Watershed Idea Foundry Unveils First Product at UDI Conference 2017
Structural Encoding represents Watershed’s first idea-to-market success.
San Antonio, Texas – Watershed, an idea foundry created by Fountainhead Investment Partners, launches its first product today at the Unique Device Identification (UDI) Conference 2017 in Baltimore. Structural Encoding is the industry’s most innovative solution for medical device identification with permanent direct part marking.
The U.S. Food and Drug Administration (FDA) is in the process of implementing requirements for all medical devices that are intended to be used more than once and to be reprocessed before each use to bear a UDI as a permanent marking on the device itself. Structural Encoding incorporates a method to embed data within any device in a way that can be read via medical imaging and it is the only solution that allows the device to be identified after implantation without access to documentation or paperwork.
“When we design solutions, Watershed looks first at what is best for the patient. The FDA’s UDI regulation is meant to make devices safer for patients by providing key information about the device that is easily accessible,” said Nick Cordaro, Watershed CEO. “We took that goal to heart and created a solution that would always be with the patient, accessible when and only if it is needed, simply with an X-ray.”
A self-contained direct part marking system solves many issues that other UDI solutions create. The Structural Encoding process does not add extra steps or paperwork, nor does it add additional inventory control issues for the hospital. For manufacturers, Structural Encoding may not even require a new 510(k). It is also a cost-efficient process that is quicker to market than other systems for manufacturers.
“Watershed’s purpose is to forge promising ideas into viable intellectual property and products that will disrupt industry norms,” said Cordaro. “Think of the possibilities when there is the ability to understand everything about a medical device through an image, and Structural Encoding is the first of the many innovations that Watershed is bringing to the market.”
Watershed is an idea foundry created by Fountainhead Investment Partners that is focused 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.
Watershed works with entrepreneurs exploring their ideas as well as companies that require research and development assistance to move their intellectual property forward. By bringing together industry experts from around the world to guide entrepreneurial ideas, Watershed can offer 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.
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