AI in MedTech: Navigating Opportunities, Challenges and Risks
📍 Join us on March 19 from 10:00 to 13:00 at Mektory, Tallinn or online for the third edition of the Health Founders Estonia Regulatory Sessions.
As AI transforms healthcare, MedTech companies face a new frontier of possibilities — and responsibilities. This session dives deep into what AI means for product development, regulatory compliance, and quality management in MedTech, we cover opportunities, challenges and risks.
🗓️ Agenda:
10:00 – 10:15 Arriving, registration, light breakfast, welcome + Start of the live stream!
10:15 – 10:40 Keynote by Matthew DiFranco: "AI in MedTech: Opportunities — From Wellness Apps and SaMD to Lifecycle Automation and LLM-Powered Compliance" + Q&A
10:40 – 11:05 Keynote by Matthew DiFranco: "AI in MedTech: Challenges — Navigating Performance, Workflow Integration and User Needs" + Q&A
11:05 – 11:35 Networking Break with light appetizers (30 minutes)
11:35 – 12:00 Keynote by Matthew DiFranco: "AI in MedTech: Risks — Cybersecurity, Bias, Overreliance and Performance Drift" + Q&A
12:05 – 12:40 Panel Discussion: AI in MedTech — Real-World Perspectives from Entrepreneurs, Consultants and Regulators + Q&A
12:40 – 13:00 Networking
Who should register?
📣 This event is ideal for MedTech start-ups and scale-ups that are:
Exploring or developing AI-powered products, from wellness apps to SaMD
Working to understand regulatory expectations around AI under MDR/IVDR
Looking to leverage AI tools in their QMS or compliance workflows
Concerned about managing AI-specific risks such as bias, drift, or cybersecurity
We also welcome public sector representatives, researchers, and ecosystem stakeholders involved in healthcare regulation, AI governance, or supporting MedTech innovation.
The event will be held in English as a hybrid event — on-site at Mektory, Tallinn and online. Seats are limited. The organizer reserves the right to review registrations to ensure the maximum number of relevant participants.
🚨 1:1 Office Hours with Matthew DiFranco.
We are offering up to 6 companies the opportunity for 1:1 individual office hours (25 minutes per company) with Matthew DiFranco.
To register, please send an email to [email protected] including your TRL level, elevator pitch, intended purpose of the device being developed, and any specific topics or questions you'd like to address. Selected startups will be confirmed on a rolling basis.
The HFE program is funded by the EU through Enterprise Estonia, in collaboration with Startup Estonia, to build a strong, globally competitive health tech ecosystem in Estonia.