11Health is a digital medical devices start up, employing 6 people in London founded by Michael Seres, Michael invented the Ostom-I Alert in a hospital ward after undergoing a small bowel transplant. With no prior technical knowledge and using chips and sensors available in everyday gadgets he was able to create a connected digital health device. For a small start up free access to a larger market in the EU meant that 11Health could sell to those, without extra spend on middle men or trade tariffs.
Health tech devices are rightly regulated. Having to meet a single criteria for regulation across all the markets in EU has been hugely beneficial. It has meant 11Health doesn’t have to pass through different tests, as it does with the US FDA.
The new EU directive is not perfect, but the principle is very helpful to business – one set of regulation. As a European company 11Health have been able to secure research grants from the EU. It not only provides funding which they don’t need to raise on the market from companies, usually from the US, that will want shares in the business. It also gives access to EU health partners to trial medical devices.
A ‘Leave Vote’ creates risks for 11Health. It has an investment round coming up and is looking to hire 14 new people in the next 2 years, but it I can’t make those decisions if access to markets, and the regulation in those markets, is unknown. Without being able to scale the business in Europe, with the free market access and single regulation its had, it wouldn’t have been able to scale up to enter the US.