Artificial Intelligence, Regulation, and Cybersecurity in Medical Device Manufacturing

 – LifeFactFuture webinar offered a deep dive into current industry challenges

On May 21, the LifeFactFuture webinar brought together experts in medical device manufacturing, regulation, and technology to discuss the future of the field. The three-hour event with keynotes from Hannele Toroi (Bittium Oy) and Nelli Karhu (Fimea) and a strong panel discussion provided a concise yet diverse overview of how artificial intelligence, regulatory strategies, and cybersecurity are shaping the development and market access of medical devices.

AI is not a single solution – but a set of questions

A clear message emerged from the webinar: Artificial intelligence is not a single, unified solution, but its application in medical devices is always case-specific. Discussions explored, for example, what information AI might overlook and how its outputs can be trusted. The connection between AI and quality management was seen as critical – especially when it comes to patient safety and regulatory approvals.

Make the use of AI explainable – also for those who are not experts in AI

From the perspective of the regulatory authority, Nelli Karhu of the Finnish Medicines Agency (Fimea) underlined that existing requirements for Technical documentation (Annex II) demands that the technical documentation shall be presented in a “clear, organized, readily searchable and unambiguous manner”, and that it “shall include a justification, validation and verification of the solutions adopted”. This entails, following current regulations, that if AI is used in the manufacturing processes of a medical devices, this should be described clearly, and it should be described in such a manner that it can be understood even by non-AI experts.

Regulatory strategy – a competitive edge for the future

Several speakers, including Hannele Toroi, Nelli Karhu, and Tuomas Granlund, emphasized the importance of regulatory strategy as a core part of business operations. Companies were encouraged to build their own regulatory expertise rather than relying solely on external consultants. A strategic approach to regulation was seen not only as a competitive advantage but also as a prerequisite for long-term product development.

“To ensure future-proofing, a lot of internal work and research is required from the organization.”
— Tuomas Granlund, Solita

Cybersecurity – not an add-on, but a foundation

One of the strongest themes of the webinar was cybersecurity. Companies such as Revvity, Darekon, Bittium, and Solita highlighted that secure software development, data ownership, and reliable partners are critical – especially when serving sensitive sectors like defense or life sciences. Fimea’s message was clear: sensitive business information must be protected with robust cyber defenses.

Collaboration and dialogue

In the interactive Miro workshop and panel discussion, the 100+ registered participants had the opportunity to share their insights and experiences. The discussion revealed that industry players not only seek information but also platforms where they can openly explore solutions to shared challenges.