ISPOR 2025
Bridging the Gap in Early Stage Clinical Research: Lessons for EU Stakeholders From the US FDA Early Feasibility Studies Program
Date: 15/05
Time: 13:45 – 14:45 (PDT)
Location: Montreal, QC, Canada
Session Type: Concurrent Breakout Session
Join us for an engaging session on Bridging the Gap in Early Stage Clinical Research: Lessons for EU Stakeholders From the US FDA Early Feasibility Studies Program. This event will explore the challenges and opportunities in early-stage clinical investigations for medical devices (MDs) and what the EU can learn from the US FDA’s Early Feasibility Studies (EFS) Program.
Moderator:
- Giuditta Callea, PhD, SDA Bocconi School of Management, Milano, Italy
Speaker:
- Kevin Drisko, Edwards Lifesciences, Irvine, CA, United States
Session Overview:
- Issue: Developing innovative, significant risk MDs often requires early-stage clinical investigations when non-clinical testing is unavailable or not informative. The US FDA’s EFS Program, established in 2013, provides guidance and oversight to MD developers while safeguarding patients. The fragmented EU regulatory system poses challenges to conducting EFS, potentially hindering innovation. This session will discuss what the EU and other global jurisdictions can learn from the FDA’s experience to facilitate safe and harmonized EFS.
- Kevin Drisko (EDW) will offer insights into the advantages of EFS as an integrated step in MD clinical evidence generation.
- Prof. Giuditta Callea will discuss the challenges of pre-market clinical research for MDs in the EU, representing multi-stakeholder perspectives and presenting findings from the HEU-EFS project.
- Audience Q&A: Prof. Callea will direct audience questions.
This session is highly beneficial for regulators, healthcare providers, patient associations, academic and research organizations, CROs, ethical and legal experts, and technology developers. Don’t miss this opportunity to gain valuable insights and engage with experts in the field. Register here!
MedTech Forum 2025
Empowering European Innovators With Early Feasibility Studies
Date: 14/05
Time: 14:10 – 15:00 (GMT+1)
Location: Lisbon, Portugal
Session Type: Parallel session
Join us for an insightful session on Empowering European Innovators With Early Feasibility Studies (EFS). This event is part of the HEU-EFS project, an initiative by the Innovative Health Initiative (IHI) aimed at developing a harmonized EU framework to enhance the uptake of EFS for medical devices across Europe. EFS are vital in the evidence-generation cycle for medical devices, and conducting these studies in a coordinated manner will bring significant benefits to patients, innovators, and the entire healthcare system.
Moderator:
- Niklas BLOMBERG, Executive Director, Innovative Health Initiative (IHI)
Speakers:
- Alexandra POULSSON, Senior Advisor, Division for Health Services, Norwegian Institute of Public Health
- Laura SAMPIETRO-COLOM, Innovation Deputy Director, Head Assessment Innovation and New Technologies Unit, Clinic Barcelona University Hospital
- Rosanna TARRICONE, Associate Dean at SDA Bocconi, SDA BOCCONI SCHOOL OF MANAGEMENT
- Fanny VAN DER LOO, Senior Director Government Affairs EMEA, Canada, Latin America, Edwards Lifesciences
- Yasemin ZEISL, Project Coordinator, European Patients’ Forum (EPF)
Don’t miss this opportunity to learn from leading experts and engage in discussions that will shape the future of medical device innovation in Europe. Register here!
World Health Day 2025
Celebrating World Health Day 2025: Embracing Healthy Beginnings for Hopeful Futures
Our commitment to healthcare innovation ensures that every individual has access to the medical advancements they need.
As we acknowledge the importance of April 7, #WorldHealthDay, we highlight the transformative impact of technology in innovating for better healthcare systems.
At HEU-EFS, a public-private partnership of 22 institutions, funded by the European Commission, our lifecycle approach to clinical evidence generation involves stakeholders from the outset, aligning medical innovation with safety and regulatory standards to foster a robust healthcare ecosystem.
The Early Feasibility Studies (EFS) initiative is a testament to our dedication to timely innovation. It’s not just about access to new technologies but ensuring these advancements are safe, effective, and enhance patient care.
Together, let’s celebrate the cause of health equity and uphold the right to health as a fundamental human right.
Join the cause for a healthier future for all!
HEU-EFS Interim Consortium Meeting
On Monday, April 7th, our Consortium partners, Advisory Board, and Patient Advisory Group held a productive interim meeting, focusing on the latest advancements from several work packages.
Key Highlights:
- Guest Speaker: We were delighted to welcome Danielle Giroud, who presented the latest updates to ISO Standard 14155.
- Valuable Input: The Advisory Board and Patient Advisory Group provided essential feedback on the importance of clear processes, stakeholder involvement at both EU and national levels, data collection, templates, and checklists.
- Next Steps: We outlined the next steps for the pilot use-cases, aiming to test and improve the future EU EFS Program.
A big thank you to all contributors for making this meeting valuable and productive. Together, we are laying a strong foundation for future success!
SDA Bocconi Fundació Clínic per a la Recerca Biomèdica Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) Hospital Clínic de Barcelona Agenas Greater Paris University Hospitals – AP-HP Idris Oncology BV Meditrial Norwegian Institute of Public Health Trinity College Dublin The Philipp University of Marburg CIMT – Centre for Innovative Medical Technology Carmat Fondazione Policlinico Universitario Agostino Gemelli IRCCS European Patients’ Forum Newronika S.p.A. Global Heart Hub Qurasoft Edwards Lifesciences Europe Medtronic W. L. Gore & Associates Philips Abbott DePuy Synthes
Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe
Work Package 3 Video Guide
We are pleased to share the progress being made in Work Package 3 of the HEU-EFS consortium, dedicated to enhancing early feasibility studies (EFS) for medical devices across Europe.
We invite you to watch the video to learn more about our work and its impact.
Alexandra Poulsson from the Norwegian Institute of Public Health and the Norwegian Medical Products Agency is leading efforts to develop comprehensive eligibility criteria for EFS. Her work ensures that technologies, medical conditions, patient severity, evidence levels, clinical sites, and expertise are all meticulously evaluated to pave the way for successful studies.
Nataliya Deych, Regulatory expert at Edwards Lifesciences Europe, emphasises the importance of collaboration between industry and regulators, highlighting the critical role of patient perspectives in shaping regulatory decisions. This commitment to innovation drives efforts to bring cutting-edge clinical programmes to European stakeholders.
Carlo Federici from SDA Bocconi contributes his expertise in health economics and technology assessments. Carlo’s research focuses on analysing the current state of pre-market clinical investigations and proposing a robust framework for EFS in the EU. His work is crucial for ensuring that medical devices are evaluated with the right evidence at the right time.
Visit heuefs.eu and follow us on LinkedIn https://lnkd.in/ekMx-4mp and X https://twitter.com/HEUEFS as we advance towards a harmonised approach to early feasibility studies, ultimately enhancing patient access to innovative medical technologies.
Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe
#IHITransformingHealth #PatientCare #Evidence #MedTech
Privileged Talk on Enhancing Access to Innovative Medical Devices
At SDA Bocconi premises, the event titled “Privileged Talk: Adopting a Lifecycle Approach to Enhance Access to Innovative Medical Devices: Regulatory Insights and Future Perspectives Amid the Ongoing Targeted Evaluation” gathered experts from industry, regulators, and academia. The discussion focused on the ongoing evaluation of the EU Medical Device Regulation (MDR), Early Feasibility Studies (EFS), the potential for an Accelerated Access Program, and the evolving link between the MDR and the Health Technology Assessment Regulation (HTAR).
Flora Giorgio (DG SANTE, European Commission), along with regulators, industry leaders, and other stakeholders, addressed key challenges and proposed solutions to refine the MDR framework. The event aimed to gather insights from various experts to enhance access and innovation in the medical device sector. Giuditta Callea (SDA Bocconi) presented the EU project on EFS to improve evidence generation, while Rosanna Tarricone (SDA Bocconi) proposed an Accelerated Patients’ Access Program for breakthrough medical devices. Marco Marchetti (AGENAS) discussed integrating the Joint Clinical Assessment (JCA) with MDR, and Flora Giorgio outlined the Commission’s priorities to improve predictability and reduce burdens while safeguarding patient safety. Andrea Rappagliosi (Edwards Lifesciences) highlighted the slow certification processes delaying innovation, and Phil Collis (Patient Advisory Group Representative) emphasized the need for stronger post-market surveillance.
The consortium emphasized the importance of collaboration among all stakeholders to boost efficiency, predictability, and innovation while safeguarding patient safety. The objectives are to improve the MDR to facilitate better access and innovation in the medical device sector, resulting in enhanced regulatory processes, faster certification, and stronger post-market surveillance.
The HEU-EFS project, involving 22 public and private consortium partners, aims to systematize information regarding the regulatory framework and pre-market evidence generation programs, develop and validate a robust methodology, and create a conducive environment for undertaking EFS in the EU.
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.
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.