To maintain its competitive edge as a supplier of IVD and pharmaceutical products, Organon Teknika (Boxtel, Netherlands, and Dublin, Ireland) invested heavily in qualified personnel and in its infrastructure throughout the 1990s. The company that invented Microelisa technology may have gotten a bit carried away in its pursuit of excellence, however. "We eventually found ourselves with a surplus in resources, personnel, and infrastructure," says manufacturing engineer Nick van de Wouw. An organizational restructuring of its manufacturing operations that emphasized primary processes led to substantial gains in efficiency and flexibility, he explains. With that structure firmly in place, the time was ripe "to see if we could manage our overcapacity by channelling our expertise into the contract services sector," says van de Wouw.

Cleanrooms at the Organon Teknika facility are suited for coating, lyophilization, aseptic filling, and related processes

The company initially tested its outsourcing potential at the 1997 Medical Design & Manufacturing East trade show in New York City. Organon Teknika's presence at the exhibition and the subsequent word of mouth resulted in a sufficient number of business leads to prompt the creation of a contract manufacturing business area. Van de Wouw was named liaison officer for contract manufacturing in January 2000, and the company trumpeted its full-fledged entry into the contract services sector by exhibiting at MEDTEC 2000 in Amsterdam.

In addition to the development and manufacture of diagnostic test systems, Organon Teknika, a business unit of the Akzo Nobel group, also produces muscle relaxants and surgical monitoring equipment. But it is the company's expertise in the development and manufacture of IVD products that is being marketed under its outsourcing banner.

"I have found that our experience in product development is particularly valued," says van de Wouw. "Many of the companies I have met lack knowledge about appropriate production technology, and they may not have the sourcing know-how that we have acquired over the years," he explains. "Knowledge of the processes involved in putting together a kit, including its validation and calibration, and the adaptation of manufacturing methods to the processes is one of the strengths that Organon Teknika brings to the table as a subcontractor."

Organon Teknika's cleanroom is equipped with pass-through autoclaves.

Versatility is another key asset prized by potential customers, adds van de Wouw, who points out that the company's sites in Boxtel and Dublin were designed to accommodate small- and large-scale quantities and to meet both routine and special production needs. "We can do as much—or as little—as the customer requires, from producing microplates to client specifications to the development and manufacture of complete IVD kits," says van de Wouw.

At its Boxtel site, Organon Teknika offers complete subcontracting services comprising final product development, production, assembly, packaging, and distribution of microplate-based ELISA and RNA-amplification-based assays. The Dublin facility provides a similar array of services for other rapid assay formats such as agglutination and lateral flow.

The firm's process technologies have attracted the attention of OEMs, notes Peter de Haan, a member of the company's operations team. To ensure optimal outcomes, he adds, the production equipment was designed in-house to perform functions such as drying, filling, washing, aspiration, spraying, spotting, cutting, and assembly.

The company's facilities are designed to accommodate small- and large-scale operations. Shown here are filling operations being performed under aseptic conditions.

Three cleanroom environments are available for a variety of operations in Boxtel. The Class 100,000 cleanroom typically is used for coating processes, bulking, purification, and conjugation, while the Class 10,000 facility is dedicated to lyophilization. By introducing a laminar-flow hood, Class 100 conditions can be achieved for the aseptic filling of vials and ampoules.

To ensure that its customers receive prompt and accurate advice at all times, Organon Teknika has implemented a product-team approach. "The customer has a single point of contact, responsible for the project from beginning to end, who can respond to all operational issues that come up," says van de Wouw. "Any questions a customer may have about delivery dates, production line availability, or whatever, can be answered precisely and quickly, because the point of contact has full knowledge of the team's current and future schedules," notes van de Wouw.

To find out more about Organon Teknika's contract services, contact Nick van de Wouw at Boseind 15, 5281 RM Boxtel, Netherlands; phone: +31 411 654463; fax: +31 411 654246; e-mail: n.wouw@teknika.btl.akzonobel.nl; Internet: http://www.organonteknika.com.

—Norbert Sparrow

Welch Allyn Inc. (Skaneateles Falls, NY, USA) has established a business unit dedicated to the development and sales of subsystems and modules for patient-monitoring OEM applications. The formation of Welch Allyn OEM Technologies (Beaverton, OR, USA), which was announced at the recent Medica trade show in Düsseldorf, Germany, was spurred by the company's acquisition of Protocol Systems Inc. and its Pryon OEM subsidiary in August 2000. "Pryon is a leading supplier of CO^₂ monitoring equipment, and this expertise has provided us with an avenue to offer a broad range of vital signs technology to OEMs," says marketing and communications director Grant Gibson, who fielded questions about the launch from the company's stand at Medica.

One-piece blood pressure cuffs developed for OEM applications have been shown to last more than 100,000 inflation cycles.

The convergence of Pryon's noninvasive blood pressure, ECG, and capnography subsystems with Welch Allyn's thermometry and blood pressure cuffs has created an "opportunity to shrink costs as well as product size for our customers," says Gibson. The POEM noninvasive blood pressure module that was introduced at Medica is an illustration of how device manufacturers will benefit from the pooling of resources, he adds.

"The POEM module is smaller and lighter and draws less power than competing products," says Gibson. It incorporates a pneumatic design that is unique in products of this type, he adds.

The palm-sized module consumes 4 W maximum power—17 mW in sleep mode—while providing a 6-second inflation rate. Weighing only 124 g, the product is available in two versions: the robust POEM Basic and an advanced module with Smartcuf motion artifact rejection algorithms. Smartcuf's capability to furnish accurate noninvasive blood pressure readings despite patient shivering, vehicle vibration, and other sources of motion artifact has been documented in an independent study. Test results are available upon request.

A palm-sized noninvasive blood pressure module that consumes 4 W maximum power was introduced by Welch Allyn OEM Technologies at Medica.

One-piece blood pressure cuffs were also introduced for the OEM market by Welch Allyn at the annual trade show. The one-piece design provides an alternative to traditional cuff-with-bladder combination systems, thus eliminating the need to remove, clean, or replace the bladder, according to the company. The latex-free cuffs are constructed of 200 denier nylon, and have been engineered to meet clinical standards for cuff sizing and fit as set forth by the Association of Medical Instrumentation and the American Heart Association. During tests, the cuffs lasted more than 100,000 inflation cycles; the one-piece construction and flat port tubing connectors that protect against leakage are among the features designed to prolong the product's life cycle.

"These products are only the first splash for Welch Allyn OEM Technologies," says Gibson, who notes that the development of smart modules is a particular area of focus. For further information, contact Welch Allyn OEM Technologies, 8500 SW Creekside Pl., Beaverton, OR 97008, USA; phone: +1 503 5264900; fax: +1 503 5264901; e-mail: alh@pryon.com; Internet: http://www.pryon.com.

—Norbert Sparrow

Avery Dennison Corp. (Pasadena, CA, USA) has announced the creation of Avery Dennison Medical, a new organization in the company's Worldwide Specialty Tape Division. The new global business is headquartered in Mentor, OH, USA, with operations in both Mentor and Turnhout, Belgium.

Avery Dennison Medical was created to operate as a full-service supplier, offering specialized adhesives such as hydrocolloids, hydrogels, films and foams, and laminates to medical device OEMs. The business unit provides contract manufacturing and can also supply components and finished devices on a private-label basis.

According to company officials, the new business unit is dedicated to applying Avery's expertise in self-adhesive materials and adhesives, along with the company's converting capabilities, to develop advanced technologies and products for the growing $392-million worldwide woundcare and skin therapy medical market.

"Our specialty tapes are already used by some of the largest medical product innovators in the industry," says Jef Smets, vice president of Avery Dennison's Specialty Tape Div. "The healthcare industry is constantly looking for new products that will improve woundcare management and patient comfort. We see an opportunity to leverage our technology base and medical industry partnerships to lead growth in this promising area."

According to officials at Avery, the demand for advanced woundcare management products is expanding at a rate of 15–20% a year. Key factors driving this growth are an overall worldwide population base that is older and the development of drugs for the treatment of obesity, arthritis, and impotence, among other conditions. "Advances in medical technology have resulted in new, minimally invasive surgical procedures, and we are seeing a rising demand for these innovations to shift from the hospital to the home, creating a renewed surge in demand for advanced, over-the-counter healthcare products," says Smets.

Colleen Ward, medical business director at Avery Dennison, views the development as part of a trend toward outsourcing in medical manufacturing. "OEMs need flexibility. Gone are the days when they could count on making one product on one production line," she says. "The creation of Avery Dennison Medical will both broaden our customer base and supply our customers with a more complete service." She adds that the company will not sell products under its own name, in an attempt to avoid competition with its customers.

Avery Dennison is a supplier of pressure-sensitive technology and self-adhesive solutions for the medical device and other industries. For more information, contact Avery Dennison Medical, Tieblokkenlaan 1, Turnhout, B-2300 Belgium; phone: +32 14 404811; fax: +32 14 404855; e-mail: medical.europe@averydennison.com; Internet: http://www.averydennison.com.

—Benjamin Lichtman

EUCOMED Convenes, Elects New Board

The EUCOMED annual general meeting was held in Berlin in October. The organization convened to elect its new board of directors and to outline its agenda for 2001.

The new year's agenda is aimed at reinforcing EUCOMED's activities on behalf of all European countries, and to refocus the group's activities on the primary issues facing the device industry. According to officials at EUCOMED, these issues include the implementation of the Mutual Recognition Agreement between the United States and the EU, and the rapid deployment of new medical technologies in the European market, accompanied by appropriate funding in national healthcare budgets.

Noting that the medical technology sector in Europe generates annual sales of €41 billion, provides more than 100,000 products worldwide, and employs more than 300,000 people, EUCOMED plans to seek greater awareness and acknowledgement of the importance of the industry. The organization will also embark on a public education campaign aimed at rejecting unscientific criticism of PVC, and will pursue the enforcement of regulations prohibiting the reuse of single-use devices.

To support its agenda, EUCOMED elected a new and enlarged board, representing a cross section of technologies within the industry. The new board includes members from both device companies and associations. Members representing national associations are:

For more information, contact Michael Baker, director-general of EUCOMED, Place St. Lambert 14, B-1200 Brussels, Belgium; phone: +32 2 7722212; fax: +32 2 7713909; e-mail: michael.baker@eucomed.be; Internet: http://www.eucomed.be.

—Jane Knox

Smart Products Inaugurates Cleanroom

Although Smart Products specializes in components for low-pressure and low-flow applications, the company's business strategy is anything but low profile. After almost doubling in capacity in 1999, the supplier of check valves, fittings, and pumps has announced the addition of a cleanroom to its facility in San Jose, CA, USA. According to owner Doris H. Patterson, it's all a matter of keeping the customer satisfied.

"More and more of our business is geared to the device industry," says Patterson, "and we were missing out on opportunities by not having an on-site cleanroom. Our clients are making increasingly stringent demands," she adds, "and we are committed to responding to their needs." Suited for moulding and assembly operations, the Class 10,000 facility is currently equipped with a 55-tn Milacron electric moulder.

A supplier of valves has installed a Class 10,000 cleanroom suited for moulding and assembly operations.

"We are forever adding capabilities and services," stresses Patterson, noting that the company has engineers on staff who can assist in product design and mould building.

Offering more than 16,000 variations on check valve configurations, Smart Products can design a custom valve from stock parts, specifying all materials and fittings as well as the cracking pressure.

For more information, contact Smart Products Inc., 1710 Ringwood Ave., San Jose, CA 95131, USA; phone: +1 408 4360740; fax: +1 408 4360744; Internet: http://www.smartproducts.com.

—Norbert Sparrow

Hot-stamp foils developed specifically for the medical and pharmaceutical industries are now available through an extensive European distribution network. Coding Products (Kalkaska, MI, USA), a division of ITW, announced alliances for the distribution of its SV-series ribbons with ITW Decorating Group companies in Europe at the recent MEDTEC exposition and conference in Amsterdam.

Formulated for printing applications involving medical bags, catheters, labels, and related items, SV foil materials meet or exceed all relevant regulatory requirements, according to Rob Fickling, sales executive, medical packaging. "We maintain complete documentation on our products, and we have even taken the step of having the formulations tested to USP Class VI requirements," says Fickling. "We are currently having a lab do migration studies on the inks," he adds.

The ribbons, which work on both PVC and new-generation non-PVC substrates, are shipped in jumbo rolls to the European sites, where they are slit to customer specifications. Available in a range of colours, the foils withstand sterilization and exposure to chemicals, and resist abrasion and smearing. Coding Products' goal, says Fickling, is to deliver a complete package to users.

For more information, contact Rob Fickling, Coding Products, 111 West Park Dr., Kalkaska, MI 49646, USA; phone: +1 231 2585521; fax: +1 231 2586120; e-mail: rfickling@codingproducts.com; Internet: http://www.codingproducts.com.

—Norbert Sparrow

In a move to strengthen its R&D capabilities, The Generics Group (Harston, Cambridge, UK), which offers customized technology consulting, development, and investment, recently acquired Genesis Medical Technology (Owings Mills, MD, USA), a medical product engineering firm specializing in product design, engineering, and small-lot manufacturing. Generics president Michael Petty says the expansion is in response to surging demand for R&D services.

"There is a growing trend toward outsourcing project-based R&D, and many companies rely on completing development projects as quickly as possible," says Petty. "Our acquisition of Genesis Medical will help us tap into this demand."

Generics' most recent project is a Diprivan ampoule for AstraZeneca Pharmaceuticals.

According to Petty, Generics will combine its sensor and wireless technology with Genesis's product design and engineering innovations. Recent projects completed by Genesis include an ambulatory blood-pressure–monitoring system, patient-monitoring systems, telemetry systems, and a noninvasive blood-pressure module. Generics has developed coding technology, low-frequency communication systems, and transmission system sensors. Petty says the most current project is a drug-delivery system for AstraZeneca Pharmaceuticals (London, UK).

Generics' capabilities include electronic systems, software, sensors and actuators, optical and laser systems, ultrasonics, mathematical modelling, industrial design and manufacturing services, rapid prototyping, transfer to volume manufacture, and regulatory consulting services including ISO and FDA compliance.

For more information, contact The Generics Group AG, Harston Mill, Harston, Cambridge CB2 5NH, UK; phone: +44 1223 875200; fax: +44 1223 875201; Internet: http://www.scigen.com.

—Jamie Graham

TMP B.V. (Enschede, Netherlands), a microelectromechanical systems (MEMS) designer, developer, and manufacturer, has been acquired by optoelectronic integrated circuit supplier, Kymata (Livingston, UK). While the acquisition will not affect most aspects of TMP's current products and services, it will strengthen the company's MEMS resources and services.

For more information, contact Kymata MEMS, P.O. Box 318, NL-7500 Enschede, Netherlands; phone: +31 53 4889 889; fax: +31 53 4889 890; e-mail: info@microproducts. nl; Internet: http://www.microproducts.nl.

The Federal Health Technology Assessment Body for the hospital sector in Germany has been established to evaluate the effectiveness of different medical treatments and determine their inclusion under the statutory health insurance. A negative evaluation will prevent a treatment from being covered by the sickness funds. The committee will only assess a treatment at the request of either the Federal Hospital Association or officials in charge of the sickness funds.

For more information, contact the Federal Association of the Medical Device Industry in Germany, Hasengartenstr. 14c, D-65189 Wiesbaden, Germany; phone: +49 611 9767517; fax: +49 611 719769; e-mail: beeres@bvmed.de; Internet: http://www.bvmed.de/english.htm.

Moll Industries (Davie, FL, USA) has formed a strategic alliance with Daltek Inc. (Dalton, GA, USA). Moll Industries, a full-service supplier of injection-molded parts and assemblies, initiated the collaboration to satisfy increased customer demand for plastic parts with durable decorative finishes. Through the partnership with Daltek, a firm experienced in aspects plastic painting and design, Moll will provide high-quality turnkey decorating processes. The companies currently have two production lines in operation.

For more information, contact Moll Industries, 2200 SW 71st Terrace, Davie, FL 33317, USA; phone: +1 877 2756655; fax: +1 954 4744391; e-mail: info@mollindustries. com; Internet: http://www.mollindustries.com.

Offering a display of technical electronic solutions for various industries, including the device industry, Intertronic 2001 is being held simultaneously with Semaine Européenne des Technologies de l'Information (SETI). The conference, held 6–9 March at the Paris Expo, Porte de Versailles, offers opportunities to meet with suppliers and exchange information.

For more information, contact Intertronic/Miller-Freeman, 70 rue Rivay, F-92532 Levallois Perret, France; phone: +33 1 47565000; fax: +33 1 47562140; Internet: http://www.intertronic.com.

The EC Medical Devices Vigilance System and Post Marketing Surveillance conference is to be held in Guildford, Surrey, UK on 24–25 January. The conference will cover the competent authorities' dedication to incident notification and evaluation and the recent commitment of more resources to the monitoring of the vigilance system within EU member states. The importance of the vigilance rules laid out in the commission directives will also be covered.

For more information, contact Management Forum Ltd., 48 Woodbridge Rd., Guildford, Surrey GU1 4RJ, UK; phone: +44 1483 570099; fax: +44 1483 536424; e-mail: info@management-forum.co.uk; Internet: http://www.management-forum.co.uk.

Formatted to present world regulations for clinical research, the International Clinical Trials course hosted by Clinical Design Group Inc. will be held 24–25 January in Las Vegas, NV, USA. The course features EU medical device directives, US FDA regulations, ISO standards, Japanese standards, the Australian Therapeutic Goods Act, the Canadian Food and Drugs Act, and the World Health Organization ethics guidelines for biomedical research. Plans for multinational clinical development and tips for solving common international clinical trial problems will also be presented at the conference.

For more information, contact Clinical Design Group Inc., 2128 W. Evergreen Ave., Chicago, IL 60622, USA; phone: +1 773 4895706; fax: +1 773 4895982; e-mail: cdginc@clinicaldesign.com; Internet: http://www.clinicaldesign.com.

The Japan External Trade Organization's biennial Healthcare Import Fair is open to overseas technology companies. Device manufacturers, wholesalers, retailers, and healthcare professionals will be in attendance. The Japanese healthcare market and general medical devices are among the issues to be discussed at the conference, which is to be held 2–9 February at the Nippon Convention Center in Chiba, Metropolitan Tokyo, Japan.

For more information, contact Japan External Trade Organization, 2-2-5 Toranomon, Minatu-ku, Tokyo 105-8466, Japan; phone: +81 3 35825242; fax: +81 3 35050450; e-mail: fad@jetro.go.jp; Internet: http://www.jetro.go.jp.