Safety is paramount when it comes to medtech, but so is cost-effective manufacturing. How do standards affect the process?
As medtech advances, more complex systems are being created to enable innovation, boost quality of life for patients and create a more efficient workflow for healthcare professionals.
While hardware is a crucial aspect, the systems enabled by medical device software development are spearheading this particular revolution.
The positives are numerous, but the importance of safety also calls for extensive regulations and the creation of standards for manufacturers to comply with.
Software standards are crucial
Dr Fergal McCaffery is at the epicentre of medical device software regulation both here in Ireland and on a global scale. Co-founder of the Regulated Software Research Centre (RSRC) at Dundalk IT, McCaffery and the research team at the centre have been instrumental in the development of standards and compliance methods for a number of years.
One such project is MDevSpice, an innovative framework for medical device manufacturers to ensure their complex software complies with the vast swathes of regulatory standards out there.
McCaffery explained the relationship between safety and cost-effectiveness that led to its creation: “From a medical device manufacturer’s perspective, they want their devices to be safe but they also want to get them developed where the overheads aren’t too daunting.”
Put simply, the MDevSpice system consolidates all of the software-related standards, which could be as many as 14, depending on the nature of the device. Where previously companies would have to wade through the regulations, implementation, standards and the interrelationship between them, they can now figure all of this out from a sole source.
McCaffery added that MDevSpice is “a way of performing an assessment gap analysis – what you as a company need to address in order to be compliant. It greatly simplified procedures.”
Ensures device safety and avoids ballooning overheads
Although there are many hardware considerations to be weighed up, McCaffery said that having software development experts creating these standards has been of major benefit to manufacturers. “Previously, a lot of the people writing the standards were from a hardware and an electronics background, not so much from a software perspective.
“The processes I have seen within software development meant that they could be brought into the medical domain and, as the amount and complexity of software increased, it could be developed in a safer way.”
The framework not only helps companies of all sizes to ensure they are safe, but also makes firms more attractive to collaborators, funders and potential buyers as they can easily demonstrate their compliance with the relevant ISO and IEC standards, all from a single origin. Some companies using MDevSpice are collaborating with medtech giants such as Medtronic and Novartis.
“MDevSpice originated on the back of the first standard the RSRC examined, IEC 800002-3, which looks at best practices for developing medical device software; we looked to improve existing standards,” said McCaffery.
The RSRC has also worked on a standard dealing with medical networks and networked devices, and two separate standards around cybersecurity for medical devices. Another spin-out from the RSRC, Nova Leah is a medical device firm focused on cybersecurity and helmed by researcher Anita Finnegan.
In terms of the issues facing medtech manufacturers for the foreseeable future, it’s all about risk management. McCaffery said that networked medical devices are becoming more commonly used, so security of these is paramount. “The weakest link in the network will be the strength of the whole network.” Interoperability is also another vital area.
He explained the overarching mission of the RSRC: “Creating more efficient and effective ways to keep devices safe but reducing overheads.”