Filters

30/05
18:00 - 21:00
Networking Cocktail


31/05
08:30 - 09:30


31/05
09:30 - 09:45
Opening session
In-person and live streaming


Plenary Room
31/05
09:45 - 10:30
Plenary session
In-person and live streaming

Global leaders from the field of medical devices, diagnostics and digital health will join the discussion and speak openly about the latest trends, challenges and opportunities they are facing.

31/05
10:40 - 11:30
Parallel session

The proposed European Health Data Space (EHDS) is a cross-cutting legislative file and Europe’s vision for the future of health. It has the goal to empower citizens and patients through more accessible electronic health data and enhancement of health data sharing. At the same time, the EU aims to enhance the availability of data to support research for much-needed innovation in the health sector. The EHDS has the potential to revolutionise healthcare to a deeper pool of EU-wide health data and unlock significant tech, AI and data analytics innovation.
To a certain extent, the future is already a reality, and we can get an idea of what could be possible if we extend the use of real-world data for research and innovation. This session brings us back to the future to highlight stories which underline the need for health data sharing and show the crucial benefits for patients, healthcare professionals and health systems by sharing their stories.

31/05
10:40 - 11:30
Parallel session

While the implementation of the MDR and IVDR are in the final stage, an additional EU regulation on HTA is at the early stages of implementation but progressing well in finalising the structural and governance set-up of this member states driven regulation.
Alongside this structural and decision-making implementation, a service contract was awarded to put forward methodologies and guidance to ensure a kick-start at the foreseen start of the application of this regulation in January 2025. The session will provide insights into how this new regulation will impact access to medical technologies once the hurdle of CE marking of a product is overcome. Speakers will discuss how leading countries seek to use this regulation, link it to their innovative access pathways and bring in patients' and healthcare professional voices. Ultimately from an industry perspective, it will be explored what can be done to adapt the assessment to the specificities of technologies and avoid it becoming an extra barrier and delaying access to innovation in Europe.
The session will include a view from the European Commission, leading EU countries, industry and a comparison to UK market access.

Plenary Room
31/05
10:40 - 11:30
Plenary session
In-person and live streaming

Agile, strategic, opportunistic, value-generating innovations: how to navigate and collaborate. A “How to session” to implement an innovative mindset and culture, with a specific focus on time. Time management, scheduling, expectation and understanding are different in start-ups and global companies despite their cooperation to deliver innovation to the patient and the healthcare systems. How to manage it?
This non-conventional, open panel discussion will offer an interactive approach, testimonies and examples.

31/05
11:30 - 12:00
Networking Break


31/05
12:00 - 12:50
Parallel session

The Digital Twins concept is no more science fiction; it has many real-life applications too. This technology allows the creation of a virtual representation of a physical object or system.
A digital twin is a digital replica of a businesses' tools, people, processes, and systems. The healthcare systems use Digital Twins to build digital representations of healthcare data, such as hospital environments, lab results, human physiology, etc., through computer models. Data that covers the individual, population traits, and environment are used to construct virtual twins.

Moderator:

Speaker:

Plenary Room
31/05
12:00 - 12:50
Plenary session
In-person and live streaming

Digital health solutions generate vast amounts of data, which will continue rapidly increasing. Real-world data (RWD) can be routinely collected in real-world settings and used and analysed to generate real-world evidence (RWE). The potential usage of RWE and its effects in healthcare is immense. By fully acknowledging and utilising these data, reliable RWE for policymakers, payers, and medtech manufacturers can be effectively considered in decision-making for health economic evaluation, reimbursement, funding, and the improvement of health outcomes overall. However, fragmentation among different stakeholders and their willingness to use RWE for decision-making is a barrier to their wider use. How can healthcare systems fully recognise and harness the value of RWE for quicker assessment and market access of medical technologies?

31/05
12:50 - 14:00
Networking Lunch


31/05
14:00 - 14:50
Parallel session

In Europe, reimbursement and funding of medical procedures and technologies are conceived and provided independently by each country. Each has its own system resulting from its particular political, administrative, and constitutional structure. This situation has led, amongst other things, to a significant disparity across European countries in the number and use of pathways that enable timely market access to innovative digital health technologies, medical devices, in vitro diagnostics, and medical procedures. Up to now, only a limited number of European countries have implemented coverage streams for promising innovative medical procedures and technologies. Similarly, only a limited number of countries are conducting concrete political initiatives to transform their healthcare and/or reimbursement and funding systems.

Join this session to discover the frontrunners in terms of pathways, to which technologies these pathways apply, who can apply for them and if they are being used in practice. Some of the main conclusions of MedTech Europe - MTRC 2022 project “Mapping the pathways enabling market access to innovative medical procedures and technologies” will be revealed.

31/05
14:00 - 14:50
Sponsored session

The Medical Device Regulation (MDR) process can be daunting for medical technology companies, but it doesn't have to be. In this session, ValueConnected's experts will explain how going through the MDR process can prepare medical technology companies to demonstrate the value of their solutions in a more credible way to payers, providers, and medical professionals.

During our session, attendees will learn aspects of how to:

• Understand how the MDR process aligns with value demonstration requirements
• Identify the critical data and evidence needed for value demonstration
• Create a value demonstration framework that leverages MDR compliance
• Communicate the value of their solutions effectively to different stakeholders

With the MDR process becoming increasingly crucial in the medical technology industry, companies must understand how to leverage this process to their advantage. This session will provide valuable insights and practical tips on how to do just that.

Plenary Room
31/05
14:00 - 14:50
Plenary session
In-person and live streaming

In November 2022, the EU Agency for Cybersecurity (ENISA) published the 2022 Cybersecurity Threat Landscape. The report follows the European Commission’s proposed Cyber Resilience Act, a regulation aimed at shoring up the cybersecurity of connected digital products. This case reflects a trend of legislative interventions reinforcing the European digital space. However, recent cybersecurity breaches (including notorious cyberattacks on the Irish Department of Health and the Health Service Executive) show that European healthcare systems remain dangerously exposed to the evolving threat landscape. This session aims to discuss the European cybersecurity threat landscape, particularly in relation to health, including possible legislative and non-legislative methods to bolster the security, safety and trust of healthcare delivery.

31/05
15:00 - 15:50
Parallel session

There is one year left until the central medical device database, EUDAMED, becomes fully functional. The session provides you with valuable considerations on how to prepare for full compliance with the database. Will EUDAMED affect Vigilance and Post-market Surveillance? Does it have any consequences for Clinical Investigations and Performance Studies? How can you plan the resources needed to interact with EUDAMED? Find out with us.

Plenary Room
31/05
15:00 - 15:50
Plenary session
In-person and live streaming

Ireland is home to some of the most remarkable medtech start-ups in the world. Ireland’s indigenous life sciences start-ups grew from a wealth of multinational experience. Four Irish start-ups have been selected based on their innovation in health and creating medtech solutions focusing on various issues, from diseases with unmet needs to digital health platforms.

Moderator:

31/05
15:50 - 16:20
Networking Break


31/05
16:20 - 17:10
Parallel session

The medtech industry, like others, has thrown resources at GDPR compliance, but despite the wealth of experts and compliance systems is the truth that total compliance is impossible, in particular for medtech organizations, which have complex data needs. Has Europe achieved the privacy objective?

31/05
16:20 - 17:10
Parallel session

The transition to the EU MDR and IVDR will have an impact on access to markets around the world. The concept of CE-marking, well established in the EU, is used in many countries outside Europe to support medical devices’ registrations. This session will address the global impact of the EU regulations and solutions to maintain access to international markets. Join us for an exciting panel discussion to explore how leading medtech manufacturers are managing the impact on their international registrations and addressing the questions posed by regulatory authorities outside the EU.

31/05
17:20 - 18:00
Plenary session
In-person and live streaming


01/06
08:00 - 09:00


Plenary Room
01/06
09:00 - 09:40
Keynote lecture
In-person and live streaming


01/06
09:50 - 10:40
Parallel session

This session will consider where we can increase Notified Body capacity to support the implementation of the IVD Regulation system. Can we simplify the complexity and reduce the time of conformity assessment and other major Notified Body activities? What role should regulators, Notified Bodies, manufacturers and other stakeholders play?

Plenary Room
01/06
09:50 - 10:40
Plenary session
In-person and live streaming

Artificial Intelligence (AI) in healthcare holds the promise to improve patient outcomes and healthcare systems. It can also tackle many healthcare challenges, including workforce shortages, healthcare financing and improving or even saving patients’ lives. With the launch of the AI Act, the EU has the potential to lead this area by building an advanced and fit-for-purpose regulatory environment and ensuring greater patient trust. While the proposed legislation will determine how and if new AI-enabled medical technologies will be placed on the market and reach patients, it begs the question of where AI-enabled medical technology is actually changing healthcare for the better on the ground and if the AI Act would become a hurdle or accelerator to the transformation.

Moderator:

01/06
10:40 - 11:10
Networking Break


01/06
11:10 - 12:00
Parallel session

The new EU Regulation on HTA introduced an interplay and new tasks for the MDCG, NB, expert panels of the MDR, and IVDR. For the Health Technology Developers, data submission to the notified bodies is listed as part of the dossier to submit for joint clinical assessments. Within the recitals of the HTA-R, it is acknowledged that the new regulation should not interfere with the MDR and IVDR and be distinct. We will bring together a panel of key actors as European commissions units responsible for the MDR/IVDR, respectively the HTA-R, the MDCG, the EMA unit overseeing the expert panels, the NB, the Member States HTA Coordination group representative to take stock of current views on concrete implementation and check&balances of the interplay.
The session aims to open the dialogue to foster the set-up of a well-defined and agreed framework of interplay. With this a starting point, we will seek further discussions with the involved actors and report back at the next MedTech Forums ahead of the final implementation in January 2025.

01/06
12:10 - 13:00
Parallel session

European healthcare systems face significant challenges: how to match the increased demand for healthcare services with an increased lack of qualified staff and improve patient outcomes and manage the total cost of care delivery simultaneously. Although existing medical technologies may not be able to solve all of these challenges, they can certainly be part of the solution. Because of an overall traditional execution of the public procurement and tender process based on volume and price, too many of these technologies still need to be implemented, and the adoption of innovative medtech. Needing a new procurement paradigm, MedTech Europe, together with BCG and EHPPA (European Health Public Procurement Association), engaged on a journey to move from volume-based procurement towards value-based procurement.
During the session, the speakers will elaborate on how (public) procurement can unlock value-based health care to improve patient outcomes and manage the total cost of care. Showcased by practical case examples from across Europe, speakers will discuss the main challenges and the key success factors.

01/06
12:10 - 13:00
Parallel session

The proposed European Health Data Space (EHDS) is a top priority for the European Union and the medical technology industry active in Europe. It promises better availability and exchange of electronic health data and provides the opportunity to introduce common standards. This legislation would help facilitate an environment that empowers the medical technology industry and other communities, such as research and patients. However, to ensure the EHDS fulfils its promise to allow seamless data flow, we need to remove obstacles to interoperability. The lack of interoperability can result in an incomplete understanding of an individual’s or population’s health needs, which can lead to poorer outcomes and higher costs from different perspectives

Plenary Room
01/06
12:10 - 13:00
Plenary session
In-person and live streaming

The current wave of regulatory activity at European level is creating a perfect storm that is causing Europe to sleepwalk towards a US-like litigation culture. A sharpening of liability laws, with the proposed drafts revising the Product Liability Directive and the AI Liability Directive strongly tipping in favour of consumers. The (uncoordinated) tightening of screws around horizontal and vertical safety regulations. The introduction of pan-European class actions and, last but not least, litigation funders are opening shops in several EU Members States incentivising a different consumer behaviour. These processes will result in an unavoidable increase in claims. The panel will discuss these developments and address what can still be done or should be done to avoid a US-like litigation culture coming to Europe.

01/06
13:00 - 14:00
Networking Lunch


01/06
14:00 - 14:50
Parallel session

The Innovative Health Initiative (IHI) is the EU’s €2.4 billion public-private partnership to create an innovation ecosystem that facilitates the translation of scientific knowledge into tangible innovations. IHI implemented the first wave of consortia in 2023 and will continuously launch calls until 2027. Its mission is to bring together diverse academic and other public stakeholders for collaborative high-impact health projects with the biopharmaceutical, biotechnology and medical technology sectors, including companies active in the digital area. This session will focus on how medical technology companies can shape and join projects under IHI and share the experience of the IHI pioneers made at different stages of building IHI partnerships.

Moderator:

Speaker:

Plenary Room
01/06
14:00 - 14:50
Plenary session
In-person and live streaming

Recent events have shown that medical devices are extremely susceptible to disruptions in their supply chain. Medical devices are subject to strict regulatory requirements and at most times, supply chain disruptions are also going to have a regulatory impact. Manufacturers have had to deal with a fair share of supply chain challenges over the past three years. Shortages of key raw materials, logistics delays, sterilization constraints, labour challenges, the list goes on resulting in skyrocketing costs and delays. This session will explore how policy makers and manufacturers are dealing with the continuous and emerging supply chain challenges and how to increase the resilience of supply chains to withstand the future disruptions.

Plenary Room
01/06
15:00 - 15:50
Plenary session
In-person and live streaming

Global leaders from the field of medical devices, diagnostics and digital health will join the discussion and speak openly about the latest trends, challenges and opportunities they are facing.

Plenary Room
01/06
15:50 - 16:00
Plenary session
In-person and live streaming