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20/04 13:00 - 13:30
Welcome and introduction

 Opening session

 


Moderator:

  • Ingmar DE GOOIJER (healthcare industry observer)

  Speakers:

  • Serge BERNASCONI (CEO, MedTech Europe)
  • Rob TEN HOEDT (Chairman - MedTech Europe, Executive Vice President and President, EMEA - Medtronic)

20/04 13:30 - 14:30
Towards the European Health Data Space

 

Johnson & Johnson

Johnson & Johnson

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.

Moderator:

  • Michael STRÜBIN (Director Digital Health, MedTech Europe)

20/04 13:30 - 14:30
What should you expect from MedTech Europe in the next few years?

 

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 !

Moderator:

  • Ingmar DE GOOIJER (healthcare industry observer)

  Speakers:

  • Rob TEN HOEDT (Chairman - MedTech Europe, Executive Vice President and President, EMEA - Medtronic)
  • Serge BERNASCONI (CEO, MedTech Europe)
  • Bernard COLOMBO (Board member, MedTech Europe, President Europe Middle East, Africa and Latin America, Roche Diagnostics International)
  • Carlos SISTERNAS (Director, Fenin)

20/04 14:30 - 15:30
Compliance: Implications of the new digital relationships

 

IQVIA

IQVIA

Whilst the expectations from regulators as well as internal stakeholders on the compliance officers stay high, this session aims at discussing how the pandemic may have accelerated the move towards more "telehealth", and as such what such a move means for the compliance professionals, how the risks may have changed and how these could be apprehended in the most efficient way.

20/04 14:30 - 15:30
IVD Regulation and the road to May 2022 – Is the system ready for medical diagnostics in Europe?

 

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?

  Speakers:

  • Elisabeth MACINTYRE (MD PhD FRCP FRCPath, Vice-Présidente, Stratégie Internationale, Université de Paris, Onco-hématologie biologique and INSERM UMR1151, INEM, Board Member, BioMed Alliance - President-Elect, European Hematology Association (EHA))
  • Erica CONWAY (IVD Medical Devices, Regulatory Services, BSI)
  • Natale BOVA (Chair of IVD Regulatory Forum at Confindustria Dispositivi Medici, the Italian Association of Medical Device Industry, Quality Assurance & Regulatory Affairs Director, Instrumentation Laboratory S.p.A. - a Werfen Company)
  • Thomas WEISS MOLLER (Chair of Competent Authorities for Medical Devices (CAMD)- Section Manager – Medical Devices, Danish Medicines Agency, Denmark)

20/04 14:30 - 15:30
Innovation in MedTech – Trends and Opportunities

 

Olympus

Olympus

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.

Moderator:

  • Miquel-Àngel GARCIA (Managing Director, Olympus Europa SE & Co. KG)

  Speakers:

  • Jean-David MALO (Director, European Innovation Council)
  • Thom RASCHE (Partner, Earlybird Venture Capital)
  • Terry PARLETT (Commerzialisation Director, Cambridge Enterprise)

20/04 14:30 - 15:30
Advancing opportunities for the medical industry: the value of innovation and partnership model enabling the adoption and uptake of medical technology innovations

 

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.
1 "Access to Medical Technology Innovations: A Proposal for a Value of Innovation and Partnership Model"

  Speakers:

  • Lieven ANNEMANS (Professor of Health Economics, Ghent University)
  • Iñaki GUTIERREZ IBARLUZEA (Director of Organisational and Managerial Innovation, Basque Foundation for Health Innovation and Research)

20/04 15:30 - 16:30
Innovative Health Initiative: the next horizon for medtech companies

 

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.

Moderator:

  • Patrick BOISSEAU (Director General, Strategic Initiatives, MedTech Europe)

  Speakers:

  • Salah-Dine CHIBOUT (Global Investigative Safety, Novartis)
  • Casper GAROS (Head Partnerships, Philips)
  • Manolis KARAMALIS (Reimbursement Director, Medtronic)
  • Pierre MEULIEN (Executive Director, IMI2)

20/04 15:30 - 16:30
The new business environment for interoperability: how the push for data will impact the industry

 

Unity

Unity

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.

20/04 16:30 - 17:30
CEO #nofilter

 

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.

  Speaker:

  • Stacey SHULMAN (Vice President Internet of Things Group and GM Health, Life Sciences and Emerging Technologies, Intel Corporation)

21/04 13:00 - 14:00
Goodbye Medical Device Directives - Hello Medical Device Regulation!

 

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

Moderator:

  • Bassil AKRA (CEO, QUNIQUE GmbH)

  Speakers:

  • Anna Eva AMPELAS (Head of Unit, European Commission - Directorate General for Health and Food Safety - Medical devices, Health Technology Assessment (SANTE.DDG1.B.6))
  • Sabina HOEKSTRA-VAN DEN BOSCH (Regulatory Strategy Principal TÜV Süd / Chair NB-Med Executive Committee / Vice-President Team-NB)
  • Julia STECKELER (CEO, MedicalMountains GmbH)

21/04 13:00 - 14:00
Corporates and start-ups cooperation in the EU Innovation ecosystem

 

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.

Moderator:

  • Nina RIJNDERS (Corporate Partnerships, NLC)

  Speakers:

  • Mark BLOEMENDAAL (CEO, Angiogenesis Analytics)
  • Remi CORLIN (CEO, Hemeo)
  • Iker SOYDAN (CEO, EchoGuide)

21/04 14:00 - 15:00
Competing with China: How an emerging MedTech industry in China is impacting markets around the world

 

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?

21/04 15:00 - 16:00
Unlocking the value of diagnostic information or how to build resilient health system? Observations from the management of untreatable respiratory tract infections – now and in the future

 

The value of health-related information never became clearer as during COVID-19 pandemic. An indispensable source of information are diagnostic tests: by identifying the responsible infection agent, testing informs about existence of SARS-CoV-2 and allows to distinguish between COVID-19 and other respiratory tract infections (viral or otherwise) with similar presentation. This way, they not only contribute to control the spread of the virus but also improve disease management in terms of accurate diagnosing and targeted treatment.

Next to the SARS-Cov-2 outbreak, the emergence and circulation of drug-resistant bacteria and viruses, leading to antimicrobial resistance (AMR), increasingly constitute another threat to public health. AMR makes infections harder to treat and increases the risk of disease spread, severe illness and death. Taking the example of respiratory tract infections, panelists in this session will discuss how better leveraging diagnostic information can indeed enhance health systems' resilience vis-à-vis these shocks.

The discussion will be enriched by two case studies which look into the value of diagnostic information for the management of respiratory tract infections, including COVID-19 and hospital-acquired such as ventilator-associated pneumonia (VAP).

21/04 15:00 - 16:00
A brave new world: A different European legal environment

 

This session aims at providing an overview of the key European law developments which will be affecting the MedTech industry in the coming years and which may not yet be on the radar screen of the companies' legal departments, including European class action systems as well as the potential revision of the product liability directive as well as the initiatives linked to the European Commission's New Consumer Agenda intended to further empower European consumers to play an active role in the green and digital transition and to address misleading online practices seen during the COVID-19 pandemic and beyond. With the additional pressure that the current pandemic put on manufacturers of healthcare products, and the new regulatory regime, the work of the legal teams is set to change.

  Speaker:

  • Kenny HENDERSON (Partner, CMS)

21/04 15:00 - 17:00
From Pandemic to Recovery & Resilience

 

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?

  Speaker:

  • Hani ABOUHALKA (Company Group Chairman, Johnson & Johnson Medical Devices Companies Europe, Middle East & Africa (EMEA))

21/04 16:00 - 17:00
Impact of sustainable corporate governance and human rights due diligence EU legislation on medtech companies

 

For a long-time and for several companies operating in Europe, Corporate Social Responsibility initiatives have been to a large extent voluntary. Thus, an option for businesses to engage in social and environmental causes. However, in a globalized world where goods and people move across continents at a fast pace, it has become more evident for the society that businesses' responsibility for the respect of human rights and the environment need to be also extended globally.
EU legislators have consequently envisaged putting forward regulations that foresee harmonized rules on sustainable corporate governance (SCG) and human rights due diligence (HRDD) in the value chain. What the impact of these upcoming rules on the medtech sector will be, it is still unknown. But the sector is well aware,  informed and ready to engage in the political debates on these issues.

This session aims to provide an overview of potential obligations that could emerge from European legislation on SCG and HRDD. In addition, an estimation of the overall impact of these obligations on medtech companies will be presented. Speakers will include an expert official from the European institutions and a representative from the medtech industry.

  Speaker:

  • Fadzai MUNYARADZI (Corporate Social Responsibility Manager Europe, Medline)

21/04 17:00 - 18:00
CEO #nofilter

 

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.

Moderator:

  • Ingmar DE GOOIJER (healthcare industry observer)

  Speakers:

  • Mick FARRELL (CEO, ResMed)
  • Greg AHLBERG (Vice President, Abbott Diagnostics EMEA)
  • Mike MUSSALLEM (Chairman and Chief Executive Officer, Edwards Lifesciences)
  • Ashley MCEVOY (Executive Vice President, Worldwide Chairman, Medical Devices, Johnson & Johnson)

22/04 13:00 - 14:00
CEO #nofilter

 

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.

Moderator:

  • Ingmar DE GOOIJER (healthcare industry observer)

  Speakers:

  • Brigitte DE VET (Vice President, Materialise Medical)
  • Thomas SCHINECKER (CEO, Roche Diagnostics)
  • Miquel-Àngel GARCIA (Managing Director, Olympus Europa SE & Co. KG)

22/04 14:00 - 15:00
Unlocking the power of data

 

ResMed

ResMed

Medical grade health data, from medical and diagnostic devices and other solutions delivered by medical technology companies, forms the foundation of the digital transformation in healthcare. Aggregating and examining health data through intelligent algorithms and analytics can help us develop new scientific and medical insights, identify population health trends, and improve diagnostics and treatments to save lives. But there are cultural and regulatory barriers that prevent us from making full use of data's potential. This session will highlight specific examples of how medtech advances the potential of health data for the benefit of patients and healthcare systems, and how such barriers could be addressed to ensure European competitiveness and to advance the delivery and practice of healthcare.

  Speaker:

  • Odile BIGAIGNON (VP Sleep & Respiratory Care Marketing, EMEA, ResMed)

22/04 14:00 - 15:00
Is EU still attractive for MedTech for the MedTech Industry?

 

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.

Moderator:

  • Ingmar DE GOOIJER (healthcare industry observer)

  Speakers:

  • Bert-Arjan MILLENAAR (Founder & CEO, NLC)
  • Kerstin WAGNER (Sr. VP Diagnostics Marketing & Sales, Siemens Healthineers)
  • Jean-Luc LEMERCIER (VP EMEA Canada & Latin America, Edwards Lifesciences)
  • Cristiano FRANZI (Baxter)

22/04 15:00 - 16:00
How Value-Based Innovation Procurement unlocks resilient health systems

 

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.

22/04 15:00 - 16:00
How about a single global regulatory system? Advancing global regulatory convergence – perspectives for the future

 

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.

  Speaker:

  • Emmet DEVEREUX (Director, Government and Regulatory Affairs, EMEA, Cook Medical)

22/04 16:00 - 17:00
The EU Green Deal: Priorities for MedTech Europe

 

The ambitious and much needed Green Deal brings with it a wealth of regulatory initiatives. They include revisions of current legislation and proposals for new legislation in various sectors, including chemicals, environment, and sustainability. The medtech sector is heavily regulated and will be greatly impacted by many Green Deal initiatives. In this context, MedTech Europe identified a number of priority policy areas where the sector could bring a valuable contribution to the decision-making process. Our members understand that the association's involvement in this process is of paramount importance for continuing to secure timely access to safe, efficient and life-saving medical technology for patients across Europe and the globe.

This panel discussion will address MedTech Europe's priorities from the perspective of member companies, highlighting potentially critical aspects of upcoming legislation that could impact patients' access to medical technology in the long term. Panelists will include senior representatives of medtech companies, members of MedTech Europe.

22/04 16:00 - 17:00
A privacy conundrum?

 

Faegre Drinker Biddle Reath

Faegre Drinker Biddle Reath

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.

Moderator:

  • Mary Devlin CAPIZZI (Partner, Faegre Drinker Biddle & Reath)

  Speakers:

  • Peter BLENKINSOP (International Pharmaceutical & Medical Device, Privacy Consortium (IPMPC))
  • Megan OLSON (Global Chief Compliance Officer)

22/04 17:00 - 18:00
Conclusions

 


Moderator:

  • Ingmar DE GOOIJER (healthcare industry observer)

  Speakers:

  • Serge BERNASCONI (CEO, MedTech Europe)
  • Rob TEN HOEDT (Chairman - MedTech Europe, Executive Vice President and President, EMEA - Medtronic)

13:00 - 13:30
Welcome and introduction

 Opening session

 


Moderator:

  • Ingmar DE GOOIJER (healthcare industry observer)

  Speakers:

  • Serge BERNASCONI (CEO, MedTech Europe)
  • Rob TEN HOEDT (Chairman - MedTech Europe, Executive Vice President and President, EMEA - Medtronic)

13:30 - 14:30
Towards the European Health Data Space

 

Johnson & Johnson

Johnson & Johnson

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.

Moderator:

  • Michael STRÜBIN (Director Digital Health, MedTech Europe)

13:30 - 14:30
What should you expect from MedTech Europe in the next few years?

 

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 !

Moderator:

  • Ingmar DE GOOIJER (healthcare industry observer)

  Speakers:

  • Rob TEN HOEDT (Chairman - MedTech Europe, Executive Vice President and President, EMEA - Medtronic)
  • Serge BERNASCONI (CEO, MedTech Europe)
  • Bernard COLOMBO (Board member, MedTech Europe, President Europe Middle East, Africa and Latin America, Roche Diagnostics International)
  • Carlos SISTERNAS (Director, Fenin)

14:30 - 15:30
Compliance: Implications of the new digital relationships

 

IQVIA

IQVIA

Whilst the expectations from regulators as well as internal stakeholders on the compliance officers stay high, this session aims at discussing how the pandemic may have accelerated the move towards more "telehealth", and as such what such a move means for the compliance professionals, how the risks may have changed and how these could be apprehended in the most efficient way.

14:30 - 15:30
IVD Regulation and the road to May 2022 – Is the system ready for medical diagnostics in Europe?

 

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?

  Speakers:

  • Elisabeth MACINTYRE (MD PhD FRCP FRCPath, Vice-Présidente, Stratégie Internationale, Université de Paris, Onco-hématologie biologique and INSERM UMR1151, INEM, Board Member, BioMed Alliance - President-Elect, European Hematology Association (EHA))
  • Erica CONWAY (IVD Medical Devices, Regulatory Services, BSI)
  • Natale BOVA (Chair of IVD Regulatory Forum at Confindustria Dispositivi Medici, the Italian Association of Medical Device Industry, Quality Assurance & Regulatory Affairs Director, Instrumentation Laboratory S.p.A. - a Werfen Company)
  • Thomas WEISS MOLLER (Chair of Competent Authorities for Medical Devices (CAMD)- Section Manager – Medical Devices, Danish Medicines Agency, Denmark)

14:30 - 15:30
Innovation in MedTech – Trends and Opportunities

 

Olympus

Olympus

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.

Moderator:

  • Miquel-Àngel GARCIA (Managing Director, Olympus Europa SE & Co. KG)

  Speakers:

  • Jean-David MALO (Director, European Innovation Council)
  • Thom RASCHE (Partner, Earlybird Venture Capital)
  • Terry PARLETT (Commerzialisation Director, Cambridge Enterprise)

14:30 - 15:30
Advancing opportunities for the medical industry: the value of innovation and partnership model enabling the adoption and uptake of medical technology innovations

 

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.
1 "Access to Medical Technology Innovations: A Proposal for a Value of Innovation and Partnership Model"

  Speakers:

  • Lieven ANNEMANS (Professor of Health Economics, Ghent University)
  • Iñaki GUTIERREZ IBARLUZEA (Director of Organisational and Managerial Innovation, Basque Foundation for Health Innovation and Research)

15:30 - 16:30
Innovative Health Initiative: the next horizon for medtech companies

 

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.

Moderator:

  • Patrick BOISSEAU (Director General, Strategic Initiatives, MedTech Europe)

  Speakers:

  • Salah-Dine CHIBOUT (Global Investigative Safety, Novartis)
  • Casper GAROS (Head Partnerships, Philips)
  • Manolis KARAMALIS (Reimbursement Director, Medtronic)
  • Pierre MEULIEN (Executive Director, IMI2)

15:30 - 16:30
The new business environment for interoperability: how the push for data will impact the industry

 

Unity

Unity

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.

16:30 - 17:30
CEO #nofilter

 

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.

  Speaker:

  • Stacey SHULMAN (Vice President Internet of Things Group and GM Health, Life Sciences and Emerging Technologies, Intel Corporation)

13:00 - 14:00
Goodbye Medical Device Directives - Hello Medical Device Regulation!

 

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

Moderator:

  • Bassil AKRA (CEO, QUNIQUE GmbH)

  Speakers:

  • Anna Eva AMPELAS (Head of Unit, European Commission - Directorate General for Health and Food Safety - Medical devices, Health Technology Assessment (SANTE.DDG1.B.6))
  • Sabina HOEKSTRA-VAN DEN BOSCH (Regulatory Strategy Principal TÜV Süd / Chair NB-Med Executive Committee / Vice-President Team-NB)
  • Julia STECKELER (CEO, MedicalMountains GmbH)

13:00 - 14:00
Corporates and start-ups cooperation in the EU Innovation ecosystem

 

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.

Moderator:

  • Nina RIJNDERS (Corporate Partnerships, NLC)

  Speakers:

  • Mark BLOEMENDAAL (CEO, Angiogenesis Analytics)
  • Remi CORLIN (CEO, Hemeo)
  • Iker SOYDAN (CEO, EchoGuide)

14:00 - 15:00
Competing with China: How an emerging MedTech industry in China is impacting markets around the world

 

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?

15:00 - 16:00
Unlocking the value of diagnostic information or how to build resilient health system? Observations from the management of untreatable respiratory tract infections – now and in the future

 

The value of health-related information never became clearer as during COVID-19 pandemic. An indispensable source of information are diagnostic tests: by identifying the responsible infection agent, testing informs about existence of SARS-CoV-2 and allows to distinguish between COVID-19 and other respiratory tract infections (viral or otherwise) with similar presentation. This way, they not only contribute to control the spread of the virus but also improve disease management in terms of accurate diagnosing and targeted treatment.

Next to the SARS-Cov-2 outbreak, the emergence and circulation of drug-resistant bacteria and viruses, leading to antimicrobial resistance (AMR), increasingly constitute another threat to public health. AMR makes infections harder to treat and increases the risk of disease spread, severe illness and death. Taking the example of respiratory tract infections, panelists in this session will discuss how better leveraging diagnostic information can indeed enhance health systems' resilience vis-à-vis these shocks.

The discussion will be enriched by two case studies which look into the value of diagnostic information for the management of respiratory tract infections, including COVID-19 and hospital-acquired such as ventilator-associated pneumonia (VAP).

15:00 - 16:00
A brave new world: A different European legal environment

 

This session aims at providing an overview of the key European law developments which will be affecting the MedTech industry in the coming years and which may not yet be on the radar screen of the companies' legal departments, including European class action systems as well as the potential revision of the product liability directive as well as the initiatives linked to the European Commission's New Consumer Agenda intended to further empower European consumers to play an active role in the green and digital transition and to address misleading online practices seen during the COVID-19 pandemic and beyond. With the additional pressure that the current pandemic put on manufacturers of healthcare products, and the new regulatory regime, the work of the legal teams is set to change.

  Speaker:

  • Kenny HENDERSON (Partner, CMS)

15:00 - 17:00
From Pandemic to Recovery & Resilience

 

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?

  Speaker:

  • Hani ABOUHALKA (Company Group Chairman, Johnson & Johnson Medical Devices Companies Europe, Middle East & Africa (EMEA))

16:00 - 17:00
Impact of sustainable corporate governance and human rights due diligence EU legislation on medtech companies

 

For a long-time and for several companies operating in Europe, Corporate Social Responsibility initiatives have been to a large extent voluntary. Thus, an option for businesses to engage in social and environmental causes. However, in a globalized world where goods and people move across continents at a fast pace, it has become more evident for the society that businesses' responsibility for the respect of human rights and the environment need to be also extended globally.
EU legislators have consequently envisaged putting forward regulations that foresee harmonized rules on sustainable corporate governance (SCG) and human rights due diligence (HRDD) in the value chain. What the impact of these upcoming rules on the medtech sector will be, it is still unknown. But the sector is well aware,  informed and ready to engage in the political debates on these issues.

This session aims to provide an overview of potential obligations that could emerge from European legislation on SCG and HRDD. In addition, an estimation of the overall impact of these obligations on medtech companies will be presented. Speakers will include an expert official from the European institutions and a representative from the medtech industry.

  Speaker:

  • Fadzai MUNYARADZI (Corporate Social Responsibility Manager Europe, Medline)

17:00 - 18:00
CEO #nofilter

 

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.

Moderator:

  • Ingmar DE GOOIJER (healthcare industry observer)

  Speakers:

  • Mick FARRELL (CEO, ResMed)
  • Greg AHLBERG (Vice President, Abbott Diagnostics EMEA)
  • Mike MUSSALLEM (Chairman and Chief Executive Officer, Edwards Lifesciences)
  • Ashley MCEVOY (Executive Vice President, Worldwide Chairman, Medical Devices, Johnson & Johnson)

13:00 - 14:00
CEO #nofilter

 

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.

Moderator:

  • Ingmar DE GOOIJER (healthcare industry observer)

  Speakers:

  • Brigitte DE VET (Vice President, Materialise Medical)
  • Thomas SCHINECKER (CEO, Roche Diagnostics)
  • Miquel-Àngel GARCIA (Managing Director, Olympus Europa SE & Co. KG)

14:00 - 15:00
Unlocking the power of data

 

ResMed

ResMed

Medical grade health data, from medical and diagnostic devices and other solutions delivered by medical technology companies, forms the foundation of the digital transformation in healthcare. Aggregating and examining health data through intelligent algorithms and analytics can help us develop new scientific and medical insights, identify population health trends, and improve diagnostics and treatments to save lives. But there are cultural and regulatory barriers that prevent us from making full use of data's potential. This session will highlight specific examples of how medtech advances the potential of health data for the benefit of patients and healthcare systems, and how such barriers could be addressed to ensure European competitiveness and to advance the delivery and practice of healthcare.

  Speaker:

  • Odile BIGAIGNON (VP Sleep & Respiratory Care Marketing, EMEA, ResMed)

14:00 - 15:00
Is EU still attractive for MedTech for the MedTech Industry?

 

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.

Moderator:

  • Ingmar DE GOOIJER (healthcare industry observer)

  Speakers:

  • Bert-Arjan MILLENAAR (Founder & CEO, NLC)
  • Kerstin WAGNER (Sr. VP Diagnostics Marketing & Sales, Siemens Healthineers)
  • Jean-Luc LEMERCIER (VP EMEA Canada & Latin America, Edwards Lifesciences)
  • Cristiano FRANZI (Baxter)

15:00 - 16:00
How Value-Based Innovation Procurement unlocks resilient health systems

 

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.

15:00 - 16:00
How about a single global regulatory system? Advancing global regulatory convergence – perspectives for the future

 

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.

  Speaker:

  • Emmet DEVEREUX (Director, Government and Regulatory Affairs, EMEA, Cook Medical)

16:00 - 17:00
The EU Green Deal: Priorities for MedTech Europe

 

The ambitious and much needed Green Deal brings with it a wealth of regulatory initiatives. They include revisions of current legislation and proposals for new legislation in various sectors, including chemicals, environment, and sustainability. The medtech sector is heavily regulated and will be greatly impacted by many Green Deal initiatives. In this context, MedTech Europe identified a number of priority policy areas where the sector could bring a valuable contribution to the decision-making process. Our members understand that the association's involvement in this process is of paramount importance for continuing to secure timely access to safe, efficient and life-saving medical technology for patients across Europe and the globe.

This panel discussion will address MedTech Europe's priorities from the perspective of member companies, highlighting potentially critical aspects of upcoming legislation that could impact patients' access to medical technology in the long term. Panelists will include senior representatives of medtech companies, members of MedTech Europe.

16:00 - 17:00
A privacy conundrum?

 

Faegre Drinker Biddle Reath

Faegre Drinker Biddle Reath

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.

Moderator:

  • Mary Devlin CAPIZZI (Partner, Faegre Drinker Biddle & Reath)

  Speakers:

  • Peter BLENKINSOP (International Pharmaceutical & Medical Device, Privacy Consortium (IPMPC))
  • Megan OLSON (Global Chief Compliance Officer)

17:00 - 18:00
Conclusions

 


Moderator:

  • Ingmar DE GOOIJER (healthcare industry observer)

  Speakers:

  • Serge BERNASCONI (CEO, MedTech Europe)
  • Rob TEN HOEDT (Chairman - MedTech Europe, Executive Vice President and President, EMEA - Medtronic)