Conference

10.25   

Chair
Michael Loftus, Consultant, Loftus Consulting

Michael has recently opened a consultancy business focusing on development of business plans, strategic change management and operational effectiveness. Prior to this, Michael was country general manager for Becton Dickinson (BD) and has worked for over 20 years in the Medical Technology Sector. He is past chairman of the Irish Medical Devices Association (IMDA) and founding president of the Medical Technologies Council (MTC). He is currently a member of the Leaders Council for the American Chamber’s Convergent Technology Network.

Strategic Change - Alignment with Opportunities

Ireland’s business environment is changing at a rapid pace. The challenges are clear and our pursuit of the ‘knowledge economy’ is well documented. But what does the ‘knowledge economy’ mean to our business sector? What changes are taking place to enable our future success and what do we need to do to align ourselves with these emerging opportunities? We will take an overview of this challenge now and probe deeper throughout the remainder of the session.

Michael Loftus, Consultant, Loftus Consulting

Michael has recently opened a consultancy business focusing on development of business plans, strategic change management and operational effectiveness. Prior to this, Michael was country general manager for Becton Dickinson (BD) and has worked for over 20 years in the Medical Technology Sector. He is past chairman of the Irish Medical Devices Association (IMDA) and founding president of the Medical Technologies Council (MTC). He is currently a member of the Leaders Council for the American Chamber’s Convergent Technology Network.

11.00 

Understanding the Clinical Needs
Each speaker will give a 10/15 minute presentation

Training Orthopaedic Surgeons of the Future: Developing Innovation

This talk will describe the new philosophy of training orthopaedic surgeons in the future. Currently surgeons are trained to a very high clinical standard. Surgeons of the future require different areas of professional development and in particular developing their innovative skills. Particular emphasis is placed on encouraging them to develop ideas with regard to medical devices that can enhance patient care.

Previously, research involved a small area of basic science. The current emphasis is to allow a trainee surgeon spend time developing a medical device innovation from the idea, to prototype, to development. Preliminary experience with this is described and the major difficulties will be outlined.

Professor John O'Byrne, Consultant Orthopaedics, Cappagh National Orthopaedic Hospital

Professor John O'Byrne is the Abraham Colles Professor of Orthopaedic and Trauma Surgery in the Royal College of Surgeons in Ireland. He is also Consultant Orthopaedic Surgeon in Cappagh National Orthopaedic Hospital and the Mater Private Hospital. He trained in Ireland and the USA, and was appointed Consultant Orthopaedic Surgeon in the National Spinal Injuries Unit in the Mater Misericordiae University Hospital in 1996, where he worked until 2003, during which time he was the Director of the National Spinal Injuries Unit and Chairman of the Division of Surgery.

His area of clinical expertise is hip and knee surgery, including sports surgery. He is directing clinical and translational research in collaboration with Trinity College Dublin, Dublin City University and University College Dublin. His main interests are in encouraging research interests and collaborations to allow trainee surgeons to develop their creative skills and innovation potential and improve channels of communication between surgeons with ideas and those who can help the ideas become reality.

Professor David Foley, Surgeon, Dept. of Cardiology, Beaumont Hospital

Aims and Objectives of the Irish Platform for Patients' Organisations, Science and Industry

This presentation gives and introduction to IPPOSI and the need for IPPOSI to attract more members from the medical device sector. IPPOSI facilitated a major meeting in Ireland on Clinical Research Infrastructure in May 2008, and Ms Mulroe will present the outcomes from that meeting. She will also discuss the importance of access of new treatments for patients with unmet medical needs.

Eibhlin Mulroe, CEO, Irish Platform for Patients' Organisations, Science & Industry (IPPOSI)

Eibhlin Mulroe has a BSSC Hons in Politics from Queens University Belfast and is an MBA graduate from the Smurfit Business School, University College Dublin. She spent the first half of her career to date working in Irish Politics and then the NGO sector where she worked as CEO of the Asthma Society of Ireland. Ms Mulroe moved to the private sector for a time and served as an Account Manager for MedMedia on the campaign side of the business, managing campaigns for major pharmaceutical and healthcare companies in Ireland. Since 2007, she became the first CEO of the Irish Platform for Patients' Organisations, Science and Industry (IPPOSI).

11.30   

Development and Approvals

Clinical Research is one of the most time consuming and expensive undertakings of a medical technology’s development lifecycle. The time involved in effective planning, meeting regulatory requirements, recruitment of patients and analysis of results is often underestimated. However ensuring that there is early involvement of clinicians in the design of the programme and use of expertise in dealing with the planning and regulatory matters will optimise the clinical development programme. There are also efforts required to ensure that the differences in clinical trial design of device technologies and that of pharmaceutical products are well understood by all parties including ethics committees, regulators and researchers themselves.

Kieran Ryan, Surgical Research Manager, Surgical R&D Committee, Dept of Surgical Affairs, Royal College of Surgeons, Ireland (RCSI)

As Surgical Research Manager at RCSI Kieran is responsible for the establishment of research network collaboratives across the surgical specialities. This post will provide support to surgeons and other clinicians in becoming more involved in clinical research and development of clinical practices. Kieran holds a B.Sc. in applied sciences (Chemistry & Mathematics) from the Dublin Institute of Technology and Trinity College Dublin. He undertook post-graduate research work with Sandoz Pharma AG and the Institute for Organic Chemistry, University of Basel in Switzerland. He holds a Higher Diploma in Quality in Healthcare and is completing his MSc in Healthcare Ethics and Law from the Royal College of Surgeons in Ireland.

Kieran has extensive knowledge and understanding of the Irish health care system through his experience as an Implementation Executive with the Irish Health Services Accreditation Board. As Healthcare Practice Leader for Aon Insurance Brokers, Kieran was retained by a myriad of healthcare organisations including acute hospitals, health boards, the Clinical Indemnity Scheme and long term care facilities in the development of clinical risk management and quality assurance programmes as well as conducting risk assessments and critical incident reviews and training. Prior to returning to Clinical Research at RCSI, Kieran was Director of Clinical Services at Ireland’s newest private hospitals, Hermitage Medical Clinic.

Technology Transfer at RCSI

Technology Transfer has become an increasingly important activity in recent years as governments at home and abroad focus considerable attention on the development of knowledge economies.  Effective technology transfer should begin long before the reporting of an invention so that the options for extracting value from new inventions are maximized.  Whether such inventions are to be commercialized through licensing activities or the creation of a start-up company clean unfettered access to intellectual property is a critical element to securing customers and investors alike.

Dr. Gearóid Tuohy, Technology Transfer Manager, RCSI

Dr. Gearóid Tuohy is responsible for the management of the Technology Transfer Office (TTO) at the RCSI. The TTO provides an intellectual property and business development service focused on protecting and commercializing all inventions arising from the College's academic research activities.  Prior to his appointment at RCSI, Gearóid served as Chief Executive Officer of Genable Technologies Limited, Chairman of Ibla Partners Limited and Executive Board Director of Optigen Patents Limited, three technology driven commercial entities founded and managed by Gearóid and colleagues at the Smurfit Institute of Genetics, TCD.  Gearóid has worked at the interface of business and technology development in the medical and biological sciences for over ten years, having completed graduate (B.Sc.) and post-graduate (Ph.D) degrees in Microbiology and Human Genetics at UCG and TCD, respectively. Following a doctoral thesis on novel drug development strategies in ocular disease, Gearóid worked as a Senior Research Fellow at TCD building significant research, management and commercial experience.  During the course of his research Gearóid and colleagues founded a specialty biotechnology company at TCD (Genable) developing novel therapeutics for a broad range of human diseases. Gearóid led the company in securing significant loan, seed and venture capital finance to fund in-house drug development programmes in addition to extending Genable’s IP assets through the execution of option, assignment and license agreements.  Prior to his research activities Gearóid worked in accounting and finance in both the UK and US and has specialized in Entrepreneurship as part of his MBA studies at Imperial College London.

14.00   

Regulatory Challenges and Strategies for Medical Device Entrepreneurs

Funding for innovative medical technology from the entrepreneurial sector is often linked to regulatory milestones.  To achieve these milestones i.e. demonstrate the safety and efficacy or performance for a new medical device can be a long, arduous, and expensive process.  This presentation will focus on some of the issues that early stage medical technology companies face including when to implement a quality management system (QMS), what your investors want to know about your regulatory strategy and regulatory and QMS implications of outsourcing. 

Derval O’Carroll, Director, Real Regulatory

Derval O’Carroll is a director at the Dublin based regulatory consultancy Real Regulatory Ltd.  Derval has over 18 years experience in the medical device and pharmaceutical industry.  Her medical device and IVD experience includes senior positions at multi national corporations and a number of Irish based start ups.  In her current role at Real Regulatory, Derval provides strategic advice and assists in document preparation for medical device clients.

Network and Research Funding
Each speaker will give a 15 minute presentation

Enterprise Ireland’s Mission is “to accelerate the development of world-class Irish companies to achieve strong positions in global markets resulting in increased national and regional prosperity”

Continuous technological change and innovation are among the main determinants of productivity growth in the industrial sector. Increasingly, firms need more access to sources of innovation. The third level sector can be a key provider of innovation.

This presentation will highlight the three key action areas in achieving the targets:

• Ensuring that R&D and Innovation are central to the enterprise agenda.
• Harnessing the potential of the Irish research community via Commercialisation of Research, and Technology Transfer between Research and the Market
• Industry collaboration with the Third Level sector e.g. Innovation Partnerships & Vouchers, Industry-Led Research Programs, Competence Centre Programs (EI and IDA)

Dr Liz Moran, Senior Biotechnology Analyst, Enterprise Ireland Lifescience & Food Commercialisation Group (EI Bio) Lifescience & Food Commercialisation

Liz Moran has worked as a Senior Biotechnology Analyst with the EI Bio Lifescience & Food Commercialisation Division for the past six years. Liz is currently the EI Commercialisation Specialist for a number of diverse research outputs, ranging from novel drug discoveries to innovative medical devices, from the Royal College of Surgeons in Ireland and the University of Limerick . She holds a PhD from Trinity College Dublin and a H.Dip in Technology Management from UCD Smurfit Graduate Business School . Prior to her present position, Liz was the Immunology Programme Leader at the former National Cell & Tissue Culture Centre (now the NICB), Dublin City University . 

The Growth of the Indigenous Medical Device Sector in Ireland

Ireland has one of the most significant clusters of medical device companies in the world. Alongside the cohort of the leading multinational firms, Ireland is growing a significant group of local firms with highly innovative export-led focus which play a vital role in the further development of the sector.

Enterprise Ireland and other state agencies are deeply involved in creating the right environment for furthering this development and in paving the way for a vibrant knowledge-intensive and sustained industry.

Tom Kelly, Manager of the Environment, Industrial and Life Sciences, Enterprise Ireland

Tom Kelly is the Manager of the Environment, Industrial and Life Sciences Division in Enterprise Ireland. He holds a BSc and PhD from NUIG and a Masters in Technology from the University of Sheffield, along with a Masters in Industrial Engineering from UCD.

Prior to his current position he worked as Divisional Manager in Scaling Division Enterprise Ireland and earlier managed the Technology Development Division. His earlier scientific work focused on the development of advanced ceramic materials and surface engineering applications.

Functional Lumen Imaging Probe (FLIP) - From Research Tool to Commercial Medical Device

The Functional Lumen Imaging Probe (FLIP) was invented by a pair of Irish and Danish researchers, Barry McMahon and Hans Gregersen as a research tool to look at the function of the lower oesophageal sphincter. The technology was acquired by Crospon Limited in 2007 and is being developed as a platform for diagnosis of sphincter dysfunction and how it relates to gastroesophageal reflux disease as well as other indications including bariatric surgery. This presentation outlines the steps taken to turn a research tool into a clinically and commercially relevant medical device.

Jonathan Bouchier-Hayes, Director of Business Development, Crospon

Mr. Bouchier-Hayes has over 12 years experience in the medical device industry and has held a variety of sales, marketing and business development roles for a mixture of early stage medical device companies and established distribution companies such as Autosuture, Genzyme, Advanced Surgical Concepts, Proxy Biomedical and Fannin Healthcare.

16.15

Do you need a napkin? An Introduction to Innovation Leadership

Damian argues that the confusion surrounding innovation stems from the tip of the innovation iceberg only and that what is below the surface represents the type of solid investment opportunity that global competitiveness demands.

This lively presentation peals back the two most pervasive layers of confusion and contrasts them with the high performance world of Systematic Innovation.

Damian Costello, Operations Director, Systematic Innovation

As part of his operations role, Damian is responsible for Systematic Innovation’s service strategy to ensure that the company’s own innovation agenda is in total alignment with its commercial objectives and its customer’s requirements. Since the early 1990s, the Systematic Innovation team has completed hundreds of man-years of research in perfecting the unique science that underpins all of the company’s services. 

Systematic Innovation continues to work with such innovation leaders as Boeing, BMW, Proctor and Gamble, Airbus, Siemens, Nestle etc. leading their most elite teams in predicting market behaviour from 2 to 20 years in advance and solving billion dollar technical and commercial problems.