Industry news
Amsterdam Sessions Focus on Evolving Regulatory Requirements, Global Product Development
ISO 9000 Revisions May Pose Problems for Device Companies
The Phase 2 revisions of ISO 9000, which are scheduled to be published in 2000, promise to be substantive. Because the medical device industry uses this standard in a regulatory context and not simply as a basis for their quality management systems, these revisions may have a far more profound impact on device firms than on other industrial sectors. A core concern raised at MEDTEC by Paul Sim, convenor of the Association of British Health-Care Industry's ISO/TC 210 Mirror Group, is the emphasis on continual improvement.
"The introduction of the concept of continual improvement in ISO 9000:2000 is intended to stimulate the efficiency of the organization, to increase its competitive advantage in the market, and to better respond to customer needs and expectations," Sim told attendees. While some device companies consider this to be a valid goal, others opine that "it makes no sense within a regulated industry," he said. Many factors will need to be considered to show continual improvement, including business performance, Sim told EMDM, and these can only be determined by the company itself. This leaves much room for interpretation, he added, and clashes with auditing procedures and the provision of objective evidence to demonstrate compliance. Consequently, companies may be placed in the position of explaining why certain elements of the standard are not relevant to their operations, said Sim. "How do you tell a customer that you don't feel continual improvement is important?" he asked.
This is but one of several issues raised by the ISO revisions of particular concern for the medical device industry, and Sim urged attendees to consult with their national standards bodies and trade associations to review available documents. The DIS is expected to be published before the end of the year and, if all goes according to schedule, ISO 9000:2000 will be formally published by the last quarter of 2000. It seems probable at this point that companies will have a two-year transition period during which they can amend their systems and documentation, Sim added.
ISO Drafts Standard for Risk Management
With the deadline for comments on the draft international standard (DIS) related to risk management fast approaching, some device manufacturers should prepare to alter the way they perform risk assessments. ISO 14971 could be adopted as early as March, according to Gertjan Reichman, manager of international regulatory affairs at Sorin Biomedica. He discussed some of the implications of the standard for device companies at the recent MEDTEC exhibition and conference in Amsterdam.
"The deadline for comments from the national member bodies is 15 December," Reichman told attendees. "The committee will vote on the final DIS at a meeting scheduled for the end of January, and the device industry may have a new international standard two months later."
The current harmonized standard on risk analysis, EN 1441, is subsumed within the standard. "ISO 14971-1 is essentially EN 1441," Reichman said, "and EN 1441 will be withdrawn once the ISO standard has been adopted."
The ISO document introduces some changes in risk management procedures that will probably have a significant impact on SMEs, according to Reichman. "It is structured more like a quality systems standard, with an emphasis on the process, qualification of personnel, the establishment of a risk management plan and risk management file," he said. "Overall, ISO/DIS 14971 has much greater documentation requirements than EN 1441," added Reichman.
Procedures Outlined for Successful Global Product Development
Speaking at the recent MEDTEC conference and exhibition in Amsterdam, Ian Cantrill, senior consultant at MTC Quintiles (Rockville, MD, USA), proposed a series of steps to aid device manufacturers in preparing for audits by US FDA officials and European notified body assessors.
"Despite the excellent work of bodies like the Global Harmonization Task Force," said Cantrill, "the international regulatory situation is likely to get tougher in coming years." According to Cantrill, the main pitfalls for manufacturers to avoid are lack of preparation for inspections and poorly structured quality management systems. He encouraged manufacturers to "plant the seeds of a good quality system" by confirming executive management's commitment to this goal and to prepare for quality assessments by identifying the processes that are most likely to be audited.
Conference attendees were also reminded of the importance of making an audit easy for an assessor. Management should implement design and manufacturing procedures in a way that is both beneficial to a company's quality system and transparent for an auditor, said Cantrill.
Presentation Highlights Plasma Solutions for Medical Applications
A summary of developments in the application of plasma treatment to plastics, textiles, and metals was presented at a conference led by Johan Palmers, project and process manager at Europlasma (Oudenaarde, Belgium).
Through the ionization of different gas mixtures, plasma treatment can perform ablation, cross-linking, activation, and deposition on a variety of surfaces. Depending on the material used, the treatment can last up to several weeks. Palmers highlighted the main medical applications of these processes, which include cleaning; adhesion promotion; sterilization; and the creation of low-friction, hydrophobic, hydrophilic, and biocompatible coatings on medical components. Devices which stand to benefit from such applications include catheters, blood filters, and medical textiles.
Plasma activation offers several advantages over other forms of surface modification, according to Palmers. It requires low energy consumption and generates no waste. Furthermore, it poses no danger of substrate damage or bulk property changes. Finally, because the technique is based on the ionization of a gas in a chamber, there is no limit to possible substrate geometries.
"Plasma treatment is an interesting solution for device manufacturers, combining the qualities of environmental and operator friendliness, controllability, and effectiveness on a variety of materials," said Palmers.
Suppliers of Private Certification Marks Prepare for Action Against German Government
A confederation of German testing and certification companies has warned that it may take legal action against the German Ministry of Health if the government moves to outlaw the use of private marks on medical products.
The Federation of Technical Monitoring Associations, VdTÜV Essen, has filed an expert opinion with the German Ministry of Justice outlining the laws and regulations it claims would be violated should private marks be banned from medical products.
The move is seen as a response to a recent warning from the German Ministry of Health. In a letter addressed to German health authorities and industry associations, Gert Schorn, head of the ministry's division for medical devices and standardization, claimed that private marks on CE-marked medical products were illegal.
At issue is the potential for private marks to distort or undermine the meaning of the CE marking. According to Article 17, paragraph 3 of Directive 93/42/EEC, "marks and inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking may not be affixed." In his letter dated 20 June, Schorn proposes the following logic: "[Private] quality signs cannot cover quality factors other than those covered by the CE marking, since the quality requirements provided for in the EC Directives are comprehensive. Such quality signs do not raise the level of safety in any way. Consequently, [they] are likely to mislead third parties with regard to the meaning of the CE marking." The debate may have serious implications for device manufacturers. Under German law, manufacturers that mislead consumers could be subject to fines or prison sentences.
Private certification and testing houses have moved to allay such concerns. Alexander von Dercks, legal counsel for TÜV Product Service GmbH (München), says, "Legally, there can and will be no consequences under German law for manufacturers using private marks." TÜV has long claimed that the CE marking is designed to allow products to travel freely in Europe, while its private TÜV mark indicates "high quality for consumers."
This view has been met with strong opposition from European industry associations such as EUCOMED, as well as from national industry groups. Rainer Hill, assistant managing director of the Federal Association of the Medical Device Industry in Germany (BVMed), rejects von Dercks's analysis and echoes the ministry's position, stating that "additional quality marks for medical devices are absolutely superfluous. A rightfully affixed CE marking for medical devices is a de facto quality mark, as it stands for product safety and efficacy."
Hill notes that BVMed has obtained evidence from an industry source indicating that a private quality mark was sold to their company based solely on the CE-marking documents, without any further testing. "The company was very upset and decided not to affix the private mark," he adds.
Arguing that such incidents raise not just a legal but also an ethical issue, Hill says, "There is a conflict of interest when a testing house is also a notified body. Effectively, such testing houses are doing the job once, and charging companies twice, which we feel is not right."
Both sides agree that the debate has great significance in the global market. Calling the use of private marks on medical devices "a step in the wrong direction," Hill hints that such marks may become another obstacle to the implementation of the EU's mutual recognition agreement with the United States. It would be unfeasible for European legislative bodies to restrict private marks, counters von Dercks: "We strongly doubt that the Ministry of Health will, for example, sue US manufacturers exporting products into the EU labelled with the UL mark. The same goes for EU-based manufacturers. Restricting private marks would effectively turn back the wheel of a common market in Europe."
A second amendment to the German Medical Device Act is under consideration in the legislature and contains a clarification of legal issues surrounding the CE marking. Forthcoming statements from the German Ministry of Health and the European Commission are also expected to communicate German and EU positions on the topic of private marks. In the meantime, von Dercks explains his company's stance: "We will avoid legal action as long as possible, but we are determined to protect the interests—especially, but not only—of small- and medium-sized manufacturers in the use of private marks and to promote worldwide competition and free trade."
Ceramic Coating Process for Implants Under Development
A company is developing a proprietary chemical vapour deposition process to coat cobalt chrome with various mixtures of ceramics to induce lubricity. According to clinical studies cited by Implant Sciences Corp. (Wakefield, MA, USA), ceramic-bearing surfaces produce less wear than cobalt chrome components, which are typically used to manufacture knee and hip joint replacements. The company currently is developing and testing the technology, which is underwritten by a US$100,000 grant from the US National Institutes of Health's Institute of Arthritis and Musculoskeletal and Skin Diseases. If the Phase I tests are successful, the firm may be eligible for additional funding.
Implant Sciences currently treats knee and hip joint total replacements with nitrogen ions for several major manufacturers of orthopaedic products. According to company president and CEO Anthony Armini, the coating would be a second-generation product to prevent the onset of wear debris and reduce or slow implant loosening that ultimately leads to joint failure and repeat surgery. Demand for technologies of this type will be in ever greater demand, he adds, as the population ages and life expectancy grows.
The company's core activity is product development for the device industry using ion implantation and thin-film coatings of radioactive and nonradioactive materials. It currently uses its technology to apply radiopaque coatings to stents, guidewires, catheters, and related devices used in interventional cardiology procedures. Radioactive coronary stents and interventional cardiology devices for the prevention of restenosis are under development.
For more information, contact Implant Sciences Corp., 107 Audubon Rd., #5, Wakefield, MA 01880-1246, USA; phone: +1 781 2460700; fax: +1 781 2461167.
Swedish Supplier Reorganizes to Bolster Medical Operations
Nolato AB (Torekov, Sweden) has reorganized its subsidiaries to create a business area for the production of medical components. The group anticipates the formation by January 2000 of a new company targeting producers of drug-delivery systems.
The reorganization pairs Nolato Medical AB (Torekov, Sweden) with a new company, Nolato Gejde AB, to be formed from the medical division of Nolato Gejde (Lomma, Sweden). Anders Jidorf, former president of another Nolato subsidiary, has been named president of the new company. The reorganization is capped by the formation of a new business area, Nolato Medical Components, which will focus on the development, manufacture, and processing of plastic and rubber components for medical devices.
"Our intention is to work with the same concept as Nolato's other business areas," says Peter Stahl, president of Nolato Medical. "We will be several companies that together offer expertise across a spectrum: manufacture of small precision parts in plastic and rubber, project management, and development." Sensing the potential for growth, Nolato intends to augment its medical business area further with a series of acquisitions. Discussions are under way with several companies in the Medicon Valley area between southern Sweden and eastern Denmark.
The formation of the new business area will serve to reinforce Nolato's presence in the medical sector. Since its founding in 1997, Nolato Medical AB has been the only subsidiary of the Nolato Group dedicated to the medical sector. The company specializes in the development of injection-moulded precision components in silicone and thermoplastic elastomers. A range of components includes latex-free standard products for anaesthesia and intensive care, silicone tubing and catheters, and catheter balloons in low-allergen latex. According to Stahl, Nolato Medical established itself in the marketplace by involving its engineers in customer projects at an early stage and offering clients cleanroom production and quality systems certified to international standards. As a result, it saw significant growth over the past two years. "We have concentrated on fewer, larger customers, and this strategy has proved profitable," says Stahl.
Based in Lomma, the medical division of Nolato Gejde develops, manufactures, and processes injection-moulded plastic products for the device industry. Cleanroom production is offered, and the company is certified to ISO 9002 and EN 46002. Christer Wahlquist, sales manager at Nolato Gejde, says, "We have played an active role in the development of materials and manufacturing methods for our clients."
Although the two companies have a history of cooperation, it was not until the autumn of 1998 that they began to form a joint business plan. The new plan envisions a division of labor in which plastic expertise is provided by Nolato Gejde and rubber expertise by Nolato Medical. Each company has hired a lead project manager to oversee joint company projects. Moreover, the companies share a common structure, have obtained the same quality certifications, and are operating according to the same procedures. Nolato officials hope this approach will allow projects to be managed more efficiently, and at reduced costs to the customer.
Company officials predict that Nolato Medical Components will distinguish itself by offering device manufacturers developmental expertise and the production of components to meet customer-specific needs. In the past, the Nolato companies have produced precision parts for pacemakers, as well as cuvettes for HemoCue AB (Ängelholm, Sweden), a wholly owned subsidiary of Mallinckrodt Inc. (St. Louis, MO, USA). The new business area is already working on several new projects for Maersk Medical a/s (Lynge, Denmark), a manufacturer of sterile disposable devices. A joint project team composed of representatives from the Nolato companies and the customer has developed a functional product made from a custom material.
Stahl notes that the restructuring sends a strong message to the device sector. "With the formation of a second medical company, the Nolato Group is showing the market that it is dedicated to the device industry," he says. "When Nolato Medical was formed in 1997, we were an experiment that worked. The message we are sending now is that Nolato is really going medical," he adds.
For more information, contact Nolato Medical AB, Torekov SE-260 93, Sweden; phone: +46 431 442260; fax: +46 431 442261; e-mail: medical@ nolato.se.
Device Subcontractor Optimizes Moulding Services
A supplier of contract moulding and related services to the medical device and pharmaceutical industries has implemented a monitoring system to improve product quality and accelerate processes. The Engel monitoring system (EMS) enables Medisize B.V. (Hillegom, Netherlands) to monitor all relevant production parameters on-line from a central computer, according to Annemarie Willems, account manager for OEM projects. "We strive to guarantee quality through controlled, validated processes rather than by inspecting the finished products. The system also allows us to generate production data that can be included in quality control documents and to increase throughput and enhance overall quality," says Willems.
EMS monitors seven moulding machines, including five tiebarless moulders that the firm recently installed. The acquisition of the machines and extension of the monitoring system is part of the company's core strategy to expand its OEM capabilities. Further improvements include the purchase in September of a SolidWorks CAD system "to generate new 3-D concepts, simulate moulding processes, and shorten development time for our clients," explains Willems.
Medisize manufactures infusion and transfusion sets and respiratory care products that it markets under its own name. Three years ago, the company decided to leverage its know-how and manufacturing resources to become a serious presence in the OEM market as well, says Willems. Current projects include the production of all the plastic parts of a dry-powder inhaler, a novel contraceptive device, and a pressure control pack that is used during ophthalmologic surgery.
In addition to moulding, the company supplies such contract services as assembly and packaging.
For additional information, contact Medisize B.V., P.O. Box 366 NL-2180 AJ, Hillegom, Netherlands; phone: +31 252 576888; fax: +31 252 519825.
Automated Cleanroom Integrates Robotic, Transport, and Storage Systems
A manufacturer of cleanroom products has designed an integrated transport and storage system for use in cleanroom processing. Terra Universal (Anaheim, CA, USA) in partnership with Shuttleworth (Huntington, IN, USA), a manufacturer of material transport systems, and Fanuc Robotics North America Inc. (Rochester, MI, USA), developed the system to automatically store, transport, and retrieve work in process. While the unit was specifically designed for the semiconductor industry, it can be easily adapted to the medical device and other sectors that routinely manufacture under controlled conditions, according to the firm.
Terra Universal's hermetically sealed storage and retrieval unit, which controls humidity, contamination, temperature, and UV exposure while managing inventory, is at the heart of the system. A vertical conveyor transports components from the storage unit to the various processing tools and retrieves them according to a programmed pattern. A precise inventory of the products, along with their location and processing status, is automatically recorded.
To make the most productive use of limited cleanroom space, the vertical conveyor connects with a horizontal transport system that can move products through contaminated areas or to another cleanroom for additional processing. The conveyors are constructed of static-dissipative polymers to minimize ESD buildup and particle shedding.
To further ensure that particulate emissions remain minimal, an LR Mate 100i robot automatically moves products to and from the storage unit and the conveyor. In addition to eliminating a potential source of human-borne contamination, the pick-and-place system increases throughput and cell layout flexibility.
The Automated Stocker and Delivery System, which has been certified to Class 1, can be customized to suit most applications. It is compatible with commonly used communication protocols to facilitate interfacing with a central control host.
For more information, contact Terra Universal, 700 N. Harbor Blvd., Anaheim, CA 92805-2553, USA; phone: +1 888 7773363; fax: +1 714 9922179.
Film Digitizer Developed for Mammography Applications
A manufacturer of film digitizers has announced the introduction of a model engineered specifically for mammography applications. Vidar Systems Corp. (Herndon, VA, USA) reports that the MammographyPro is both the highest-resolution medical film digitizer available and the first digitizer designed specifically for use with mammography films. The unit was developed for sale to systems solutions providers for integration into teleradiology systems.
The MammographyPro offers an optical density range suitable for diagnostic applications such as computer-aided diagnosis (CAD). The digitizer was designed primarily for use in CAD teleradiology systems now being developed to enhance the diagnostic accuracy of mammography. Such systems use pattern-recognition software to help identify subtle abnormalities that would be difficult and time-consuming for a radiologist to detect.
Incorporating the company's high-definition CCD technology, the new digitizer features a spot size of 31 µm and a 0.00–3.65 optical density range. Brian Beardslee, director of Vidar's medical business division, says, "The MammographyPro surpasses the abilities of other medical film digitizers in terms of spatial and contrast resolution. We see this digitizer as an important tool to help improve the early detection of breast cancer." The unit, which is CE marked, is currently undergoing clinical studies at several universities and research institutes. Results of these studies will be presented at the 1999 RSNA Conference scheduled for 28 November–3 December in Chicago.
For more information, contact Vidar Systems Corp., Herndon, VA, USA; phone: +1 703 4717070; fax: +1 703 4711165; e-mail: corporateinfo@vidar.com.
Turnkey Rapid-Test Manufacturing System Launched
A trio of companies with more than 30 years of combined rapid-test experience have jointly developed a turnkey rapid-test manufacturing system. The Lab in a Box will be on display at the British Biocell International (BBI; Cardiff, UK) stand at Medica in Düsseldorf, Germany, 17–20 November, and the company is inviting visitors to put the system through its paces by using it to produce sample rapid tests of their own at the show.
A supplier of immunogold and ancillary reagents, BBI developed Lab in a Box with the assistance of Millipore and Kinematic Automation. The system comprises all the equipment and materials necessary to produce up to 50,000 rapid tests within two months of purchase, according to marketing manager Lyn Rees. BBI's team of scientific and technical personnel will install Lab in a Box at the purchaser's site and also provide the necessary training. A true turnkey operation, adds Rees, no prior experience in rapid-test manufacture is required to successfully operate the system.
The company will demonstrate the system in Hall 1 at Medica.
For more information, contact BBI, Golden Gate, Ty Glas Ave., Cardiff CF4 5DX, UK; phone: +44 1222 747232; fax: +44 1222 747242.
New Identifiers Launched for Product Safety Marks
A supplier of testing services has introduced country-specific identifiers to augment its ETL and Warnock Hersey product safety marks. As of 1 July 1999, all new and existing clients displaying the marks are authorized to use special identifiers for the United States and Canada. The new identifiers—"US" and "C"—will be affixed to the existing marks at the 4 o'clock and 8 o'clock positions.
According to Intertek Testing Services (ITS; Cranleigh, Surrey, UK), the new identifiers are designed to make identification easier for manufacturers, buyers, specifiers, regulators, and inspection authorities by indicating that products are compliant with US or Canadian safety standards. In addition, the identifiers will help manufacturers conserve space on their products' nameplates.
ITS has established a five-year transition period before use of the identifiers becomes mandatory. Beginning 1 July 1999, new clients ordering preprinted labels are no longer issued the plain ETL or Warnock Hersey marks. The company encourages clients that are restocking labels and nameplates to order new supplies bearing the "US" or "C" identifiers.
For more information, contact Intertek Testing Services, Cranleigh, Surrey, UK; phone: +44 1483 268800; fax: +44 1483 267579; e-mail: mfarnes@ itsqs.com.
In Brief
Krauss-Maffei Acquires Fahr Bucher
Krauss-Maffei Kunststofftechnik GmbH (München) recently acquired Fahr Bucher Service GmbH (Gottmadingen, Germany), whose stuffing machines will be marketed with Krauss-Maffei's feed units. The company now offers a range of feed systems capable of handling critical and tough materials. Krauss-Maffei's thermoset injection machines are based on the company's thermoplast injection moulding machines.
For more information, contact Krauss-Maffei Kunststofftechnik GmbH, Krauss-Maffei-Str. 2, D-80997 München, Germany, phone: +49 89 88992592; fax: +49 89 88993092; e-mail: radigg-k@krauss-maffei.de.
Awards Honour Designers and Manufacturers
Canon Communications llc is now accepting submissions for the 2000 Medical Design Excellence Awards (MDEA) programme. MDEA honours designers and manufacturers of medical components, materials, and finished devices in the following categories: critical-care and emergency products; dental instruments, equipment, and supplies; finished packaging; general hospital devices and therapeutic products; implant and tissue-replacement products; in vitro diagnostics; over-the-counter self-care products; radiological and electromechanical devices; rehabilitation and assistive technology products; and surgical equipment, instruments, and supplies. Entries can be submitted directly by medical device manufacturers or through authorized industrial public relations or design firms. The deadline for applications is 20 December 1999. Winners will be selected at Medical Design & Manufacturing (MD&M) 2000 West on 18–20 January in Anaheim (CA, USA), and celebrated at MD&M East 2000 on 6–8 June in New York City. For more information, contact Canon Communications llc, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064, USA; phone: +1 310 9969434; e-mail: mdea@cancom.com.
Applicare Acquired by GE Medical
GE Medical Systems (Waukesha, WI, USA) recently acquired Applicare Medical Imaging (Zeist, Netherlands), a systems provider for the archiving, display, and transmittal of electronic medical images and information created by ultrasound, x-ray, magnetic resonance, and other imaging devices.
Applicare's products include a range of PC/NT-based systems suited for picture archiving and teleradiology. The company will continue to supply PACS components through its existing OEM channels.
GE Medical Systems provides medical diagnostic equipment and services, including conventional and digital x-rays, magnetic resonance, ultrasound, computer and positron emission tomography, and nuclear medicine.
For more information, contact General Electric Company, P.O. Box 414, Milwaukee, WI 53201, USA; phone: +1 414 5443530; fax: +1 414 5443384.
Christ GmbH Collaborates with Pharmatec
The recent collaboration of Christ GmbH (Stuttgart, Germany) and Pharmatec GmbH (Dresden, Germany), will allow Christ to offer a complete range of water treatment process systems for the pharmaceutical and biotechnical industries. Christ's line of ultrapure water systems, ranging from preliminary to final treatment, will now include distillation plants and ultrapure steam generators. Christ designs, manufactures, installs, and certifies the systems.
For more information, contact Christ GmbH, Mittlerer Pfad 9, D-70499 Stuttgart, Germany; phone: +49 711 8871624; fax: +49 711 8871663.
IEC Issues Multilingual Dictionary on CD-ROM
The International Electrotechnical Commission (IEC; Geneva) has published a 1999 Multilingual Dictionary on CD-ROM, which lists some 17,000 terms and will be updated annually. The content is based on the international electrotechnical vocabulary as prepared by the IEC technical commission. Terms and definitions are available in English and French; equivalent terms in Arabic, Dutch, German, Italian, Japanese, Polish, Portuguese, Russian, Spanish, and Swedish are included without definitions. All files contained in the CD-ROM are in Acrobat PDF format.
For more information, contact the IEC, 3, rue de Varembé, P.O. Box 131, CH-1211 Geneva, Switzerland; phone +41 22 9190211; fax: +41 22 9190300; e-mail: info@iec.ch.
Shows and Conferences
Interhospital Absorbed by Medica
The Interhospital trade fair will be combined with Medica 99, which is scheduled for 17–20 November in Düsseldorf, Germany. Medica's 15 exhibit categories will cover laboratory and medical technology, information and communication technology, clinical chemistry, diagnostics and reagents, pharmaceuticals, consumables, medical furniture and equipment, and building technology and facility management. More than 2800 exhibitors and 120,000 visitors are expected to attend.
For more information, contact Messe Düsseldorf GmbH, Stockumer Kirchstr. 61, D-40474 Düsseldorf, Germany; phone: +49 211 4560995; fax: +49 211 4560548; e-mail: info@messe-duesseldorf.de.
MD&M West Returns to Anaheim
The Medical Design & Manufacturing (MD&M) West 2000 Conference and Exposition will take place at the Anaheim Convention Center (Anaheim, CA, USA) on 17–20 January 2000. The event will be co-located with the Pacific Design Engineering show.
MD&M will host more than 1000 OEM suppliers displaying products and services for the medical industry. Special-feature pavilions will include medical electronics, medical packaging, IVD suppliers, and a medical equipment networking pavilion sponsored by Microsoft. A three-day conference schedule will include such topics as US FDA quality systems, medical electronics, materials advancements, and medical packaging.
Sponsored by Desktop Engineering magazine, the Pacific Design Engineering show will address the needs of engineers, corporate management, and purchasing and marketing departments. New pavilions will showcase contract manufacturers, motion control and sensors, and motors and drives.
For more information on these events, which are hosted by the Canon family of design and manufacturing publications, contact Canon Communications llc, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064-1549, USA; phone: +1 310 4454200; fax: +1 310 9969499./P>
EuroMold Hosts Rapid Tooling Conference
An estimated 50,000 visitors will attend EuroMold 99, on 1–4 December in Frankfurt, Germany, which will include more than 1500 exhibitors from 38 countries. The event will feature exhibits on mould-making technologies and applications and a conference on rapid tooling, scheduled for 3 December. The conference will compare indirect, pattern-based methods of rapid tooling including technologies that involve RTV silicone rubber, aluminium-filled epoxy, and sprayed metal. A number of direct methods for rapid tooling fabrication will also be discussed. Rapid tooling technology can be applied to medical supplies and instruments.
For more information, contact DEMAT Exhibition Managing GmbH, Post Fach 11 06 11, D-60041 Frankfurt, Germany; phone: +49 69 234331; fax: +49 69 253071.
