“How do you quantify what you might be missing out on?”

“How do you quantify what you might be missing out on?”

Intelsens was interviewed by Brexit Border Blog on behalf of Intertrade Ireland. The interview was first published on Intertrade Ireland’s website.

One look at the front page of the website of Intelesens underscores the collaborative nature of this pioneering health manufacturer. Badged with the EU Regional Development Fund, it also proudly boasts links to local Trusts, hospitals in England, Ireland and America, big names like Intel Health and the Wellcome Trust as well as other high profile international organisations. Spun out of the University of Ulster, the company describes itself as an established medical technology company that has developed a portfolio of intelligent, wearable, non-invasive, wireless vital-signs monitoring devices for the hospital and home patient monitoring markets. Basically, it is about being able to monitor people easily and wirelessly, freeing up vital hospital beds particularly intensive care and also allowing people to be monitored at home. The system saves money but also can be a component in a wider emerging connected health strategy. Chief Finance Officer Deirdre Francis confirms the collaborative global nature of Intelesens work. It’s a small company employing 33 full-time-equivalent staff with only a small number of European employees and turns over about a million annually. But its work is ground-breaking in establishing new, innovative pathways. In the broad sweep of Brexit implications it is – in order – less affected by staffing, financial and tariff implications, potentially more by regulatory and standards, and in a major way by the threat to European Research and Development funds. The company has established that, as a medical device, its product is tariff-free to the US, but that isn’t the case with all of its components: some elements are tariff-free but others are not. The greatest impact so far on its business has been in currency markets with a thirty percent increase in prices for some of its raw materials. The company trades in the US which applies very strict monitoring on imported medical devices, even down to small numbers, with the Food and Drug Administration (FDA) carrying out often lengthy monitoring. That experience raises a major concern about what happens if such a scenario is replicated in a European context post-Brexit. Intelesens has to go through strict regulatory approval processes culminating in its devices being CE marked. The letters “CE” are an abbreviation of the French phrase “Conformité Européene (European Conformity). By its nature the product is also patentable and Intelesens has filed in a number of EU states. Before Brexit there were plans for an overarching patent structure for Europe; For Deirdre there are implications with Britain being clearly outside of that structure and also of the debate about its formulation, yet forced to conform to the outcome.  “The problem for us is the complete unknown. Not even the powers-that-be seem to know what to do to get us out of it. We are left with the mess and exposure to issues which affect currency, price and regulation but with no way to mitigate them,” says Deirdre. “We don’t have control.” Perhaps the biggest issue for the company is research and development. Back to the website again and it is clear that those behind the company have been particularly successful in attracting European monies across a wide range of projects. That is in some cases based on collaboration across countries and disciplines – a requirement of the EU R and D funding system. The UK Chancellor of the Exchequer has pledged that this funding will be maintained until 2020 but Deirdre feels that assurance does not go far enough. The nature of these collaborations is the significant time frame for development and application and it is her real fear that potential partners will not engage in the wake of Brexit, but seek more secure partners within a European umbrella in the future. Her worry is that the phone won’t ring or be answered and she asks: “How do you quantify what you might be missing out on?” Against this backdrop the company has not got direct access to vital information or support as it relates to Brexit and relies heavily on the media for such information as it can find.  “It annoyed us tremendously at the start, but we’ve attempted to inform ourselves and we’ve developed a plan”