Welcome Reception
The LISAvienna and AUSTROMED host organizing team warmly welcomes you to The MedTech Forum in Vienna!
Join us for the Welcome Cocktail Reception at the Vienna City Hall, featuring informal networking, delightful Viennese cuisine, and the enchanting ambiance of the festival hall. We look forward to seeing you in Vienna, where a blend of rich cultural heritage and excellent business prospects awaits you!
Directions: Vienna City Hall, Lichtenfelsgasse 2, Feststiege 1, 1010 Vienna, Austria
This is an EcoEvent, how to get there:
Metro: U2 (Schottentor/Ring), U3 (Volkstheater/Ring)
Tram: 1, 71, D, U2Z (Rathausplatz/Burgtheater), 2 (Parliament)
Cycle: Cycle paths nearby, bicycle parking available, bike rental station at Rathauspark
Speakers:
- Philipp Hainzl (Managing Director, LISAvienna)
- Johannes Sarx (Managing Director, LISAvienna)
- Jörg Neumayer (Member of the Vienna City Council)
- Oliver Bisazza (CEO, MedTech Europe)
- Gerald Gschlössl (President, AUSTROMED)
Welcome coffee
Opening Key Note
Moderator:
- Sue Saville (Health Event Facilitator)
Speakers:
- Oliver Bisazza (CEO, MedTech Europe)
- Eva Czernohorszky (Head of Technology Services, Vienna Business Agency)
- Philipp Lindinger (Managing Director, AUSTROMED)
- Tanja Spennlingwimmer (Head of the business unit IP Management I Deep Technologies I Entrepreneurship, Austria Wirtschaftsservice GmbH)
CEO #nofilter
Moderator:
- Sue Saville (Health Event Facilitator)
Speakers:
- Bronwyn Brophy (CEO, Vitrolife)
- Katarzyna Mazur-Hofsaess (CEO Care Enablement & Member of the Management Board, Fresenius Medical Care)
- Thomas Edward Polen JR (Chairman of the Board, CEO and President, BD)
MDR Sprint: Turbocharge Companies for a Smooth Transition
This practical panel session will address the immediate challenges faced by stakeholders during the transition to the MDR and will focus on short-term, actionable solutions designed to alleviate the hurdles hindering SMEs and bigger companies from navigating this regulatory shift smoothly.
Moderator:
- Miroslav Palat (CEO, CzechMed)
Speakers:
- Cyrille Fleury (Chairman and CEO, MENIX Group)
- Michel Marboeuf (Senior Director Global Regulatory policy & intelligence, Stryker)
- Carmen Ruiz-Villar (Deputy Director Medical Devices Department, Spanish Agency for Medicines and Medical Devices (AEMPS))
- Alexey Shiryaev (Global Head of Clinical and Regulatory Affairs, DNV and Team-NB)
Cyber resilience of European healthcare: readiness of the sector
Against the backdrop of COVID-19, geopolitical strains and the recent ENISA threat landscapes (both for healthcare in May 2023, and for the general state of cybersecurity in November 2023), healthcare is increasingly becoming a priority target for State and non-state actors, as well as a lucrative target for would-be cyber-criminals. The panel would bring together stakeholders from across the sector, as well as a cybersecurity agency expert, to discuss the cyber-readiness of the European healthcare sector.
Moderator:
- Cynthia O'Donoghue (Partner, Reed Smith LLP)
Speakers:
- Martha De Cunha Maluf-Burgman (Director Regulatory Affairs Digital Health, Edwards Lifesciences)
- Alina Urs (Senior Cyber Security Coordinator, National Cyber Security Directorate, Romania)
Successfully Navigating Exits and Financings in Tough Times
Despite a challenging environment for M&A and fundraising amidst an evolving EU regulatory landscape, this panel features strategics, investors and start-up CEOs who are doing deals in spite of these obstacles, and are here to share their strategies in achieving these goals.
Moderator:
- Stephen Levin (Editor-in-Chief, Market Pathways/Medtech Strategist)
Speakers:
- Christoph Massner (Principal, Earlybird Venture Capital)
- Daniel Rose (Former CEO, LimFlow)
Europe is the most innovative continent when it comes to enhancing women’s healthcare”: really?
Is Europe leading in women’s health innovation? As a new EU policy cycle approaches, policymakers should reflect on initiatives to prioritize women's health on the agenda. This entails fostering interaction with innovators, and Hologic is eager to address this critical issue for millions of EU women.
Speakers:
- Souad Belarbi (Governmental Affairs & Market Access Director, Hologic)
- Tanja Brycker (Vice President, Strategic Development, Breast & Skeletal Health and Gynae Surgical Solutions, Hologic)
- Barbara Huemer (Municipal Council and Provincial Parliament of Vienna, Grüner Klub im Rathaus)
- Alexandra Resch (MD, Prof. of Radiology,, Departement of Radiology, St. Francis Hospital, Vienna, Austria)
Clearing the Compliance Hurdles: Preparing for FDA Inspections
This interactive session will address strategies for preparing for and handling FDA inspections, response strategies, and compliance requirements. Topics will include common deficiencies identified in FDA inspections and developing an effective remediation plan.
Speaker:
- Michael Heyl (Partner Global Regulatory, Hogan Lovells)
Networking break
Localisation trend in the medtech industry
This session will be an opportunity to discuss various ways countries are going about localisation policies, to what extent localisation of manufacturing actually improves access to medical supplies and what makes companies tick when it comes to investment decisions, whether or not to localise their production/presence in different markets.
Moderator:
- Carlos Gouvea (Executive President, CBDL)
Speakers:
- Benish Aslam (Lead, Government Affairs and Policy, Asia Pacific Medical Technology Association (APACMed))
- Daphne Dernison (Head Government and Public Affairs Europe, Philips)
- Tanya Vogt (CEO, SAMED)
- Victor van Vuuren (Director, Holavic Consulting)
A Compass for Collaboration: Navigating Stakeholders’ Roles in Transitioning To Value-Based Healthcare
Health system transformation requires a multi-stakeholder approach, yet it remains unclear how e.g. providers, patients, payers and industry may support the transition. Panellists from the European Alliance for Value in Health will discuss what each stakeholder may contribute, and what is expected from the others.
Moderator:
- Casper Paardekooper (Partner, Vintura & European Alliance for Value in Health)
Speakers:
- Stephanie Fridd (Director Value Based Care, Philips)
- Ilaria Giannico (Secretary General, European Union of Private Hospitals)
- Rebecca Steele (Manager Life Sciences, European alliance for Value in Health)
Towards an EU Cardiovascular Health Plan - The Role of Medtech Industry
The panel explores EU's response to rising cardiovascular disease, affecting 60M Europeans daily. Amid aging population and non-communicable diseases, how can the EU ensure equitable access to prevention, early detection, and treatment? How can MedTech foster sustainable change for CVD patients?
Moderator:
- Alexander Olbrecht (Director Digital Health, MedTech Europe)
Speakers:
- Birgit Beger (CEO, European Heart Network)
- Daniel (Neil) Johnson (Executive Director, Global Heart Hub)
- Jean-Luc Lemercier (Corporate Vice President EMEACLA & JAPAC, Edwards Lifesciences)
- Franz Weidinger (European Society of Cardiology)
Rethinking Innovation: Driving Organizational Value from the Inside Out
In a competitive, regulated medtech landscape, how can organizations innovate swiftly while ensuring patient safety? This session explores strategies with industry leaders, addressing barriers to innovation, leveraging tech for product availability monitoring, and streamlining operations for faster regulatory approvals.
Speakers:
- Federico Danei (Head of Global Regulatory Affairs, OTTO BOCK HEALTHCARE PRODUCTS)
- Leo Lindhorst (Head of Innovation Health Solutions, Carl Zeiss Digital Innovation GmbH)
- Annemien Pullen (VP MedTech Cloud, Veeva Systems)
Promotion of medical devices in the EU and interactions with healthcare professionals
This interactive session will address key challenges manufacturers may face in the EU when promoting their device at conferences, on their website or on social media and when interacting with healthcare professionals during clinical, scientific, and marketing activities.
Speaker:
- Fabien Roy (Partner Global Regulatory, Hogan Lovells)
Lunch break
Regulation on HTA: A new reality for Access to Innovation in Europe
For selected highly innovative technologies a Member States driven EU regulation is being implemented in 2024. The application of JSC start in 2025. JCA reports will be ready in 2026. To know how this impact your business and have the lastest intelligence, a panel of the key actors will tell you.
Moderator:
- Yves Verboven (Senior Adviser - External Consultant, MedTech Europe)
Speakers:
- Marco Marchetti (Vice Chair HTA Coordination Group / Direttore UOC HTA, Agenas)
- Maya Matthews (Head of Unit, State of Health, European Semester, Health Technology Assessment, European Commission)
- Andrea Rappagliosi (Sr Vice President Public Affairs EMECLA, Edwards Lifesciences)
On the power of regional medtech innovation ecosystems: Austria at a glance
Join this session to explore Austria’s medtech sector and the reasons why Vienna plays a key role in the regional innovation ecosystem. Discover key companies, thriving SMEs, emerging start-ups, key players in academia, and funding opportunities and support structures driving innovation.
Moderator:
- Philipp Lindinger (Managing Director, AUSTROMED)
Speakers:
- Alexander Biach (Business Location Advocate, Vienna Chamber of Commerce)
- Veronika Binder (CEO, Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH)
- Christian Harwanegg (CEO, MacroArray Diagnostics GmbH)
- Anni Koubek (CEO, QMD Services)
- Bernhard Wittman (CEO, Sigmapharm Arzneimittel GmbH)
Uncovering Europe's Innovation Allure
Explore the draw of European medtech investments, and weigh its vast market and innovation prowess and stability, versus challenges like regulatory environment and bureaucracy. Discuss recommendations and gain insight into Europe's innovation edge, and prospects for a competitive future.
Moderator:
- Koen Segers (Senior Director, Deloitte)
Speakers:
- Hubert Gambs (Deputy Director-General DG GROW - Internal Market, Industry, Entrepreneurship and SMEs, European Commission)
- Peter Sauwens (Life Sciences strategy Director, Deloitte)
- Stuart Silk (President Europe, Latin America, Canada & EEMEA, Stryker)
- Pascal Waucquez (Sr Vice President, Clinical Operations - Europe, Middle-East, Turkey, Russia (EME), bioMérieux UK Ltd)
- Gavin Wood (Company Group Chairman, J&J MedTech EMEA, Johnson & Johnson MedTech EMEA)
IEEE 11073: How the SDC Interoperability Standard will transform Medtech Products
Medical device manufacturers must meet growing demands for integrated and sustainable healthcare applications. Explore the IEEE 11073 SDC standard for service-oriented, cross-vendor device communication and how its adoption can promote scalability in medical device development and maintenance.
Moderator:
- Elisa Kunze (Key Account Manager, CARL ZEISS DIGITAL INNOVATION)
Speakers:
- Attila Gagyor (Management Consultant Health Solutions, Carl Zeiss Digital Innovation GmbH)
- Leo Lindhorst (Head of Innovation Health Solutions, Carl Zeiss Digital Innovation GmbH)
The Power of the Digital Thread: Weaving quality into product engineering
Achieving regulatory compliance and business agility is a key challenge. A ‘digital thread’ along the product lifecycle can help automate compliance and manage risk end-to-end. Deloitte and PTC experts will discuss benefits of digital thread throughout design, manufacturing, service, and improvement.
Speakers:
- Robert Grummt (Business Development Manager Life Science, PARAMETRIC TECHNOLOGY)
- Christian Schiel (Partner, Deloitte GmbH Wirtschaftsprüfungsgesellschaft)
The Climate Crisis - our next Health Crisis?
Climate change increasingly impacts citizen’s health. How can the medtech sector contribute to decarbonizing healthcare and what is needed for building resilient, sustainable healthcare systems? Speakers will share their views on how to prevent the climate crisis turning into a next health crisis.
Moderator:
- Sue Saville (Health Event Facilitator)
Speakers:
- Martin Fuhrer (Senior MedTech Executive, Siemens Healthineers)
- Hubert Gambs (Deputy Director-General DG GROW - Internal Market, Industry, Entrepreneurship and SMEs, European Commission)
- Antonios Kolimenakis (World Health Organisation (WHO))
- Véronique Tordoff (Image-Guided Therapy Leader Europe, Philips)
Transforming the medtech procurement of innovations culture
How to overcome the barriers to procurement of innovations and to transform procurement culture into one that encourages added value for citizens and market innovation. Promoting innovation procurement through knowledge sharing, matchmaking, and influencing EU policy on innovation procurement.
Speakers:
- Danny Havenith (Directeur General MercurHosp ASBL, Chairman European Healthcare Public Procurement Alliance)
- Carlos Larrañeta Gómez-Caminero (Procure4health Community coordinator, Andalusian Public Health System)
IVDR state of transition - pulse check and outlook
The expert panel will discuss the current state of the IVDR transition: recent progress, challenges and impact on stakeholders. What do the latest learnings and time extensions mean for stakeholders now - and in the future?
Moderator:
- Anna Hallersten (Head Regulatory Policy Europe, Roche Diagnostics)
Speakers:
- Peter Bischoff-Everding (Legal officer, European Commission)
- Rana Chalhoub (Regulatory Affairs Director, Mecomed)
- Christian Harwanegg (CEO, MacroArray Diagnostics GmbH)
- Thierry Sirdey (Chair of the CAMD (Competent authorities for Medical Devices), ANSM French national medicinal products safety agency)
Case Study Analysis: What you need to know about the new EU product liability rules and why
Anticipate shifts in European regulatory landscape, aligning with U.S. litigation trends. Navigate proposed liability changes, safety regulations, environmental litigation, and pan-European class actions. Join the panel to strategize and discuss proactive measures for companies to prepare.
Moderator:
- Adrienne Franco Busby (Strategic Litigator and Advisor to Product Manufacturers, Faegre Drinker Biddle & Reath LLP)
Speakers:
- Aline Lautenberg (General Counsel, MedTech Europe)
- Shuna Mason (Partner, CMS London)
- Simon Neill (Senior Legal Director, Johnson & Johnson Law Department EMEA)
Cybersecurity from business risk to competitive advantage
On the backdrop of the ever-increasing focus on Cybersecurity in MedTech from a regulatory and risk perspective, join us in this interactive session to explore a different angle – Cybersecurity through the lens of your customers and how to leverage Cybersecurity to gain a competitive edge in the market.
Speaker:
- Cristian Dumitrescu (Cybersecurity Partner, Ernst & Young)
Networking break
Unlocking the transformative potential of GenAi
GenAI is transforming MedTech, unlocking significant value through scale and productivity. How can you apply GenAI for growth, process simplification and efficiency gains? Join us to explore successful GenAI use cases and discuss the next steps for fast-tracking GenAI benefits for your organization.
Speakers:
- Venky Anant (Partner, McKinsey & Company)
- Karsten Dalgaard (Senior Partner, McKinsey & Company)
- Yashaswi Gautam (Senior Partner, McKinsey & Company)
Capacity-Enhancing Innovation: the enabler for resilient healthcare systems?
Amidst critical healthcare workforce shortages, hospitals face capacity challenges, necessitating innovation in processes, technology, and mindset. With the Belgian Presidency prioritizing an EU health workforce strategy, the MedTech Industry must foster consensus on innovation's role in addressing shortages. This session explores reconciling urgent care needs with workforce gaps, defining the industry's role, and initiating mindset shifts for sustainable change.
Moderator:
- Christelle Saint Sardos (Senior Director, Public Affairs EMEA, Canada, Latin Amercia, EDWARDS LIFESCIENCES)
Speakers:
- Marco Marchetti (Vice Chair HTA Coordination Group / Direttore UOC HTA, Agenas)
- Leandro Pecchia (Past-President EAMBES, Professor in Biomedical Engineering, University Campus Biomedico and University of Warwick)
- Andrea Rappagliosi (Sr Vice President Public Affairs EMECLA, Edwards Lifesciences)
- Rabea Stockert (Senior Consultant, Flying Health)
Alignment of device data driven by EUDAMED – what are the possibilities?
There is an increasing need for medical device data: in patient medical records demanded by hospitals, in supply chain demanded by customers and in tenders and reimbursement demanded by regulators. How and when EUDAMED and UDI will play a role in supplying reliable information about devices?
Moderator:
- Kevin Taylor (Director, Medical Device Interface, Global Regulatory Affairs, Johnson & Johnson Innovative Medicine)
Speakers:
- Wolfgang Füreder (Purchaser, Hospitals of Barmherzige Brüder)
- Flora Giorgio (Head of Unit, European Commission)
- Glenda Marsh (Sr. Director EMEA Regulatory Affairs, Johnson & Johnson MedTech)
- Lionel Tussau (Lead Healthcare, Bayard)
Learn from the best: some IHI winners sharing their experiences
Several MedTech Europe corporate members are partners in IHI consortia running medical research and innovation projects. They all share something: the transformation of an idea into a project that will soon advance the medical research and impact the healthcare system. Get inspired to be the next one !
Moderator:
- Patrick Boisseau (Director General, Strategic Initiatives, MedTech Europe)
Speakers:
- Niklas Blomberg (Executive Director, Innovative Health Initiative (IHI))
- Christian Muehlendyck (Scientific Partnerships Lead Europe, Middle East and Africa (EMEA) J&J MedTech, Johnson & Johnson)
- Nathalie Virag (Senior Director Medtronic Global Technology and Innovation, Medtronic)
- Fanny van der Loo (Director Public Affairs, Edwards Lifesciences)
Understanding the IVDR
Get the chance to ask your specific questions regarding a successful implementation of the IVDR and contact other IVD manufacturers. Learn from the experience from different projects and get the answers you need.
Speakers:
- Diana Hohage (Senior QA/ RA Manager, qtec services GmbH)
- Anna Schade (QA/ RA Manager, Qtec Services GmbH)
CEO #nofilter
Moderator:
- Sue Saville (Health Event Facilitator)
Speakers:
- Martin Fuhrer (Senior MedTech Executive, Siemens Healthineers)
- Patrick Malanaphy (Head of Life Science EMEA, Henkel AG & Co. KGaA)
- Urmi Prasad Richardson (President EMEA, Thermo Fisher Scientific)
- Marc Stoesz (General Manager Enterprise Solutions, GE HealthCare International Region)
Networking reception
Speakers:
- Oliver Bisazza (CEO, MedTech Europe)
- Martin Fuhrer (Senior MedTech Executive, Siemens Healthineers)
Welcome coffee
Digital Healthcare Transformation: Breaking Barriers, Shifting Mindsets
This discussion explores the crucial transition to digital transformation in healthcare and the necessary adaptations in incentives and perspectives to enhance patient care. Leveraging insights from industry leaders, we analyse existing obstacles and past failures and present practical solutions. Additionally, we examine how recent legislation can revolutionise healthcare through comprehensive digitalisation, fostering innovation, streamlining processes, and enhancing patient satisfaction.
Moderator:
- Aloha McBride (Ernst & Young)
Speakers:
- Anne Busch (Head of Master Health Care Informatics, Fachhochschule Wiener Neustadt GmbH)
- Rachel Dunscombe (CEO, openEHR)
- Michael Forisch (Global Head of Digital Quality and Regulatory, Roche)
- Miroslav Palat (CEO, CzechMed)
- Pascal Verdonck (Prof MedTech & Chair Maria Middelares Hospital, Ghent University)
Designing and implementing value-based agreements
A value-based agreement is a reimbursement model that links payment for an intervention (medical device or service) to the achievement of predefined outcomes. The session will discuss the barriers to application and how to overcome together with a framework supporting companies considering VBAs.
Speakers:
- Maisie Borrows (Strategic Growth Lead, LCP Health Analytics)
- Rebecca Sloan (Senior Market Access Specialist, LCP)
Recognizing the value of medical technology in cancer care
The adoption of medical technologies has been lacking behind, despite significantly affecting patient outcomes and benefiting healthcare systems across the care continuum. Recognizing their value can enable equal patient access, sustainable funding and advance Europe's cancer care commitment.
Moderators:
- Katalin Ersek (Access & Policy Lead EMEA-LATAM, Roche Diagnostics International)
- Francesco Florindi (EMEA Strategic Partnerships Manager Predictive Genomics, Thermo Fisher Scientific)
Speakers:
- Ivana Cattaneo (Chair of the EFPIA (European Federation of Pharmaceutical Industries and Associations) Oncology Platform, Executive Director Therapeutic Area Advocacy and Precision Medicine - Novartis)
- Richard Price (Head of Policy, European Cancer Organisation)
- Bettina Ryll (Founder, The Melanoma Patients Network Europe and Member of the Cancer Mission Board.)
Digital label for medtech and beyond – how could this work?
Labels have become overcrowded in recent years with information unrelated to identification, handling and safety of the medical device.This session will explore how an e-label concept could help manage this challenge and whether there is a potential for future regulatory acceptance.
Moderator:
- Jesus Rueda Rodriguez (Director General - Strategies, Special Projects & International Affairs, MedTech Europe)
Speakers:
- Shekhar Nambi (Director, Digital Identification & Traceability, Johnson & Johnson)
- Vincenzo Renda (Director Single Market & Digital Competitiveness, DIGITALEUROPE)
- Matthias Scherer (Head of medical devices market surveillance, Austrian Agency for Health and Food Safety)
IHI: 50 min to quit being a dummy
By participating in IHI projects, MedTech Europe corporate members can access EC funding for cross-sectorial research and innovation that associate SMEs, global companies and public partners in pharma, medtech and biotech. The session will explain how to proceed and what are the benefits.
Moderator:
- Patrick Boisseau (Director General, Strategic Initiatives, MedTech Europe)
Speakers:
- Hugh Laverty (Head of Scientific Operations, Innovative Health Initiative (IHI))
- Christian Muehlendyck (Scientific Partnerships Lead Europe, Middle East and Africa (EMEA) J&J MedTech, Johnson & Johnson)
- Nathalie Virag (Senior Director Medtronic Global Technology and Innovation, Medtronic)
- Fanny van der Loo (Director Public Affairs, Edwards Lifesciences)
GenAI: Are we maximising the value of GenAI to enable patient-centric solutions?
This session will discuss the transformative journey and prerequisites required to support the pivotal shift from generative AI being applied to enhance internal processes and functions to external usage, enabling patient-centric solutions.
Moderator:
- Ben Desmet (Partner - Deloitte Life Sciences Practice, Deloitte)
Speakers:
- Alan Fraser (Chairman, Regulatory Affairs Committee, BioMedAlliance)
- Aditya Kudumula (Partner of Life Sciences Practice, Deloitte)
- Katarzyna Markiewicz-Barreaux (AI Strategic Intelligence Lead, Philips)
- Florian Schwiecker (Chief Partnerships Officer, Corti.ai)
Navigating EU Regulations impacting use of health data in MedTech
In the rapidly evolving landscape of healthcare technology, the responsible and secure use of health data is paramount. The European Union (EU) has been at the forefront of shaping regulations to facilitate the exchange and utilization of health data while safeguarding individual rights and privacy. This panel session aims to delve into the complexities of EU regulations, including the AI Act, the Data Act, and the European Health Data Space (EHDS), and explore key considerations for medical technology companies in complying with these regulations and the potential of the EHDS to create a unified European market for digital health data.
Moderator:
- Mary Devlin Capizzi (Moderator, Faegre Drinker Biddle & Reath - IPMPC Secretariat)
Speakers:
- Sofia Sjöö (Chief Privacy Officer, Mölnlycke Health Care)
- Verena Thaler (Manager Data Governance, MedTech Europe)
- Renate van Kempen (De-identification Expert | Data Scientist | Microsoft Certified Trainer, B.A.I.M.E)
Spotlight on innovative Start ups : How to collaborate
Explore start-ups' views on collaborating with large firms and major customers in social insurance. Gain insights from successful SMEs sharing experiences in R&D partnerships, product development, and sales collaborations. In addition, learn more about sought-after future partners.
Moderator:
- Johannes Sarx (Managing Director, LISAvienna)
Speakers:
- Tamara Faiza Madeleine Gerbert (Co-Founder and Head of strategy, Brightmind.AI GmbH)
- Tamás Petrovics (CEO and Co-Founder, XUND)
- Bernhard Redl (CEO, edupression.com powerd by SOFY GmbH)
- Josef Schabauer (Member of the Board of Directors Austromed, Austromed)
- Nayeli Schmutz (Chief Medical Officer & Co-founder, PIPRA AG)
Global market focus: CHINA
China is a vast and dynamic country with a rapidly growing economy, diverse cultures, and a significant global impact, especially when it comes to manufacturing, and healthcare. In this session, we will zoom in on the dynamics, trends, and unique opportunities shaping the landscape of medical technology in China and their impact beyond.
Moderator:
- Trevor Gunn (VP International Relations, Medtronic)
Speakers:
- Christian Clarus (Director Global Government Affairs, B. Braun Group)
- Agatha Kratz (Director, Rhodium Group)
Data-Driven Content Management - Navigating the complexities of documentation compliance
Meeting complex regulatory requirements for Medical and In Vitro Diagnostics Device Manufacturers, especially with Eudamed, is crucial. Incomplete submissions and disorganized technical documentation cause common delays in market approval. This presentation delves into a data-driven, componentized content management approach, ensuring consistency, and expediting documentation for device registration.
Speaker:
- André Schlotz (Vice President Global Solutions, RWS Group)
Networking Break
Unlocking Efficiency & Governance in the MDR and IVDR Maze
From fostering agile governance structures to streamlining operations, reducing bottlenecks, simplifying approval processes and establishing clearer guidelines, our panelists will brainstorm on actionable recommendations aimed at shaping more efficient and future ready MDR and IVDR regulatory frameworks.
Moderator:
- Olga Van Grol-Lawlor (Senior Global Regulatory Intelligence & Advocacy Manager, Boston Scientific)
Speakers:
- Peter Bischoff-Everding (Legal officer, European Commission)
- Tom Melvin (Associate Professor of Medical Device Regulatory Affairs, Trinity College Dublin)
- Thierry Sirdey (Chair of the CAMD (Competent authorities for Medical Devices), ANSM French national medicinal products safety agency)
- Graeme Tunbridge (Senior Vice President Global Regulatory and Quality, Medical Devices, BSI)
Improving Healthcare Safety and Supporting Improved Care Deliver
Healthcare delivery in Europe faces unprecedented challenges, as observed with the continuing struggles with backlogs, and long-term healthcare staff fatigue. This has led to hospital facing rising recruitment and retention challenges and increasing HCP demonstrations, demanding better working conditions. This session will explore these challenges and the solutions industry can support.
Speakers:
- Jacqui Fletcher (Consultant nurse, Jacqui Fletcher Limited)
- Clemens Kaltenberger (Vice President, Austrian Paramedic Association)
- Ali Medhi (Care Group Medical Director, NHS)
- Sherieta Misrielal-Boedhoe (Director, Marketing Medical Acute Care & sage, Stryker)
Global regulatory matters: reliance in practice
Strong regulatory capacity is essential for a well-functioning healthcare system and implementation of reliance practices has been a topic of growing interest internationally. In this panel discussion, we are going to explore examples of reliance and discuss what it takes to facilitate reliance in practice.
Moderator:
- Rana Chalhoub (Regulatory Affairs Director, Mecomed)
Speakers:
- Jasjit Baveja (Associate Director, Policy, Ph.D., MTAA)
- Flora Giorgio (Head of Unit, European Commission)
- Janet Trunzo (Senior Executive Vice President, Technology & Regulatory Affairs, Advamed)
Building a Secure and Resilient Digital Healthcare Ecosystem: Reality or Utopia?
Today, medical devices are accelerating their growth into a digital ecosystem that facilitates continuous data exchange between patients and healthcare providers. A group of experts will explore how the industry is managing the complexity of this ecosystem and discuss patient readiness for technology adoption, as well as cybersecurity implications.
Moderator:
- Alexander Olbrecht (Director Digital Health, MedTech Europe)
Speakers:
- Corinne Dive-Reclus (Global Head of Digital Diagnostics Business, Roche Diagnostics International Ltd.)
- Daniele Fazio (VP Business Development, Flex)
- Maryline Marquet (Ernst & Young)
- Jan Sömen (Digital Portfolio Executive, Siemens Healthineers)
The impact on medical device reimbursement as part of the ongoing shift from inpatient to outpatient care in USA and Europe.
Speaker:
- Stephen Hull (Senior Vice President, Avania Market Access)
EU Green Deal: challenges and opportunities for the medtech sector
As Europe‘s net zero transformation is fully on, each sector has to contribute. What challenges and opportunities does the medical technology sector face in the transition? Is Circularity fact or fiction? How to succeed in the transition to more sustainable materials and chemicals? What should a Green Deal 2.0 look like?
Moderator:
- Sue Saville (Health Event Facilitator)
Speakers:
- Daniela Delledonne (Vice President & General Manager, EMEA, BD LifeSciences Biosciences)
- Bill Doherty (Executive Vice President, COOK MEDICAL)
- Myrthe Eussen (Dutch Green OR Network)
- Flora Giorgio (Head of Unit, European Commission)
- Julija Gusca (Professor, Institute of Energy Systems and Environment at Riga Technical University)
MedTech Exodus? Reclaiming Europe's Innovation Edge
In this session, our panel will dissect the MDR and IVDR challenges that have inadvertently triggered an outflow of innovation from Europe's vibrant ecosystem and discuss potential solutions and reforms aimed at steering medical technology innovation back to the heart of Europe.
Moderator:
- Oliver Bisazza (CEO, MedTech Europe)
Speakers:
- Samih Al Mawass (Divisional Vice President, Vascular, EMEA (Europe, Middle East and Africa), Abbott)
- Alan Fraser (Chairman, Regulatory Affairs Committee, BioMedAlliance)
- Niall MacAleenan (Director of Medical Devices, HPRA)
- Céline Saint Olive Baque (CEO, NORAKER - Innovative Biomaterials)
Global Clinical evidence: challenges and opportunities of RWE sources
In this session we plan to explore different approaches to collecting clinical evidence for medical devices worldwide. Specific focus will be given to the opportunities and challenges of Real World Evidence (RWE), particularly how it could be leveraged for the MDR.
Moderators:
- Heike Fischer (Strategic, Clinical & Regulatory Planning with Clinical Research, Deloitte)
- Ian Lyons (Associate Partner, McKinsey & Company)
Speakers:
- Philip Desjardins (Partner, Arnold & Porter)
- Nataliya Deych (Vice President Regulatory Affairs, Edwards Lifesciences)
- Richard Holborow (Global Head of Clinical Compliance, BSI)
- Donal O'Connor (Clinical Manager Medical Devices, HPRA)
Innovative Payment Schemes in Europe: Updates, Reality, and Trends
Traditional reimbursement schemes struggle to incorporate innovation. Alternatively, innovative payment schemes (IPS) can provide timely patient access to innovative medical technologies and procedures. This panel will discuss the latest updates on the 17 main European IPS and share stakeholders’ perspective on their current implementation.
Speaker:
- Richard Charter (Alira Health, VP & Partner – MedTech Market Access & Commercial Strategy)
Transform your Post Market Surveillance with GenAI and Automation
Post Market Surveillance, such as complaint handling, adverse event reporting and regulatory reports have gotten burdensome, complex and a lot more visible with MDR and IVDR. Some of these functions are also extensions of customer service. Join us to see real world examples of how MedTech companies have applied modern AI and automation to transform post market surveillance.
Speaker:
- Plarent Ymeri (CEO, Smarteeva Software)
Lunch Break
Never again – Pandemic Preparedness for Medtech
During the COVID-19 pandemic many heroic efforts were made by health systems, including MedTech companies at the heart of the crisis. So how is the MedTech sector preparing for the next pandemic? Global commitments are being discussed but in practice will we be ready when the next pandemic comes?
Speaker:
- Jesus Rueda Rodriguez (Director General - Strategies, Special Projects & International Affairs, MedTech Europe)
Circularity4Health: Driving EU Action for Net-Zero Health Systems
70% of global emissions are tied to material handling and use while extraction and consumption are growing at almost unprecedented rates. This session will discuss the opportunities of circular business models to improve people’s health and well-being, the barriers to and enablers of more circular, resilient health systems and concrete policy needs.
Moderator:
- Sigrid Linher (Director Sustainability & Environment, MedTech Europe)
Speakers:
- Hannah Casey (Senior Manager, Network Development, Ellen MacArthur Foundation)
- Andrea Rockall (President, European Society of Radiology)
- Harald Tepper (Sr. Director Sustainability, Philips)
Generative AI in Marketing
Join Jochen Tham, CMO at ZEISS Meditech, and experts from BCG for an immersive workshop on GenAI in marketing. Learn to craft campaigns with GenAI, enhancing creativity and efficiency, and gain insights from a leading marketing executive on how to scale AI and evolve the marketing operating model.
Speakers:
- Lisa Hartmann (Principal, BCG)
- Jan-Frederik Jerratsch (Managing Director & Partner, BCG)
- Jochen Tham (Head of Digital Customer Experience, CARL ZEISS)
Patient Engagement – a business imperative for Medtech?
Recent trends in IHI, HTA and R&D have made patient engagement both an obligation and a commercially astute initiative for MedTech.
This session will bring together industry and patient group leaders to look at Patient Engagement in healthcare.
Moderator:
- Annabell Merklin (Patient Advocacy and Communications Sr. Manager, Edwards Lifesciences)
Speakers:
- Patrick Boisseau (Director General, Strategic Initiatives, MedTech Europe)
- Daniel (Neil) Johnson (Executive Director, Global Heart Hub)
- Anca Toma (Executive Director, European Patients’ Forum)
- Emma Wright (Chief Medical Officer, Mölnlycke Healthcare)
Market Data Surveys: unique insights for the medical device field
Medical device sector is a very dynamic sphere, where it is of paramount importance to have reliable information to make strategic decisions. Please join this session to learn more about the Market Data team, uniqueness of our surveys and what we can offer to meet your information needs.
Speaker:
- Andras Körizs (Manager Market Data, MedTech Europe)
Real world data – a game changer for the Medtech Industry?
Explore opportunities and challenges for the use of Real-World Data (RWD) for the development of medical technologies. How does the European Health Data Space act as an enabler? What are the challenges that innovators face?
Moderator:
- Ian Lyons (Associate Partner, McKinsey & Company)
Speakers:
- Dipak Kalra (President, The European Institute for Innovation through Health Data)
- Erika Mosor (Researcher, Medical University of Vienna: Section for Outcomes Research, Center for Medical Data Science)
- Christian Muehlendyck (Scientific Partnerships Lead Europe, Middle East and Africa (EMEA) J&J MedTech, Johnson & Johnson)
- Amra Racic (Senior Director Government Strategy, MedTech at Veeva Systems)
IVDs - how will the diagnostics ecosystem change?
This session examines the state of the diagnostic market in Europe, considers its strongest trends, the outlook for key technologies and where the sector will evolve in the future.
Moderator:
- Oliver Bisazza (CEO, MedTech Europe)
Speakers:
- Daniela Delledonne (Vice President & General Manager, EMEA, BD LifeSciences Biosciences)
- Prateek Natani (Director, Deloitte Life Sciences Practice)
- Daniel White (VP Sales CDS, France, Iberia, UK and FAS EMEA, Cepheid)
Joint Scientific Consultation - Evidence and Europe
Innovation likely to be subject to joint clinical assessment, has an opportunity to undergo a parallel expert panel – joint HTA Joint Scientific Consultation (JSC). A panel of Expert Panels MDR/IVDR, Notified Bodies, Member States JSC representative and the European Commission
Moderator:
- Yves Verboven (Senior Adviser - External Consultant, MedTech Europe)
Speakers:
- Silvy Da Rochas Dias (Head of Office, expert panels and group office, EMA)
- Richard Holborow (Global Head of Clinical Compliance, BSI)
- Alexandra Poulsson (Sr. Advisor Norwegian medical products agency, Norwegian Medical Product Agency)
- Stephanie Said (Sr. Advisor G-BA, Chair of the HTA Coordination Group Subgroup on Joint Scientific Consultations (JSC))
European Alignment on Digital Health Assessment
Securing reimbursement and funding for digital health solutions has been a barrier to their adoption. Can we harmonise their evaluation across Europe? This session convenes experts in digital health for discussions on the potential and limitations of coordinating efforts at the European level.
Moderator:
- Alexander Olbrecht (Director Digital Health, MedTech Europe)
Speakers:
- Katarzyna Markiewicz-Barreaux (AI Strategic Intelligence Lead, Philips)
- Uta-Maria Ohndorf (General Manager, Roche Diagnostics Austria)
- Thomas Pieber (Head of Clinical Department of Endocrinology and Diabetology, Medical University Graz)
- Louisa Stüwe (Project Director, Digital Health Delegation, French Ministry of Health)
Standing on the shoulders of giants
Discover Partners in Research, MedTech Europe’s dynamic new membership category that supports SMEs and startups to tap-in to the many exciting opportunities available in the R&I space. Partners in Research can connect with MedTech Europe global medtech companies at the Research & Innovation Committee, join other R&I activities, share their experiences, and access future cooperation opportunities; at the same time, they can get support to navigate the EU funding programmes, and have the possibility to join IHI projects from the industry side.
Speakers:
- Patrick Boisseau (Director General, Strategic Initiatives, MedTech Europe)
- Christopher Breyel (Executive Director Member Relations & Services, MedTech Europe)
Conclusions
Speaker:
- Oliver Bisazza (CEO, MedTech Europe)