Anita Finnegan - Nova Leah
What is your idea?
SelectEvidence® is an intelligent software tool that provides medical device manufacturers with a standardized, repeatable, traceable, auditable approach to implementing FDA & EU cybersecurity requirements across their product portfolios.
What problem are you solving and what is innovative about your approach?
Medical devices need to be secure. While there have been no known malicious attacks to medical devices, controlled hacks carried out on implantable medical devices such as pacemakers, insulin pumps and defibrillators have demonstrated how vulnerable devices can be.
In October 2014, the FDA published a cybersecurity guidance document that outlines requirements for medical device manufacturers to demonstrate the security assurance of a device prior to placing it on the market.
Until then, manufacturers had needed to demonstrate a device to be safe and effective. Now they must balance security with safety and effectiveness. SelectEvidence® helps manufacturers achieve this balance.
SelectEvidence® is an expert system, containing repositories to support the process of cybersecurity risk management, to accelerate risk analysis and to reduce time to market for new products.
What’s the backstory here and how did you get involved?
With the support of Science Foundation Ireland funding, Dr Fergal McCaffery at Dundalk Institute of Technology developed an assessment framework for medical device software. The project expanded to include medical device cybersecurity because this was a key concern for the industry, and I worked on it for a PhD study.
My background is in engineering and quality management, and during my PhD I developed a new method that uses assurance cases to demonstrate confidence in the security of medical devices.
I am also author and international project leader for a number of medical device security standards providing guidance to manufacturers to follow the security assurance framework.
We felt this work could provide a solution for a substantial addressable market internationally, so we proposed the concept for SelectEvidence® to Enterprise Ireland, who supported it through the Commercialisation Fund.
Nova Leah is the resultant spin out from Dundalk Institute of Technology and the Regulated Software Research Centre (RSRC), and it was set up to commercialise the SelectEvidence® system.
How is this idea commercially attractive?
The United States is the largest medical device market in the world with a market size expected to reach $133 billion by 2016. In 2012, the US market value represented 38% of the global medical device market.
We are initially targeting two of the larger US medical device market segments: diagnostic imaging devices, which at $37.5 billion represented 30% of the US Medical Device Market in 2013 and electro-medical devices, which made up 19% of the US Market in 2013.
Because of our current and previous work within the International Standards Community we have developed strong connections with large multi-national medical device organisations. We are using these connections as an initial route to market.
What are you looking for at the Big Ideas event?
We are seeking investment to grow Nova Leah and gain dominance in the market for medical device cy