Timing Guidelines for Testing Hydrophilic Coatings
Often device manufacturers save the selection and testing of hydrophilic coatings for last. Don’t! The coating is a core component of the device design and often one size does not fit all.
What is the overall goal of the device (i.e., guidewire, catheter, stent, coil, IOL cartridge)?
How long is the device’s in-body dwelling time?
Is the substrate heat sensitive?
Recommendations for Sourcing Hydrophilic Coatings
1. Don’t wait to start coating feasibility testing as the last step prior to regulatory approval.
Ideally the coating vendor selection and testing should begin much earlier in the development cycle.
2. Coating machine sourcing, testing and customization will take time to identify, select, build and perform IQ, OQ and PQ testing.
Contract coating services can often significantly reduce the time required since the testing process will be built using the vendors internal systems.
3. Devices with coatings must go through Verification and Validation, as per Design Controls,
so don’t forget to build in these timelines when planning for regulatory submission.
Learn how Biocoat’s testing program can help identify the best hydrophilic coating to maximize your device’s effectiveness.
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