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Industry news

Medical Design Excellence Awards to Honor Innovation

Recognizing the need to salute exceptional quality and innovation in the medical device industry, European Medical Device Manufacturer publisher Canon Communications LLC (Santa Monica, CA, USA) has announced that it is collaborating with the Industrial Designers Society of America (IDSA) to present the Medical Design Excellence Awards. The annual awards program, introduced this year, seeks to acknowledge excellence in the design and engineering of finished medical devices as well as materials and components intended for medical applications. "We congratulate Canon on its leadership in sponsoring this breakthrough awards program," said Robert T. Schwartz, IDSA executive director and COO. "We hope this competition will foster commitment to design excellence, which is so crucial to success in the medical products, materials, and components markets."

Awards will be presented in two categories--finished medical devices, and materials and components for medical applications--with entries to be evaluated for their functional improvement, business impact, and innovation. All products commercially available in the United States are eligible for entry in the program. Submissions will be judged by a panel of industry experts convened by IDSA.

"This initiative creates an important opportunity for the industrial design profession," says Kent Ritzel, IDSA Medical Section chair and director of Metaphase Design Group (St. Louis, MO, USA). "It will bring IDSA members and others involved in medical product development the level of interaction typically enjoyed by more visible consumer and high-tech industries."

The deadline for entry submission is 26 January 1998. The winners will be recognized during Medical Design & Manufacturing East 98 Conference and Exposition in New York City, 2­4 June 1998. For more information about the Medical Design Excellence Awards, visit www.devicelink.com/awards/; contact IDSA (Great Falls, VA, USA) by phone at +1 703 7590100 or fax at +1 703 7597679 for an entry form and rules; or contact Amy Allen at Canon Communications at +1 310 3925509 (phone) or +1 310 3924920 (fax).

Domino Leaves Its Mark on Bard

It was the fine print that clinched the deal for Domino UK Ltd. (Bar Hill, Cambs, UK), according to project engineer Roger Meek of Bard Ltd. (Clacton-on-Sea, Essex, UK). The UK subsidiary of C. R. Bard Inc., a leading manufacturer of cardiovascular, urological, and surgical products, selected Domino to engineer a customized solution for coding quality control, traceability, and end-user data on a variety of small medical devices. Along with Domino's "fastidious customer service," Meek notes that the company's Pinpoint printing technology was a determining factor.

"We selected Pinpoint technology because it enables us to produce very small, exact, high-quality codes," says Meek. Pinpoint is used in conjunction with a system designed by Domino that achieves minimal reject rates and a significant reduction in changeover times between batches, Meek adds.

Pinpoint products provide noncontact high-speed printing of near-letter-quality characters as small as 0.6 mm. The printers routinely attain speeds of 3000 characters per second. The Pinpoint system is available with the company's Codebox 3 and Solo 6 ink-jet printers.

Domino designs, manufactures, and distributes industrial printing equipment, and controllers and consumables for applications associated with high-speed printing of variable information. For more information about the company's capabilities and its products and services, contact marketing manager Terry Nicklin, Domino UK Ltd., Bar Hill, Cambs CB3 8TU, UK; phone: +44 1954 782551; fax: +44 1954 782874.

Acutek Opens Swiss Office

A supplier of custom pressure-sensitive adhesive components to the medical device industry, Acutek (Inglewood, CA, USA) has opened a corporate office in Muttenz, Switzerland. Neil Murchin has been named director of sales for Europe and will manage the site.

Vice president of sales and marketing Karen Kline explains that the decision to open a branch office was determined by a surge in European demand for the company's products. "Since the beginning of the year, inquiries for our services have increased tremendously," says Kline. "We felt that if we were going to be responsive and committed to Europe, we needed to have a full-time presence."

Acutek has been making pressure sensitives since 1978. Its production capabilities include flexographic printing, precision rotary and flatbed die-cutting, multilayer lamination, island placement, design and prototyping, subassembly, and packaging. The company is certified to ISO 9002 and follows good manufacturing practices.

For more information, contact Neil Murchin at Acutek, Bl. Hagnaustr. 25, CH-4132 Muttenz, Switzerland; phone: +41 61 3123423; fax: +41 61 3123429.

Maxon Drives US Mission to Mars

Engineers at the Jet Propulsion Laboratory (JPL; Pasadena, CA, USA) weren't the only ones celebrating when Pathfinder successfully tumbled onto the Martian surface in July. While it may have escaped the attention of the world media, an epidemic of high spirits also broke out at Interelectric AG (Sachseln, Switzerland). The Swiss firm developed the miniature motors used in Sojourner, the vehicle that is exploring the planet's terrain.

Dubbed Mission Thumbnail, Interelectric AG and its US subsidiary, Maxon Precision Motors, supplied JPL with eleven 16-mm-diam RE016 motors for Sojourner. Six of the motors power the wheels, four are assigned to the steering mechanism, and one is used to operate the scientific equipment. According to Maxon, the modified motors are characterized by an ironless rotor and a special lubricant in the ball-bearing assembly that can withstand temperatures between ­80° and 70°C.

For more down-to-earth applications, the company recently introduced an interactive CD-ROM catalogue. In addition to containing complete information on the company's products, the CD-ROM allows users to input data and calculate drive solutions. The programme requires Windows 3.0 or Windows 95, a 386 cpu, and 4 Mbyte of RAM. Adobe Acrobat Reader, which is recommended to run all the programme functions, is included with the CD-ROM.

For additional information, contact Interelectric AG, Brünigstr. 220, Sachseln CH-6072, Switzerland; phone: +41 41 6661500; fax: +41 41 6661650; internet: www.maxonmotor.com.

International Regulatory Consultants Enters Alliances

International Regulatory Consultants L.C. (IRC; Salt Lake City, UT, USA) recently entered into affiliations with Medical Device Safety Service GmbH (MDSS; Wenningsen, Germany), Medlink Europe B.V. (Nieuwegein, Netherlands), and Relsys International Inc. (Irvine, CA, USA). IRC, which is dedicated to helping medical device manufacturers coordinate their European, North American, and Asia/Pacific Rim regulatory affairs and quality systems compliance, views these agreements as a means to facilitate communication with its clients worldwide. The alliances, according to IRC managing director and partner Donald F. Grabarz, will help ensure that clients receive a "timely, meaningful, and culturally appropriate response to their questions. We now have a presence in Germany, the Netherlands, Switzerland, and Belgium," adds Grabarz.

As for the international agreement with US-based Relsys, Grabarz notes that it will enable IRC to provide a gamut of global support services with a particular focus on European and US users of the company's complaint-handling software. In addition to supplying training for Relsys's EasyTrak, a programme designed to help device manufacturers comply with global vigilance procedures and US medical device reporting requirements, IRC will assist in the development of upgrades and other compliance support programmes. The overriding purpose, says Grabarz, is to eliminate the guesswork in terms of complaint-handling and device-reporting procedures as well as to streamline administrative efficiency.

The alliances with MDSS and Medlink will amplify and enhance the technical and regulatory support services IRC provides to its customers throughout the world, adds Grabarz.

For further information, contact International Regulatory Consultants L.C., 2471 E. Shadow Wood Cir., P.O. Box 17801, Salt Lake City, UT 84117-0801, USA; phone: +1 801 2723550; fax: +1 801 2728543; Internet: www.intregcon.com.

In Brief Perfecseal Recognized for Manufacturing Excellence Perfecseal Inc. (Philadelphia, PA, USA) was one of nine recipients of the 1997 Shingo Prize, an award that honors companies that demonstrate excellence in productivity and process improvement, quality enhancement, and customer satisfaction. The prestigious Shingo Prize, named for Shigeo Shingo, the manufacturing expert who developed the Toyota production system, is awarded annually to a handful of companies in the US, Canada, and Mexico. A manufacturer of packaging materials for the health-care industry, Perfecseal has locations in the UK, North America, Puerto Rico, and Asia.

For more information, contact Perfecseal's Northern Ireland plant, Springtown Ind. Est., Londonderry BT48 0LY, UK; phone: +44 1504 260744; fax: +44 1504 262829.

Sifam Sets Sights on Single-Shot Moulding

Sifam Moulded Products (Welwyn Garden City, Herts, UK) recently inaugurated a 24,000-sq-ft facility, which contains a 200-t Sandretto moulder and 600-sq-ft cleanroom and was designed to provide integrated design, tooling, and moulding services. "Our primary function is to provide a specialist single-shot service," says marketing manager John Tamsitt. "Furthermore, we offer excellent cleanroom facilities for the production of lenses and other clear items for the medical, test, and other industries," he adds. The cleanroom is equipped with a dedicated 30-t Boy Procan machine with interchangeable barrels to avoid degradation. "Our cleanroom service allows us to manufacture cases and lenses under one roof, which means not only reduced transportation costs and lead times but also vastly improved quality control," says Tamsitt.

For more information, contact Sifam Ltd., Woodland Rd., Torquay, Devon TQ2 7AY, UK; phone: +44 1803 613822; fax: +44 1803 613926.

Biex Heads East

Biex S.r.l., which was bought by S.I.F.RA EST (Trieste, Italy) in February 1995, recently shut down its facility in Mirandola (MO), Italy, and moved its operations to the S.I.F.RA EST headquarters. Biex specializes in the extrusion of polyvinyl chloride, polyethylene, polyurethane, and EVA and supplies coextruded and multilumen tubing; S.I.F.RA EST produces medical-grade PVC compounds, tubing, and lay-flat tubing along with PVC and PVC-free bags. According to marketing manager Leonardo Maghetti, the company decided to integrate operations in order to optimize human and financial resources. The vertically integrated firm will not only be able to provide its clients with a broad range of quality products, he adds, but it will be better able to supply technical assistance during product development.

For more information, contact Leonardo Maghetti at S.I.F.RA EST S.p.A., Via Caboto 19, I-34147 Trieste, Italy; phone: +39 40 823802; fax: +39 40 823605.

EUCOMED: Restructuring in Progress

The secretariat of the European Confederation of Medical Devices Associations (EUCOMED; Brussels) has been reorganized into three business areas, each of which will be headed by a director responsible to director-general Michael C. Baker. Richard Moore, who has served as project officer, health care and environment, at the European Committee for Standardization (CEN) since 1991, and Zeger Vercouteren, EUCOMED's current director of commercial affairs, have been appointed to head two of the business areas. A third director is currently being recruited.

Moore, who has a background in biology, will represent EUCOMED in all CEN- and ISO-related matters, while Vercouteren will assume responsibilities for medical device regulations, EU liaisons, new business opportunities, and special projects.

Baker and Vercouteren are scheduled to chair sessions on new developments in device sterilization and the directive on packaging and packaging waste at the Medical Equipment Design & Technology Exhibition & Conference (MEDTEC) in Amsterdam this month.

For information about its activities, contact EUCOMED at Rue du Collège St. Michel 17, B-1150 Brussels, Belgium; phone: +32 2 7722212; fax: +32 2 7713909.

PEM International Receives ISO 9002 Certification

PEM International Ltd. (PIL; Doncaster, S Yorks, UK) was recently certified to ISO 9002. "This approval underscores our company's ongoing commitment to quality and to consistent products and performance worldwide," says Kenneth A. Swanstrom, company CEO and president. As the sales and distribution company for Penn Engineering & Manufacturing Corp. in Europe, PIL markets PEM's line of self-clinching and -broaching fasteners.

For more information, contact PEM International Ltd., Doncaster Rd., Doncaster, S Yorks DN3 IQR, UK; phone: +44 1302 886961; fax: +44 1302 885341.

Griffith Micro Science Announces EN 550 Certification

Griffith Micro Science Ltd. (Somercotes, Derby, UK) recently reported EN 550 accreditation for its facilities in Somercotes, Derby, UK; Herentals, Belgium; Zoetermeer, Netherlands, and Mörfelden, Germany. Its French sites in Rantigny and Lyon were certified earlier. This European standard for validation and routine control of EtO sterilization complements the company's existing ISO 9001 and EN 46001 certifications. Griffith has also announced that it is increasing capacity at its Somercotes plant and that it plans to open a new facility near Lyon, at Anse.

For more information, contact Griffith Micro Science Ltd., Cotes Park Est., Somercotes, Derby DE55 4NJ, UK; phone: +44 1773 830505; fax: +44 1773 830506.