Abstract:
Lubricious, hydrophilic coatings on cardiovascular devices have had a long history of improving physician control and device delivery, reducing procedure time and insertion forces, minimizing tissue irritation and damage, and increasing patient comfort. Recent guidance documents from the U.S. Food and Drug Administration (FDA) indicate increased scrutiny of particulate generated from medical devices, including particulate generated from coatings. While the USP, FDA and ASTM documents provide some guidance regarding particulate testing for injectables, none of them provide specific test methods or acceptance criteria for particulate testing on medical devices. The challenges of developing a reliable test method for particulate generation from hydrophilic coatings will be discussed, including simulated use models, particulate counting and sizing systems, and sample handling considerations. The relationship between lubricity, durability, and particulate generation will be shown. A new platform of medical device coatings that maintain excellent lubricity, durability and manufacturability while providing low particulate generation will be presented.

We will discuss:

• Lubricious coatings
• Hydrophilic coatings
• Coating Evaluations
• Friction testing
• Particulate testing

Intended audience: Product and process development engineers

About the speaker:
Sean Stucke, Director of Commercial Development

Sean specializes in medical device coating processes, testing methods and development. Sean has 15 years of coatings development experience working with a broad array of medical devices including catheters, guidewires, and implantable devices. Sean obtained his B.S. in Chemical Engineering from the University of North Dakota.