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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.

Key Considerations

A quality hydrophilic coating provider, like Biocoat, will help you address:

What is the overall goal of the device (i.e., guidewire, catheter, stent, coil, IOL cartridge)?

What substrate material(s) are being used?

What type of curing, thermal or UV, best suits my device?

What are the critical performance criteria for the coating?

How long is the device’s in-body dwelling time?

Is the substrate heat sensitive?

What type of sterilization method is anticipated?

Will the device be coated at your facility or will you require contract coating services?

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.

Tell us about your project and our team will respond within two business days.

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