What happens when the medical technology you’ve designed is so new, the regulations for use haven’t been written yet? Can old rules govern new technology?
Rapid Response Revival is living this conundrum as it seeks additional regulatory approvals for its next-generation personal defibrillator, CellAED.
In this conversation, Rapid Response Revival Chief Compliance Officer, Pradeep Kuriyakkott discusses the many challenges on the road to achieving regulatory approvals for a next-generation medical device.
Why are medical device regulations needed?
“Medical device regulations are there to ensure that when someone buys, or uses it is safe to use and performs as intended.
“It’s about ensuring the medical device presents the lowest possible risk to user and patient.
“As a medical device manufacturer, we are responsible for ensuring that whatever we create adheres to the particular rules and standards for the part of the world we’re producing our devices for.
“Different countries and regions have different systems and rules. We’ve just been through the EU’s CE Certification process; other examples include the FDA regulatory system covering the United States, and the TGA’s approval process in Australia.
“Each system sets rules based on the design and manufacturing of the device itself. They also set standards for usability of that device.
“Each regulatory body has a responsibility to protect their people. Their citizens need to be able to trust that any medical equipment approved for that territory is safe to use.”
Does securing approval from one regulatory system fast-track others?
“While a lot of these systems are based on shared global standards, each have their own rules that need to be met if you want to supply medical devices in their territories.
“To that end, each major regulatory system is different. Our product certification CE Mark award has been certified by a European Notified Body. Having CE Mark will not necessarily fast track the approval process in another regulatory jurisdiction. If we want to make our devices available in different parts of the world, we need to follow their regulatory processes irrespective of our approvals in other territories.”
What do regulations cover?
“Medical device regulations cover every aspect of its design, manufacturing, delivery, storage and use.
“For example, we need to be very specific about what a device is going to be used for, who will use it, where and when it will be used, and why.
“As you’d expect, regulators need to know all about a device’s design, how it’s built, and what it is built from. But they also need to know how it is applied, with every step validated and stress-tested. This is why clinical evaluation is also an important aspect of regulatory assessment.
“The level of detail required to secure regulatory approval for an AED is staggering, and rightly so. They need to know risks associated with use are as low as possible, and that performance is optimal in every way.”
What is required to secure regulatory approval?
“Regulatory approval processes are complicated and time consuming, both in terms of what it takes to meet the requirements, and the lengthy assessment periods.
“Take CE Certification. This is a jurisdiction covering multiple countries and territories. It’s a big market, with stringent requirements.
“Quality system certification is a major component of achieving this certification. All of our systems and processes for design, manufacturing and application of a medical device are documented and assessed, according to both international and individual territory standards across the jurisdiction.
“Once documentation is audited, a further six months is provided for demonstration of the efficiencies of quality management policies and systems in practice, according to the standards.
“This takes a team working full-time, covering every minute aspect of the regulations.
“Process compliance is a prerequisite for securing regulatory approval for a product..
“Without quality system certification, we couldn’t have secured CE for CellAED. It was a huge amount of work – but it meant that the product we will introduce to the EU will be a superior device.
“Going through this process ultimately meant our device is the best it can be.”
What happens when the regulatory standards don’t cover your type of device?
“That’s a good question. CellAED is a very different type of AED, it’s a game-changer. Its design is brand-new, which is great for affordability and usability. It’s not so great though when regulators aren’t used to seeing this type of AED.
“One challenge is that our AED works differently. It uses systems that differ significantly to other AED designs that have come before.
“It also integrates many more capabilities than existing AEDs, like IoT (Internet of Things) connectivity and functionality, in a much smaller unit.
We identified the best suitable standards in the mark, use of the state-of-the-art standards and apply to our product for compliance.
“A lot of time and effort was invested by our designers and engineers to design a smaller, powerful, easy-to-use, smart AED. Then, to get CE approval, we had a full-time team working in around-the-clock shifts to marry all the device component systems in a way that met all the relevant regulations.
“Some of these were straightforward, but many weren’t. We’ve had to respect and adapt to the fact that when you take a giant leap forward, the old rules are still going to govern your new technology.
“Regulatory standards for medical devices are written for designs that already exist. But our device is nowhere near standard, it’s state of the art. Which makes what we’ve achieved so far even more remarkable.”
“Achieving CE was an enormous achievement for a small Sydney-based company like ours. It took two years of continuous work for Rapid Response Revival to reach this point – which may sound long, but no other start-up has achieved CE for a medical device in such a short time, as per our Notified Body.
“We achieved this because of the people who made it happen. I’ve worked in many other industry sectors, and I’ve never seen a team pull together like this.
“The CE certification for CellAED is a demonstration of the shared dedication to the mission of reducing the unacceptably high rate of death associated with sudden cardiac arrest.
“We’re all here for the same reason. The proof of that is how far we’ve come, so quickly.”
RELATED ARTICLE: Why we invented CellAED
DISCLAIMER: CellAED is currently only approved for use in the member states of the EU (European Union). If you would like to be kept informed on when regulatory approval has been secured for your location, register your interest here.
