physicians are embarrassed to put the headset on, they may not even get to the point where they're evaluating the technology. But if the prototype is well built from an ergonomic standpoint, we're much more likely to get a fair technology assessment," Nelson adds.

The part across the top of the headset was prototyped using FDM because it is contoured and curved. Cunagin says interface area accuracy on contoured geometry can be difficult to achieve with other rapid prototyping processes. The electronics pack that supplies power to the two displays also was prototyped on the FDM system. The 3 x 2 x 1-in. pack contains a high-density PC board with the electronic equivalent of two television sets, plus video converters. "We chose FDM parts for the electronic covers and case housing because the operating temperature was more than SLA or laminated object manufacturing could withstand," Cunagin says.

For testing purposes, the surgeons were videotaped using the headset for actual surgical procedures. Logica interviewed the participants during and after the procedures, and collected their comments on improving the device. "Once the physicians used a functioning prototype, the advantages became more obvious to them," Cunagin says. "The same surgeons who said they weren't sure about the technology during earlier discussions could now see the benefits immediately."

Four functional headset prototypes have been built to date, with a combination of FDM and SLA parts. More than 24 procedures have been performed successfully using the prototype headsets.

MPMN is actively seeking success stories like this. If your company has one to tell, please contact associate editor Karim Marouf at 3340 Ocean Park Blvd., Ste. 1000, Santa Monica, CA 90405; 310/392-5509 or E-mail karim.marouf@cancom.com

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Pumps



Pumps


Diaphragm vacuum pumps

A range of diaphragm vacuum pumps use a dynamic mass-balancing mechanism. This feature of the Model N843 and N880 pumps instantly and automatically compensates for out-of-balance conditions caused by various force loads of gas pressure. This allows smooth running characteristics over the entire operating range. The pumps are especially suitable for use as vacuum roughing pumps used to pump down turbo-molecular pumps. KNF Neuberger Inc., 2 Black Forest Rd., Trenton, NJ 08691.
 


Micropump

Micropumps are designed to provide the performance of larger pumps while maintaining a miniature size. Although they are only 1.6 cu in. in total volume, the Model AA pumps provide flow rates of up to 2.7 L/min, pressures up to 9 psig, and vacuums up to 16 in.Hg. Applications include blood pressure monitoring, medicine delivery systems, and air monitoring devices. Sensidyne, 16333 Bay Vista Dr., Clearwater, FL 33760.
 


Varistaltic tubing pumps

Specially designed for a variety of liquid-handling needs, a line of varistaltic tubing pumps are microprocessor controlled and programmable to accommodate flow rates in a 0.15-2600 ml/hr or 1-6500 ml/min range. The Compulab 3 units can be used as continuous pumps, preset volume dispensers, or combination dilutor/dispensers. Their microprocessor-based controller features a user-friendly, menu-driven program that is accessed from an 80-character backlit keypad and display. The controller also has the ability to change pump speeds and dispensed volumes on the fly while the pumps are in operation. Barnant Co., 28W092 Commercial Ave., Barrington, IL 60010.
 


Liquid diaphragm pump

A value-priced liquid diaphragm pump is designed with a minimum number of moving parts for added dependability. It can be specified with FDA- or NSF-compliant materials and is available in Carilon, a Shell Chemical Co. thermoplastic with good chemical properties. The pump is self-priming and transfers fluids approaching the viscosity of 90-wt gear oil. Maximum output pressure is 20 psi, and maximum flow is 20 gal/min. Smart Products Inc., 1710 Ringwood Ave., San Jose, CA 95131.
 


Miniature peristaltic pumps

Miniature peristaltic pumps deliver 0.0003 to 22 ml/min. The Model P625 pumps measure only 1.1 x 1.3 x 2.4 in. Removable, sterilizable tube sets come in a range of materials and sizes, including new formulations with expanded chemical compatibility. Typical operating currents are less than 30 mA, making the pumps suitable for battery power. Speed control circuitry is included. Instech Laboratories Inc., 5209 Militia Hill Rd., Plymouth Meeting, PA 19462-1216.
 


Diaphragm pump

Fitted with a brushless dc motor and advanced materials, a diaphragm pump is engineered for 10,000 hours of service, 80°C environments, and continuous duty. Applications include medical devices and analytical instruments. The compact pump is designed to be optimized for specific OEM applications. Specifications include flows to 8 L/min, pressure to 30 psi, and vacuum to 20 in.Hg. Hargraves Technology Corp., 116 Gasoline Alley, Ste. 113, Mooresville, NC 28117.
 


Miniature dispense pumps

Suitable for use in automated clinical instruments, chemically inert dispense pumps are available in both preset (50 µl) and variable-volume models. The pumps offer size and weight savings over conventional syringe and peristaltic pumps, according to their manufacturer. Variable-volume pumps are available in 50-, 250-, and 750- µl configurations, dispensing in 0.1-, 0.5-, and 1.5- µl increments, respectively. Power consumption for all units is less than 2.5 W. The Lee Co., PO Box 424, Westbrook, CT 06498.
 


Modular digital pump

Device manufacturers can design smaller and lighter instruments using a modular digital pump. The XP 3000 module stands only 5 in. and weighs only 2.5 lb. It automates pipetting, diluting, and dispensing with precision over a wide range of speeds using a variety of syringe sizes. The unit communicates through RS-232, RS-485, or CAN protocol and operates from a single 24-V-dc power supply. Cavro Scientific Instruments Inc., 242 Humboldt Ct., Sunnyvale, CA 94089.
 

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Resin Meets Critical Needs of Dual-Lumen Catheter



Resin Meets Critical Needs of Dual-Lumen Catheter

Resin supplier also helps in part design and processing

When a company decides to redesign a product after 14 years of production, the smart move would be to look for advice from customers, staff, and even materials suppliers. In redesigning its Mahurkar dual-lumen catheter, Kendall Sherwood–Davis & Geck (Mansfield, MA) did just that. The catheter is used in hemodialysis, aphoresis, and infusion procedures, and is inserted into major arteries. As a result, the company sought a new resin that could meet all the critical needs of the catheter in terms of biocompatibility and sterilization. And, as the device is commonly sutured in place through a rotatable suture wing that attaches to the catheter hub, it was important to select a resin that met all rigidity and durability criteria. To make sure it found a resin that would do the job, the company invited the catheter's long-standing resin supplier, the Bayer Corp.'s Polymers Div. (Pittsburgh), to join in on the product's redesign.

"It's not often that you get to redesign an older product like this," says Michael Hillson, senior manufacturing engineer for Kendall Sherwood–Davis & Geck. "We wanted to do it right and felt that Bayer had to be involved, too." The two companies worked together throughout the process, from initial planning stages to material selection and molding trials. Bayer's involvement included opening the doors of its Application Development Center to design engineers from the OEM, giving them a chance to work side by side with Bayer's material specialists. Technicians from the resin supplier evaluated samples of the catheter hub and recommended improvements to the part design, mold design, processing, and assembly. In addition, Bayer developed new guidelines to improve the bonding of the catheter's implant length to the catheter hub. As Hillson notes, Bayer's help freed up his time, allowing him "to focus on part design, rather than on the material's quality, and it significantly expedited development. We had a new part design and a new mold, and we tested parts within six months."

During the resin selection process, Bayer provided the OEM with long-term aging data on its ABS resin, Lustran ABS 348. In addition, Kendall Sherwood–Davis & Geck ran its own series of tests, including drying a sample for 100 hours, as opposed to the normal 3-hour drying period. As the company found, the overdrying did not significantly affect the resin's properties or processing, and parts molded with the overdried resin met the OEM's demanding quality standards. As a result, the company decided to use Lustran ABS 348 in the redesigned catheter.

To complete a redesign of its dual-lumen catheter in only six months, Kendall Sherwood–Davis & Geck sought the assistance of Bayer Corp., Polymers Div.

In addition to thermal stability during processing, the resin combined a balance of physical properties, intermediate-abuse resistance, and rigidity. It is sterilizable using radiation or ethylene oxide and meets the biocompatibility requirements of the FDA-modified ISO 10993, Part I. The redesigned catheter hub, which connects two catheter tubes to the implant length, is processed in two-cavity molds in the OEM's own facilities. The hub's wall sections range in thickness from 0.015 to 0.225 in.

As Kendall Sherwood–Davis & Geck found, though, the resin was up to the task. The resin runs clean in complicated tooling, and produces no significant variation in the parts produced. As Hillson says, "The Lustran ABS 348 is a very forgiving material in that parts are extremely consistent." Using the resin, the company can run molds five days a week, 24 hours a day, cost-effectively producing a high volume of the new catheter without worrying about material quality.

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Products Featured on the November 1998 issue of MPMN

Products Featured on the November 1998 issue of MPMN

Electrical discharge machining produces burr-free parts

Electrical discharge machining (EDM) produces accurate, burr-free finished parts. Wire EDM is suitable for producing complex, contoured shapes in tough-to-machine materials such as medical-grade stainless steel and titanium. Using more than 40 high-speed machines, a contract manufacturer offers efficient, economical wire EDM production. The company's EDM facilities can work with job runs of 50 to 50,000 pieces, and prototyping services are available. Adron Tool Corp., P.O. Box 960, Menomonee Falls, WI 53051.




Part designer offers valves, manifolds, flow switches, and level controls

A company offers highly accurate technology and products for medical OEM applications. Two- and three-way solenoid valves, operators, manifolds, single- and multipoint level switches, and fixed- and variable-flow switches are offered. Valves are available with a metering option that provides adjustable flow for dispensing a specific rate or flow of a fluid or gas. A variety of value-added assemblies are offered, including cartridges installed into a manifold base and a wide array of fittings and electrical terminations. KIP Inc., 72 Spring Ln., Farmington, CT 06034.




Linear stepper actuator eliminates the need for a reduction gearbox

For medical applications that require a regulating, measuring, or leveling motion, a linear stepper actuator offers cost-effective, space-saving precision positioning. Based on a 36-mm motor, the UBL series linear actuator eliminates the use of a reduction gearbox, decreasing cost, number of parts, assembly time, and labor required. Linear stroke for the series is 8, 13, or 45 mm, with 0.033-mm displacement per step. The linear actuator models are available as either a two-phase or four-phase stepper. SAIA-Burgess Electronics Inc., 1335 Barclay Blvd., Buffalo Grove, IL 60089.



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Singling out the Top Contenders

Editor's Page

Singling out the Top Contenders

Welcome to the MPMN 100 issue, where we give top billing to the components, materials, services, and literature that our readers requested most often during the past 12 months. MPMN instituted this annual feature six years ago to identify what you find most interesting in the magazine and bring you more of it.

In the spirit of the top 100, I thought I'd share parts of another other "top" list, along with one of my own.

In a recent study, Frost & Sullivan reported the most challenging issues facing the medical and data communications contract manufacturing industries. The key medical device issues identified in the study include the following:

1. With more medical OEMs moving toward "virtual manufacturing facilities," contract manufacturers are required to invest in information technology to provide OEMs with production, test, and distribution data in real time.

2. OEMs are demanding more advanced technologies, requiring contract manufacturers to make significant investments in new equipment.

3. In an effort to integrate vertically to meet OEM demand for more services, contract manufacturers run the risk of losing some of their core competencies.

4. Contract manufacturers face a tight labor market and are competitively bidding against other industries for the same workforce.

5. Because of the highly regulated nature of the medical device industry, generalist contract manufacturers are having difficulty entering the market.

Having just returned from the Industrial Designers Society of America National Conference and now gearing up for the Medical Equipment Design & Technology Exhibition and Conference and the upcoming Medical Design & Manufacturing (MD&M) events in November and January, here are my top-five reasons why it's important to take the time to participate in industry conferences and trade shows:

1. Feedback. Companies spend thousands of dollars on market research to find out what their customers think about their products, and much of this information can be obtained free for the asking. Exhibiting at trade shows can invite valuable user feedback, customer validation about what you are doing right, and creative input into ways to improve your product.

2. Face-to-face contacts. Trade events provide the ideal venue for making new contacts and strengthening old relationships.

3. Free advice. Conference speakers usually allocate time at the end of their sessions for audience questions, and you can usually approach them afterwards for more detailed information.

4. Competitor intelligence. With most companies unveiling or previewing new products on the show floor, you can often gather significant information about your competitor's products and observe how the products are being received by potential buyers.

5. Inspiration. Spending time with colleagues from afar, being exposed to new information, and taking a few days away from the office can help stimulate the solution to a problem or provide new insight into a project.

If nothing else, coming to Southern California in January for MD&M West and taking some time out for Disneyland and Rollerblading aren't bad ideas.

Amy Allen

Packaging Equipment


 

Packaging Equipment

Vacuum sealer

A vacuum sealer features an alarm-activated control that engages if
seal parameters are not within a preset range. Seal temperature, time, and pressure are preset using the Med Vac's digital controls, which feature LED readouts. Machine calibration and validation are possible using an external connection. The manufacturer can also customize the machine to meet customer needs. Packaging Aids Corp., P.O. Box 9144, San Rafael, CA 94912-9144.
 


In-line thermoformers

A series of high-speed, computer-controlled pressure formers are capable of preheat, form, punch, die-cut, trim, stack, and automatic unload of trays, capsule blisters, and clamshells.

The SC-series units are available with scrap windup or scrap grinding of the trim. Key features include program memory, computer setup, 8-10-minute changeover, and data collection for product certification. Free training is included. Zed Industries Inc., 3580 Lightner Rd., Vandalia, OH 45377.




Heat sealer

A rotary heat sealer is designed to imprint date and code information during the sealing process, thereby saving time and eliminating a second step in the packaging of medical devices and diagnostics. The Miniro H meets FDA traceability requirements and is CE and ISO compliant. It uses a direct-contact heat system to produce high-integrity seals on Tyvek medical pouches. The precision heating is followed by a pressure roller system designed to compensate for the thickness variations found in Tyvek, permitting a greater sealing pressure and eliminating the need for Teflon belts, which require frequent replacement. Packworld USA, 539 S. Main St., Nazareth, PA 18064.
 


Pouch sealers

Temperature-controlled thermal impulse heat sealers for closing sterile peel pouches and dust covers can seal ready-made bags and pouches made of films and laminates. The air- and watertight seals are completed inside the jaws before the package is removed from the machine. A programmable controller has three temperature settings to ensure tight, repeatable seals. If a target temperature is not reached, the heat sealers communicate the failure to the operator, suspending operation until the operator takes corrective action. Vertrod Corp., 2037 Utica Ave., Brooklyn, NY 11234-3299.
 


PC-controlled tray sealer

A PC-controlled medical tray sealer is easy to set up and operate. The BM2020's PC controller and touch screen interface provide time, temperature, and pressure control. A real-time acquisition package, which can be customized to user-specific applications, saves and automatically stores all data in a user-specified file for each seal cycle the machine makes. This stored data provides the user with infinite product traceability. Options include bar code scanners/readers, network capabilities, and custom height configurations. Belco Packaging Systems Inc., 910 S. Mountain Ave., Monrovia, CA 90016.
 


Tabletop heat sealer

A validatable continuous rotary heat sealer provides high seal quality at low cost. The tabletop MPS 6340 heat sealer is suitable for lightweight applications such as pouches up to 8 oz. It provides versatility with an adjustable head for sealing angles that range from 0° (vertical) to 90° (horizontal), easy access for quick changes of economical Teflon-coated bands, and an optional product shelf for consistent loading and sealing performance. Using air-pressurized heating and cooling bars, digital temperature control, and a digital tachometer, the unit also offers audio alarms, an external thermocouple jack, and reverse feed for the validation of sealing parameters. Emplex Systems Inc., 2045 Midland Ave., Scarborough, ON M1P 3E2, Canada.
 


Induction cap sealers

With FDA enforcing its regulations concerning tamper-resistant packaging, more and more pharmaceutical and medical device packagers are concerned with maintaining tamper-resistant, airtight, and spill-proof seals on packaged goods. The Foiler induction cap sealer meets or exceeds these government regulations. It allows packagers to seal from 10- to 120-mm closure sizes at high speed. Multiple applications can be run on the same line without making coil changeovers. Other features include remote capabilities up to a distance of 50 ft, power to 4 kW for maximum line speeds, and autostart capability. Pillar Technologies, PO Box 110, Hartland, WI 53029.
 


Automatic pouch open/fill/seal system

An open/fill/seal system is suitable for premade pouches and bags, with or without zipper closures. The Pouchmaster automatic bar seal system is a miniature, robotic PLC-controlled system that is compact (4 x 5 in.) and of a modular design. It has four robotic work stations that easily open and process a variety of barrier packaging materials. The system is cleanroom compatible and can easily be integrated with automatic fillers. About Packaging Robotics Inc., 6661 Arapahoe Ave., Ste. 2, Boulder, CO 80303.
 


Pouch-making machine

Designed to produce a full range of pouches used by the medical industry, an ac-servo-driven sealing press is available in two basic models for processing webs up to 26 or 36 in. wide, respectively. The servo drive offers benefits such as closed-loop control over sealing pressure and dwell, giving precise repeatability; microadjustable pressure control; smooth, high-speed press actuation; and very low noise levels. GN Packaging Equipment, 855 Britannia Rd. E., Mississauga, ON L4W 4T2, Canada.
 


Medical tray sealer

Featuring a compact design, a medical tray sealer can accommodate packages as big as 12 x 16 x 3 in. The sealer is equipped with process controls that ensure packages are manufactured to the highest standards. It creates high-integrity seals that withstand the rigors of sterilization. With installed validation ports, users can quickly and conveniently conduct process assessment. Calibrated instrumentation includes a solid-state digital display dwell timer, a temperature controller, a thermocouple, and a pressure gage. EMD Products, PO Box 7491, Libertyville, IL 60048.
 

When Less Is More: Minimally Invasive Therapies Herald Maximally Influential Changes

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI November 1998 Column

A surgeon's vision of the future includes a critical role for the contributions of biomedical design engineers.

Among the most enduring images of modern medicine is that of the lone surgeon—the last line of defense—standing fast against disease and death with an armament of art, science, and cold steel. What, then, could provoke a distinguished member of this heroic band to depict his fellow practitioners as "Neanderthals . . . a species that certainly should become extinct in the next 20 years"? And why would such a heretic be the featured speaker at a gathering of biomedical engineers?

John E.A. Wickham, senior research fellow and surgeon at Guy's Hospital in London, is credited with coining the term "minimally invasive surgery" and with organizing the first MIS department, set up at the University of London's Institute of Urology in 1986. In his plenary address during the recent annual meeting of the Biomedical Engineering Society, held in Cleveland, Wickham proposed a scenario for the future of minimally invasive therapies that, if accurate, holds profound implications not only for health-care providers but for the device industry as well.

In brief, Wickham predicts that the traditional domains of the "open" surgeon will be rapidly taken over by teams of endoscopists and interventional radiologists, working closely with bioengineers and instrument manufacturers. These changes would apply to most current surgical specialties, encompassing urologic, obstetric/gynecologic, gastrointestinal, orthopedic, neurologic, cardiothoracic, and vascular procedures. The fact that minimally invasive operative methods are becoming more common is neither new nor surprising, given that the techniques can often reduce patient morbidity and save money compared with standard treatments.

But Wickham foresees a more extensive transformation resulting from the wide-scale adoption of minimally invasive therapies. Demands for new technology will include the need for more sophisticated equipment, ranging from miniaturized scopes to advanced tissue-manipulation and tissue-lesioning tools, active and diagnostic robotics, and next-generation imaging devices and optics. Anesthesia practices will follow trends in surgery, with more emphasis on peripheral nerve blocks and the development of "on/off," reverse-potential blocks. Operating suites and radiology rooms will have to be reengineered to accommodate new equipment, personnel, patient-transport systems, and work-flow patterns. Common ailments involving diverse organ groups will be treated at peripheral facilities staffed by "general" endoscopic surgeons and interventional radiologists, with the more complicated procedures done at regional centers by "intensivists" in the same disciplines.

How quickly these events are realized will largely depend, says Wickham, on "whether the diffusion of new technology is to be guided by physicians or by politicians." If health-care policy does not become more supportive of technological innovation, Wickham fears that the physician's "flexible, discretionary judgement necessary for patient well-being" will continue to be compromised by government regulation and market forces intent on preserving the status quo. He quotes J. S. Mill, who found that "the despotism of custom is everywhere the standing hindrance to human achievement." It might even keep some of the smarter Neanderthals standing around the tables a few extra years.

Promoting innovative technology is also the focus of the second annual Medical Design Excellence Awards, sponsored by MDDI's publisher Canon Communications. I want to remind our readers that the deadline to submit entries for the competition is February 8, 1999. Information on how to achieve recognition for the product(s) of your inspiration can be found at www.devicelink.com/awards.

Jon Katz
jon.katz@cancom.com


Copyright ©1998 Medical Device & Diagnostic Industry

Henney Delivers Positive Message to Device Makers

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI November 1998 Column

WASHINGTON WRAP-UP

The nominee's response to detailed questioning by a Senate committee reveals an openness and willingness to cooperate with industry.

James G. Dickinson


Also:
  • Draft pilot program to reduce warning letters
  • Additional device standards recognized
  • HIMA wants FDA to use entire standards
  • FDA needs more device review prototypes
  • HIMA seeks further-expanded MRA
  • Ruling satisfies Myo-tronics—for now

    Medical device manufacturers may have felt alienated by David Kessler's FDA, but his successor-designate and former deputy, Jane Ellen Henney, MD, has been making deliberate if measured efforts through government channels to show a more friendly countenance to the industry.

    On September 23, Henney's appointment was approved in a voice vote by the Senate Labor and Human Resources Committee and subsequently approved by the full Senate. In the days leading up to her confirmation hearing, Henney answered 140 written questions that had been put to her in advance by committee chairman James M. Jeffords (R–VT). Sixty-seven of the questions were about medical devices—far more than about any other subject.

    The questions purportedly originated with Jeffords and his colleagues, but the content was heavily influenced by the medical device industry. Similarly, most of the information in Henney's answers appeared to have been provided by FDA officials and their overseers in the Department of Health and Human Services.

    It could hardly have been otherwise, given Henney's four-year absence from the agency and the intricate nature of some of the questions. For example, she could hardly have been expected to know whether a senator's constituent should be able to get a 510(k) for a laser based on another laser's approved use with a slightly different kind of tissue—one of the questions posed to her.

    Despite the fact that Henney may have been repeating the party line, the nominee took advantage of numerous opportunities to show that she is personally sensitive to many industry concerns. These include issues to which FDA had seemed unresponsive during and since the time Henney last served at the agency (1992–1994).

    For instance, Henney was at CDRH when the center—in the wake of the generic drug scandal—choked off many channels of communication between device sponsors and reviewers. In her answers to Jeffords, however, she emerges as a champion of open communication. To a question about industry-FDA interaction prior to publication of a guidance document, Henney maintained that, if confirmed, she would "work diligently to continue to improve the communication between the agency and the regulated industry. . . ."

    Other responses showed Henney to be an advocate of equal time and access to briefing packages for sponsors at FDA advisory committee meetings; a supporter of fair treatment for sponsors in administrative appeals, including freedom from reprisals when officials make unfavorable decisions; and a voice for continued grassroots dialogue with industry. "I believe there is always value in communication, particularly when it is undertaken at a stage where it can guide the parties in making appropriate decisions," Henney said in answer to a question about early FDA meetings with potential premarket approval (PMA) applicants.

    Henney's answers showed considerable sympathy for manufacturer positions in other areas as well. She said, for example, that FDA should require "only such data as are necessary" and not default to requiring the most burdensome type of clinical studies. She also gave a cold shoulder to the oft-recurring plea for device user fees, despite being nominated by a White House that seeks them every year. Historically, Henney said, "user fees have succeeded only when they result from consensus among the agency, the Congress, industry, and consumers."

    Henney supports third-party reviews of medical devices and will give them her top priority, applauds CDRH reengineering efforts, favors requiring only the minimal amount of information needed to demonstrate substantial equivalence, and favors reliance on harmonized international device standards. She also endorses the "reasonable assurance" standard for device effectiveness rather than the "substantial evidence" standard applied to drugs and will encourage FDA reviewers to rely on information in approved PMAs when it is available and relevant to the evaluation of a newer device.

    On the issue of whether CDRH should consider possible off-label uses when reviewing a device as opposed to confining itself to the sponsor's requested indications, Henney said she agreed with the solution found in the FDA Modernization Act of 1997—that off-label uses should be considered only after the rest of the review is done.

    Asked whether FDA should issue warning letters to companies that are implementing corrections to GMP problems found during an inspection, Henney showed how well she knows the agency. Even though she was not privy to the information that FDA would, within the following week, propose a pilot program for device manufacturers eliminating such warning letters in good-faith situations, Henney told Jeffords she believes that "in the case where a firm responds to an inspection finding and the agency deems the response to be adequate, a warning letter usually is not warranted."

    In responding to a question that might have been inspired by the publicity hound reputation of her predecessor, Henney implied that she would be just the opposite. The question asked in what circumstances FDA should use publicity to achieve a consumer protection result. "I believe," Henney replied altruistically, "that FDA should use publicity wisely to provide the American people with critical, useful public health information in an accurate and timely manner. I think that some circumstances in which publicity is effective are announcements of recently approved products that may provide significant new clinical benefits and options to patients; warnings about adulterated or misbranded foods, drugs, and devices that are being withdrawn or recalled from the market because they may pose serious or life-threatening health risks; and continuing education efforts such as FDA's Office of Women's Health 'Use Medicines Wisely' campaign."

    This answer might be indicative of Henney's like-mindedness with the people she will be leading at FDA. As physical security barriers have increasingly shielded them in their daily work from outsiders and voice mail has freed them from many past intrusions on their time—especially from the media—Henney's FDA may see itself more in charge of its own publicity than has been the case in the past. And whereas David Kessler enjoyed a love affair with the media and was able to manage it to his and the agency's advantage, this is a rare skill, and Henney may not be so fortunate.

    In any case, Henney is the first nominee for commissioner to be subjected to such a grueling, intense, and diversely detailed senatorial screening process.

    Her answers to Jeffords's 140 questions show a deft blending of reliance on institutional data, political acumen, philosophical caution, and native reserve. All of these qualities will serve her well as commissioner.

    Few FDA behaviors have aggravated industry more than the agency's past penchant for issuing publicly embarrassing warning letters when the matters complained of have already been cooperatively cleaned up by the subject company.

    The situation has arisen out of two tendencies within FDA. The first is a lawyer-driven perceived need to "put the firm on official notice" to the effect that problems have been found and duly reported and that the agency is poised to administer heavy punishment if it becomes necessary (courts like to see this sort of thing). The second tendency is a bureaucracy-driven inclination to issue warning letters later rather than sooner (sometimes many months later).

    Now comes an FDA draft pilot program under which much of this kind of delayed enforcement could become a thing of the past. Constrained to do more with much less money, FDA said in an August 27 Federal Register notice that—for medical device companies only—it wants to pilot test an 18-month program under which warning letters for quality system, 510(k), and labeling violations will not be issued in the following circumstances:

    1. The firm responds adequately and within 15 days to the FDA 483 notice of inspectional observations.

    2. The violation(s) are not found in "non–quality system" inspections such as for mammography, radiological health, or bioresearch.

    3. The establishment does not manufacture drugs as well as devices.

    4. The establishment does not manufacture devices that are regulated by the Center for Biologics Evaluation and Research.

    5. The establishment does not have a "recidivous" history with FDA.

    6. The inspection did not uncover quality system, 510(k), or labeling deficiencies that could cause serious adverse health consequences.

    7. The inspection was not a compliance follow-up inspection to a previous one that resulted in a warning letter or regulatory action for quality system, 510(k), or labeling violations.

    8. The inspection did not disclose other significant device violations—in addition to quality system, 510(k), or labeling violations—that warrant the issuance of a warning letter or other regulatory action (e.g., medical device reporting or premarket approval infractions).

    9. The firm's management did not fail to make available to FDA personnel all requested information and records required by regulations or laws enforced by FDA.

    10. The violations do not involve advertising and promotion issues.

    11. The inspection uncovered no devices that were never cleared by FDA via a 510(k), unless they were exempt from this requirement (section 807.81(a)(1) or (a)(2)).

    12. There was no major change or modification in the intended use of the device(s).

    13. The device(s) are not electronic products that emit radiation.

    The draft pilot program—which won't begin before FDA has evaluated public comments it is receiving until October 13, 1998—will be applicable to all medical device inspections except those conducted under FDA contracts by the states of California, Colorado, and Texas.

    An additional 241 consensus standards for use in the CDRH "510(k) paradigm" submission process have been recognized by FDA. Under the paradigm, device manufacturers can submit declarations of conformance to recognized standards in lieu of submitting data that ordinarily would be evaluated by FDA reviewers. The complete list of FDA-recognized standards is available on the Internet at http://www.fda.gov/cdrh/modact/recstand.html.

    FDA should recognize relevant national and international consensus standards in their entirety unless the agency has valid scientific reasons for deviating from such standards, the Health Industry Manufacturers Association told FDA in a recent letter. Specifically, HIMA cited the ASTM standard PS 77-97 that FDA didn't fully incorporate in its May 4, 1998, draft guidance "Testing for Skin Sensitization to Chemicals in Latex Products." In the guidance, FDA proposes setting the sample size at 300 subjects when the standard recommends 200; the agency also calls for a 1 x 1-in. test patch while the standard suggests a 2 x 2-cm patch.

    FDA should publish a flowchart of internal processes for all device submissions, HIMA told CDRH on August 18 at a FDA Modernization Act stakeholders meeting in Washington, DC. In addition, more templates, prototypes, and examples of successful submissions should be made available. For inspections, HIMA suggested that "FDA should consider ISO certifications in prioritizing and should ultimately harmonize" with ISO. HIMA also called for joint training with FDA investigators so that device manufacturers could have a better understanding of inspection criteria.

    In August 3 comments, HIMA urged FDA to widen its mutual recognition agreement (MRA) with the EU to allow third-party review of even more medical devices than are covered by its recently expanded list. All eligible devices other than permanently implanted or life-sustaining/supporting devices or those requiring clinical data should be eligible for review by EU conformity assessment bodies (CABs), HIMA maintained, and FDA should accept international standards in its reviews rather than write new guidances.

    Despite FDA advance submission of allegedly "biased" information against its products to the Dental Products Advisory Panel in August, Myo-tronics, Inc., president Roland Jankelson said afterward that the company "got what we wanted"—namely, a recommendation for Class I classification of its jaw-tracking and sonography monitoring devices. Jankelson, who has been battling what he calls a "flawed" process at CDRH since 1994, when a panel decision against his products had to be vacated because it was tainted by membership conflicts of interest, says he expects more trouble from FDA in the future.


    Copyright ©1998 Medical Device & Diagnostic Industry