Surface treatment can be performed to make a medical device more compatible for a specific purpose, to render it antimicrobial, or to protect sensitive parts and electronics from corrosion and signal failure. Whatever your application, here is some sound sourcing advice from suppliers of surface treatment services.
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Be prepared for the unexpected: Find a supplier of surface treatment services that can rapidly move processes from one facility to another in case of a production problem.
(Photo courtesy SPECIALTY COATING SYSTEMS INC.) |
Ensure That the Vendor Can Fulfill Your Real Needs
When you go shopping in the surface treatment and coatings world, it is easy to find yourself in the wrong aisle. “Ask yourself, which properties of my device do I want to improve?” advises Carola Hansen, Ph.D., Product Manager, DSM Biomedical (Geleen, Netherlands). “Focus on the most important main function of your coating. Should it increase lubricity? Should it give antimicrobial properties? Find a company that will help you select a coating that improves the properties of your device along with the best way to apply it,” says Hansen.
“Once a coating material has been selected, customers should also be confident that the supplier is able to meet high-volume production requirements, possibly including daily production and delivery,” says Lonny Wolgemuth, Senior Medical Market Manager, Specialty Coating Systems Inc. (Indianapolis, Indiana, USA). “Along those lines, if a customer requires global production, they should look for a provider that has global locations. Finally, look for a provider that has the ability to move standard manufacturing processes from one facility to another so that you are protected in the case of an unforeseen incident.”
Take Time to Test Your Surface Treatment
An excellent coating will differentiate your device from your competitor’s products. Ask your coating supplier which coating will provide the best competitive advantage for your device, and test your coated product extensively in relation to competitor products.
Be Process Oriented
A robust production process will reduce your total coating costs. Production problems and out-of-spec products can account for huge expenses. “Do not compare only the costs for the coating itself from one supplier to the next,” recommends Hansen. Try to gain insight into the total coating costs, she adds, and use that as your basis of comparison.
Examine Your Provider’s QC Systems
It is important to determine that your vendor’s quality systems are in line with your own internal quality requirements, according to Hansen. “Ask under what quality conditions the coating reagents are prepared and decide if they are in line with your requirements.”
Because of their sensitive and delicate nature, medical devices often must be coated in a clean environment. “For that reason, customers should also evaluate providers based on their clean room capabilities,” Wolgemuth adds. “It is important to look at the providers’ cleanroom capacity to ensure it can handle production volumes, the standard of cleanliness claimed, and any certifications maintained for the clean room to ensure that cleanliness.”
Don’t Neglect Regulatory Compliance Issues
Medical device customers should evaluate US providers based on the content maintained in their device and drug master files, and European and Asia/Pacific providers based on similar data files. “Providers that have comprehensive testing results [on file] can authorise coating customers to reference the content of those files in their submissions, saving the customer valuable time and money,” Wolgemuth says.