Structural Encoding is the industry’s most innovative solution for medical device identification with permanent direct part marking. The technology was launched by Watershed in June at the Unique Device Identification (UDI) Conference in Baltimore. Manufacturers can license the technology for use in their medical devices to meet the U.S. Food and Drug Administration’s (FDA) regulation around permanent marking of the device itself.
“Structural Encoding incorporates a method that embeds data within any device in a way that is read through medical imaging,” said Watershed CEO Nick Cordaro. “Just imagine the impact this can make for patients, surgeons, and hospitals to have complete knowledge of an implant merely by taking an X-ray – no more tracking down long-lost paperwork to determine origin or history of an implant.”
Nvision has initially launched three devices in the nv line with Structural Encoding. nva® is an anterior cervical interbody fusion system; nvp® is a posterior lumbar interbody fusion system; and nva® is an anterior lumbar interbody fusion system. The devices have FDA clearance and are ready for implant.
“When we looked at solutions for UDI compliance in the marketplace, Structural Encoding was by far the most advanced,” said Tom Zink, Nvision Director of Engineering. “Not only is it the best solution for the patient long-term, it requires the least adjustment for the hospital and surgical teams. For a manufacturer like Nvision, Structural Encoding is also one of the quickest solutions to market with minimal design changes or new FDA approvals.”
About Watershed Idea Foundry
Watershed is an idea foundry created by Fountainhead Investment Partners that focuses on biomedical growth and innovation. Watershed's purpose is to forge promising ideas into viable intellectual property and products ready for the marketplace, ultimately creating profitable businesses, bringing together industry experts from around the world to guide entrepreneurial ideas.
Watershed works with entrepreneurs exploring their ideas as well as companies that require research and development assistance to move their intellectual property forward. Watershed offers services ranging from proof of concept and product development to manufacturing demonstration and regulatory consulting to funding readiness.
Through Fountainhead Investment Partners, the foundry provides an environment where talent and innovation are funded, nurtured, and guided to create a turning point for ideas.
For Nvision Biomedical Technologies