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Articles from 1997 In October

Motor Provides Steady Power to X-Ray Viewing Device

Motor Provides Steady Power to X-Ray Viewing Device

Enables diagnosticians to view multiple films as a series

In order to make diagnoses from x-ray film, doctors need to use a tool known as an x-ray viewer. An x-ray film­changer system is essential to a film viewer because without it, diagnosticians cannot view the films as a series.

Elema-Schonander (Hoffman Estates, IL), a division of Siemens Medical Systems, manufactures a high-speed film-changer system used in vascular imaging (angiography) and a motorized high-capacity film viewer called the Rolloscope. In the early 1980s, the company contracted with Panlmatic Co. (Elk Grove Village, IL) to reengineer its original Rolloscope and start production of the Rolloscope II. With the success of that model, Elema-Schonander began testing of a motorized viewer dedicated to mammography--the Rolloscope M. With 85 rows for film viewing, the Rolloscope M holds 1020 films sized 18 x 24 in. and 680 films sized 24 x 30 in. Despite its high-volume capacity, the Rolloscope M is small enough to roll through a standard door.

Every second, Elema-Schonander's high-speed film changer can expose six x-ray films as large as 14 x 14 in. When the system is added to the Rolloscope viewing device, which holds up to 200 large x-ray films, diagnosticians can view a large number of films as a series. The viewer is motorized so that radiologists can quickly and easily review any series of x-ray films.

For the Rolloscope machine, Elema-Schonander needed a reliable and powerful motor that would fit into the viewer's mounting configuration. These requirements were met by a 42A5BEPM-GB Model 4060 motor supplied by Bodine Electric Co. (Chicago). While other manufacturers were unable to fit their motor drives into the film viewer's configuration, Bodine's 42-frame permanent-magnet gearmotor provided a large frame size and strong right-angle drive, supplying the load capacity required to wind and unwind the huge film spool.

Another benefit was the steadiness and power of the Bodine motor. In typical systems, the drums driving the film reels have tortion springs that tend to wind up the drum after the radiologist scrolls to the correct exposure, similar to a window shade retracting despite the care taken trying to keep it steady. For the diagnostician, this is unacceptable because it would cause the film to creep up and out of view. The steady power of the Bodine motor helps eliminate this problem.

In addition, the Bodine motor provides high starting torque, adjustable speed, and predictable performance for a range of operating conditions. Standard features that add to the life of the motor include a vented gear housing, a ball bearing on the output shaft (for increased radial load capacity), permanently lubricated gearing using oil, and a hardened and ground worm hobbed on the motor shaft. A hardened helical output gearing is built in for quiet operation and high output torque.

Seeking reliability and performance in a motor, Elema-Schonander discovered that Bodine could deliver what it takes to power its Rolloscope line of x-ray film viewers.

For more information on motors from Bodine Electric Co., call 800/726-3463.

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MPMN October 1997: Products Featured on the Cover

MPMN October 1997: Products Featured on the Cover

Brushless dc motors offer long life and high performance

A line of dc motors offers brushless longevity and slotless performance with brush manufacturability. To accommodate a variety of applications, the Elcom II motors can be configured for back EMF, Hall sensor, or optical encoder commutation. Other features include gearheads, timing belt pulleys, cables and connectors, and modified shafts. Special configurations are also available. The Series 3400 version measures 30 x 30 x 53 mm and provides maximum continuous torque of 25.0 mN-m. Pittman, 343 Godshall Dr., Harleysville, PA 19438. Phone: 215/256-6601.

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Heat-seal press suitable for medical product manufacturing

Capable of sealing areas measuring up to 24 x 36 in., a heat-seal shuttle press can be used for packaging medical products as well as for manufacturing devices made with thermoplastic films. The press can be fully validated and provides complete control of temperature, time, and pressure. The company's Accu-Temp impulse heat system continually monitors and adjusts the temperature of the heat-seal band to within 3 degrees of the desired setting. An optional data logger records the sealing parameters of each cycle, providing useful documentation for FDA validation. Packworld USA, 539 S. Main St., Nazareth, PA 18064. Phone: 610/746-2765.

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Specialty compounds can be molded or extruded

Suitable for manufacturing a variety of medical devices, specialty compounds have been formulated to meet extrusion or molding requirements for flexible, semirigid, and rigid applications. Materials are engineered to achieve features such as gel-free clarity, color stability after sterilization, radiopacity, migration resistance, and slipperiness with DEHP, phthalate-free, and halogen-free alternatives. Recent product introductions include a line of compounds that use vegetable-derived stabilizers and lubricants rather than bovine derivatives for increased clarity and gamma stability. AlphaGary Corp., 170 Pioneer Dr., P.O. Box 808, Leominster, MA 01453. Phone: 800/221-6599.

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Editor's Page

Editor's Page

Medical Design Awards Program Debuts

In July 1985, the first product tabloid created specifically for medical device designers and manufacturers was launched. In that 12-year span, Medical Product Manufacturing News has grown alongside the industry, publishing information on nearly 100,000 products and services from thousands of manufacturers. Our mission is the same now as it was then: to present the best available components in a concise, easy-to-read format.

Continuing with that mission, we are proud to introduce the first Medical Design Excellence Awards. Sponsored by Canon Communications, publisher of MPMN, the program will recognize not only those products we've brought to you in the past, but also your creations--the cutting-edge medical devices in which those products became integral components.

Collaborating on the awards program is the Industrial Designers Society of America (IDSA). IDSA also cosponsors, along with Business Week magazine, the annual Industrial Design Excellence Awards, which recognize design excellence in computers, medical equipment, consumer products, packaging, multimedia, exhibits, and automobiles.

Awards will be presented for both finished medical devices as well as materials and components used in medical applications. Entries will be evaluated for their functional improvement, business benefit, and innovation by a panel of industry experts convened by IDSA at its Great Falls, VA, national office.

Entries chosen as finalists will be published in the May issues of MPMN and Medical Device & Diagnostic Industry (MD&DI) and will be recognized during the Medical Design & Manufacturing (MD&M) East 98 Conference and Exposition in New York City (June 1­4, 1998), where the products will be on display. The winners will be announced at a ceremony held in conjunction with the show and will also be featured in the July/August issue of MPMN and the July issue of MD&DI.

The deadline for entry submission is January 26, 1998. Complete rules and an entry form can be found opposite page 32 in this issue, or you can download them from our Web site ( Booth 256 at the MD&M Minneapolis Conference and Exposition (November 4­6, 1997) will also have information on how to participate. I hope that many of you will enter your products into this competition. It's time to get the recognition you deserve.

Ursula Jones

[email protected]

PDM Software Tracks Product Development Process


PDM Software Tracks Product Development Process

Helps device manufacturers meet design control requirements

Workgroup Technology Corp. (Lexington, MA) has developed a tool that provides medical device manufacturers with complete product data management (PDM) capabilities, enabling them to meet regulatory requirements. The CMS 7.0 software package manages the actual work outputs--or deliverables--of product managers, change coordinators, engineers, and other professionals throughout the product life cycle. It provides vault and version control, file security, product structure management, configuration management, process management, information distribution, viewing, and integration with desktop applications.

The software is particularly useful for medical device manufacturers trying to implement ISO 9000, QS-9000, FDA's quality system regulation, and the European Medical Devices Directive. CMS 7.0 makes this easier by modeling and institutionalizing processes, maintaining complete audit trails, and keeping process and product information tightly coupled.

Conventional PDM has focused only on managing information once engineering has released it, and has not significantly affected the front end of the development cycle. Likewise, conventional work flow technology has not been effective in automating product development because its rigid task-based approach does not accommodate the creative and iterative engineering process.

CMS 7.0 provides real-time visibility into the state of completion of deliverables, as well as any dependencies a deliverable may have on others. Features include stage-based process modeling, process synchronization, real-time project tracking, project and deliverable reuse, and enterprise-distributed vault.

For more information, contact Workgroup Technology Corp. at 617/674-2000.

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New Equipment

Cutting Machine Designed for Processing Medical Tubing

Available with an optional solvent dispenser

A benchtop Programmable cutting machine has been developed by TechnoMed Inc. (Salem, NH) for use with medical tubing. The Readycut machine features an optional internal system that dispenses solvent onto the tubing for immediate assembly. When the operator's hand interrupts a photosensor, the prewetted tubing is automatically released.

The Readycut machine is particularly well suited for manufacturing tubing sets where cut-length precision, cut accuracy, and the quantity of solvent dispensed are critical. Cut lengths can vary from 2 to 390 in. in 0.04-in. increments, with average repeatability of ±2%, depending on the tubing material used. Outside diameters from 1.57 to 3.89 in. can be accommodated.

Fifty different production cycles can be stored in the system's memory, offering flexibility and repeatability. An in-progress counter displays the actual number of sequences or steps completed and the preset quantity per batch. An uncoiling system and tubing reel holder are also included.

In addition to the Readycut, TechnoMed also offers the Technocut and Rotocut tubing-cutting machines as well as various other types of assembly and testing equipment for medical product manufacturers. All tubing-cutting machines are CE marked, microprocessor controlled, and cleanroom compatible. The company also supplies medical-grade components and subassemblies used in the manufacture of dialysis, IV therapy, infusion, nutrition, and cardiosurgery tubing sets and assemblies.

For more information, contact TechnoMed at 603/893-6765.

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Polyurethane Tape Provides a Breathable Contamination Barrier

For wound-care dressings and securing devices to skin

A polyurethane medical tape from 3M Medical Specialties (St. Paul, MN) comprises a 0.8-mil semipermeable film coated with a hypoallergenic, nonlatex, pressure-sensitive acrylate adhesive on one side that gently yet securely adheres to the skin. The 3M 9841 tape is suitable for medical products where breathability, long-term adhesion, and conformability are required.

The transparent tape enables complete visual monitoring of the wound without disturbing or removing the dressing. Acting as a liquid and microorganism barrier, the tape protects skin from outside contaminants, like bacteria and body fluids, and promotes quick healing. The waterproof, washable surface enables users to bathe and swim while wearing the tape, and the tape's breathability lets oxygen in and moisture vapor out, promoting normal skin function and extending wear time.

Because the adhesive is gentle to the skin and contains no rubber ingredients, it is suitable for neonatal and geriatric skin types and can be worn for extended periods with minimal risk of irritation. The flat profile conforms to irregular body contours.

Compatible with EtO and gamma sterilization methods, the tape is suitable for such applications as wound-care dressings, burn care, IV tube attachments, ostomy product attachments, and securing of devices to the skin.

For more information, contact 3M Medical Specialties at 800/228-3957.

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Research Defines User and Customer Needs

R&D and Design Play Important Role in Development of New Biopsy Forceps

Developing a medical device is challenging enough when the product category has been pioneered by others. However, being the first to market with an innovative product is fraught with risks equal to the potential benefits.

G I Supply, a division of ChekMed Systems Inc. (Camp Hill, PA), faced this daunting task when it began developing the Respose forceps, the industry's first "resposable" biopsy forceps, which combines a reusable handle with a disposable tip. G I Supply discerned a market for the product within the fast-growing group of disposable forceps users.

G I Supply faced two key challenges. The company realized that not only would the product have to meet the needs of very particular users, but also that a strong product identity and a well orchestrated introduction would be essential to achieve instant recognition. G I Supply hired BOLT, an R&D and design firm based in Charlotte, NC, to help it meet these challenges.

Research Defines User and Customer Needs

To better understand the potential market, the design team launched a two-pronged research effort, blending user-needs research with market research to create a clear picture of both the customer and the user. User-needs information was acquired through user-task analyses, interviews with clinicians, and observation and videotaping of biopsy procedures. Market research was focused on the people who make purchasing decisions, and data were acquired through qualitative focus groups and interviews with clinicians, hospital department managers, and administrators. Through these research efforts, a model of the end-user and customer needs began to emerge.

The dimensions of this model relating to the end-user included the need for a kink-resistant coil spring to enhance the reliability of the reusable handle as compared with other products whose coil spring often became kinked during use; an ergonomic handle design; user-oriented features including various jaw styles, cautery capability, and a flush port to enhance cleaning; the degree of ease and security that must be designed into the tip attachment method (the tip incorporates the spike and jaws which actually cut the tissue); the ease-of-use and safety issues that must be addressed in the product design and discussed in the product literature; and the preferred reprocessing methods.

The customer-related facets of the model included the price points at which the product was perceived as being either too expensive compared to competitors' products or too inexpensive to be of appropriate quality; the preferred number of disposable tips to be sold within each package; the required clinical references and reprocessing information for the reusable handle; the potential barriers to sales; and the advantage of a unique handle appearance that could set the product apart from the competition.

Design Difficulties

Armed with this user/customer model, BOLT began an intensive design and engineering effort. The mechanical attachment of the tip was developed for ease of use and reliability. The handle was designed to be attractive, comfortable, and easy to use. The production materials were researched, tested, and specified to meet the rigors of use and reprocessing. Solid-modeling CAD software was used to develop models for illustrations and for stereolithography rapid prototypes. These renderings and rapid prototypes were shown to a clinical-users group for evaluation and input, and ultimately the CAD database was used to produce the final tooling for the injection-molded handle components.

The tip attachment method presented a particularly thorny design challenge. Research had shown that this attachment must be quick and easy, inherently safe, and clearly perceived as such prior to purchase. G I Supply had partnered with Marlow Surgical Technologies (Willoughby, OH), owners of a patent for disposable tips on medical devices, to manufacture the Respose. However, while Marlow's products were all laparoscopic devices, the biopsy forceps is a much smaller instrument, and therefore the tip attachment method used by Marlow would not be acceptable to users of the Respose.

After weeks of design, prototyping, and testing, the design team developed a tip attachment method that uses the properties of nickel-titanium alloy (nitinol) to provide a snap feature that allows the tip to be easily attached and removed. The team also developed a transparent tip cover that gives the user a handle to grasp while attaching a new tip, and also gives protection during removal of a used tip.

Creating the Right Identity

While the designers and engineers were detailing the product, the BOLT identity specialists were developing a strategy with G I Supply for the product's introduction. Positioning the product against the competition was the focus of the product-identity program.

Referring to the market research, BOLT developed an identity statement that defined the graphic identity of the product. Similar to a corporate mission statement, the identity statement succinctly describes the appropriate messages to be communicated through the brand identity. Once the statement was approved, it became the foundation for BOLT's development of the Respose name, product logo, product packaging, and sales literature. BOLT also helped G I Supply to design its trade show booth for the rollout of the new product.

Frank Carter, CEO of ChekMed, recalls, "It was important that we present a cohesive image to our market with the introduction of this unique device. The product design, the engineering detail, the packaging, the sales collateral, even the booth had to reflect our corporate character and our commitment to our customers."

Successful product development requires more than just a good design­it requires a comprehensive team approach to determine the product's identity and a well-planned strategy for its introduction. Clearly, the Respose met all of these requirements.

To learn more about R&D and design services from BOLT, call 704/372-2658.

MPMN is actively seeking success stories like this. If your company has one to tell, please contact Editor Ursula Jones at 3340 Ocean Park Blvd., Ste. 1000, Santa Monica, CA 90405; 310/392-5509.

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Laser marking systems

Three product lines of laser marking systems mark virtually all medical products, including tubing, syringes and syringe caps, surgical or dental tools, IV bags, and implants. The systems permanently mark clean date and batch codes, bar codes, 2-D symbologies, graphics, and logos. These markings, readable with machines or the human eye, can be used for product traceability on plastics, metals, glass, rubber, and paper. Lumonics Corp., P.O. Box 9010, Oxnard, CA 93031. Phone: 805/485-5559.

Corona treating system

A corona discharge surface-treating system is especially suited for use on plastic medical components. The Plasma-Jet system treats selected surfaces of plastic tubing, extruded profiles, and molded parts to improve the bonding of inks, adhesives, and coatings. Corona treatment with the system uses an electrical discharge to increase the surface wettability before direct printing, hot stamping, labeling, and component assembly operations. This type of treatment is important for manufacturers who use water-based compounds and UV-curable inks, which demand higher surface-energy levels than older solvent-based inks. Corotec Corp., 145 Hyde Rd., Farmington, CT 06032. Phone: 800/423-0348.

Thermal printer and applicator

A label printer and applicator will thermal-print to pressure-sensitive labels and apply them to premade pouches, bags, and flats at rates of 12 in. of stock per second. The PAL Labelmaster applicator is PC controlled and supplied with menu-driven software. Electronic label sensing in both the printer and applicator allows the use of release liners without pin-feed holes. The unit can process bags, pouches, and flats up to 16 in. wide and 24 in. long. Labels can be up to 4.5 in. wide and 6 in. long. About Packaging Robotics Inc., 6661 Arapahoe Ave., Ste. 2, Boulder, CO 80303. Phone: 303/449-2559.

Pad printer

A pad printer with a patented covered inkwell or interchangeable sealed-cup ink mechanism enables gradient measurements to be printed directly on the surface of a catheter. The TPU 250 printer offers a cost-effective method for pad-printing flexible and rigid catheters. The combination of an accurate pad-printing machine with a precision vacuum, parts-locating fixture ensures a precise imprint location. Nontoxic, FDA-compliant inks supply effective adhesion on a variety of catheter substrates including P-BAX, PVC, and silicone. Teca-Print USA Corp., 10 Cook St., Billerica, MA 01821. Phone: 508/667-8655.

Thermal-transfer printer

A compact programmable thermal-transfer printer can print code dates, pricing, variable information, and scannable bar codes directly onto such substrates as film, foil, lamination, and chipboard cartons. The EasyPrint Flow is designed to replace conventional hot stamp and ink coders on horizontal-flow wrappers, baggers, cartons, and continuous moving webs at print speeds up to 600 mm/sec. The printer uses thermal-transfer technology to print text and bar codes in a print area of up to 5 x 7.5 in. The cassette-loaded ribbon changer accepts 450-m rolls of transfer foil. Bell-Mark, 331 Changebridge Rd., Pine Brook, NJ 07058. Phone: 201/882-0202.

Slot sensor

A slot sensor provides high sensitivity and fast response for label and edge detection and register-mark reading. The SR21 sensor can adapt to difficult backgrounds as well as low- and variable-contrast conditions. Featuring a yes/no teach-in process, the sensor's bicolored green/red LED guides the operator during the setting phase and provides diagnostic information. An 80-microsecond response time permits precise detection. The rugged unit comes in a metal housing, provides Class I electrical shock protection, and tolerates ambient temperatures from 32° to 131°F and 35­83 RH. Operating on 10­30 V dc, the compact sensor includes a two-position, 90° rotatable M8 connector for mounting flexibility. Balluff Inc., 8125 Holton Dr., Florence, KY 41042. Phone: 800/543-8390.

Printing and labeling system

A printing and labeling system applies pressure-sensitive labels to nearly any shape or size product including multipanels. Compatible with most commercial print engines, the Final Touch 401 handles many printing combinations such as direct thermal, thermal transfer, variable-size text, bar codes, and graphic images. Labels up to 14 in. long are printed and dispensed on demand. The machine can be equipped with an up to 18-in.-diam supply roll. Standard features include photoelectric label sensors; end-of-label, low-ribbon, and end-of-ribbon detectors; and a rewind system to minimize web tension. Options such as on-line bar code inspection, label software, and wireless transmission are available. With a rugged design and reach capability up to 28 in., the unit is suitable for harsh applications in large product manufacturing environments. New Jersey Machine, 56 Etna Rd., Lebanon, NH 03766. Phone: 603/448-0300.

High-resolution printing

A company specializes in high-resolution printing for the medical industry in a dust-free environment on flat, textured, or curved surfaces including substrates that are difficult to imprint, such as polypropylene, acetal, polyethylene, or PVC. The company inventories a wide variety of inks, including medical grade, that will withstand repeated sterilization. It can print large or small production runs and welcomes prototype work. Hi-Tech Screenprint Inc., 195 Bay State Dr., Braintree, MA 02184. Phone: 781/356-0700.

Graphics printing system

Designed to provide affordable and easy-to-use ink-jet imaging and handling for mailing applications, the Model 2001 graphics printing system delivers dependable operation in office or in-plant environments. The highly versatile system can handle virtually any mail type or product size. The images printed can be individual lines of text or blocks of information up to 2 in. in height. There are 16 print styles to choose from, and the user can automatically incorporate standard postal bar codes and bit-map graphics and layouts. Videojet Systems International Inc., 1500 Mittel Blvd., Wood Dale, IL 60191. Phone: 800/654-4663.

Label printer/ applicator systems

A series of printer/applicator systems provides on-line printing and applying of direct-thermal and thermal-transfer labels. The fully automated PA/4000 series provides label placement accuracy and print quality. This next-label-out system allows container-specific variable information on each label. It also offers high-resolution bar codes, text, and graphics at 203 dpi and a print speed of up to 8 in./sec. Diagraph Corp., 3401 Rider Trail S., St. Louis/Earth City, MO 63045. Phone: 314/739-1221.

Four-color printer

A digital, four-color thermal-transfer-label printer can print on both sides of labels simultaneously; it can also cut and stack them for easy access. The QuickLabel-4 requires no printing plates, messy inks, toners, or hot-stamp dies. Label data go directly from a PC to the printer, allowing variable data to be altered during printing. The unit operates without hesitation between labels at speeds up to 5 in./sec even when a different database field is selected for each successive label. The printer's all-metal construction makes it reliable in hostile factory environments. Astro-Med Inc., Astro-Med Industrial Park, West Warwick, RI 02893. Phone: 800/343-4039.

Printers/ applicators

A series of first-label-out thermal transfer printers/applicators use either a patented tamp-blow or blow-on method of application. The 2138 series is available with a variety of options such as powered unwind, 203- or 300-dpi, and low- and out-of-label-or-ribbon alarm. Other models are also available. Printing speeds are programmable up to 12 in./sec depending on printer selection. Label-Aire, 550 Burning Tree Rd., Fullerton, CA 92633. Phone: 714/441-0700.

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Getting to Washington through Local Politics

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI October 1997 Column


Ted Juraschek and Bill Clinton have at least one thing in common: They both began an important phase of their careers in January 1993 in Washington, DC. Juraschek is director of government relations for Becton Dickinson and Co. (BD), which is headquartered in Franklin Lakes, NJ. In this capacity, he spends almost as much time in the nation's capital as the president.

Juraschek became involved in government relations by a nontraditional route. "Most people in my position spend time in Washington after college, working for a member of Congress or a congressional committee," Juraschek notes. "From there, they move into jobs as Washington representatives for companies or organizations. They know the day-to-day workings of Capitol Hill and have friends there.

"I didn't have that opportunity. But I really know the company and how it works, which also has its advantages."

Juraschek began his career with Becton Dickinson in 1976. While working in the company's primary-care division in the late 1980s, he became interested in how public policy affects business operations. "I realized how important it is for companies to be able to communicate effectively with the people who make and enforce regulations," Juraschek says.

Under the tutelage of Jim Tobin, the government relations director, Juraschek quickly realized how much he had to learn. In 1989, Juraschek took over the position and became Becton Dickinson's one-man government affairs department.

"My real break came early in 1993, when management supported my internship with the Health Care Leadership Council in Washington," Juraschek says. "I spent January and February making calls on congressional offices and getting a feel for what it takes to function effectively there. I developed an understanding of what is required to be an effective government affairs professional."

One of his biggest challenges now is helping members of Becton Dickinson's management team focus on public policy issues that affect the company.

"Most managers concentrate on the financial aspects of their businesses. That's their job. They look at next month, next quarter, maybe next year," Juraschek observes. "I deal with issues that may take years to resolve. Political change is an evolutionary process."

Juraschek uses several approaches to energize employees and managers around important issues such as FDA modernization and product liability reform. He has developed a grassroots network of people who are interested in public policy matters that affect the company and the industry. Juraschek mails them informational letters on various topics and encourages them to write to their elected representatives.

"We have also developed a 'grasstops' program," Juraschek notes. "We encourage our managers and executives to become actively involved with one or more members of Congress or a representative from the state legislature. That enables our people to see how truly dedicated these men and women are, and it gives us an avenue for introducing Becton Dickinson to legislators."

In 1996, Juraschek ran a three-pronged program for the election year. It was, he says, a step-by-step process to help employees and management become more knowledgeable about what's going on in the political arena.

"Our get-out-the-vote campaign at BD's Franklin Lakes headquarters, held in conjunction with the League of Women Voters, was very successful," Juraschek says. "We registered some 200 voters and arranged for absentee ballots for more than 30 others. The turnout surprised even the League people."

The second prong of the program was to bring the two candidates for New Jersey's open seat in the U.S. Senate to Becton Dickinson. At sessions two weeks apart, the candidates met with the management team followed by a forum with interested employees. The final prong brought Congresswoman Marge Roukema (R­NJ) to Franklin Lakes on November 8 to talk about the election results and their implications.

"I see the government relations program at Becton Dickinson as an important element in Chairman Clateo Castellini's commitment to participatory management," Juraschek says. "Employees who are politically aware can help us achieve legislative goals consistent with our business strategies. That's a large part of what I'm trying to accomplish."

Edward E. Waldron is a freelance contributor to MD&DI.

Copyright ©1997 Medical Device & Diagnostic Industry

A Preview of Coming Attractions

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI October 1997 Column

One of the occupational hazards of being a monthly magazine editor is developing a skewed sense of time. Even as your hands are working on the issue of the moment, your head is three months or more in the future, working on issues to come. Thus, although it's still September as I write these words, I'm preoccupied with January and the rest of 1998.

In this case, however, rather than distracting me from the task at hand, my preoccupation is giving me my subject matter. For some reason, editors traditionally share their long-term plans with advertisers but not readers. Here I break with tradition and offer the following preview of MD&DI in 1998. MD&DI's editorial mission­to cover the full range of issues affecting the medical device industry­will not change in 1998. Indeed, it will be reaffirmed.

As most readers will know, the perils of electromagnetic interference (EMI) has been a topic of intense discussion among industry, FDA, and the media in the past couple of years. As microelectronics continue to be incorporated into an ever-wider array of medical products, this issue will become still more important. Although MD&DI has frequently published articles on EMI in the past two years, we feel the time is right to inaugurate a monthly column on the topic. Longtime MD&DI authors and EMI experts Bill Kimmel and Daryl Gerke will kick off the column in January and will be followed by a host of other expert authors in subsequent issues.

Another subject that has received much attention in the last two years, both in the medical device industry and among the general public, has been the Internet and the World Wide Web. As the Web and its related technologies become increasingly important sources of information and modes of communication­and now, as well, vehicles for electronic commerce­they are becoming increasingly important in the medical device industry. To help keep our readers aware of the benefits of browsing the Web, we will introduce a monthly column featuring Web sites pertinent to the industry. The column will be jointly written by Richard Hunter and David Vine, authors of a guide to the Web for the device industry that will be published by Canon Communications early next year.

In addition to these new columns, MD&DI will offer an increased number of features on key design and manufacturing technologies for the industry. Scheduled topics include extrusion, flow control, bar coding, electronic data interchange, sensors, wireless electronics, software, filtration, and testing. Each month the magazine will also feature components, materials, and services in such categories as die-cutting, laser technologies, adhesives, and surface treatment.

We will continue to cover important industry issues, such as regulatory and legal affairs, quality assurance, and business and marketing, as well as key events such as the Medical Design & Manufacturing shows. The results of the sixth annual business outlook survey will be published in the March issue; the salary survey results will be in August.

And, finally, throughout the first half of the year we will be reporting on developments in the first annual Medical Design Excellence Awards, which I announced in this space last month. Detailed coverage is scheduled for the May issue, which will feature the finalists and their products, and for the July issue, which will offer an extended article on the winners.

Lest you conclude that we've planned out the coming year's editorial content to the last period and there's no room for you to participate, be assured that we are always on the lookout for suggestions for articles and authors to write them. Whether you're interested in the topics described above or in others, please let us know.

John Bethune

[email protected]

Copyright ©1997 Medical Device & Diagnostic Industry

Easing the Transition into China's Market

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI October 1997 Column

To the Editor:

I thought the article in the July MD&DI, "China's New Business Climate Warms Up," was excellent. My company does medical device manufacturing in China for export and for the domestic Chinese market. I can tell you that the market today is not what it was a few years ago. It is growing quickly, but there are still numerous obstacles. With all the challenges in the U.S. market, overseas expansion certainly must rank as a key strategy for many U.S. device manufacturers. It's an alluring market, but one that should be approached with caution.

I would suggest that the authors give more concrete advice about where U.S. companies can seek assistance when entering the market. U.S. companies wanting to expand in Asia can contact the U.S. Foreign Commercial Service at the U.S. Consulate in Hong Kong. Also, HIMA has an office in Singapore. The American Chamber of Commerce in Hong Kong has a Health and Medical Industry Committee that is active. Several other American Chambers of Commerce have similar groups (Beijing and Taipei are two that come to mind). The American companies operating in Singapore and Malaysia also participate in industry groups in those locations. I have contact numbers for these organizations if you are interested.

I was gratified that the article did not emphasize finding the right partner, which is the cliché about doing business in China that raises more questions than it answers. The right partner usually means finding someone who has good connections (guanxi). As the article pointed out, this is becoming less important. Probably more important is finding distributors that are well funded, well run, and able to provide sufficient geographical reach to cover a large portion of the Chinese market, which, like the U.S. market, is just too large for one company to handle. It is probably better to establish distributorships in the major cities like Beijing, Shanghai, Guangzhao, Chongqing, and Wuhan. A more extensive distribution system would include second-tier cities such as Shenzhen, Xian, Harbin, and Dalian. Setting up and managing good distributors in these locations is not trivial. Distance between the cities (as well as from the home office in the United States), language, customs, lack of infrastructure, corruption, and inadequate financing will all take a toll on the distributor relationship. If a company is serious about China, it will need a local headquarters either with its own staff (expatriate or local) or with a good partner. In either case, the U.S. company has to be prepared to play by the local rules and customs. As you so often hear out here, "But this is China."

Hong Kong is still the best place to start for market entry into China. As the China market opens up, Hong Kong will lose its preeminence as the stepping stone to China but will remain an important headquarters site. This is particularly true for companies that want to manufacture in China. The business and legal infrastructure in Hong Kong is on a par with those of other developed countries, while China is still a bit like the Wild West. Furthermore, Hong Kong provides access to transportation, communication, financing, and talent. It is a free port allowing duty-free import and export of equipment and material. Hong Kong has low taxes (16% flat tax), simple government regulations, and a pro-business attitude, and it is located on the doorstep to southern China.

David Groll, Managing Director
Vincent Medical Manufacturing
Company, Ltd.

Hong Kong

Copyright ©1997 Medical Device & Diagnostic Industry

Managing A Small Company through Big Changes

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI October 1997 Column

An interview with Edward F. Voboril, chairman and chief executive officer of Wilson Greatbatch Ltd. (Clarence, NY).

Small companies struggle against the tide of consolidation of purchasing organizations with few paddles in their boats. Edward F. Voboril, chairman of the Health Industry Manufacturers Association's Smaller Company Council, hopes that this new HIMA council will help them find solutions to this dilemma, as well as other issues affecting smaller firms. Operating a small device manufacturing company in today's health-care environment has presented some daunting challenges. From biomaterials to market access, everything is getting tougher for the majority of companies in the device industry.

Voboril discusses these critical issues that face the industry and the solutions he sees to overcome them. He also talks about leading a management buyout of the small family-owned company he has run since 1990. Voboril talks about his experiences overseeing the buyout and the opportunities that it created for the company. He describes the marketing strategies the company has planned to ensure its growth into the next century.

Q. What is the most pressing issue facing the medical device industry?

A. I think we've only seen the tip of the iceberg on biomaterials availability. This situation is much more critical than many outside the device industry want to believe. If we don't get some kind of meaningful product liability reform for biomaterials suppliers, we're going to see more and more of the bigger companies pulling out. We all know that over the years we've pretty much piggybacked on the needs of other, larger industries for a lot of basic materials. The relatively small amounts of materials that we've purchased from the large material and component suppliers has almost been at their pleasure, and we've relied on that.

The biomaterials availability crisis triggered by the breast implant scare has put a lot of small device companies at risk of not surviving. If small companies manufacture only one or two products and can't obtain sufficient product liability insurance coverage, they're at risk of seeing their whole business disappear because they can't get the materials they need to make their products. It's critical, and unless we get some meaningful reform in the very near future, this thing is very likely to come unglued.

Q. What can companies do in the meantime?

A. Companies are working off of their stockpiles and trying to find suppliers overseas, although many overseas suppliers will no longer sell to the U.S. market. Manufacturers should write their congressional representatives in support of S. 364 and H.R. 872.

Q. How do you see group purchasing affecting the device industry?

A. The consolidation of a lot of the large providers such as Columbia HCA is causing hardships for small device companies. We've gotten into the situation where these purchasing organizations want to do business only with larger companies. They tend to look for a bigger company that can offer a full line of products. If the volume falls below a certain dollar amount, the purchasing organization may not even want to handle the transaction. So a lot of smaller companies right now are having what I call market access issues. They're having a hard time finding customers that will literally give them the time of day to sell their products. Purchasing organizations are basically telling them, "Go get hooked up with a bigger company, and we'll talk to the bigger company about your product." Even worse, they might say, "Why don't you just sell out to a bigger company?" Of course, a lot of small companies don't want to do that. I'm probably overstating that a bit, but there is no question that smaller companies are having a hard time gaining access to the purchasing people in the larger organizations.

Q. Do you see FDA reform as a less important issue now than it has been in the past?

A. I think it is still important. Of course with Kessler's departure, we will get a better lay of the land when we have a new FDA commissioner. Then we'll know how much more partnering we'll see between HIMA and the agency. Our position at HIMA is in promoting the public benefit. It's important to get new technologies that offer better outcomes to the market as soon as possible. And our argument is that FDA still hasn't focused enough on that aspect of its mission. To the extent that we can facilitate FDA reform that will help get better medical technologies to the public faster, then that's an important outcome for everyone. It still takes FDA too long to approve products. Products still get approved in Europe much earlier than they get approved in the United States.

Q. Have FDA's steps--reengineering, real-time PMA review, and the mutual recognition agreement (MRA)--helped foster a better environment?

A. While most companies believe that CDRH's reengineering effort is laudable, many prefer to withhold opinion on its success until many initiatives, still in the proposal phase, have been implemented. The agency, however, as part of its organizational transformation process, has solicited input from industry throughout the various reengineering stages. Interaction with industry occurred early in the process when FDA held focus group sessions with industry representatives. FDA also invited industry representatives to serve as members on its product development protocol (PDP) reengineering team. This team, composed of FDA staff and industry, worked cooperatively to develop guidelines for implementation of an efficient, practical PDP process that the team will present at a public workshop in October. Finally, as CDRH unveils proposals developed by its reengineering teams, it has asked industry to provide feedback before the agency moves forward with implementation. An illustration of this outreach to industry is FDA's presentation of the new 510(k) paradigm to representatives from various trade associations in a public meeting.

From the agency's effort to involve industry early in the process, during the reengineering teams' development of proposals, and after initiatives are presented, one could conclude that these steps have helped to foster a better environment for industry.

Q. How will you bring your experiences to bear on your position as the representative for small device companies at HIMA?

A. I'm on the executive committee of HIMA's board of directors. Over the past couple of years, we've been looking at ways to make HIMA more relevant to the smaller companies because our industry is predominantly made up of smaller companies. A few years ago there was a prevailing attitude that the issues were pretty much the same for all device companies no matter what their size. We've discovered that for smaller companies, the impact of consolidation and market access are much more of a survival issue than even FDA approval.

We've made HIMA a more user-friendly organization for smaller companies. We've implemented a help desk--a gatekeeper--to help callers find someone at HIMA to answer their questions or identify other organizations available for information on issues such as ISO 9001 certification. HIMA has established a Web site so that members can get updates on key national and international developments.

Finally, we're taking an outreach approach to helping smaller companies. Rather than asking them to come to Washington, which can be expensive, we've taken HIMA on the road. We had our first Western regional meeting in July, which drew about a dozen chief executives of smaller companies. We spent most of the time getting feedback from these folks on what was happening in their businesses and what they would like to see HIMA do or help them with.

Q. How do your personal experiences help you in this position?

A. Wilson Greatbatch (WGL) is like a lot of other companies. We don't have a Washington office, so we don't have anybody to represent us there. For example, when the biomaterials availability flap cropped up two or three years ago, we made great use of HIMA in terms of understanding how the industry was going to respond to some of the bigger suppliers like DuPont pulling out of the business. It was also helpful to have HIMA as a facilitator to access key congresspeople to discuss the potential impact of biomaterials availability and to build up to the product liability reform that we think we're going to see. There's no way we would have had access to that kind of information and people if we didn't have HIMA to help us frame the situation.

Q. What was the impetus behind the WGL management buyout?

A. WGL had been a family-owned company. There have been a couple of fairly important junctures in the company's development. About seven years ago, Warren Greatbatch, who was CEO and chairman at that time, decided that he wanted to bring someone on board who had experience with larger organizations in the medical electronics field. That provided me with the opportunity to join the company as CEO to take it through its next stage of growth. As we began to look at some significant investments that we thought were possible in order to take full advantage of all our opportunities, Warren Greatbatch and the family started to think about how they might diversify their investment while not standing in the way of having the company realize its full potential. So this was another fork in the road, so to speak. A decision was made several months ago that perhaps a financial partnership with an organization like Donaldson, Lefkin, and Jenrette (which ultimately took the form of the management buyout here) would be the best way to set the stage for the next round of growth for the company.

Q. What's your strategy for moving forward?

A. There are three areas of growth that tie into our current strategy. First and foremost, we intend to continue to supply power sources for the implantable medical device field. This has primarily been cardiac rhythm management products such as bradycardia pacemakers and implantable cardiac defibrillators, but there are a host of emerging applications, including drug pumps and neurostimulation devices, some involving new technology we have developed at Wilson Greatbatch. For example, we're in the process of scaling up a new technology for capacitors that are used in implantable cardiac defibrillators that we think will provide important performance benefits.

Q. Is that where you see your primary path for growth?

A. We still see significant growth and new products in our implantable power source business. But, even though that's been the foundation for the company's success in the past, we see two important areas for diversification beyond that. We also make a number of other components for implantable medical devices. Many of the same customers that buy our batteries also buy precision components made of titanium, stainless steel, and platinum for products such as pacemakers. We have decided to invest in growing that business both internally and potentially through acquisition or joint venturing. This will add significantly to the portfolio of components that we provide, especially to the cardiac rhythm management businesses.

We would like to be in the position to manufacture almost every component used in the pacemaker except for the microelectronics. Buyers look at where the costs are. The qualification, the auditing, and the support of a large supplier base is a very expensive activity. By consolidating more of the components under one umbrella, we can help our customers significantly reduce their transaction costs by serving as a source for more of the parts they need to incorporate into their devices.

Q. Will you market your own pacemaker someday?

A. It is not our intention to actually ever build a complete pacemaker. However, if we manufacture a lot of the components, then that creates an opportunity for us to add value to the product by providing subassemblies to customers. The idea is to help reduce their transaction costs in terms of sourcing more of the components from a single supplier.

Q. Are you working on any new technologies or applications?

A. We are introducing our first rechargeable batteries, using a lithium ion technology similar to batteries used in consumer and computer applications. These batteries are of particular interest for products like left ventricular assist devices, where light weight, rechargeability, and quality are key.

Q. Do you have other plans for this technology?

A. We've actually targeted a couple of niches where we're going to be introducing battery-powered instrumentation under our own trade name. We've got a separate division called Greatbatch Scientific, and we have a number of products in the pipeline for approval at FDA. We're developing nonmagnetic batteries for magnetic resonance imaging applications. We hope to develop a line of instrumentation for products used in MRI applications and in image-guided therapy where some battery-powered instruments are used during biopsies and other procedures. So, subject to FDA approval, we'll have those products on the market by the end of this year. That will be the first time the company has ever brought a complete product to market. Those are niches that we feel we can pursue without representing any conflict of interest with our traditional customer base.

Q. How has your role changed within the company?

A. Perhaps I have a little more frequent contact with board members. We were a very closely held company when it was owned by the Greatbatch family, so I had fairly frequent contact with the directors and shareholders; in that respect, it's not so different. Where things will change, of course, is that ultimately we will think about taking the company public.

Q. Do you have any plans for expansion to other locations?

A. Even if we look three years into the future, I'd say approximately 70­75% of our business will be based on lithium battery technology, and we think that we've been able to facilitate development and timely product introduction by having R&D, manufacturing, and quality control all closely integrated and based in the same location. I've experienced other situations in my career where departments were spread all over the world. Believe me, being able to walk down the hall and talk to R&D or to quality or to manufacturing enables people to work closely together and effectively as a team. It's hard to measure, but there's a distinct competitive advantage to having that proximity, and we just don't see any reason to change that.

In addition, I don't think it's very well known that there is actually quite a cluster of medical technology companies in western New York and southern Ontario. So we're not out in the wasteland here. We're in an area that has some interesting opportunities for networking and partnering and access to technology, comparable to well-known clusters like Minneapolis, southern California, and Boston. Within the past few months we found an attractive building, about 50,000 sq ft, located a half mile from our existing headquarters, and we'll be taking occupancy by the end of the year.

Q. How will acquisitions play into your business strategies?

A. Within a year or so, we probably will have some operations outside of the Buffalo area. We expect to complete one or more acquisitions as part of our external business development. That is one reason we felt we needed the additional financial strength that comes from an investment banking firm.

Q. How is the current health-care climate affecting your marketing strategies?

A. There is a lot of consolidation in the industry at all levels, and at least at the component supplier level, we want to be a consolidator instead of being consolidated. That trend is clearly going to continue. Although we see price pressures in most markets, the cardiovascular field is still very much a technology-driven marketplace. If people look at outcomes and the total cost of treating or caring for the patient, most of the products our components are designed into are cost-effective therapies. Recent studies have compared implanting cardiac defibrillators to drug therapy. The studies showed by quite a margin that the devices were the most cost-effective approach in terms of long-term outcomes. We view the type of markets we serve as technologically demanding.

Copyright ©1997 Medical Device & Diagnostic Industry