Eugene Canavan is the Director of the Design Partners Healthcare and Science team. With over 24 years product development experience, Eugene is an extremely accomplished industrial designer and a recognised expert in Human Factors Engineering. He has been the recipient of numerous international awards including the prestigious IF Product and Red Dot Design Awards in Europe, the Good Design Award in Japan and the American IDEA award. Eugene is also a guest lecturer at the Centre for Medical Device Design at NCAD and as an external examiner for Product Design and Innovation at Carlow IT.
Nick Baker is the Technical Manager for Medical Devices at Lloyd’s Register Quality Assurance (LRQA), with responsibility for conformity assessment activities and certification under the In-Vitro Diagnostics Medical Devices Directive. Prior to this Nick was at the British Standards Institute where he was a scheme manager responsible for applying for designation as a Notified Body under the IVD Directive and the conformity assessment activities of ocular devices under the Medical Devices directive. He is a member of the IVD working group for Notified Bodies and the MHRA External Strategy Group for the IVD Revision. Nick has previously worked in the in-vitro diagnostics industry, including Wellcome Diagnostics (later Murex Diagnostics) with experience in the design and production of immuno-assays for infectious diseases. He started his career in clinical chemistry laboratories in the National Health Service and is a Fellow of the Institute of Biomedical Sciences.
Dr. Faycal Benayad-Cherif is product manager at FOBA. He has more than 25 years of experience in product development and management. He has developed the IMP (Intelligent Mark Positioning) system, a machine vision technology that offers unique means of improving laser marking and engraving processes through mark verification and alignment.
Dr. Benayad-Cherif has received his PhD. in Engineering Design (Biomedical) and a Master’s degree in Electrical Engineering from Tufts University (Boston, Massachusetts), as well as a bachelor in Physics. He is the author of several technical publications and holds several US and international patents on robotics and imaging technology.
Cathal Brennan worked in the medical device industry for over 14 years; as a research and development engineer in a number of leading biotech companies and subsequently as a medical device assessor in the HPRA.
As an engineer he worked on the design and development of various implants and delivery systems. My experience in the HPRA includes both pre-market (e.g. clinical evaluation, classification, notified body assessment, market surveillance) and post-market (vigilance) aspects of the regulation of medical devices.
Cathal is currently involved in developing guidance in the area of standalone software as a medical device for users and manufacturers. And is also involved in a number of European Commission working groups, including standalone software and classification.
Diarmuid Cahalane is the co-founder and Regulatory Director of Metabolomic Diagnostics, a Cork based Biotechnology company. The company is in the process of commercialising a risk stratification predictive screening test for Preeclampsia a condition of pregnancy which kills 50,000 women a year and more than half a million babies. He has been working in life sciences for over 20 years and is a regulatory expert with vast experience of software as a medical device, and e-health. In his capacity as a member of the Preeclampsia Biomarker Consortium he regularly meets with patient advocacy groups, clinicians and regulators including the American College Of Obstetricians and Gynaecologists, the US Food & Drug Administration, (FDA) and CEN and NSAI here in Europe. He is also an Enterprise Ireland mentor for early stage life science companies, especially those in the eHealth and Software fields."
SEÁN CANNEY TD
Minister of State with responsibility for the Office of Public Works and Flood Relief
County Councillor: 2004 – 2016
TD: Feb 2016 – to date (Elected for constituency of Galway East)
Appointed Minister of State in May 2016
Department of Public Expenditure and Reform with responsibility for the Office of Public Works and Flood Relief
Education and Professional Qualifications:
Chartered Quantity Surveyor
Fellow of Chartered Institute of Building
Associate Chartered Institute of Arbitration
Married to Geraldine McHugh with three sons
Brian Combe is Managing Director of i4 Product Design, an Edinburgh based product development company who have an excellent track record for supporting companies of all sizes getting their product to market. With a background in mechanical engineering and expertise in designing products for plastic injection moulding, Brian has over 24 years product development experience within a consultancy environment, witnessing a substantial throughput of projects for a diverse range of medical, consumer and industrial based products.
Michael is a specialist in the seed capital & business angel arena. He is a board member of EBAN and National Director of HBAN which has raised over €48M of direct business angel money into over 250 start-up & growth companies. Michael is manager of the Dublin BIC, a public private business support organisation. Dublin BIC manages the €53M AIB seed venture fund, the HBAN angel network, the Guinness Enterprise Centre (home to 90 start-ups) and provides investor ready business planning supports to entrepreneurs.
Brendan Cunniffe is a medical device engineer with 20 years’ experience spanning large multinationals and indigenous start-ups. His Ph.D. was in the finite element analysis of cardiovascular devices and he has spent much of his career using innovative design tools in the design of novel therapies. He has taken multiple Class III devices through CE marking and FDA approval. A twice-winner of a National Innovation Award (2001 & 2013), he was previously Director of R&D for APICA Cardiovascular Ltd, a Galway-based start-up acquired by Thoratec Corp. in 2014 for US$75m. He is currently Managing Director of Prelude Medical Ltd.
Based in Limerick, Republic of Ireland, Christy Dolan in the Sales Manager for Teleflex Medical OEM’s Northern Europe territory. In this role, he builds close customer relationships to supply high precision, high quality components and devices. An accomplished engineer, Christy understands his customers’ needs in many aspects of the business. He has extensive experience from both an engineering and commercial perspective. His dedication to his customers and the OEM business helps Teleflex Medical OEM continue as a global leader for custom-engineered extrusions, catheters, introducers, medical balloons, sutures, and bioresorbables.
Christy holds an Honours Degree in Polymer Engineering from Athlone Institute of Technology and an MBA in Manufacturing Technology Management from Open University.
Garry Duffy carried out his PhD in the Regenerative Medicine Institute (REMEDI) at NUIG on adult stem cell therapeutics for cardiovascular disease. He joined the Anatomy Department at the Royal College of Surgeons in July 2008 and is a PI in the Tissue Engineering Research Group. In 2013, he was awarded a Fulbright Scholarship to carry out research in advanced materials for cardiac regeneration at Brigham and Women’s Hospital and Harvard Medical School. He currently co-ordinates an EU project on Advanced Materials for Cardiac Regeneration (AMCARE) which aims to develop new biomaterial based approaches for adult stem cell delivery to the heart.
Siobhain Duggan is Director of Innovation and Healthcare at GS1 Ireland. Prior to joining GS1 Ireland in November 2010 she worked for Hewlett Packard for 11 years and held several roles in the area of Product Marketing, Business Development and Supply chain at their European offices in Munich, Zurich and Geneva. Siobhain also spent a year with BMW in Munich working in their Logistics operations department. Siobhain holds a Bachelors degree in International Commerce and German from UCD and has also completed all of her ACCA accounting exams. Siobhain brings a wealth of international supply chain experience to her role as well as a passion for patient safety in Healthcare.
Siobhain is currently working on a number of projects to promote the adoption of GS1 Standards for healthcare in Ireland. These include projects regarding a National Product Catalogue for Ireland to include GS1 coding and standardisation of data from Suppliers which facilitates e-Commerce and many other applications in healthcare. Existing GS1 Ireland projects relate to the serialisation of medication and Instrument trays for full supply chain visibility and increased patient safety.
The industry is leveraging GS1 Standards and the support of GS1 experts to prepare for the Medical Device regulation (Unique Device Identification (UDI)) and the Serialisation requirements for the EU falsified medicines directive.
Siobhain believes: “if you can run a hospital/healthcare provider as efficiently as a supermarket this will have a real and positive impact on patient safety and increased efficiencies and greater effectiveness in the delivery of ‘patient centred care”.
Karl D’Souza has been with SIMULIA for over 15 years and has served in multiple roles including engineering analysis, product management, market strategy, and business development. He is currently responsible for product portfolio management in the SIMULIA Virtual Human Modeling team. He has a B. Tech in Materials Engineering from IIT Bombay, an MS in Mechanical Engineering from SUNY Buffalo, and an MBA from Bryant University. He is based at SIMULIA HQ in Providence, RI.
David E Barton, PhD, DipRCPath
- Chief Scientist, National Centre for Medical Genetics, Dublin, Ireland
- Adjunct Associate Professor, School of Medicine & Medical Sciences, University College Dublin
- Chair, Board of Management, European Molecular Genetics Quality Network
- Spokesperson on the regulation of genetic testing for the European Society of Human genetics
- Member, HPRA Advisory Committee for Medical Devices
Having trained in Trinity College Dublin, and The Queen’s University of Belfast, David Barton carried out medical genetics research at Yale University and Cambridge University before setting up the NHS molecular genetics diagnostic laboratory in Cambridge, UK. He returned to Dublin to set up his current laboratory at the National Centre for Medical Genetics in 1995.
Prof. Barton has been involved in work to monitor and improve the quality of genetic testing for many years, working with UK NEQAS, the European Molecular Genetics Quality Network EMQN (which he now chairs), the OECD, WHO and EuroGentest. He co-ordinated the EU CRMGEN project, developing certified reference materials for genetic testing. In EuroGentest he continued to work on reference materials development and also has responsibility for examining the role and impact of IVD regulation in genetic testing.
David Barton has published over 120 papers in peer-reviewed journals. Research interests include the genetics of vesicoureteral reflux, male infertility and the development of novel DNA diagnostic devices..
Prof Barton is a member of the ESHG’s Genetics Services Quality Committee, Chair of the Irish Molecular Diagnostics Network and a Board Member of the Genetic and Rare Diseases Association.
Alan Gormley joined GS1 Ireland in January 2010 and works as one of GS1’s technical experts in relation to all Automatic Identification and Data Capture (AIDC), data sharing (EDI, master data and data synchronisation) as well as solutions incorporating EPCIS.
Alan works as a liaison between industry and GS1 and supports initiatives to bring GS1 standards-based solutions to market, in line with Member needs. Collaborating with solution providers nationally and globally, Alan works in numerous industries such as healthcare, aerospace and retail to help implement GS1 Standards for traceability, patient safety and efficiency driven solutions. Alan's specialities include barcode quality, verification and process improvement. Alan participates in numerous global working groups to develop supply chain standards for multi-industry use.
Alan holds diplomas in both process and polymer engineering, in addition to a Bachelor’s Degree from University College, Galway (NUIG) and a Masters Degree from Trinity College, Dublin.
James L. Greene has over 27 years experience in medical devices focused on the treatment of cardiovascular disease. In December 2010 Mr. Greene founded and served as CEO for Apica Cardiovascular Ltd. and APK Advanced Medical Technologies, Inc., which was founded in 2013 and is based in Atlanta, Georgia. Apica was an early staged venture backed start-up company based in Galway, Ireland and developed a novel platform for access and closure of the left ventricle enabling transapical delivery of therapeutic devices for Structural Heart disease. Apica’s ASC™ platform achieved CE Mark in August, 2013. APK Medical is developing an access platform for implantation of Mechanical Circulatory Support Systems. Apica and APK were recently acquired on 03 July, 2014 by Thoratec Corporation, Pleasanton, California. Previously, Mr. Greene served as CEO for MitralSolutions, Inc., another venture backed start-up pioneering new technology for minimally invasive mitral valve repair. Mr. Greene’s earlier VP and Director level positions in Bioheart, Medtronic, AVE, Perclose, and Guidant provide a deep breadth of knowledge in concept ideation, financing, product development and commercialization of cardiovascular and endovascular products both in Europe and the United States. Mr. Greene holds a B.A. degree from Furman University, Greenville, S.C. and served in the United States Military following graduation for 7 years. Mr. Greene currently serves as Senior Director of Commercialisation, Structural Heart Disease, Thoratec Corporation and resides in Shelfield Green, England.
- Cardiovascular: Update in Transcatheter Heart Valve Technologies and Transcatheter aortic valve implantation (TAVI): what’s next?
- Discussion Panel: Market Access, Funding & Reimbursement. In a clinical evidence based world how will we fund clinical studies to prove that medical devices should be reimbursed?
As Development Director of Maddison, Patrick has a dual commercial and technical role. He applies an experience and knowledge gained over 20 years working in product design, including medical products, FMCG, business electronics and consumer products. Maddison is a multi-disciplinary team of experienced product designers and engineers. We solve complex usability and technical problems to deliver effective medical devices and user interfaces. We develop products ranging from disposable diagnostics to complex therapeutic devices. We have a particular specialism in creating simple solutions to challenging physical and virtual patient user interfaces.
John was appointed Minister for Training, Skills and Innovation on the 19th May 2016.
John was first elected to the Dáil in 2011.
Prior to his election to the Dáil, John sat on Waterford City Council from 1999. He was Mayor of Waterford City in 2009/2010.
Collette works for Plextek Consulting in medical business development, helping companies with their strategic positioning relating to product development. Previous to working at Plextek she worked at NHS innovations with a lead role in bringing together industry and clinical organisations for product adoption and also was the programme lead for the national SBRI healthcare programme, whilst in this role she focussed on the mHealth and telehealth space and developed a network bringing together, industry, clinical and academic stakeholders. She also worked in a strategic role in healthcare at Cambridge Consultants for world leading corporate organisations and highly innovative start-ups.
David Keegan is a Consultant Vitreo-retinal Surgeon at the Mater Misericordiae University Hospital. and National Clinical Lead for Diabetic Retinopathy Screening. He runs the Retinal Clinical Trials Unit at the Mater University Hospital.
His clinical interests include management of surgical and medical retinal disease:- including use of the Intra-ocular Magnifying Telescope for macular degeneration the development of the National Inherited Retinal Disease Register
Mattias is leading market access activities at Synergus.
He has over 20 years of experience from the Medical Device Industry. Mattias started his career within quality and regulatory and has held several positions within production, quality, logistics and R&D in a global medical device corporation specialized in intensive care. During the years, Mattias also developed a very unique and extensive reimbursement and market access knowledge and is today combining his regulatory and business development insights when consulting medical device companies worldwide on how to develop their reimbursement and regulatory strategies. He has considerable experience in development of Pan-European reimbursement strategies for medical device companies. Mattias is also a frequent speaker at international reimbursement and regulatory conferences.
Mr. Block is an internationally recognized expert in FDA medical device regulations. As the president of Ken Block Consulting, he is responsible for clearance and approval plans for a wide variety of medical devices types and technologies. Mr. Block has conducted in-person meetings with FDA, including for the discussion of 510(k) strategy, performance/software validation, and usability testing requirements for innovative medical devices. He encourages medical device companies worldwide to enter the large US market, through intelligent regulatory strategy and execution.
Caitríona Lally is a Professor in Bioengineering in the Department of Mechanical & Manufacturing Engineering and the Trinity Centre for Bioengineering in Trinity College Dublin. Her research is focused on arterial tissue mechanics, vascular imaging, vascular mechanobiology and tissue engineering. She has secured considerable research funding from SFI, Enterprise Ireland and the IRC and was awarded a prestigious ERC Starting Grant in 2014.
A biochemist by background following studies at Liverpool University and postgraduate further studies at Manchester University. Extensive R+D experience gained over 20 years in dermatological related research and product development in the consumer goods and healthcare fields. Previously employed by Unilever and Boots in the UK in various roles, including skin research, product development and safety and efficacy testing. Joined Dow Corning in 2010 an now globally responsible for the Dow Corning medical device materials market.
Lucy is the Business Development Manager at eg technology. As part of the Senior Management Team, Lucy is responsible for identifying opportunities in the market where eg technology can add significant value in the development process, to secure new business and to manage the initial engagement process. Lucy is also responsible for managing and promoting the profile of the company.
Lucy has a BSc in Biochemistry and is an Associate of King’s College London. Having started her career in clinical research immunoassay design and automation she has significant experience in product design and development in the Medtec, Biotech and precision electro-mechanical market. Lucy has a strong track record in the whole development process and she is currently actively involved in the entrepreneurship scheme at the Judge Business School, University of Cambridge.
Sean is an expert on the application of design thinking and Lean New Product Development. Sean and his team have developed a set of visual tools and techniques on how these involve senior management and deliver a practical approach to delivering significant business impacts built around delivering better customer / client ‘outcomes’. This customer ‘outcomes’ approach has delivered breakthrough services and products for Sean’s clients and embedded a practical process that changes the mind sets and culture within that organisation on how they identify, verify and validate the ‘needs’ and ‘desires outcomes’ of their target markets.
In 1996 Sean set up Dolmen, an award-winning new product and service development company, who operate out of Dublin with a team of 11 innovation and design experts and 5 associates.
Sean has been certified and licenced by IRDG to be a leader of the world renowned ‘Lean Product Development’ process as championed by American writer and expert consultant Ron Mascateli. This approach has been proven to lead to a more effective, efficient and speedier Product Development and Innovation process across many industries.
Sean has jointly with Raomal Perera, INSEAD has developed a process called LeanDisruptor (LeanDisruptor.com). This process is focus on the front end of LEAN New Product Development and using Lean principals to identify, verify and validate under, unmet and unarticulated market needs and developing new solutions based on defining customer ‘desired outcomes’ and KPIs. This process has delivered an 86% success rate to date in delivering product – market fit..
Sean mentors and present lead workshops for the following accelerator programmes:
- DCU/ Ryan Propeller 2013,14
- MasterCard Start Path 2014
- Cartier European Female entrepreneur 2013,14
Gar Murphy is a European IT Director at Cook Medical. Gar has over thirty years industry experience working for SME and Multinational companies chiefly within the Information Technology sector. Gar has worked for COOK Medical (based in Limerick) for the past 18 years in various IT management roles. He has been instrumental in the various global standardisation strategies within COOK for the past decade. He holds a BA in Information Technology and an MSc in Technology Management from the University of Limerick.
Olive O’Driscoll is a biomedical engineer with 14 years medical device experience in industry, academia and the NHS. Olive is an inventor of three ENT devices, one of which was successfully licensed in 2013. She has held key management positions in multi-nationals and a VC backed Start-up Company and has led international, clinical trials with more than 15,000 patients in 200 countries. She has worked as a field based research engineer and was a member of a large sales force in the EU responsible for launching cardiovascular medical devices for Medtronic Cryocath. Olive has excellent commercial, clinical, R&D and regulatory medical device expertise and is wholly dedicated to the commercial success of AventaMed.
Martin O’Connell is an electrical engineer and also an All-Ireland champion accordion player. Nasal Medical was set up in 2014 when cattle on Martin’s family farm were destroyed having contracted TB.
ABOUT NASAL MEDICAL
Nasal Medical is a medical device company that create anatomically designed products for healthy breathing. There are three products:
1. a nasal filter which helps people suffering with hay fever and pollution.
2. a nasal dilator which helps people suffering with sleep apnea, congestion and snoring and
3. a sport enhancement aid which helps athletes increase oxygen intake.
Dr Daniel O’Mahony is a Partner at the pan European life sciences VC Seroba Life Sciences, investing in companies developing new medical devices or therapeutics.
Daniel brings a wealth of experience in product development, strategic planning, licensing, intellectual property management and commercialization across the Medtech, pharma and biotech industry sectors and in venture capital and corporate investments. He previously worked in Elan Corporation plc and had also established the Technology Transfer Office at NUI, Galway.
Daniel graduated with a Ph.D. from the National University of Ireland, Cork and holds a business degree in technology management from the Smurfit Business School, UCD. He has held academic appointments at the Genetics Department, Trinity College, Dublin, the Weis Research Centre, Geisinger Clinic, Pennsylvania, USA and the Department of Medicine & Experimental Therapeutics at UCD. He has published in several scientific journals, is co-inventor on numerous patent families and is a regular panel member at major international medtech conferences.
Dr O’Mahony currently sits on the boards of Novate Medical and PQ Bypass Irl. Ltd. He also sat on the boards of Apica Cardiovascular (acquired by Thoratec, 2014), Covagen (acquired by Cilag/Janssen Pharmaceutical companies of the Johnson & Johnson Group, 2014) and Stokes Bio (acquired by Life Technologies).
Gordon Padkin has worked for Freescale and formerly Motorola for 15 years in the microcontroller area. His current position is Business Development Manager for Northern Europe. He has worked in numerous different product & technical marketing roles gaining a broad view on the European & Global market trends and developments as well as new developments in the embedded control space to address these emerging trends.
Professor Philip Procter Bio
Background and Professional Profile
I have over 30 years’ experience in research, development, marketing and business development of Orthopaedic medical devices in an international environment with three of the leading companies in the industry: Howmedica, Synthes, and Stryker. Achievements included worldwide commercialization of the Gamma locking nail hip fracture device and pioneering evidence based design of Asian trauma implant variants (per annum >300mil$), and establishing a novel screw augmentation regulatory claim for HydroSet injectable calcium phosphate cement (per annum sales >30mil$).
I have 7 years’ experience as a self-employed consultant (ConsultPhilipProcter SARL, France) working primarily with SME’s in the medical device sector. I provide services that include Product management, Technical marketing, Product Development, as well as Independent Reviewer and Chief Engineer roles.
GPBio Ltd, Ireland: In 2013 I co-founded a company whose business focus is the development and commercialisation of tissue adhesives.
BASS Bone Augmentation Solutions Syndicate, Ireland (BASS): In 2013 I founded a syndicate of SME’s whose objective is to collaborate to provide innovative solutions for augmenting fixation of orthopaedic implants in compromised bone. A commercial example is CelgenTek Innovations Corporation in which a group of smaller companies combine to reach a commercial goal.
ConsultPhilipProcter SARL: Over the last decade I have focused on translational research to projects that link University based research to relevant clinical problems. The scope includes development of injectable biomaterials, implant coatings that enhance implant fixation, and the local delivery of antiporotic and antibiotic drugs. I currently direct applied research at Angstrom Laboratories University of Uppsala Sweden that focuses on adhesives intended for use in human tissue repair.
Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs external seminars, webinars and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has many published articles on biocompatibility topics.
He is a participating member on all Association for Advancement of Medical Instrumentation (AAMI) TC 194 and 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, discussing biocompatibility methods and voting on changes to those standards. As one of a select group of experts in the industry, Thor’s participation on the committees offers him insight on industry changes and helps prepare clients for changes in testing.
Benjamin Sarda is Director of Product Marketing at Orange Healthcare, the Orange group’s digital healthcare division, where he is responsible for defining and leading the eHealth product development roadmap along with identifying market entry strategies across the healthcare ecosystem
Prior to Orange Healthcare, Benjamin led the creation of Orange Assistance, an Orange subsidiary providing home computer assistance services to Orange customers. Benjamin has held various director-level positions within Orange.
Before joining the Orange group, Benjamin worked in the area of medical imaging at INSERM (Institut national de la santé et de la recherche médicale), a publicly funded medical research entity in France.
He began his career as a system engineer at Eutelsat, a satellite telecommunications operator.
Benjamin is a graduate of the Ecole Nationale Supérieure des Telecommunications de Bretagne and holds a MS in signal processing.
Anne started academic life with a degree in Microbiology from Trinity College and then to Galway to complete a Masters in Biotechnology in NUIG. Following that Anne worked for a number of years in industry in the IVD area product development.
Anne moved into regulatory in 2002 when she joined the IMB principally in quality assessment of vaccines and blood products. During this time Anne completed an M. Sc. in Industrial Pharmaceutical Science from the RCSI. In 2007 Anne moved to the devices area as a senior manager with focus on Vigilance and Compliance.
Bart Vansteenkiste has worked for Domino for over 12 years in different commercial roles. A master degree of Electromechanical Engineering and his former role as Pharmaceutical and OEM key account manager for Belgium, gave him the perfect background to join the head quarters based FMD group in 2011.
Bart is fluent in Dutch, English, French and Spanish which is a big benefit in his current role, advising Domino’s customers and sales channels on the implications of the legislative requirements and the implementation of 2D coding, serialisation, aggregation and Track & Trace projects.
Marie is a Patent Attorney of more than 20 years’ experience. Her work includes prosecuting patent applications across a variety of technology sectors such as pharmaceuticals, materials sciences and polymers as well as mechanical technologies including medical devices and renewable energy systems.
Prior to joining Hanna Moore & Curley, Marie spent several years as the Director of another firm of Patent Attorneys in Dublin. Her original university degree was in Industrial Chemistry and Marie worked in the United Kingdom as a research scientist with Imperial Chemical Industries plc and subsequently, conducted post-graduate research in the Chemistry Department of University College, Cork.