Full Description

When have given a surgical procedure known as a stoma you lose control of the very thing that would take for granted. Going to the toilet! A stoma is a procedure where part of your intestine is brought to the outside of your stomach and your bodily waste is collected in a bag known as a stoma bag. Patients can have three different types of stomas but all result in the nerve endings being cut and therefore you lose control over when you go to the toilet and how much comes out.I was given an ileostomy as part of my intestinal transplant and was subjected to the daily life of a bag that leaked and overflowed and healthcare professionals who wanted to know how much was coming out and when. Currently the only way of knowing that is to empty your output in to a measuring jug and then record the data manually. This is a big problem and is often not done. Therefore ongoing issues such as dehydration, electrolyte loss or even blockages are common place. 95% of all patients have leaks in the first three months and 65% of patients still experience these 5 years on.Whilst lying in hospital I spent a lot of time watching my bill expand as it filled with my effluent. So I bought some parts on eBay, the main part was a flexible sensor strip that came from a nintendo wii glove. The reason behind that was if you put your hand in a glove and bent your fingers so the glove would send a signal. The same principle occurred to me that if I could put a flex sensor on the outside of bag then when the bag moved a signal could be sent. Thanks to many You Tube videos and the help of a friend my first hacked sensor was built. From there we worked out an algorithm to measure the change of movement in the bag. Every movement correlated to an output volume and so very soon we had a sensor that was connected via bluetooth low energy modules to a free mobile app. The app allows patients to set multiple alarms on their phone to alert them as and when the bag is filling. No more leaks and spills. In addition the bag automatically captures the output volume showing it on the phone in real time and enabling healthcare professionals to remote monitor patients. No more jugs! We then realised that we needed regulatory clearance in order to be able to use the device. We phoned the FDA in the US who agreed to help directly in trying to secure FDA 510K clearance. I spent time learning about human factor studies, biocompatibility testing and all the required elements and 9 months later we successfully secured approval. Our device is also now CE marked and is a Class 1 device with the MHRA. We have developed a hospital app for our product that allows up to 20 patients to be connected to one iPad in hospital.
We are now moving our technology in to the urology market working on leg catheter bags as well. Our app is fully integrated with Apple ResearchKit and HealthKit. It is also reimbursable via Medicare in the US and various commercial payers and can be bought directly from our website.