Are Device Companies Ready for the Euro?

While large firms are setting up procedures to integrate the single currency into their operations, many small and medium-sized companies have yet to begin planning for monetary union. This lack of diligence may result in a loss of business, caution experts.

Jeanette Marchant

Just when medical device manufacturers in Europe thought it was safe to relax after the exigencies of meeting the regulatory requirements of the Medical Devices Directive, they face yet another daunting experience: the introduction of a single European currency. Within six and a half months of the CE mark becoming mandatory on 14 June 1998, the euro will become the official currency of the 11 member states of the EU that are participating in the first phase of monetary union on 1 January 1999. Some companies still are unaware that they need to CE mark their products. How prepared are they—and indeed all manufacturers—for the euro?

Industry association EUCOMED (Brussels) is keen to make its members aware that they need to take action now to prepare for the euro. "While many companies are giving it due consideration, particularly the larger concerns and those involved in cross-border trade, there is little indication that small and medium-sized companies are doing so," says EUCOMED director-general Michael Baker.

Many issues are common to all business sectors. Whether companies are in or out of "euroland," they will need to address issues such as setting up a euro bank account and understanding the currency exchange mechanism, says Baker. For companies operating within euroland, staff can request that they be paid in euros from January 1999. "How many companies are prepared for that?" he asks.

Issues posed by the single currency that companies should be looking at, according to Baker, include:

• Understanding the treasury and banking implications.
  
  
• Adapting accounting and invoicing systems.
  
  
• Reviewing information technology and legal aspects.
  
  
• Studying the impact on relationships with customers and suppliers.
  
  
• Training and informing staff.
  
  
• Addressing strategic marketing issues.

"The thinking process should take place now, but implementation can be introduced over the next three years," says Philippe Ansiaux, whose Brussels-based consultancy Expect S.A. includes many health-care companies among its clients. He warns that if companies do not have the flexibility to bill their clients in either euros or local currencies, they could lose business.

One company that is "not sitting on its hands" is Smith & Nephew plc (London). Alan Fryer, group director of the company's European business, says that "companies that are prepared for the euro will do well." Smith & Nephew has set up two working parties to tackle the issues of accounting and the commercial aspects of the single currency, involving senior country managers. "It affects all subsidiaries, all parts of every management, not only the European divisions," says Fryer. To facilitate the transition, companywide guidelines are being drawn up.

The accounting implications are manifold. Price lists will need to be in dual currencies, which presents problems in rounding up or down. "Contracts that have been negotiated in lira, for example, and which cannot be rounded exactly could render the contract null and void," cautions Fryer. Other questions that need to be considered include deciding whether balance sheets should be prepared in euros or local currencies, setting budgets, and redefining performance measures, which will entail accounting restatements. "The investment required, such as information technology (IT), should not be underestimated," according to Fryer.

Conducting Business from a Pan-European Perspective

The single currency promises to engender a pan-European approach to business. Commercial decision making will be more centralized at Smith & Nephew and marketing strategies will be viewed in European terms rather than solely at a local level. Distribution has already been streamlined through the company's Dutch distribution centre, which supplies European operations. This has not been driven by the euro but by the need to reduce costs and rationalize stock, explains Fryer. Invoicing and documentation are handled centrally and this "will make the leap to the euro easier for us than for companies organized along more traditional lines," he believes.

Companies have to decide when to introduce the euro into their budgeting activities. Smith & Nephew may run budgets in euros in 2000, although this has yet to be decided. Group results will continue to be published in pounds sterling. German medical device company Paul Hartmann (Heidenheim/Brenz), which has adopted a very positive stance on the euro, is committed to having it as an official lead currency for the Hartmann Group from 1 January 2000. The European subsidiary of Boston Scientific (Natick, MA, USA) will move to reporting to its US parent in euros during the transition phase: in 1999 it will introduce double reporting and shift to euros on a step-by-step basis by 2002, according to Michel Darnaud, president of Boston Scientific Europe (Paris).

Transparency of Pricing Raises New Questions

One company that aims to be among the first to embrace the euro is Siemens (Erlangen, Germany). It began preparations two years ago with the formation of a working group in Munich under the leadership of senior management to formulate company policy. Each Siemens division within Europe has appointed a "euro manager" and is adapting corporate policy to its own business operations and procedures so that by January 1999, it will be ready to conduct business in the new currency.

From 1 October 1999—the beginning of the company's financial year—the euro will be Siemens' internal currency and all staff will be paid in euros. While customers will be able to purchase Siemens products in French francs or German marks, all internal bookkeeping will be in euros. Local currencies will be converted at the moment of entry into accounts.

The transparency in prices that will result from the euro will have implications for the medical device industry (although the impact is expected to be less pronounced than for pharmaceuticals). The fragmented nature of the device industry, where individual products rarely achieve sales comparable to those of drugs, means that prices receive less focused attention. Nevertheless, customers will find it easier to compare prices from different suppliers and this will trigger questions in areas not previously scrutinized for medical devices, says Darnaud.

Euro manager of Siemens' medical division, Claus-Wilhelm Behnke, who is vice-president of business administration for computed tomography(CT), believes that the euro will have little impact on the market for high-end products such as MRI and CT scanners. Because of the competitiveness of the medical industry, a strong euro currency against the dollar or yen could have a "slight impact," he says.

At the other end of the medical equipment market, Behnke considers that better transparency of pricing may accelerate the decline in prices of items such as hearing aids, and simple electromedical and x-ray equipment. The wide price variations that exist for some products are likely to erode as prices come under greater scrutiny.

Boston Scientific's Darnaud is concerned about the potential for price harmonization in a European market where healthcare systems differ markedly: reimbursement mechanisms range from product reimbursement (such as the TIPS list in France) to the DRG (diagnosis-related group) flat-rate system for in-patient hospital treatment in Germany. In addition to the differing reimbursement systems, there are discrepancies in the ways in which hospitals pay: companies wait just 15 days for payment in the UK and northern Europe but 90 to 100 days in France and as much as 250 days in Spain and Italy.

Furthermore, in some countries prices include freight charges to the customer while in others, such as the UK, a separate charge is permitted. Training and physician support are also factors that have been costed into prices in some countries but not in others. Clearly, companies will have to respond through communication programmes and public relations strategies to explain the differences in pricing systems to their customers.

Developing a Pricing Strategy

Ansiaux agrees that companies will need to be prepared to justify price differences within Europe. He considers it good strategic policy to define factory-gate price bands, independent of local variables (such as VAT). While most multinationals have already developed a pricing strategy, they have not necessarily implemented it yet. Companies that have adopted a euro pricing policy before January 1999 will have a head start, believes Ansiaux. But he cautions: "Once a company has published the price in euros it will be difficult to change the price."

Price corridors are being introduced by companies such as Smith & Nephew. The margins between the lower and upper limits set for products will vary according to products, with some narrower than others, says Fryer. He believes that extreme variations in prices may be eliminated in the device sector but that there will continue to be differences.

Boston Scientific introduced the price corridor concept some time ago, says Darnaud, but "is redefining a more pan-European policy." New products will first have a euro price, then a local price. "New products are easier to deal with and every product we launch will have a European price." The Paris-based company has a task force looking at the prices of existing products by product family to identify areas where there are significant price discrepancies and where there may be potential problems. "We are trying to be proactive," says Darnaud.

The short product life of medical devices means that by 2002, when local currencies are due to cease being legal tender, Boston Scientific will have almost renewed its product line. "Some 80% of our product line is less than three years old, so the transition phase of the euro is consistent with the pace of product introduction."

With respect to marketing practices, Siemens' Behnke says that the euro will not effect changes but may speed up trends already in motion. With one currency, sales and service organizations will no longer respect national borders and this will influence the way companies sell their products. While purchasing may undergo change, Behnke points out that the different healthcare systems within Europe present an obstacle to the development of large organizations such as those in the United States. If large chains develop, this will be independent of the euro, he says, adding that the currency "may move the market."

Although many companies see the euro as purely an additional cost item, those viewing it in broader terms could gain from opportunities. Ansiaux believes that the euro could act as a catalyst for changes, particularly for smaller companies that could benefit from having one distributor, one financial centre, and a local treasury function.

Introduction of the Euro May 1998: Austria, Belgium, Finland, France, Germany, Ireland, Italy, Luxembourg, The Netherlands, Portugal, and Spain enter euroland. 1 January 1999: The euro becomes the official currency of the 11 first-wave members, although national currencies may continue to be used at the euro exchange rate. 1 January 2002: The euro currency enters circulation in Euroland. 30 June 2002: National currencies in the 11 members of euroland will no longer be legal tender.

Device Suppliers Choose Ireland

The presence of major medical device manufacturers along with relocation incentives has prompted two US-based suppliers to the device industry to open facilities in Ireland. Harmac Medical Products Inc. (Buffalo, NY), a full-service contract manufacturer of single-use medical devices, opened a 27,000-sq-ft plant in Castlerea, Co. Roscommon in July, while Adhesives Research Inc. (Glen Rock, PA), a supplier of pressure-sensitive adhesives, announced that it would be opening a 24,000-sq-ft facility in Limerick by the end of the year.

Harmac manufactures an array of custom disposable medical and laboratory products including fluid delivery bags and sets, catheters, drug delivery systems, and blood filters in its US plant. The FDA-registered company's new European subsidiary, to be known as Harmac Medical Products Ltd., initially will supply enteral feeding bag products to Abbot Laboratories in Sligo, Ireland. Ultimately, the ISO 9001/EN 46001–certified company plans to add radio frequency welding, heat sealing, cleanroom assembly, and injection moulding capabilities to the Irish plant. A Class 10,000 cleanroom has already been installed.

Adhesives Research Inc.'s facility will offer capabilities in product development, technical support, manufacturing, finishing, and warehousing. The full manufacture of pressure-sensitive adhesives, from polymerization to final slitting, will also be performed at the facility. Adhesives Research is certified to ISO 9002.

For additional information on either of these companies, contact them directly at the following locations. Harmac Medical Products Inc., 2201 Bailey Ave., Buffalo, NY 14211-1797, USA; phone: +1 716 8974500; fax: +1 716 8970016. Adhesives Research Inc., P.O. Box 100, Glen Rock, PA 17327, USA; phone: +1 717 2357979; fax: +1 717 2358320.

Medium-Energy, High-Power E-Beam System Developed for In-Line Sterilization

Acompany that specializes in the installation of radiation processing systems on factory production lines has announced the availability of an in-line E-beam system for the sterilization of medical products. The Minilac, which was jointly developed by RPC Technologies (Hayward, CA, USA) and Mölnlycke Health Care AB (Göteborg, Sweden), is reportedly the world's first medium-energy, high-power commercial linear accelerator designed for in-line sterilization of medical products.

"The combination of medium energy and high power is what's unique about this product," says Gray Buetzow, marketing manager at RPC Technologies. "Industry has seen specialized products adapted from existing lines, but that is not the case here. The Minilac was designed from the ground up. This is not a one-off, this is our product line," explains Buetzow.

In joint development for three years, the Minilac had its trial run at a Thai facility that manufactures drapes and gowns. The company, which had been using contract sterilization services, achieved significant savings in time and expenses by bringing the process in-house, according to Buetzow.

Packaging, sterilizing, and loading the product into the shipping carton takes no more than five minutes with the Minilac system, says Buetzow. Instead of placing individual products in shipping units prior to sterilization, manufacturers are able to sterilize products before loading them into the shipping containers. Customized quantities can then be packed into shipping cartons to meet specific customer needs.

Throughput rates for a single product line exceed 5 m/min; by incorporating product tracking systems and bar code readers, products routed from single or multiple production lines can be sterilized. A programmable logic controller and PC-compatible interface provides comprehensive monitoring, control, product tracking, and data logging.

The Minilac system meets all AAMI, EN, and ISO guidelines for E-beam sterilization and occupies only 37 m² of floor space.

For more information, contact RPC Technologies, 21325 Cabot Blvd., Hayward, CA 94545, USA; phone: +1 510 7858040; fax: +1 510 7851518; E-mail: gbuetzow@rpctechnologies.com.

Abrasive Water-Jet Profiling Project Announced

A project under the EC Innovation programme will seek to develop contract abrasive water-jet profiling centres across Europe. The objective of the Diajet initiative is to build competitive CNC abrasive water-jet profiling systems and to demonstrate the business benefits that small companies can derive by providing contract profiling services. BHR Group Ltd.'s Fluid Engineering Centre (Cranfield, Beds, UK) will also establish training and support mechanisms for start-up companies that are exploiting its Diajet profiling technology.

According to external relations manager Ed Bloomfield, abrasive water-jet cutting with CNC manipulation is the only method able to profile metals, ceramics, glass, polymers, and composites from sheet or plate stock. Brittle materials are profiled as easily as layered composites using the technology.

Another advantage of the Diajet system is the capability of producing parts free of heat-affected zones with a surface quality that precludes secondary finishing in most cases. Because programming, setup, and manufacturing response are rapidly executed, the process is well suited for just-in-time small-batch production.

For more information about the Diajet system and EC-supported project, contact BHR Group Ltd., The Fluid Engineering Centre, Cranfield, Beds MK43 0AJ, UK; phone: +44 1234 750422; fax: +44 1234 750074; E-mail: ebloomfield@bhrgroup.co.uk.

Process Developed for Deburring Stents

Following manufacture, intravascular stents typically must undergo deburring so that the sharp edges do not penetrate or otherwise damage the balloon material during extension. Using abrasive jet machining (AJM), Technisch Buro Samoen B.V. (Ridderkerk, Netherlands) has developed a method for removing burrs around the inner and outer diameters without damaging the devices' tantalium windings.

AJM is a well-accepted process that involves directing a stream of powder particles to a surface through a tungsten nozzle attached to a flexible hose. The size and hardness of the particles varies depending on the application, as does the quantity of powder and the air velocity. Because it does not induce heat or stress in the surface being treated, AJM is well suited for both hard materials and delicate components.

Configuring the AJM process to remove burrs in stents was not difficult, says Rudolf J. van Ameijde. "What did pose a problem," he adds, "was making sure that all of the angles of the material were abraded without causing damage to the stents' tantalium windings." The windings are easily deformed by exposure to the air and powder stream. The solution apparently resides in the way that the product is positioned during the machining process. "It took a long period of testing," says van Ameijde, but the technology now works and, in fact, is being used as a part of fully automated systems.

In addition to deburring and beveling operations in stents, cannulae, and related devices, AJM is suited for cutting, etching, frosting, shaping, cleaning, and deflashing hard and brittle components. For more information on AJM equipment or processes, contact Technisch Buro Samoen B.V., Rindijk 92, NL-2982 XH Ridderkerk, Netherlands; phone: +31 1804 10576; fax: +31 1804 11001.

Foundry Invests in Time-Compression Tools

A foundry that serves the health-care industry recently announced the purchase of two state-of-the-art rapid prototyping (RP) systems, a Sinterstation-2500 from DTM Corp. (Austin, TX, USA) and an SLA-5000 from 3D Systems (Valencia, CA, USA). It is reportedly the only foundry in the world with complete in-house rapid prototyping capability. Solidform (Fort Worth, TX, USA) also owns a 3-D printer and has built more than 11,500 castings from approximately 1050 different RP patterns.

"This acquisition expands our ability to be the leader in time-compression applications and meets our requirement for verifiable dimensional attributes of part geometries," says Solidform's general manager Larry André. The company's time-compression technologies include CAD tool design, virtual design review via the Internet, precision sand or investment-cast aluminium parts from RP masters in as few as five days, and production quantity wax patterns.

For additional information, contact Solidform Inc., P.O. Box 7656, Fort Worth, TX 76111, USA; phone: +1 817 8312626; fax: +1 817 8318258.

Tyvek Developed for Desiccant Use

A new Tyvek substrate that is thinner than previous formulations has been specified for use with desiccant packaging. Tyvek 1025B, which retains a high degree of strength and puncture resistance and is not affected by moisture, will be supplied by Phoenix Health Care Products LLC (Milwaukee, WI, USA) for packaging applications.

The Tyvek is sealed with the company's proprietary desiccant heat seals by means of vertical or horizontal wrapping machines. The resulting pouches reportedly have withstood rigorous testing. The lighter-gauge material will enable customers to achieve cost savings and reduce the amount of waste material, according to the company.

Phoenix Health Care Products supplies an array of packaging materials including coated paper and films, film and foil laminates, and forming films. Packages with a detectable prior opening feature and cold-seal and heat-seal coatings for sterile disposable devices are specialties. Printing and design and development services are also available.

For additional information, contact Phoenix Health Care Products LLC, 6161 N. 64th St., Milwaukee, WI 53218-1543, USA; phone: +1 414 4381200; fax: +1 414 4381330.

High-Melt TPU Film Introduced

A polyether thermoplastic polyurethane specifically formulated for heat resistance provides melt temperatures between 190° and 210°C. The thin urethane film was developed by Stevens Urethane (Holyoke, MA, USA) for use in multilayer laminations and other applications where materials are subjected to high temperatures.

Because of the elevated temperatures required to make ST-1665 bond with other materials, its strength and barrier characteristics are not affected by processing temperatures that would melt other urethane films, according to the company. The material is suited for any application requiring high-temperature performance, either during the manufacturing process or in the end-use product.

A lighter-gauge Tyvek substrate used with desiccant packaging will help customers achieve cost savings. Urethane film ST-1665 is designed for applications requiring high-temperature performance.

For more information, contact Stevens Urethane, 9 Sullivan Rd., Holyoke, MA 01040, USA; phone: +1 413 5338100; fax: +1 413 5521195; E-mail: tagraham@stvure.com.

Austrian Region Establishes Medical Technology Centre

Can a medical technology centre with international ambitions be created by sheer force of will? That is what is at stake in lower southern Austria, where the Institute of Precision Engineering (Vienna) and TZU GmbH (Wiener Neustadt, Austria) hope to leverage the recently opened Wiener Neustadt Technical College, a business location incentive plan, and the proximity of hospitals and clinics into the foundation of a full-scale medical technology centre.

Recognizing that the further miniaturization of medical devices is a key industry trend, Wiener Neustadt's project focuses on gaining expertise in microtechnology and microtribology. To achieve this, the technical college offers courses in microengineering and medical technology and several dedicated laboratories will be established in the region. Specifically, Wiener Neustadt plans to welcome laboratories devoted to microtechnical handling, assembly, and automation; advanced production techniques; and the development of biomechanical systems. According to the project report, experienced international partners will be involved in the establishment of these laboratories whose work will be closely linked to the needs of industry. Wiener Neustadt Technical College and Vienna Technical University will be cooperative partners.

Boosters of the project acknowledge that the introduction of this technological focus to the area may not produce significant results in the short term. They are, however, confident that the unique nature and scope of the initiative will increase the region's visibility in the medical device sector. The recent arrival of medical-technology-related projects spearheaded by Vienna's Institute of Precision Engineering and the Erwin Schrödinger Gesellschaft für Mikrowissenschaften to the technical centre are two examples TZU cites as proof that the region is headed in the right direction.

For more information on Wiener Neustadt's Centre for Medical Technology, contact TZU GmbH, Johanes-Gutenberg-Str. 3, A-2700 Wiener Neustadt, Austria; phone: +43 2622 89084141.

In Brief

Prototype Manufacturer Covers New Ground in Italy

International prototype manufacturer Arrk Corp. (London) has recently opened Arrk Italia (Milan), a division that will accommodate a growing Italian customer base, according to the firm. The Italian market was previously serviced from the firm's European headquarters in London.

The company manufactures prototypes, mock-ups, and working models of new product designs using 3-D computer data and 2-D designs. Among the services available are stereolithography, rapid prototyping, CNC machining, fabrication, casting, hand finishing, and rapid tooling for short-run production. A manufacturing base in London services offices in England, Germany, and France. Facilities are also located in the United States, Japan, Thailand, Malaysia, and Korea.

For more information, contact Arrk Europe Ltd., Unit 11 Commercial Way, Abbey Rd., London NW10 7XF, UK; phone: +44 181 9616366; fax: +44 181 9650201.

ITT Industries Acquires UK Fluid-Handling Components Producer

ITT Industries (White Plains, NY, USA), a manufacturer of pumps for the worldwide market, recently announced its acquisition of Sinton Engineering Group (Kirkham, UK), a firm that specializes in the production of such fluid-handling components as valves, custom fabrications, and specialty fittings.

Founded in 1976, Sinton operates according to ISO 9001 standards and reportedly has annual sales of approximately US$7 million. The company began serving as a factory-authorized distributor for ITT Industries in 1991, and later assumed the role of licensee, supplying ITT's Pure-Flo products including valves and processing components throughout Europe.

The acquisition of Sinton follows closely ITT Industries' purchase of A. G. Johansons Metallfabrik AB (Kolback, Sweden), also a manufacturer of stainless components and custom fabrications.

For more information, contact ITT Industries, 33 Centerville Rd., Lancaster, PA 17603, USA; phone: +1 717 2911901; fax: +1 717 2912025.

Private Investor Purchases Notified Body mdc GmbH

Dr. Müller-Lierheim GmbH (München, Germany), a company that provides training, regulatory, and testing services for the medical device industry, and mdc device certification GmbH (Memmingen, Germany), a German notified body accredited for the certification of nonactive medical devices according to the Medical Devices Directive, have recently announced that private investor Martin Puls has purchased 100% of the notified body's shares, which were formerly held by Dr. Müller-Lierheim GmbH.

The sale of mdc GmbH reportedly is a critical step toward Dr. Müller-Lierheim's intended withdrawal from certification and testing. The action follows rather closely the April signing of a joint venture contract between Dr. Müller-Lierheim GmbH and the Zhejiang Medical Device Institute to form the Zhejiang ML Medical Device Consultant Company. In the future, Dr. Müller-Lierheim GmbH will focus on the supply of international medical device information, and training and consulting services, according to the company.

According to Harald Rentschler, mdc president, the notified body has received significant support from the management of the Müller-Lierheim Group during the past four years and has the foundation for a successful, independent future.

For more information, contact Dr. Wolfgang G. K. Müller-Lierheim, Sambergerstr. 8, D-81477 München, Germany; phone: +49 89 7917787; fax: +49 89 7917383; or mdc medical device certification GmbH, Krautstr. 2, D-87700 Memmingen, Germany; phone: +49 8331 955229; fax: +49 8331 955255.

Moulding Firms Form Joint Venture

Custom and contract moulder Plastic Molding Technology (PMT; Seymour, CT, USA) and mould-maker ESOX s.r.o. (Bratislava, Slovakia) have signed a joint venture agreement. The agreement will enable PMT Slovakia s.r.o. and parent firm PMT USA to offer European customers up to 40% lower costs on high-quality insert- and injection-moulded components. Plans reportedly are under way to secure ISO 9000 certification for ESOPLAST s.r.o., the new joint venture company, by July of next year. The newly renovated facility will have four Battenfeld injection moulding machines and a full line of Conair auxiliary equipment.

For more information, contact PMT Slovakia S.r.o., Pionierska 15, 83102 Bratislava, Slovakia; phone: +42 1 7259122; fax: +42 1 7273046.

EUCOMED Appoints Third Business Area Director, Completes Reorganization

EUCOMED (Brussels) has completed the restructuring of its Brussels Secretariat with the appointment of Markus Siebert to business area director. The appointment, which took effect on 6 July, completes a structure that comprises three business areas. Zeger Vercouteren and Richard Moore will continue in their respective roles as directors of the other two regions.

According to EUCOMED, Siebert will focus on issues of increasing importance to the organization's members and to the medical device industry in general. Some of the issues with which Siebert will be involved are reimbursement, late payments, public procurement, and developments in electronic commerce.

Siebert is currently deputy managing director of Bundesverband Selbstaenger Physiotherapeut-Innen (IFK e.V.), an association representing the interests of freelance physiotherapists in Germany.

For more information, contact EUCOMED, Rue de Collège St. Michel 17 B8, B-1150 Brussels, Belgium; phone: +32 2 7722212; fax: +32 2 7713909.

Scapa Tapes Earns ISO 9001 Certification

Scapa Tapes North America (Windsor, CT, USA) has announced the certification of its Windsor facility to ISO 9001 standards. The facility, which serves as the North American headquarters for the company's specialty adhesive film and tape group, was upgraded from ISO 9002 to ISO 9001 status on 30 June following an 11-month registration effort.

For more information, contact Scapa Tapes North America, 111 Great Pond Dr., Windsor, CT 06095, USA; phone: +1 860 6888000; fax: +1 860 6887000.

Shows and Conferences

SAITEX Comes to Johannesburg

Johannesburg will host SAITEX, the South African International Trade Exhibition, 6–10 October at the Expo Centre. According to show organizers, the Medtrade Africa Pavilion will be the highlight of this year's global trade-only event. Special events to be held in conjunction with Medtrade Africa include the annual conference of the Woundcare Society of South Africa to take place 7–8 October. The conference will feature presentations and workshops on the latest innovations in wound treatment.

For more information, contact Expo International, Waardbeekdreef 21, B-1850 Grimbergen, Belgium; phone: +32 2 2698456; fax: +32 2 2697953.

Biomedicine and Health Exhibition to Be Held in Milan

MOSAN–MilanoSalute, the Scientific and Industrial Exhibition on Biomedicine and Health, will take place 7–10 October at the Milan Fair, Milan. The international event will highlight advanced research projects commissioned by European and Italian governmental and nongovernmental agencies in fields related to biomedicine and health. Research projects in such fields as gene therapy and genetic diseases, neurosciences and addiction, and prostheses and rehabilitation will be presented. The trade fair is intended to promote academic and industrial interchange and technology transfer within the sector.

For more information, contact ASSOEXPO, Via Domenichino 11, I-20149 Milan, Italy; phone: +39 0248 15541;
fax: +39 0249 80330.

Exhibition Focuses on Packaging and Labelling

FachPack 98, the Trade Fair for Packaging and Labelling Technology, will take place 14–16 October at the Messezentrum Nürnberg in Nürnberg, Germany. More than 600 exhibitors are expected to display packaging materials and supplies, labelling and marking equipment, packaging ancillaries, monitoring and testing equipment, and packaging machinery. Internal logistics such as transport and conveying systems, storage equipment, ancillary storage equipment, and in-plant logistics software will also be featured.

For more information, contact Nürnberg Messe GmbH, Messezentrum, D-90471 Nürnberg, Germany; phone: +49 911 86060; fax: +49 911 8606228.

Dutch Capital to Host MEDTEC 98

MEDTEC, a unique international exhibition and conference dedicated exclusively to the supply and service of Europe's medical manufacturers, will be held 7–9 October at RAI International Exhibition and Congress Centre, Amsterdam. Approximately 300 exhibitors are expected to display the latest equipment, materials, components, contract services, and information.

For more information on this event, which is sponsored by European Medical Device Manufacturer magazine, see the MEDTEC section in this issue or contact MEDTEC, UK office, P.O. Box 12997, London NW5 2WX, UK; phone: +44 171 4854343; fax: +44 171 2672788; E-mail: medtec.98@timeworks.co.uk.

Manufacturing Week Returns to Birmingham

Manufacturing Week 98, an annual industry event for engineers and technical managers, will return to the NEC in Birmingham, UK, on 10–12 November. The trade fair comprises two distinct events: the Design & Engineering Show (DES), which highlights such products as motors, materials, and electro-optical components, and the Automation, Production, & Maintenance Equipment (APME) show, which focuses on areas including material handling, protective coatings, automation and control, and lasers and sensors. The events are co-located with the Computers in Manufacturing (CIM) and Tooling shows. Seminars and political forums will address the latest issues in manufacturing.

For more information, contact The Reed Exhibition Companies Ltd., Oriel House, 26 The Quadrant, Richmond, Surrey TW9 1DL, UK; phone: +44 181 9107947; fax: +44 181 9107829.

Medicin Scandinavia 98 to Be Held in Sweden

The medical trade fair Medicin Scandinavia will take place 24­26 November at the Swedish Exhibition & Congress Centre, Göteborg. Exhibitors are expected to display such products as medical/technical equipment, pharmaceuticals, materials, and computers and information technology.

For more information, contact the Swedish Exhibition & Congress Centre, S-412 94 Göteborg, Sweden; phone: +46 31 7088000; fax: +46 31 160330.

Web Sightings

The Internet has become an invaluable tool for device manufacturers seeking information on everything from regulatory requirements and industry associations to upcoming conferences and expositions across the globe. Here is a selection of noteworthy sites on the World Wide Web that anyone involved in the design, manufacture, and marketing of medical devices would be well advised to bookmark.

Managed by the European Commission, Europa contains home pages for all of the EC institutions as well as a news page that posts press releases and information on upcoming events. The search engine guides users to such on-line resources as mutual recognition agreements and the medical device directives.

Information about EU-supported research and development projects can be found at Cordis, which holds several discrete databases centered on research news, opportunities, projects, study results, partners, publications, contacts, acronyms, and documents. Also worth exploring is EUDOR. The EU's document repository, this site offers easy access to official EC communications, notably the "L" and "C" series of the Official Journal of the European Communities.

Manufacturers conducting business in the United States can find a wealth of helpful information on the home page of US FDA's Center for Devices and Radiological Health (CDRH). It includes an overview of the agency, a staff search engine, recent CDRH Federal Register notices, and much more. A searchable version of the Federal Register holds the complete text for volumes published after 1994 as well as US FDA regulations, announcements of public meetings, and other regulatory-related communications.

The Regulatory Affairs Professionals Society (RAPS) Web site at was under construction at the time of printing. Once completed, the association promises visitors a searchable database of articles from the 1997 and 1998 issues of the society's publication, Regulatory Affairs Focus, and an on-line forum.

Valuable market data can be accessed at the Web site for the Health Industry Manufacturers Association (HIMA). Excerpts from HIMA reports, a news section, and an index of industry acronyms are included.

Tech Expo features a comprehensive listing of national and international technical organizations. Where available, links to the organizations are included.

If you're planning your travel schedule for the 1998/1999 season, Trade Show Central might be worth checking out. The site contains a searchable database of more than 50,000 shows, conferences, and seminars at more than 7000 locations worldwide. Users can search by show and conference type or name, by location, or by date.

Does your company have a must-see site? If so, send a press release to Web Sightings, European Medical Device Manufacturer, Vogelsbergstr. 13, D-65205 Wiesbaden, Germany, or fax the information to +49 6122 51090.