Coatings, suppliers, and the benefits

DSM’s ComfortCoat is a hydrophilic material that creates a hemocompatible surface on medical devices. The coating is used on catheters, guidewires, and other devices across a variety of medical market segments. The coating benefits cardiovascular, vascular, urinary, and neurological devices where lubricity, wear resistance in tortuous paths, low particulate release, and water retention are important to performance. Fundamentally, any catheter or device small enough to be delivered via catheter, can benefit from ComfortCoat.

For example, when advancing a catheter over a guidewire and through a blood vessel, physicians can meet natural resistance as a result of static friction to the vascular inner surface. A hydrophilic surface coating can reduce resistance, enabling the catheter to slide more easily. Hydrophilic surfaces attract water molecules, which creates a lubricious surface. These characteristics are significant to medical applications because they:

• Lessen friction forces associated with advancing a device
• Decrease the amount of potential tissue trauma
• Reduce the chance of an infection by inhibiting bacteria adherence
• The slippery surface makes navigating blood vessels more comfortable for patients and easier for physicians, leading to more accurate device positioning.

Choosing a coating and supplier

Durability and resistance to wear are important considerations in choosing a coating. Device shape, size, and function are relevant when determining how much of the surface should be coated. Furthermore, medical devices are sterilized through a variety of methods, so choosing a coating that can endure multiple processes is also important.

Other due diligence topics may include questions about equipment, throughput, coating processes, quality systems, and compliance with regulatory and international standards. DSM has FDA master files that contain technical information, including extensive testing data that demonstrate safety around surface activity, potential extractable components, and their potential effect on the host.

Medical device manufacturers should seek a coating supplier that can serve as a strategic partner and add value throughout the device lifecycle. Some suppliers simply use common industrial chemicals, offering no development or testing support. Others work closely with manufacturers to create custom-designed application processes that run through research and development, pre-clinical studies, clinical studies, regulatory approval, commercial production, and bringing the device to market.

Certain coating suppliers can provide custom-designed coating application processes as well as in-house coating services, which include coating, testing, packaging and labeling, and additional customized processes such as cutting. 
 

On the horizon

There is a growing demand for smaller products for minimally invasive surgeries that reduce risks and quicken recovery time for patients. The medical coatings sector will continue to evolve by producing coatings for emerging market needs and by creating coating application processes that serve a wide range of sizes and geometries of devices and components.

DSM 
www.dsm.com

About the author: Dr. Hinke Malda is director of medical coatings at DSM Biomedical and can be reached at hinke.malda@dsm.com.