The HEU-EFS Consortium has announced its creation. This four-year project, funded by the Innovative Health Initiative of the Horizon Europe Framework Programme and involving 22 public and private organizations from across Europe (including the EEA and Switzerland), aims to improve the pathway for generating early evidence for medical device innovators. This will help promote access to innovative technologies for patients with unmet needs, strengthen excellence in clinical development, increase the attractiveness of the EU, and support healthcare system efficiency. One of the participating entities is the Hospital Clínic de Barcelona, member of CataloniaBio & HealthTech. 

Technological innovation in healthcare continues to expand to meet the growing needs of patients. However, the journey that innovators take to bring these innovations to patients in a timely and harmonized manner has become long and complex. This is partly due to rising R&D costs, increasingly stringent European regulations, and the lack of harmonized approaches among Member States for early evidence generation. 

HEU-EFS aims to reverse this trend. It will focus on developing a harmonized approach for EFS for medical products in the European Union. EFS are small clinical studies designed to gather information on an innovative medical technology at an early stage of the development process, before initiating a larger clinical trial. 

HEU-EFS will develop and validate a robust and unified approach that allows for early insights into technological evidence generation and makes the EU a conducive environment for undertaking EFS. This will help improve the efficiency and effectiveness of product development and ensure that the EU can attract investments towards patient-centered and user-efficient innovations that add value to the healthcare system. 

The consortium is funded by a €19 million grant from the Innovative Healthcare Initiative (IHI), a public-private partnership between the European Commission and European life science industry associations. The project is coordinated by Bocconi University, with industrial partners led by Edwards Lifesciences.