HEU-EFS Project Featured in the European Heart Journal
We are pleased to announce that the HEU-EFS Project has been featured in a special article in the European Heart Journal, administered by the European Society of Cardiology. This article, part of the Digital Health and Innovation section, discusses the priorities for medical device regulatory approval and highlights our project’s efforts to develop a harmonized framework for early feasibility studies (EFS) in the EU.
Key takeaways:
- EFS can speed the development of innovative devices and investigate initial safety and performance.
- The HEU-EFS Project aims to develop an EU harmonized framework to improve the uptake of EFS.
- The European Society of Cardiology advocates for the evolution of the Medical Device Regulation system to facilitate priority access for innovative devices addressing unmet needs and orphan cardiovascular (CV) medical devices in the EU.
- Global regulatory harmonization is essential to streamline CV medical device authorization across selected jurisdictions and enable the reprocessing of single-use devices.
Launched in January 2024, the HEU-EFS Project is a public-private partnership with 22 consortium partners working over the next four years to assess the current status of pre-market evidence generation and develop robust methodologies for EFS in the EU. Our project aims to improve the uptake of EFS and accelerate the development of innovative medical devices.
We invite you to read the whole article and learn more about our project.
Deliverables
Webinar: Patient Involvement in Medical Devices
Our partner, Global Heart Hub, represented by Marta Bragagnolo, Patient & Stakeholder Engagement Executive, delivered an insightful presentation on the HEU-EFS project during the recent webinar on Patient Involvement in Medical Devices, organised by the European Patients’ Academy on Therapeutic Innovation (EUPATI).
The webinar featured a diverse panel of experts, patients, academics, industry leaders, and regulators, discussing how new regulations are shaping the MedTech sector and sharing best practices.
Tom Melvin, Associate Professor at Trinity College Dublin, presented the regulatory perspective and Claudia Louati, Head of Policy at European Patients’ Forum, participated in the panel discussion.
Webinar key takeaways
- Patient-first approach: Involving patients from the early stages of medical device development is crucial.
- Training matters: Both patients and developers need the right tools and knowledge to collaborate effectively.
- DEI spotlight: Equal representation in studies for men and women is essential for better, more inclusive medical devices.
- New regulatory insights: Understanding the codes of principles and frameworks for patient involvement is key to making an impact.
Patient involvement in the HEU-EFS project
The Patient Advisory Group is crucial for the HEU-EFS project as it ensures that patient perspectives are integrated into every stage of the project. This involvement helps tailor medical devices to real patient needs, enhances the relevance and effectiveness of the solutions developed, and fosters trust and collaboration between patients and developers. By actively engaging patients, we can drive meaningful innovations and improve healthcare outcomes.
You can learn more about our efforts by reading the slides presented by Marta Bragagnolo.
You can watch the recorded session on EUPATI’s YouTube page.
#HEUEFS #PatientInvolvement #MedicalDevices #DEI #RegulatoryInsights
Ispor Europe 2024
[17-20 November 2024 | Barcelona, Spain] A look back to our participation at this year’s ISPOR Europe conference in Barcelona, a leading global event for Health Economics and Outcomes Research (HEOR).
Our team, alongside academic partners, presented three impactful research posters showcasing the latest evidence and findings in Early Feasibility Studies. These efforts underscore our commitment to improving patient care and healthcare efficiency.
Here’s an overview – follow the links for more information:
- Global Assessment of Pre-Market Approval Pathways for Medical Devices: Highlighting the Need for Harmonization across 55 Jurisdictions
Study from SDA Bocconi, presented by Francesco Malandrini
Read more
- The EU Regulatory Framework for Medical Device Early Feasibility Studies: What Do We Know to Date?
Study from Trinity College Dublin, presented by Majella Geraghty
Read more
- Use of Early Feasibility Studies to Inform the Development of Medical Devices
Study from SDA Bocconi, presented by Franco Luigi Zurlo
Read more
The HEU-EFS Project, supported by the Innovative Health Initiative (IHI) and involving 22 public and private partners, led by the Centre for Research on Health and Social Care Management (CERGAS) of SDA Bocconi, aims to establish a standardized methodology for adopting Early Feasibility Studies (EFS) in the EU. This 4-year project will have a significant impact on evidence generation along the medical device lifecycle and will improve patient access while positioning the EU as a leader in the MedTech sector.
A big thank you to everyone involved for their research and contributions at ISPOR 2024, making innovation possible and improving patient care.
Francesco Malandrini, Majella Geraghty, Franco Luigi Zurlo, Ornella Tangila Kayembe, Laura Sampietro-Colom, Giuditta Callea, Rosanna Tarricone, Carlo Federici, Tom Melvin, Nicolas Martelli, Andrea Rappagliosi, Adrián Valledor Sánchez, Monica Tocchi, MD, PhD, Alexandra Poulsson, Marta Kerstan Sebastian Kuhn, Daniela Catania, Silvia Vainieri, Philippe Auclair, Manon Gielkens, Cinzia Santin, Ruben Roijers Lise Kvistgaard, Helen Banks, Ilja Michaelis, Marlen Peseke, Maria Luisa Buzelli
Annual Consortium Meeting in Geneva
[7-8 October 2024, Geneva] – The HEU-EFS Consortium gathered for our annual consortium meeting, marking a significant milestone in our journey towards harmonizing Early Feasibility Studies (EFS) across Europe.
Meeting Recap:
- Research and analysis on the state of play of premarket programs and implementation barriers to EFS (WP1) & regulatory framework and institutional and organizational characteristics of EU competent authorities (WP2)
- The initial results of the research-focused work packages have been shared and discussed with the HEU-EFS advisory bodies, including the Patient Advisory Group and the Advisory Board. Their feedback is crucial to ensure that both WP1 and WP2 provide a solid foundation for methodology development activities.
- In reviewing the premarket programs, the University of Bocconi has designed a survey for MedTech innovators, including companies, SMEs, and start-ups involved in medical device development and clinical investigations. The survey aims to gather their experiences and challenges in pre-market clinical investigations. Take the survey here.
- Click here to watch what WP1 and WP2 are focusing on, as described by our Work Package leaders.
- Research and analysis on the regulatory framework and institutional and organizational characteristics of EU competent authorities (WP2)
- Engaged in interactive sessions with the Patient Advisory Group (PAG) and Advisory Board (AB) to gather valuable feedback.
- Methodology development: evidence requirements, data, and statistical tools (WP3)
- The orchestration of methodology development activities is now the primary focus of the HEU-EFS project. To establish a widely accepted framework, HEU-EFS ensures the inclusion of all key stakeholders in the methodology development process.
The collaboration and expertise of our consortium members were on full display as we worked together to address the challenges and opportunities within the EFS ecosystem. We are excited to share that our collective efforts are paving the way for a more efficient and effective European Health System.
Online Survey for Sponsors of Medical Device Clinical Investigations
Introduction
Sponsors of pre-market clinical investigations for medical devices are invited to participate in an online survey conducted as part of the Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) project (Grant Agreement no. 101112185).
Funded by the Innovative Health Initiative (IHI), HEU-EFS aims to develop a robust, standardized methodology and set recommendations to streamline Early Feasibility Studies (EFS) within the EU.
Establishing a clear, harmonized framework for EFS in the EU is expected to benefit patient access, innovation uptake and investment attractiveness in Europe.
Survey
This survey focuses on pilot pre-market clinical investigations (CI) to assess a medical device early in its development phase. These include first-in-human, early feasibility, and traditional feasibility clinical investigations. When answering, please consider specifically the challenges of planning, monitoring and conducting CI in Europe.
Take the survey https://bit.ly/HEU-EFS_Survey
The survey will be open until 11 November.
The results will be presented in a dedicated webinar and on the HEU-EFS project webpage.
ISPOR Europe 2024
[17-20 November 2024 | Barcelona, Spain] Representing the HEU-EFS project, partners from SDA Bocconi and Trinity College Dublin will present a series of poster sessions.
Subject of Debate
Innovative, high-risk medical devices can revolutionize treatment but often require numerous modifications before arriving at a final design. Addressing both the important risks and significant benefits for patients, research centres, regulatory bodies, and sponsors is crucial. The main objective of the 4-year HEU-EFS Project, funded by the Innovation Health Initiative and involving 22 public and private partners, is to develop a harmonized methodology for the uptake of Early Feasibility Studies (EFS) in the EU that mitigates risks and reinforces benefits for various stakeholders.
Poster Sessions and Presenters:
- Global Assessment of Pre-Market Approval Pathways for Medical Devices: Highlighting the Need for Harmonization across 55 Jurisdictions
Session Time: 18 November 4:00 PM – 7:00 PM – HPR67
Speaker: Francesco Malandrini from SDA Bocconi - Use of Early Feasibility Studies to Inform Development of Medical Devices
Session Time: 20 November 9:00 AM – 11:30 AM – MT58
Speakers: Franco Luigi Zurlo from SDA Bocconi - The EU Regulatory Framework for Medical Device Early Feasibility Studies: What Do We Know to Date?
Session Time: 18 November 4:00 PM – 7:00 PM – HPR98
Speaker: Majella Geraghty from Trinity College Dublin
Who Should Attend:
These poster sessions can provide valuable insights for a diverse group of stakeholders, including EU-wide and national regulators, competent authorities, notified bodies, HTA bodies, healthcare providers, patient organizations, research organizations, legal and ethical experts, CROs, and health technology developers.
Work Package 2 Video Guide
In this video, you will hear from Tom Melvin (Trinity College Dublin) and Nicolas Martelli (Hôpital Européen Georges-Pompidou) as they elucidate that Work Package 2 of the HEU-EFS project is dedicated to ensuring the future EU EFS Program aligns with existing regulations and standards, and involves evaluating the readiness of EU competent authorities to support robust pre-market clinical investigations, particularly for Digital Health Technologies.
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.
Work Package 1 Video Guide
In this video, you will hear from Giuditta Callea (SDA Bocconi) and Marta Kerstan (DePuy Synthes) as they explain the comprehensive research and analysis we employ as a consortium to understand Early Feasibility Studies (EFS) and their regulatory environment, ultimately aiming to develop a harmonised EU methodology that will enhance their adoption and support medical innovation in Europe.
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.