Conference Programme

10.40

Chair’s Opening Address
David Purcell

10.45

UK Position on Current Medical Device Issues

• Revision of Directives
• Re-Use of Single Use Products/Reprocessing
• Advanced Therapy Products/Tissue engineering
• New Approach Review

Mika Reinikainen, Managing Director, Abnovo Ltd

Mika has recently set up his own medical device consulting company, Abnovo Ltd. He previously headed Quintiles Consulting Europe. He provides consulting advice on regulatory strategy, crisis management, enforcement of compliance and determination of borderlines between legal regimes. He has more than 28 years of experience managing European medical regulatory affairs in industry, as healthcare legal counsel in a law firm and as a regulatory consultant. He has also been involved directly in the development of the Medical Devices Directives (as Consultant to the European Commission and through trade associations) and of technical standards (former Chairman of CEN TC 257). He is a founder and Chairman of the European Association of Authorised Representatives (EAAR). He is a former Vice President Europe of the Regulatory Affairs Professionals Society (RAPS). He holds a Master’s degree in law from the University of Nice (France) and a Master’s degree in Business Administration from Wharton (University of Pennsylvania, USA).

11.30

MDD and AIMD Review – An Industry Perspective

• Timetable
• Main new requirements for the MDD
• Main new requirements for the AIMD
• Overall EUCOMED judgment on the modifications
• What’s coming next?

Dario Pirovano, Consultant, Director Regulatory Affairs, EUCOMED

Dario Pirovano is an engineering, mechanical and biomedical doctor. He has worked in industry for 8 years (R&D and regulatory in the anaesthesia, IC and neonatal care sector), and then in the Commission of European Communities with responsibility for drafting and negotiating 90/385 and 93/42 directives. He also has 10 years consulting experience on regulatory matters helping industry, notified bodies and authorities.  Since October 2002, he has been a consultant to EUCOMED with responsibility as Director Regulatory Affairs

12.15

Revision of the New Approach and Consequent Effect on Medical Device Legislation

• The objectives of the new approach revision
• The draft Regulation on accreditation and market  surveillance
• The draft decision on a common framework for the marketing of products
• The impact of the regulation and decision on the medical device legislation
• Next steps

Jos Putzeys, Manager, JKN Consult

13.00

Lunch

14.00

Re-use of Single Use Medical Devices

• Reuse of single use medical devices
• Revision of the medical devices directive
• Status in EU member states and USA
• Design of single use vs. multiple use devices
• A reality check: studies on refurbished single use devices

Peter Schroeer, Director Quality Systems and Regulatory Affairs, Ethicon Endo-Surgery (a Johnson and Johnson company)

Peter Schroeer is a chemical engineer and Director Quality Systems and Regulatory Affairs at Ethicon Endo- Surgery (a Johnson and Johnson company) for the EMEA region. He started his career in the chemical Industry where he served as a production manger. In the medical devices Industry he set up manufacturing and servicing structures for active and passive medical devices, lead QS certification programs according to ISO 9000 and ISO 13485. He is a certified EOQ (European Organisation for Quality) Quality Manger and ISO 9000 auditor and he is a member of the BVMed Reuse Task Force and chairman of the EUCOMED reuse task force.

14.45

Break

15.15

Revised Sterilisation Standards – What a Notified Body Expects To See For Validation Reports

• Introduction to the main sterilisation standards ISO11135, ISO11137 and ISO17665
• Overview of the changes to the structure of the standards
• Validation protocols
• Validation reports
• Regular review of sterilisation process by manufacturer
• Common non-conformities found at Notified Body audits

Henry Sibun, Manager - Medical and Health Services, TÜV Product Service

Henry Sibun started working for TÜV Product Service in 1998.  He is a Lead Notified Body Auditor and during this nine year period he has conducted hundreds of audits of medical devices companies in Europe and America.  In 2003 he became Manager of the UK Medical & Health Services audit team of TÜV Product Service.  His areas of expertise include the Medical Devices Directive, non-active medical devices, sterilisation, microbiology and quality management systems.

16.00

Environmental Compliance for Medical Devices

• Pressures on the environmental impacts of  products
• Overview of environmental legislation & standards  directed at products
• Impacts on business
• Possible compliance systems
• Likely future requirements

Professor George Howarth, formerly Technical Director of Smith & Nephew Consumer Products and also Director of Group Environmental Affairs. Currently Chairman of the ABHI Environment Business Compliance Forum and Member of the EUCOMED Environmental Focus Group

Professor George Howarth has spent most of his career with Smith & Nephew – first as Technical Director of Smith & Nephew Consumer Products and then as Director of Group Environmental Affairs - with environmental responsibilities within Smith & Nephew since 1991 covering more than 30 manufacturing sites world wide.

George is also Chairman of the Association of the British Healthcare Industries (ABHI) Environment Business Compliance Forum, a Member of the EUCOMED Environmental Focus Group and various associated working groups since EFG was formed in mid 90’s.  In October 2000, George was appointed Royal Academy of Engineering Visiting Professor on Sustainable Development in Engineering Design within the School of Design, Engineering & Computing at Bournemouth University.

16.45

Chair’s Closing Address

17.00

End of Day One

10.40

Chair’s Opening Address
James Pink, Head of Business Development, BSI Global

James Pink joined BSI healthcare from Symmetry Medical European Operations where he was European Director of Engineering and Regulatory Affairs. Prior to that he was with BSI as a medical device Lead Assessor, Qualifying Reviewer and Medical Devices Lead Tutor for a range of medical device related assignments and courses.  James has over 10 years experience in medical device regulation first being introduced as an Engineer within Medical Physics at the Royal Hallamshire Hospital, Sheffield, England.

10.45

Opportunities and Issues around conducting Medical Device R&D in Europe

• Complexity of medical device R&D in globally competitive environment
• Clinical trial environment and access to clinical networks
• Opportunities for funding R&D in Europe
• European Technology Platforms
• Support mechanisms to connect people and finance

Sue Dunkerton, Director, Health Technologies Knowledge Transfer Network

Sue Dunkerton CEng, FIMMM, BSc, is Business Manager at TWI Ltd (one of Europe’s leading Research & Technology Organisations); Director of the DTI supported Health Technologies Knowledge Transfer Network and Director of Medilink East, a regional medical device support organisation.  With over 25 years experience in materials and advanced processes across the medical, electronics and sensors sectors, Sue has been actively engaged in knowledge transfer and supporting innovation.  Sue has been an active participant in the UK Health Industries Task Force, working alongside ABHI, DTI, Department of Health, and the NHS Institute for Innovation and Improvement. 

11.30

Risk Management – Product, Process, Business

• Overview of Risk Management Tools
• Adopting a Risk Management Process (Product and Process)
• Integrating Risk Management from design to process
• Evaluating the effectiveness of your Risk management Process

James Pink, Head of Business Development, BSI Global

12.30

Lunch

14.00

In-vitro Corrosion Testing of Medical Implants

• Pitting and Crevice Corrosion
• Cyclic Polarization Testing
• Long-term Potential Monitoring
• Interpreting the Results

Nigel Corlett, Managing Scientist, Exponent

Nigel Corlett is a Corrosion Scientist with Exponent International and specializes in the degradation of metals and alloys, corrosion and electrochemical testing, and materials-related failure analysis.  He provides consulting services to medical device and implant manufacturers, including corrosion testing and the evaluation of pitting corrosion and crevice corrosion susceptibilities.  After 10 years working with Exponent in California, Dr. Corlett has recently returned to the United Kingdom and is based in Harrogate.

14.45

Basic Principles in Biocompatibility Testing

• ISO 10993 description
• Biological safety of medical devices
• screening of materials
• In vitro and vivo testing
• Managing process
• Material changes from a biocompatibility standpoint

Dr Gaëlle Clermont, Scientific Manager, Biomatech – NAMSA

Dr Gaëlle Clermont is Scientific Manager for special functional studies at Biomatech. With specialized expertise in vascular products evaluation, Dr Clermont has been involved in several European research programs including those related to tissue engineered techniques.

15.30

Break

15.45

Design Transfer to Manufacturing

• To follow
• To follow
• To follow
• To follow

Richard Walker, Director, Quintiles Global Consulting

Richard Walker is responsible for business development and provides consulting services within the new Global Consulting organization of Quintiles. He has more than 25 years of practical experience in the high compliance medical device and pharmaceutical industries including manufacturing, R&D and QA/RA management of start-ups, SMEs and major corporations. Previously, he has held positions in Diomed, Medisense (Abbott), Amersham, Applied Photo Physics/Royal Institution, Royal Military College and Smith Kline and French.  Richard is a member of the Royal Society of Chemistry, the Institute of Management and the Institute of Directors as well as a Fellow of the Institute of Quality Assurance.

16.30

Turbo Charging Project Management of New Product Developments in R&D

• Establishing and maintaining effective teams
  • Why do projects fail?
  • What is excellent Project Leader development?
  • What skills are required by leaders and teams?
• Project start up
  • How intervention in a team can optimise efficiency and performance
• Working with uncertainty – Risk Management, a key differentiator for success
  • Tools and techniques
  • Establishing a culture of risk management

Stephen Clegg, Senior Project Director, Medical Diagnostics, GE Project Management

17.15

Chair’s Closing Address

17.30

End of Day One

09.15

Chair’s Opening Address
Eoin Barry, Managing Director, ARV Excellence

Eoin Barry developed the MDLeanSigma© Programme and co-founded ARV Excellence. Eoin has worked with leading manufacturing and medical device organisations including AlliedSignal Turbo-charging Systems (Honeywell), Howmedica International (Stryker), Boston Scientific and Guidant in research and senior engineering roles.  Eoin certified as a black belt with AlliedSignal in 1996. Eoin has experience in medical devices include orthopaedic implants, cardiac rhythm management devices, stents and catheters.

09.30

Process Validation Master Planning

• Validation master planning
• Identifying Hazards
• Identifying critical control points
• Establishing critical limits: Advanced tools
• Documenting the master plan
• Verification and record keeping
• Sources of information for preparing plans

Eoin Barry, Managing Director, ARV Excellence

10.15

Clinical Evaluation – Meeting the EU Clinical Data Requirement for Medical Devices using the Literature Route

• Clinical evaluation of medical devices and update of the regulatory requirements pre and post CE mark
• New MDD requirements
• Critical literature process - requirements for conduct of clinical investigations
• Challenges with combination products

Danielle Giroud, Founder and CEO, D-Target

Danielle Giroud started her career in the Medical Device Industry in 1987 as a Product Manager for vascular stents for Schneider, Europe. She subsequently worked for Serono and Collagen Inc. Danielle is an active member of the ISO 14155 'Clinical investigations for medical devices' and 'clinical investigation plan' working group. In 1997, she founded d-TARGET, a clinical research organization specializing in medical device clinical trials in Europe.

11.00

11.15

Risks, Design and Validation Aspects in an Automated Production

• Presenting a case: an automation project where software for controlled production was implemented
  • Risk analysis methodology
  • Main design aspects for an automated production system
  • Structure and content of software validation
  • Tracing between risks, design and validation

Ulrika Siösteen, Solutions Director, Compliant Logistics

Ulrika Siösteen is a senior project manager of applications in the areas of automated production equipment within the pharma and medical industry. She is solutions owner of Compliant Logistics platform “Pharmasuite” and “Electronic Batch Report”

12.00

Software Validation - Understanding and Meeting the Requirements of the Revised Medical Devices Directive

• The update to the Medical Devices Directive (MDD) which extends the scope to specifically include software in its own right
• Examples of software products that may be considered medical devices under the updated MDD
• The resulting quality system implications for software development organisations
• The validation requirements for a software medical device

Steve Grundy, Founder, Parachute Consultancy Services and Jed Place, Founder and Principal Consultant, Medical Device Technology Consultants

Steve Grundy has been employed in the in vitro Diagnostics Industry for over 25 years, holding managerial roles in reagent product development, software development, software QA and IT.

For the last 5 years, through his company, Parachute Consultancy Services Limited, he has been providing consultancy services to small and medium sized diagnostic companies in the fields of risk analysis, software development and software and systems validation.

Jed Place is the founder of Medical Device Technology Consultancy, a specialist consultancy that provides a range of services to the medical devices and drug delivery industries. Specific strengths are in the fields of regulatory affairs, quality systems and technology (product development and manufacturing).

Recent major assignments include regulatory consultancy and project management for a new glucose monitoring device for global markets; the development and implementation of a quality management system for a leading pharmaceutical company across multiple sites; definition and implementation of a Validation Master Plan covering multiple processes for a medical device manufacturer to FDA requirements.

12.45

Lunch

14.00

Lean Product Development

• An explanation of Lean principles, and a brief summary of the history of Lean
• How to apply the Lean philosophy to product development - which aspects work and which don't
• Case studies to illustrate the key points
• Hints and tips to help make Lean work in practice

Stewart Fox, Managing Consultant - Product and Process Engineering Practice, PA Consulting

Stewart Fox is a Managing Consultant with PA's Product and Process Engineering Practice.  He is a mechanical engineer with broad experience in the development of industrial and healthcare products and particular expertise in medical device development. He has managed large, multidisciplinary development projects in the areas of minimally invasive surgery and cardiology, and completed several consultancy assignments in drug delivery, diagnostics and R&D efficiency.

14.45

Decreasing Product Release Times

• Quality by Design
• ICH Q8 and Design Space
• When is Design of Experiments Appropriate
• How to budget experiments to best utilize your data
• How does Risk Management Impact Release Times

Steven Walfish, President, Statistical Outsourcing Services

Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to variety of industries.  Prior to starting Statistical Outsourcing Services,   Steve was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD.  Prior to joining HGS, he was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry. He brings over 18 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting.  Mr. Walfish has held positions with Johnson & Johnson and Chiron Diagnostics where he worked with large data sets for monitoring process data.

15.30

Break

15.45

CAPA: How to Measure System Effectiveness

• It starts at product design.
• Root Cause analysis
• Measuring system issues
• Post Market Data analysis
• Tools and Techniques

Steven Walfish, President, Statistical Outsourcing Services

16.30

Chair's Closing Address

16.45

End of Conference

Before 12 January

Reg Fee

VAT

Total

After 12 January or on-site

Reg Fee

VAT

Total

09.15

Chair’s Opening Address
Dr Stephen Blatcher BEng CEng PhD, Principle Engineer, Drug Delivery Group, PA Consulting

As a Principal Consultant in PA Consulting's Drug Delivery Group, Stephen has led a number of programmes to help companies understand the opportunities and risks associated with developing combination products. He has delivered process solutions for manufacturing drug eluting implants and managed the technical risk on the development programmes of a number of biotherapeutic delivery devices.

09.30

Biological Medical Devices

• Animal tissue use in products
• Human tissue engineering
• Why regulation can now aid development processes
• Implications for product timescales

Phil Brown, Director, Regulatory Affairs, QA and Reimbursement, Wright Medical Technology

Phil Brown started his career with Smith and Nephew. Trained as a chemist, Phil progressed to work within the regulatory department where he covered woundcare, orthopaedics and tissue engineered materials and products.  He moved to Genzyme Biosurgery in 1998, again responsible for the human and animal tissue programmes as well as absorbable medical devices.  He has latterly worked as a consultant with both Quintiles Consulting and D-Target specialising in new technologies and borderline materials, before taking up his present role within Wright Medical Technology.  Phil currently chairs the Advanced Product working groups in both ABHI and EUCOMED.

10.15

New Polymeric Biomaterials with Built-In Surface Modifiers

The use of molecular self assembly to create well-defined surfaces has become an important research method in ‘two-dimensional nano-technology’.  A reactive group binds to the surface, ‘spacer chains’ then line up through intermolecular interactions to present a well-ordered outer layer of ‘head groups’.  Head groups can be chosen from a wide range of passive, reactive or biologically-active groups to obtain enhancement of a variety of surface properties including biostability, lubricity, anti-microbial activity, thromboresistance, drug delivery and selective binding.  New polymeric biomaterials that can be processed by extrusion and molding and other high-volume methods favored by device manufacturers consist of familiar polymer backbones with Self-Assembling Monolayer End Groups (SAME™).  These specially-designed end groups resemble the monomers used in self-assembling monolayer research where the monomers are deposited from solution onto a (gold-plated) substrate where they form a layer one molecule in thickness.  SAME polymers, on the other hand are chemically bonded to the self assembling end groups during polymer synthesis.  Every polymer molecule may contain two or more end groups capable of migrating to the surface of a device and spontaneously assembling there.  For this reason the surfaces can be self healing.  An added advantage is that most SAME-modified polymers can achieve the desired surface modification without the need for post-fabrication coatings or surface treatments.  The potential applications for SAME-modified polymers in medical products are numerous including diagnostics, disposable and implantable devices, and many therapeutic and prosthetic uses of biomedical polymers.

Robert S. Ward, President/CEO, The Polymer Technology Group 

Robert Ward is a chemical engineer and president/CEO of The Polymer Technology Group (PTG) in Berkeley, California, a company he founded in 1989.  PTG’s business includes custom synthesis, and the R&D/manufacturing of biomaterials, specialty polymers and medical devices.  PTG uses a vertically-integrated approach ranging from molecular design to the cleanroom manufacturing of devices.

Robert has applied a similar approach over his 33-year career in biomaterials, including 10 years at Thoratec Corporation, and 7 years at Avco Medical Products, where he produced Avcothane-51, one of first polyurethanes ever developed as a biomaterial. He has developed a wide range of medical devices and patented polymer compositions that are currently in clinical use. These include many chronically-implanted biomaterials and components for cardiovascular, urological, ophthalmic and orthopaedic applications.

Robert won the 2003 Technology Innovation and Development Award from the Society for Biomaterials.  In 2004 he was named one of the 100 most notable people in the medical device industry.

11.00

Break

11.15

Enabling Technologies for Future Orthopaedic Surgical Processes

• Imaging
• Supply chain changes
• Navigated surgery
• Robotics
• Enhanced vision 
• Other enabling technologies

Alan Ashby, Vice-President Global Concept Development, DePuy

Alan Ashby has spent the last twenty years working in orthopaedic product development, initially for Howmedica (part of Pfizer, and now part of Stryker), including 2 years each in Ireland and France, and eventually becoming their European Director of Development. Alan has worked for Johnson & Johnson since the end of 1996; his first role was as Director of European R&D and New Business Development for the Professional Products Franchise, which included Orthopaedic and Neurosurgical products.

On the acquisition of DePuy at the end of 1998 he became Vice-President of International R&D, running the international development organisation.

In 2000 he took a new role as Vice President Business Development New Technologies and was responsible for developing technologies and businesses in minimal access and computer assisted surgery, and in the emerging tissue-engineering field. 2002 saw the creation of a new internal venture business called iOrthopaedics to commercialise computer assisted surgery products and he became responsible for the operations and R&D of that new business.

Since the beginning of 2005 Alan has held the position of VP Global Concept Development with responsibility to research, develop, quantify & champion technology derived business development opportunities & concepts that have applicability across the multiple franchises of the business (Orthopaedics, Trauma, Spine, Sports Medicine, Neuro-surgery).  This includes the development of a new analysis and development group to incubate new business concepts; business development, licensing, acquisition and co-development activities, and creating the process with business franchise management to develop strategic innovation plans and objectives that can be used to align long range product and service objectives and related technology plans.

He is also a director of Medilink a non-profit organisation for the promotion and development of the health care industries in Yorkshire and Humberside.

12.00

The Use of RF Technology in Healthcare - Past, Present and Future

• Overview of RF technologies
• Benefits of using RF
• Enabling RF technologies
• Design considerations

Peter Morgan, Managing Consultant, PA Consulting 

Peter Morgan works within PA's Applied Technologies group where he is responsible for the application of new technologies in the field of medical devices.  He has worked across the medical device spectrum encompassing implantable devices, diagnostic probes through to point of care diagnostics.

12.45

Lunch

14.00

Imprinted Polymers - A New Medical Material

• Sensors based on Molecularly Imprinted Polymers
• Biocompatibility and biofilm formation
• Detoxification materials
• Non-invasive diagnostics and imaging

Professor Anthony P F Turner, Director, Cranfield Ventures, Cranfield University

Professor Turner’s name is synonymous with the field of Biosensors.  Formerly Principal of Cranfield University at Silsoe, he returned to full-time research in February 2006 and is now a Distinguished Professor of Biotechnology in Cranfield Health, a new school Cranfield University.  He has edited the principal journal in the field, Biosensors & Bioelectronics, since its foundation in 1985 and edited the first textbook on Biosensors in 1987.  He founded the World Congress on Biosensors in 1990 and has chaired it since then. In addition to his academic activities, Tony Turner has held a range of commercial positions continuously since 1982, commencing with Project Director for MediSense’s in vitro diagnostics programme.  In this role he led the team that invented, designed and developed the world’s most successful type of biosensor, the mediated amperometric enzyme electrode for glucose.  He continues this commitment to innovation today as a Director and Chairman of the Scientific Advisory Board for Pelikan Technologies in Palo Alto

14.45

Microelectronics Medical Devices meet Consumer Electronics: Bringing the Economies of Scale of the Semiconductor Industry to Healthcare

• Delivery of products with increased processing power and functionality within the consumer electronics industry by CMOS semiconductor technology scaling
• Capabilities of current and future nanoscale semiconductor processes
• How semiconductor technologies can bring similar economies of scale to healthcare
• Enabling new healthcare systems and devices which improve patient care and quality of life

Alison Burdett, Director of Technology, Toumaz

Alison Burdett received her BEng (Hons) degree in 1989 and her PhD in 1992, both from the Department of Electrical and Electronic Engineering, Imperial College of Science, Technology and Medicine, London, UK.  From 1992-1994 she worked as an integrated circuit design engineer for GEC-Plessey Semiconductors.  In 1994 she joined the Department of Electrical and Electronic Engineering, Imperial College, London, as Senior Lecturer in Analogue Circuit Design.  In 2001 Dr Burdett left Imperial College to co-found Toumaz Technology Ltd, a spin-out company from the university involved in ultra low power and RF integrated circuit design, where she is currently Director of Technology at Toumaz Technology.  Alison is a Chartered Engineer, a Fellow of the Institute of Engineering and Technology (FIET) and a Senior Member of the Institute of Electrical and Electronic Engineers (SMIEEE).  She has published over 60 refereed technical publications and holds 10 patents.

15.30

Break

15.45

Molecular Imaging: Emerging Concepts and Their Clinical Applications

• Molecular imaging (MI) defined as the in vivo characterization and measurement of biologic processes at the cellular and molecular level
• Advantages of MI over conventional imaging,
  • assisting clinicians in diagnosing disease earlier
  • directing site-specific therapy, monitoring treatment and aiding in prognosis.
• Collaboration and development of ever more sophisticated imaging techniques and compounds
• This talk will describe developments in the field and give examples of some of the latest achievements in MI

Professor S Homer-Vanniasinkam, Consultant Vascular Surgeon, The General Infirmary at Leeds & & Professor of Translational Vascular Medicine, University of Bradford

Professor Shervanthi Homer-Vanniasinkam was appointed Consultant Vascular Surgeon at The General Infirmary at Leeds in October 1995 and was awarded a Personal Chair in Clinical and Experimental Vascular Research by the University of Bradford in June 1998.  In 2006, she was appointed to the first Chair in Translational Vascular Medicine at the University of Bradford.

In addition to her clinical work as a full-time vascular surgeon, she is actively involved in a number of basic, applied and translational research projects.  She has successfully implemented a multidisciplinary research programme within the hospital and the universities of Bradford and Leeds. She has also been the
principal investigator for many clinical trials, both investigator-initiated and based at Leeds General Infirmary and other multi-centre studies.

More recently, Professor Homer-Vanniasinkam has been associated with emerging technology projects and is keenly interested in the medical applications of these technologies; she has been appointed as the first Chair of the UK Nanomedicine Network which is being set up by the Institute of Nanotechnology

16.30

Chair’s Closing Address

16.45

End of Conference