Originally Published March/April 2001
EMDM Industry News
Mikron Expands Moulding Operations
In a move aimed at strengthening its market share in plastics processing across a range of industries, Mikron Holding AG (Biel, Switzerland) has acquired the Dutch moulding concern Axxicon Group N.V. (Eindhoven, Netherlands). The acquisition was made in tandem with the formation of Mikron's new Mould Technology division and the announcement that the company has signed a letter of intent to acquire an unnamed US mould maker.
With the formation of a new division dedicated to mould technology, Mikron hopes to offer optimized services for the production of complex plastic products such as this injection pen.
Mikron plans to integrate the acquired mould- making companies with its own mould construction activities to form a worldwide division supplying advanced injection moulds for the mass production of complex plastic parts. The Mould Technology division will be a part of Mikron's Production Equipment business segment, and will supply outside clients as well as Mikron's own Components business segment. With 10 manufacturing facilities and 900 employees worldwide, the Mould Technology division is expected to have sales of x130 million.
According to officials at Mikron, the growing market for high-volume plastic moulds is undergoing structural change and is developing from a small-time, local trade to an industrially driven and globally oriented business. Company officials estimate the volume of the market at x1.3 billion, with an annual growth rate of 20%.
Grégoire Bagnoud, manager at Mikron Plastic Technology, explains that the formation of the Mould Technology division will make the company more attractive as a strategic partner to medical OEMs. He notes that the division will be able to generate injection moulds for globally identical products on extremely short deadlines.
Bagnoud explains that the acquisitions are a good fit with Mikron's strategy to act as a partner to the medical and pharmaceutical industry, supplying them with both production equipment and components, as required. "Both companiesAxxicon and the planned US acquisitionare experts in industrial mould making," says Bagnoud, observing that the companies are capable of duplicating moulds 2, 3, 5, or 10 times with the same quality and precision in each cavity. "They also build moulds with very high cavitation," he says, "and their sales to medical and pharmaceutical companies are a big portion of their total sales."
Mikron already supplies the medical sector with flexible, high-speed, automatic assembly and robotic assembly systems through Mikron S.A. Boudry (Boudry, Switzerland), which heads the the company's Assembly Technology division. Bagnoud reports that with the formation of the new division, Mikron will be able to provide products and services ranging from tool design, moulds, and assembly lines to plastic components.
According to Bagnoud, Mikron will be the first company able to offer this range of services in-house to both the European and US markets. "Pharmaceutical companies complain about the interface problem between their suppliers, and the time lost because each party places the blame on the other when something goes wrong," he says. "We are convinced that our strategy to have everything under one roof meets a strong need of the medical industry, and we are already receiving very positive signals from the market," he adds. "But not every customer is obliged to buy a complete solution from us: you can just ask for moulds, moulding, or assembly equipment. We will give you what is best suited to your needs."
For more information, contact Axxicon Group N.V., Luchthavenweg 55-e, P.O. Box 8820, NL-5605 LV Eindhoven, Netherlands; phone: +31 40 2661060; fax: +31 40 2661070; Internet: http://www.axxicon.com.
Benjamin Lichtman
Companies Team Up to Offer Custom Medical Tubing Services
Long-time business partners Precision Extrusion Inc. (South Glens Falls, NY, USA) and Zynergy Core Technology Ltd. (Runcorn, Cheshire, UK) have announced the formation of Zynergy Precision Extrusion (ZPE), also in Runcorn. The joint venture will combine the manufacturing expertise of Precision Extrusion and the polymer technology of Zynergy in a "European platform for custom medical tubing extrusion," according to Precision Extrusion's Michael Badera.
The newly formed Zynergy Precision Extrusion provides device OEMs with a range of custom services.
ZPE will offer a full range of extrusion services as well as comprehensive design assistance involving material selection, tubing configurations, die manufacture, and project management. Extrusion capabilities will include single-lumen and multilumen tubing, coextrusion, braiding, and bump tubing.
Zynergy Core Technology supplies custom high-performance biomaterials, coatings, and process technologies to device OEMs. The company's proprietary ZyTar range of polyurethanes have particular applications in the production of interventional cardiology catheters. In partnership with other group subsidiaries, the company can provide comprehensive prototyping services.
Precision Extrusion specializes in the manufacture of small-diameter, close-tolerance single- and multilumen tubing to customer specifications. In addition to polyurethanes, the company routinely extrudes nylon, PVC, LCP, polycarbonate, LDPE, HDPE, Pebax, and other engineering resins. Most of the materials can be combined with fillers to produce radiopaque compounds.
For more information on the joint venture, contact Zynergy Precision Extrusion, 10 Seymour Ct., Tudor Rd., Manor Park, Runcorn, Cheshire WA7 1SY, UK; phone: +44 1928 571200; fax: +44 1928 571201; Internet: http://www.zynergy.co.uk.
Norbert Sparrow
Johnson Matthey Acquires Shape Memory Applications
Johnson Matthey (West Chester, PA, USA) has signed a letter of intent to purchase all the stock of Shape Memory Applications Inc. (SMA; San Jose, CA, USA), a supplier of tubing, wire, sheet, and fabricated components using nickel titanium. "Our expertise in precious metal alloys and micromachining is a perfect fit with SMA's nitinol knowledge base," says Alan Myers, director, noble metals, at Johnson Matthey. "We share the same customer base and will be able to offer our clients expanded development solutions and procurement efficiences," he adds.
Nickel titanium, commonly referred to as nitinol, has a number of properties that are of interest to device manufacturers, including the shape memory effect, elasticity, and high damping capability. The properties can be modified by introducing changes in alloy composition, mechanical processes, and heat treatment.
Memory Metalle GmbH (Weil am Rhein, Germany), which handles European sales for SMA, will continue to represent the nitinol product line in Europe. Sales in the rest of the world will be folded into Johnson Matthey's operations.
For further information, contact Johnson Matthey Inc., Precious Metals Div., 1401 Kings Rd., West Chester, PA 19380, USA; phone: +1 610 6488000; fax: +1 610 6488105; Internet: http://www.jmmedical.com.
Norbert Sparrow
Fibre-Optic Catheter Pressure Transducer Developed for Low-Cost Applications
Using the proprietary white-light interferometric interrogation technique, a fibre-optic microelectromechanical system (MEMS) pressure transducer provides in vivo blood pressure, intrauterine, and intracranial measurements in disposable or reusable applications. The device was developed by Fiso Technologies (Sainte-Foy, QC, Canada) to satisfy the medical industry's need for an extremely small catheter-tip pressure transducer that would not be affected by electrical interference, according to company president Claude Belleville.
The fibre-optic disposable blood pressure transducer combines the advantages of catheter-tip and external invasive blood pressure transducers.
Equipped with a 0.55-mm tip and 0.25-mm cable, the Model FOP-M-055-300 device is insensitive to cable bending and high levels of electromagnetic and radio-frequency noise "that typically plague physiological measurements," says Belleville. It also minimizes inaccurate pressure readings, he adds, "because of its proximity to the measurement site."
Integrated into a catheter, Fiso's pressure sensor exhibits a 50-Hz frequency response. Other designs rely on technologies that are less sensitive to frequencies. In addition, the pressure-sensing element in other designs is situated at some distance from the measurement site, thereby running the risk of generating inaccurate readings, according to Belleville.
Fiso's sensor is accurate at 25°C to ±1% of the reading or 1 mmHg, whichever is greater, and exhibits low drift over time. Temperature sensitivity over the 20°80°C range is <0.2 mmHg per degree centigrade.
For more information, contact Fiso Technologies, 2014 Jean-Talon N., Ste. 125, Sainte-Foy, QC G1N 4N6, Canada; phone: +1 418 6888065; fax: +1 418 6888067; Internet: http://www.fiso.com; e-mail: sales@fiso.com.
Norbert Sparrow
STS Biopolymers Acquires MCTec
STS Biopolymers (Henrietta, NY, USA), a polymer-based-coating supplier, and MCTec B.V. (Venlo, Netherlands) have merged into a single supplier of coating technology. Like STS Biopolymers, MCTec develops lubricious and drug-releasing coatings for devices such as catheters and stents. However, reel-to-reel wire- and tube-coating applications are MCTec's forte in the industry and will complement STS Biopolymers' dip and spray coating technologies. According to STS chairman Richard Whitbourne, the merger will lower clients' costs and expand both facilities' production capabilities. The reel-to-reel PTFE coating technology will be the primary factor in lowering costs, especially for guidewire manufacturers, Whitbourne adds.
In the guidewire manufacturing process, a fine metal wire is wrapped around a metal mandril and welded to each end to create a spring. Usually, the finished ensemble is then sent through an electrostatic spray to apply a Teflon coating.
MCTec's reel-to-reel method provides an attractive alternative to the electrostatic spray coating process for some manufacturers. A PTFE coating is applied to the fine wire before it is coiled around the mandril, making it unnecessary to coat the entire guidewire.
"By applying the coating on the wire ahead of time, the manufacturer not only eliminates a step in the manufacturing process, but is provided with a much more uniform coating," explains Whitbourne. "Things like corner cracking, Teflon clumping, and wire stiffening are no longer concerns."
In addition to treating guidewires, MCTec applies PTFE or lubricious coatings to other medical components including electrostimulation devices, movable core wires, stainless-steel hypotubes, and other catheter tubes. STS Biopolymers hopes to integrate MCTec's high-speed reel-to-reel process with its services, which include the application of lubricious, hydrophilic, drug-delivery, and ultrasound echogenic coatings.
Both facilities will continue to operate and incorporate the technology of the other. A name for the newly formed company is yet to be determined. For more information, contact MCTec B.V., P.O. Box 9, 5900 AA, Venlo, Netherlands; phone: +31 77 3878369; fax: +31 77 3878230; e-mail: info@ mctecbv.com; Internet: http://www.mctecbv.com.
Jamie Graham
Robots Take Up Residency in the OR
Industrial robots that conform to Class 1 cleanroom requirements are the core components of an automated cell that mills patients' femurs to prepare them for the insertion of hip prostheses. Orto Maquet (Rastatt, Germany), a manufacturer of operating tables that has marketed the cell thus far in Germany and France, specified the RX 90 CR robot, developed by Stäubli (Horgen, Switzerland), for this application primarily because of its precision and repeatability.
Robots mill femurs 10 to 20 times more accurately than surgeons.
"Maquet claims that the robot drills the bone to an accuracy of 0.1 mm," says Jean-Luc Burquier, group division manager, robotics, at Stäubli's production unit in Faverges, France. "A surgeon typically achieves an accuracy of 1 to 2 mm, making the robot 10 to 20 times more accurate than its human counterpart." The machine's extraordinary precision results in less bleeding during the procedure and accelerates rehabilitation, which goes a long way toward allaying any misgivings the patient may have of being operated on by a robot, adds Burquier.
The RX 90 robot attracted the attention of Maquet engineers at the annual Hannover Fair trade show in Germany. "It is made of stainless steel and smooth polyurethane, making it suitable for use in Class 1 environments," notes Burquier. In addition, all of the cables and motors are embedded inside the arm, and the robot has a compact footprint. "We worked with Maquet for a couple of years to adapt the robot to their specifications and to incorporate additional safety features required by the application," adds Burquier.
The first operation using CASPAR (computer-assisted surgical planning and robotics) was conducted in 1997 in Germany. Maquet is currently exploring other applications, adds Burquier, and has achieved two world firsts: the replacement of cruciate knee ligaments in 1999, and the insertion of a tricompartment knee prosthesis. French and German hospitals are using CASPAR, and the cell will soon be installed in hospitals in Belgium and Italy. The company is seeking approval from US FDA to market the device in the United States.
For more information, contact Stäubli AG, See Str. 240, CH-8810 Horgen, Switzerland; phone: +41 172 52511; fax: +41 172 86211; Internet: http:// www.staubli.com.
Norbert Sparrow
In Brief
Adam Spence Europe Bought from Parent Company
Adam Spence Europe (Boyle, Co. Roscommon, Ireland) was purchased by its Irish management from the parent company, Adam Spence Corp. (Wall, NJ, USA). The newly purchased company, which specializes in precision thermoplastic extrusions and components, will change its name to ANSAmed Ltd.
For more information, contact ANSAmed Ltd., Abbeytown, Boyle, Co. Roscommon, Ireland; phone: +353 79 63038; fax: +353 79 63039; e-mail: sduffy@ase.ie.
Nypro to Produce Safety Syringes for Medisys
A precision injection moulding company, Nypro Inc. (Oldenburg, Germany) signed a contract to produce safety syringes at high volume for Medisys plc (London). Nypro provides outsourcing services ranging from mould design and development to assembly. Other projects the company has recently completed include insulin pens for Eli Lilly (London), inhalers for Glaxo Wellcome (Greenford, Middx, UK), and contact lens cases for Johnson & Johnson (New Brunswick, NJ, USA).
For more information, contact Nypro Kunststofftechnik GmbH, Sebenter Weg 36, D- 23758 Oldenburg, Germany; phone: +49 4361 490730; fax: +49 4361 4907359; e-mail: information@nypro.com; Internet: http://www.nypro.com.
Spire Corp. Forms Medical Subsidiary
Spire Corp. (Bedford, MA, USA) has completed a corporate restructuring, resulting in the formation of Spire Biomedical Inc. (SBI) in January. SBI applies biotechnology surface engineering to implantable medical devices, primarily in the orthopaedic and cardiovascular markets.
For more information, contact Spire Biomedical Inc., One Patriots Park, Bedford, MA 01730-2396, USA; phone: +1 781 2756000; fax: +1 781 2757470; e-mail: biosales@spirecorp.com; Internet: http://www.spirebiomedical.com.
New German Health Minister Announced
A new German health minister was recently announced. Ulla Schmidt, a teacher and deputy leader of the Social Democratic parliamentary group, took over the position previously held by Andrea Fischer of the Green Party. Schmidt is known in Parliament for her defense of Germany's proposed pension reforms.
For more information, contact Bundesministerium Für Gesundheit, Am Propsthof 78A, D-53121 Bonn, Germany; phone: +49 228 9411170; fax: +49 228 9414919; e-mail: schorn@bmg.bundy.de; Internet: http://www.bmgesundheit.de.
Philips Medical Systems to Acquire Agilent Technologies
Philips Medical Systems (Amsterdam) plans to develop remote diagnosticsincluding automatic external defibrillators and home-care technologywith its acquisition of Agilent Technologies (Geneva). Agilent's patient-monitoring, ultrasound imaging, resuscitation, and information management products and services will augment Philips' current diagnostic imaging systems technologies.
For more information, contact Agilent Technologies Europe, Rue de Veyrot 39, CH-1217 Meyrin 1/Geneva, Switzerland; phone: +41 22 7806111; fax: +41 22 7806542; Internet: http://www.agilent.com.
New PVC Plant Answers Growing Demand
Hydro Polymers doubled its medical compounds capacity with the creation of a new PVC-compounding line in Newton Aycliffe, Co. Durham, UK. The new plant was added to meet an increasing demand for PVC. The compounds comply with a range of specifications and regulatory requirements. Hydro Polymers Ltd. is part of the Petrochemicals Division of Norsk Hydro ASA (Oslo, Norway).
For more information, contact Hydro Polymers Ltd., Newton Aycliffe, Co. Durham DL5 6EA, UK; phone: +44 1325 300555; fax: +44 1325 300215; e-mail: hplenquiries@hydro.com; Internet: http://www. hydropolymers.co.uk.
Scapa Group Grows with Medifix Acquisition
Scapa Group plc (Blackburn, Lancs, UK) finalized an agreement to acquire Medifix Adhesive Products Ltd. (Luton, Beds, UK). Medifixa wound-management product supplierhas two dedicated manufacturing facilities in the UK. Scapa, a medical tapes supplier, hopes to increase its range of products and services, which now covers the areas of wound care, medical device fixation, and transdermal drug-delivery programs. The purchase follows the company's acquisitions of Acutek and Great Lakes Technologies.
For more information, contact Scapa Medical, Ave. Louise 149/24, 1050 Brussels, Belgium; phone: +32 2 5357485; fax: +32 2 5357575; e-mail: appsupport@scapamedical.com; Internet: http://www.scapamedical.com.
BVMed Changes Name to Reflect New Focus
The Federal Association of the Medical Device Industry in Germany (BVMed) has changed its name to the German Medical Technology Association to reflect its broadened scope. The organization, which will continue to use the well-known BVMed abbreviation with its new name, plans to open membership to service providers, not just device manufacturers. According to Manfred Beeres, BVMed's director of communications, the organization hopes to become involved with new technologies in the medical industry. The biotechnology, tissue engineering, and genetic engineering sectors are the newest areas of business for BVMed.
For more information, contact the German Medical Technology Association, Hasengartenstr. 14 c, D-65189 Wiesbaden, Germany; phone: +49 611 9767517; fax: +49 611 719769; e-mail: beeres@bvmed.de; Internet: http://www.bvmed.de/english.htm.
Shows and Conferences
ABHI Conference Surveys Regulatory Climate
The annual Association of British Healthcare Industries conference, to be held on 2728 March in London, will review the current European regulatory environment. Sponsored by the British Medical Devices Agency, the conference includes a review of Notified Bodies, possible reforms of the medical device directives, harmonization developments in Eastern Europe, an IVD directive update, labelling across Europe, products incorporating human tissue, quality systems and standards, and product safety and liability.
For more information, contact IBC Global Conferences Ltd., St. George's House, 195-203 Waterloo Rd., London SE1 8WD, UK; phone: +44 20 74535492; fax: +44 20 76366858; e-mail: cust.serv@informa.com; Internet: http://www.abhi.org.uk
Hannover Fair Showcases Eight Industry Sectors
The Hannover Fair, to be held 2328 April in Hannover, Germany, comprises eight separate trade fairs: factory automation; industrial IT and software; microtechnology; motion, drive, and automation; compressed-air technology and factory equipment and tools; energy; subcontracting technology; and research and technology. The microtechnology fair will highlight micropumps, microfluids, analytics, lab-on-a-chip technology, microreaction systems, and microdosage systems for the life science sector. Over 170 speakers are scheduled to speak on new technologies and trends at the research and technology fair, and the Center of Plastics Technology will display the latest moulding equipment at the subcontracting technology fair.
For more information, contact Deutsche Messe AG, Messegelände, D-30521 Hannover, Germany; phone: +49 511 890; fax: +49 511 8932626; Internet: http://www.hannovermesse.de.
Thousands Expected to Attend Packaging Expo
Pakex 2001 offers an arena to source new suppliers of packaging products and services, as well as information on current packaging industry trends and issues. The primary theme of this year's event is the global packaging supply chain, encompassing all areas from materials to converting to the impact of packaging on the retailer and consumer. More than 30,000 visitors are expected to attend the event, which will be held 26 April in Birmingham, UK.
For more information, contact Reed Exhibition Companies, Oriel House, 26 The Quadrant, Richmond, Surrey TW9 1DL, UK; phone: +44 20 89107910; fax: +44 20 89402171; Internet: http://www.pakex.co.uk.
Pharmaceutical Products Displayed at TechnoPharm
Pharmaceutical raw materials, processing technologies, quality assurance methods, special packaging materials, and laboratory and analytical equipment will be displayed at the TechnoPharm exposition in Nürnberg, Germany. Held on 2729 March, the event is suited for small to midsize companies.
For more information, contact NürnbergMesse GmbH, Messezentrum, D-90471 Nürnberg, Germany; phone: +49 9 1186060; fax: +49 9 118606228; e-mail: info@nuernbergmesse.de; Internet: http://www.nuernbergmesse.de.
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