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Working together in Ireland

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  1. Doing Business in Ireland Sharon Higgins Director IMDA The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress Harvard University 29 March 2007

  2. Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  3. Why do business in Ireland? • Because Ireland has and continues to ‘do the business’ for companies operating here • Don’t take my word for it…… Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  4. Trajectory of Ireland’s Economy 1988 1997 2004 Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  5. 1,000 overseas companies have chosen to invest in Ireland as their European base ICT Pharmaceuticals Medical Devices Financial & International Services E-business Engineering Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  6. Ireland - The knowledge Economy • Free and pro business economy especially for foreign business • 3rd of 157 (2006 index of economic freedom) • A quality education system • – 4th of 60 IMD World competitive framework • 5th for level of university education attained • A dynamic information infrastructure • Lowest leased line costs in the OECD • Innovation systems • Science Technology and Innovation Strategy • Science Foundation Ireland Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  7. ‘Ahead of the Curve’ - Enterprise Strategy Group Comparative Advantage Competitiveness Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  8. Medical Devices and Diagnostic Sector in Ireland

  9. Medical Technology Companies in Ireland Abbott Vascular Devices Accellent Aerogen (Nektar) Beckman-Coulter Bioniche Lifesciences Inc Boston Scientific Brivant* Caragh Meditech* Contech Medical Creganna* Labcoat Goodman Medtronic Merit Medical Micron Clean* Nelipak Tyco (Puritan Bennett) Ulbrich Xenith Biomed Zerusa* Letterkenny Perfecseal Institute of Technology Boston Scientific (IVT) Medisize (DHC) Zeus Industrial Products Northern Ireland Abbott Diabetes Moll Industries Ireland Sligo Institute of Technology National Tool-making Centre Abbott - 3 plants Amcor Flexible Andrew Medical Hospira Lotus Automation* Pro-Tek Medical* Sligo B Braun Hospicare Charles River Hollister Biomedical Diagnostics Institute Dundalk Abbott Cavan Institute of Technology Baxter Healthcare - 2 plants Fort Wayne Metals The Conway Institute of Biomolecular and Biomedical Research BBE Healthcare Endura Coatings ANSAmed* Innocoll Technologies Allergan - 2 plants AMO Isotron (Gammaster) Field Boxmore National Pharmaceutical Biotechnology Centre Vistamed* Harmac Abbott B Braun Becton Dickinson Athlone Optical Conor Medsystems Elan Tyco Mallinckrodt Utah Medical Innocoll Transitions Optical De Royal Welch- Allyn DublinUniversities Dublin City University Trinity College University College Oakley National Centre for Biomedical Engineering Science National Centre for Laser Applications Athlone Galway USCI Regenerative Medicine Institute (REMEDI) Georgia Tech Irl. Institute of Technology Institute of Technology Dublin DublinInstitutes of Technology Blanchardstown Dublin Tallaght National University of Ireland Steripack* Institute of Technology Boston Scientific Isotron Midland Bandages* Tyco Healthcare Viasys (Intermed)) Cook Ireland Essilor J&J Vistakon Ophtecs Stryker Howmedica Teleflex Medical Rupp & Hubrach Olympus Essidev Vitalograph Enfer Scientific Phardiag* AMO Bayer Diagnostics Becton Dickinson Biotrin Technologies J&J Consumer KCI Medical Nova Science Nypro Ireland Omega Teknika Smith & Nephew Specialty Coating Tech Group Trinity Biotech Tyco Biomedical & Environmental Sensor Technology Centre Oral B Allergan(Inamed) Institute of Technology Biomedical Electronics Centre Limerick University of Limerick Institute of Technology J & J Cordis Clearstream* Abbott Vascular Boston Scientific Lake Region Filtertek Listal Carl Zeiss Waters Corp. Bausch & Lomb Institute of Technology Institute of Technology Waterford Piercan Institute of Technology Microbrush Legend : University College Cork University, Institute of Technology Cork National Microelectronics (Nanotechnology) Research Centre Speciality / Research Centre Airports Alcon J&J DePuy GE Healthcare Millipore Audit Diagnostics* Stryker Instruments Boston ScientificStryker Orthopaedics Donovan Medical (Tornier) IDA Regional Offices Medical Device Companies * Indigenous Irish Companies Equipment & Diagnostics Hospital Products Orthopaedic & Implants Vascular Intervention Opthalmic / Vision Allergan (Inamed) Bio-medical Research BBE Healthcare Donovan Medical J&J DePuy Stryker Howmedica Stryker Instruments Stryker Orthopaedics Viasys (Intermed) Abbott Aerogen Bayer Diagnostics Beckman Coulter Biotrin Technologies Tyco (Puritan Bennett) Vitalograph Welch Allyn Abbott Baxter Healthcare B Braun Becton Dickinson De Royal Hollister Oral B Tyco (Sherwood & Mallinckrodt) Utah Medical Alcon Athlone Optical Bausch & Lomb Carl Zeiss Essilor J&J Vistakon Oakley Ophtechs Rupp & Hubrach Transitions Optical Abbott Vascular Boston Scientific Brivant Clearstream Conormedsystems Labcoat Medtronic Nova Science USCI Solution Providers Pack, Print & Sterilisation Filtration Interventional Wire & Tubing Shared Services Amcor Flexibles Field Boxmore Isotron (Gammaster) Nelipak Steripack* Filtertek Listal Millipore Accellent ANSAmed* Contech Medical Endura Coatings Harmac Goodman Medisize Donegal Healthcare Pro-Tek Medical* Vistamed* Allergan AMO Bayer Diagnostics Baxter Financial Services Cook Ireland De Royal J&J DePuy Tyco Welch Allyn Accellent Creganna Fort Wayne Metals Lake Region Merit Medical Teleflex Medical Ulbrich Zeus Industrial Products Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  10. Irish Medical Devices and Diagnostics SectorEmployment continues to rise steadily Source - forfas Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  11. Companies Ranked by Medical Device Revenues 2005 (US$, Million) 1 Johnson & Johnson 2 General Electric • Medtronic • Baxter International 5 Siemens 6 Fresenius 7 Philips 8 Tyco International 9 Boston Scientific • Stryker • B Braun • Guidant • Zimmer • Becton Dickinson 11 of worlds top 14 in Ireland (7 with multiple locations) Red – manufacturing/ R&D MD based in Ireland Blue – not manufacturing MD in Ireland Pink – since taken over by Abbott/ Boston Scientific Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  12. Irish Export Markets Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  13. Key Success Driver – Global Access • Facilitated by.. • Centers that promote Innovation • Convergent Technologies • Focus on high value-added activity • Competence & Skills to suit future needs • A competitive and proactive regulatory environment Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  14. Challenges & Opportunities

  15. Skills & Education Support for Business Innovation Supportive Regulation Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  16. Regulatory Infrastructure & Challenges European Framework Global Market

  17. Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  18. Medical Device Legislation - EU pacemakers; implantable infusion pumps; Inmplantable cardiac defibrillators + related software and accessories Directive 90/385/EEC Active Implantable Medical Devices S.I. No. 253 of 1994 US, X-ray, heart valves hip-implants, ECG, EEG, intravascular catheters, stents, syringes, wheelchairs, dental materials ... Directive 93/42/EEC General Medical Devices S.I. No. 252 of 1994 Lab analysers, reagents , HIV/hepatitis tests, pregnancy tests, assays, calibrators, control materials specimen receptacles ... Directive 98/79/EC In-vitro Diagnostic Medical Devices S.I. No. 304 of 2001 Medizinprodukte - RichtlinienMedical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  19. Ireland’s CA and NB • Competent Authority • The Irish Medicines Board • Notified Body • The NSAI Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  20. Role of the IMB • To authorise the manufacture, preparation, importation, distribution and sale of human and veterinary medicinal products • To regulate the post marketing surveillance of medical devices, grant approval for clinical investigations, manage a register of low risk medical devices, monitor Notified Bodies for conformity assessment in Ireland, etc • To provide information on medicinal products and medical devices to healthcare professionals • To advise the Minister for Health and Children and the Minister for Agriculture and Food, as required • To enforce the Regulations made pursuant to the Act Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  21. IMB - relationship with industry • Firm but fair • IMB/ IMDA Liaison Group • Quarterly meetings • Two way discussion forum • User Fees • Guidelines • Online registration • Vigilance Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  22. NSAI 3,000+ Registered / Certified Firms – Medical ++ Carry out in excess of 6,000 assessments per year Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  23. Regulatory Challenges for Irish Industry • Reach • MDD Review • E-labelling • Risk Management • FDA Small business Fees • IMB - 2007 Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  24. Reach • Single system for the registration, evaluation and authorisation of all chemical substances manufactured, imported or used in products or processes in the EU. • Companies that manufacture, import or use such substances in excess of one tonne per annum, will be required to register the substance with a central competent authority. • A company, if unprepared, could discover that crucial raw materials are no longer available or that the use of the raw material is simply no longer permitted. • Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 and Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC were published in the Official Journal on 30 December 2006. Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  25. Reach - timelines • 1 June 2007 – REACH enters into force • 1 June 2008 – European Chemicals Agency (ECA) in operation and main titles of REACH apply • 1 June 2008 – “New” substance registration • 1 June 2008 – November 2008 – Pre-registration for phase-in of existing substances • November 2010 – 1st phase-in substance deadline* • June 2013 – 2nd phase-in substance deadline* • June 2018 – 3rd phase-in substance deadline* Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  26. Medical Devices Directive Review • Changes proposed to • Definition – medical purpose • Conformity assessment • Clinical evaluation requirements • Post market surveillance • Transparency • Co-operation Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  27. Timelines MDD • European Parliament due to vote in plenary on 29 March or during April session (depending on progress) • Issues to be overcome: • reuse and reprocessing of single-use devices • proposed for a ban on hazardous substances in devices Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  28. Bear in mind that ….. Markos Kyprianou, European Commissioner for Health and Consumer Protection, at a meeting at the European Parliament on February 27 • Modernisation of the EU's legislation for medical devices (envisaged for discussion 2008) • Reviewing the legal framework on pharmaceuticals Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  29. E-Labelling • New paragraph proposed in article 11 of Directive 93/42/EEC stating “the Commission may in accordance with the procedures referred to in article 7(2) adopt measures allowing instructions for use to be provided by other means” • Not prohibited in IVD legislation • Working group in Europe focusing on guidance for IVDs Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  30. E-Labelling, cont’d • Subgroup has prepared a draft MED.DEV for consideration (drafting group led by Ireland) • IMB support moving in this direction under defined circumstances and only for devices for professional use and not at point of care • Pilot in Ireland under discussion Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  31. Risk Management • ISO 14971 is being reviewed • Expected to be published by April ’07. • Currently there are about 190 proposed amendments. Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  32. FDA - Small business Fees • MDUFMA pre-market approval (PMA) application fees for US firms with annual gross sales of US$ 30 million or less do not pay a fee for their first PMA filing • Those with gross sales of US$ 100 million or less can receive a reduction of 38% (US$ 98 648). • Non-US companies are unable to apply because the current system requires that they submit Federal tax returns to show eligibility • Raised with EU Commission – discussions ongoing to address Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  33. Irish Medicines Board • Resources • Combination products • User Fees Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  34. Irish Medical Devices Association

  35. IMDA Vision Ireland; the location of choice for research and development, manufacture and marketing of innovative products in the Medical Device and Diagnostic Sector. Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  36. R&D HRD IMDA Board Marketing QA/ RA SCM IMDA working structure 81 member companies IBEC and IMDA Executive Group Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  37. Quality/ Regulatory Affairs • Regulatory Steering Committee • Quality Working Group • Quality Mailing List Eucomed EDMA Advamed Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  38. IMDA • Influence Legislation • Training and education • Information • Network Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  39. Collaboration – key to futureVision 2020 and MTC convened Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  40. Reach – Support available • REACH helpline to assist members to prepare • alanna.mcguinness@ibec.ie, 01 605 1584 • aoife.clarke@ibec.ie, 01 605 1519 • marian.byron@ibec.ie, 01 605 1624 • Working closely with the Health & Safety Authority who also have also a designated hotline • Locall , 1890 289 389. reachright@hsa.ie Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  41. MDD related Legislation • IMDA RSC • Eucomed • EDMA • Department of Health and Children • Irish Medicines Board • National Standards Authority of Ireland • European Commission Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  42. Clinical Trials activity….. Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  43. Training and Education Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  44. Imagine! Careers in Medical Technology • 19 Scientists & Engineers describe working in the Med Tech sector. They describe their: • Responsibilities • Educational Background • Products/Services their company makes • Tips for success to future graduates • Postgraduates in Med Tech (30) • Useful CAO/Postgraduate Websites listed • Company Lists for School Tours & Graduate placement programs Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007

  45. Feel free to contact me at: Sharon Higgins Director IMDA 84-86 Lower Baggot Street Dublin 2 Ireland ++353 1 6051564 ++353 87 2313437 Sharon.higgins@ibec.ie www.imda.ie Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007