Programme 2020

All sessions are tentative and subject to change

Tuesday 26 May

09:00 - 09:30

Opening and introduction


09:30 - 10:30

CEO #nofilter

Global leaders from the field of medical devices, diagnostics and digital health will sit together and speak openly about the latest trends, challenges and opportunities they're facing.

11:00 - 12:00

GMTCC introduction & Keynote: view from the regulators

GMTCC

This keynote will be sharing the regulators views on the following aspects: what is working and what isn't with the current anti-bribery & corruption efforts; how can industry help and what are the key points the medtech industry should be aware of. In addition, considering that the industry is composed of more than 80% of SMEs, are there specific considerations for these companies?

Live on stage! 4 start-ups disrupting healthcare

The heart of smart medtech starts-ups beats for innovation. At the convergence of AI, blockchain, software, smart materials, 3D printing, microfluidics, and cyber physical systems, some European medical researchers and entrepreneurs are making major breakthroughs that allow for easy and more accurate diagnoses, improved treatments, drug discovery, customized prosthetics, and more. With the support of top universities and programmes like Horizon 2020, European startups are leading the way. Four of them have been selected for their disruptive innovation and their expected impact on healthcare and on patients' lives. They will showcase on stage their demonstrator or prototype.

WHO policies

Medical devices have become integral to World Health Organisation (WHO) policy making. As the leading organization in developing Global Health policies WHO is committed to the world wide roll out of universal health coverage, the development and implementation of an Essential List of Diagnostics (EDL), defining policies to combat Non-Communicable diseases (with a focus on cardiovascular, diabetes and cancer), emerging diseases and anti-microbial resistance, as well as putting together and promoting a regulatory model for medical devices which is being adopted across numerous jurisdictions.
This session will bring together experts to better understand the opportunities and challenges that arise for the medical technology sector from the WHO policies and how those policies are shaping healthcare in different regions of the world.

12:10 - 13:10

AI policy in health

IQVIA IQVIA

The new von der Leyen Commission has made a push to advance artificial intelligence with a coordinated policy approach to regulate AI and an intent to build a European health data space. A prominent part are the ethical guidelines for trustworthy AI which seem to pave the way for an appropriate regulatory environment. MedTech Forum has invited NN from the Commission to present latest updates on test the AI roadmap, and experts will offer feedback from various perspectives including a Member State, a legal/data protection view, and a medtech company working on AI solutions in healthcare. There will be ample room for audience interaction.

Good bye Medical Device Directives - hello Medical Device Regulation!

26 May 2020 is the Medical Device Regulation's (MDR) Date of Application, marking the end of the MDR transition period. A lot has been accomplished during the past 3 years. However, many compliance deadlines are still to come (e.g. Eudamed) and implementation remains challenging. 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 are the benefits of MDR for stakeholders?
- What has been achieved during the MDR transition period?
- Which Acts and Guidance documents are still needed to make the MDR work?
- State of the Play on national MDR adaption laws: are they adequate?
- MDR without Eudamed - do national fall back solutions meet the needs?
- What needs to happen in order to successfully hit the May 2024 deadline (after which Directives certificates will become void).
- Scenarios that are likely to unfold in the coming months/years with insight into how these may be addressed

Medical education 3.0.

GMTCC


13:30 - 14:30

Sponsored session: How Technology Can Simplify Compliance in the World of Global Regulatory Changes

Veeva Veeva


14:30 - 15:30

Plenary session - keynote


15:45 - 16:45

A roadmap to incorporating value in healthcare decision-making across Europe

Value-based healthcare offers opportunities for improving outcomes and efficiency in health systems. Yet, payrs, healthcare organisations, the medtehc and the pharma industry in many health systems have struggled with the question of where to start their 'value journey'. However, some success stories are emerging.

Against this background, Rifat Atun - Professor of Global Health Systems at Harvard University - will provide a roadmap to greater 'value creation' in healthcare. Drawing on successful case from across the world, Professor Atun will identify factors that have enabled success and can help guide health systems in moving towards and scaling-up value-based decision-making models. The presentatino will also explore how the medtech industry can effectively contribute to transition and scale-up of value-based health care models.
Professor Atun's presentation will discuss 'Incorporating value in investment decisions in health across Europe' a reflection paper commissioned by MedTech Europe, and developed in conjunction with 'Creating Value in European Healthcare' working group to foster value-driven thinking in healthcare investment decisions in Europe.

Ask the experts

Roundtable discussions designed for smaller groups of 12 people together with 1 leader (expert) focusing on one topic. Topics will be defined shortly.

Leading in disruption with new business building

McKinseyGMTCC GMTCC and McKinsey

Real at-scale business building is not a choice…it is a strategic, differentiating capability .
The success of today's market leaders is based on business building. In fact, the biggest growth stories of past 20 years are down to business building. 8 out of 10 of the world's largest companies are serial business builders. However, business building is a skill that many incumbents across industries lack - and medtech is no exception - and often, corporate builds aren't blockbuster successes. Adding to this, medtech companies need to face the increased expectations from regulators and internal stakeholders alike, as well as the risk profiles which are continuing to expand (e.g. privacy).
Join the session to hear from successful players across industries how they embraced new technologies and ways of working, disrupted their industries and stayed ahead of competition. Learn how they structured collaboration between the start-up and the 'mothership' along aspects like talent, time horizon, Legal & Compliance, culture, etc. Reflect on the lessons for the medical devices industry.

Policy, incentives and rules: A new momentum for data sharing in Europe

Reed Smith

The objective of a European health data space and the new ambition for big data and AI in healthcare have shed new focus on the sorry state of health data in Europe: hemmed in by legal uncertainty, fragmented by inconsistent formats, and locked in proprietary, institutional silos. With the European Commission's communication on digital health (April 2018), and the eHealth Network's Investment Guidelines for an interoperable eco-system for digital health (June 2019), there is new momentum to break down barriers for the exchange of health data. The German EU presidency for the second half of 2020 has committed to further advance the digital transformation of health and care. In this panel, senior policymakers from EU Member States will discuss their vision for their healthcare systems, and the role of the medtech industry.

16:55 - 17:55

A global perspective on chemicals legislation

Chemicals regulations are on the rise in different regions across the world.
This presents challenges for medical technology companies to ensure that globally marketed products are compliant with all applicable requirements. It necessitates constant monitoring of so-called lists of 'declarable' and/or 'restricted' substances which are different in different regions.
How can companies keep track of multiple (often divergent) chemicals lists and how can industry achieve harmonisation, if not through a globally harmonised list of chemicals at least through harmonised reporting standards? Can full material declaration be (part of) the solution?

Dance at your own rhythm; just make sure you start dancing now! The same recommendation applies to the usage of Value-Based Procurement by MedTech suppliers

The initial applications of Value-Based Procurement (VBP) have been encouraging and strong momentum is building across Europe, but most organizations are still at early stages of maturity. Via several concrete examples, the session will demonstrate that the VBP approach is applicable to all MedTech technologies and that all MedTech suppliers have the capacity to take steps (even if only small ones) to start using this approach in practice.

It's More Than Just Data: How medtech is providing life-changing insights

ResMed

The digital transformation of healthcare empowers people to make better choices about their own care, supports clinical decision making with real world evidence, and enables efficiencies to save cost in the healthcare ecosystem. Digital health solutions enable patients to manage their chronic or acute conditions with more independence and improve their quality of life. Healthcare professionals reach better and quicker clinical decisions and avoid unnecessary tests or errors. Healthcare systems gain efficiency by delivering some healthcare remotely instead of keeping patients in the hospital, avoiding unnecessary care through prevention and coaching, or by creating efficiencies in how healthcare is delivered. At the foundation of this transformation is medical grade health data, from medical and diagnostic devices and other solutions delivered by medtech companies. This session will explore the value of data from a patient and professional perspective, and how it is valued, or should be.

Trade agreements

Medical Technologies have always benefitted from trade – all nations can benefit from medical technologies and robust trade agreements have a central role to play in ensuring that patients around the world have access to needed medical technologies. The European Union has been focusing its efforts in the development and implementation of a series of trade agreements with key regions of the world –Australia, Canada, Japan, Korea, Mercosur and New Zealand to facilitate trade. However there are also growing concerns about the impact of different trade sanctions and the re-imposition of tariffs which have an impact on global trade in medical devices. This sessions explores the latest developments and trends in trade policies and trade agreements and points to how to get the most out of trade agreements for the medical technology sector.

Wednesday 27 May

08:30 - 09:30

What does the future hold for the C-suite?

MedTech industry is facing structural shifts and disruption, with intensifying financial pressures and competition from new entrants to the health care market - especially Silicon Valley, big tech companies, and private equity firms. Companies will need to evolve quickly and adapt their business models, with data at its core. How does the C-suite address this challenge to keep the company successful? In this session, you will find out which approach is adopted by Chief Executive Officers, Chief Compliance Officers, Chief Technology Officers or Chief Strategy Officers to adapt to those changes.

09:40 - 10:40

GMTCC: Chief Compliance Officer Panel

GMTCC

With the expectations and the role of Chief Compliance Officers evolving and new risk profiles appearing, this panel aims at learning about different approaches CCO have taken on how they organise their compliance organisations; what they are working on now and what they are contemplating as next topics. Where is the compliance function heading to, what are the big trends and how to make sure that the compliance function is future-fit?

IVDR: clinical evaluation for dummies

May 2022 is the hard deadline for most of the IVD devices to comply with the IVD Regulation, and most manufacturers are in the process of gathering clinical data to support the products claims. All manufacturers have to carry out a performance evaluation, to demonstrate the scientific validity, analytical performance and clinical performance of the device. How will the new performance evaluation requirements affect the industry? What sources of data can be used to meet these requirements? How can we leverage clinical data and when is it deemed sufficient? Attend this session to learn more about the new clinical requirements.

Value-driven access model: HTA to foster the adoption of transformative innovation?

During this session, the panelist will reflect upon the importance of 'value creation in healthcare' and the related discussion of moving towards a value-driven access model that enables better patients' access to innovative medical technologies and the diffusion of the latter into the healthcare systems.
The implementation of value-driven decision making requires efficient and adapted tools to recognize and measure the overall value of the innovative medical technologies. These tools, currently under development, shall eventually foster the adoption of innovation and reward the value created by medical technologies. Furthermore, incorporating 'value' considerations into funding and reimbursement models as well as investment decisions will be of utmost importance. Against this backdrop, the session will discuss those tools while particularly referring to HTA as one of them and its role in support of value-driven access model. The session will also be placed in the context of the European Commission's proposal for regulation on 'EU HTA cooperation' on which MedTech Europe's stance will be shared.

11:10 - 12:10

Clinical Evaluation Consultation Procedure (CECP): Enabler or impediment to innovation?

The MDR came into force in 2017. It stipulates the establishment of expert panels to support the assessment of specific innovative high-risk devices via the Clinical Evaluation Consultation Procedure (CECP) - more commonly known as the ''scrutiny'' procedure - and to contribute to the prospective improvement of the overall framework.
This session will seek to find answers to the following points:
- How is the scrutiny process working in practice?
- What long-term impact is it likely to have on business and innovation?
- Key challenges and opportunities

GMTCC Ethical AI in MedTech: What is there to know?

GMTCC

While AI in MedTech today can partly rely on existing regulatory frameworks, there may be highly iterative, autonomous AI models and technologies which may require the development of additional (technically neutral) guidance and/or a revised international regulatory approach which would facilitate regulatory approval of a rapid cycle of product improvement and allow these devices to continually improve while providing effective safeguards.

What is the best approach to build new regulatory infrastructures and how to build trust from a legal perspective (e.g. allocation of responsibility and liability), considering specifically the sector which is already highly regulated?

Horizon Europe: take your chance now or never

Horizon Europe, the next Framework Programme of the European Commission starts early 2021 for seven years. Focusing research and innovation on the ecological, social and economic transitions and related societal challenges like healthcare Horizon Europe is leveraging Europe's scientific strengths into leadership in breakthrough and disruptive innovation and set ambitious goals for issues that affect us daily. Focusing on cutting-edge research and innovation projects spanning from research and innovation to deployment, it offers a wealth of opportunities for healthcare sector, especially medtech which is a new priority in Horizon Europe. However, EU programmes look sometimes complex, bureaucratic, and lengthy. It's time to be prepared and learn from the European Commission how to best participate, don't miss it!

12:10 - 13:10

GMTCC Big data & privacy

Drinker Biddle & Reath LLP Drinker Biddle & Reath LLP

Big healthcare data has considerable potential to improve patient outcomes, predict outbreaks of epidemics, gain valuable insights, avoid preventable diseases, reduce the cost of healthcare delivery and improve the quality of life in general. However, this potential can only come if the data's security is preserved and patient's right to privacy is guaranteed. The session aims at discussing the security and privacy challenges in big data as applied to healthcare industry, and potentially identify ways in which they may be addressed in order to support future research and development of innovative MedTech products.

How to make the MDR's transition ("grace") period a success

Manufacturers of medical devices had in general a transition time of 3 years to meet the requirements of the MDR. However, certificates issued under the former Directives can only remain valid until maximum 27 May 2024.
This session will address the following:
- In practice, how do manufacturers keep certificates valid during the extended transition time?
- How can manufacturers make the grace period a success and take full advantage of it; what are the pitfalls?
- What will notified bodies be focusing on, e.g. during audits, technical documentation reviews?
- Which guidance do notified bodies still need from Regulators?
- Is there still a notified body capacity issue?
- Assessing different Notified Body interpretations: how can we ensure a harmonised approach?
- Understanding Notified Body priorities for MDR implementation

MedTech Start ups & Innovation development ; Perspectives on Europe's attractiveness !

In the past, Europe has been a prime geographical area for the development of MedTech start-ups and innovation with a favorable environment for an early market access. In the recent years and a few more to come, the market access principles have been and are being reset. How is this “reset” affecting European attractiveness for startups and innovation development ? Find out MedTech investors short, mid and long term perspectives of the ongoing “reset” for start-ups and innovation in Europe.

To know, or not to know – how diagnostic information can enable patient-centric, sustainable & value-driven healthcare

The introduction of the VODI concept by Wurcel et al. 2019 as an academic publication has already been a large step forward in promoting the various value components of diagnostic information which have been largely unknown until recently. So that the concept doesn't remain mere theory, MedTech Europe is working - together with Executive Insight (supporting consultancy) and the great support of its members - on the development of a set of case examples. This set of case examples aims to illustrate the full breadth of value that diagnostic can provide along the patient pathway in areas where is this high unmet and a significant disease burden.
During this session, the VODI case example project will hence be introduced, along with the presentation of already two out of series of other cases planned for the upcoming months (among those pilot case in the area of chronic and acute heart failure). The cases will then be discussed among key targeted audience (list of possible panelists see below) to test response and discuss operationalization of VODI in general in healthcare decision-making.

14:30 - 15:30

Plenary session - keynote


15:30 - 16:00

Conclusions


© Copyright 2018 - Europa Organisation - All rights reserved | Legal notice | Cookies | Privacy policy