Digital Health 11 Health |
At the moment the device has 220 paid customers
in the UK. In the USA, Ostomi-i Alert Sensor has just received full FDA 510k approval, which represents a major breakthrough in getting it accepted in the American market. The process took a lengthy six months and involved the FDA examining every aspect of the product from looking at the original drawings, safety, user testing and clinical testing. Now the product is attracting attention from a number of different areas. The company continues to work through social media with groups including the Stoma Nurse community and is educating users and carers in its use which dramatically simplifies the management of the stoma bag. The alternative to using the discreet device,
explains Seres, is to measure output by emptying it into a jug and measuring it manually. The device calculates output for the user without having to go through this process. Feedback has been positive, with 98 per cent of
users saying they are happy with the device and 8 UK hospital sites beginning clinical trials this year.
global-opportunity.co.uk
11 Health is now moving from its research and
development phase to a strengthened sales and marketing drive. More staff are being recruited and the business is growing. The goal, says Michael Seres, has been to ‘clear
regulatory hurdles’ . Now it is to get the device embedded in stoma care worldwide. Interest has already been identified in Israel, South East Asia, Indonesia and China. The product continues to be refined and
developed with phase 2 and 3 in the pipeline. Phase 2 should be available later this year along with software updates for the app. ‘A solution that was developed by patients for
patients’ is how Michael Seres describes a product that already received numerous accolades, including 11 Health being named a Nominet Top 100 company in 2014.
Further information
www.11Health.com
Issue 01 | Global Opportunity Healthcare 2015 103
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