Conference

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

Maria E. Donawa is the President of Donawa Consulting based in Rome. Dr Donawa qualified as a pharmacist and medical doctor, specializing in Pathology, before serving with the US FDA for six years. Moving to Europe in 1986, she founded a regulatory consultancy, which has grown into Donawa Consulting, with offices in Italy, Switzerland, UK and USA. The firm provides clinical research, quality management system, and regulatory affairs services to medical technology companies and is a full service European CRO.

10.00   

Changes of the Medical Device Legislation in Europe - Impact of Directive 2007/47/EC 

Directive 2007/47/EC introduces several important amendments to the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC).  The new Directive is set for transposition into national legislation in December 2008; compliance with the new requirements will be mandatory from 21 March 2010, for both new and existing CE Marked devices.  This presentation reviews what the changes mean for the medical device manufacturer, in respect of demonstrating conformity with the Directives, and offers guidance on preparing for the changes.

Kevin Webb, Head of Regulatory & QA, Mediqol

Since joining Mediqol in 2002 Kevin has managed the provision of regulatory consultancy services to manufacturers of medical devices and human tissue-derived therapeutic products including the generation and review of regulatory approval strategies, to enable timely and cost effective international market entrance of clients products and the management of applications for international regulatory approval (including compilation and submission of product dossiers, answering queries in relation to the application and liaison with international regulatory authorities).

10.45   

Clinical Implications of the Revised Medical Devices Directive (MDD 2007/47/EC)

A greater emphasis on clinical data and clinical evaluations is required with the revised MDD directive 2007/47/EC. The clinical evaluation must follow a defined and methodologically sound procedure. This presentation will highlight the key objective of the revisions with emphasis on:

• Evaluation of Clinical DataClinical investigations for class III devices & implantables Post-market clinical performance Provision to centralise data on clinical investigations in EU Databank Clarification re Medicinal products/Medical Devices Classification changes Obligations of manufacturers, notified bodies &
• Clarification the existing requirements to ensure better implementation

Dr. John O'Dwyer, Medical Devices European Manager, NSAI

John O’Dwyer is the Medical Devices European Manager for NSAI. He is a medical doctor with extensive experience in the healthcare sector including general medical professional training, anaesthesia training and broad research experience. He has many years of clinical and regulatory experience especially with high risk devices and drug-device combinations.

He has published many scientific papers, regulatory and clinical articles and has presented at many regulatory, medical and scientific meetings. He has Masters Degrees in Medicine (MMedSc) and in Business Administration (MBA). He is an affiliated member of the Faculty of Pharmaceutical Medicine and a member of the Association of Pharmaceutical Physicians in Ireland. He is also a member of the Clinical Evaluation Taskforce Committee for the EU Notified Body Experts group (NBMED).

11.30   

Changing Conformity Assessment Requirements under the MDD

Changes to the MDD will require manufacturers to review their technical documentation, post market surveillance and clinical follow-up.  New physiological definitions may change classifications.  Manufacturers and Notified Bodies will be affected by the changes and the timescales for all parties will be set out

Norman Richardson, Senior Medical Device Specialist, Medical and Health Services, TÜV Product Service

Norman Richardson BSc (Eng), MIEE is a Senior Medical Devices Specialist, Medical & Health Services at TÜV Product Service Ltd. Norman Richardson completed an honours degree in Electrical Engineering before starting work as a Senior Physicist at the National Hospital for Neurology and Neurosurgery in London.  Norman gained experience in the design of equipment for neurological diagnosis, surgery and research before moving on to design patient monitoring equipment.From 1974 to 1995 Norman worked as a Principal Engineer for the Department of Health (now the MHRA) where he was a specialist in the safety and efficacy of medical equipment used in critical, coronary, intensive and baby care environments and in some surgical procedures (ophthalmological, dermatological, dental and neonatal surgery).  Further specialist areas of expertise included infusion systems, electrodiagnostic equipment and in the electrical safety of medical equipment for the professions supplementary to medicine such as chiropody, optometry, physiotherapy and for pathology laboratories.  This role included auditing manufacturers, investigating adverse incidents, publishing Hazard Notices and Safety Bulletins for the UK Health Service and speaking at conferences and to Institutes. After leaving the Department of Health Norman spent five years managing two UK medical device Notified Bodies (including the set-up of one of these).  This was followed by five years as the European Regulatory Affairs Manager and Corporate Auditor for an American multinational.
 
Norman joined TÜV Product Service, in 2008 as a Senior Medical Device Specialist where he is also updating his Notified Body auditor training.

Norman is a Member of the Institution of Engineering and Technology (formerly the IEE).

12.25   

Open Q&A (with morning speakers)

12.45   

Lunch

Use Error vs. Abnormal Use. Scenarios for Medical Devices. Implications for Reporting

The revised guidance for  Vigilance in the EEA ( Meddev 2-12-1 Rev5)  supporting the medical device directives has introduced reporting criteria for incidents derived from user error and abnormal use. The presentation will explore the difference  between use error and abnormal use by reviewing practical examples and  will explain implications for reporting.

Sarah Barrs, Manager Regulatory Affairs International, Abbott Vascular

Sarah Barrs is the Manager for Regulatory Affairs International at Abbott Vascular and has 18 years experience working in the Medical Device industry, holding several positions in R&D, Quality Control, Reliability Engineering, Quality Assurance and the last ten years in Regulatory Affairs and Compliance.

Sarah has a degree in Mechanical and Manufacturing Engineering and is a Member of the Chartered Quality Institute and is an IRCA (International Register of Certificated Auditors) registered Auditor.

14.45   

Break

US and Europe: Intelligent Strategies for Addressing the Differences

Fortunately, there are similarities between US and European device regulatory requirements; however, important differences exist, such as those related to medical device classification, regulatory reviews of technical documentation, and requirements for clinical data, technical documentation, quality system, design controls, software validation, and inspection and auditing activities. This presentation will provide practical advice on effective strategies for addressing these differences.

Maria Donawa M.D., President, Donawa Consulting

Maria E. Donawa is the President of Donawa Consulting based in Rome. Dr Donawa qualified as a pharmacist and medical doctor, specializing in Pathology, before serving with the US FDA for six years. Moving to Europe in 1986, she founded a regulatory consultancy, which has grown into Donawa Consulting, with offices in Italy, Switzerland, UK and USA. The firm provides clinical research, quality management system, and regulatory affairs services to medical technology companies and is a full service European CRO.

510(k)s: Process and Pitfalls

The range of specific and general guidance documents, forms, and on-line activities needed for the preparation of 510(k)s has grown rapidly in recent times. This presentation will cover the latest 510(k) guidance and requirements and provide practical advice on preparing 510(k) submissions, helping delegates to avoid common pitfalls that may lead to unnecessary delays in obtaining FDA 510(k) clearance.

Roger Gray, Director, Global Regulatory Affairs, Donawa Consulting

Roger Gray, BSc, CEng, MIMechE, is the Director of Global Regulatory Affairs at Donawa Consulting. Mr Gray has 30 years' experience in the medical device industry, following a period in R&D consultancy. Working in the minimally-invasive and electromedical fields, Mr Gray has been responsible for quality system development and implementation, from BS 5750 through US QSR to ISO 13485:2003, as well as US and European device market clearance. In his present role, Mr Gray is responsible for assisting clients with US and European regulatory and quality system issues, together with managing the company's Authorized Representative portfolio.

16.30

End

Sharon  has held a number of other senior roles held within IBEC including; Technical  Directorships  of  Pharmachemical  Ireland,  the  Irish Chemical Marketers  Association,  the  Services  Council and has also practiced as a Human Resources Executive.  Before joining IBEC in 1996, she worked in Élan Corporation as a Validation Engineer for a number of years.

A  founding  member of the Irish Medical Technology Council, Sharon is also the a member of the Association of Secretaries General in Eucomed and EDMA, a  member  of the Healthcare Advisory Committee for the National Standards Authority  of  Ireland  Healthcare  Forum  and the National Health Strategy Consultative Forum.

10.00   

Clinical Trial Infrastructure in Ireland and ICRIN’s Role in Networking Clinical Researchers

Recent substantial investment by the government indicates a long-term commitment to the development of research infrastructure in Ireland. This presentation will address why the issue of clinical research is being hampered for a variety of reasons and the role of the Irish Clinical Research Infrastructure Network (ICRIN) under the umbrella of Molecular Medicine Ireland (MMI) to promote harmonisation of training, tools and practice in all aspects of clinical research in order to support academic and industry sponsors in clinical research in Ireland.

Siobhan Gaynor, Senior Associate, Irish Clinical Research Infrastructure Network (ICRIN)

Siobhan joined ICRIN/Molecular Medicine Ireland from the all-Ireland Cooperative Oncology Research Group (ICROG) where she was Quality and Training manager. Siobhan has over 14 years experience in clinical trials, in industry, academia and in the contract research sector.  Siobhan is an experienced Good Clinical Practice trainer and auditor and has experience of monitoring and managing multinational trials in a number of disease areas.  Siobhan has also worked as a research pharmacologist in the UK for a multinational pharmaceutical company. Siobhan is a graduate of Trinity College Dublin and has a degree in Physiology.

10.45   

Challenges Faced by Medical Device Start-up Companies in Ireland

This talk will broadly address many of the difficult situations and decisions facing the would-be Entrepreneur and will briefly cover areas such as; selecting the right idea, Intellectual Property, management, funding and planning for exit.

Dr. James Coleman, MCh, FRCS, MBA Chairman and Chief Executive Officer, Trinitas Ventures Limited

In November 2005, Dr. Coleman co-founded Trinitas Ventures Limited a medical device research and development incubator based in Citywest, Dublin, Ireland. Vasorum Limited is the first company to be spun out of Trinitas Ventures and is focused on developing products for the interventional cardiology market. AltaScience Limited is the second company presently being spun out of Trinitas Ventures and is focused on a new hysteroscopic gynaecological procedure.

Prior to founding Trinitas Ventures, Dr. Coleman co-founded Nova Science Limited (Interventional Cardiology) in 1999 which was acquired by Abbott Vascular in February 2007. In parallel with the founding of Nova Science, Dr. Coleman also co-founded Chiroxia Limited which was a joint venture with Henkel-Loctite developing a biocompatible cyanoacrylate technology for medical applications.

11.30   

New Technology Development Process

The process by which new technology is defined, developed and ultimately transferred into the new product development and commercialisation cycle is critical to the overall success of a product. Organizational structure can inhibit or foster creativity and innovation. This presentation will discuss how the Stryker approach to technology development offers a structure within which the creativity of the concept development process can be managed. 

Hilda Mulvihill, Business & Process Development, Stryker Orthopaedics

Hilda Mulvihill is a member of the Business & Process Development team at Stryker Orthopaedics, Limerick. Prior to joining Stryker, Hilda worked at Medtronic Vascular in Galway. She has a broad range of experience across a number of R&D projects and has also been granted a number of patents for her work. Hilda holds Ph.D. in Biomaterials from the University of Limerick and is a certified project manager (PMP).

12.45   

Lunch

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

Based in Boston Scientific Galway, Terry has been working on DES program management for the past three years.  Prior to this Terry worked for Biocompatibles for nine years in the UK on a range of medical device development projects in applications from coronary stents to embolisation technologies. Terry graduated with a PhD in Biomedical Polymers/Chemistry from the University of Surrey, UK.

Medical Device Materials: Thinking Beyond Stainless Steel and Nitinol

This presentation addresses some of the non-traditional material solutions available to designers. These alternatives can provide better tuning of mechanical performance, corrosion resistance, imaging behaviour or tissue response. Cobalt-chromium alloys, titanium alloys, refractory metals and biodegradable metals are reviews as well as a variety of metallic and inorganic coatings.

Barry O’Brien, Medical Device Materials Consultant

Barry has over 20 years material science and engineering experience with over 12 years in the medical device industry. Previously he worked as Principal R&D engineer at Boston Scientific. He has experience with device materials and coatings, from orthopaedic implants through to a variety of cardiovascular devices including stents, filters and aneurysm coils. He is the named inventor on approximately 20 medical device patent applications and has over 12 papers presented in peer-reviews journals and conferences. Barry is also a member of American Society of Metals (ASM) and a certified member of Project Management Institute (PMI).

14.45   

Break

Use Error for Medical Devices - How Far Should We Going Analysing These?

The analysis of use errors and their root cause is linked with the concept of usability of a medical device. Means of prevention and implications for product design and continuous improvement are reviewed by a manufacturer.

Sarah Barrs, Manager Regulatory Affairs International, Abbott Vascular

Sarah Barrs is the Manager for Regulatory Affairs International at Abbott Vascular and has 18 years experience working in the Medical Device industry, holding several positions in R&D, Quality Control, Reliability Engineering, Quality Assurance and the last ten years in Regulatory Affairs and Compliance.

Sarah has a degree in Mechanical and Manufacturing Engineering and is a Member of the Chartered Quality Institute and is an IRCA (International Register of Certificated Auditors) registered Auditor.

Overview of a Product Development Process - From Concepts to Commercialisation

Neil McKenna, Project Manager, PMP, Boston Scientific

16.30   

End