Much of what has been written about the EU MDR emphasizes the increased regulatory burden that it puts on medical device companies. Giotto Compliance looked at the bright side of the new regulations and viewed EU MDR requirements as a catalyst to drive innovation in clinical evaluation workflow and an opportunity for regulatory teams to embrace digitalization and AI-powered automation.

Francesco Palma, an applied mathematician with experience in productizing artificial intelligence technologies and co-founder and Vice President of Product at Giotto Compliance, shares how new EU MDR requirements can benefit MedTech manufacturers and developers, beyond gaining regulatory approval.

How did EU MDR impact the development of the Giotto Compliance platform?

Palma: EU MDR started to become a hot topic as we were piloting a data extraction tool with a leading MedTech manufacturer to streamline literature reviews. Due to that timing, the EU MDR significantly impacted our product roadmap. From the beginning, we tailored our product functionalities on the specific use case of EU MDR compliance. The constraints of the new regulatory framework guided us in differentiating our platform from other generalist software.

Which areas of regulatory intelligence offer the most innovation potential?

Palma: The literature review process is often still very decentralised, manual and time-consuming. This area is a low-hanging fruit to start benefiting from digitalization and AI automation. But the potential for innovation goes much further. It makes no sense that the complete workflow of a CER is not fully digitalized, from the digital drafting and submission to digital revision and approval. This innovation must also be extended to the Notified Bodies to achieve efficiency gains throughout the whole CER workflow. This is an area where we see great potential for improvement and innovation.

What are the main challenges in transitioning to an automated, digitalized system, particularly after the EU MDR?

Palma: “Change management” on the customer side is probably the main challenge. When we present the platform to potential customers, they always perceive the tremendous impact that digitalization and automation can have in the clinical evaluation workflow. And there is always an initial “wow” factor, typical of innovative products.

Afterwards, customers understand that to embrace this innovation they need to change their legacy systems and workflows. The larger the company, the more difficult it is to change internal procedures and old habits. We have been able to tackle this challenge by having an ultra-customer-centric culture and offering a transition period in which we work closely with customers to ensure the product’s fit with the CER workflow is seamless and flawless.

What can we expect from automated platforms, such Giotto Compliance’s, in the future?

Palma: Our focus is on improving the current digitalization and automation features, but we want to go much further than that. Our vision for Giotto Compliance is to become the reference all-in-one platform to digitalize the entire clinical evaluation process of medical devices under EU MDR. This includes the digitalization of end-to-end activities related to data collection, screening and analysis in line with compliance requirements as well as solutions allowing customers to draft, submit and update entire CERs in digital and collaborative revision frameworks. The ultimate objective of Giotto Compliance is to provide all parties involved in the certification process with a unique interface where all data and decisions can be easily consulted, questioned and clarified.

Working alongside great customers and the right partners, we can translate that ambition into the most powerful all-in-one platform for clinical evaluation reports.