LIVE Discussion on Early Feasibility Studies & the HEU‑EFS Project

Organised by TrendSanità

TrendSanità recently organized a LIVE discussion dedicated to the growing role of Early Feasibility Studies (EFS) in advancing medical device innovation across Europe. The session featured Giuditta Callea, coordinator of the Horizon Europe–funded HEU‑EFS project, who contributed her expertise on how EFS can support fast yet safe pathways from laboratory development to real‑world patient access.

During the event, participants:

• Explored the objectives and latest outcomes of the HEU‑EFS project, including recommendations, templates, and metrics developed by 22 international partners
• Discussed how EFS strengthen early clinical evidence in alignment with ISO 14155 and EU regulatory requirements
• Reviewed the project’s achievements and looked at future directions for harmonising EFS across the EU
• Reflected on the strategic value of EFS for innovation, patient access, and the competitiveness of the European medical device sector

This LIVE session offered professionals from industry, clinical research, patient organizations, and regulatory fields an opportunity to gain clarity on the EFS landscape and engage with experts shaping its evolution.

Speakers:

• Giuditta Callea – SDA Bocconi School of Management, Principal Investigator HEU‑EFS
• Marta Bragagnolo – Global Heart Hub, HEU‑EFS Partner
• Guido Beccagutti – Director General, Confindustria Dispositivi Medici

Host:
Rossella Iannone, Editor‑in‑Chief, TrendSanità

See the full event here: https://trendsanita.it/dispositivi-medici-cosa-sono-gli-early-feasibility-studies/