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