Overview
HTA plays an essential role in decision making and informing policy on the use of medical devices as a part of its broader scope for all technologies, as well as the efficient use of resources in health care. The mission of the Medical Devices Interest Group (MDIG) is to promote and develop the interdisciplinary and multi-stakeholder assessments of medical devices and value-based healthcare in a consistent and comprehensive manner.
Aims and Objectives
The MD IG has the goal to produce relevant, objective research to inform and improve policy making that is intended to improve population health. The IG will advance the dialogue on Medical Device HTA methods and evidence based policy making. This will reflect all stakeholder groups and ensure the unique role of HTAi is considered in policy discussion.
Those interested in this IG will:
- Contribute to ensure best practices in the HTA of medical technologies are shared and rigorously evaluated in a manner that considers the nuances of the medical device space.
- Ensure the implementation of HTA is discussed and advanced to key policy makers.
- Ensure all stakeholders are engaged and given a place to provide feedback on the strengths, weaknesses, challenges and opportunities of introducing Medical Device innovation into healthcare systems under the responsibility of increasing patient outcomes and lowering system costs.
- Rigorously seek to include new stakeholders for dialogue, most notably payer and procurement thought leaders who are crucial actors in the implementation of medical device and value based healthcare assessments.
Newsletters
Webinars
December 3, 2024 | 15:00 GMT
Panelists:
- Marco Marchetti | Co-Chair HTA Member State Coordination Group (HTACG), EU
- Richard Charter | Co-Chair, HTAi Medical Devices Interest Group
- Anastasia Chalkidou | Co-Chair, HTAi Medical Devices Interest Group
- Jarno Suominen | Technical Officer, HTAi Medical Devices Interest Group
Session Details
Introducing our latest webinar from the HTAi Medical Devices Interest Group, “Navigating HTAR Implementation Acts: Future Perspectives and Key Considerations for Medical Devices.”
During the webinar session, we’ll explore how the new Health Technology Assessment Regulation (HTAR 2021/2282) impacts the medical device industry. We’ll cover the essential requirements, potential challenges, and strategic insights to help you navigate this regulatory landscape effectively.
December 6, 2023 | 12:00 CET (UTC +1) | 04:00 MST (UTC -7)
Panelists:
- Marco Marchetti | Board of Director in Health Technology Assessment international.
- Petra Hoogendoorn | Horizon Europe Label2Enable project
Session Details
On regulatory basis, the safety, performance, risks and benefits of medical devices are strongly regulated before market access. Strong regulation-based approach can create the impression that market penetrated solutions are uniformly applicable. However, market access in itself does not guarantee the effectiveness or applicability of the device. The same applies to wellness technology, in which regulation is clearly at a lower level compared to medical devices. In addition to assess and qualify digital solutions the need for harmonization of assessment criteria is essential so the open market is not siloed between countries.
It is a shared interest of manufactures, users and assessment bodies that digital solutions and mobile apps in the social, health and welfare sectors are evaluated with uniform criteria to support decision making while taking into account the needs of technology companies and citizens. The assessment criteria should not silent innovations or research but support them to ensure quality on high standard. From this point of view modularized and unified assessment methods support quality apps without additional market restriction.
September 20, 2023 | 07:00 MDT (UTC -6)
Panelists:
- Richard Charter | Co-Chair, HTAi Medical Devices Interest Group, Canada
- Anastasia Chalkidou | Co-Chair, HTAi Medical Devices Interest Group, United Kingdom
- Jarno Suominen | Technical Officer, HTAi Medical Devices Interest Group, Finland
Session Details
Building on the results of a recent research study into HTA best practices for Robotic-Assisted Surgery, this webinar will present and open discussion about the challenges in assessing a rapidly developing technology. We will explore how HTAs can guide decision-making and policy discussions and consider the future of robotic surgery and related digital technologies. How can HTAs be ready?
This webinar is hosted by the HTAi Medical Devices Interest Group, and is open to all interested participants regardless of HTAi membership status.
HTA and Value-Based Healthcare: Methods
March 4, 2021 9:00 a.m. MST
Panelists:
- Richard Charter, Vice-President, Alira Health
- Iga Lipska, Research Project Manager at National Health Fund
- Anastasia Chalkidou, Associate Director and Senior Research Fellow in HTA
- Joseph Casey, Professor, Director of Partnerships and Programme
Session Details
This session will discuss the methodological differences between HTA and Value-Based Healthcare and how they can be applied to Medical Devices. The aim is to provide participants with a comprehensive understanding of how HTA and VBHC methods can be used in practice. It will further the goals and mission of the Medical Devices Interest Group, including advancing the dialogue on Medical Device HTA methods and evidence-based policy-making to develop the way we evaluate a rapidly evolving technology sector.
HTA and Value-Based Healthcare: Methods
March 25, 2021 8:00 a.m. MST
Panelists:
- Richard Charter, Vice-President, Alira Health
- Andrea Rappagliosi, Vice President Market Access, Public Affairs & Communication EMEA, Canada and LATAM Edwards Lifesciences
- Joseph Casey, Professor, Director of Partnerships and Programme
Session Details
This session will build on the methods discussed in the first session through a series of case studies. Using real-life experiences, the speakers will distinguish the roles of HTA and Value-Based Healthcare in the evaluation and implementation of medical technologies and discuss value-based access programs (managed entry agreements). This session aims to give participants an understanding of how to implement the different methods in practice and will discuss how they complement each other in a rapidly evolving MedTech landscape.
Resources and Materials
Events
HTAi 2025 Annual Meeting in Buenos Aires, Argentina
