A video guide to the HEU-EFS project

In this video, you will hear from Rosanna Tarricone (SDA Bocconi) and Andrea Rappagliosi (Edwards Lifesciences Europe) as they explain the challenges and opportunities of medical device innovation in the European Union. You will also learn more about the HEU-EFS project’s objectives, activities, and expected impact.

At HEU-EFS, we believe that collectively, as a consortium of 22 institutions, SMEs and private companies, we can impact the health and well-being of people in Europe and beyond.

To learn more about the HEU-EFS’s progress and outcomes, follow us on LinkedIn and X.

Call for interest: Applications welcome for HEU-EFS’s Patient Advisory Group

Consortium partners are pleased to announce a call for representatives for a Patient Advisory Group (PAG) for the project ‘Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS)’. Applications remain open until 20 February 2024.

The Patient Advisory Group will discuss and provide recommendations for structured patient contribution to Early Feasibility Studies, in short EFS, to make more patient-centred medical devices. Early Feasibility Studies (EFS) are small-scale research studies or tests done in the very early stages of developing a medical device or treatment to see if it is practical, safe, and worth pursuing further. EFS help assess whether an idea or concept has potential before investing more time and resources into full-scale development and testing. The patient perspective in Early Feasibility Studies is highly important.

The PAG is meant to form a hub for patient centricity and engagement across HEU-EFS’s implementation. The aim is to recruit a maximum of ten representatives. Read more here

CSI Focus for Heart Failure

On December 4th, the HEU-EFS IHI initiative was presented at the annual leading conference in the field of device-based heart failure therapy, CSI Focus for Heart Failure (D-HF).

The HEU-EFS Consortium was invited to introduce the HEU-EFS project at a session dedicated to moving the field of heart failure focused devices forward. Moderated by Drs. Horst Sievert and William T. Abraham, the topic complemented the other speakers and was presented to a audience of clinicians and industry.

The program was positively received and enabled the expansion of the external advisory board to include representation of ethics committees.

More information on the conference and the session can be found here:  https://www.csi-congress.org/conferences-courses/focus-workshops/csi-focus-d-hf/archive

Other Materials

Callea, G.; Federici, C.; Freddi, R.; Tarricone, R. Recommendations for the Design and Implementation of an Early Feasibility Studies Program for Medical Devices in the European Union. Expert Rev Med Devices2022, 1–11. https://doi.org/10.1080/17434440.2022.2075729.

This paper explores the characteristics of EFS, focusing on the studies conducted under the US FDA EFS program, started in 2013, but with implications for similar studies in Europe made possible by the International Standard ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice and provisions in the EU Medical Devices Regulation, effective since 2021. The perceptions and opinions of an expert, multidisciplinary panel of key stakeholders (clinical investigators, biomedical engineers, academics, members of scientific and professional associations, members of ethics committees, developers of new technologies) were also collected regarding the need for an ad hoc EFS program in the EU to provide a standardized procedural framework these types of pre-market studies. Findings indicate a favorable environment for an EFS program in the EU, with process, resources and ethical issues indicated as determinant factors for its effective design and implementation.

Tarricone, R.; Ciani, O.; Torbica, A.; Brouwer, W.; Chaloutsos, G.; Drummond, M. F.; Martelli, N.; Persson, U.; Leidl, R.; Levin, L.; Sampietro-Colom, L.; Taylor, R. S. Lifecycle Evidence Requirements for High-Risk Implantable Medical Devices: A European Perspective. Expert Review of Medical Devices2020, 17 (10), 993–1006. https://doi.org/10.1080/17434440.2020.1825074.

The paper summarizes findings from an expert discussion group and supporting literature in addressing two broad research questions:

  1. What is the appropriate level (in terms of type, quantity, quality) and timing of evidence that is sufficient to satisfy value assessors and payers needs throughout the lifecycle of lifesaving implantable medical devices (MDs)?
  2. How could the evidence generation ecosystem be adapted to optimize patient access vis-à-vis risks for patients, healthcare providers, payers and technology developers?

Focused on high-risk, implantable MDs, the paper provides a review of the European regulatory and HTA environments for MDs, with reference to global regulatory environments, and outlines, describes and critically discusses clinical evidence generation needs throughout the lifecycle of MDs, divided into four relevant stages: i) pre-clinical, pre-market; ii) clinical, pre-market; iii) diffusion, post-market; and iv) obsolescence & replacement, post-market.

Tarricone, R.; Banks, H.; Ciani, O.; Brouwer, W.; Drummond, M. F.; Leidl, R.; Martelli, N.; Sampietro-Colom, L.; Taylor, R. S. An Accelerated Access Pathway for Innovative High-Risk Medical Devices under the New European Union Medical Devices and Health Technology Assessment Regulations? Analysis and Recommendations. Expert Review of Medical Devices2023, 0 (0), 1–13. https://doi.org/10.1080/17434440.2023.2192868.

This perspective article presents relevant literature and expert opinion to explore the need for an accelerated access program for medical devices in the European Union, that would combine elements of accelerated approval programs observed in other jurisdictions with post-approval evidence generation and monitoring needed for HTA, pricing and reimbursement. Leveraging learnings from accelerated approval programs worldwide, ties between the two new EU regulations, and provisions in the regulations for expert panel advice and increased stakeholder involvement, the recommendations cover various stages from the approval process through coverage and clinical uptake in the lifecycle of MDs, with the goal to safely speed patient access to innovative, life-saving technologies and increase collaboration among Member States on coverage decisions.

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Press release: Improving patient access to innovative medical technologies in the European Union

The link to the print version of the press release

European consortium to develop a “Harmonized Approach to Early Feasibility Studies for Medical Devices in the European Union” (HEU-EFS)

[30 January 2024, Milan] – The HEU-EFS Consortium has announced its creation. This four-year project, funded by the Innovative Health Initiative under the Horizon Europe Framework Programme and involving 22 public and private organisations across Europe (including EEA and Switzerland), aims to improve the early evidence generation pathway for medical device innovators. This will contribute to foster access to innovative technologies for patients with unmet needs, strengthen clinical development excellence, increase attractiveness of the EU, and support healthcare system’ efficiencies.

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”.