SPECIAL REPORT ON AUTOMATION
AUTOMATING DEVICE MANUFACTURE BENEFITS MORE THAN THE BOTTOM LINE
To optimize gains in productivity, manufacturers are advised to research automation options during the early stages of product design.
Mark Moylan
Automating the manufacture of medical devices offers three distinct advantages, according to Henk Bakker, president of Colpitt B.V. (Zandvoort, Netherlands), a supplier of automation equipment for the fabrication of medical bags. "First, the manufacturing process is cleaner because there is less likelihood of in-process operator contamination. Second, quality is improved because manufacture is not subject to operator error. And third, the overall output speed is higher."
Gains in hygiene, repeatability, and productivity may be among the benefits of automated systems, but for many manufacturers researching process automation, the impetus comes from bottom-line considerations. Automation is unquestionably a remedy for rising labour costs in the long term, but it often requires a far more substantial outlay in the short term than manufacturers anticipate.
Sticker shock is common among manufacturers researching automation, says Lawrence Davie, managing director of Arthur G. Russell UK Ltd. (Arbroath, Angus, UK), makers of high-speed feed systems. "People are not used to the costs," he says. "They want low production costs, but they are sometimes surprised by the initial capital investment."
Cutting Corners May Slow Productivity
To reduce costs, automation engineers may request changes in product design to optimize production processes and meet a client's productivity demands. Bakker tells of one project that involved the installation of an automation system to produce a medical bag with rounded corners. It was determined that overall production speed could be increased by keeping the corners square, thus eliminating a step in the automation process and reducing waste. The design change was incorporated and the output time specified by the customer was respected. "Most of the time, altering the product is not a problem," says Bakker, who adds that a close working relationship between the marketing and manufacturing departments can be a big help in achieving satisfactory results in a timely manner.
"Key to a successful automation strategy," says Martin Bonensteffen of Sortimat Automations GmbH (Winnenden, Germany), "is to initiate discussions with the equipment manufacturer as early as possible in the design phase of a new product." Sortimat will draw up know-how confidentiality agreements, adds Bonensteffen, which enables potential customers to enter into a feasibility study with Sortimat in total confidence. "When it's a major project, we will conduct the feasibility study with the understanding that the customer may eventually contract with someone else," says Bonensteffen. Of course, Sortimat's goal is to see the project through to fruition, and that is what generally happens.
Sortimat has designed, built, and installed automation systems for a number of global medical device companies such as Becton Dickinson. In September, it was announced that Sortimat would supply an automated assembly system to NMT Group plc (Livingston, UK), which has developed the Zero-Stik safety syringe. Production of the 3-ml syringe is scheduled to begin by the end of 1998.
Standard Parts, Custom Solutions
Manufacturers of automated machines rely heavily on standard parts in the design and construction of their lines. It's common practice among equipment manufacturers to customize standard machines to meet a client's specific needs. "We will modify existing machines in order to use fewer raw materials or to accommodate a change in product design," says Sandra Cappelle of Bader & Partner Medizintechnik GmbH (Neumünster, Germany), a supplier of turnkey systems for the manufacture of medical disposables. Sortimat and Colpitt only build custom equipment, but they also make an effort to use standard components whenever possible to minimize maintenance of the system throughout its lifetime. Less design work also means faster delivery times, adds Henk.
Automated manufacturing can generate substantial gains in productivity. For example, Kahle Europea S.p.A. (Caravaggio, BG, Italy), a maker of assembly systems for needles, syringes, and catheters, manufactures a machine that attains speeds of 600 syringes per minute. "FDA and CE requirements are met at manufacture," says Kahle president Julie Logothetis. "Successful automation relies on the feed system," she notes, adding that Kahle offers feeders as part of its line. She cites, as an example, a catheter assembly system supplied by Kahle that requires four integrated units to complete the process. A continuous and reliable feed of components is critical to the system's performance and, ultimately, the manufacture of a quality product. Sortimat also builds feed systems in-house because, says Bonensteffen, "any problems that may arise can be dealt with that much quicker."
A changing marketplace as well as evolving materials are also fueling the drive to automate among manufacturers. Dave Carlberg, president of Kinematic Automation (Twain Harte, CA, USA), a supplier of manufacturing systems for the test-strip industry, cites the proliferation of take-home pregnancy and blood-glucose tests as examples. "Diagnostics is expanding," he says, "and the goal in manufacturing is to reduce labor and increase quality. Automating production enables product consistency to go up."
Setup Times Vary
The amount of time required to set up an automated line varies from manufacturer to manufacturer, but for special fast-speed units, it can take anywhere from 12 to 18 months after the initial contact with the equipment manufacturer. "We deliver our standard machine in 4 months," says Logothetis, but customers should expect a 12-month wait for specialized equipment, she adds. "Sortimat's order-to-delivery time is between 6 and 14 months, "but it depends greatly on the size of the project, how much is specified, and whether we will be involved in product development," says Bonensteffen. Bader & Partner require at least 8 to 10 months, while Colpitt's delivery time varies from 3 months to 1 year, depending on the complexity of the project.
Automating device manufacture enhances quality, improves reliability, and increases production speed. While the initial investment may send some manufacturers reeling, the expense can be necessary to remain competitive in certain market sectors, particularly if the production plant is located in a region where labor costs are high. In addition to setup costs, changes in product design may be needed to meet production requirements.
Manufacturers considering the acquisition of automated systems would be best served to weigh their options in the company of capital-goods suppliers that have experience dealing with medical device manufacturingrelated issues. Equally important, they should begin discussions while product design is still in its infancy. An understanding of the overall automation process will help to ensure that everything runs smoothly and efficiently from concept to completion.
