Lero researchers from the Regulated Research Centre at Dundalk Institute of Technology have launched a new medical device cybersecurity company that plans to create 78 jobs over the next four years. The Lero DkIT spinout company, Nova Leah (www.novaleah.com) has developed an expert cybersecurity risk management software application aimed at global medical device manufacturers and healthcare providers.

Nova Leah, has just opened an office in Boston to serve the North American market. Initial investors include US venture capital company COSIMO Venture Partners and Enterprise Ireland.

“We believe that cybersecurity for medical devices will be a significant new market,” said Rob Frasca of COSIMO Venture Partners. “A first of its kind, we are not aware of any other company worldwide that can provide medical device manufacturers with an automated solution to implement and maintain cybersecurity requirements across medical device product portfolios.”

“The recent WannaCry ransomware attack on the UK’s NHS highlights the importance of cybersecurity in the health sector. Today’s medical devices incorporate high levels of software and are connected across networks, online or wirelessly,” commented Nova Leah CEO, Anita Finnegan.

“As a result, medical device manufacturers are facing two major challenges: ensuring compliance with stricter regulatory measures and minimising the probability of malicious breaches aimed at medical devices and healthcare IT networks.”

The new cloud based system, SelectEvidence®, which follows a five-year R&D programme at Dundalk Institute of Technology, is designed to guide medical device manufacturers implementing cybersecurity requirements and best practices over the lifetime of device in compliance with US FDA (Food & Drug Administration) recommendations for information security threats and risks during premarket and post market activities.


co-founders of medical device cybersecurity company Nova Leah (from left) Peter Finnegan, Anita Finnegan (CEO) and Dr Fergal McCaffery.
Photo Karl Hussey / Fennell Photography

Anita Finnegan added that data breaches in the US are estimated to be costing healthcare providers $5.6 billion annually*. Nova Leah is initially targeting customers in the imaging and electro medical device sectors in the US, a market that is estimated to be worth $155 billion of which connected devices account for approximately $51 billion. It is estimated that there are more than 6,500 medical device manufacturers in the US.**

Lero researcher Dr Fergal McCaffery, based at Dundalk Institute of Technology, a non-executive director of the new firm added, “SelectEvidence® ensures speedier market deployment for devices, reduced compliance costs and fewer market recalls due to data hacks; all of which boost profitability of our target organisations.”

One of Nova Leah’s first customers is an Irish based device manufacturer, Orreco.

“Orreco holds biomarker and other information on elite and professional athletes. Security, compliance and data protection is therefore a priority,” commented Fiona Slevin, COO. “Using SelectEvidence® we were able to design our software platform to global security standards, thus strengthening our confidence in the features designed to optimise security, safety and protection of data.”

“The launch of this spinout company is further evidence of the quality and global potential of the software research being carried out across the Lero organisation,” commented Professor Brian Fitzgerald, director, Lero – the Irish Software Research Centre, which is supported by Science Foundation Ireland. “It also emphasises the national asset in terms of medical device research that is based at the Dundalk Institute of Technology.”

Dr Joe Healy, Divisional Manager, High Potential Start Up Division, Enterprise Ireland, added, “Enterprise Ireland’s mission is to partner with innovative Irish businesses and entrepreneurs with the drive and ambition to scale in international markets. Enterprise Ireland has worked closely with Dr Anita Finnegan over the past five years and seen first-hand how the college based research and then the start-up company Nova Leah has gone from strength to strength. Enterprise Ireland looks forward to working with Nova Leah to continue to support their growth ambitions as they strengthen their customer base and grow internationally.”

Anita Finnegan has over 15 years’ experience working in regulated environments such as medical devices, automotive and construction. She is an international project leader with ISO/IEC SC62a Joint Working Group 7 and Working Group 4. Nominated by NSAI, she also represents Ireland as the medical device security expert at international standards meetings. Her PhD research provided the basis for Nova Leah’s SelectEvidence® product.

Dr. Fergal McCaffery is a Science Foundation Ireland (SFI) principal investigator. He is director of the Regulated Software Research Centre (RSRC) in Dundalk Institute of Technology and the medical device software engineering competency area leader in Lero, the Irish Software Research Centre which is supported by SFI.

Lero, the Irish Software Research Centre (www.lero.ie) is a global leader in software research. It combines the best in Irish software talent by bringing together researchers from Dublin City University, Dundalk Institute of Technology, NUI Galway, Maynooth University, Trinity College Dublin, University College Cork, University College Dublin and University of Limerick. It is funded by Science Foundation Ireland as well as by contracts from Irish and international technology corporations.