Technological innovation in health care continues to expand to respond to increasing patient needs. However, the innovators’ journey to bring such innovations to patients in a timely and harmonised manner has become long and complex. This is partly due to rising R&D costs, ever-stricter European regulations as well as a lack of harmonised approaches in Member States for early evidence generation.
This creates uncertainty for innovators and a decline in attractiveness of Europe, with delays in bringing these breakthrough technologies to the EU market. Ultimately patients in Europe are missing out on the latest medical technology innovations that could improve their prognosis and quality of life. HEU-EFS aims to contribute to revering this trend. It will focus on the development of a Harmonised Approach to EFS for Medical Devices in the European Union. EFS are small clinical studies designed to gain early insights into an innovative medical technology early in the development process, before starting a larger clinical trial.
EFS represent a crucial first step in the evidence-generation pathway, allowing innovators to test their potentially breakthrough innovations and build a robust business case, and the healthcare systems to better accompany the introduction of those new innovations that could bring value to patients in need.
Although the possibility to undertake EFS is formally recognized by the international standard, in the EU there is no procedure, standard or guideline dedicated to this type of study. This means that EFS are barely used in Europe, and early evidence generation is taking place elsewhere in the world. HEU-EFS will develop and validate a robust, unified approach to allow early insights into technology evidence generation and to make the EU a conducive environment to undertake EFS. This will contribute to improving efficiency and effectiveness of product development, and ensure that the EU can attract investments into patient-centric, end-user efficient innovations, that bring value to the healthcare system.
“The HEU-EFS program is a crucial step for positioning the EU as a worldwide epicenter for cutting-edge technologies. This strategic stance will draw investments in research and development, ideas, and expertise, thereby ensuring swift access to top-tier healthcare for patients”, says Rosanna Tarricone, Associate Professor at the Department of Social and Political Sciences and Associate Dean for Government, Health and Non-Profit Division SDA Bocconi, Bocconi University. The consortium is funded by a €19 million grant from the Innovative Health Initiative (IHI), a public-private partnership between the European Commission and European life science industry associations. The project is coordinated by Bocconi University and the industry partners are led by Edwards Lifesciences. Engagement of wide range of stakeholders – universities, hospitals, contract research organizations, patient associations, health technology assessment agencies, MedTech companies and start-ups, regulatory authorities, notified bodies, professional associations and members of ethics committees – will drive a wide acceptability of the framework across countries and sectors.
According to Andrea Rappagliosi, Senior Vice President Public Affairs EMEA, Canada and LATAM at Edwards Lifesciences, “The new HEU-EFS EU program will allow innovative MedTech companies to significantly contribute to improve access for patients in Europe. This will contribute to a triple win: a healthier population, a more efficient health and hospital system, and a more attractive and competitive EU”.
“Global Heart Hub is delighted to be part of the HEU-EFS project consortium, teaming up with the European Patients’ Forum (EPF) to advance patient centricity in the project. Global Heart Hub strive to ensure the patient voice is heard, represented and meaningfully engaged early on, benefitting everyone involved in the development and use of medical devices,” says Neil Johnson, Executive Director, Global Heart Hub