From backend to bedside: Practical steps to launch a digital medical device
Bringing a digital medical device to market in Europe is no small feat: regulatory hurdles, technical infrastructure, hospital procurement processes, and market positioning all need to come together at the right time, in the right way.
This hands-on workshop brings together four practitioners who work in the trenches of digital health every day, each covering a critical pillar of a successful market entry. Expect honest, experience-backed insights, plenty of time for Q&A, and practical takeaways you can act on straight away.
📅 AGENDA
08:30 — Registration
09:00 — The right people at the right time, Andreea Munteanu, Hive
09:15 — Regulatory architecture, Stefan Bolleininger, Consultys
DMD classification, notified body expectations, clinical evidence planning and realistic timelines. Followed by Q&A
09:40 — Technical backend & deployment readiness, Eric Krzeslo, iCure
Backend architecture, interoperability, data governance, cybersecurity and documentation. Followed by Q&A
10:05 — Hospital engagement & pilot deployment, Henk Vansteenkiste, Vixor Health
Engaging healthcare providers, structuring pilots, navigating procurement and building long-term partnerships. Followed by Q&A
10:30 — Becoming loved by doctors and patients, Hélène Viatgé, AppThera
Physician enablement, behavioural barriers to adoption, workflow integration and cultural blind spots.
11:00 — Close
⚠️ Important note:
This workshop is organised as a side event of the European Digital HealthTech Conference hosted by Luxinnovation.
Please note that registration for the main conference is mandatory in order to attend this session. Hive will share the list of registered participants with Luxinnovation to ensure that all attendees are correctly registered for the conference.