Sharklet’s “Disposable Sterile Micropattern Silicone Catheter” was recently recognized as an Innovative Medical Device by the Administration for Market Regulation of Drugs and Medical Devices in China.
Urinary catheters are a mature category of medical consumables, yet currently available products on the market still fail to address two major clinical pain points simultaneously:
(1) catheter-associated urinary tract infections (CAUTIs), and
(2) pain and discomfort caused by catheter insertion and indwelling.
Sharklet’s “Disposable Sterile Micropattern Silicone Catheter”embosses the Sharklet micropattern structure onto the surface of the catheter body. This enables the product to deliver clinically meaningful antibacterial and pain-reducing performance without the use of chemical antimicrobials.
The origins of Sharklet’s innovative technology date back to the 1990s, derived from a U.S. Navy research program aimed at preventing marine organism fouling on ship hulls. Jointly developed by the Departments of Materials Science and Biomedical Engineering at the University of Florida, the technology was published in 2007 in an academic journal of the American Institute of Physics. The study demonstrated that the Sharklet micropattern reduced Staphylococcus aureus colonization by 95%—without using any bactericidal agents.
In the same year, Sharklet Technologies, Inc. was founded, dedicated to advancing physical, surface-based antimicrobial technologies and bringing them into medical applications. By forming unique micro-scale surface structures, Sharklet inhibits the attachment, colonization, and migration of bacteria and other microorganisms. Experimental data show that the technology can suppress common pathogens such as E. coli and S. aureus by 90–95%.
A key hallmark of a truly innovative technology is its ability to establish new industry standards. Sharklet led the development of ASTM E3285-22—the world’s first international test standard for microbe surface-contact transmission. This marked authoritative recognition of the technology’s scientific foundation. Today, Sharklet’s micropattern technology has been deployed across multiple sectors, including urinary catheters, medical gloves, antimicrobial films, and automotive interiors.