A Research Agenda for Medical Devices in the EU
Declan Kirrane ISC Intelligence in Science, moderator
Mark Ferguson Director General, Science Foundation Ireland and Chief Scientific Adviser
to the Government of Ireland; Chair, European Innovation Council Advisory Board
Karina Angelieva Vice Minister of Science, Bulgaria
Sean Kelly MEP Committee on Industry, Research and Energy, European Parliament, Brussels
Abhay Pandit Scientific Director, SFI Research Centre for Medical Devices (CÚRAM), Ireland
10h15 Panel 1: Medical Devices Research and Development in Europe
Beat Lechmann Johnson & Johnson Medical Devices
Maria Lavitrano Director and Vice President European Open Science Cloud (ESOC), Association; University of Milan Bicocca and director of BBMRI.it
Ann O’Connell Head of Funded projects for Medtech & Engineering, IBEC
Conchi Garcia Pardo iTEAM Research Institute, Mobile Communications Group, Universitat Politècnica de València, Spain
11h10 Panel 2: Key Developments and Artificial Intelligence in Medical Devices
Barry O´Sullivan MRIA, School of Computer Science, University College Cork and Insight Centre for Data Analytics and SFI Centre for Research Training on AI.
Valentina Isetta Innovation Manager EIT Health (Ireland-UK)
Gernot Kronreif Austrian Center for Medical. Innovation and Technology. ACMIT Gmbh
11h50 Panel 3: Global Perspectives: Medical Devices for the SDGs
Momeena Omarjee South Africa Health Products Regulatory Authority (SAHPAR)
Arti Ahluwalia Open Biomedical Engineering e-platform, University of Pisa
Nicola Di Lorenzo General Secretary, European Association for Endoscopic Surgery and other interventional techniques EAES
14h00 Panel 4: Regulation and Data
Kurt Zatloukal Medical University Graz, Austria
John Greaves Director, Global Standards, Architecture, Conformity and Propagation, ConsenSys Health
John O’Dea CEO, Palliare, Ireland
Tsvetelina Ivanova Chief Compliance Officer, COMAC Medical, Bulgaria
14h50 Panel 5: Skills and Education for a Competitive Europe
Ian Jones CEO, InnoPharma, Ireland
Graham Wilkie DG Education and Culture, European Commission
Sandor Kovacs Syreon Research Institute, Today’s research for tomorrow’s health, Hungary
15h30 Panel 6: White Paper: A research agenda for Medical Devices in the EU
Abhay Pandit Scientific Director, SFI Research Centre for Medical Devices (CÚRAM), Ireland
Karina Angelieva Minister of Science, Bulgaria
Rita Lawlor PhD, CIPP/E, CIPM Fellow of Information Privacy (IAPP)
Maria da Graça Carvalho MEP, Committee on Industry, Research and Energy; Special Committee on Artificial Intelligence in a Digital Age
16h15 Concluding Remarks
Next Steps and Conclusion
Abhay PanditDirector of CÚRAM, SFI Research Centre for Medical Devices
Professor Pandit’s research integrates material science and biological paradigms in developing solutions for chronic diseases. Professor Pandit has developed next generation reservoir delivery vehicles with high payload capacity, programmable degradation profiles and inbuilt gradients of physical, chemotropic and protective cues which facilitate spatiotemporal localised sustained delivery of multiple biomolecules to target injury mechanisms at the molecular and cellular levels.
The biomaterial platforms have been validated to act as inductive templates for constructive remodelling and as templates for the induction of de novo functional, site-appropriate, tissue formation. These platforms have been developed for neural, musculoskeletal and cardiovascular clinical targets with numerous other targets currently under development.
Professor Pandit has received numerous awards and distinctions. He was inducted as an International Fellow in Biomaterials Science and Engineering by the International Union of Societies for Biomaterials Science and Engineering and elected as a Fellow of the Tissue Engineering and Regenerative International Society. He was also elected to the American Institute of Medical and Biological Engineering (AIMBE) College of Fellows in recognition of his outstanding contributions to establishing a national centre which will develop transformative device-based solutions to treat global chronic diseases. He is the first Ireland-based academic to be bestowed with these honors. He has been an elected member on the Council for both the Tissue Engineering and Regenerative Medicine International Society and European Society for Biomaterials Society. Professor Pandit has published more than 250 papers in peer-reviewed journals, filed numerous patent applications and has licensed four technologies to medical device companies. In recognition of his track record in technology transfer Prof. Pandit secured the Academic/Emerging Medical technology Company of the Year – Silver Award for 2013 awarded by the Irish Medical Devices Association, Enterprise Ireland and IDA Ireland. Prof Pandit is an Executive Editorial Board of the Tissue Engineering journal, an Associate Editor of the Biomaterials journal. He has co-ordinated four EU grants to date and has generated research contracts from industry and government funding agencies totaling €90M.
Barry O’Sullivan Professor at MRIA School of Computer Science, University College Cork, and Insight Centre for Data Analytics and SFI Centre for Research Training on AIBarry O’SullivanProfessor at MRIA School of Computer Science, University College Cork, and Insight Centre for Data Analytics and SFI Centre for Research Training on AI
Barry O’Sullivan holds the Chair in Constraint Programming at University College Cork in Ireland. He is the founding Director of the Insight Centre for Data Analytics at UCC, Director of the Science Foundation Ireland’s Centre for Research Training in AI, and Principal Investigator at the Confirm Centre for Smart Manufacturing. He is an Adjunct Professor at Monash University, Australia. Professor O’Sullivan was Vice Chair of the European Commission’s High-Level Expert Group on Artificial Intelligence and a scientific advisor to AI Watch, an initiative of the European Commission’s Joint Research Centre tasked with monitoring the uptake of AI in Europe. He is an award-winning academic working in the fields of artificial intelligence, constraint programming, and operations research. He also works in AI and data ethics, as well as public policy-making related to AI. He serves as a Councillor at the Association for the Advancement of Artificial Intelligence. Professor O’Sullivan is a Fellow and a Past President of the European AI Association, Fellow of the Irish Academy of Engineering, Fellow of the Irish Computer Society, and Member of the Royal Irish Academy.
Conchi Garcia-Pardo Senior researcher at the Institute of Telecommunications and Multimedia Applications (iTEAM) of the Universitat Politècnica de València (UPV)Conchi Garcia-PardoSenior researcher at the Institute of Telecommunications and Multimedia Applications (iTEAM) of the Universitat Politècnica de València (UPV)
Senior researcher at the Institute of Telecommunications and Multimedia Applications (iTEAM) of the Universitat Politècnica de València (UPV), where she is project leader for wireless communications in medical devices. She has participated in 20 R&D projects about wireless communications. She is author of more than 20 papers on high-impact journals, 30 international conferences, 2 book chapters, and 2 patents. She was organizer and chairman of the workshop WIBCOMM- Wireless Body Communications in Medicine (IEEE PIMRC 2018), and TPC Chair for IEEE International Symposium on Medical Information Communication Technology (ISMICT) 2019, and IEEE HealthComm 2019. From 2020, Dr. Garcia-Pardo is Associate Editor at Frontiers in Networks and Communications journal, and Topic Editor at Journal of Sensor and Actuator Networks. She is also member of the Spanish Committee on Radiofrequency and Health (CCARS). In the last 5 years, she has supervised 6 PhDs about wireless propagation around the human body, body tissue characterization and EM phantom formulation in the framework of the WIBEC (Wireless In-Body Communications Environment) H2020 European Project.
Declan Kirrane Director ISC Intelligence in Science and Coordinator EU Africa Radio Astronomy PlatformDeclan KirraneDirector ISC Intelligence in Science and Coordinator EU Africa Radio Astronomy Platform
Declan Kirrane is Managing Director of ISC Intelligence in Science, a specialized science, technology and R&D public affairs firm based in Brussels, Belgium. ISC develops and implements Strategic Research Agendas for science and technology-based organisations in the EU and US.
His practice areas cover IP, R&D consortia development, management and dissemination and is responsible for themes of ICT, health, security, defence, space and related policies, legislation, programmes and funding mechanisms. Declan Kirrane has a background in analysing the relationship between public and private R&D funding and the impact on R&D performance: he has worked extensively on science and technology policy evaluation methodologies and technology options for policy- and decision-makers. The EU’s Digital Agenda, emerging European space, security and defence policies are part of his remit.
Ian JonesFounder and CEO of The Innopharma Group and President of Innopharma Education
Innopharma provide education and technology solutions to the high-tech manufacturing sectors of (bio)pharma, medtech, foodtech and ICT. Innopharma Education (www.innopharmaeducation.com) focuses on providing up/re-skilling for individuals looking to enter or progress their career within the high-tech manufacturing sectors of (bio)pharma, medtech, foodtech and ICT. They partner with governments, corporations and academic institutions to ensure a sufficient supply of appropriately skilled resources. Innopharma Education are the leaders in high-tech up-skilling in Europe and have gained tremendous accolades for their unique public-private partnership approach. They have engaged with EU Parliament, Commission and Cabinet with respect to Industry 4.0 and high-tech up-skilling.
John GreavesDirector Global Standards Architecture, Conformity and Propagation
Director, Global Standards Architecture, Conformity and Propagation. Chair INCITS (International Council for Information Technology Standards). Secretary IEEE P2418.6 Blockchain in Health Care and Life Sciences: Vice Chair IEEE P2677 BOPS (Blockchain Omnidirectional Pandemic Surveillance Standard).
John O´DeaCEO, Palliare, Ireland
John has 30 years’ experience in the medical device industry and is CEO of the Palliare group of companies. John previously worked at Medtronic following their 2017 acquisition of GI Diagnostic company Crospon, which he founded in 2006.
John co-founded Caradyne, an Irish respiratory medical device company, which was acquired by Respironics, Inc. in 2004. Over the past 35 years, John has held R&D management positions in Nellcor Puritan Bennett and engineering positions in Digital Equipment, Inc. and Dataproducts, Inc.
John is a named author on 18 U.S. Patents. John is Chairman of the External Advisory Board of BioInnovate Ireland at NUI Galway. He is a past Chairman of the Board of the Irish Medical Devices Association and is a Past President of Engineers Ireland. In 2016, John was awarded a Doctor of Engineering (honoris causa) by NUI Galway for his contribution to the Irish medical device industry and received the 2016 Outstanding Contribution to MedTech Award from the Irish MedTech Association, IDA Ireland, and Enterprise Ireland.
John holds Bachelor and Master’s Degrees in Mechanical Engineering and a PhD in Electronics Engineering, all from University College Dublin, and an MSc in Clinical Research from NUI Galway.
Karina AngelievaDeputy Minister of Education and Science of Bulgaria
Karina Angelieva is a former Counselor, Head of Sector Education and Research at the Permanent Representation of the Republic of Bulgaria to the EU. She holds Master degrees in European integration and in Contemporary History from Sofia University “St. Kliment Ohridski”. Previous positions held include Director-General of Structural Funds and International Educational Programs at the Bulgarian Ministry of Education and Science and Director of the Joint Innovation Centre at the Bulgarian Academy of Sciences (JIC – BAS). Ms. Angelieva is a founder of the Club of Young Scientists in Bulgaria and has been in charge of the coordination of National contact points’ network for the EU Framework Program for Research and Innovation for 10 years. On 1 September 2018 she was appointed Deputy Minister of Education and Science of Bulgaria.
As a longtime employee of the Ministry of Education and Science in the period 2002-2009, Ms. Angelieva was involved in the coordination of the 6th EU Framework Program for Research and Technological Development, overseeing the national contact network, organizing information days and training for representatives of academic and business sector to boost their participation in the program. Karina Angelieva was the head of projects under the PHARE program on the topic of overall modernization of the research system in Bulgaria. She provided analysis and recommendations for the introduction of modern European practices in program financing on a national level. Ms. Angelieva participated in various working groups, including the group tasked with the preparation of the National Charter for SMEs and of the methodology for the Technology Transfer centers and evaluation of innovations in Bulgaria as a preparation for the participation in the OP “Competitiveness”.
Karina Angelieva has extensive expertise and practical experience in the field of research and innovation, including the coordination, preparation and management of projects related to the development and deployment of new applications and services in the field of technology transfer, inter-sectoral partnership “industry-academy” and others. As a former director of the JIC at the Bulgarian Academy of Sciences (BAS), she led the innovation policy of the Academy and contributed to the establishment of an effective cooperation between BAS and the industrial sector. She also guided the participation of JIC in the Bulgarian consortium of Enterprise Europe Network.
Deputy Minister Angelieva is a member of the Commission Board of the Bulgarian-American Commission for Educational Exchange (Bulgarian Fulbright Commission). She is devoted to promoting science communication in Bulgaria and has been the driving force behind the success of the 31st EU Contest for Young Scientists (EUCYS) held Sofia in 2019. On her initiative the Bulgarian Science Portal was launched in 2019 as a step towards defragmenting the science information and communication landscape on a national level.
Kurt ZatloukalDirector of BBMRI.at
Kurt Zatloukal, M.D., is Professor of Pathology and head of the Diagnostics and Research Center for Molecular Biomedicine at the Medical University Graz. His research work focuses on the molecular pathology of metabolic liver diseases and cancer as well as molecular diagnostics. He is working on the development of biobanking-related technologies and machine learning approaches for digital pathology. He coordinated the preparatory phase of the European biobanking and biomolecular research infrastructure (BBMRI) and is now director of its Austrian national node. In this context solutions have been developed for providing access to quality controlled human biological samples and medical data for research and innovation.
Mark W.J. Ferguson Director General, Science Foundation Ireland and Chief Scientific Adviser to the Government of IrelandMark W.J. FergusonDirector General, Science Foundation Ireland and Chief Scientific Adviser to the Government of Ireland
Professor Mark W.J. Ferguson commenced as Director General of Science Foundation Ireland in January 2012 and as Chief Scientific Adviser to the Government of Ireland in October 2012. Professor Ferguson is Chair of the European Commission Pilot Advisory Board for the European Innovation Council and is a founding member of the Small Advanced Economies Initiative. He was Chair of the eHealth Ireland Committee, (2015 – 2017), a member of the EU High Level Expert Group on Horizon 2020 Impact (2017) and has been involved in a number of international reviews of R&D systems, including Hungary, Denmark and Canada. Previously he was Professor in Life Sciences at the University of Manchester (since 1984) and co-founder, CEO and Chairman of Renovo Group plc (1998-2011).
He is the recipient of numerous international research awards including the 2002 European Science Prize (jointly), and is the author of 329 research papers and book chapters, 61 patent families and author / editor of 8 books. He has contributed to a number of scientific films, documentaries, TV and radio programmes and held offices in 16 international scientific societies, including President of the European Tissue Repair Society. He has wide ranging research interests in cellular and molecular mechanisms in scarring and wound healing, developmental mechanisms in normal and cleft palate formation, alligator and crocodile biology including temperature dependent sex determination.
Mark graduated from the Queens University of Belfast with degrees in Dentistry (BDS 1st class honours), Anatomy and Embryology (BSc 1st class honours, PhD) and Medical Sciences (DMedSc), holds Fellowships from the Royal Colleges of Surgeons in Ireland (FFD), and Edinburgh (FDS), Fellowship of the Irish Academy of Engineering and is a Founding Fellow of the UK Academy of Medical Sciences (FMedSci). He is a member or Fellow of a number of learned Societies, and was made a “Commander of the British Empire” (CBE) by the Queen in 1999 for services to Health and Life Sciences.
Momeena OmarjeeNames and Scheduling – Clinical
Unit head of the Names and Scheduling Department and Acting Manager of Medical Devices Department.
18 Years of experience within the pharmaceutical sector, 8 of which have been at the Regulator.
Bachelor of Pharmacy Degree from Rhodes University and a Masters in Pharmaceutical Policy and regulation from the University of Western Cape and Hibernia College
Nicola Di Lorenzo General Secretary of EAES - European Association for Endoscopic Surgery and other interventional techniques Università Roma Tor Vergata - ItalyNicola Di LorenzoGeneral Secretary of EAES - European Association for Endoscopic Surgery and other interventional techniques Università Roma Tor Vergata - Italy
Nicola Di Lorenzo MD, PhD, MEMdS, FACS
General Secretary of EAES – European Association for Endoscopic Surgery and other interventional techniques
Università Roma Tor Vergata – Italy
Associate Professor of General Surgery
General Secretary of EAES – European Association for Endoscopic Surgery and other interventional techniques
Executive Board member of IFSO -International Federation for the Surgery of Obesity and Metabolic Disorders
President – Italy Chapter of American College of Surgeons (ACS)
Rita T. LawlorPh.D., CIPP/E, CIPM Fellow of Information Privacy (IAPP)
Rita T. Lawlor is a Computer Science graduate of Trinity College Dublin with a doctorate in Oncological Pathology from the University of Verona where she is co-founder of the ARC-Net (www.arc-net.it) applied cancer research centre and is director of the ARC-Net biobank coordinating research activities. She is an IAPP Fellow of Information Privacy (International Association of Privacy Professionals) with CIPP/E and CIPM certifications for European data protection and is chair of the ISBER GDPR Task Force. She is a member of the management team of ICGC-ARGO, International Cancer Genome Consortium to accelerate research in genomic oncology and is a member of the board of the Italian Foundation on Pancreas Diseases (FIMP).
She is past president of ESBB, the European, Middle Eastern and African Society for Biopreservation and Biobanking (www.esbb.org) and a former director of ISBER, International Society for Biological and Environmental Repositories (www.isber.org). She is a member of the steering committee of BC-NET (Biobank Cohort Network of Low Middle Income Countries) of IARC (International Association for Research on Cancer). She co-authored the IARC Technical Publication on Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research.
Her current research interests are in molecular diagnostic markers and therapeutic targets and the role of cancer heterogeneity and molecular characterization of samples in the application of individualized medicine.
Robert Eiss Senior global health adviser to the Director of the National Institutes of Health (NIH) and Fogarty International CenterRobert EissSenior global health adviser to the Director of the National Institutes of Health (NIH) and Fogarty International Center
Robert Eiss serves as senior global health adviser to the Director of the National Institutes of Health (NIH) and Fogarty International Center. At NIH, Mr. Eiss assumed lead responsibility for the Fogarty International Center’s first long-range plan, which reoriented its programs to address infectious and non-communicable disease research and training needs of low-and middle-income countries. Mr. Eiss has held executive management posts at the White House Office of National Drug Control Policy (ONDCP) and at an international NGO established by the Rockefeller Foundation to improve access to innovative medicines. At ONDCP, he served as director of planning and budget, involving budgetary oversight of national drug control agencies, establishment of a system of performance measures to monitor program effectiveness, and the management of a research portfolio on illicit drug consumption and consequences. As CEO of an international NGO, he promoted innovative and strategic management of intellectual property to speed the development of medical products that reduce global health disparities. Mr. Eiss holds degrees from the University of Maryland at College Park and Oxford University