Originally Published EMDM January 2006
Medtec 2006 Preview
The Future of Automated Production
Brian Buntz
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Modularity is a key design element of assembly equipment from sortimat Technology. The company’s flexible systems enable manufacturers to adapt quickly to changing market requirements. |
As medical device OEMs face growing pressure to contain costs, many of them turn to automation. Depending on the application, it can boost throughput and introduce cost-efficiencies. Because of its traceability and accuracy, automation can be a necessity for assembling medical devices with exceptionally small parts that need to be precisely positioned. Whether it is for competitive reasons or because the assembly process itself demands it, automation is destined to play a key role in medical device manufacturing. For that reason, MEDTEC will include an assembly and automation pavilion at the 2006 event in Stuttgart, Germany. EMDM spoke with some of the exhibitors to find out what makers of automation systems are doing to help medical technology OEMs meet the challenges of the future.
A Modular Approach
“Automation processes are more sophisticated because medical devices are becoming more complicated,” says Julie Logothetis of Kahle Automation (Summit, NJ, USA). “The industry is changing to keep up.” Her company has addressed industry’s need for flexibility with a high-speed syringe-assembly machine. The machine can be tailored to assemble standard three- and four-part syringes and safety syringes. Kahle’s technology for the continuous-motion dispensing of fluid within the syringe barrel is combined with torque-controlled assembly of the luer-lock needle. The equipment can be built to handle syringes of any size, and attains assembly speeds ranging from 300 to 700 parts per minute.
The automation sector is adjusting to strict regulatory demands and varying consumer needs by adopting a modular approach. “Assembly machines should be modifiable,” explains Silke Fischer at sortimat Technology GmbH & Co. (Winnenden, Germany). “For instance, manufacturers often need to make partially automated systems fully automatic, and convert low-output systems to high output.” Sortimat’s Jetwing assembly platform can be adapted to product-specific assembly lines to meet changing market requirements. The platform concept enables assembly lines to be built from standard and variable production modules, decreasing installation time compared with other systems. For further flexibility, the company offers a variety of add-ons, such as machine vision, laser marking, and welding units.
ATS Automation (Munich, Germany) also uses a modular approach based on standard platforms. “The modules can be retrofitted and reused for the next generation of a product line,” explains Steve Hoenig, sales manager at the company’s US plant in Ohio. “We are constantly adapting our existing automation technology products to new applications for the healthcare sector,” he adds. “Recently, we introduced FlexsysPak, a packaging system based on the SuperTrak high-speed, servo-driven pallet conveyor.”
FlexsysPak is suitable for a variety of tasks including kitting, assembly, dispensing, and packaging. It can be scaled or configured to fit a variety of packaging process modules. Unlike conventional chain- or belt-driven conveyors, it has a configurable pallet conveyor that can run continuous and indexed operations simultaneously. Third-party process modules can be integrated into and synchronized with the pallet conveyor. Pallet programmability also enables the system to handle various pallets and products. Integrated tracking of pallets allows unique station routings to be programmed for each product.
Another example of designed-in flexibility is epitomized by the Ismeline system from Ismeca Automation (La Chaux-de-Fonds, Switzerland). The Ismeline is described as an easy-to-maintain and cleanroom-compatible platform for automatic assembly. Modular construction enables tooling integration on both sides of its chassis. Based on 1-m-long sections, the chassis can be constructed in 2-, 3-, or 4-m configurations with 100-, 200-, or 400-mm index pitches. Fixtures benefit from a “three-sides-open” design and are accurately positioned at all times via a cam-based indexing system. Stations can be installed either inside or outside the fixture path. An extensive range of standard units for assembly or process operations can be mounted at prelocated interface points on the chassis. Fully synchronized cam-drive and cycle rates below 1 second make the platform suited to high-output assembly operations.
The Importance of Automated Testing
To satisfy rigorous safety demands, automated testing has been widely integrated into the production of medical devices. “Medical device automation requires more attention to documentation and adherence to norms than many other industries,” says Erik Poulsen, Ismeca Automation director of sales and marketing. And for good reason: for recipients of devices such as pacemakers, thorough mistake proofing combined with sound design can mean the difference between life and death. Poulsen explains, “If for some reason a medical device fails to be tested and verified during an automated manufacturing operation, it should result in a critical alarm. The suspect device will be either destroyed or returned to the test cycle,” adds Poulsen. “The responsibility of correct manufacture falls on the operator, who must act correctly according to procedures,” he adds. “Because no one wants inefficient paper-based documentation anymore, the manufacturing process is documented with an electronic signature.”
The merging of testing and assembly operations dates back to Toyota’s industrial engineer Shigeo Shingo’s concept of poka yoke—Japanese for mistake proofing. Shingo’s system requires complete testing of all components both before and after assembly. Originally applied to assembly line construction in 1961, this form of mistake proofing is now used throughout the automation industry to eliminate defects through prevention and detection.
Dealing extensively with validation and electronic signatures, automated manufacturing regulations are increasingly demanding. “Integrating validation into automation is not difficult, but it is time-consuming,” Kahle’s Logothetis explains. “Establishing a good relationship with an automation vendor is the key to successfully integrating validation into a project,” she says. “The specifications outlined by the quality system regulation contained in 21 CFR Part 820 must be fulfilled by the medical device manufacturers,” says Logothetis. “But as an automation partner, Kahle helps its customers fulfill requirements by supplying validation documentation and test procedures.”
Also important are GAMP 4 (the latest version of Good Automated Manufacturing Practices) and 21 CFR Part 11. The most broadly used international guideline for computer system validation in the healthcare industry, GAMP 4 goes beyond mistake proofing of assembly by applying validation to the product’s entire life cycle. 21 CFR Part 11 concerns regulation of electronic records and signatures for systems delivered to the United States. Complying with the guideline is a multifaceted effort, requiring a company to establish an audit trail and user-administration documentation.
“Automation in the medical device industry is just at the beginning of a growth cycle,” says Hoenig. “The trend in the automotive industry is to send manufacturing operations to Asia and Mexico. Because of the stringent demands of regulatory bodies and the need to protect intellectual property, most medical device manufacture remains in the country of final sale,” he adds. “Additionally, the need to cut costs in the manufacturing environments of the West creates further incentive to automate.”
Despite the economical potential of automation, European companies outsourced 21% of product assembly in 2000. If left to continue at the present rate, that number will reach 40% by 2007, according to EUPASS, a consortium comprising 21 industrial and academic partners in nine countries dedicated to maintaining a European base of precision assembly services (see accompanying sidebar, page 42). One possible solution is that the growing field of precision microassembly will buck the outsourcing trend. As medical technology becomes more intricate, keeping manufacture on the continent may become simpler.
Copyright ©2006 European Medical Device Manufacturer
