Medical Device Link.

Originally Published EMDM May 2003

Showstoppers

A selection of innovative new products and services exhibited at Medical Design & Manufacturing (MD&M) West (Anaheim, CA, USA), Design and Manufacturing (Chicago), and MEDTEC (Stuttgart, Germany)

Manufacturing equipment
Laser supplier introduces twin-rod upgrades

Successfully introduced with a line of drilling lasers, twin-rod (TR) technology is now available to upgrade a company’s entire JK series welding lasers. Developed by GSI Lumonics (Rugby, Warks, UK), the twin-rod oscillator design combines high beam quality with a compact laser head. Benefits include a smaller focal-spot size, greater working distances, and enhanced processing capabilities, according to Andrew Dodd, a member of the company’s North American sales team. The technology was presented to medical device OEMs at the February MD&M West show in Anaheim, CA, USA.

“This is truly a new development for welding applications,” says Dodd. “It was driven by customer requests for welding solutions in ever-smaller components. The upgrade enables users to increase power in their existing units by about 20%,” he says. The retrofitting process is extremely easy, he adds.

The TR upgrade includes a replacement laser head, power supply adapter heads, a single-fibre input module, a focus head with 160- or 200-mm recollimation, a focus lens, and a 15-m Luminator fibre-optic cable. The small-diameter cable does not require alignment following changeovers, and a proprietary coupling technology provides back-reflection protection during the welding of highly reflective materials.

The company also presented its JK700TR pulsed Nd:YAG lasers at the event. The systems, which integrate TR technology, are suited for a variety of medical welding, drilling, and cutting applications.


Metal fabrication
Company presents contract stent- manufacturing services

Citing growing demand from OEMs for bare coronary stents and premounted stent delivery systems, Fortimedix (Nuth, Netherlands) highlighted its manufacturing capabilities at the recent MEDTEC exhibition and conference in Stuttgart, Germany.

“We have been producing custom stents for OEM customers for three years,” says sales and marketing manager Henk Meens. “The current demand is for products with enhanced flexibility. Direct stenting is also very popular,” he adds. Fortimedix has invested in state-of-the-art design and development capabilities to better serve its existing and potential clients, notes Meens, and it also provides CE marking services. The firm has the capacity to produce up to 50,000 units per year.

The Kaon bare coronary stent, which was introduced at MEDTEC, features reinforced end crowns with struts that are wider than the stent’s body to ease implantation and visibility under fluoroscopy. The company’s proprietary polishing technology ensures a compliant and uniform surface finish. The bare stents are available in lengths from 9 to 33 mm. The coronary stent delivery systems have the same features and are designed to balance desirable delivery properties with postexpansion performance. Stent lengths of 9, 12, 15, 18, 22, and 28 mm are available mounted on a semicompliant stent delivery catheter.

“These are the first in a range of products that we will be introducing this year,” says Meens. The company is currently developing nickel titanium and cobalt chromium stents that will also be made available to OEM customers.


Printing equipment
Flexibility is designed into thermal-transfer system 

A thermal-transfer system prints text, graphics, bar codes, expiry dates, and other variables directly onto a variety of packaging materials. The DP Futuro from Bein Pack & Print (Langen bei Bregenz, Austria) offers crisp 300-dpi resolution printing in print lengths up to 630 mm. The product was presented to medical device OEMs at the recent MEDTEC show in Stuttgart, Germany.

The DP Futuro is well suited for use in the medical device sector and, indeed, all regulated industries, according to company director Helmut Bein. “Regulatory requirements state that you must use or otherwise account for any preprinted stock,” says Bein, “so it makes a lot of sense to print as needed directly onto packaging materials.” The unit’s short preparation times, its traceability features, and the ability to incorporate changes instantly should also interest device OEMs, notes Bein.

The printer can be integrated into vertical or horizontal packaging systems. An automatic ribbon-saving option can minimize print costs even when the unit is operating at maximum capacity, adds Bein.

Software
MES expedites manufacturing processes

A developer of enterprise management execution systems (MESs) introduced a new MES solution at the MD&M West show in Anaheim, CA, USA. The InSite Medical Device Edition software from Camstar (Campbell, CA, USA) enables medical device manufacturers to improve production quality, reduce regulatory risks, increase yields, and accelerate time to market by streamlining manufacturing processes.

“Everything becomes easier in a digital infrastructure,” says vice president of business development Robert Rudder. “This software is created for a world that requires that anybody can be anywhere and still have access to the system.” The software is fueled by the company’s proprietary MES engine, which manages real-time production information and processes. The technology framework maintains operational efficiency and supply-chain optimization, and reduces the cost of regulatory compliance.

The Web-based system offers several features that are critical to medical device manufacturers. InSite Electronic Signature and Records ensures full compliance with FDA’s 21 CFR Part 11 by providing strong security access, an automated audit trail, fraud detection, data retention and archiving, and unique user names and passwords. The software’s Paperless DHR automatically creates device history records for each manufactured item, including materials consumed, processes utilized, and electronic signature collection. InSite Corrective and Preventative Action (CAPA) identifies and tracks quality issues, issue resolutions, workflow management, and CAPA action implementation. InSite Operator Certification ensures that employee training and certification processes can be modeled, managed, tracked, and enforced in real time.

“User groups with different functions can have visibility of orders and quality data across different manufacturing plants,” Rudder explains. “Data move fast, and issues are resolved in a timely fashion.” The software distributes the product specifications, which guarantees compliance with new process changes. Manufacturing processes are synchronized because data are seamlessly transferred between manufacturing sites, OEMs, suppliers, and customers. “The multilingual software solution reduces variability and improves traceability,” Rudder says.

Company seals deal on show floor

A four-side-seal packaging machine on display at MEDTEC 2003 in Stuttgart, Germany, truly earned its showstopper status. The 4SS Model 400 designed for high-speed custom medical packaging applications not only drew a crowd to the stand of Doyen Medipharm Ltd. (Barton, Cambs, UK) but it attracted a buyer, as well. During the show, the company sold the machine it was exhibiting to Flexible Medical Packaging Ltd., a supplier of device and pharmaceutical contract packaging services based in Lancaster, UK.

The 4SS Model 400 attains 50 m/min heat-seal speeds and can process up to 400 packs per minute. Product changeover can be accomplished in less than 10 minutes, and the machine’s patented design ensures control of all validated sealing parameters. Delivered fully validated with all relevant documentation, it is suited for packaging a wide range of products including wound-care and diagnostic devices, drapes, surgical gloves, sutures, and catheters.

The company also recently introduced a free on-line German-language seminar devoted to the validation of packaging equipment. The seminar at www.doyenmedipharm.com shows medical device manufacturers how to write and implement an internal validation plan. Combining pictures, text, animation, and an audio commentary, the presentation explains how to generate planned maintenance and SOPs within the validation framework and establish compliance with US FDA regulations.

Electronic components
Linear encoders offer high tolerance to contamination

Manufacturers of positioning and fibre stages, as well as those requiring very small measurement components, may be interested in a new line of miniature incremental exposed linear encoders. The LIF 400 series was showcased by Heidenhain (Schaumburg, IL, USA) at the Design and Manufacturing Show in Chicago. With travel up to 1 m, the encoders maintain a long-wave accuracy grade of ±3 µm, and are suitable for installations with limited space as well as those with large mounting-tolerance requirements.

The series features a new type of grating called Supradur. This grating style offers an unusually high tolerance to contamination such as oil, dust, and fingerprints, owing to the precisely measured layers of glass and reflective material. This configuration prevents contaminants from interfering with the light-based, noncontact scanning principle.

Other features include optical limit switches that allow the user to place limits anywhere directly on the scale. This also enables the scale to be mounted closer to a motor than scales with magnetic switches. Additionally, the scale has a separate homing track with an integrated reference mark, allowing the encoders to differentiate on which side of the reference mark the scanning unit is located.

Manufacturing equipment
Bar code scanners designed for clinical instruments

Specifically designed for integration into clinical analyzers and related instruments, a line of bar code scanners meets demanding space and budgetary requirements without compromising performance. The MS-3 series was introduced to medical device OEMs by Microscan (Renton, WA, USA) at MD&M West in Anaheim, CA, USA.

The readers are available in laser scanner, CCD scanner, and stand-alone CCD scan-engine versions in a 1.75 ¥ 0.85-in. package. A large scan width and >70° scan angle enable the MS-3 laser scanners to read bar codes on test tubes, reagent packs, and microtitre plates within a distance of 1.5 in. Throughput attains 1000 operations per second.
Weighing a scant 2.5 oz, the MS-3 laser and CCD readers can be easily mounted onto robotic equipment. The scanners can also be embedded into instruments, machinery, or other applications that require a small, fast, and reliable bar code reader.

The company also presented its Quadrus EZ smart camera to MD&M attendees. Reading standard linear bar codes as well as RSS and composite symbology and Datamatrix codes, the product can help manufacturers comply with regulatory requirements related to product labeling. Quadrus EZ has the capability to read multiple code types on a variety of products on the same production line with the same bar code reader, according to the firm.

Production equipment
Conveyor platforms available in standard and custom lengths 

Designed for reliable operation with minimal service requirements, a line of conveyor platforms provide efficient parts transfer for small material-handling applications. Featured by Dorner (Hartland, WI, USA) at the Design and Manufacturing Show in Chicago, the Series 2200 platforms include sealed bearings with a unibody aluminum frame for maximum strength and dependability, an optional V-guide belt-track system that keeps the belt in place, and rack-and-pinion tensioning for quick belt changing. The conveyors are available in flat-belt end-drive, centre-drive, and cleated-belt models in widths from 2 to 24 in., and standard lengths from 2 to 24 ft. Custom lengths in 1/8-in. increments are offered without additional production or shipping time. 

Metal components
Articulated stands permit unrestricted mobility

Offering simple, quick, and precise positioning, articulated stands with a proprietary clamping mechanism are suited for use in medical and laboratory settings. The Fisso Articulated Arm units afford greater freedom of movement than the human arm and can be easily fastened in any orientation. Baitella AG (Zurich, Switzerland) exhibited the product line at MEDTEC 2003 in Stuttgart, Germany.

Achieving a radius of movement ranging from 130 to 1000 mm, the stands are equipped with a mechanical central clamping mechanism that is virtually maintenance free. The device does not rely on pneumatic technology, nor does it require the use of hydraulic oil: precise movement is produced by means of a ball-and-socket joint. Articulated stands have been integrated into surgical suites and intensive-care units and are typically used during anaesthesia procedures; the company supplies a stand designed to hold respiratory tubing of various sizes.

Motors
Supplier launches on-line forum

A new on-line service designed to provide engineers with up-to-date technical product information was introduced by Baldor (Fort Smith, AZ, USA) at the Design and Manufacturing Show in Chicago. The new feature, called ProSpec, can be accessed at the company’s Web site, www.BaldorProSPEC.com. Engineers and buyers can go to the Web site, log on, and register to access a clearinghouse of information about motors and motion control products. Once there, they can use the “Ask the Engineer” feature to pose technical or general questions to Baldor engineers. 

“ProSpec provides engineers who are buying or specifying a product with a place to go when they need fast and accurate technical product information,” says Kevin Dunn, ProSpec team leader. “ProSpec is about building relationships with specifying engineers who may not have a purchase order on their desk right now, but have a need for information and advice on an application or a project that they are putting their name and reputation on,” says Dunn.

Other features include access to up-to-date product specifications, performance data, wiring diagrams, noise and vibration data, technical manuals, and drawing downloads. Computer-based tutorials, white papers, and registration to on-site workshops will also be available.

Copyright ©2003 European Medical Device Manufacturer