Conference

09.30 Registration & Coffee

Session 100 – Regulation

09.50 Chair
Maria Donowa M.D., President, Donawa Consulting

10.00 Changes of the Medical Device Legislation in Europe - Impact of Directive 2007/47/EC 
Kevin Webb, Head of Regulatory & QA, Mediqol

10.45 Clinical Implications of the Revised Medical Devices Directive (MDD 2007/47/EC)
Dr. John O'Dwyer, Medical Devices European Manager, NSAI

11.30 Break

12.00 Changing Conformity Assessment Requirements under the MDD
Norman Richardson, Senior Medical Device Specialist, Medical and Health Services, TÜV Product Service

12.25 Open Q&A (with morning speakers)

12.45 Lunch

14.00 Use Error vs. Abnormal Use. Scenarios for Medical Devices. Implications for Reporting
Sarah Barrs, Manager Regulatory Affairs International, Abbott Vascular

14.45 Break

15.00 US and Europe: Intelligent Strategies for Addressing the Difference
Maria Donowa M.D., President, Donawa Consulting

15.45 510(k)s: Process and Pitfalls
Roger Gray, Director, Global Regulatory Affairs, Donawa Consulting

16.30 End

Session 101 – R&D and Design

09.50 Chair
Sharon Higgins, Director, Irish Medical Devices Association (IMDA)

10.00 Clinical Trial Infrastructure in Ireland and ICRIN’s Role in Networking Clinical Researchers
Siobhan Gaynor, Senior Associate, Irish Clinical Research Infrastructure Network (ICRIN)

10.45 Challenges faced by medical device start-up companies in Ireland
Dr. James Coleman, MCh, FRCS, MBA Chairman and Chief Executive Officer, Trinitas Ventures Limited

11.30 Break

12.00 New Technology Development Process
Hilda Mulvihill, Business & Process Development, Stryker Orthopaedics

12.45 Lunch

After Lunch Chair
Terry Vick, Director of Program Management, Boston Scientific

14.00 Medical Device Materials: Thinking Beyond Stainless Steel and Nitinol
Barry O’Brien, Medical Device Materials Consultant

14.45 Break

15.00 Use Error for Medical Devices - How Far Should We Go In Analysing These?
Sarah Barrs, Manager Regulatory Affairs International, Abbott Vascular

15.45 End

Day Two Thursday 25th September 2008

09.00 Registration & Coffee

09.20 Chair
Steven Walfish, President, Statistical Outsourcing Services

09.30 Introduction to Environmental Regulations for Medical Devices
Catherine Kinsella, EHS Manager, Medtronic

10.15 Break

Session 200 – Strategies for Optimal Risk Management

10.25 Chair
Steven Walfish, President, Statistical Outsourcing Services

10.30 Defining and Controlling your Design: Setting Yourself Up for Success!
Gary Fahey, Design Control Manager, Abbott Ireland

11.15 MES - The Benefits to Compliance and Operations Management. How eManufacturing Mitigates Risk in Medical Device Manufacture
Mark McKechnie, Prinicpal Consultant, Seabrook Research

12.00 Integrating Operational Excellence and Risk Management Approaches; Tools for Achieving Breakthrough in Economic Medical Device Manufacturing  
Eoin Barry, Founder and Director, ARV Excellence

12.45 Lunch

14.00 Usability Engineering: Process and Validation - Understanding Usability Standards for Medical Devices
Niall Murphy, Consultant, PanelSoft

14.45 Robust Design to Minimize Risk – Part 1
Steven Walfish, Statistical Outsourcing Services

15.30 Break

15.45 Robust Design to Minimize Risk – Part 2
Steven Walfish, Statistical Outsourcing Services

16.30 End

Session 201  - Innovation

10.25 Chair
Michael Loftus, Consultant, Loftus Consulting

10.30 Strategic Change – Alignment with Opportunities
Michael Loftus, Consultant, Loftus Consulting

11.00 Understanding the Clinical Needs
Each speaker will give a 10/15 minute presentation
Professor John O’Byrne, Consultant Orthopaedics, Cappagh National Orthopedic Hospital
Professor David Foley, Surgeon, Dept. of Cardiology, Beaumont Hospital
Eibhlin Mulroe, CEO, Irish Platform for Patients’ Organisations, Science & Industry (IPPOSI)

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

12.25 Open Q&A (with morning speakers)

12.45 Lunch

13.45 Technology Transfer at RCSI
Derek Young, Head of Surgical Innovation Centre, Royal College of Surgeons in Ireland

14.15 Regulatory Challenges and Strategies for Medical Device Entrepreneurs
Derval O’Carroll, Director, Real Regulatory

14.45 Network and Research Funding
Each speaker will give a 15 minute presentation
Dr Liz Moran, Senior Biotechnology Analyst, Enterprise Ireland Lifescience & Food Commercialisation Group (EI Bio)
Tom Kelly, Manager of the Environment, Industrial and Life Sciences, Enterprise Ireland
Richard Hendron, Manager Medical Technologies Division, Industrial Development Agency (IDA) Ireland

15.15 Break

15.30 Functional Lumen Imaging Probe (FLIP) - From Research Tool to Commercial Medical Device
Jonathan Bouchier-Hayes, Director of Business Development, Crospon

16.00 The Science of Innovation
Damian Costello, Operations Director, Systematic Innovation

16.30 End