Programme 2020

All sessions are tentative and subject to change

Monday 25 May

18:00 - 22:00

Opening cocktail & dinner


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.

The IVDR and the road to May 2022 – Is the system ready?

As a manufacturer you will have to comply with the IVDR by May 2022. This is only 2 years away and many challenges pave the way to achieving compliance, including anticipated bottlenecks in reviews by notified bodies, and ongoing needs to interpret certain provisions of the Regulations. Concluding the transition as soon as possible is vital for IVD manufacturers.
In this multi-stakeholder panel discussion, key questions that will be addressed include:
- Overall is the system on track with the time remaining?
- Where should you be in your implementation at this point of the transition?
- Understanding how best manufacturers can utilise the transition time to the IVDR
- What key MDR implementation learnings can benefit the IVDR implementation benchmark?
- Understanding how Notified Bodies and planning and preparing for the 2022 deadline

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 in healthcare: vision and reality

Reed Smith Reed Smith

While AI in MedTech today is subject to the Medical Device and the In-vitro Diagnostics Regulations and other existing regulatory frameworks, new AI technologies such as highly iterative and autonomous AI models may require the development of additional guidance and/or a revised international regulatory approach. More enabling frameworks would facilitate regulatory approval of a rapid cycle of product enhancement and allow these devices to continually improve, while still providing effective safeguards for patients.
What is the best approach to building such new regulatory frameworks, considering that the sector is already highly regulated? How can we build more trust from a legal perspective (e.g. allocation of responsibility and liability)? How can some of the specific concerns that exist in healthcare be addressed (including ensuring safety, ethics and bias, and the doctor-patient relationship), while at the same time enable innovation so we can make full use of new innovative technologies to benefit patients, providers and the overall healthcare systems?

GMTCC: Medical education 3.0.

GMTCC

Medical conferences fulfill a critically important role in the ongoing education of healthcare professionals and organisations. In a rapidly evolving landscape, new skills are needed as new technologies are radically changing the face of medical education. But while medical conferences are key to sharpen physicians’ knowledge, share research, try new equipment, in order to guarantee the best health-care delivery and patient outcomes, what can be done to improve the quality of learning and facilitate the implementation of upskilling strategies? How to best navigate the novel forms of medical training (e.g. virtual events, innovative training centers and partnerships) and reconcile the needs and interests of both organizers (Healthcare Organisations and Healthcare Professionals) and medtech manufacturers?

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

13:30 - 14:30

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

Veeva Veeva


14:30 - 15:00

HealthTech Awards hosted by The MedTech Forum

The #HealthTech Award 2020 will honour the most promising game changers developing emerging technologies for healthcare in Europe, and offer them larger visibility and recognition. Three categories will be rewarded this year: best concept/invention, best product/deal and a special prize from the HealthTech TAB (Translation Advisory Board). Applications are open to all innovators based in Europe: academia, start-up companies, SMEs, industries, private inventors, and to all emerging HealthTech : nanomedicine, advanced materials, photonics, robotics, electronics, digital health, etc. Do you develop breakthrough innovation in healthcare? A new technological solution able to change the life of thousands of patients? Would you like to see your great invention highlighted in front of a large audience of Key Opinion Leaders and influent media of the field? APPLY ONLINE TODAY, and be the next HealthTech Awardee in 2020! http://www.healthtech-award.eu/

The #HealthTechAward2020 is organised by the NOBEL Project and hosted by the MedTech Forum.

15:00 - 16:00

Keynote speech: Together we can make a difference

Michel Fornasier was born without a right hand. As a result, he's made a personal commitment to provide physically disabled children with innovative hand prostheses through his charity, Give CHILDREN a Hand. Together with specialists, designers and 3D printers, the charity produces customised hand protheses for children.
But besides physical help, children also need emotional support - they need a role model, someone to protect them and strenghten their self-esteem. For that reason, Michel Fornasier created the comic book series "Bionicman". The disabled superhero fights against prejudice and all forms of bullying.
Get inspired by Michel's story and find out what his message is to the medtech industry.

16:00 - 16:30

Networking break


16:30 - 17:30

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, payers, healthcare organizations, the medtech 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 presentation 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.

GMTCC: Impact of digital disruption on legal & compliance functions

GMTCC

While the challenges for the legal & compliance functions intensify, given the increased expectations from regulators as well as internal stakeholders, as well as the risk profiles which are continuing to expand (e.g. privacy), new technologies such as artificial intelligence, may provide new tools to help facing those challenges. How much is real about this hype? What are the key changes brought by those technologies, what does it mean for the L&C functions, and what are their limitations and constraints to its adoption?

Leading in disruption with new business building

Business developments

McKinsey 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

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.

17:30 - 17:35

Change of room


17:35 - 18:35

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?

A new way forward: A Value and Innovation driven access model

During this session, the panelists will reflect upon the importance of ‘value creation in healthcare’ and the related discussion of moving towards a value and innovation 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 adaptive tools and pathways to recognize, measure and reward the overall value of innovative medical technologies. These tools, currently under development, shall eventually foster the adoption of innovation and reward the value created by medical technologies. The session will discuss those tools while particularly referring to: innovation financing schemes, value-based procurement and whether/how Health Technology Assessment (HTA) should be implemented, and its role in supporting 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.

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.

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

ResMed 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.

Let's make trade great again!

Free trade enables delivery of life saving and life supporting medical technologies to patients around the world - all nations can benefit from unhindered access to medical technologies and robust trade agreements play a central role in ensuring that. Trade policy is one of the exclusive competences of the European Union (EU) and a lot of efforts has been put into the development and implementation of trade agreements with EU's key trade partners.
Over the past few years, trade policy has become a highly politicised domain. Growing protectionism and its impact on global trade and supply chains are highly impactful for the medical technology industry.
This session explores the latest developments and trends in trade policy and points to how to get the most out of trade agreements for the medical technology sector. This session will focus in particular on the examples of the EU relations with Switzerland, Turkey and the UK - markets, which for a number of years have been closely integrated with the EU and where trade agreements have a key role to play in defining the future relationship with the EU, and ultimately defining the market access rules for medical technologies.

18:35 - 20:30

Networking cocktail


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

Dance to your own rhythm; just make sure you start dancing now! How MedTech suppliers should "dance" to the Value-Based Procurement rhythm

The initial applications of Value-Based Procurement (VBP) have been encouraging, and strong momentum is building across Europe; however, many MedTech suppliers are still at an early stage of VBP maturity. During this session, you will hear how several major European medtech procurers are urging their suppliers to take the VBP route together with them. Via several concrete examples, the session will also demonstrate that VBP is applicable to all medtech technologies and that all medtech suppliers have the capacity to take steps (even if only small ones within their current business models) to start using this approach in practice.

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?

How to navigate through the IVDR clinical evidence requirements

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.

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 What's coming up the EU law front and are you prepared?

GMTCC

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 revision of the product liability directive and its link to the new framework of the liability of emerging technologies.

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 – Unlocking the value diagnostic information to improve heart failure care

Even though information on health-related outcomes is readily available and critical for diagnosis, treatment and monitoring, its value is often neglected as it is used ineffectively or in a non-timely manner. This is in particular true for in-vitro diagnosis which deliver information with the ability to advise and improve all decisions along the patient pathway, adding value at each step of the patient journey and to everyone involved – from patients, healthcare professionals, healthcare systems and society.


The role of diagnostic information becomes evidently clear in heart failure which is a common condition across Europe. Patients suffering from heart failure are confronted with a poor quality of life which can also affect their mental wellbeing. Heart failure doesn’t not only pose significant sustainability challenges to healthcare systems but also represents socio-economic burden in terms of productivity of patients but also their carers. Yet, heart failure care is often fragmented, rarely guideline-based and hence full of untapped opportunities to improve disease management. Diagnostic information can be part of the solution to tackle these shortcomings which has been illustrated in a case study by MedTech Europe precisely illustrates how diagnostic information proves to provide value for patients, healthcare professionals, healthcare systems and society.

With the case study as a starting point, Panelists will share address question such as how to create a healthcare delivery system that fully leverages the value of diagnostic information and removes barriers to timely diagnosis, optimal treatment and guideline-based care?

14:30 - 15:30

Plenary session - keynote


15:30 - 16:00

Conclusions


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