Medical device cybersecurity experts, Nova Leah, and clinical support software specialist, Tapa Healthcare, are the latest companies to ‘spin out’ from Dundalk Institute of Technology. The products and solutions offered by both companies were developed through research funded by Enterprise Ireland’s Commercialisation Fund. The research was also supported by the Institute’s Regulated Software Research Centre (RSRC), a recognised centre of excellence in the areas of medical software device engineering and research, led by Dr. Fergal McCaffery.

Nova Leah was founded by current CEO, Anita Finnegan and also Fergal Mc Caffery and Peter Finnegan. Anita, the author and international project leader for two International Medical Device Security Standards (IEC 80001-2-8 and IEC 80001-2-9), has developed a cybersecurity medical device risk analysis solution, SelectEvidence.
Over the last number of years, security researchers have been demonstrating how vulnerable medical devices are to security attacks and, as a result FDA have set out new cybersecurity regulations for manufacturers.

SelectEvidence is an expert system that continuously monitors cybersecurity vulnerabilities and supports medical device manufacturers in designing, verifying and certifying secure medical devices to meet FDA cybersecurity requirements, industry security standards and best practices for connected medical devices. Nova Leah is currently working with some leading global medical device manufacturers and regulators. Presently, Nova Leah employs three people and expect to recruit a further 10 in 2017.

Tapa Healthcare is co-founded by CEO Dr Peter Donnelly, Dr John Kellett, Rhona McAteer, Neil Clynch and Alan Murray. The company has developed a novel Rapid Electronic Assessment Data System (READS) for nurses, doctors and healthcare administrators.

READS collects comprehensive patient data very efficiently, reducing nursing documentation time by up to 90%. The system then uses multiple predictive clinical models and algorithms to identify potential adverse events and risk of patient deterioration and recommends actions to provide appropriate and timely treatment. The READS patient centric proactive care model has significant impact on clinical outcomes and prevents avoidable events.

Currently READS is a CE marked registered medical device and is being evaluated in hospitals in Ireland, UK, Denmark and Uganda. Tapa Healthcare employs 10 full and part time staff and plans to grow to 20 staff during 2017.

Both Nova Leah and Tapa Healthcare benefitted from the Enterprise Ireland Commercialisation Fund. The companies also received consultancy and technology transfer supports from the Regional Development Centre at DkIT, aimed at helping companies develop the entrepreneurial knowledge and skills required to lead a new commercial venture.

Neil Mc Loughlin, Technology Transfer Manager at the Regional Development Centre at DkIT, works closely with both companies and oversaw their transition from DkIT research projects into ‘spin-outs’, together with management of intellectual property licensing.

Speaking today he said: “both Nova Leah and Tapa Healthcare are great examples of innovative ‘spin-outs’ that address a clear gap in the market. As experts in their respective fields of cybersecurity and global clinical support, they possess the technical and market knowledge necessary to develop unique products and services. At DkIT we were delighted to support the transformation of research into compelling business ventures. The expertise, products and services offered by Nova Leah and Tapa Healthcare, in conjunction with the RSRC ensures that the North East is firmly placed on the map in terms of its unique offering in MedTech.”

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