TUBING
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Don’t be shy in demanding that your tubing supplier understand the technical requirements of your company’s medical devices.
(Photo courtesy MICROSPEC) |
Know Your Manufacturer
“It is important to do your homework,” says Roger Danielsson, Director of Quality Assurance, Optinova AB (Godby, Finland). “To learn about the supplier, you should make a visit to their manufacturing facility and meet the people involved,” he recommends. John Stover, Director of Product Management from NewAge Industries Inc. (Southampton, Pennsylvania, USA) agrees on the importance of researching tubing manufacturers. “There are many resellers of tubing in the market place, some of which position themselves as manufacturers,” he explains. “Since you really want to know how the tubing is processed and what controls are in place to ensure the quality of the final product, knowing the actual manufacturer is an obvious necessity,” Stover says.
Look for Technical Depth and Innovation
Kathy Hess, Site Manager at Creganna (Marlborough, Massachusetts, USA), stresses the importance of a tubing supplier’s technical background. “You should be confident that your extrusion partner has the technical expertise necessary to advise you on topics such as material selection, downstream processing, potential design or processing trade-offs, as well as validation and manufacturing strategies,” she says. Danielsson recommends looking for a supplier with a thorough understanding of statistical techniques such as statistical process control.
“You should look for a company that thoroughly understands extrusion process design,” suggests Tim Steele, Chairman and Chief Technology Officer of Microspec Corp. (Peterborough, New Hampshire, USA). As extrusion systems become more sophisticated, suppliers can produce increasingly complex extruded components. Smart process design supports high quality, functionality and simple device assembly, he explains. Steele also points out that a tubing supplier should be agile enough to adapt to the quickly changing demands of the device industry.
Verify Quality Control Procedures
“Check that the manufacturing facility follows good manufacturing practices,” Stover advises. To ensure consistent product quality, he suggests verifying that the manufacturing parameters, procedures and practices consistently follow properly documented work instructions.
Get Notified
Stover suggests that medical device companies have an agreement in place with tubing manufacturers stating that they will be notified in advance any time a material or manufacturing equipment change is going to take place. “This facilitates a risk assessment that will help you determine how that change might affect your device,” he says.
“It is also important to make sure tubing is made from a raw material that has full lot traceability all the way back to the resin ingredient manufacturers,” Stover says.
Communicate Your Requirements
A good supplier engages its technical staff with its clients, Steele says. “Device manufacturers can help out tubing companies by making their requirements and inspection methods clear from the start,” he says.
“Involve the tubing supplier early on,” recommends Danielsson. “That can save a lot of money in the long run.”
Hess recommends being aware of specifications such as OD, ID, length, the number of lumens and tapering tolerance expectations. “You also should have an understanding of expectations for compatibility with downstream processing,” she adds.
