MEDTEC 99 PREVIEW
MEDTEC Exhibition and Conference
Welcome to the Shows
Perhaps you're looking for a supplier of raw materials or tubing. Well, you could attend Interplas or Fakuma in the fall. Or maybe your production equipment is beginning to show its age. No problem; just pencil in a day or two at Manufacturing Week. Need a vendor that can perform precision machining? You'll always have Paris and Midest.
There is a show for virtually every industry, and attending these events can turn into a full-time job if you're not careful. Meanwhile, as you snake up and down the aisles trying to identify suppliers with an understanding of the device industry's unique demands, real work is piling up on your desk. There is a better way to do your sourcing.
MEDTEC was designed to provide Europe's device OEMs with a convenient single event for their product, service, equipment, and informational needs. Now in its third year, this annual event is really several shows under one roof, where the common thread is not a product or service category, but the ability of the exhibitors to meet the exacting standards of a highly regulated industry. MEDTEC organizers have done the legwork of finding qualified potential partners so that you can concentrate on what really matters: specifying parts or materials and negotiating costs and delivery times.
Similarly, the two-day conference is tightly focused on those issues that have a direct impact on medical device professionals. Whether the topic is innovations in material science or the Y2K bug, recognized industry experts will ensure that the discussions zero in on those aspects of particular relevance to the device industry. Attendees will also benefit from the synergy engendered by a colocated exhibition and conference, where the exchange of ideas continues on the show floor as assertions are put to the test and alternatives are investigated.
EMDM's show preview section includes conference highlights, product profiles, and exhibitor news, but space restrictions permit us to provide only partial coverage of the abundant resources available at MEDTEC. For comprehensive up-to-the-minute information on MEDTEC 99, go to our Web site. Or contact MEDTEC at P.O. Box 12997, London NW5 2WX, UK; phone: +44 171 485 4343; fax: +44 171 267 2788; e-mail: medtecshow@timeworks.co.uk.
MEDTEC 99 will take place 21–23 September at the RAI International Exhibition and Congress Centre in Amsterdam. The event is organized by Canon Communications llc and is sponsored by European Medical Device Manufacturer.
Material Issues
Heightened interest in PVC, latex replacement materials
To a patient, a warning label on a medical device is off-putting, to say the least. In the United States, latex-containing devices are required to carry such a label, and since 30 June, US FDA requires that packaging containing natural latex bear a similar disclaimer. Most industry experts agree that it is only a matter of time until similar legislation is passed in Europe. So it's not surprising that manufacturers are eager to learn about developments in substitute materials. MEDTEC attendees will have several opportunities to investigate latex-free materials at a dedicated conference session and on the exhibition floor.
The recent FDA requirement has had a chilling effect on device manufacturers using cold-seal packaging, which traditionally employs natural latex. According to John Merritt, global product director at Rexam Medical Packaging who will present a paper on cold-seal packaging, manufacturers have three options. They can add the warning label, which entails redesign and printing expenses and may adversely affect market perception. They can convert to a heat-seal system, but that comes at a significant cost. Or they can switch to a latex-free cold-seal material. Several compounds are suitable candidates, he notes, but determining the proper blend for a given application will require intensive research and development.
Several packaging suppliers, including Oliver Products Co., Perfecseal, and Tolas Healthcare Packaging, will be happy to continue the debate with attendees on the show floor.
Makers of disposables will be displaying a variety of latex-free products at MEDTEC, as well. B. Braun Medical, which has introduced a line of latex-free check valves, reports that, when tested against standard latex, its substitute material offers superior performance while eliminating the risk of latex-sensitive reactions at the injection site. Netherlands-based International Medical Products B.V. has developed an aqueous-based polyurethane that, according to product manager Harry te Winkel, has roughly the same characteristics as latex. It is currently used to make protective covers for ultrasound transducers and may have an application in the manufacture of catheter balloons.
Polyvinyl chloride has also been getting its share of headlines. Denmark recently introduced an action plan that aims to reduce and phase out the use of phthalates, and some experts suggest that it is only a matter of time until PVC prohibition spreads to other countries. One potential alternative material—a blend resin produced from a thermoplastic rubber called Hybrar and polypropylene—will be presented by Ronald Foster, director of market development for Kuraray America Inc. He will discuss the properties and characteristics of this material, which is reported to be a viable alternative to flexible vinyl compounds used in such medical applications as bags and tubing.
Sessions Chart Regulatory Landscape
Tougher US FDA foreign inspections, notified bodies on the agenda
According to a recent telephone survey of MEDTEC 98 visitors, European and US regulations remain the most important issues confronting device manufacturers in 1999. To arm attendees with up-to-the-minute information on regulatory affairs around the globe, MEDTEC organizers have invited key industry experts to present papers on such topics as US FDA foreign inspection procedures, the similarities and differences in ISO and US FDA quality system requirements, and recent developments in the product approval process.
European device manufacturers that market products in the United States should plan to attend a session devoted to US FDA foreign site inspections, which may undergo some changes. Notably, companies may face an automatic detention if they do not make a good faith effort to allow auditors to inspect their facilities, Arvin Schroff, deputy director of the agency's office of enforcement, recently announced. Ongoing efforts aimed at establishing a level playing field for all manufacturers will be explored at another session devoted to the always-volatile issue of the relationship between notified bodies and device manufacturers.
Moulding Applications Explored at MEDTEC
Cleanroom injection moulding . . . in theory and in practice
The essential requirements of the Medical Devices Directive state that products must be manufactured in areas where the presence of microbiological and particulate contaminants is controlled. The challenges of injection moulding under cleanroom conditions will be underscored by Dr.-Ing. Erwin Bürkle, R&D director at Krauss-Maffei Kunststofftechnik GmbH, during a conference session.
The costs associated with installing an environmentally controlled area can be substantial. Companies can achieve significant savings, however, by carefully examining their needs and by establishing a multidisciplinary project team up front, says Bürkle. In addition to the moulder and a cleanroom specialist, the team should include machinery experts, mould makers, and material suppliers, he expains. Start your planning by focusing on your product specs, he adds, and you will increase the odds of achieving satisfactory and cost-effective results.
Because they generate less heat and release fewer contaminants than conventional machines, electric moulders have been touted as the equipment of choice for cleanroom applications. But electric machine technology has other benefits for medical moulding applications, according to Kent Royer of Cincinnati Milacron, who will be presenting a paper on this topic at MEDTEC.
Electric moulding equipment is able to operate in a Class 10,000 cleanroom without requiring any special modifications, says Royer, and it achieves fast cycle times as well as energy economies. Royer also notes that electric machines are well suited for micromoulding applications, and he predicts that future designs will further refine this capability.
For a better understanding of micromoulding technology, attendees will want to stop by the Battenfeld stand to learn about the company's Microsystem 50/2 SE. Equipped with a cleanroom enclosure, the system is suited for the production of parts weighing less than 0.1 g. It has been used to mould an implantable polycarbonate sensor housing weighing 0.002 g.
Not only are product components getting smaller, so are production machines. Exhibitor MCP Equipment (Stone, Staffs, UK) will be showing its line of benchtop moulding systems, including moulders suited for processing liquid silicone rubber, that are very popular with device manufacturers.
Many device OEMs prefer to outsource their moulding jobs. To demonstrate its moulding expertise in a controlled environment, Netherlands-based AKF/AKG Industrie B.V. (Naarden) will operate a cleanroom moulding installation on the show floor. The firm has teamed up with partner companies Arburg The Netherlands B.V., which supplies the machinery, and D.B.U. Industrietechniek B.V., specializing in cleanroom construction, for this demonstration.
