Industry News

• Nelipak, Oliver Launch One-Stop Shop for Trays, Lidding, and Sealing
• Acutek International Acquired by Scapa Group
• Global Device Conference
• Genetic Medicine and Nanotechnology to Shape Future of Healthcare
• 3M Creates New Division for Drug Delivery
• PEEK Opens Working Space in MIS Arena for Plastics Supplier
• In Brief
• Company To Develop Tools for Production of Mesoscale Electronic Devices
• Needle Sensor Enables Real-Time In Vivo Diagnostics
• Web Sightings
• Lab-in-a-Box Slashes Rapid-Test Development Time
• Shows and Conferences

Nelipak, Oliver Launch One-Stop Shop for Trays, Lidding, and Sealing

When Nelipak (Venray, Netherlands), a supplier of custom thermoforming and contract packaging services, inaugurated one of Europe's first cleanrooms 19 years ago, industry was not beating down the doors. "We were pioneers in sterile thermoforming," says director Frank Nelissen, "and our first priority was to educate industry on the merits of clean packaging." Meanwhile, the cleanroom sat idle. "We had zero turnover for the first couple of years," he says. Eventually, the tide turned for Nelipak, which currently reports annual revenues of o30.6 million. Nelissen is confident that his newest project, a one-stop shop for trays, lidding, and sealing established as a joint venture with Oliver Products Co. (Grand Rapids, MI, USA), will be a much more immediate hit with OEMs. "The reason is simple," he claims. "This is something that industry wants and needs, and there's nothing quite like it in the world."

Acclerated prevalidation is one of the advantages of the one-stop shop concept, according to director Frank Nelissen.

Nelipak-Oliver Systems was designed to fill a gap, says Nelissen. In addition to providing an array of thermoforming and packaging services at its Netherlands and Ireland facilities, Nelipak also builds sealing machines to customer specifications and has an extensive tool-building department. "Customers routinely come to the firm with a project and, knowing our capabilities, simply hand over its development to us," says Nelissen. "But there was a missing link—Tyvek," he adds. "Rather than reinvent the wheel, we went to Oliver and began discussions on a joint venture." Nelipak-Oliver Systems began full-scale operations in January at the Nelipak site in Venray.

Nelipak brings its design expertise to the joint venture.

"Oliver is bringing the coating and printing technology and the overall expertise in processing Tyvek," explains Martin Jeurissen of Oliver, whose career has been entwined with the nonwoven for so many years that he has been nicknamed Mr. Tyvek. "Nelipak," he continues, "is bringing its logistics, marketing, and sales knowledge as well as its proven cleanroom technology to the venture." A purpose-built Class 10,000 cleanroom is dedicated to the conversion of Oliver materials and their integration into packaging systems.

A one-stop shop for trays, lidding, and sealing services presents several advantages to manufacturers, according to Jeurissen. "First and foremost, there is clear accountability," he says. "If you buy the different elements from various suppliers and, for example, the lid doesn't seal to the tray properly, who is responsible?" Jeurissen asks. "Is it a result of flawed materials specification, sealing parameters, sterilization processes?" By multiplying suppliers, you create opportunities to shift the blame when things go wrong, he says. "With Nelipak-Oliver Systems, you're dealing with a single source that is accountable for the entire system," adds Jeurissen.

OEMs will also benefit from Nelipak's design expertise and familiarity with CAD/CAM processes, adds Nelissen. Nelipak has funneled significant resources into its design department over the years, he notes. "We are not a commodities trader," he says. "We only do custom products, and one of our goals traditionally has been to provide our global customers with consistently high-quality products." To that end, the firm recently purchased Unigraphics software. It represents the ne plus ultra in CAD software, according to Nelissen. "Companies can get us involved in the project from the start, hand it off to us, and accelerate their time to market without cutting any corners on quality," says Nelissen.

The one-stop shop concept also can accelerate prevalidation processes, according to Jeurissen. "We can show an OEM that if he seals this lid to this tray using this method, he will have a validated system," says Jeurissen. This capability is supported by Oliver's extensive experience performing OEM audits, he adds. "Every reel we produce can be traced back to who bought it, which machine it ran on, and which operator was at the controls. Traceability is airtight," stresses Jeurissen.

Current trends in healthcare practices reinforce the viability of a one-stop tray, lidding, and sealing shop, according to Nelissen. "Hospitals are not interested in sterilizing products. They want kits. And laparoscopic and other newer surgical methods entail a greater use of disposables." Nelipak-Oliver Systems, Nelissen maintains, represents a reliable outsourcing partner that frees up OEMs to focus on their core business.

"We chose the name of the joint venture with great care," says Nelissen. "Our emphasis was on the word systems. We're not just providing a piece of Tyvek or a lid," he stresses. "We're in the business of supplying our customers with a solution."

For more information, contact Nelipak-Oliver Systems, Maasheseweg 75, NL-5804-AB Venray, Netherlands; phone: +31 478 582001; fax: +31 478 588536; e-mail: info@nelipak.nl.

—Norbert Sparrow

Quality Marks Prompt Heated Exchange at Global Medical Device Conference

The contentious debate over the use of quality marks issued by private testing and certification organizations migrated to Cancún, Mexico, for the winter. The topic was at the centre of an animated discussion at the eighth Global Medical Device Conference.

Speaking on behalf of TÜV Product Service (München, Germany) at a session devoted to the topic, U.S. director of medical operations Martin Leighton reiterated his company's claim that CE marking is not an ironclad guarantee that devices conform to all of the safety requirements. Low-risk devices are, in fact, self-certified, he noted, and they require little or no oversight from a third-party conformity assessment body. CE marking indicates that "prerequisite essential regulatory and safety requirements have been met and it serves as a passport to the European market," said Leighton, "but it is not a quality mark." There are markets beyond the EU where CE marking is not recognized, Leighton added, and TÜV's distinctive octagonal mark enables manufacturers to clearly display testing and certification information.

U.S. director of medical operations at TÜV Product Service Martin Leighton defended the use of private quality marks at the recent Global Medical Device Conference in Cancún.

Leighton also stressed that quality marks such as the one marketed by TÜV (other certification and testing houses offer their own marks to customers) respond to the needs of the global market. Prohibiting the use of quality marks other than CE marking within member states of the European Union is a regional and thus retrograde approach, he intimated.

Response from industry came fast and furious. Michael Baker, director general of EUCOMED, initiated the volley by objecting to the "arrogance of companies such as TÜV" that are sowing confusion over the merit and meaning of CE marking. "TÜV has made a considerable amount of money placing CE marking on products, and now they want industry to invest in yet another mark." The multiplication of quality marks and the consequent diminishment of CE marking actually works against the objective of global harmonization, he added.

John Place, director general of the European Diagnostic Manufacturers Association, objected strongly to TÜV's assertion that CE marking was not a guarantor of quality. "The directive clearly states that it is a criminal offense to place CE marking on a product that does not meet the essential requirements," he noted, echoing the position of the German ministry of health. That body has threatened to outlaw the use of private certification marks on medical products placed on the German market (see the November/December 1999 issue of EMDM, page 12).

Members of industry attending the session objected to the fleeting competitive advantage the quality mark may afford. One attendee pointed out that if he were to place the TÜV mark on his product, his competitive edge would have a life span of approximately one month. "That's how long it would take my competitors to affix the TÜV mark to their products," he said. "At that point, it becomes yet another quasimandatory mark that you have to have because everyone else has it."

While the European Commission remains officially neutral on this issue, the head of the medical devices sector, Antonio Lacerda, told attendees that a distinction can be made between quality marks that do offer the consumer some element of added value and those which are nothing more than a marketing ploy.

—Norbert Sparrow

Technology Assessments Pose Threat for Industry

If industry does not initiate a global dialogue on healthcare technology assessment (HCTA), it may find itself buried by a flurry of national legislation. Citing a variety of technology assessment schemes that have been implemented or are under consideration in Germany, France, the UK, and Japan, executive vice president of the US-based Health Industry Manufacturers Association Ed Rozynski cautioned conference attendees against complacency.

If industry does not institute a comprehensive dialogue on technology assessment, it may find itself confronted with an eclectic array of national initiatives, Ed Rozynski, executive vice president of the Health Industry Manufacturers Association, told conference attendees.

"Industry has not done enough to identify appropriate technology assessment processes and to demonstrate to payers and users that there are long-term cost savings to the use of more sophisticated devices," said Rozynski. "Technology assessment may be well-intentioned," he said, "but it must be made clear that it adds time to the approval process."

Alan Kent, the head of the UK Medical Device Agency, cited the recently established National Institute of Excellence as an example of how a well-intentioned policy can go astray. "The first task of NICE was to analyze hip implants, and it has issued a draft which is currently being critiqued by manufacturers," said Kent. "The organization is beginning to realize that it has been given an impossible task . . . there simply isn't a body of health—economic data available for analysis. The idea is that NICE will issue advice that will then cascade down to the appropriate parties," continued Kent, "but what is not clear is how they will get doctors and other healthcare players to follow their advice."

US Drafts Reuse Guidelines

US FDA strategy regarding the reuse of single-use devices (SUDs) is a work in progress, stressed Larry Kessler, director, Office of Surveillance and Biometrics, at the agency's Center for Devices and Radiological Health. FDA plans to publish a guidance document by this spring.

The proposal encompasses a risk categorization scheme that proceeds from the assumption that reprocessing any device adds to its inherent risk. (The draft can be accessed on the Internet at http://www.fda.gov/cdrh/reuse/.) "The fact of the matter is that it is unlikely to make it any safer," Kessler commented. The agency has developed a risk rating based on device classification, he continued, which takes into account a reprocessed device's potential for transmission of infection or disease, and its potential for mechanical failure. This data would then be used to determine the timing of premarket notification submissions. "Critical premarket issues," Kessler said, "include establishing specifications to ensure the device is as safe and effective as it was prior to reprocessing and the ability to perform thorough process definition and validation studies given the facility and sterilizer limitations."

During the question and answer period that followed the session, Kessler addressed the issue of reprocessors, a growing sector of activity in the United States. "Ultimately, they will be subject to the same controls and expectations as OEMs. This may lead to the diminishment of reprocessing, because the cost of doing business will no longer be feasible."

Kessler also urged principals in the debate to adopt a more relativist position within a global context. "The issue of reuse is far more complex and has greater ramifications than are often taken into account," he said. Consider simply the situation of reuse in developing countries, he continued, where spending a little more money and using a disposable as intended by the manufacturer often is not an option. "The choice there may well be either to reuse the device or to let the patient die," he said.

Gains in Harmonization

Thirty countries in the world have some form of device regulation, not all of which is very burdensome . . . yet. With that warning, Guidant Corp.'s chief compliance officer Michael Gropp defended the achievements of the Global Harmonization Task Force (GHTF) in Cancún.

"The GHTF is not simply a cozy club of regulators and industry," he stressed. "It has had an effect." Gropp cited Canada and Australia, which have incorporated essential principles drafted by GHTF into their device regulations. "Japan is not there yet, but it may happen down the road," he added.

"At Guidant, it's a rare month that one of our plants isn't being audited somewhere in the world," said Gropp. "Dealing with 30 different regulations can be a real headache. . . .Wouldn't it be nice to harmonize this procedure?" he asked rhetorically. "That's why GHTF is important," he added, while acknowledging that greater visibility and more widespread implementation of the recommendations of the organization's four study groups represent challenges for the future.

Acutek International Acquired by Scapa Group

Acutek International (Cornamona, Co. Galway, Ireland), a specialty converter of medical disposables, has been acquired by Scapa Group plc (Blackburn, Lancs, UK). Following a year of negotiations, the companies made the announcement in a joint press conference at the Medical Design and Manufacturing West 2000 show in Anaheim, CA, USA.

Acutek specializes in the design and production of custom pressure-sensitive adhesive components. The company has converting operations in Cornamona and Inglewood, CA, USA, with sales offices located in Brussels and Inglewood. Following the acquisition, operations will continue uninterrupted at the company's Cornamona manufacturing facility, which was recently certified to ISO 9001/EN 46001.

The Technical Tapes division of Scapa is a leading manufacturer of pressure-sensitive adhesive films and tapes. The company provides medical OEMs with both critical component materials and converted products. Critical component materials include coated and laminated films, foams, and fabrics. Medical applications for the company's products include wound care, device fixation, and transdermal drug delivery. The acquisition of Acutek will expand Scapa's converting capabilities to include precision rotary die-cutting with island placement, flexographic printing, and custom multilayer laminating. Markets served by these technologies include pulse oximetry, wound care, drug infusion therapy, diagnostic testing, and consumer medical devices.

Speaking at the press conference, Stuart Ganslaw, president and general manager of Scapa Tapes North America (Windsor, CT, USA), said that the acquisition is a further step in establishing Scapa as a fully integrated global supplier of medical components. "We will now be able to do it all, from the compounding of the adhesive to the delivery of the converted product to the healthcare community," he said. The joining of an adhesive compounder with a converter was described by the two companies as a milestone in the medical tape industry. "This will certainly position Acutek for a strong presence in the European medical market, where it's difficult enough to find a converter," said Jerry Muchin, president and founder of Acutek.

The new company will join Scapa's medical operations and retain the name Acutek International. The company's efforts will focus on seven strategic industry sectors, including medical tapes—a market that Scapa values at $2.63 billion.

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

—Benjamin Lichtman

Genetic Medicine and Nanotechnology To Shape Future of Healthcare

The past several months have been rife with predictions for the future. Adding a scientific note to this millennial chorus, a special panel of researchers at Battelle (Columbus, OH, USA) has produced a list of the 10 strategic technologies expected to shape business and society over the next 20 years. According to the panel, genetic medicine, nanotechnology, and high-power energy packages are among the technologies that have broad implications for the medical device industry.

A major theme of the forecasts is a trend toward personalization. "The 20th century was the time of big technologies, mass production, mass wars, and mass politics," says Stephen Millett, thought leader and manager of Battelle's technology forecasts. "But in the years ahead, new technologies will become much more personalized, and they will closely affect almost every aspect of our lives."

Among the developments envisaged by the panel is the advent of individualized, genetic-based healthcare. Batelle scientists foresee a future in which doctors will be able to detect and correct many genetic diseases before they manifest themselves—even in the womb. "In the short term, people are looking for cures," says Eric Majewski, business development associate at Battelle's Medical Products division. "But in the long term, the goal is to use genetics to predict and prevent the development of diseases in individual patients." Battelle forecasters also expect that a new generation of pharmaceuticals will originate from genetic research, leading to treatments, cures, and preventive measures for conditions ranging from life-threatening diseases to cosmetic problems.

The company's researchers further highlight the medical industry as an important area for the application of nanomachine technology. "We may be able to develop nanomachines that will go into your body and find and destroy individual cancer cells while not harming healthy cells," says Battelle senior research scientist Kevin Priddy. The machines, he adds, could also be used to deliver drugs to highly localized places in the body, to clean arteries, and to repair the heart, brain, and other organs without surgery. Majewski views such developments as a natural extension of minimally invasive procedures. "Any technology that can make a process less invasive will ultimately benefit the end-user," he says.

Advances in nanotechnology stand to benefit from another important trend involving high-power energy packages. Battelle prophesies that by 2020, next-generation batteries, inexpensive fuel cells, and microgenerators of electricity will combine to make implantables and other electronic products smaller and more mobile. Decentralized power sources will be affordable and environmentally clean.

According to Battelle scientists, the paradigm of decentralization will soon apply to healthcare itself. "There will be a large-scale shift in the presence of medical technology from hospitals into homes," says Millett, explaining that tomorrow's medical devices will need to be friendly and attractive, effective in noninstitutional environments, and affordable for consumers. Millett also stresses the importance of aesthetics in the future of medical devices. "Medical equipment will increasingly be used in home-healthcare settings, but no one wants a room in their house to look institutional," he says. "Consequently, the materials and ergonomics of medical devices will become essential to product design."

Other strategic technologies predicted for the year 2020 include omnipresent computing, designer foods and crops, intelligent goods and appliances, worldwide safe water, enhanced reality, advanced waste reduction, and personalized public transportation. Millett describes the company's technology forecasts, which began in 1995, as "exercises in expert judgement" that can also serve to stimulate innovation. "We have the conviction that if we're not presenting ideas like these, then we're not serving the interests of our current and potential clients. These forecasts act as dialogue pieces that allow us to communicate our ideas to a large audience," he says.

Battelle is a nonprofit research company staffed by 7500 employees. The firm has developed expertise in various branches of the medical industry, including polymers, sterile disposables, and pulmonary delivery therapeutics. Current medical projects include research into instantaneous diagnostic feedback for the production of rapid clinical tests.

For more information, contact Batelle, 505 King Ave., Columbus, OH 43201, USA; phone: +1 614 4246424; Internet: http://www.battelle.org.

—Benjamin Lichtman

3M Creates New Division for Drug Delivery

3M (St. Paul, MN, USA) has announced the creation of a new division dedicated to the drug delivery market. 3M Drug Delivery Systems Division (Loughborough, Leics, UK) was recently launched to supply inhalation, transdermal, and transmucosal technology to the global pharmaceutical market. The division provides both systems development and components for metered dose inhalers (MDIs) and transdermal patches. In addition to providing valves and canisters for MDIs, the division offers contract filling and packaging services that can be used to produce market-ready products.

A new division of 3M dedicated to drug delivery technology provides systems development and components for metered dose inhalers.

Graham Brewin, 3M's business manager for drug delivery systems in Europe, explains that the division was formed from the company's larger pharmaceutical division in recognition of the significant and unrealized potential for the growth of delivery devices as an individual business. "We have always been one of the largest suppliers of drug delivery technology in the world," he says, "and the creation of 3M Drug Delivery Systems affords us more autonomy and the opportunity to grow on our own merits." Describing the field of transmucosal drug delivery as "embryonic," Brewin suggests that the division's expansion plans will include this area and indicates that the company is considering acquisitions.

Ed Erickson, who heads the new division as vice president, highlights the growing significance of drug delivery technology in the pharmaceutical sector, predicting that as more compounds are discovered in vitro using mechanism-based assays, innovative technologies will be called on to transport them to their active sites. "I think we'll see more synthetic molecules that have desirable clinical effects but need to be delivered through alternate routes," he says. In the past, 3M's dry delivery business has focussed on the inhalation and transdermal markets. Although the core activities of 3M Drug Delivery Systems will be concentrated in the pharmaceutical sector, Erickson notes that the division is also considering partnerships with manufacturers to develop device-based technologies.

3M is a diversified global manufacturing company employing more than 71,000 people in more than 60 countries. Its Drug Delivery Systems Division reportedly is the world's largest contract manufacturer of MDIs.

For more information, contact 3M Drug Delivery Systems, Morley St., Loughborough, Leics LE11 1EP, UK; phone: +44 1509 613429; fax: +44 1509 613099; Internet: http://www.3M.com/DDS.

—Benjamin Lichtman

PEEK Opens Working Space in MIS Arena for Plastics Supplier

A biocompatible polymer has been chosen as a replacement for metal in a minimally invasive port-access surgical system. The polyaryletherketone resin, marketed under the name PEEK by Victrex plc (Thornton Cleveleys, Lancs, UK), was selected by Surgical Innovations Ltd. (Leeds, UK) for the fabrication of cannulae designed to create an internal working space during abdominal surgery. The polymer is also used in the system's valve assembly, which maintains the level of CO₂ gas required for the working space.

Stuart Moran, engineering director at Surgical Innovations, cites "the inherent purity, chemical resistance, and steam sterilizability of PEEK" as primary considerations in specifying the polymer. These characteristics allow surgeons "to reuse the system many times over."

Cannulae made from a polyaryletherketone resin permit repeated sterilization and reuse of a port-access system.

PEEK can withstand up to 3000 autoclave sterilization cycles at temperatures up to 134ºC. Use of the polymer in devices requiring routine sterilization allows them to be reused, thereby maximizing their performance value. The semicrystalline material maintains high mechanical strength, resistance to stress cracking, and hydrolytic stability in the presence of chemicals such as morpholine, an anticorrosion agent frequently used in autoclaving processes. Minimal absorption of protein structures found in biological systems makes the USP Class VI polymer particularly suited for use in instrument parts that come into direct contact with wounds.

PEEK's chemical and hydrolytic resistance, as well as its purity and biocompatibility, also suited material requirements for an intracardiac micro-blood pump. The component, manufactured by Impella Cardiotechnik AG (Aachen, Germany), maintains the pumping function of the heart during bypass surgery. The haemocompatible polymer was used in the pump's rotor, which comes into direct contact with blood during the procedure. The rotor turns at more than 30,000 rpm, ensuring a pumping capacity of 4.5 L and requiring thin-wall rotor blades of high mechanical strength. PEEK's ability to be machined after moulding allows for the manufacture of the blades, which include metal inserts that must be overmoulded to high dimensional accuracy.

For more information, contact Victrex plc, Victrex Technology Centre, Hillhouse International, Thornton Cleveleys, Lancs FY5 4QD, UK; phone: +44 1253 897703; fax: +44 1253 897701; Internet: http://www.victrex.com.

—Michelle Stuckey

In Brief

FEMAC Offers One-Stop Approval for Electrical Devices

Electrical medical device manufacturers will now have access to one-stop approval and testing processes for international licenses. The new service, provided by the Far East Market Access Services GmbH (FEMAC; Stuttgart, Germany), will make it easier for European companies to obtain licenses for exporting products into Eastern Europe, North America, and Asia. FEMAC, a subsidiary of the TÜV Rhineland/Berlin-Brandenburg Group (Berlin), also functions as a European Union representative for those companies outside of Europe interested in accessing the European market.

For more information, contact FEMAC, Friedrichstr. 10, D-70174 Stuttgart, Germany; phone: +49 711 228670; fax: +49 711 2286799.

FDA Regulates Aluminium Content in Drug Products

US FDA has amended labelling requirements for aluminium content in large-volume parenterals (LVPs), small-volume parenterals (SVPs), and pharmacy bulk packages (PBPs) used in total parenteral nutrition (TPN) therapy. The US FDA's decision was prompted by new evidence linking the use of parenteral drug products containing aluminium to toxic accumulation of aluminium in the tissues of patients on TPN therapy. A 25-µg limit has been placed on the amount of aluminium permissible in LVPs used in TPN. New requirements also mandate that this limit be included in LVP package inserts and that SVP and PBP labels specify the maximum level of aluminium used at expiry. LVPs, SVPs, and PBPs must also contain warning labels regarding aluminium toxicity. The amendment further requires that manufacturers develop validated assay methods for determining aluminium content in drug products used in TPN.

For more information, contact US FDA, 5630 Fishers Ln., Rm. 1061, Rockville, MD 20852, USA; phone: +1 301 5942041; e-mail: webmail@oc.fda.gov; Internet: http://www.fda.gov.

Ulbrich Moves to Larger Facility

Ulbrich of UK Ltd. (Sheffield, UK) has relocated its operations to a new 25,000-sq-ft facility in Sheffield. The larger plant will enable Ulbrich, a supplier of stainless steel, nickel alloy, and other strip products, to increase its inventory and equipment.

For more information, contact Ulbrich of UK Ltd., Hawke St., Sheffield S9 2SU, UK; phone: +44 114 2561200; fax: +44 114 2561329; e-mail: ulbrich@ulbrich.com; Internet: http://www.ulbrich.com.

Kendro Conducts Rotor Training Course for Lab Workers

A training course in rotor use is designed to minimize instrument downtime and repair costs and to extend instrument life. Particularly suited for laboratory workers, the course teaches participants operating and cleaning techniques, as well as safe handling tips. The class is offered by Kendro Laboratory Products GmbH (Hanau, Germany), a supplier of products and services designed specifically for centrifuge users.

For more information, contact Kendro Laboratory Products GmbH, Postfach 1563, D-63405 Hanau, Germany; phone: +49 6181 35300; fax: +49 6181 355973; e-mail: info@kendro.com; Internet: http://www.kendro.com.

Welding Machines Garner Baxter Award

Paul Kiefel GmbH (Freilassing, Germany) was awarded the 1999 Baxter Supplier Award for its high-frequency and thermocontact welding machines. The company's machines are used to weld plastic films for a line of infusion, blood, and dialysis bags produced by the Baxter Group (Deerfield, IL, USA). The Baxter Group cited the reliability and efficiency of Kiefel's machines as key factors in its decision.

For more information, contact Paul Kiefel GmbH, Industriestr. 17-19, D-83383 Freilassing, Germany; phone: +49 8654 780; fax: +49 8654 78490; e-mail: kiefel@kiefel.de; Internet: http://www.kiefel.de.

PRA International Acquires Arcam

PRA International Inc. (Vienna, VA, USA) has acquired Arcam, a contract research organization based in Paris. Under the conditions of the agreement, Arcam will operate using the PRA name. This is the company's second European expansion effort in the last year; it acquired Valorum (London) in February 1999.

PRA International Inc. provides a range of clinical trials management and product development planning services to medical device, pharmaceutical, and biotechnology companies worldwide.

For more information, contact PRA International Inc., 161 rue de Courcelles, F-75017 Paris, France; phone: +33 1 43181616; fax: +33 1 44402139; e-mail: success@ praintl.com; Internet: http://www. prainternational.com.

—Michelle Stuckey

Company To Develop Tools for Production of Mesoscale Electronic Devices

The US Defense Advanced Research Projects Agency (DARPA) has awarded Potomac Photonics Inc. (Lanham, MD, USA) a contract to develop a laser-based tool for the fabrication of next-generation passive electronic devices. The four-year contract, valued at w7.65 million (US$7.5 million), also grants Potomac full commercial rights to the tool.

Approximately 40 µm wide, this conductive gold metal line was deposited using a laser technique being developed by Potomac Photonics Inc.

The award is part of DARPA's Mesoscopic Integrated Conformal Electronics (MICE) programme, the goal of which is the development of a commercially available machine capable of producing mesoscale electronic devices in a conformal manner on virtually any substrate. Larger than silicon chips but smaller than printed circuit boards, mesoscale electronic circuits promise to allow further miniaturization of medical and other devices.

Potomac's MICE tool showcases the company's experience in laser microfabrication technology, as well as a proprietary deposition process developed at the US Naval Research Laboratory in Washington, DC. This combination has already resulted in the fabrication of conductors, resistors, capacitors, and inductors.

For more information, contact Potomac Photonics, 4445 Nicole Dr., Lanham, MD 20706, USA; phone: +1 301 4593031; fax: +1 301 4593034; e-mail: scohn@potomac-laser.com.

—William Leventon

Needle Sensor Enables Real-Time In Vivo Diagnostics

A needle sensor that can perform in vivo measurements is the most recent application of a biosensor that was introduced in 1998. The instrument will enable healthcare providers to perform fast and simple diagnostic procedures on patients, according to Chemel AB (Lund, Sweden).

"The Sire Biosensor in its initial design has been used to successfully detect various analytes in blood and urine," notes Kristin Kriz, who is conducting research on the device at Lund University. "Therefore, the only obstacles to this new application are mechanical in nature and are specifically associated with miniaturization of the instrument." Identical in appearance to an ordinary injection needle, the diagnostic device incorporates membranes and small wires in a relatively complex design.

The biosensor needle may have several innovative applications within intensive-care units, according to Kriz. Because the electrode is designed as an injection needle, the concentration of clinically interesting metabolites can be measured directly in the patient's muscle and blood. For example, it can enable a physician to determine whether a patient is on the verge of glucose shock. Another advantage of the biosensor needle, cited by Kriz, is its potential use as a tool to perform real-time analyses of how a patient's overall metabolic state is affected by a given medication.

A prototype of the device is currently undergoing a series of tests that will culminate with in vivo measurement testing at local hospitals. If the product development plan remains on schedule, the device may be commercially available within a couple of years, according to Kriz.

For additional information, contact Chemel AB, Research Park Ideon, SE-223 70 Lund, Sweden; phone: +46 46 2862490; fax: +46 46 2862499; e-mail: info@chemel.com; Internet: http://www. chemel.com.

— Norbert Sparrow

Osmonics opens Web-based lab store

Osmonics (Minnetonka, MN, USA) recently introduced an e-commerce site designed to help researchers and scientists purchase filters and related filter media. The on-line lab store, located at http://www.osmolabstore.com, showcases more than 1000 filter products. A filter selection wizard enables customers to search for products based on their characteristics, chemical compatibility, or application. The site also features monthly specials and a technology library.

BEI revamps site

BEI Sensors & Systems Co., Kimco Magnetics Div. (San Marcos, CA, USA), has updated its Web site, which is located at http://www.beikimco.com. The refurbished site now features a product search engine with the option of searching for motors, linear actuators, or rotary actuators. Users can also access technical information on the company's range of electronic sensors and motion control products.

Colder offers 3-D coupling models on-line

Colder Products Co. (St. Paul, MN, USA) now offers design engineers on-line access to 3-D models of couplings. Customers can download the models for free using FlashModeler, a model server available through the Colder Web site at http://www. colder.com. On-line model availability is expected to speed up the design process for a number of fluid-handling applications.

Ismeca goes on-line

Ismeca International S.A. (La Chaux-de-Fonds, Switzerland) recently launched its new Web site located at http://www.ismeca.com. Visitors can choose to click onto semiconductor or medical product pages, where they'll find links to product descriptions. The site also features comparison tables that allow customers to locate products easily.

—Michelle Stuckey

Lab-in-a-Box Slashes Rapid-Test Development Time

Companies wanting to enter the rapid-test market typically can spend as much as two years developing the technology and sourcing equipment before achieving full-scale manufacturing capabilities. With the recently developed Lab-in-a-Box (LIAB), BBInternational (BBI; Cardiff, UK) promises to slash start-up time to two months regardless of prior experience. To prove its point, the firm set up a working model of the system at Medica in Düsseldorf, Germany, and invited show attendees to try their hands at producing sample tests. According to marketing manager Lyn Rees, the concept was so successful that it prompted the company to reprise the experience at Medical Design & Manufacturing West (MD&M) in Anaheim, CA, USA, in January.

LIAB was developed in conjunction with Millipore, a supplier of membranes and filtration equipment, and Kinematic Automation, which produces systems for the production of rapid diagnostic test strips. BBInternational is a global supplier of gold conjugates and silver and gold colloids. "By purchasing this package," Rees stressed, "companies are buying the expertise of three firms with more than 30 years of combined experience in rapid testing processes."

Research scientist Nicola Robinson demonstrates BBInternational's rapid-test manufacturing system to Norbert Sparrow, editor of EMDM (middle), and Bob Truncali from sister publication IVD Technology at the recent Medica show.

At the front end of LIAB is a BBI Bioprinter that captures antibodies or antigens on a solid-phase substrate. The Bioprinter can run 24 hours a day and produce several million tests annually. For small to medium-size production runs, system purchasers can opt for a Kinematic module that dispenses reagents onto card stock. An optional dip-and-dry machine can be added to accelerate throughput.

Rapid test processing continues as the membranes are laminated and sliced into test strips by means of a membrane cutter or programmable shear cutter. The strips are then placed in a vacuum drying oven to ensure proper binding of the antibody or antigen to the membrane. Downstream, a roller-driven machine closes the tops and bottoms of the plastic housings of the test devices. A pouch sealer is also available for sealing the strips or devices inside aluminium pouches.

A turnkey system that eliminates protracted research and development and the recruitment of a multidisciplinary team is only part of LIAB's appeal, said Rees. "It's also extremely easy to use and requires no prior experience in rapid-test manufacture." More than 200 visitors to Medica—and at least one member of the press—took the BBInternational challenge to produce rapid-test strips at the stand. While I did require a little help from a BBI technician, I had a pouch of ready-to-use rapid-test strips in hand within 15 minutes. "That's all there is to it," beamed Rees. "You could be producing 50,000 tests in two months."

In addition to providing system purchasers with on-site installation and training assistance, BBInternational offers ongoing technical support from its Cardiff laboratories. The firm also supplies off-the-shelf and custom gold conjugates to system users. The objective, said Rees, is to ensure consistent output wherever the LIAB is set up. "The guidelines and processes are the same . . . we are bringing uniform quality to the table."

In addition to smaller companies that want to enter the rapid-test market with a minimum of fuss, the product has also sparked interest among larger medical device firms. "We have had some major players come by the stand to take a look at LIAB for use in their R&D departments," noted Rees. "They have told me that the product is cost-effective enough for them to consider using it in product development applications, which allows them to keep the technology in-house."

For more information about LIAB, contact BBInternational, Golden Gate, Ty Glas Ave., Cardiff CF14 5DX, UK; phone: +44 1222 747232; fax: +44 1222 747242; Internet: http://www.bb-international.com.

— Norbert Sparrow

Shows and Conferences

Milan Hosts Device-Related Seminar Series

Clinical Design Group Inc. is conducting a series of two-day seminars on device-related topics in April at the Hotel Cavour in Milan, Italy. The courses, which are based on reports published by the sponsoring company, will include Good Monitoring Practices, 4—5 April; Clinical Trials Design, 6—7 April; International Clinical Trials, 10—11 April; and Project Management for Clinical Trials, 12—13 April.

For more information, contact Clinical Design Group Inc., 2128 W. Evergreen Ave., Chicago, IL 60622, USA; phone: +1 773 4895721; fax: +1 773 4894281; e-mail: cdginc@ix.netcom.com; Internet: http://www.clinicaldesign.com.

Cleanrooms 2000 to Be Held in Dublin

The Irish Cleanroom Society is planning a second cleanroom show and conference, Cleanrooms 2000, to be held 9—11 May in Dublin. The event will feature a full programme of lectures and papers, as well as a technical exhibition. Because of space limitations, participation in the show will be limited to companies that provide goods and services to the cleanroom industry.

For more information, contact the Irish Cleanroom Society, c/o Ardmac Group Ltd., Coes Rd., Dundalk, Ireland; phone: +353 42 9388973; e-mail: conor.murray@ardmac.com, Internet: http://www.cleanrooms-ireland.ie.

Biomedical Symposium Comes to Germany

The fourth Symposium on Modelling and Control in Biomedical Systems will be held from 30 March to 1 April in Greifswald/ Karlsburg, Germany. Organized by the VDI/VDE—Society for Measurement and Automatic Control, the symposium will provide a forum for the presentation and discussion of new developments in the biomedical field relevant to the medical, healthcare delivery, pharmacokinetic, and biological industries.

For more information, contact VDI/VDE—Society for Measurement and Automatic Control, Postfach 10 11 39, D-40002 Düsseldorf, Germany; phone: +49 211 6214215; fax: +49 211 6214161; e-mail: rosenzweig@vdi.de; Internet: http://www.vdi.de/gma/tagungen.htm.

Hannover Messe Returns to Germany

Hannover Messe 2000 will return to the Hannover Fairgrounds (Hannover, Germany) on 20—25 March. Last year's show attracted 300,000 visitors and 7510 exhibitors. This year, the event will feature exhibits on factory automation, materials handling and logistics, product and material engineering, energy, surface treatment, and R&D.

For more information, contact Hannover Messe International GmbH, Messegelande, D-30521 Hannover, Germany; phone: +49 5 118931600; fax: +49 5 118932646; e-mail: hannover-messe-international@t-online.de; Internet: http://www.hfi.de.

Scanplast 2000 to Showcase Plastics Industry

The Swedish Exhibition and Congress Centre in Göteborg will host Scanplast 2000 on 11—15 April. The international trade fair, which will focus on the plastics and rubber industries, will feature raw materials, auxiliary chemicals, and semiprocessed products. Tools, machinery and production equipment, and maintenance, subcontracting, and engineering and design services will also be showcased.

For more information, contact Svenska Mässan, S-412 94 Göteborg, Sweden; phone: +46 031 7088000; fax: +46 031160330; e-mail: info@swefair.se; Internet: http://www.swefair.se.

Analytica Highlights Equipment Selection

Analytica, the 17th International Trade Fair and Analytica Conference for Analysis, Biotechnology, Diagnostics, and Laboratory Technology, will convene at the New München Trade Fair Centre (München, Germany) on 11—14 April. The biennial event will feature exhibits on analytical and diagnostic equipment and methods, chemistry, reagents, and laboratory systems. The conference offers an opportunity for dialogue between users and suppliers of equipment. It will also provide information on equipment selection.

For more information, contact Messe München GmbH, Messegelände, D-81823 München, Germany; phone: +49 89949 11488; fax: +49 89949 11489; e-mail: info@analytica.de; Internet: http://www.analytica.de.

—Michelle Stuckey

ILLUSTRATION BY MICHAEL HIRANO

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