MedTech Forum 2025
๐๐ฑ๐๐ฎ๐ป๐ฐ๐ถ๐ป๐ด ๐๐ฎ๐ฟ๐น๐ ๐๐ฒ๐ฎ๐๐ถ๐ฏ๐ถ๐น๐ถ๐๐ ๐ฆ๐๐๐ฑ๐ถ๐ฒ๐ ๐ถ๐ป ๐๐๐ฟ๐ผ๐ฝ๐ฒ
The #MTF2025 event in Lisbon, Portugal was a significant milestone for the project, which aims to revolutionize Early Feasibility Studies (EFS) for medical devices in Europe.
๐๐ฒ๐ ๐ง๐ฎ๐ธ๐ฒ๐ฎ๐๐ฎ๐๐
- ๐๐ผ๐น๐น๐ฎ๐ฏ๐ผ๐ฟ๐ฎ๐๐ถ๐๐ฒ ๐๐ณ๐ณ๐ผ๐ฟ๐๐: The session highlighted the power of collaboration among industry, academia, healthcare, and patient associations. This cross-sectoral partnership is crucial for developing a harmonized EFS methodology.
- ๐ฃ๐ฎ๐๐ถ๐ฒ๐ป๐-๐๐ฒ๐ป๐๐ฟ๐ถ๐ฐ ๐๐ฝ๐ฝ๐ฟ๐ผ๐ฎ๐ฐ๐ต: Integrating patient input ensures that medical devices are tailored to patient needs, enhancing their effectiveness and acceptance.
- ๐๐น๐ฒ๐ฎ๐ฟ ๐๐๐ถ๐ฑ๐ฎ๐ป๐ฐ๐ฒ: Providing a roadmap for EFS will streamline processes for innovative companies, hospitals, and competent HTA authorities, making Europe a more attractive location for medical device innovation.
๐๐๐๐๐ฟ๐ฒ ๐๐บ๐ฝ๐น๐ถ๐ฐ๐ฎ๐๐ถ๐ผ๐ป๐
- ๐๐ผ๐ผ๐๐๐ถ๐ป๐ด ๐๐ผ๐บ๐ฝ๐ฒ๐๐ถ๐๐ถ๐๐ฒ๐ป๐ฒ๐๐: A harmonized EFS methodology will enhance Europeโs competitiveness in the global medical device market.
- ๐๐ฐ๐ฐ๐ฒ๐น๐ฒ๐ฟ๐ฎ๐๐ถ๐ป๐ด ๐๐ป๐ป๐ผ๐๐ฎ๐๐ถ๐ผ๐ป: Well-run EFS will speed up the development and patient access to innovative devices, ultimately improving healthcare outcomes.
- ๐ฅ๐ฒ๐ฎ๐น-๐ช๐ผ๐ฟ๐น๐ฑ ๐๐บ๐ฝ๐น๐ฒ๐บ๐ฒ๐ป๐๐ฎ๐๐ถ๐ผ๐ป: The involvement of all stakeholders, driven by a common objective, increases the likelihood of successful implementation in the real world.
Next Steps
- ๐๐ผ๐ป๐๐ถ๐ป๐๐ฒ๐ฑ ๐๐ผ๐น๐น๐ฎ๐ฏ๐ผ๐ฟ๐ฎ๐๐ถ๐ผ๐ป: We will continue to work closely with our partners to refine and implement the EFS methodology.
- ๐๐ป๐ด๐ฎ๐ด๐ฒ๐บ๐ฒ๐ป๐ ๐ฎ๐ป๐ฑ ๐๐ฒ๐ฒ๐ฑ๐ฏ๐ฎ๐ฐ๐ธ: Ongoing engagement with stakeholders will be essential to ensure the methodology meets the needs of all parties involved.
Thank you to the moderator and excellent speakers at #MTF2025 for their insightful contributions and for making complex issues accessible and engaging to a wider audience.
Moderator
Niklas Blomberg, Innovative Health Initiative (IHI)
Speakers
- Rosanna Tarricone, SDA Bocconi
- Alexandra Poulsson, Norwegian Institute of Public Health
- Laura Sampietro-Colom, Hospital Clรญnic de Barcelona
- Fanny van der Loo, Edwards Lifesciences Europe
- Yasemin Zeisl, European Patients’โ Forum
Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe
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:ย 14/05
Time:ย 14:10 – 15:00 (GMT+1)
Location:ย Lisbon, Portugal
Session Type:ย 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!
Call for Papers on Early Feasibility Studies for Medical Devices
Clinical Therapeutics is inviting submissions for a special issue on Early Feasibility Studies for Medical Devices. This issue aims to delve into the characteristics, patterns, and growth of EFS studies, comparing regulatory systems between the US and Europe, and evaluating the impact of the FDA EFS Program.
Key Aspects
- Focus: Initial clinical safety and performance of medical devices in early development.
- FDA EFS Program: Established in 2013 to foster innovation and early access for American patients.
- Topics: Success in attracting early clinical investigations, safety issues, patient benefits, and feedback mechanisms.
Case studies on technologies that reached the market post-EFS are welcomed, as well as submissions with a focus on initial clinical safety and performance of medical devices in early development.
๐๐๐ฒ๐๐ ๐๐ฑ๐ถ๐๐ผ๐ฟ๐:
Giuditta Callea, Associate Professor and Carlo Federici, Research Fellow, from SDA Bocconi, and members of the HEU-EFS coordination team.
๐ฆ๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป ๐๐ฒ๐ฎ๐ฑ๐น๐ถ๐ป๐ฒ: September 30, 2025
For more details, visit the Clinical Therapeutics journal page https://www.sciencedirect.com/special-issue/321847/early-feasibility-studies-for-medical-devices-goldmine-or-fool-s-gold.
Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe
#EFS #HealthcareInnovation #MedicalResearch #EvidenceGeneration
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. Itโs not just about access to new technologies but ensuring these advancements are safe, effective, and enhance patient care.
Together, letโs 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 Fundaciรณ Clรญnic per a la Recerca Biomรจdica Institut dโInvestigacions Biomรจdiques August Pi i Sunyer (IDIBAPS) Hospital Clรญnic 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’โ 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. Carloโs 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 Patientsโ Access Program for breakthrough medical devices. Marco Marchetti (AGENAS) discussed integrating the Joint Clinical Assessment (JCA) with MDR, and Flora Giorgio outlined the Commissionโs 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.
HEU-EFS at the ESC Cardiovascular Round Table with EMA
Advancing Patient-Centered Innovation
The HEU-EFS consortium was proud to be represented at the European Society of Cardiology Cardiovascular Round Table (CRT) meeting with the European Medicines Agency (EMA) in Amsterdam. This high-level event brought together leading voices from cardiology, regulatory bodies, industry, and patient communities to explore how Patient Experience Data (PED) and Patient Reported Outcomes (PROs) can shape the future of cardiovascular care.
Notably, Maria Luisa Buzelli (SDA Bocconi) and Prof. Piotr Szymaลski, Advisory Board member of HEU-EFS and Chair of the ESC Regulatory Affairs Committee (2024โ2026), contributed to the discussions, reinforcing the consortiumโs commitment to regulatory innovation and patient-centered research.
Key Outcomes from the Round Table
The roundtable featured open and constructive dialogue on the role of PED and PROs in clinical trials and regulatory decision-making. Highlights included:
- Elevating PROs to Primary Endpoints
There is growing consensus that Patient-Reported Outcomes (PROs)โincluding quality of life, fatigue, and symptom burdenโshould be recognized not merely as supportive data but asย primary endpointsย in cardiovascular clinical trials. This shift reflects a broader commitment to capturing outcomes that matter most to patients. - Patient Experience Data (PED) as a Lens on Real-World Impact
Patient representatives provided compelling narratives illustrating how PED can reveal treatment effects that traditional clinical endpoints may overlook. These insights underscore the value of integrating lived experiences into evidence generation. - Regulatory Alignment and Openness
EMA representatives reaffirmed their commitment to incorporating PED and PROs into regulatory decision-making. Ongoing initiatives aim to refine methodologies and frameworks that support this integration. - Strategic Role of ESC Volunteers
ESC volunteers are instrumental in operationalizing patient engagement. By identifying and preparing patient contributors with relevant clinical experience and communication skills, they ensure that patient voices are authentically and effectively represented in ESC initiatives
As Prof. Szymaลski noted, โThis is a pivotal moment for aligning regulatory science with what truly matters to patients.โ
Why This Matters for HEU-EFS
The HEU-EFS project is deeply aligned with these goals. By integrating patient perspectives into the design and evaluation of future cardiovascular therapies, HEU-EFS aims to ensure that innovation translates into meaningful patient benefit. The CRT meeting served as a powerful platform to showcase this vision and to engage with key stakeholders shaping the future of cardiovascular regulation.
Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe
#ESCardioCRT #HealthcareInnovation #PatientAccess #MedTech #EvidenceGeneration #ClinicalTrials
