European Industry news
Sensing Growth in the Medical Biosensor Market
Although biosensors have existed for nearly 30 years, it has only been in the past decade that commercial applications have taken advantage of the technology and grabbed the attention of some of the big names in the biotech field. Biosensors are devices with biological or biologically derived sensing elements—such as an enzyme or antibody—integrated within or associated with a transducer, which can recognize a biological species or substances such as neurotoxins. Each biosensor produces electronic signals based on the concentration of a specified substance.
A report from the Business Communications Company, Inc. (Norwalk, CT, USA) predicts that during the next five years the sensor market will build exponentially on its past decade of success, in which the sensors' main function was to quickly measure biological and chemical substances. Sensors are expected to play an increasing role in research and in an expanding array of technologies. The number of products will also increase.
| Market | AAGR 1998—2003 (%) |
| Medical | 17.6 |
| Industrial | 32.0 |
| Environmental | 11.8 |
| Government | 3.4 |
| Research | 4.6 |
| Total | 17.0 |
Last year, the total biosensor market was estimated at US$765 million. It is expected to grow at an average annual rate of 17%, enabling it to reach US$1.7 billion by 2003. The significant expense of bringing a biosensor-based product to market is presumed to be the reason that the growth rate of the technology was slower during its first 15 years. The emergence of new applications has increased biosensor use, however, particularly in the medical market, which accounts for more than 90% of total sales. Medical biosensor sales numbers are expected to double by 2003, from US$692 million in 1998 to more than US$1.5 billion.
Other market segments covered in the biosensor report include industrial processing, environmental monitoring, government (primarily for systems that detect biological weapons), and research. The latter category has some crossover into the medical arena—for example, in drug discovery applications. Although the potential for biosensors seems to be vast, development has lagged in part because the engineers that understand sensors don't necessarily have the biological background to put them to optimum use. That problem is decreasing, however, as scientists from various disciplines work together to bring biosensors to the forefront of technology.
For additional information, contact Business Communications Company, Inc., 25 Van Zant St., Norwalk, CT 06855, USA; phone: +1 203 8534266; fax: +1 203 8530348.
Ventilator Project Spurs Supplier's Medical Activities
A supplier of precision bearings and a manufacturer of respiratory and patient-monitoring products have joined forces to develop a ventilator system with a no-wear, long-life pump. The Puritan Bennett 740 ventilator system is manufactured by Mallinckrodt Inc. (Carlsbad, CA, USA) and features a patented, frictionless piston that eliminates the need for an oxygen blender, compressor, or wall air. The frictionless piston allows the pump to operate over an extended period of time, significantly increasing the life span of the ventilator.
John Power, a former R&D manager at Puritan Bennett's facility in Galway, Ireland, recalls the stringent requirements of the project: "The frictionless pump needed to achieve a high degree of accuracy and response—two of the critical functions in ventilation—while still maintaining a rugged and cost-effective construction that would allow the ventilator to be sold in markets that could not previously afford a product of this sophistication."
The ventilator's pump has no seal, but is driven by a piston that creates a calculated, low-level leak. A feedback control loop adjusts the speed of the piston, which in turn controls the pressure inside the pump. A custom segmented bearing developed by Thomson Industries Inc. (Port Washington, NY, USA) allows for precise control of the piston to maintain this delicate balance of pressure.
"We hold a patent on the segmented bearing technology used in this pump," says Al Ng, chief engineer at Thomson, "and we can produce tailored bearings on extremely short notice. Such components offer the benefits of a standard product, but they are tailored to special needs." Thomson now offers the Smart MultiTrac ball bushing bearing as a standard component and foresees its use in analytical as well as respiratory devices. "We are surprised and excited by the number of medical applications for our bearings and are exploring more opportunities in this area," says Ng.
For additional information, contact Thomson Industries Inc., 2 Channel Dr., Port Washington, NY 11050, USA, phone: +1 516 8838000; fax: +1 516 8839039; e-mail: thomson@thomsonmail.com.
Collaborative Venture Takes Giant Step into Device-Oriented Microtechnology
A technology-driven UK consultancy with extensive experience in the healthcare sector and a German-based institute for applied research and development have announced that they will collaborate on the development of microtechnology-based medical devices. The partnership's initial offering is an ambulatory infusion pump that delivers precisely controlled amounts of medication. The device is designed to be worn or carried by the patient. According to Cambridge Consultants Ltd. (CCL; Cambridge, UK) and the Institut für Mikrotechnic Mainz (IMM; Mainz, Germany), the pump will be smaller and lighter than those that are currently available because it integrates IMM's microengineered pumps and CCL's drug-delivery technology. A demonstration model is expected to be available before the end of the year.
The integration of CCL's product design and development skills and IMM's microengineering expertise will enable the partnership to overcome the manufacturing problems, cost issues, and regulatory hurdles that have traditionally prevented this technology from fulfilling its promise in the medical arena, according to CCL director Brian Moon. "In working together, our two companies will be a formidable design force," he says. "CCL, with its expertise in product development, market knowledge, and understanding of the regulatory issues that underpin all device designs, is a perfect partner for IMM. Together, we will bring down many barriers that stand in the way of medical device development and deliver real benefits to those who use the products," adds Moon, who heads CCL's healthcare industry practice.
Future projects of the joint venture will combine micromechanical components with standard engineering to achieve greater efficiency and effectiveness in healthcare applications. Potential applications cited by the companies include advances in instruments for minimally invasive surgery, drug delivery systems, artificial organs, implants with enhanced biocompatibility, and multiparameter diagnostic systems.
For more information, contact Andrew Watts at Cambridge Consultants Ltd., Milton Rd., Cambridge CB4 4DW, UK; phone: +44 1223 420024; fax: +44 1223 423373; e-mail: watts.andrew@camcon.co.uk; or Ursula Eul at Institut für Mikrotechnic Mainz, Carl-Zeiss-Str. 18-20, D-55129 Mainz, Germany; phone: +49 6131 990117; fax: +49 6131 990205; e-mail: eul@imm-mainz.de.
University Researcher Partners with Device Firm to Develop Cryogenic Probe
A cryogenic probe that uses liquid nitrogen and magnetic resonance imaging (MRI) technology in the minimally invasive treatment of liver tumors is currently undergoing feasibility studies at Tricumed Medizintechnik GmbH (Kiel, Germany). Developed by Professor Stephan Klein at the Fachhochschule in Lübeck, Germany, and researchers at Lübeck Medical University, a first functional model of the device was presented in the Innovations and Research & Technology pavilion at the recent Hannover Messe 99.
Measuring approximately 2 mm diam and 120 mm long, the probe forms a 25-mm-diam ice ball to freeze tumors. Unlike 5- to 12-mm-diam probes that are used in conventional surgery, Klein's much-smaller device enables the use of keyhole surgery and MRI technology in the treatment of patients.
During a rare lull at his stand, Klein enumerated the challenges that researchers overcame to build a functional prototype of the device. "The main difficulties were the small size, of course, and also the choice of materials. The material has to be compatible with ISO 10993, the standard pertaining to biocompatibility, and it must not produce artifacts in order to be used with an MRI system," he says. "In addition, we had to resolve insulation problems, because the shaft's temperature must be maintained above 0°C for purposes of lubricity," says Klein. To achieve this, Klein constructed a probe with three coaxial titanium tubes in outer diameters of 2.1, 1.3, and 0.75 mm. "One of the tubes transports liquid nitrogen to the tip to perform the procedure, another evacuates the nitrogen in gas form, and the third is attached to a pump," says Klein. Thermal decoupling of the probe's shaft and tip was achieved by means of vacuum insulation of the shaft.
Klein and partner Tricumed, which develops and markets implantable infusion pumps and related accessories, are satisfied with the results thus far and will begin testing the device on animals at the end of this year. Clinical trials will follow.
For more information on this project or to inquire about other collaborative projects with the university, contact Stephan Klein at Fachhochschule Lübeck, Stephensonstr. 3, D-23562 Lübeck, Germany; phone: +49 451 5005375; fax: +49 451 5005235; e-mail: klein@fh-luebeck.de.
Miniature Carbon Fibres Energize Promise of Artificial Muscles
Artificial muscles composed of sheets containing billions of submicroscopic carbon fibres may revolutionize the direct conversion of electrical energy into mechanical energy. An international team of researchers predicts that recent progress made in this field could lead to key applications in the medical sector.
The team led by Ray Baughman of AlliedSignal Inc. (Morristown, NJ, USA) demonstrated that two electrolyte-filled carbon nanotube sheets connected to a battery can perform mechanical work similar to the way in which natural muscles accomplish the task. In fact, they have an advantage over their biological model because they are more durable. Benefits of this technology over known technologies include a dramatically increased ability to do work and generate forces as well as the capability to operate at low voltages and elevated temperatures, according to the company.
Considerable research remains to be done before the artificial muscles are ready for commercialization. Notably, both the carbon nanotube material and the devices that are derived from it require optimization before the technology can be applied, says Baughman. "Overcoming these challenges," he adds, "could result in our actuators being used in artificial hearts and limbs, optical fibre switches, nanoscale machines, and robotics."
The team's research activities are funded by the US Defense Advanced Research Projects Agency. Scientists and engineers that make up the research group come from the Max Planck Institute in Stuttgart, Germany; the University of Pisa, Italy; Georgetown University, Washington, DC; and several other prestigious international institutions. AlliedSignal Inc. recently filed for patent protection of discoveries on the artificial muscles that were made in its research facilities.
For more information, contact AlliedSignal's European headquarters at 44 avenue Georges Pompidou, F-92300 Levallois-Perret, France; phone: +33 1 55631500; fax: +33 1 55631586.
Symposium Explores Evolving Computer, Medical Device Interface
Futurists, design engineers, and computer specialists will participate in a symposium to discuss the role that computers will play in healthcare, medical devices, and other arenas in the next 25 years. Cosponsored by IBM (Armonk, NY, USA) and the Industrial Designers Society of America (IDSA; Great Falls, VA, USA), the Designabout on Pervasive Computing will bring together 100 IDSA members, IBM representatives, and design futurists to discuss the shape of things to come and perhaps influence their appearance and functionality.
"Designers should play an important role in anticipating and conceiving the appliances that will provide the interface between individuals and the information they are seeking," says Robert E. Steinbugler, manager of strategic design at IBM. Part of the symposium's objective, he adds, is to position industrial design on the development curve ahead of technology and bring forth ideas that technology can then help to implement.
Registration for the event, which will be held at IBM's conference centre in Palisades, NY, USA, on 1–3 December, is limited to a maximum of 100 IDSA members. Information is available at http://www.idsa.org. In keeping with the futurist theme, the cosponsors are discouraging the use of paper and plan to communicate with registrants exclusively by e-mail whenever possible.
To ensure that other designers, business executives, and the public at large are exposed to the ideas presented at the Designabout, the results of the symposium will be published on-line at both the IDSA and IBM Web sites. In addition, the Spring 2000 issue of the IDSA journal will feature in-depth coverage of the event.
If you would like more information but are unable to use the Internet, contact IDSA, 1142 Walker Rd., Great Falls, VA 22066, USA; phone: +1 703 7590100; fax: +1 703 7597679.
Catheter Packaging Earns Accolades
A thermoformed package designed to house a coronary imaging catheter was honored by the Society of the Plastics Industry at the 1999 Thermoforming Institute National Awards in Scottsdale, AZ, USA. The package, designed and manufactured by Prent Corp. (Janesville, WI, USA), received first place in the light-gauge medical packaging category and was also named thermoform package of the year. The sterile-barrier container suspends and immobilizes a fibre-optic catheter coil and its accessories, while serving as a protective shipping unit, a preparation station, and a catheter channel.
Judges were impressed by the nestable design, which achieved more than 200% savings in the shipping and handling of empty packages. The container also allows preparation and insertion of the catheter prior to its removal from the package. The package was designed using 3-D solid surface modelling software and then modelled and tooled in-house by means of 3-D CNC technology.
Certified to ISO 9001, the thermoformer specializes in medium-run, deep-draw, nestable packaging solutions. Engineers design and build machinery and tooling suited for specific project requirements. The company has production facilities in the United States, Asia, and Central America, and recently established an alliance in Europe with Nelipak Thermoforming (Venray, Netherlands).
For additional information, contact Prent Corp., 2225 Kennedy Rd., Janesville, WI 53547-0471, USA; phone: +1 608 7540276; fax: +1 608 7542410; e-mail: prent@prent.com.
In Brief
Blanson Installs Europe's Largest Autoclave
Blanson Ltd. (Leicester, UK), a member of BI Group plc, has completed construction on a new facility that houses what is reportedly one of the largest autoclaves in Europe. The autoclave is suited for use in the production of medical devices such as hyperbaric chambers and fluid manifolds found in heart-lung dialysis machines and chromatography columns used for testing drugs. The plant also features a Class 100 cleanroom and a nitrogen-generation plant.
Blanson manufactures cast and engineered Acrilite acrylics. The company recently developed a method of adhesion that has benefited medical applications of this material.
For more information, contact Blanson Ltd., Morris Rd., Leicester LE2 6BR UK; phone: +44 116 27050522; fax: +44 116 2700370; e-mail: jwilliams@bi-group.com.
Ion Beam Applications Acquires Griffith Micro Science
Griffith Micro Science (Oak Brook, IL, USA), the inventor of the EtO sterilization process, has been acquired by Ion Beam Applications (Louvain-la-Neuve, Belgium). Griffith Micro Science provides sterilization and sterilization management services to device OEMs. The company currently operates 19 facilities worldwide, including locations in Belgium, France, Germany, the Netherlands, and the UK.
According to Kevin Swan, CEO of Griffith Micro Science, "The medical device industry is increasingly outsourcing its sterilization services and is looking for a one-stop shopping solution to meet their needs. By combining our leadership in sterilization management and IBA's leadership in e-beam and x-ray systems for ionization, we expect to create new synergies for our customers." Ion Beam Applications designs and produces particle accelerators for medical imaging, cancer therapy, and industrial applications.
For more information, contact Griffith Micro Science, 2001 Spring Rd., Ste. 500, Oak Brook, IL 60523, USA; phone: +1 630 5711280; fax: +1 630 5711245.
Contract Printer Opens New Facility
CI Inc. (Norton, MA, USA), formerly Creative Imprints, has opened a new facility that doubles the company's operational capacity. The plant features an environmentally controlled production room and new equipment. 
The company, which recently attained ISO 9002 certification, provides contract printing services with medical-grade inks. CI uses proprietary ink formulations and specialized pretreatment processes to achieve ink adhesion on plastics such as polypropylene, polyethylene, and Delrin.
For more information, contact CI Inc., 15 A Commerce Way, Norton, MA 02766, USA; phone: +1 508 2857650; fax: +1 508 2857260; e-mail: info@creativeimprints.com.
Medica Group and Tecnoideal Reorganize
The Medica Group and Tecnoideal (Mirandola, MO, Italy) have restructured their operations. The Medica facility has been expanded and will now manufacture medical devices and provide R&D services, while Tecnoideal will focus on manufacturing equipment and R&D for the biomedical sector. Medica's line of solvent dispensers and testing equipment, including leak and obstruction testers, will now be produced by Tecnoideal.
For more information, contact Tecnoideal, Via Lea Cazzuoli 43, I-41037 Mirandola (MO), Italy; phone: +39 0535 23653; fax: +39 0535 27443; e-mail: tecnoideal@aecanet.it.
Sensym, Foxboro Merge
Sensym (Milpitas, CA, USA) and Foxboro ICT (San Jose, CA, USA) have merged to create Sensym Foxboro ICT. The sensor manufacturers have named Sensortechnics GmbH (Puchheim, Germany) distributor for their now-combined product lines. The new company's products include pressure sensor chips and amplified sensors from 2 mbar to 10 bar, force sensors, stainless-steel sensor cells and transducers from 100 mbar to 350 bar, high-precision process-control-grade transmitters, and high-purity transducers.
For more information, contact Sensortechnics GmbH, Aubinger Weg 27, D-82178 Puchheim, Germany; phone: +49 89 800830; fax: +49 89 8008333; e-mail: info@sensortechnics.com.
Standards libraries available on-line
A library of 4500 international standards can now be purchased from the International Electrotechnical Commission (IEC; Geneva) via its Web site at http://www.iec.ch. The bilingual English/French standards are available in hard-copy format and will be delivered within five days of ordering. Single-workstation users can download 1000 PDF versions of standards issued since September 1996. Users can search by text or reference number and can purchase up to 20 standards per visit. Approximately 1000 standards are available in Spanish. The site also offers general information on the IEC.CSSINFO (Ann Arbor, MI, USA) also has launched a Web site that contains a bibliographic database of safety, quality, and design standards from more than 300 standards-developing organizations, as well as a variety of technical books. Visitors to http://www.css info.com can browse standards categorized by issuing organization, document number, and titles or keywords. Users can also order standards on-line in either paper or PDF format.
Web site links cleanroom users and suppliers
A nonprofit organization that supplies materials and services to cleanroom users, the Belgium Cleanroom Workclub (BCW; Avelgem, Belgium), located at http://www.bce.be, has installed a database of cleanroom users and suppliers on its Web site. The home page includes a list of applicable standards; a library of relevant books, magazines, and videos; and product information. Visitors can use e-mail to contact a permanent secretariat, which will endeavour to answer cleanroom-related questions. The site also provides a link to the forum of the International Confederation of Contamination Control Societies, where visitors can discuss cleanroom issues and problems, and a calendar of upcoming conferences.
Shows and Conferences
Roadshow 99 Highlights Surface Analysis
CSMA Ltd.'s annual programme of regional seminars begins 6 October in Livingston, Strathclyde, UK, at the Hilton National, Almondview. Roadshow 99 will feature new ways in which surface analysis can be used for environmental monitoring and cleanroom evaluation. New methods for image- and depth-profiling analysis of polymers and other materials will be introduced. Eight half-day and two full-day seminars will be held in the UK and Ireland.
For more information, contact CSMA Ltd., Armstrong House, Oxford Rd., Manchester M1 7ED, UK; phone: +44 161 2375811; fax: +44 161 2371008; e-mail: enquiries@csma.ltd.uk.
Conference Examines Labelling Requirements
IBC Conferences Ltd. will hold the fourth annual conference on medical device labelling 6 October at the Forte Posthouse, Regents Park, London. The conference will examine the content and use of labels and instructions for medical devices in the EU, specifically current interpretations of labelling requirements and the effects of the IVD directive. It will also cover the use of symbols, language requirements, and labelling issues for home-use products.
For more information, contact IBC UK Conferences Ltd., Gilmoora House, 57-61 Mortimer St., London W1N 8JX, UK; phone: +44 171 4535492; fax: +44 171 6366858; e-mail: cust.serv@ibcuk.co.uk.
Interplas 99 Showcases Polymers
More than 34,000 visitors are expected to attend Interplas 99, 3–7 October at the National Exhibition Centre in Birmingham, UK, hosted by Reed Exhibition Companies Ltd. The international polymer event features a processing centre showcasing a range of production equipment and tooling. The application centre highlights materials, finished and semifinished goods, and converters.
For more information, contact Reed Exhibition Companies Ltd., Oriel House 26, The Quadrant, Richmond, Surrey TW9 1DL, UK; phone: +44 181 9107853; fax: +44 181 9107989; e-mail: interplas@reedexpo.co.uk.
Cleanroom Design Course Will Be Held in Dublin
A course on cleanroom design and construction will be presented by Ken Goldstein of Cleanroom Consultants Inc. on 6 October in Dublin, Ireland.
For more information, contact ep ElectroMat Ireland Ltd., Oranmore, Galway, Ireland; phone: +353 91 790693; fax: +353 91 790694; e-mail: emat@iol.ie.
Medical Device Forum Announced
The third Medical Device Forum sponsored by the MDA Medical Device Academy will be held 15–16 October at the Marriott Hotel, Freising, München, Germany. The two-day event will include segments on CE marking, US FDA initiatives, international standards, and risk analysis and management.
For more information, contact MDA Medical Device Academy, Krautstr. 2, D-87700 Memmingen, Germany; phone: +49 8331 9445012; fax: +49 8331 47478; e-mail: mda@mueller-lierheim.com.
Älter Werden 99 Features Geriatric Care
Messe Stuttgart International will hold Älter Werden 99 19–21 October. In addition to more than 300 exhibitors, the event includes a forum that will discuss healthcare issues relevant to an aging population.
For more information, contact Messe Stuttgart International, Kochenhof 16, Postfach 10 32 52, D-70028 Stuttgart, Germany; phone: +49 711 2589584; fax: +49 711 2589305; e-mail: smk.wiesinger@t-online.de.
Milan Welcomes Mosan Milanosalute 99
Mosan Milanosalute 99 will be held 19–22 October at the Milan Trade Fair. The exhibition will feature healthcare-related equipment, products, services, and technology.
For more information, contact Assoexpo, Via Domenichino 11, I-20749 Milan, Italy; phone: +39 02 4815541; fax: +39 02 4980330; e-mail: assoexpo@assoexpo.com.
Manufacturing Week Returns to Birmingham
Manufacturing Week 99, a platform for new product launches in the manufacturing industry, will take place at the NEC, Birmingham, UK, 26–28 October. The exhibition will include a design engineering section and an area devoted to automation, production, and maintenance equipment. Colocated shows focus on computers in manufacturing, preowned production equipment, and inspection, metrology, and testing equipment.
For more information, contact Reed Exhibition Companies Ltd., Oriel House 26, The Quadrant, Richmond, Surrey TW9 1DL, UK; phone: +44 181 9107853; fax: +44 181 9107989.
