Programme

For the first time,  Board of MedTech Europe's representatives will provide and debate their vision of MedTech Europe focus, priorities and objectives for the next few years.  This will be a unique opportunity to know, to understand, to question and to participate to the orientation of your trade Association. Your feedback and engagement during this open discussion will be important and taken into consideration to steer MedTech Europe forward. Despite outstanding results in our last Members Satisfaction Study with level of satisfaction and recommendation never achieved before, at MedTech Europe we do not want to take this for granted and sit on our success. MedTech Europe "raison d'être" remains: Serving our members expectations and this interactive session shall help us continue to improve !

The European Health Data Space reflects a compelling vision to integrate Europe's national and regional health data systems and to harness the health data of European patients and citizens to drive research, innovation and new treatments. This session will deliver an update and a roadmap on how we get there.

Ten years ago, Boston Consulting Group challenged us on whether we were “Still Deploying Milkmen in a Megastore”. During this session, BCG will launch the results of its third global “Milkman” commercial benchmarking study in medtech. Hot off-the-presses, the report covers 150 businesses (including 9 of the 10 largest players) representing more than $85 billion in annual revenues. The authors will share how COVID-19 has been a wake-up call for many medtech companies to fix their old commercial model. By forcing commercial teams to find new ways to interact remotely with their customers, the pandemic has shown what is possible in terms of building a next-generation, omnichannel commercial model. BCG will showcase how a pioneering medtech company has found its “Six Million Dollar Sales Rep” model, embedded in a tailored, end-to-end customer journey ranging from digital and data driven marketing all the way through to customer success management. BCG will conclude by recommending six steps for medtech companies to take in order to seize this substantial opportunity to build a competitive advantage.

Whilst the expectations from regulators as well as internal stakeholders on compliance officers remains high, this session aims at discussing how the pandemic has accelerated the move towards virtual interactions (e.g. support; Events), what this transition means for life science, and more specifically medtech, compliance professionals, and what can be done to effectively mitigate new and emerging risks.

Only 13 months remain until all in vitro diagnostic tests will need to comply with the new IVD Regulation. The COVID-19 outbreak has highlighted how critical IVD tests are to our health system. At the same time, the pandemic has greatly slowed down progress by authorities and other actors to build the necessary infrastructure for the entire system. Many challenges pave the way to achieving compliance, as much infrastructure including key guidance, will come later in the transition period and there are a handful of notified bodies available to support certification to the new IVD Regulation.

In this multi-stakeholder panel discussion, key questions that will be addressed include:
- Overall is the system on track with the time remaining? Is a plan B needed and what should it look like?
- Where should manufacturers be in their implementation at this point of the transition?
- What is the impact for healthcare professionals and laboratories?

The sources of innovation in MedTech have changed over the past decades with an increasing number of novel innovation drivers (Start-ups, Incubators, Collaborations etc.) "disrupting" the traditional model of large corporate R&D units. At the same time we are observing a shift in the focus areas from classical technology to complex systems involving digital tools and encompassing the entire patient journey. This session will provide an overview on this transition of innovators & focus areas in MedTech over the past years in Europe. Together with our panel of seasoned experts we will discuss what is needed to succeed in this changing environment and the role of collaborations between public, private and academic drivers of innovation.

The Innovative Health Initiative is the next European Public Private Partnership for Health Innovation, built on the success of IMI and ECSEL partnerships. A multi sectorial approach is set up for the first time to integrate pharma and medtech sectors to bridge the gap to address today's health and translational challenges.
The chairmen of Research & Innovation of the 3 large trade associations EFPIA, COCIR and MedTech Europe on stage together for the first time will present the expectations of the pharma and medtech companies to jointly deliver breakthrough innovation for the benefit of patients and make Europe again a place for healthtech innovation.
The Innovative Health Initiative is expected to kick off in a few months. So it's the last chance for participants to listen to the latest insights and recommendations on how to best take advantage of this unprecedented opportunity and maximise your return on your investment in the partnership.

The digital transformation of healthcare is based on data exchange between the different devices and IT systems. National and European policymakers are increasingly championing data interoperability based on recognised standards and profiles to enable digital health scenarios including EMR/EHR transfers, telehealth, and remote monitoring. Some EU Member States have started to include requirements for interoperability standard as a condition for buying and reimbursement, which should and will impact health IT providers and manufacturers of medical devices. This session will analyse the strategic impact of this new environment for interoperability for manufacturers and technology providers, and offers paths to join it.

Truly innovative medical technology offerings are likely to have a strong impact on patients, care delivery, health systems and/or society. Therefore, ensuring the adoption and uptake of medical technology innovations is key to benefit patients, healthcare providers, citizens, and society across the EU. In return, appropriate incentives should be put in place and the industry should be rewarded for the value created. Question is, how to advance opportunities for the health systems and the medical industry to do so? This session will look at the so-called "value of innovation and partnership model" (VIP-model) enabling the timely introduction of medical technology offerings that claim to be truly innovative, and accounting for those that show other levels of innovativeness such as sustaining/continuous innovation. As indicated by Prof. Lieven Annemans, the implementation of the VIP-model would facilitate the adoption and uptake of medical technology innovations by building partnership and dialogue among all relevant actors in the health system, from health authorities, payers, care providers to the medical technology industry. These stakeholders will sit together and share their view on how to face challenges for the VIP-model's implementation.

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.

The #HealthTechAward (www.healthtech-award.eu) honors the most promising game changers in advanced technologies for health in Europe. It offers great visibility, recognition and custom mentoring to its Awardees, selected by an international jury of experts in healthcare innovation.

Three categories will be rewarded this year.
•    best concept/invention
•    best product/deal
•    a special prize from the HealthTech TAB (www.healthtechtab.eu)
The HealthTech Award is organised by the NOBEL Project (www.nobel-project.eu). Its prize ceremony is hosted by the MedTech Forum.

Find out who the winners are! Discover the very best of HealthTech innovation made in Europe! Join us at the ceremony of the HealthTech Award!

26 May 2021 is the new Medical Device Regulation's (MDR) Date of Application, marking the end of the MDR transition period. A lot has been accomplished during the past 4 years. The bulk of MDR certification is actually still expected and implementation remains challenging with many compliance deadlines still to come (e.g. Eudamed) and many regulatory building block not yet fully operational or in place. All stakeholders need to remain diligent to ensure the long-term success of the new regulatory system.
This multi-stakeholder panel will discuss the following topics:
- What has been achieved during the MDR transition period?
- COVID-19 and its impact on MDR implementation
- What needs to happen in order to successfully hit the May 2024 deadline, after which Directives certificates will become void:
-> Which Acts and Guidance documents are still needed to make the MDR work?
-> MDR without Eudamed - do national / EU fall back solutions meet the needs?
-> What do manufacturers need to do ?
-> State of the Play on national MDR adaption laws: are they adequate?
- Scenarios that are likely to unfold in the coming months/years with insight into how these may be addressed

Europe is a great ecosystem for innovation in healthtech, and in medtech in particular, with active regional innovation hubs, companies used to cooperate with stakeholders, excellent universities and research institutes and public and private investors. The Reflection Paper on Innovation in Medtech, released by MedTech Europe in Nov 2020 has highlighted the value of bridging the gap between innovative start-ups and global companies More can be done in strengthening their cooperation. Three success stories will be presented in tandem talks between corporates and start-ups to illustrate the ups and downs of such cooperation.

The MedTech industry is undergoing unparalleled change. Over the last 10 months, many health systems have made more progress in digital engagement than in the previous 10 years. Similarly, customers' expectations and preferences are shifting dramatically, with over 30% of HCPs expecting the remote model to be here to stay. Winners in the industry will be determined by how quickly and how well they can embrace these changes. And early successes show that this move is worth making - the prize can be up to 20% increase in customer satisfaction and a 5-10% revenue uplift.

In this panel discussion, McKinsey will share its latest research on MedTech customer sentiment and expectations, and add practical insights. We will lay out how successful companies tap into data and digital to redesign customers’ experiences; we will share our recipes for success and pitfalls to avoid as you fundamentally change your ways of working through cross-functional, agile teams. Join us to learn how to capture the full value of the omnichannel transformation.

This session explores the challenges and opportunities of the growing Chinese medtech industry - not only in China but also in third countries and potentially even in Europe for the rest of the MedTech Industry.

The healthcare market and the medtech industry in China continue to be on the raise. However, access to the Chinese market for the non-Chinese companies becomes increasingly challenging. The new public procurement policy in China makes it difficult for the foreign companies to compete. While Chinese medtech companies are becoming increasingly competitive also outside of China. What does this exponential growth and strategic policy mean for the non-Chinese medtech industry and how will this influence market trends in the future? How long can China get away with not reciprocating the level of market access to other countries? The European Union and China have recently reached an agreement on the investment package - what will it mean for the European companies that want to compete with Chinese mechtech in China and beyond? What is the expected development and impact of Chinese MedTech companies in European markets in the future?

Our presentation will focus on a predictions study from the Deloitte Centre for Health Solutions latest research report 'Predicting the future of healthcare and life sciences in 2025; The future unmasked'  and in partic0ular our sixth prediction 'Medtech and the IOMT are crucial drivers of value-based care' which predicts that MedTech companies will be driving the future of health, using transformative technology and sophisticated data analytics capabilities to enhance product and services and drive the realisation of ‘4P’ medicine.  It considers what MedTech companies need to do to benefit from digital transformation, whether its adapting their existing business models, inventing new ones or both and suggests that the industry's future will depend on its ability to demonstrate to providers and payers how connected medical devices contribute to the new value-based paradigm.
We will also discuss our research paper ‘Winning in the future of MedTech’ which acknowledges that while MedTech are well-positioned to drive the future of health, most cannot do it alone and need therefore to partner with consumer technology and specialised digital health companies to meet the changing market. Moreover that the future of health will be driven by an omnipresent, proactive, and integrated system of health and well-being where transformational technologies (such as artificial intelligence, quantum computing, cloud storage, augmented and virtual reality) are poised to play a significant role. A future in which medical devices that meld hardware and software will drive the development of a new value-based care paradigm.
Our session will conclude with a view on the regulatory and cyber implications needed to provide the trust for patients and business partners. More than ever, trust will be an important driver to make the future of health work in a more complex world where different partners are working together exchange data and rely on each other to provide the care for patients.

While we were already observing some larger healthcare trends, the pandemic most often accelerates them and calls for a disruptive view on our industry and value chain we are in. May it be the use of digital and robotic tools to improve surgeries and patient care as well as deliver effective HCP training; or the solutions for infection-prevention and safety; or again reducing healthcare’s environmental footprint, more than ever, our industry has a role to play in delivering valuable economic sustainable and innovative healthcare. During this session, experts from various parts of the healthcare system will discuss these long-lasting trends and how to accelerate positive changes, to positively impact patients’ lives.

The value of health-related information such as those derived from diagnostic testing never became clearer as than during COVID-19 pandemic. Diagnostic tests haven proven to be indispensable source of information to tackle the unprecedented circumstances of the SARS-CoV-2 outbreak: By identifying the responsible infection agent, testing allows to detect the existence of SARS-CoV-2 and to distinguish between COVID-19 and other respiratory tract infections (viral or otherwise) with similar presentation. As such, the use of diagnostic information does not only contribute to minimize the risk of the virus spreading but also improves disease management in terms of accurate diagnosing and targeted treatment.

Taking the example of respiratory tract infections against the backdrop of the COVID-19 pandemic, panelists in this session will discuss how better leveraging diagnostic information can enhance health systems’ resilience vis-à-vis shocks moving forward. Panelists are asked to outline suggestions to health policymakers at both the EU and national level that can unlock the potential of diagnostic information for more disease prevention, high-quality and efficient healthcare.

The discussion will be further enriched by the Value of Diagnostic Information (VODI) framework.

This session will focus on a key area of developing legal and reputational risk: European class actions.  Specific themes for discussion will include:
    •    Identifying the risk – what is changing?
    •    Mass tort crisis management
    •    The impact of the Representative Action Directive
    •    Lessons from the U.S. and where claimant law firms/litigation funders focus.
In-house legal departments are the front line of defense in emerging class action risk, but other stakeholders should be aware of key changes underway in Europe, including senior executives, risk managers and compliance colleagues.

The medical technology industry has been crucial in the fight against COVID-19. As efforts are continuously pulled to slowly exit from the pandemic, focus on the long-term recovery is increasing. One of the key questions of the day is how Europe can increase its preparedness for (and resilience against) future public health crises.
 
This session aims to contribute to the ongoing debates on how the EU institutions and Member States might safeguard healthcare systems for crisis preparedness and crisis response. The panels will respectively explore the following questions:
- How can global supply chains be preserved and, potentially, how to facilitate additional long-term production of critical medical technologies in Europe and therefore avoiding shortages?
- What are the conditions to make use of EU purchasing instruments to their fullest? What other cross-border purchasing models could be explored?
- How to ensure effective and sustainable stockpiling of healthcare products?

The medical device and diagnostics industry is facing the most challenging time in its history. While industry has to put significant measures in place to respond to COVID-19, from submitting urgent filings, to supply chain interruptions, and adapting to a new way of collaborating, regulatory teams still have to keep pace and plan for changes like European MDR and IVDR.
 
Mid 2020, the MDCG allowed notified bodies to perform remote audits under MDD and IVDD in specific cases when the inability of notified bodies to conduct on-site audits could raise the risk of shortages of vital devices.
 
With the rapidly approaching DoA of both the MDR/IVDR and the continued presence of the Covid-19 pandemic, the European Commission acknowledged the exceptional circumstances that would justify "extraordinary measures" like virtual audits while the pandemic is still upon us. However, a harmonized approach by all the EU member states and notified bodies is not yet in place.
 
In this session both representatives from industry, notified bodies, and competent authorities share their perspectives on how virtual audits can be executed in a safe and compliant way, share best practices in remote audits, and explain how they leverage technology to perform virtual audits.

For a long-time, and for several companies operating in Europe, corporate social responsibility initiatives have been largely voluntary. Businesses could therefore opt to engage in social and environmental causes. However, in a globalised world where goods and people move quickly across continents, there are growing calls to hold businesses more accountable for their human rights and environmental impact, locally and internationally.
As a result, EU lawmakers have envisaged bringing forward a piece of legislation to harmonise rules on Sustainable Corporate Governance (SCG) and Human Rights Due Diligence (HRDD) in the supply chain. The full impact of this pending legislation on the medical technology sector is still uncertain. The sector is aware, informed, and ready to engage in the upcoming political debates over these topics.
The purpose of this session is to provide an overview of the potential obligations that could emerge from European legislation on SCG and HRDD. In addition, an estimate of the overall impact of these obligations on medical technology companies will be presented. The speakers will include an expert official from the European Institutions and a representative from the medical technology industry.

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're facing.

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’re facing.

Aggregating and examining health data through intelligent algorithms and analytics can help us identify population health trends, develop new scientific and medical insights, and improve diagnostics and treatments to save lives. But trust and regulatory barriers need to be addressed before we can make full use of data’s potential. This session will highlight specific examples of how medtech advances this potential and how such barriers could be addressed, to ensure European competitiveness and to advance the delivery and practice of healthcare.

The environment for accessing the European market is now changing very significantly and rapidly. The implementation of the new Medical Device and In Vitor Diagnostics regulations, the GDPR regulation, the new up coming HTA EU cooperation regulation, Brexit, are among some of the critical changes which are potentially  transforming the attractiveness of the European market. Some say Europe is or will shortly become the last place to introduce innovation in the world while a few years ago it was the first place to benefit from innovations. Nevertheless, Europe continues to offer an area of the world with the biggest demand for Medical Technologies with a population of over 400 million, an ageing population, skilful and strongly educated healthcare actors, engineers, chemists, social medicine with access for most and still strong economies with high purchasing powers. The panel will discuss and balance the growing challenges of access to the European market vs it still demand attractiveness. Conclusions might quite surprising.

Using the Accelerated Access Collaborative (AAC) in the UK as a live example, this session is designed to showcase a leading EU pathway designed to accelerate coverage and adoption of medical innovation and technologies.  The session will discuss the recent findings of the broader, EU-wide Alira Health report commissioned by MedTech Europe on accelerating funding and reimbursement of medical technologies in Europe.  It will begin with an overview on the 26 innovative pathways around Europe, then focus on the AAC in England, with a panel discussion and open QnA with multiple stakeholders engaged with the AAC process.  Audience members will leave with key insights into launching innovative medical technologies in Europe, and the UK.

The changing role of procurement: from simple purchasing instrument to major strategic tool to move to resilient health systems and to innovate the delivery of sustainable, high value quality care.

The global landscape of regulatory requirements continuous to evolve. With 2021 marking the 10th anniversary of the International Medical Device Regulators Forum (IMDRF) what are the perspectives for advancing regulatory convergence in the medical devices and IVD fields? Is the single medical device review programme a dream or an attainable objective? What does the rebranding of the Asian Harmonisation Working Party into a Global Harmonisation Working Party mean and what are the group's ambitions for strengthening regulatory collaboration?
These are just some of the questions that this session is going to address. This session explores the experience with attempts to facilitate regulatory convergence so far and what are the perspectives for the future.

Emerging technologies are disrupting the relationship between IVD manufacturers, labs and treating physicians; analytics platforms are providing insights to treating physicians with increasing speed and accuracy which can go beyond the data provided from lab tests.
 
Patients are also being empowered in this changing ecosystem with greater direct access to IVD tests, remote monitoring and new digital services which can make diagnoses through AI-enabled chatbots.
 
We will discuss how the anticipated integration of existing and emerging players will play out over the coming years considering the new generations hardware, biomarkers, sensors and the role artificial intelligence tools and how regulators will react as the ownership of data and insights continues to evolve.

The ambitious and much needed EU Green Deal brings with it a wealth of regulatory initiatives. These include revisions of current legislation and proposals for new legislation in various sectors, including chemicals, environment, and sustainability. The medical technology sector is heavily regulated and will be greatly impacted by many EU Green Deal initiatives. Simultaneously, our sector continues to play an innovative role in the overall context of sustainable healthcare. For this reason, MedTech Europe identified several priority policy areas, where the sector could provide a valuable contribution to the decision-making process. Our members understand that the association’s involvement in this process is of paramount importance to secure timely access to safe, efficient and life-saving medical technologies for citizens across Europe and the globe.
This panel discussion will address MedTech Europe’s priorities and highlight potential challenges of the upcoming legislation for our industry and citizen access to medical technologies in the long run. Among the panellists, there will be representatives from the medical technology industry and medicine laboratories.

The medtech industry faces important challenges in processing health data, whatever the purpose, given the legal fragmentation across the EU on the application and interpretation of GDPR. If one adds the pandemic coupled with the "Schrems II" ruling, this gave rise to a doubling down of privacy and data protection needs. With data protection and international data transfers taking central stage in 2020, the discussion on global data (protection) becomes increasingly politicized as companies and policy-makers look to navigate the economic imperatives and privacy frameworks. This session aims at discussing how these privacy challenges could be addressed from a policy perspective to allow Europe's digital ambition to come true while at the same time protecting and improving the health of European citizens and to ensure the accessibility, effectiveness and resilience of their health systems.

The Covid-19 pandemic has challenged health care systems in an unprecedented manner and many patients have had their care delayed and disrupted. We estimate that close to 1 million patients across Europe will not have had access to an orthopedic surgery due to Covid-19 related restrictions from the beginning of the pandemic through the end of Q2, 2021. These cases compound the structural patient backlog in many parts of Europe that were already struggling with patient waiting list pre-Covid.
To address this enormous backlog, healthcare payers, providers and industry need to rethink the optimal way to deliver the necessary care to patients in pain, and needing urgent intervention.  Experience from the US shows that for certain procedures and patient segments, outpatient care, i.e. same day discharging of patients after surgery is a safe and effective way to provide orthopedic care, while making a better use of existing healthcare infrastructure.
What are the benefits of outpatient care in orthopedics? What experience do we have so far in Europe with this new type of care pathway? What are the barriers that need to be addressed?
This session will discuss the value of day case surgery in reducing the backlog in elective surgery. It identifies the benefits, the opportunities as well as the current barriers to outpatient care. Health care professionals, executives from outpatient care centers and market access specialists will share their experiences and discuss the potential it will bring to European health care systems in becoming more resilient and efficient in the future.