Rory Mooney - Class Medical
What is your idea?
We have developed an innovative medical device to improve patient safety and comfort when a urinary catheter is being put in place.
What problem are you solving and what is innovative about your approach?
Urinary catheterisation – where a tube is inserted into the urethra to drain urine – is a common procedure carried out in hospitals, nursing homes and care-in-the-home settings.
However, the conventional approach to transurethral catheterisation is notorious for discomfort and for the risk of urethral injury. A particular problem is if the catheter’s anchoring balloon is misplaced and inflation occurs in the urethra, which can in turn lead to quality-of-life issues, prolonged hospital stays and potential litigation and associated costs.
Our device, the Trans-Urethral Catheterisation Safety Syringe (TUCSS) valve, is designed to avoid incorrect positioning of urinary catheters. Its unique selling point is that it prevents inadvertent inflation of the anchoring balloon in the urethra and provides a visual indication if the balloon is not appropriately placed.
It uses a pressure-sensitive safety valve to ensure the anchoring balloon cannot be inflated in the incorrect position, and the device will cause saline to decant if the position needs to be altered. Our device is suitable for use with all Foley urinary catheters on the market.
What’s the backstory here and how did you get involved?
Urologist Dr Niall Davis approached myself and Dr Michael Walsh at the University of Limerick about the problem of misplaced urinary catheters in the clinic.
With more than 20 years of medical device industrial and clinical experience and with research expertise in urology, science and engineering, we developed the TUCSS concept which won the inaugural Enterprise Ireland/Cleveland Clinic Clinical Innovation Award.
With the support of Enterprise Ireland, we spun out Class Medical, developed the TUCSS prototype, which has been tested in cadaver studies. We are currently carrying out functional tests with patients in the clinic.
How is this idea commercially attractive?
Around 115 million transurethral catheters are sold annually around the world, and with a global ageing population this number is set to rise. Our device can work with every single one of these catheters to make their placement safer to improve patient outcome and avoid litigation costs, which can run into millions of dollars per patient. An annual saving of 85% has been projected for individual hospitals following a recent study, before considering ligation costs. There are currently no competing technologies.
Clinical feedback is that this device would be well adopted and we are speaking with manufacturers and distributors. We anticipate working with a large existing company in this space to ensure our innovation has clinical traction and a rapid route to market through sales channels.
What are you looking for at the Big Ideas event?
We are looking to build up exposure for our innovation and to secure investment to bring TUCSS through device validation. We are seeking finance to complete Class 1 CE marking and 510(k) submission by Q3 2016 in addition to building stock for initial quarterly sales projected for Q3 2016.