TESTING EQUIPMENT
 |
When the workpiece is a precision medical device, it’s important to use the right measurement device for the job.
(Photo courtesy OPTICAL GAGING PRODUCTS) |
Understand Your Requirements
“This may seem obvious, but many medical device suppliers are so focused on developing new products and meeting time to market requirements that they do not give enough thought to quality processes,” says James Ritchey, Director of Medical Devices and Biomaterials Markets at Instron (High Wycombe, UK).
Flexibility Is Not Always the Answer
“Fundamentally, you must be sure to choose the right system for the job at hand.” says Toby Kemp, Market Manager, Dynamic Systems at Instron. There may be pressure to opt for flexible systems to meet a variety of medical device tests, he says, but laboratories should specify testing equipment that offers the appropriate level of accuracy for specific testing applications.
Find a system that can accommodate the specific measurement requirements of your application, says Tad Davis, International Technical Specialist at Optical Gaging Products (Rochester, New York, USA). “For instance, a through-the-lens laser can measure the shapes of surface contours, and a touch trigger probe can access areas on parts not easily measured by video or laser.”
Consider Accuracy and Throughput
Davis also suggests using multisensor technologies to provide testing data at the appropriate resolution and accuracy. “Modern medical devices must meet critical design tolerances,” he explains. “Automatically performing measurements with multisensor metrology systems can meet both the necessary accuracy and throughput requirements that manufacturers need,” he adds. “Automated measurement routines that use several sensors, some of which may be [engaged] without user involvement, can improve overall process efficiency,” Davis notes.
Quality Is an Investment
One of the first steps in establishing a solid testing process is selecting a reliable and robust supplier ofcalibration services, Ritchey says. He suggests looking for appropriate certifications. “Many test instruments in the medical device industry require specialised treatment and approaches for their maintenance and calibrations,” he adds. “Shortcuts in this area can have catastrophic ramifications.”
The Importance of Durability
Time to market is crucial for makers of implantable devices and fatigue durability testing sets the pace, says Scott Anderson, Director of Cardiovascular Products at Bose Corp. (Framingham, Massachusetts, USA). “The implantable medical device maker needs to choose a fatigue test instrument that has proven durability for billions of cycles without maintenance and has the frequency and displacement capabilities to minimise the duration of the test,” Anderson says. “This combination of performance and durability testing is critical because when it comes to time to market, each day saved could be worth hundreds of thousands to millions of euro in revenue,” he adds.
