Rethinking regulation, with Neuronostics
Hardian supported Ross Parkman, Technical Director at Neuronostics, a company on a mission to improve the lives of people with epilepsy to gain their initial CE mark.
Their first product, BioEP, is a revolutionary, patented biomarker that calculates an individual's risk of having seizures from routine EEG recordings. In real-world terms, BioEP will enable faster and more accurate diagnosis of epilepsy resulting in better prognoses for patients. The company is currently developing and validating clinical decision support tools powered by BioEP in partnership with 15 NHS Trusts and 4 global neurology centres.
Ross, the company’s first employee, leads on all technical elements; everything from desktop computing, to designing and implementing Neuronostics’ technologies, which, importantly, includes handling regulatory compliance. As an early-stage company developing its first SaMD (Software as a Medical Device), we, at Hardian Health, have been supporting the Neuronostics team to navigate the complex and ever-changing regulatory landscape.
Ross and I reflected on how Neuronostics secured MDD self-certification (just in time!) and chatted about our long-term partnership.
Rethinking regulation
Medical devices, like medicines, need to be regulated; Ross and I, along with many working in the sector can, I’d hope, unanimously agree. Unfortunately, on whomever the responsibility falls, it can feel a little like a tick-box exercise. I note this through my own experience, responsible for regulatory compliance whilst leading UK startups, but through these processes I successfully secured the world’s-first CE marking for an AI-supported triage service and the first UK-based CE mark for a deep-learning medical device.
I believe it to be most productive to frame regulation as a minimum entry requirement to market, not a barrier. Over the past few decades, the technology sector has evangelised and prioritised speed and innovation, travelling much faster than the speed of regulators. However, when lives are on the line, let’s be clear, "move fast and break things" is far from desirable. As a clinician by background, patient safety is always at the forefront of my mind and regulation helps to provide clear boundaries, within which healthtech companies can innovate.
With a background in engineering and extensive experience working as a technical consultant at a Microsoft Gold partner, Ross shares our passion for finding solutions to problems. Having never been through any regulatory processes, Neuronostics sought help to avoid delays and any costly mistakes.
Navigating healthcare regulation can be rife with challenges. The industry is full of jargon that can be confusing and overwhelming, with the first regulatory submission often being the longest and the hardest. With a new technical language and framework to learn, amidst the chaos of the Covid-19 pandemic and the repercussions of Brexit, Ross described it to be a steep learning curve for the company. Neuronostics, though, managed, with our help, to successfully secure MDD certification for their product just before the 26 May 2021 deadline. Following this deadline, new medical devices have to meet the requirements of the E.U.’s Medical Device Regulation (MDR) to be placed in the continental market. Devices under the previous regulation (MDD) must also eventually re-certify but Neuronostics now has time to work through the newer, more stringent requirements.
To use or not to use
The cornerstone of regulatory compliance is ‘intended use,’ i.e. what is the purpose of your medical device? Defining the intended use is the basis for all decisions, including whether or not the product is a medical device, and if so, which risk classification it appears under. Ross described how navigating the vocabulary used by regulators early on in the process enabled Neuronostics to save valuable time and money with their first submission - a key learning point for those approaching regulation.
Another key learning lies in an assumption. You may (mistakenly) believe that once a certified medical device reaches the market, there is time to rest on your laurels. Unfortunately not. Once your product hits the market, you must be confident in maintaining the regulatory documentation around your product too. Technical documentation is living content that must be reviewed and updated regularly. I’m pleased to say that we helped Neuronostics to build documentation for regulatory certification and an electronic quality management system (eQMS) to enable this. Ross noted how the eQMS has provided structure and focus for the company and reassurance that regulatory requirements are being consistently met, training Ross and his team on how to maintain important documents in the eQMS.
Creating long term impact
At Hardian Health, we want to ensure that our clients are best prepared for the future. Ross and his team have been equipped with the know-how to comfortably navigate subsequent regulatory processes in future - an element on which we pride ourselves. Hardian Health will now provide additional support, when and if required, forming a more fruitful long-term partnership.
As regulatory experts, we challenge ourselves every day to keep our ears as close to the ground as possible and ensure that we are able to support our clients through their product roadmaps and overall growth, however ambitious and impactful. Neuronostics is a great example of such a company and I look forward to seeing their increasing impact on patient care.
Hardian Health is clinical digital consultancy focussed on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.
