No medical device can be sold in Europe without a CE mark. From pulse oximeters to diagnostic software, there are now over 106,000 product families that must undergo this process, yet there are just 52 bodies authorised to carry it out, with ever-dwindling staff numbers. Whilst those in need of more effective diagnoses and treatments have to wait longer, the companies developing them – 90 per cent of which are start-ups and SMEs – rarely have an in-house regulatory structure capable of managing the required documentation. Ardeevo was set up to offer them precisely this expertise.
At the heart of this Rome-based start-up, founded in partnership with Znext, lies the combination of the two founders’ legal and technological expertise: Giovanni Stracquadaneo, a legal expert, lecturer in healthcare innovation and serial entrepreneur, and Alessandro Santopaolo, an expert in artificial intelligence applied to healthcare and robotics.
Ardeevo supports companies throughout the entire regulatory process for medical devices, from product qualification and classification right through to the submission of the technical dossier. The entry point is Clark, the platform’s regulatory assistant, who gathers information via a guided interview and guides users through the next steps as they arise.
Based on this data, an artificial intelligence system consults a knowledge base comprising hundreds of regulatory documents, drafts the sections of the dossier, links each statement to the relevant regulatory reference from which it derives, and checks the overall consistency of the dossier. No document is issued without undergoing a mandatory review by an expert.
It is precisely this combination that sets Ardeevo apart. According to a survey carried out by the start-up among 70 industry operators, no other company currently combines, within a single platform natively based on artificial intelligence, the consistency check of the entire technical dossier, the selection of the most suitable notified body for each individual device, and systematic review by regulatory experts.
The business model turns the traditional consultancy model on its head: a fixed price per risk class, defined delivery times and payments linked to stages of progress. As required by European legislation, the technical documentation remains the responsibility of the manufacturer, whilst the conformity assessment is the responsibility of the notified body. Ardeevo intervenes at an earlier stage – the stage where most delays and costs currently occur.
“Today, regulatory matters are seen as an obstacle to be dealt with at the end of a project, when the product has already been built and any changes cost time and money. We want to bring them to the very start of the process and turn them into an advantage, because those who know the rules from day one design better and reach the market sooner,” explains Stracquadaneo, CEO (pictured on the left alongside Santopaolo), in a statement. “In other words, Ardeevo provides start-ups and SMEs with the same regulatory expertise that large companies can rely on, without the burden of an in-house team.”
As with every start-up in its venture-building programme, Znext is partnering with Ardeevo as a co-founder, providing a pre-seed investment of 150,000 euros, ongoing operational support and access to the expertise and network of the Zanichelli Group. Ardeevo thus becomes the fifth company on the industrial platform established on Zanichelli’s initiative, following Ekory, Pausetiv and Zetamed – all launched as part of the venture-building programme – and Factanza Media, in which Znext acquired a majority stake last April.
This decision is aimed at a large market. According to a press release issued by the company, the European medical technology market is worth around 170 billion euros, accounting for 26.4 per cent of the global total, second only to the United States. According to Ardeevo’s estimates, expenditure on compliance with the MDR and IVDR regulations will reach around 22 billion euros by 2033.
“Bringing artificial intelligence to a regulated sector such as the medical sector means changing the way thousands of businesses operate, starting with SMEs and start-ups. It is they who are currently feeling the brunt of the imbalance in a sector where certification requests are on the rise, whilst the capacity to assess them is dwindling,” says Elena Lavezzi, CEO of Znext. “Ardeevo is exactly the kind of business we want to build. Giovanni and Alessandro have complementary skills; they understand the problem from the inside and have identified a market that has so far been only partially served. Our role is to give this insight the industrial solidity it needs to become a business.”
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