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.”
We used our systematic seven-stage development process to design and innovate a nasogastric tube clearing device that would clear sluggish and clogged feeding tubes while the tube remained in the patient.
The clinical need was understood, state of practice was identified, and the clinical consultants were selected. A strong proposal was written and submitted, resulting in a Phase I Small Business Innovation Research (SBIR) grant from the National Science Foundation (NSF). During the SBIR, our device was investigated (Stage 1) and proven feasible (Stage 2). We submitted a Phase II SBIR proposal, and it was awarded.
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.
Weekly over 2000 clinicians receive an email newsletter, the Tuesday Tube Facts (TTF). TTF are educational as well as reminding the clinicians about TubeClear’s clinical benefits.
Thanks to the financial support of the National Science Foundation, angels and strategic investors, Actuated Medical’s team of engineers, scientists, and product development experts, commercialize the TubeClear system (www.tubeclear.com). Currently, it is being manufactured and marketed by Actuated Medical and sold via external distributors.
“Actuated Medical has the right mix of skills needed to develop cutting-edge medical devices, but more importantly, they are extremely sensitive to user needs.” – Janice Penrod,Ph.D., RN, FGSA, FAAN, Professor, College of Nursing, Director, Center for Nursing Research at Penn State College of Nursing