Nova Leah, a spinout company from Lero, Ireland’s national software research centre, has developed a new cybersecurity risk management software application aimed at North American medical device manufacturers.
The new cloud based product, SelectEvidence, was developed by Anita Finnegan, a Lero researcher from the Regulated Research Centre at Dundalk Institute of Technology following a five-year R&D programme.
Nova Leah is backed by Irish Government agency Enterprise Ireland. Lero is supported by Science Foundation Ireland which is the Irish national foundation for investment in scientific and engineering research.
It has just opened an office in Boston to serve the North American market. Initial investors include 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,” comments 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.”
She adds that data breaches in the U.S. are estimated to cost 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 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.**
The new cloud based system, SelectEvidence is designed to guide medical device manufacturers implementing cybersecurity requirements and best practices over the lifetime of device in compliance with FDA (Food & Drug Administration) recommendations for information security threats and risks during premarket and post market activities.
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.”
Nova Leah is currently on-boarding a number of global connected medical device manufacturers. One of its first customers is Irish based device manufacturer, Orreco.
“Orreco holds biomarker and other information on elite and professional athletes. Security, compliance and data protection is 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 features designed to optimise security, safety and protection of data.”
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 globally. We look forward to working with Nova Leah to continue to support their growth ambitions.”