Understanding the regulatory pathway, with Spotlab

Hardian worked closely with Miguel, co-founder of Spotlab and Adriana, Spotlab’s biomedical engineer and regulatory affairs manager to assist them with CE marking for their software IVD.

Spotlab is a social enterprise on a mission to use AI medical imaging diagnostics to democratise access to diagnosis - reducing the times, costs, distances and carbon footprint of existing imaging methods. As well as creating AI diagnostic software, Spotlab is also using 3D printing to transform our smartphones. Bringing software, an app-based interface and 3D printed hardware together, Spotlab has created an end-to-end diagnostic ecosystem, focused across a range of areas including infectious diseases, haematology and pathology.  

When I first heard about Spotlab, I was fascinated by how they’d successfully taken something as ubiquitous as a mobile phone and turned it into something that can digitise some forms of medical imaging, and, in the pathology space, can also review and analyse blood and microscopic samples. To myself and the Hardian team, it was clear that they were on the road to creating an entirely new paradigm.

I caught up with Miguel and Adriana to discuss where the idea came from and their journey through regulatory pathways to becoming a certified medical device.

The regulatory reality and the power of partnership

As a spin out from the Polytechnic University of Madrid, Miguel and the Spotlab team initially began their work as a cutting-edge research project. As a collective, they had an understanding of the healthcare and medical space, and so, as their research snowballed from research project into a proof of concept and by engaging with end-users, they realised the time had come to ‘level-up’ and align with the appropriate quality and security standards. 

Miguel and team quickly realised the risks and complexities of the regulatory frameworks and consequently approached Hardian Health for partnership and support and I’m delighted they did so for the opportunity to work with them.

It’s true; regulation is a long and complex process. Bringing complex technologies and AI algorithms into those frameworks is more complicated still. At Hardian Health, we often find that the first regulatory submission for a client is often the longest and the hardest, because, frankly, there is a new language and framework to learn, and in a small company, it’s often a steep learning curve for many of the team. However, by the end of our time working together in the initial phase, Spotlab were able to work through additional regulatory processes far more quickly and with relative autonomy - a goal that we pride ourselves on at Hardian Health.

Unchartered territory

The shared learning process is a critical one, especially for AI-led innovations where there is not always a clear regulatory pathway. With our more innovative clients that are breaking new ground, we often work together to fully understand the product whilst carving out a brand new regulatory pathway that is fit for purpose and specific to the technology’s specific use case and nuance. This was our approach with Spotlab.

The combined IVD hardware and Software-as-Medical-Device (SaMD) offering that Spotlab has built was a welcome challenge for Hardian to unpack and de-risk. Complex, lengthy regulatory steps, whether those stipulated by the CE marking process or the UK’s MHRA, have to be broken down into small manageable steps.

The first stage was to take inventory; advice I would give any company looking to approach regulation. This means asking yourself - where did you start? Where have you got to? And where do you want to go? Spotlab’s platforms can best be described as combining image acquisition, telemedicine services and AI algorithms, so, naturally, even the regulators themselves might struggle to know where to begin! After much deliberation, we went back to basics and together took a stepwise approach, focusing first on achieving IVD regulation to lay the foundation for the submission and approval of the clinical algorithms. As a consequence, building on those experiences, it’s been quicker and easier for them to produce and receive approval on newer algorithms. 

Looking to the future, Miguel now has big plans for Spotlab. For the company, one algorithm is just the beginning; a gateway to something much bigger. They’re on a mission to build an ‘AI factory,’ which is how they will assist with the AI diagnosis of 105 different diseases that they’ve already identified. Creating the AI factory has enabled them to develop a robust roadmap with structured and replicable parameters for how the data is created, how the algorithm is trained and how the bias of the algorithm is assessed. 

I like the term factory. When a company brings a product to market, they have to invent every single one of the processes, and we’ve worked with the Spotlab team to ensure that their processes are suitable for regulatory submission. So as they progress from a single product and regulatory submission, not only will they have built an AI factory, together we’ll have also created a regulatory factory that complements and supports the AI factory, to ensure that the algorithms for every one of those 105 diseases can receive approval. That learning can then be applied to every company that wants to create such a factory in future.

When you know what you know, ask for help with what you don’t

I asked Miguel what advice he’d give himself if he could go back to the beginning. Whilst he credits much of Spotlab’s success to having a diverse and multidisciplinary team, his advice is to seek out an expert to support you in areas where you need help. When we spoke, he explained that regulation can be a huge barrier to entry for many startups in the medical device space due to the abundant complexities and I’m very pleased that our team was able to add so much value - particular thanks goes to Mike Pogose on my team for his hard work. 

Through my experience with Spotlab, I’ve seen just how important partnership is, and the value of taking a measured approach to get things right the first time around. As a result, the company has gone from strength to strength and the time investment they made in those early stages is paying back many times over now as they continue to accelerate new algorithms through approval, sending them on their way to achieving that 105 milestone.

Hardian Health is clinical digital consultancy focussed on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.