Programme 2019

All sessions are tentative and subject to change

Tuesday 14 May

08:00 - 18:00

Gaston Berger Amphitheatre

SNITEM START-UP DAY

Organised by SNITEM (the French association for medical devices) and ranked as the benchmark of the French health startup ecosystem, the fifth edition of the Innovative Medical Device Startup Day will offer exchanges and debates around regulatory strategy, market access, key steps to create a startup and sources of project financing, etc. Key features of the event include:
• Start-up area: as in 2018, the startup jury will select a dozen start-ups showcased at the Espace Innovation, on the same level as the B to B meetings. These 12 companies in the spotlight will pitch their ideas throughout the Day until the jury prize and the public's "coup de coeur" prize are awarded:
• B to B area: a large space dedicated to B to B meetings where the 1000 attendees (start-ups, Medical Device manufacturers, institutions, investors, competitiveness clusters, lawyers, etc.) can discuss their projects together and initiate new collaborations.
The participation is free and the language of the event is French (simultaneous translation in English will be available). For more information, visit the start-up day website.

10:00 - 13:00

AdvaMed Global Compliance Steering Committee Meeting (Members only)

GMTCC


MedTech Europe Ethics & Compliance Committee (ECC) Meeting (Members only)

GMTCC


13:00 - 14:00

Networking lunch

GMTCC


14:00 - 15:30

1st GMTA Global Compliance Network meeting

GMTCC


15:30 - 16:00

Coffee Break

GMTCC


16:00 - 17:30

1st GMTA Global Compliance Network meeting (con't)

GMTCC


18:00 - 21:00

MedTech Forum & GMTCC opening reception & cocktail dinner


Wednesday 15 May

09:00 - 09:30

Gaston Berger Amphitheatre

Opening

Plenary


09:30 - 10:30

Gaston Berger Amphitheatre

CEO #nofilter

Plenary

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. The audience will have the opportunity to ask direct questions that will be answered with #nofilter.

10:30 - 11:00

Coffee break GMTCC

GMTCC


10:40 - 11:30

Gaston Berger Amphitheatre

Life with diabetes and digital health: about connections, data and control

Digital Keynote

Digital health solutions and the sharing of health data promise to empower patients with information and to support them in managing their health. To address concerns about possible abuse of data, the GDPR gives citizens and patients effective control over their data. Yet, both promises, of empowerment and control, have not yet fully materialised. Individual data relevant for health remains locked in silos: the smartphone apps linked to connected medical and health devices, and the proprietary platforms and clouds where they are stored. As long as this fragmented digital ecosystem persists, it will remain difficult for patients, health professionals and researchers to aggregate it, combine it with other sources, and derive meaning. Claus, a technophile and fan of connected devices, will report from the reality of living with diabetes juggling multiple devices, and from his project to develop a truly patient-centred data platform where control of data is given back to where it belongs: the individual

Louis Armand Room East

Make it your trade deal

Business developments

In the last few years the EU has been quietly but effectively negotiating a network of bilateral trade agreements around the world. As more of these trade agreements are being ratified and become a reality they create opportunities for MedTech around the globe - from Canada (CETA) to Japan, Mercosur and China - see how companies small and large can benefit from trade agreements to access markets, protect their overseas investments and their intellectual property. Trade agreements are a powerful but underutilized mechanism which can help build global partnerships can be a decisive factor from companies, especially SMEs to grow and shape their business

Louis Armand Room West

Will the future EU HTA cooperation respond to countries' needs and impact access to medical technologies?

Access

HTA and HTA cooperation in Europe is at a crossroads: the current cooperation based on projects is coming to an end and a new EU Regulation on HTA is in the making. This session will look at whether HTA cooperation is turning into reality and if it responds to common countries' needs. The European Commission's proposal for a Regulation aims to introduce EU Joint Clinical Assessments (JCA) for selected technologies with a mandatory uptake by Member States - the remaining part of the HTA to be done at national level. It also foresees the possibility for voluntary cooperation for clinical of other medical technologies and non-clinical assessments on any technology. After the adoption of the European Parliament's position, the Member States are now expressing their expectations and views and are negotiating a common text. In that context, the French and German authorities have already expressed their vision and doubts, in particular on the mandatory use of the EU reports, and the starting point for medical technologies to be in the scope of that new EU Regulation while the MDR/IVDR are not yet fully implemented.

The representatives of the German and French authorities will provide their detailed view on whether these JCA would effectively ensure further access to medical technologies, the expected starting point for medical technologies, the anticipated number of assessed products and the potential impact on the IVDR/MDR implementation

11:00 - 11:15

Auditorium

Keynote: view from the regulators

GMTCC

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

11:15 - 11:35

Auditorium

Plenary session

GMTCC

The two chairwomen will discuss the AdvaMed and MedTech Europe compliance priorities as well as how these relate to the topics tackled in the MedTech Forum

11:30 - 12:00

MedTech Forum coffee break and networking


11:35 - 12:50

Auditorium

Transparency: What's next for industry?

GMTCC

With the spreading transparency laws around the world, is there a need to start discussing global transparency? To help to debate this topic, it is also interesting to learn from the pharmaceutical industry what they would do better in insight; how did the public react to their disclosure; what were the main questions, and whether there are discussions to also tackle transparency at international level

12:00 - 12:50

Gaston Berger Amphitheatre

Notified Bodies: A key pillar of the new EU regulatory system

Access

In May 2017, the new EU medical technology Regulations 745/2017 for medical devices and 746/2017 for in vitro diagnostics entered into force. Industry welcomes the Regulations' objectives: a modernised framework, transparency and in particular a strengthened Notified Body system. However, as fewer and fewer Notified Bodies have to manage more and more extensive work, under extreme time pressure, manufacturers' ability to keep products on the market beyond the 26 May 2020 and 26 May 2022 deadlines could be seriously jeopardized.
This session "Notified Bodies: A key pillar of the new EU regulatory system" provides insight into the key challenges Notified Bodies and industry are experiencing as the 26 May 2020 / 2022 deadlines of the new Regulations approach. The multi-stakeholder panel will explore solutions which might be put in place to address these challenges.

Louis Armand Room East

Integrated healthcare and convergence of industries

Business developments

An increasing number of companies are preparing themselves to enter the new "offer model" of integrated Healthcare and a few have even already experienced it. Health Care Organisations are also increasingly interested in such model as one of the solution of their current organisational, supply and financial challenges. What does it take to build an Integrated offer ? How do you do it? Is this for all Healthcare organisations or just a few that can handle such radical change? How do you measure outcome and success for both Industry and HCOs? These are a few of the questions which will try to be answered during this session.

Louis Armand Room West

Reimbursement is so last year: new business models for digital health

Digital

ZSSponsored by ZS

In today's landscape, market access for digital technologies is often hampered by the lack of adequate financing methods. The most common reimbursement models in Europe usually finance health providers delivering services and procedures. But the emergence of digital technologies that improve outcomes, ease of access and quality of life outside the normal healthcare setting pose a challenge to these reimbursement models. Innovative Medtech companies continue to develop and bring new digital health technologies to market, by partnering in new ways with payers or by finding new revenue streams. This session will offer reflections and case studies of successful business models for digital health, in Europe and beyond

12:50 - 14:15

Lunch break and networking


13:20 - 14:10

Louis Armand Room East

Monetizing innovation in MedTech - Capturing the full offer value in a new era

Sponsored session

Simon KucherSponsored by Simon Kucher

Product innovation has long been the engine for profitable growth in the medical technology industry. However, with constrained healthcare budgets, HTAs and procurement professionalization, capturing reasonable returns on R&D and L&A investments is becoming an increasing challenge. Successful medical technology companies make market access a top strategic priority in guiding portfolio, clinical development and launch decisions. They furthermore explore new business models in the context of better addressing customers' clinical and budgetary challenges as well as monetizing the value of customer services and digital solutions.

Join Simon-Kucher & Partners where our experts along with an external industry speaker will present insights and practical food for thought on:
- Why finding new ways to monetize innovation is key for the industry
- How to successfully manage market access for product innovations
- How to optimally monetize digital opportunities
- How to best capture the value of customer services
- How to develop and deploy winning customer solutions

Louis Armand Room West

Blueprinting agile transformations - Value at stake and practical applications of enterprise agility in MedTech

Sponsored session

McKinsey McKinsey


14:15 - 15:30

Louis Armand Room East

Post-mortem analysis of the MedTech Europe Code (Workshop)

GMTCC

This workshop is open to up to 12 companies with two representatives each: one Europe/EMEA business leader and one Europe/EMEA compliance officer to discuss the practical challenges (e.g. speaker support) met by companies with regards to the MedTech Europe Code. Key outcomes will be worked into the issues that the MedTech Europe expert groups (i.e. ECC and Code Committee) will tackle. Therefore the presence of the two chair persons of these groups

Louis Armand Room West

Distributors session

GMTCC

This session aims at addressing aspects such as:
- How do companies manage distributors and agents with practical implementation of the new regional codes, as well as policing of these same codes?
- Best practices in third party screening as well as engagement of new business partners
Sub-distributors/agents - what level of due diligence is being applied by companies

Auditorium

The digital transformation & compliance: Roundtable discussion with Chief Privacy Officers

GMTCC

This session aims at discussing issues arising from the new digital age and the changing business models, such as:
- What are the new risks coming for the new digital age;

- How to ensure data stewardship, in order to deliver new products? What type of governance set up should companies think about?
- What are the privacy/data protection/GDPR considerations to keep in mind?
- Is there a role for compliance when we talk about Artificial Intelligence?

14:20 - 15:20

Gaston Berger Amphitheatre

Value: driver of change in healthcare

Plenary

Over the past years, Value Based Health Care has been proposed as the way forward to reform health care systems. This new concept comes with opportunities but also brings challenges regarding its implementation. In this session, key healthcare stakeholders will provide their perspectives on the reality of implementing Value driven health systems in Europe. Hear from international organisations such as OECD, National Authorities, health system representatives, providers and the industry.
The session will dive into the concept of value, initiatives from International organizations in the field of reforming healthcare with a focus on patient relevant outcomes (PaRIS), considerations by health systems under reform pressure and providers seeking for investment. MedTech Europe will share its view on how it can effectively contribute to the opportunities that a value driven healthcare environment can bring to all stakeholders

15:30 - 16:00

Coffee break GMTCC

GMTCC


15:30 - 16:10

Gaston Berger Amphitheatre

Can "value" in healthcare guide investment in technology?

Over the past years, health systems driven by value (instead of services) has been proposed as the way forward to reform health care systems. The main considerations behind the concept of Value Based Health Care are the outcomes that matter to patients and the cost of care delivery. However, what is of "value" depends on the stakeholders' perspectives and perception, multiple perspectives of value are given as it is in the eye of the beholder what is considered of value and ultimately for what people and health systems are willing to pay for. To build a shared view on the "Value" concept, initiatives are taken to define a broad view of "Value" within European healthcare systems worthwile investing in The Keynote speaker will provide a joint view of current perspectives on the Value definition and how the Value concept can be translated into practice to guide access and investments in MedTech and to implement a value based access model along the lifecycle and for different types of MedTech innovations

Louis Armand Room East

Genomic testing and personalised medicine

Business developments

Personalised medicine has become a key subject in the vision of many on the future of healthcare. But what is it that we are talking exactly? What kind of an answer is personalized medicine to the current challenges of providing better and safer affordable healthcare? IVDs are a major key to the development of personalized medicine as is the monitoring and communication capacities of and increasing number of devices. Companion diagnostics is a very interesting entrance into personalized medicine and what about Genomic testing? During the discussion a few expert will attempt to respond to such important questions

Louis Armand Room West

MDR - Is the system ready for business?

Access

Only 12 months remain before the Medical Devices Regulation enters into application. How should you be spending the last remaining 12 months left of the transition period in order to best position your business? What can you do, and how can you manage business uncertainties as the regulatory system is still being built? Hear the perspectives of this multi-stakeholder panel, consisting of representatives from the national competent authorities, the European Commission, hospitals and industry

16:00 - 18:15

Loft

Ask the experts session

GMTCC

This session will be set up in roundtable discussions. The time allocated will allow them to get to the heart of key issues. Attendance is limited to 12 persons per table. After 40 minutes, the participants are invited to switch tables. Each table lead will prepare in advance a one-pager with key topics/trends that they plan to address. After the discussions, key discussion points/outcome will be added to this one-pager and circulated to all participants

Brexit: Legal and practical challenges

Speaker:

    Best practices in investigations

    Speaker:

      Data Protection & GDPR: one year on

      Speaker:

        Transparency in the Middle East

        Speaker:

          Applying the MTE Code in France

          Speaker:

            Human rights & supply chain integrity

            Speaker:

              International exchange on “compliance governance”

              Speaker:
                 

                16:10 - 16:40

                MedTech Forum coffee breaks and networking


                16:40 - 17:30

                Gaston Berger Amphitheatre

                Virtual hospitals: the new reality?

                Bus. dev. Keynote

                Several trends in the healthcare industry are driving virtual hospitals: hospital consolidation, advances in remote-monitoring technology, and new payment structures. In this session you'll hear from an seasoned hospital CEO and university professor what the current status is and what to expect in the future

                Louis Armand Room East

                Value driven financing of innovation - A new era of dialogue between Payers and industry ?

                Value

                While health systems are looking for new opportunities to transform and are considering value driven approaches, the following key challenges have been identified:
                - Few health systems reward value
                - Siloed budget approach does not optimize value throughout the patient pathways and
                - Payment decision based on value is a new concept.
                While there are multiple schemes there is a clear need for a good taxonomy, good practice principle and learnings. Some latest developments within Europe and other jurisdictions will be discussed

                Louis Armand Room West

                The digital transformation of healthcare: managing the change

                Digital

                GensearchSponsored by Gensearch

                The digitalization of the healthcare sector comes with immense opportunities. Access to information empowers citizens and patients. Healthcare professionals benefit from timely information and decision support systems. Medical knowledge and public health improve with advanced data analytics and artificial intelligence.
                But digitalization will disrupt the way healthcare is delivered. All stakeholders are acquiring new roles and responsibilities. Buyers come with new expectations from the industry, while the market is seeing new entrants (app developers, consumer device makers). This disruption needs to be managed. Change managers will be reflecting on the challenges and opportunities

                17:40 - 18:30

                Gaston Berger Amphitheatre

                Associations' chairs #nofilter

                Plenary

                Leaders from healthtech associations will share their perspectives on the European landscape for our industry. The audience will have the opportunity to ask direct questions that will be answered with #nofilter

                18:30 - 20:00

                Networking Cocktail


                Thursday 16 May

                09:00 - 10:00

                Gaston Berger Amphitheatre

                CEO #nofilter

                Plenary

                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. The audience will have the opportunity to ask direct questions that will be answered with #nofilter

                10:05 - 11:10

                Auditorium

                MedTech as solution providers: Compliance challenges

                GMTCC

                The industry has been discussing the concept of value in healthcare systems as well as what it means in terms of new commercial models for a few years, but the legal and compliance challenges that these bring along a numerous and vary depending on which part of the world you are looking at. This session aims at discussing the significant organisations, legal and compliance challenges in the transition from a product-driven industry to one focused on services. To help that discussion, the panel will be looking at some hypotheticals

                10:10 - 11:00

                Louis Armand Room East

                IVDR: Hungry for data

                Access

                As we enter 'year 3' of the IVD Regulation's transition period, most manufacturers will have assessed the safety and performance data they have for their products. The next major step is to plan and launch studies that might be needed to fill any remaining evidence gaps. How are the studies going, how will they affect the industry? How can we leverage big data? Is industry using third parties to gather data or conducting studies in-house? Attend this session to learn more about the different business models out there, so that you can benchmark your own investment decisions

                Louis Armand Room West

                Disruptive business models and uberisation of healthcare

                Business developments

                Disruptive Healthcare models like uberisation of healthcare, hospital of the future, all connected patients etc…have been at the center of many symposium in the last few years. Today the original concept of such new models are being challenged by our environment in Europe (more control, less freedom, more regulations, etc…). Can such new model become reality or were these just illusions? If they were not illusions what will it take to make them happen in Europe and when? Are the US moving forward on these new models? What are the key new disruptive models being looked into in 2019? All exciting questions and subjects which could help understand where are we going next?

                Louis Armand Room West

                How 3D Printing innovation is generating value for Health Systems

                Parallel Session

                Johnson & Johnson Johnson & Johnson

                As a breakthrough technology, 3D Printing delivers clinical innovation and has the potential to drive health system efficiency by reducing cost and saving time. How will 3D Printing enable new behaviours in Hospitals, and what changes are required to ensure that 3D Printing can improve clinical outcomes, reduce cost and enhance the patient experience?

                11:00 - 11:30

                Coffee break and networking


                11:30 - 12:20

                Gaston Berger Amphitheatre

                Brexit is real

                Access

                A few weeks prior to The MedTech Forum 2019, the deadline for the UK leaving the EU will have passed. Whether an agreement has been reached and a transition period is in place, or the UK leaves the EU without an agreement in a hard Brexit scenario, Brexit will be real. After years of speculation this session will inform on the realities that the Medtech Industry has to face when dealing with Brexit. As we know more we will let you know!

                Louis Armand Room East

                Is diagnostic information of value in health care practice ?

                Value

                Health systems around the world seek to address patients' unmet health needs and governments strive to keep healthcare spending sustainable, while providing equal access to care. This has fuelled debate around what constitutes a valuable healthcare intervention in a health system. Until recently, the value of information and especially the value of information by IVD was not explicitly included as part of this discussion. However, investment in diagnostic information is key to improve clinical decision making.
                The value of diagnostic information "VODI" concept was recently published and European organisations from different chronic and acute disease areas will debate the concept and its relevance within the management of their disease. VODI is a holistic framework within Value Driven Health Systems

                Loft

                MedTech Forum Ask the experts

                Ask the experts

                Topic will be determined shortly

                11:30 - 12:50

                Louis Armand Room West

                Role of industry in CME education

                GMTCC

                This session aims at discussing industry’s role in supporting continuing medical education. What type of measures can be put in place to safeguard the provision of high quality, balanced medical education? What level of industry involvement is appropriate in order to allow essential interaction between the medical profession and medical industry?

                 

                Auditorium

                Compliance effectiveness & Risk management

                GMTCC

                This session aims at discussing:
                - How to harness data inside of the organisation in order to support the compliance function?
                - How to leverage the activities of other business parts within the same organisation?
                Best practice exchange on how to measure effectiveness of key elements of compliance programs and initiatives with the data and analytics

                Room 1

                Best practice exchange when providing educational grants: 1,5 years after the phase out of direct sponsorship

                GMTCC

                This session is aimed at allowing companies to exchange of best practices in providing Educational Grants in Europe, following the ban of direct sponsorship at the beginning of 2018. How is this being managed within the different companies? How are companies monitoring compliance?

                12:20 - 13:50

                Lunch break and networking


                13:00 - 13:50

                Louis Armand Room East

                Milkman 3.0 - Digitizing the MedTech Commercial Model

                Sponsored session

                Boston Consulting GroupSponsored by Boston Consulting Group

                BCG will provide "hot off the press" insights from their ongoing global medtech commercial benchmarking study (Milkman 3.0) on how to accelerate sales growth and improve go-to-market efficiency by leveraging the power of AI and analytics. During this interactive session, Goetz and Basir will walk you through specific use cases on next generation sales, digital marketing and dynamic pricing to illustrate the business potential for medtech and how to realize it in an agile way

                13:50 - 14:40

                NGOs shaping MedTech

                Business developments

                Within healthcare Non-Governmental Organisations (NGOs) are playing a pivotal role in many aspects of care - as part of that role they have specific needs and interests when it comes to medical technology - some develop their own solutions, others are in search of answers to problems which they face in the field and others are vital in ensuring access to medical technologies around the world. This session sheds light on the role that NGOs are playing and on how their needs and work links to medical technologie

                Gaston Berger Amphitheatre

                Advancing digital health in Europe's regions: vision, leadership, investment

                Digital

                Digital health deployments require that people and institutions work together: citizens and patients trust the system with their personal data; healthcare providers embrace the contribution of digital systems, and industry delivers the technologies.
                But this works only when healthcare authorities/payers set the technical, legal and financial frameworks for the exchange of data.
                Careful observers in Europe know that small regions and countries are much better at delivering this framework than bigger ones, while industry often dismisses them as too small for scale. But it pays to pay attention to small regions and countries, if only because they are the laboratories of change

                Louis Armand Room East

                New Horizons in Value Driven Procurement, will the EU accelerate change ?

                Value

                With the new EU public procurement directive now transposed in all the Member States and given the interest at EU level to drive innovation, this session will look at the European Commission's initiatives in the field of value-based procurement for healthcare and at how these might foster a change in practice in Most Economic Advantageous Tendering and Procurement of Innovative Solutions.
                Several new EU initiatives and the development of Coordination and Support Actions funded by the EU will be highlighted. A specific focus will be put on the deliverables and the learning from a project conducted by a consortium of leading procurement organizations in Europe coordinated by MedTech Europe. In this project, the organizations are teaming up around a novel approach of value-based procurement of innovative solutions in the field of rapid diagnostics and integrated care. Attendees will also have the opportunity to hear and debate about the drive towards value-based cross border procurement and about the tangible impact of all these initiatives in procurement practices

                14:00 - 14:40

                Auditorium

                Plenary session: Closing remarks & discussion

                GMTCC

                This closing discussion aims at reviewing the key take-aways from the last two days; how the integration of GMTCC into the MedTech Forum worked? What are the key challenges for the year ahead

                14:50 - 15:40

                Gaston Berger Amphitheatre

                Disruptor's story

                Plenary

                In 2016 Onduo received half a billion dollars in funding from Verily and Sanofi to address one of the biggest problems in healthcare: diabetes. Onduo approaches diabetes care through "the marriage of technology and medicin" and hear from Onduo's CEO where they stand today

                15:40 - 16:00

                Gaston Berger Amphitheatre

                Conclusions

                Plenary


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