In this Case Study, we will unpack the compliance journey of Copenhagen-based Brain+, which led to the placement of the first Class 1 SaMD digital-CST tool on the UK Market
Bringing NICE-recommended treatments to UK Dementia patients through SaMD
At 8foldGovernance, we understand the power of a Human Touch in compliance. Our partners at Brain+, pioneers of Ayla – your Digital-CST assistant for dementia care – share this ethos.
In this Case Study, we will unpack the compliance journey of Copenhagen-based Brain+, which led to the placement of the first Class 1 SaMD digital-CST tool on the UK Market, compliance with the NHS Digital Technology Assessment Criteria (DTAC), and securing three contracts with leading home care providers in the UK.
Brain+ are pioneering digital Cognitive Stimulation Therapy (CST), the world’s leading non-drug dementia treatment recommended and endorsed by Alzheimer’s Disease International, the World Health Organisation (WHO) and the National Institute for Health and Care Excellence (NICE) in the UK. They are on a mission to bring the world’s first scalable dementia care platform to market, with the mission of improving the lives of patients and their families.
The Brain+ team were already actively exploring new markets before deciding on the UK and were having numerous conversations in countries such as Germany to find a means of distribution and reimbursement for their digital care platform.
Brain+ engaged 8fold to assess the regulatory landscape in the UK and EU and advise on how best to proceed; after a thorough review of their plans and products, we agreed that the UK was a market they wished to prioritise.
8fold helped Brain+ to identify the specific compliance requirements for the UK – which are prerequisites for working with the NHS, including a variance in the registration pathway for Software as a Medical Device (SaMD). Their technology could be self-certified as a Class 1 device, preventing the need for expensive notified body fees in Europe; a significant opportunity for them to bring impact to the market quicker.
Whilst the business already employed a Compliance Manager to help handle day-to-day operations, they knew they needed a partner to help them meet the UK’s specific regulatory requirements and also prepare for future registration in Europe under EU MDR. They lacked the knowledge internally of multiple compliance frameworks and pathways, which could potentially derail their go-to-market strategy.
With their pre-market strategy determined and go-to-market plan in motion, the team at Brain+ knew they needed a trusted partner.
8fold had an exceptional reputation, so we knew we could trust them.
Simon Neilsen,
Chief Strategy and Innovation Office
The Brain+ team already had an awareness that their product may be classified as a Medical Device according to the regulations in Europe, but hadn’t considered the approval pathway in the UK as a way of potentially expediting market access. For Software as a Medical Device in the UK, technologies which do not fall under the conditions of Rule 9 or Rule 10 in the guidance are classified as Class 1, meaning they are self-certified. This presented a significant opportunity for an early-stage startup keen to bring its technology into use.
They were also unsure about what they already had in their compliance portfolio, which would contribute to compliance with the NHS Digital Technology Assessment Criteria (DTAC) – an essential requirement for their go-to-market plan.
Working with our Director of Professional Services & Head of Quality and Regulatory Affairs, Daniel Mannion, we conducted a detailed Regulatory Review and produced a clear strategy outlining the applicable regulations and approval routes for both the UK and Europe and the interlock between NHS compliance requirements such as DCB0129 – the NHS Clinical Safety Standard.
Brain+ were keen to build sustainable foundations for governance, risk management and compliance and knew the risk of having a siloed approach to the different regulatory requirements would slow down their go-to-market strategy in the UK, but also across Europe in the future.
With our deep expertise across Medical Devices, Data Protection, Clinical Safety, and Cyber Security, we were able to develop a true, integrated modular management system encompassing everything they needed to be a Class 1 Medical Device in the UK and comply with the DTAC framework. This approach ensured:
Daniel Mannion, Head of Quality and Regulatory Affairs, led the implementation of an ISO 13485 compliant Quality Management System, development of a suitable Class 1 Technical File and advised on the completion of a robust Clinical Evaluation, leveraging internal expertise within Brain+ to ensure the literature review and content of the clinical evaluation was best suited to Ayla, your CST-assistant.
Working with the team and using our tried and tested methodology,Daniel was able to develop a QMS which formed the backbone of the Integrated Modular Management System, whilst tailoring specific procedures to the business’s unique needs. There was also consideration made in document structures to account for later registration in the European Union as a Class 2a Medical Device, which would require approval by a Notified Body.
In addition to providing initial support during implementation of the management system, the team were keen to retain Daniel as a subject-matter expert to help train and educate internal staff available through our Quality Management as-a-Service offering. This support ensures they remain compliant whilst allowing for necessary governance updates following staff changes, all for a fixed monthly fee.
Working with Karen Whitton, Head of Clinical Safety, Simon Santos, Head of Information Governance and Annie Marsh, Project Support Co-Ordinator, each of the 5 domains of DTAC was addressed, considering existing controls and the requirements of the ISO 13485 compliant Quality Management System.
Karen worked closely with Daniel and the Engineering Team to establish an integrated Clinical Risk Management system, harmonising the requirements between ISO 14971, the medical device risk management standard and DCB0129, the NHS Clinical Safety Standard. This was an essential activity, meaning that updates to the Hazard Log would be equivalent for both standards, the Risk Management plan remained consistent, and she could play an integrated role in the ongoing management of the QMS. We believe it is essential for Clinical Safety Officers (CSO) to have an integrated role with Quality and Regulatory functions. This ensures that documentation is not duplicated and risks are accurately interpreted by a trained healthcare professional.
Simon helped the team augment their existing information governance and security practices to comply with UK and EU GDPR requirements, whilst also ensuring compliance with the NHS Data Security Protection Toolkit (DSPT), an essential tenet for NHS market entry. By integrating controls into the modular management system, Simon was able to consolidate documentation and work with key individuals to address the requirements of the DSPT and ensure a wholesale approach to information security and data protection, preparing Brain+ for compliance in the future with ISO 27001.
Annie worked closely with the team to finalise their DTAC submission and also address the requirements of Cyber Essentials. Working closely with Simon, Daniel and Karen, Annie was able to utilise the modular management system to easily locate documentation and develop a compliant and detailed DTAC submission, ensuring that future versions can be easily updated without duplication.
It’s hard implementing these standards in a busy startup team while entering a new market, and we benefited greatly from having a trusted partner like 8fold help guide us through the transition.
Simon Nielsen, Chief Strategy and Innovation Officer
Through our collaboration, not only were Brain+ able to launch their product into the UK, but they also experienced many additional benefits through our Modular Management System implementation, namely:
Overall reduction in ongoing compliance costs – By working with our team as trusted partners, they removed the need for additional headcount to manage their QMS and supporting documentation. Through a clear, integrated approach, updating and improving documentation has become simple and manageable, allowing the business to focus on impacting the lives of individuals with dementia
Improved Process across multiple departments – The Quality Management system has helped Brain+ streamline activities and supported a cultural shift toward accountability across all teams. By continuing to collaborate with the 8fold team, it has given the business confidence in its ability to get the right advice, at the right time, in line with best practices to move product development forward.
Successful Procurement in 3 leading UK Home Care Groups – Based on the effectiveness of the platform and the assurance provided through the collaboration with 8fold, Brain+ have been aale to realise their ambition of launching into the UK market.
Whilst the focus remains on building momentum in the UK Home Care market, Brain+ hopes to register its Medical Device in the EU in the future, enabling access to the broader European Market. By working with 8fold, they aim to make this transition seamless, building upon the strong governance foundations they have established in the UK to bring impact to dementia patients worldwide.
If you’re building a Software product for the UK Healthcare Market and want to address the many statutory, regulatory and NHS-specific compliance requirements without the administrative overhead, 8foldGovernance can help.
With an expert team of Governance, Regulatory and Compliance specialists, we can help you bring impact for patients, for healthcare, for good.
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