Grants to Fund Development Success

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From Concept to FDA Clearance

The Challenge

On his first visit to Actuated Medical, Paul Frankhouser, a former executive vice president of Arrow International, said: "You know where you need to use your technology? Feeding tube cleaning. There is nothing on the market that reliably clears clogged tubes."

Our Approach

We used our systematic seven-stage development process to design and innovate a nasogastric tube clearing device that would solve the clinical challenge Mr. Frankhouser had brought to our attention.

The clinical need was understood, state of practice was identified, and the clinical consultants were selected. A strong proposal was written and submitted in December 2007, resulting in a Phase I Small Business Innovation Research (SBIR) grant from the National Science Foundation (NSF)—awarded in July 2008. During Phase I, our device was investigated (Stage 1) and proven feasible (Stage 2). We submitted a Phase II SBIR grant proposal in December 2008, which was awarded in July 2009. The device was developed from concept to verification-and-validation testing (Stages 4 & 5), and a 510(k) application for market clearance was submitted to the FDA June 2011.

Over 50 nurses and doctors were surveyed during the device's development to ensure that the final device would be effective and easy to use.

The Results

Thanks to the financial support of the National Science Foundation SBIR program and the hard work of Actuated Medical engineers, scientists, and product development experts, our feeding and decompression tube clearing device, TubeClear®, has gained market clearance for nasoenteral, nasogastric, gastrostomy, and jejunostomy feeding and decompression tubes.

Mr. Frankhouser joined Actuated Medical's Board of Directors shortly after his first visit to Actuated Medical. He is an active member of our medical device development team as Director of Innovation.

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