EU Medical Device Industry News
French Study Urges Reimbursement Reform
A study has found that key governmental decision makers involved in healthcare issues as well as medical device manufacturers are dissatisfied with the current French healthcare system. Chief among their concerns were perceived barriers that deny patients access to lifesaving medical technologies. The report titled Medical Technologies in France cited the example of implantable defibrillators, which are not reimbursed by the government, as an example of the "lack of attention, or even hostility, of policymakers and opinion leaders" toward medical technology, according to healthcare consultancy JNB-Développement S.A. (Paris), which published the report.
The study pointed out that the two pricing lists for private hospitals—the tarif interministériel des prestations sanitaires (TIPS) and nomenclature générale des actes professionnels—are cumbersome and lacking in transparency, and often discourage innovation. In addition, the system is rife with delays in updating the pricing lists to account for new technology.
The study proposes a set of reforms to remedy these problems. In the short term, the authors recommend that the TIPS committee permit a broader interpretation of some existing rules to speed the listing process for new technologies and to include some devices that are currently not reimbursed. A midterm goal recommended by report authors is to streamline the assessment process under the aegis of a joint medical benefit and pricing committee that would make reimbursement decisions within 120 days. Lastly, the report encourages the establishment of diagnosis-related-group– or fee-for-procedure–type payment regimens.
The French trade association SNITEM has not officially endorsed the report but has said it will air its conclusions during discussions with government officials on the reform of pricing and reimbursement procedures.
For additional information, contact JNB-Développement S.A., 45, rue de Babylone F-75700, Paris, France; phone: +33 1 47532760; fax: +33 1 47532769.
MRI System Receives Design Award
The Airis II magnetic resonance imaging system, designed and manufactured by Hitachi Systems offices in Japan and United States, was named a gold award winner at the Medical Design Excellence Awards dinner and ceremony on 26 May. The event was held during the Medical Design & Manufacturing (MD&M) Exposition and Conference in New York City.
Hitachi was one of 12 firms to receive a gold award, and the only multinational firm to receive such an honor. "Winning this award, along with achieving great market success with the Airis II, provides confirmation that at Hitachi, our approach to new product design must be a good one," says Sheldon Schaffer, vice president, marketing, at Hitachi Medical Systems America Inc. (Twinsburg, OH, USA). "There's always a concern with respect to market requirements and engineering design being of the same mind. This award confirms that marketing and engineering working together can deliver a quality product the marketplace is asking for. In our situation, this is particularly valuable given that our major marketing effort is in the US and the major engineering force is in Japan." The Airis II was designed in Hitachi's Tokyo office.
Twenty-eight silver winners were also named. Of these, two were European companies. The ClearPlan easy fertility monitor was designed by Cambridge Consultants Ltd. (Cambridge, UK) and Althofen Electronics (Althofen, Austria), and manufactured by Unipath Ltd. (Bedford, UK). The Braun ThermoScan thermometer was designed, developed, and manufactured in Kronberg, Germany.
This year's competition marked the first time the awards were open to worldwide competition. Of the 175 entries, eight were international submissions received from the UK, Hungary, and Germany. The 40 award winners were selected in 11 categories, including surgical equipment, instruments, and supplies; diagnostic devices; general therapeutic healthcare products and critical-care and emergency products; home medical equipment and supplies and self-care products; clinical laboratory equipment and supplies; dental instruments, equipment, and supplies; finished packaging; healthcare furnishings and patient-transfer equipment; implant and tissue-replacement products; other medical and healthcare products; and rehabilitation and assistive-technology products.
For more information about the Medical Design Excellence Awards, send e-mail to sally.lane@cancom.com, or send a fax to +1 310 4454269.
Device Industry Suppliers Open One-Stop Shop
Seven US suppliers to device OEMs have pooled their resources to offer manufacturers one-stop sourcing for multiple services. Through its multifacility manufacturing network, MedSource Technologies Inc. (Minneapolis, MN, USA) can provide an array of services that include product development, microprecision machining, wire forming, precision stamping, laser processing, plastics manufacturing, and assembly. Injection moulding, manufacturing, sterilization, and packaging in a cleanroom environment are also available.
The seven companies that have joined together are Brimfield Precision, Hayden Precision Industries, InstruMed, Kelco Industries, MicroSpring Co., Portlyn Corp., and Texcel. The integration was dictated by a demand for one-stop service that has been gaining momentum among customers, according to MedSource CEO John Hertig.
"The markets that we serve are experiencing rapid change, and our customers as a result are changing the way they do business with their suppliers," says Hertig. In particular, he has spotted a determination by current and potential clients to improve their supply chains. Hertig adds that the successful supplier of the future must offer a full range of services, including multiple manufacturing capabilities and functional design and assembly. By placing these well-qualified companies under one umbrella, MedSource is poised to become "the preferred global supplier of medical contract manufacturing and support services," Hertig anticipates.
For additional information, contact MedSource Technologies, 2 Carlson Pky., Minneapolis, MN 55447, USA; phone: +1 612 2492345.
Cleanroom Goes to Head of the Class
A company that provides ultraprecision machining to standard, miniature, and subminiature levels has installed a Class 100,000 cleanroom that surpasses requirements for its category established by US Federal Standard 209E. The 930-sq-ft addition to the Norman Noble Inc. facility in Cleveland, OH, USA, enables the company to monitor airborne particulate levels, as the standard stipulates, but it also permits regulation of temperature, humidity, and microbial growth. The firm chose to aim for a higher standard in anticipation of tougher European requirements, according to specialty project manager Rick Schulz.
"We made the extra effort," says Schulz, "to avoid downtime needed to make the upgrades, which will be called for when the new standard is implemented." The cleanroom, which is currently used for device assembly and packaging, was designed to facilitate upgrades of the entire facility or simply portions of it when microenvironments are needed to perform specific tasks.
Certified to ISO 9002, Norman Noble offers complete subcontracting services from concept to prototype to high-volume production, finishing, and coating. The company has more than 25 years' experience in electrical discharge machining (EDM); other capabilities include laser micromachining, plunge EDM, wire-cut EDM, and Swiss-type automatic lathe and conventional machining.
For more information, contact the company at 5507 Avion Park Dr., Highland Heights, OH 44224, USA; phone: +1 216 7615387; fax: +1 216 7613038; e-mail: toddnoble@compuserve.com.
Packaging Companies Form Consortium
Seven companies from the European Sterilization Packaging Association (ESPA) have joined forces to develop a reliable microbial barrier challenge test for use in manufacturing applications. The Barrier Test Consortium Ltd. (BTC) was formed by DuPont Engineering Products (Luxembourg), Henry Cooke Ltd. (Beetham, Cumbria, UK), Kimberly Clark Corp. (Joure, Netherlands), Oliver Products GmbH (Mannheim, Germany), Perfecseal, a Bemis Co. (Londonderry, UK), Rexam Medical Packaging Ltd. (Stoke Gifford, Bristol, UK), and Westfield Medical Ltd. (Bath, UK).
According to William Inman, president of BTC, "Standardization issues are at the forefront of the packaging industry." In response to this trend, BTC is working to develop a fast, reliable test for microbial barrier properties, which it hopes will be adopted as a standard. "Both ISO and the European EN series of standards for medical packaging have a gap where such a test should be," says Inman. "We're hoping to fill that gap."
Currently, many packaging suppliers contract out to independent laboratories for such tests, which tend to be time-consuming and expensive. The advent of a standardized microbial barrier test promises to give companies a control process that can be integrated with their manufacturing facilities.
"There is considerable pressure in the medical packaging industry with regard to both environmental issues and performance testing," says Inman. "Quite frankly, I believe that a lot of the environmental and waste legislation coming out of Europe recently has encouraged each country to adopt its own policy," he adds. "The BTC is working on an important test aimed at performance issues, and we hope our test will underpin an industry approach and an international standard." BTC recently signed a contract with Air Dispersions Ltd. (Manchester, UK) for the development of a barrier test method for sterilizable medical packaging.
For more information, contact the Barrier Test Consortium Ltd., c/o ESPA, Ave. de la Vieille Source 61, B-1410 Waterloo, Belgium, phone: +32 2 3874548; fax: +32 2 3870303.
German Association Promotes Nanotechnology
An association devoted to the conversion of nanotechnology-based research into viable products and processes has been established in Germany. The Competenz Centrum Ultrapräzise Oberflächenbearbeitung e.V. (CC UPOB; Braunschweig) plans to foster cooperation among companies, universities, and independent research centres to develop manufacturing and metrological processes with industrial applications. CC UPOB is encouraging an exchange of ideas and expertise in four core technologies: mechanical and chemical processing, ion-beam technology, optical processing, and the metrological characterization of surfaces. It will promote optical and x-ray layer technology, ultraprecise 3-D structuring, and nanopositioning and nanomeasurement as ancillary endeavours.
The multidisciplinary body has announced that it will organize workshops and seminars to raise awareness of the organization's goals, assist in technology transfer, and support standardization efforts.
For additional information, contact CC UPOB, c/o PTB, Bundesallee 100, D-38116 Braunschweig, Germany; phone: +49 531 5925011; fax: +49 531 5925015.
In Brief
Medical Device Link Introduces E-mail Newsletter
A weekly e-mail newsletter provides news and information of interest to medical device professionals. Sponsored by the Web site Medical Device Link, the free newsletter tracks notable industry trends and announces new additions to the site, including market research reports, news stories, annotated links, supplier directories, and job postings. The newsletter also gives details about upcoming industry trade shows and lets readers know whenever another Canon publication—such as European Medical Device Manufacturer, Medical Device & Diagnostic Industry, Medical Product Manufacturing News, IVD Technology, Medical Electronics Manufacturing, and Pharmaceutical & Medical Packaging News—becomes available on-line. Readers will find a free subscription form on the site.
NDH Medical Plans New Facility
NDH Medical Inc. (St. Petersburg, FL, USA) announced plans for the construction of a new manufacturing facility and headquarters in Sevierville, TN. The 25,000-sq-ft plant will house equipment and support services for the company's custom extrusion and contract manufacturing operations and will include cleanroom areas. The facility has a growth capacity of 100,000 sq ft.
NDH Medical supplies single- and multilumen tubing, paratubing, and coextrusions to the device sector. The company also offers latex-free tubing and polyvinyl chloride alternatives.
For more information, contact NDH Medical Inc., 11001 N. Roosevelt Blvd., St. Petersburg, FL 33716, USA; phone: +1 727 5702293; fax: +1 727 5703793.
Applied Silicone Launches UK Facility
Applied Silicone Corp. Europe (Derby, UK) recently announced the opening of its UK facility. The company, which manufactures silicone biocompatible elastomers, gels, adhesives, dispersions, sheeting, and special formulations and offers prototype extrusion and moulding services, is no longer affiliated with AG Silicones Ltd.
For more information, contact Applied Silicone Corp. Europe, The College Business Centre, Uttoxeter New Rd., Derby DE22 3WZ, UK; phone: +44 1332 369116; fax: +44 1332 368613; e-mail: appliedsilicone@griffin.co.uk.
Acutek Opens First European Plant
Acutek International (Brussels) recently began operations in its first European medical device manufacturing facility. The Acutek Teoranta plant is located in Corr na Móna, Ireland, near the Co. Galway–Co. Mayo border. The company's full range of pressure-sensitive-adhesive–converting services reportedly has attracted interest among European device manufacturers since its sales office opened in Switzerland in 1997. Acutek shares the 1325-m2 plant with Vitalo Plastics N.V., a packaging supplier that also serves the medical industry.
For more information, contact Acutek International, Ave. Louise 149/24, B-1050 Brussels, Belgium; phone: +32 2 5357485; fax: +32 2 535757.
Shows and Conferences
Hospital 99 to Be Held in St. Petersburg
The Lenexpo Exhibition Centre in St. Petersburg, Russia, will host Hospital 99 and Pharmatsiya 99 on 13–16 September. The joint trade fair will include international hospital, pharmaceutical, and OTC drug exhibitions. The show is supported by the St. Petersburg Committee of Public Health, the Pharmaceutical Association, and the Stomatology Association of St. Petersburg. The fair will also feature Mother & Child 99, showcasing products and services for the gynaecological and obstetric industries, and Emergency Medicine 99, which will display respiratory systems and equipment for laboratories and rescue teams. Optic Expo 99 will provide exhibits for the optical and ophthalmological industries.
For more information, contact ITE Group plc, Byron House, 112a Shirland Rd., London W9 2EQ, UK; phone: +44 171 2869720; fax: +44 171 2860177; e-mail: press@ite-exhibitions.com.
Lodz Hosts Medicine 99
A world congress on medical science and technology and Medicine 99 will be held in Lodz, Poland, 7–9 September. A seminar on technology transfer is planned, and the exhibitors will present a range of medical equipment and components. Event organizers include the Chamber for International, Economic, and Scientific Cooperation; the Medical University of Lodz; and UNESCO-UNISPAR Poland.
For more information, contact the Chamber for International, Economic, and Scientific Cooperation, 272B Piotrkowska St., 90-361 Lodz, Poland; phone: +48 42 6816621; fax: +48 42 6819666.
Seminar Series Offered in Brussels
Clinical Design Group Inc. is sponsoring a series of two-day seminars on device-related issues in Brussels this November. Based on reports published by the sponsoring company, the courses offered are Project Management for Clinical Trials, 2–3 November; Good Monitoring Practices, 4–5 November; Clinical Trials Design, 8–9 November; and International Clinical Trials, 10–11 November.
For more information, contact Clinical Design Group Inc., 2128 W. Evergreen Ave., Chicago, IL 60622, USA; phone: +1 773 4895721; fax: +1 773 4894281.
