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 Governance Experts + 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.
SPEAKERS:
Matthew DiFranco has 20+ years international experience in healthcare innovation, including AI in radiology, medical imaging machine learning research, digital pathology, medical device design and characterization, nuclear medicine and pre-clinical imaging.
Over the past few years Matthew has worked with health tech start-ups at the management and executive levels to shape product, regulatory and clinical strategies.
As Chief Scientific Officer at ImageBiopsy Lab, a Vienna-based startup delivering validated, reliable automation to musculoskeletal radiology, Matthew led FDA and MDR clinical validation strategy for a novel AI radiology software as a medical device (SaMD), managed scientific key accounts in academia as well as the Pharma and Medical Device industries, and identified emerging innovations and applications for AI in medical imaging.
Hille Hinsberg is a member of Estonian Connected Health Cluster and works to leverage data-driven innovation in health and care services. She works at the intersection of service design, analysis, and digital solutions, helping organisations choose, evaluate, and implement solutions that actually work in practice.
Hille is supporting governments across the world design efficient governance processes and digital services. With 20+ yrs of experience as a policy analyst, impact evaluation expert and digital transformation consultant, she has worked for the government, a non-profit think tank, the Open Government Partnership global network, and the OECD. She has Master´s Degree in Technology Governance and Digital Transformation.
Hille is an active enthusiast of open government, open source technology and data re-use, being founder and board member of Open Knowledge Estonia.
Toomas Seppel specializes in law pertaining to the technology and creative industries. He is working with various start-ups, FinTech, e-commerce, SaaS, tech defence and health tech companies.
Within the technology industry, he advises on EU laws concerning software-based services, implementation of new technologies, and expansion into new business markets. He also covers matters related to companies with crypto-based business models.
Toomas takes a proactive stance on the current concern with privacy, data laws, and AI, advising companies on the building of products and services that comply with the General Data Protection Regulation (GDPR) and AI Act. Since 2018, he is the founder of GDPR Register, a legal tech company providing software for GDPR compliance.
In the music and film industries, he advises all participants, including publishers, labels, artists, composers, managers, and film producers.
The focus extends to contract law matters, copyrights, financing and funding structures, rights clearance, and image rights, supporting creators through development, production, and distribution.
He actively mentors startup companies through Prototron and Tehnopol programs – key players in the Estonian start-up ecosystem – and advises Solaride pro bono.
He is also frequently recommended by Chambers Europe, IFLR1000, and The Legal500.
Siim Nahkur is the founder and CEO of Synbase, an Estonian healthtech company providing clinical decision support to healthcare professionals across multiple countries. Under his leadership, Synbase launched Estonia's first nationwide clinical decision support service in 2020 — recognised as Estonia's Best Public Digital Solution in 2021.
Siim has a background spanning Celsius Healthcare, the Estonian Connected Health Cluster, and Kliinik.ee, and holds a degree from TalTech.
He is also a co-author of peer-reviewed research on health data use in primary care and the developer of WiseSpace, a tool for secure healthcare data de-identification. Synbase has been recognised with the European Quality Innovation Award in Healthcare (2018) and the Estonian Quality Association Annual Award (2016).
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.