By Michael Seres @mjseres
At the age of 12 I was diagnosed with the incurable bowel condition, Crohn’s disease. I had multiple surgeries and in 2011 became the 11th patient in the UK to undergo a rare intestinal transplant. As part of that transplant I had a procedure known as an ileostomy, which is where part of your bowel is basically brought to the outside of your body and waste is collected in an ostomy bag. In this procedure you lose control of one thing – what comes out.
And not just that. Your clinicians and doctors want to know the volume of output because that determines how your gut is functioning, how your bowels are reacting, and the only way of doing that at that time was to manually empty your bags into jugs. I tried to find some technology that may help me but there was none. So I decided to have a go at making my own. I bought some parts off eBay, watched some YouTube videos, and hacked together a sensor while I was in hospital. That sensor ended up becoming the connective device Ostom-i Alert that we have now.
In simple terms, ostom-i Alert is a sensitive device that clips onto the outside of any medical bag.
It senses a change of resistance in the bag when output forms and sends that signal via Bluetooth to your mobile phone. On your phone you’ll install a free app that allows you to set multiple alarms to alert you as your bag is filling. From a clinical perspective Ostom-i Alert also captures that output data as volume, stores it in the Cloud and allows your doctors and clinicians to remotely monitor you.
Patients with stomas have big issues with dehydration and electrolyte loss because they can’t manage their output, which means that readmission rates are very high. By remotely monitoring, we’ve been able to reduce readmissions and improve patient self-management.
Launching a CE-marked device wasn’t easy.
To turn my clunky hack into a proper device that could be used by patients I needed two things: investment and someone who believed in the project and would take it forward. So, in Dragon’s Den style, I met as many people as I could until I found a lovely guy, Adam Bloom, who invested and together we formed 11 Health. Adam took a real gamble on me, because I was just a patient hacking a product.
There are many regulatory hurdles you need to overcome to get a device marketable, including CE marking, MRHA and FDA clearance. It took us about ten months to go through those regulatory clearances. We’d done some product testing with patients. We’d also visited America and spoken to the largest community of stoma patients. I used social media too, to find out whether my needs were the same as other patients around the world, and whether my product really made sense to them.
The focus of our business right from the beginning was patient-led innovation.
The future is looking very bright for Ostom-i Alert, which is exciting as it was never designed to be a business; it was designed to be a product to help myself and then other patients to improve quality of life. Ultimately, 11Health would like to be part of the standard in care after ostomy surgery or for any person that wears an ostomy appliance. We want our technology to help improve the quality of their lives – just as it has transformed mine. I can’t think of a better business goal than that.
Connect with Michael Seres on Instagram @michael.seres.