IMDA Annual Review 2013_FINAL
Transcription
IMDA Annual Review 2013_FINAL
NIER) PPL BIOMECHANICS SOTA PROSTHETICS AND ORTHOTICS STRYKER INSTRUMENTS STRYKER ORTHOPAEDIC SYMMETRY MEDICAL IRELAND BOSTON SCIENTIFIC CORK MILLIPORE IRELAND BV EPIC SOLUTI OR SOLUTIONS SENSL TECHNOLOGIES CREST SOLUTIONS CREST SOLUTIONS QUMAS SEABROOK RESEARCH ABBOTT DIABETES CARE SYNERGY FLOW MEDISIZE DONEGAL HEALTHCARE MOLL INDUST AND WISS MEDI TEO. ZEUS INDUSTRIAL PRODUCTS (IRELAND) ARGUTUS MEDICAL BIOSENSIA BIOTRIN INTERNATIONAL COVIDIEN CRESCENT DIAGNOSTICS ENZOLVE TECHNOLOGIES SIEMENS HEALTHC GNOSTICS ALTASCIENCE ARANN HEALTHCARE ARRONN HEALTHCARE FANNIN HEALTHCARE MEDITEC MEDICAL TRULIFE VASORUM ABBOTT MEDICAL OPTICS X-BOLT ORTHOPAEDICS ALERE BLUEBRI HNOLOGIES NEOSURGICAL PRESSCO REINSHAW ELECTRONICS SPECIALTY COATING SYSTEMS TECH GROUP IRELAND 3STRATA TECHNOLOGIES AUDATUM BIANCAMED CAPTEC CENTRIC HEALTH CLINTECH HEA E DARIUS MEDICAL DMF SYSTEMS GARIVO TECHNOLOGIES HEALTHCOMMS HEARTPHONE HELIX HEALTH INTEL – DIGITAL HEALTH GROUP MANITEX S3 GROUP SENSORMIND SENSORMIND SENSORTRX SHIM EARCH SLAINTE TECHNOLOGIES TELE HEALTH SERVICES VALENTIA TECHNOLOGIES ABBOTT IRELAND BAXTER FINANCIAL SERVICES BAXTER SHARED SERVICES & COMPETENCIES COVIDIEN DABL® HAPTICA I EARCH KCI MEDICAL PRODUCTS OMEGA TEKNIKA QUEST DIAGNOSTICS QUINTILES SEALPACK VALENTIA TECHNOLOGIES VENN LIFE SCIENCES BECKMAN COULTER BIOMEDICAL AEROGEN AEROSURGICAL AOT ICAL RESEARCH COVIDIEN CROSPON JANYSIS PROXY BIOMEDICAL TRANSITIONS OPTICAL APOS APICA CARDIOVASCULAR BOSTON SCIENTIFIC IRELAND CAPPELLA MEDICAL DEVICES CAREFUSION CRE ICAL LIMITED GOODMAN MEDICAL MARVAO MEDICAL MEDTRONIC VASCULAR GALWAY MERIT MEDICAL IRELAND NEURAVI NOVATE MEDICAL VASCULAR SOLUTIONS ZERUSA LIMITED (“VS IRELAND”) VER ICAL VYSERA BIOMEDICAL ACCELLENT / STARGUIDE ADVANT MEDICAL ANECTO CAMBUS TEORANTA CARAGH PRECISION CLADA MEDICAL DEVICES CONTECH IRELAND CREGANNA-TACTX GALWAY TOOL ULD HALO MEDICAL TEORANTA LAKE REGION MEDICAL INTERNATIONAL RESEARCH & DEVELOPMENT CENTRE M&M QUALTECH METAL IMPROVEMENT COMPANY OUTSOURCE TECHNICAL CONCEPTS SYNE RICH PRECISION METALS VIVASURE MEDICAL WAYGLEN EMEDIA SYNCROPHI CLS MEDPHARMA EMBRICON M&Q PACKAGING SPECIALISED STERILE ENVIRNOMENTS LISTAL MUTEBUTTON RESPIREFECTOR HNOLOGIES VISTAMED VISTAMED SEROSEP COOK IRELAND FLEMING MEDICAL IREMA IRELAND JOHNSON & JOHNSON VISION CARE STRYKER ORTHOPAEDICS CROOM PRECISION MEDICAL DESIGNWISE AUTOMA ERTEK BV RR DONNELLEY SHANNON MICROCOIL TAKUMI PRECISION TELEFLEX MEDICAL ACCENDO FIRECREST CLINICAL KNEAT SOLUTIONS ABBOTT IRELAND DIAGNOSTICS FINESSE MEDICAL TOOL AND PLA USTRIES COMPANY BECTON DICKINSON & CO BECTON DICKINSON INSULIN SYRINGE ALLARD UK AMRAY MEDICAL BELLURGAN PRECISION ENGINEERING G-PACE BLUEACRE BAXTER HEALTHCARE SA BAX LTHCARE SA HOLLISTER ULC ABBOTT MEDICAL OPTICS ALLERGAN FORT WAYNE METALS IRELAND CHARLES RIVER BIOLABS ISOTRON WESTPORT VOLEX EUROPE WELCH ALLYN ARCROYAL AQF MDI MED IDIEN MIDLAND BANDAGES KELPAC MEDICAL ISOTRON IRELAND STERIPACK MEDICAL PACKAGING ANSAMED HARMAC MEDICAL PRODUCTS ABBOTT IRELAND DIAGNOSTICS ABBOTT IRELAND B BRAUN HOSPIC PIRA INNOVATIVE SCIENCE AMCOR FLEXIBLE SLIGO ARROTEK MEDICAL AVENUE MOULD SOLUTIONS PROTEK MEDICAL GROUPNOS TECHNOLOGIES TECHNICAL IDEAS TECHNOPATH MANUFACTURING ABB CULAR BOSTON SCIENTIFIC MICROBRUSH INTERNATIONAL (YOUNG INNOVATIONS) BAUSCH & LOMB IRELAND APS MATERIALS FASTFORM RESEARCH SCHIVO PRECISION EIRCOM EHEALTH SOLUTIONS RIG PHIN TEGAN INNOVATIONS AMERICAN MEDICAL SYSTEMS (AMS) COVIDIEN KCI INC ATHLONE OPTICAL M&V MEDICAL DEVICES MERGON HEALTHCARE PPD TECHNICAL ENGINEERING GROUP TREND TECHNOLO LINGAR UTAH MEDICAL PRODUCTS WPA MOBILE INTERTEK BIOCLIN TELEFLEX MEDICAL EUROPE CARL ZEISS VISION IRELAND CLEARSTREAM TECHNOLOGIES ABT MEDICAL LAKE REGION MEDICAL EMERGE PONSE T COAG TRINITY BIOTECH PLC ADVANCED SURGICAL CONCEPTS NYPRO VASCOCARE MEDICAL BECKMAN COULTER IRELAND INC. VITALOGRAPH ESSILOR TOG ORTHOTICS ZIMMER ORTHOPAEDICS ICAL PHARDIAG SMITHSTOWN LIGHT ENGINEERING SPS, HI-LIFE TOOLS BODYTAB AUDIT DIAGNOSTICS NEONATAL DIAGNOSTICS RADISENS DIAGNOSTICS RAMAN DIAGNOSTICS ENBIO MITAMED SANMINA SCI AL ORATORIES IRELAND DEPUY (IRELAND) DONOVAN MEDICAL EQUIPMENT (TORNIER) PPL BIOMECHANICS SOTA PROSTHETICS AND ORTHOTICS STRYKER INSTRUMENTS STRYKER ORTHOPAEDIC SYMMETRY MED AND BOSTON SCIENTIFIC CORK MILLIPORE IRELAND BV EPIC SOLUTIONS LINCOR SOLUTIONS SENSL TECHNOLOGIES CREST SOLUTIONS CREST SOLUTIONS QUMAS SEABROOK RESEARCH ABBOTT DIABETES C ERGY FLOW MEDISIZE DONEGAL HEALTHCARE MOLL INDUSTRIES IRELAND WISS MEDI TEO. ZEUS INDUSTRIAL PRODUCTS (IRELAND) ARGUTUS MEDICAL BIOSENSIA BIOTRIN INTERNATIONAL COVIDIEN CRESC GNOSTICS ENZOLVE TECHNOLOGIES SIEMENS HEALTHCARE DIAGNOSTICS ALTASCIENCE ARANN HEALTHCARE ARRONN HEALTHCARE FANNIN HEALTHCARE MEDITEC MEDICAL TRULIFE VASORUM ABBOTT MED CS X-BOLT ORTHOPAEDICS ALERE BLUEBRIDGE TECHNOLOGIES NEOSURGICAL PRESSCO REINSHAW ELECTRONICS SPECIALTY COATING SYSTEMS TECH GROUP IRELAND 3STRATA TECHNOLOGIES AUDA CAMED CAPTEC CENTRIC HEALTH CLINTECH HEALTH CARE DARIUS MEDICAL DMF SYSTEMS GARIVO TECHNOLOGIES HEALTHCOMMS HEARTPHONE HELIX HEALTH INTEL – DIGITAL HEALTH GROUP MANITE UP SENSORMIND SENSORMIND SENSORTRX SHIMMER RESEARCH SLAINTE TECHNOLOGIES TELE HEALTH SERVICES VALENTIA TECHNOLOGIES ABBOTT IRELAND BAXTER FINANCIAL SERVICES BAXTER SHA VICES & COMPETENCIES COVIDIEN DABL® HAPTICA ICON RESEARCH KCI MEDICAL PRODUCTS OMEGA TEKNIKA QUEST DIAGNOSTICS QUINTILES SEALPACK VALENTIA TECHNOLOGIES VENN LIFE SCIENCES BECK LTER BIOMEDICAL AEROGEN AEROSURGICAL AOTI BIO MEDICAL RESEARCH COVIDIEN CROSPON JANYSIS PROXY BIOMEDICAL TRANSITIONS OPTICAL APOS APICA CARDIOVASCULAR BOSTON SCIENTIFIC IREL PELLA MEDICAL DEVICES CAREFUSION CREAGH MEDICAL LIMITED GOODMAN MEDICAL MARVAO MEDICAL MEDTRONIC VASCULAR GALWAY MERIT MEDICAL IRELAND NEURAVI NOVATE MEDICAL VASCU UTIONS ZERUSA LIMITED (“VS IRELAND”) VERYAN MEDICAL VYSERA BIOMEDICAL ACCELLENT / STARGUIDE ADVANT MEDICAL ANECTO CAMBUS TEORANTA CARAGH PRECISION CLADA MEDICAL DEVICES CONT AND CREGANNA-TACTX GALWAY TOOL AND MOULD HALO MEDICAL TEORANTA LAKE REGION MEDICAL INTERNATIONAL RESEARCH & DEVELOPMENT CENTRE M&M QUALTECH METAL IMPROVEMENT COMP SOURCE TECHNICAL CONCEPTS SYNECCO ULBRICH PRECISION METALS VIVASURE MEDICAL WAYGLEN EMEDIA SYNCROPHI CLS MEDPHARMA EMBRICON M&Q PACKAGING SPECIALISED STERILE ENVIRNOME AL MUTEBUTTON RESPIREFECTOR ASH TECHNOLOGIES VISTAMED VISTAMED SEROSEP COOK IRELAND FLEMING MEDICAL IREMA IRELAND JOHNSON & JOHNSON VISION CARE STRYKER ORTHOPAEDICS CRO CISION MEDICAL DESIGNWISE AUTOMATION FILTERTEK BV RR DONNELLEY SHANNON MICROCOIL TAKUMI PRECISION TELEFLEX MEDICAL ACCENDO FIRECREST CLINICAL KNEAT SOLUTIONS ABBOTT IREL GNOSTICS FINESSE MEDICAL TOOL AND PLASTIC INDUSTRIES COMPANY BECTON DICKINSON & CO BECTON DICKINSON INSULIN SYRINGE ALLARD UK AMRAY MEDICAL BELLURGAN PRECISION ENGINEERING G-P EACRE BAXTER HEALTHCARE SA BAXTER HEALTHCARE SA HOLLISTER ULC ABBOTT MEDICAL OPTICS ALLERGAN FORT WAYNE METALS IRELAND CHARLES RIVER BIOLABS ISOTRON WESTPORT VOLEX EUR CH ALLYN ARCROYAL AQF MDI MEDICAL COVIDIEN MIDLAND BANDAGES KELPAC MEDICAL ISOTRON IRELAND STERIPACK MEDICAL PACKAGING ANSAMED HARMAC MEDICAL PRODUCTS ABBOTT IREL GNOSTICS ABBOTT IRELAND B BRAUN HOSPICARE HOSPIRA INNOVATIVE SCIENCE AMCOR FLEXIBLE SLIGO ARROTEK MEDICAL AVENUE MOULD SOLUTIONS PROTEK MEDICAL GROUPNOS TECHNOLOGIES TECHN S TECHNOPATH MANUFACTURING ABBOTT VASCULAR BOSTON SCIENTIFIC MICROBRUSH INTERNATIONAL (YOUNG INNOVATIONS) BAUSCH & LOMB IRELAND APS MATERIALS FASTFORM RESEARCH SCH CISION EIRCOM EHEALTH SOLUTIONS RIGNEY DOLPHIN TEGAN INNOVATIONS AMERICAN MEDICAL SYSTEMS (AMS) COVIDIEN KCI INC ATHLONE OPTICAL M&V MEDICAL DEVICES MERGON HEALTHCARE HNICAL ENGINEERING GROUP TREND TECHNOLOGIES MULLINGAR UTAH MEDICAL PRODUCTS WPA MOBILE INTERTEK BIOCLIN TELEFLEX MEDICAL EUROPE CARL ZEISS VISION IRELAND CLEARSTR HNOLOGIES ABT MEDICAL LAKE REGION MEDICAL EMERGENCY RESPONSE T COAG TRINITY BIOTECH PLC ADVANCED SURGICAL CONCEPTS NYPRO VASCOCARE MEDICAL BECKMAN COULTER IRELAND LOGRAPH ESSILOR TOG ORTHOTICS ZIMMER ORTHOPAEDICS DMC MEDICAL PHARDIAG SMITHSTOWN LIGHT ENGINEERING SPS, HI-LIFE TOOLS BODYTAB AUDIT DIAGNOSTICS NEONATAL DIAGNOSTICS RADIS GNOSTICS RAMAN DIAGNOSTICS ENBIO MITAMED SANMINA SCI ALCON LABORATORIES IRELAND DEPUY (IRELAND) DONOVAN MEDICAL EQUIPMENT (TORNIER) PPL BIOMECHANICS SOTA PROSTHETICS HOTICS STRYKER INSTRUMENTS STRYKER ORTHOPAEDIC SYMMETRY MEDICAL IRELAND BOSTON SCIENTIFIC CORK MILLIPORE IRELAND BV EPIC SOLUTIONS LINCOR SOLUTIONS SENSL TECHNOLOGIES CR UTIONS CREST SOLUTIONS QUMAS SEABROOK RESEARCH ABBOTT DIABETES CARE SYNERGY FLOW MEDISIZE DONEGAL HEALTHCARE MOLL INDUSTRIES IRELAND WISS MEDI TEO. ZEUS INDUSTRIAL PRODU LAND) ARGUTUS MEDICAL BIOSENSIA BIOTRIN INTERNATIONAL COVIDIEN CRESCENT DIAGNOSTICS ENZOLVE TECHNOLOGIES SIEMENS HEALTHCARE DIAGNOSTICS ALTASCIENCE ARANN HEALTHCARE ARR LTHCARE FANNIN HEALTHCARE MEDITEC MEDICAL TRULIFE VASORUM ABBOTT MEDICAL OPTICS X-BOLT ORTHOPAEDICS ALERE BLUEBRIDGE TECHNOLOGIES NEOSURGICAL PRESSCO REINSHAW ELECTRO CIALTY COATING SYSTEMS TECH GROUP IRELAND 3STRATA TECHNOLOGIES AUDATUM BIANCAMED CAPTEC CENTRIC HEALTH CLINTECH HEALTH CARE DARIUS MEDICAL DMF SYSTEMS GARIVO TECHNOLO LTHCOMMS HEARTPHONE HELIX HEALTH INTEL – DIGITAL HEALTH GROUP MANITEX S3 GROUP SENSORMIND SENSORMIND SENSORTRX SHIMMER RESEARCH SLAINTE TECHNOLOGIES TELE HEALTH SERV ENTIA TECHNOLOGIES ABBOTT IRELAND BAXTER FINANCIAL SERVICES BAXTER SHARED SERVICES & COMPETENCIES COVIDIEN DABL® HAPTICA ICON RESEARCH KCI MEDICAL PRODUCTS OMEGA TEKNIKA QU GNOSTICS QUINTILES SEALPACK VALENTIA TECHNOLOGIES VENN LIFE SCIENCES BECKMAN COULTER BIOMEDICAL AEROGEN AEROSURGICAL AOTI BIO MEDICAL RESEARCH COVIDIEN CROSPON JANYSIS PR MEDICAL TRANSITIONS OPTICAL APOS APICA CARDIOVASCULAR BOSTON SCIENTIFIC IRELAND CAPPELLA MEDICAL DEVICES CAREFUSION CREAGH MEDICAL LIMITED GOODMAN MEDICAL MARVAO MED TRONIC VASCULAR GALWAY MERIT MEDICAL IRELAND NEURAVI NOVATE MEDICAL VASCULAR SOLUTIONS ZERUSA LIMITED (“VS IRELAND”) VERYAN MEDICAL VYSERA BIOMEDICAL ACCELLENT / STARGUIDE ADV ICAL ANECTO CAMBUS TEORANTA CARAGH PRECISION CLADA MEDICAL DEVICES CONTECH IRELAND CREGANNA-TACTX GALWAY TOOL AND MOULD HALO MEDICAL TEORANTA LAKE REGION MED RNATIONAL RESEARCH & DEVELOPMENT CENTRE M&M QUALTECH METAL IMPROVEMENT COMPANY OUTSOURCE TECHNICAL CONCEPTS SYNECCO ULBRICH PRECISION METALS VIVASURE MEDICAL WAYG DIA SYNCROPHI CLS MEDPHARMA EMBRICON M&Q PACKAGING SPECIALISED STERILE ENVIRNOMENTS LISTAL MUTEBUTTON RESPIREFECTOR ASH TECHNOLOGIES VISTAMED VISTAMED SEROSEP COOK IREL MING MEDICAL IREMA IRELAND JOHNSON & JOHNSON VISION CARE STRYKER ORTHOPAEDICS CROOM PRECISION MEDICAL DESIGNWISE AUTOMATION FILTERTEK BV RR DONNELLEY SHANNON MICROCOIL TAK CISION TELEFLEX MEDICAL ACCENDO FIRECREST CLINICAL KNEAT SOLUTIONS ABBOTT IRELAND DIAGNOSTICS FINESSE MEDICAL TOOL AND PLASTIC INDUSTRIES COMPANY BECTON DICKINSON & CO BEC KINSON INSULIN SYRINGE ALLARD UK AMRAY MEDICAL BELLURGAN PRECISION ENGINEERING G-PACE BLUEACRE BAXTER HEALTHCARE SA BAXTER HEALTHCARE SA HOLLISTER ULC ABBOTT MEDICAL OP ERGAN FORT WAYNE METALS IRELAND CHARLES RIVER BIOLABS ISOTRON WESTPORT VOLEX EUROPE WELCH ALLYN ARCROYAL AQF MDI MEDICAL COVIDIEN MIDLAND BANDAGES KELPAC MEDICAL ISOT AND STERIPACK MEDICAL PACKAGING ANSAMED HARMAC MEDICAL PRODUCTS ABBOTT IRELAND DIAGNOSTICS ABBOTT IRELAND B BRAUN HOSPICARE HOSPIRA INNOVATIVE SCIENCE AMCOR FLEXIBLE S OTEK MEDICAL AVENUE MOULD SOLUTIONS PROTEK MEDICAL GROUPNOS TECHNOLOGIES TECHNICAL IDEAS TECHNOPATH MANUFACTURING ABBOTT VASCULAR BOSTON SCIENTIFIC MICROBRUSH INTERNATIO UNG INNOVATIONS) BAUSCH & LOMB IRELAND APS MATERIALS FASTFORM RESEARCH SCHIVO PRECISION EIRCOM EHEALTH SOLUTIONS RIGNEY DOLPHIN TEGAN INNOVATIONS AMERICAN MEDICAL SYSTEMS (A IDIEN KCI INC ATHLONE OPTICAL M&V MEDICAL DEVICES MERGON HEALTHCARE PPD TECHNICAL ENGINEERING GROUP TREND TECHNOLOGIES MULLINGAR UTAH MEDICAL PRODUCTS WPA MOBILE INTER CLIN TELEFLEX MEDICAL EUROPE CARL ZEISS VISION IRELAND CLEARSTREAM TECHNOLOGIES ABT MEDICAL LAKE REGION MEDICAL EMERGENCY RESPONSE T COAG TRINITY BIOTECH PLC ADVANCED SURG CEPTS NYPRO VASCOCARE MEDICAL BECKMAN COULTER IRELAND INC. VITALOGRAPH ESSILOR TOG ORTHOTICS ZIMMER ORTHOPAEDICS DMC MEDICAL PHARDIAG SMITHSTOWN LIGHT ENGINEERING SPS, HILS BODYTAB AUDIT DIAGNOSTICS NEONATAL DIAGNOSTICS RADISENS DIAGNOSTICS RAMAN DIAGNOSTICS ENBIO MITAMED SANMINA SCI ALCON LABORATORIES IRELAND DEPUY (IRELAND) DONOVAN MED IPMENT (TORNIER) PPL BIOMECHANICS SOTA PROSTHETICS AND ORTHOTICS STRYKER INSTRUMENTS STRYKER ORTHOPAEDIC SYMMETRY MEDICAL IRELAND BOSTON SCIENTIFIC CORK MILLIPORE IRELAN SOLUTIONS LINCOR SOLUTIONS SENSL TECHNOLOGIES CREST SOLUTIONS CREST SOLUTIONS QUMAS SEABROOK RESEARCH ABBOTT DIABETES CARE SYNERGY FLOW MEDISIZE DONEGAL HEALTHCARE M USTRIES IRELAND WISS MEDI TEO. ZEUS INDUSTRIAL PRODUCTS (IRELAND) ARGUTUS MEDICAL BIOSENSIA BIOTRIN INTERNATIONAL COVIDIEN CRESCENT DIAGNOSTICS ENZOLVE TECHNOLOGIES SIEM LTHCARE DIAGNOSTICS ALTASCIENCE ARANN HEALTHCARE ARRONN HEALTHCARE FANNIN HEALTHCARE MEDITEC MEDICAL TRULIFE VASORUM ABBOTT MEDICAL OPTICS X-BOLT ORTHOPAEDICS ALERE BLUEBRI HNOLOGIES NEOSURGICAL PRESSCO REINSHAW ELECTRONICS SPECIALTY COATING SYSTEMS TECH GROUP IRELAND 3STRATA TECHNOLOGIES AUDATUM BIANCAMED CAPTEC CENTRIC HEALTH CLINTECH HEA E DARIUS MEDICAL DMF SYSTEMS GARIVO TECHNOLOGIES HEALTHCOMMS HEARTPHONE HELIX HEALTH INTEL – DIGITAL HEALTH GROUP MANITEX S3 GROUP SENSORMIND SENSORMIND SENSORTRX SHIM EARCH SLAINTE TECHNOLOGIES TELE HEALTH SERVICES VALENTIA TECHNOLOGIES ABBOTT IRELAND BAXTER FINANCIAL SERVICES BAXTER SHARED SERVICES & COMPETENCIES COVIDIEN DABL® HAPTICA I EARCH KCI MEDICAL PRODUCTS OMEGA TEKNIKA QUEST DIAGNOSTICS QUINTILES SEALPACK VALENTIA TECHNOLOGIES VENN LIFE SCIENCES BECKMAN COULTER BIOMEDICAL AEROGEN AEROSURGICAL AOT ICAL RESEARCH COVIDIEN CROSPON JANYSIS PROXY BIOMEDICAL TRANSITIONS OPTICAL APOS APICA CARDIOVASCULAR BOSTON SCIENTIFIC IRELAND CAPPELLA MEDICAL DEVICES CAREFUSION CRE ICAL LIMITED GOODMAN MEDICAL MARVAO MEDICAL MEDTRONIC VASCULAR GALWAY MERIT MEDICAL IRELAND NEURAVI NOVATE MEDICAL VASCULAR SOLUTIONS ZERUSA LIMITED (“VS IRELAND”) VER ICAL VYSERA BIOMEDICAL ACCELLENT / STARGUIDE ADVANT MEDICAL ANECTO CAMBUS TEORANTA CARAGH PRECISION CLADA MEDICAL DEVICES CONTECH IRELAND CREGANNA-TACTX GALWAY TOOL ULD HALO MEDICAL TEORANTA LAKE REGION MEDICAL INTERNATIONAL RESEARCH & DEVELOPMENT CENTRE M&M QUALTECH METAL IMPROVEMENT COMPANY OUTSOURCE TECHNICAL CONCEPTS SYNE RICH PRECISION METALS VIVASURE MEDICAL WAYGLEN EMEDIA SYNCROPHI CLS MEDPHARMA EMBRICON M&Q PACKAGING SPECIALISED STERILE ENVIRNOMENTS LISTAL MUTEBUTTON RESPIREFECTOR HNOLOGIES VISTAMED VISTAMED SEROSEP COOK IRELAND FLEMING MEDICAL IREMA IRELAND JOHNSON & JOHNSON VISION CARE STRYKER ORTHOPAEDICS CROOM PRECISION MEDICAL DESIGNWISE AUTOMA ERTEK BV RR DONNELLEY SHANNON MICROCOIL TAKUMI PRECISION TELEFLEX MEDICAL ACCENDO FIRECREST CLINICAL KNEAT SOLUTIONS ABBOTT IRELAND DIAGNOSTICS FINESSE MEDICAL TOOL AND PLA USTRIES COMPANY BECTON DICKINSON & CO BECTON DICKINSON INSULIN SYRINGE ALLARD UK AMRAY MEDICAL BELLURGAN PRECISION ENGINEERING G-PACE BLUEACRE BAXTER HEALTHCARE SA BAX LTHCARE SA HOLLISTER ULC ABBOTT MEDICAL OPTICS ALLERGAN FORT WAYNE METALS IRELAND CHARLES RIVER BIOLABS ISOTRON WESTPORT VOLEX EUROPE WELCH ALLYN ARCROYAL AQF MDI MED IDIEN MIDLAND BANDAGES KELPAC MEDICAL ISOTRON IRELAND STERIPACK MEDICAL PACKAGING ANSAMED HARMAC MEDICAL PRODUCTS ABBOTT IRELAND DIAGNOSTICS ABBOTT IRELAND B BRAUN HOSPIC PIRA INNOVATIVE SCIENCE AMCOR FLEXIBLE SLIGO ARROTEK MEDICAL AVENUE MOULD SOLUTIONS PROTEK MEDICAL GROUPNOS TECHNOLOGIES TECHNICAL IDEAS TECHNOPATH MANUFACTURING ABB CULAR BOSTON SCIENTIFIC MICROBRUSH INTERNATIONAL (YOUNG INNOVATIONS) BAUSCH & LOMB IRELAND APS MATERIALS FASTFORM RESEARCH SCHIVO PRECISION EIRCOM EHEALTH SOLUTIONS RIG PHIN TEGAN INNOVATIONS AMERICAN MEDICAL SYSTEMS (AMS) COVIDIEN KCI INC ATHLONE OPTICAL M&V MEDICAL DEVICES MERGON HEALTHCARE PPD TECHNICAL ENGINEERING GROUP TREND TECHNOLO LINGAR UTAH MEDICAL PRODUCTS WPA MOBILE INTERTEK BIOCLIN TELEFLEX MEDICAL EUROPE CARL ZEISS VISION IRELAND CLEARSTREAM TECHNOLOGIES ABT MEDICAL LAKE REGION MEDICAL EMERGE PONSE T COAG TRINITY BIOTECH PLC ADVANCED SURGICAL CONCEPTS NYPRO VASCOCARE MEDICAL BECKMAN COULTER IRELAND INC. VITALOGRAPH ESSILOR TOG ORTHOTICS ZIMMER ORTHOPAEDICS ICAL PHARDIAG SMITHSTOWN LIGHT ENGINEERING SPS, HI-LIFE TOOLS BODYTAB AUDIT DIAGNOSTICS NEONATAL DIAGNOSTICS RADISENS DIAGNOSTICS RAMAN DIAGNOSTICS ENBIO MITAMED SANMINA SCI AL ORATORIES IRELAND DEPUY (IRELAND) DONOVAN MEDICAL EQUIPMENT (TORNIER) PPL BIOMECHANICS SOTA PROSTHETICS AND ORTHOTICS STRYKER INSTRUMENTS STRYKER ORTHOPAEDIC SYMMETRY MED AND BOSTON SCIENTIFIC CORK MILLIPORE IRELAND BV EPIC SOLUTIONS LINCOR SOLUTIONS SENSL TECHNOLOGIES CREST SOLUTIONS CREST SOLUTIONS QUMAS SEABROOK RESEARCH ABBOTT DIABETES C ERGY FLOW MEDISIZE DONEGAL HEALTHCARE MOLL INDUSTRIES IRELAND WISS MEDI TEO. ZEUS INDUSTRIAL PRODUCTS (IRELAND) ARGUTUS MEDICAL BIOSENSIA BIOTRIN INTERNATIONAL COVIDIEN CRESC GNOSTICS ENZOLVE TECHNOLOGIES SIEMENS HEALTHCARE DIAGNOSTICS ALTASCIENCE ARANN HEALTHCARE ARRONN HEALTHCARE FANNIN HEALTHCARE MEDITEC MEDICAL TRULIFE VASORUM ABBOTT MED CS X-BOLT ORTHOPAEDICS ALERE BLUEBRIDGE TECHNOLOGIES NEOSURGICAL PRESSCO REINSHAW ELECTRONICS SPECIALTY COATING SYSTEMS TECH GROUP IRELAND 3STRATA TECHNOLOGIES AUDA CAMED CAPTEC CENTRIC HEALTH CLINTECH HEALTH CARE DARIUS MEDICAL DMF SYSTEMS GARIVO TECHNOLOGIES HEALTHCOMMS HEARTPHONE HELIX HEALTH INTEL – DIGITAL HEALTH GROUP MANITE UP SENSORMIND SENSORMIND SENSORTRX SHIMMER RESEARCH SLAINTE TECHNOLOGIES TELE HEALTH SERVICES VALENTIA TECHNOLOGIES ABBOTT IRELAND BAXTER FINANCIAL SERVICES BAXTER SHA VICES & COMPETENCIES COVIDIEN DABL® HAPTICA ICON RESEARCH KCI MEDICAL PRODUCTS OMEGA TEKNIKA QUEST DIAGNOSTICS QUINTILES SEALPACK VALENTIA TECHNOLOGIES VENN LIFE SCIENCES BECK LTER BIOMEDICAL AEROGEN AEROSURGICAL AOTI BIO MEDICAL RESEARCH COVIDIEN CROSPON JANYSIS PROXY BIOMEDICAL TRANSITIONS OPTICAL APOS APICA CARDIOVASCULAR BOSTON SCIENTIFIC IREL PELLA MEDICAL DEVICES CAREFUSION CREAGH MEDICAL LIMITED GOODMAN MEDICAL MARVAO MEDICAL MEDTRONIC VASCULAR GALWAY MERIT MEDICAL IRELAND NEURAVI NOVATE MEDICAL VASCU UTIONS ZERUSA LIMITED (“VS IRELAND”) VERYAN MEDICAL VYSERA BIOMEDICAL ACCELLENT / STARGUIDE ADVANT MEDICAL ANECTO CAMBUS TEORANTA CARAGH PRECISION CLADA MEDICAL DEVICES CONT AND CREGANNA-TACTX GALWAY TOOL AND MOULD HALO MEDICAL TEORANTA LAKE REGION MEDICAL INTERNATIONAL RESEARCH & DEVELOPMENT CENTRE M&M QUALTECH METAL IMPROVEMENT COMP Irish Medical Devices Association What does the future hold for medtech in Ireland? How to face the challenges and where the opportunities are to be found in 2014 Contents 3Foreword Industry vision 4 A message from our 2013 Chairman, John O’Dea Ireland will be a global leader in innovative patient-centred medical technology products and solutions 5 Incoming Chairman’s message Medtech in Ireland by numbers (2013) 6 Progressing towards our goals 8 Driving our future 10 Put it to the Board Strategic themes 1. 2. 3. 4. 13 IMDA Code of Ethical Business Practice is mandatory Ecosystem development Industry foresight Entrepreneurship IMDA services to members 14 Always on-message: Promoting medtech sector in 2013 16 Patients must come first in MDD revisions 18 What IMDA does for YOU Mission element 01 Mission element 02 Driving significant agenda items in the industry vision Providing services, support and information which will add value to members’ businesses 20 More R&D by more companies 23 Medtech investments in 2013 24 Operational Excellence in action 25 The MÓR™ Benchmark Model 26 Skills today, opportunities tomorrow 28 CEO Forum 2013 31 Gongs, glitz and glamour – Medical Technology Industry Excellence Awards 2013 The Irish Medical Devices Association (IMDA) promotes and supports an environment that encourages the sustainable development and profitable growth of multinational and indigenous medical technology companies. © Copyright Irish Medical Devices Association, 2014. 2 IMDA Annual Review 2013 33 IMDA events 2012 34 In conclusion – Danny McCoy, CEO Ibec Valedictory commets from Sharon Higgins, Ibec Head of Sectors 35 IMDA membership 2013 Foreword A warm welcome to the Irish Medical Devices Association Annual Review 2013. I want to start by thanking our outgoing chairman John O’Dea, Crospon, for his hard work during a very important period for the medtech sector in Ireland. Throughout the year, John and vice-chair Bill Doherty, Cook Medical, along with the board members, provided sound advice and sterling direction through a difficult and complex series of meetings, negotiations and representations. We appreciate John’s fine work and look forward to Bill’s chairmanship in 2014, and welcome Liam Kelly, Teleflex Medical, as vice-chair. I take this opportunity to thank all the individual board members and the members of IMDA’s many taskforces and steering groups for their hard work and unstinting service throughout the year. These individuals take time out of their already bursting schedules to work for the collective good of the entire medtech sector and I want to record our thanks and appreciation. I also want to pay tribute to Sharon Higgins, former IMDA director, who has been elevated to director of sectors in Ibec after 14 years of dedicated service to IMDA. Sharon has been such a large part of the IMDA’s development that her shoes will be very difficult to fill, but with eight years’ experience on the IMDA executive I am looking forward to giving it my very best efforts. There is no doubt that 2013 was a significant year in the medtech sector, and one that won’t be forgotten for a long time. Despite the upheaval of the uncertainty surrounding MDD and IVD revisions, and the tremendous effort that went into representing the industry’s position, IMDA’s work continued and a full programme was achieved in 2013. This annual review outlines some of the progress and outputs of our work over the past 12 months. I hope you find it interesting and informative. February 2014 marks the mid-point in IMDA’s Statement of Strategy 2012-2015 and we undertook a mid-term review to assess progress against the board’s key performance indicators. I would like to specifically highlight the introduction of our Business Foresight Model in conjunction with Deloitte, and the launch of IMDA’s Academic Forum. IMDA represents nearly 180 companies and, as part of Ibec, has expertise and a vast network of high-level contacts in Ireland and overseas. This network of collective experience and expertise helps us to work effectively and to get the job done. I believe the progress that has been made so far in our representations on a variety of issues endorses our responsible and insistent approach to these discussions. I take this opportunity to thank all our members and our dedicated IMDA executive for their hard work and commitment throughout 2013. Although we will never allow complacency to lessen our commitment, I think we can be pleased with our results in 2013 and look forward to 2014 with a sense of cautious optimism. We wish our members, partners and allied organisations a very prosperous New Year and look forward to working with you to strengthen and advance Ireland’s leading position in the international medtech industry. Sinéad Keogh Director, IMDA Introducing the IMDA team Dr Áine Fox Senior Executive Adrienne McDonnell Executive Dermot Doherty Executive Fiona Harrison Executive Assistant IMDA Annual Review 2013 Pauline O’Flanagan Network Manager Michelle Reinecke-Quain Network Administrator 3 A message from our 2013 Chairman, John O’Dea It has been a busy and varied year in medtech and I am pleased to have been involved in advancing Ireland’s interests at a time of uncertainty and change. Ireland’s medtech sector is a key contributor to the Irish economy — the sector employs 25,000 —the largest employer, per capita, in Europe, with annual exports of €7.9bn, which represents nearly 9% of Ireland’s total exports. R ecently, Ireland came first on the Forbes “List of the Best Countries for Business”, a reflection of the vision, commitment and foresight of our Government. Ireland ranks near the very top for low tax burden, investor protection and personal freedom. Ireland still maintains an extremely pro-business environment that has attracted investments by some of the world’s biggest companies over the past decade. Ireland hosts 17 of the world’s top 25 medtech companies in addition to a very innovative indigenous base. In fact, half of the 250 medtech companies based here are indigenous. This year, we successfully defended our 12.5% corporation tax regime at home and abroad. In partnership with lbec, we worked directly with the OECD to help it better understand the structure of globalised business in Ireland and the implications of international tax reform. We also influenced the recent enhancements to the R&D tax credit, an important measure that will support continued investment in medtech R&D. IMDA welcomed the changes adopted by the European Parliament on the revision of the MDD and IVD directives, as certain aspects of the current system need meaningful enhancement to reflect changed expectations and technological advances. Industry has repeatedly called 4 for greater transparency, improved monitoring of the market and greater stakeholder involvement. These measures will serve to strengthen the current system and support the future health needs of Irish and European patients. While there are still a number of proposals that Industry are concerned about, including “product scrutiny”, over the next year, we will continue to work in partnership with key stakeholders to promote a regulatory framework that is predictable, that safeguards patients and protects innovation. This year also saw positive changes to capital gains tax for entrepreneurs and enhancements to promote a more positive business environment for start-ups. IMDA championed the medtech position on the development of a national apprenticeship model to support key skills development. It is also very encouraging to see the prioritisation of medical devices, diagnostics and manufacturing competitiveness in the most recent Science Foundation Ireland research centres call — a reflection of our government’s commitment to investing in research capability and supporting manufacturing excellence here. Specifically, this year, as part of the implementation of IMDA’s strategy, we launched our business model foresight strategy in conjunction with Deloitte to deliver best-quality industry foresight for members. Our code of ethical business practice will support positive IMDA Annual Review 2013 industry clinician engagement, a key driver of innovation in the sector. The establishment of our Medtech Academic Forum will forge stronger relationships between industry and academia to create new start-ups, increase R&D in Ireland and ensure future skills needs for the sector continue to be met. We completed our mid-term strategy review in 2013 with very favourable results and a new IMDA constitution was approved. Although the sector is facing changes, the industry in Ireland is in good shape and I take this opportunity to wish my successor Bill Doherty and our new vice-chair Liam Kelly every success in 2014. John O’Dea CEO, Crospon Medtech in Ireland by numbers (2013) Incoming Chairman’s message This is an exciting time for the medtech sector and I look forward to working with the Board and the IMDA Executive team over the coming year. We are fortunate to have a vibrant and progressive industry in Ireland, focused on helping patients throughout the world. The Irish medtech sector has a strong international reputation for manufacturing and R&D; however there are opportunities for further growth and to develop Ireland as global centre for medtech. Manufacturing and R&D remain core activities but we must also embrace opportunities in supply chain, shared services, sales and marketing, finance and other key areas. The future is not without challenges as governments continue to wrestle with the cost and regulatory implications of providing healthcare for citizens. Changing demographics, the recent financial crisis and the emergence of eHealth have increased the pace of change. This has implications for every aspect of our business, from product development through to sales and marketing. New products must not only demonstrate better clinical outcomes for patients but also improve economic outcomes for healthcare providers. We need to increase our efforts to demonstrate the value medtech brings to society and the economy. Finally, and perhaps of more immediate urgency, is the revision of the Medical Devices Directive. This legislation has the potential to change the regulatory landscape in Europe and we must ensure that innovation is not smothered by bureaucracy. We have a good regulatory system in Europe which has served patients well and which can be strengthened and improved, but we must ensure that patients continue to have timely access to new technologies and treatments. Finally, thanks to John O’Dea for his exemplary leadership in his role as Chairman of IMDA, I look forward to working with Liam Kelly, Teleflex Medical, and the IMDA Board to progress the industry agenda in 2014. Bill Doherty Executive Vice-President Cook Medical 7 250 The number of medtech companies in Ireland 50% The number of clinical research facilities translating knowledge into patient care The percentage of indigenous Irish medtech firms 25,000 5th Ireland is the fifth largest exporter of medical technology products in Europe 50% The percentage of ventilators worldwide in acute hospitals that are Irish-manufactured 30 million The number of people with diabetes who rely on an injectable device manufactured in Ireland IMDA Annual Review 2013 The number of people employed in the industry 2nd Ireland’s GLOBAL ranking for adaptability and flexibility of workforce Ireland’s GLOBAL ranking as a destination for FDI €7.9 Billion The annual value of Irish medtech exports 33% The percentage of the world’s contact lenses manufactured in Ireland 5 Mid-term Strategy Review Progressing towards our goals The IMDA Statement of Strategy 2012 – 2015 provides a framework against which to asses our progress, and contains objectives which we work towards. We conducted a mid-term strategy review in December 2013, before the CEO Forum in Galway. U sing the key performance indicators set out in the Statement of Strategy as benchmarks against which to measure our progress, the IMDA Chair, John O’Dea (Crospon), outlined the work that has been done over the past 20 months and measured it against the key performance indicators contained in the strategy document. We are pleased to report significant progress has been made. Some objectives have been achieved outright and substantial progress has been made towards completing other goals. This annual review reports on the work done and the progress that we have made. Entrepreneurship The Entrepreneurship Taskforce, under the new chairmanship of Frank Keane (Vitalograph) conducted an audit of the challenges facing the industry and entrepreneurs in particular and responded to the identified demand for improved access to experience by promoting a mentorship programme for entrepreneurs in companies identified as high potential startups (HPSUs). This mentoring process will commence in 2014. Access to finance and funding sources was also identified as a potential problem for entrepreneurs and IMDA was an active media partner in the IN³ Medical Device 360° conference which included a range of workshops and break-out sessions on financing new and existing businesses. IMDA and Enterprise Ireland joint hosted a session at the conference. Ecosystem development Services to members The benefit of a well-structured and cohesive industry approach was seen this year in our representations on MDD and IVD revisions. The entire medtech ecosystem united to present a cogent argument against excessive regulation and oversight of our industry. The industry launched a comprehensive public relations and lobbying campaign on several fronts with industry members, strategic partners and other stakeholders working together for the common good. Working in partnership like this reinforces the bonds of mutual interest and makes our industry stronger. Providing high quality services to members is the fundamental reason the IMDA exists. The organisation is here to serve, represent and promote the medtech sector in Ireland and to do what is necessary to ensure its development and growth. Throughout this annual review, you will see how IMDA has: • represented the industry, giving voice to its members; • provided timely, relevant information and acted as a focal point for action and debate; • supported the development of skilled employees and attracted high quality graduates to the industry; and • provided opportunities for collaboration, experience sharing and networking. 6 IMDA Annual Review 2013 Board-led taskforces Implementation of the IMDA Statement of Strategy 2012-2015 M Public Relations Entrepreneurship Business Foresight Code of Ethics Academic Forum Funding Framework OR G A R BE TIONS SA NI IMDA M E • • • • • • IMDA Board IMDA Executive Team Member-led Working Groups, Steering Committees and Taskforces Industry training • IMDA Skillnet • IMDA Springboard • Sales and Marketing • Innovation, Research Development and Commercialisation (IRDC) • Operational Excellence • Quality and Regulatory Forum • Regulatory Affairs • Skills and Knowledge IRISH MED STATEME ICAL DE VICE NT OF S Irish Me dical Dev ices Ass ociation is a busines s sector S ASSOCI TRATEGY ATION 2012-201 5 within IBE C www.im da.ie IMDA Annual Review 2013 7 Industry foresight Driving our future M ore than ever, companies need to anticipate what is coming down the track, and they need reliable, accessible intelligence on which to base projections and forecasts. IMDA’s Industry Foresight Taskforce, chaired by John Harris (Lake Region Medical) made significant progress in this area, culminating in the publication of the Business Foresight Model. IMDA and Deloitte have jointly published a Business Foresight Model for Ireland, designed to provide a menu for medtech companies, from which they can select the elements that best suit their individual circumstances. Actions to Support Strategic Development IMDA will: • Act to influence and support our member’s strategic development; • Develop an understanding of the business models being used by industry and suppliers, and their impact on Irish medtech companies; • Establish forums to enable industry leaders to share knowledge and discuss the impact of changing models and prepare for the future; The business model is set out under the following themes: • overview of market trends; • strategies and business models to meet the challenges; • strategic initiatives to respond to challenges; and • key strategies for businesses in Ireland. Implementation of Business Foresight Model IMDA conducted two workshops on these themes in 2013, funded by the IMDA Skillnet. The first was in Galway on 8 May and the second was in Cork on 21 November. Adapting your Global Commercial Strategy to Get Paid The Galway workshop focussed on strategies for getting paid and maximising profits. Adopt the right approach for the right technology It is clear that different technologies require different approaches. In some cases lots of data will be necessary to demonstrate the products clinical and economic benefits; in other cases practical demonstrations in clinical environments will require much less data. It is essential to understand the specific market access situation for your technology. Multiple stakeholders Successful introductions of new devices require engagements • Identify the critical competencies and skills needed to align with new business models; • When appropriate, advocate and influence a new business environment. Pictured at the Business Model Foresight Workshop ‘Adapting your Global Commercial Strategy to Get Paid’ in Galway were (L-R): Sharon Higgins, Ibec; John Power, Aerogen; and Patricia Smith, Bio Medical Research. 8 Pictured at the Business Model Foresight Workshop ‘Developing Ireland as a Centre of Excellence for Design and New Product Development’ were (L-R): James Winters, DePuy; Barry Kennedy, i2e2; Sinead Keogh, IMDA; Willie Boxwell, Abbott Vascular Clonmel; and Seamus Ledwith, Medtronic. IMDA Annual Review 2013 The medtech sector is experiencing a period of rapid change brought about by a combination of increased regulatory pressure, additional demands on healthcare budgets, and resource constraints in the industry generally. with many different stakeholders at different levels to establish options for funding and adoption. Very few countries, if any, have a clear national decision maker that will make a decision for a specific technology to be reimbursed and adopted. Most medtech companies will have to engage with many different stakeholders and entities. It is important to allocate sufficient time and resources to complete this process. HTA, comparative effectiveness and health economics Most innovative technologies will be required to establish clinical and economic data to demonstrate their effectiveness. In some cases this will require randomized clinical trials. Developing comparative date for clinical and economic benefits is essential. Developing Ireland as a Centre of Excellence for Design for Manufacture and New Product Development The Cork workshop was aimed at c-suite and senior R&D engineers. The event started with a number of case study presentations, followed by a think-tank session in break-out format to tease out the key issues. Three following three main themes emerged from these sessions, which will inform IMDA’s agenda for 2014. Overview of funding avenues and issues required Need for an improved level of understanding of funding and funding supports available to support business and skills development. Pictured at the Business Model Foresight Workshop ‘Developing Ireland as a Centre of Excellence for Design and New Product Development’ were (L-R): Kieran Deverey, Deloitte; Paudie O’Connor, Boston Scientific Clonmel; Adrienne McDonnell, IMDA; and John Harris, Lake Region Medical. Influencing corporate entities to attract investment into Irish sites There is an opportunity for Irish based medical technology companies to compete internationally for investment from their corporates across a number of functions, including New Product Development (NPD) and Design for Manufacture (DFM). The opportunity exists for Medical Technology companies to share best practice and become centres of excellence in Ireland. These skillsets are an integral component to the future success of the sector in Ireland. In 2014 IMDA, via the IRDC Working Group, will work towards developing a new design programme, as a key output from this Business Foresight Model Workshop. Improving design capabilities in Ireland – development of a new design programme There is a shortage of medical technology design engineers in Ireland. Design engineers who have exposure to design concept right through to manufacturability play a critical role in the development of innovative technologies. Pictured at the launch of the IMDA/Deloitte Business Model Foresight Report were (L-R): John O’Dea, Crospon, Sharon Higgins, Ibec; and Frank Keane, Vitalograph. IMDA Annual Review 2013 9 Put it to the Board We asked the members of IMDA’s Board for their views on the opportunities, challenges and issues facing the medtech sector in the coming year, and on the ways that IMDA assists medtech companies in Ireland. R Adapting, developing, innovating Bill Doherty Donal Balfe Executive Vice President, Cook Medical Vice President, Coviden Our industry must continue to adapt as healthcare systems globally strive to provide increased levels of care with less resources. Delivering technologies to help patients will always be our core goal but we must also deliver products and services that add economic value to healthcare systems. As proposals to revise the MDD continue through the European legislative process this must also remain a priority area in 2014. The Irish Medtech sector continues to flourish, the ongoing global economic recovery and development of new and emerging markets offer many opportunities; the challenge is to capitalise on this. Failure to succeed in this will leave Ireland as a niche player at best. RChallenges we face in 2014 Patricia Smith Liam Kelly Safety and quality issues (e.g. PIP breast implant scandal) have dominated the headlines and created public uncertainty and distrust. Unfortunately these developments damage confidence in responsible medical device development and will lead to more challenging market entry hurdles with increased industry costs and could cause delays for innovative devices that are badly needed by patients. The industry is working hard to restore confidence in responsible medtech and to prevent an overly strict and innovation-stifling regulatory environment. Global companies are looking at their cost base and Ireland can be a very attractive location for business to locate, not only to manufacture but for R&D, customer service, demand planning, QA/ RA, sales and marketing. We need to build the skill base to encourage these companies to locate in the world’s number one country, according to the “Forbes Best Countries for Business 2013”. CEO, Bio Medical Research 10 Executive Vice-President, Teleflex Medical IMDA Annual Review 2013 Willie Boxwell John Harris As medical technology advances, new products, new processes and new opportunities emerge. Our industry must embrace innovation but we must do so in a cost competitive manner. Operational excellence, lean manufacturing and process control will be more important than ever before in 2014 and beyond. Pressure on healthcare costs will continue to increase and our industry must respond with imagination, discipline and innovation. Price pressure is likely to remain a feature of the medtech market for the foreseeable future and we need to make sure that the market appreciates the quality and efficacy of the products we supply. The industry needs to establish a pricing structure that achieves a balance between value, service and price, and defend this structure against price erosion and excessive discounting. Site Director, Abbott Vascular Vice-President, OUS Operations, Lake Region Medical John O’Dea CEO, Crospon Uncertainly remains regarding the scope, extent and implementation aspects of the enhanced scrutiny procedure in Europe. Ultimately, this aspect of the MDD revision has the potential to slow down the availability of new technologies to European patients. This in turn may reverse the recent influx of US venture capital to European-based start-ups. The strength of the euro versus the US dollar is a concern for competitiveness. As an export-driven business, the most pressing global issue is the increasingly negative climate for reimbursement for new medical device technologies. RDefending, supporting, developing medtech Phil Watson Frank Keane The IMDA’s most important achievement of 2013 was a major piece of work by several of the board members in making the Irish and EU politicians aware how vital it was to achieve a balance between improving the MDD while maintaining a regulatory environment that would allow R&D to continue, encourage innovation and avoid delays in getting new therapies to the patients that need them. The medical device arena is undergoing rapid change, driven by increasing cost and regulatory pressures on one hand, and convergence with other technologies, such as IT and pharmaceutical, on the other. The IMDA, through its working groups, seminars and training courses, provides invaluable guidance to its members to understand and respond to these complex changes. CEO, Capella Medical Devices General Manager, Vitalograph IMDA Annual Review 2013 11 We need to build the skill base to encourage these companies to locate in the world’s number one country, according to the “Forbes Best Countries for Business 2013”. Liam Kelly, Executive Vice-President, Teleflex Medical Paudie O’Connor Vice-President and Managing Director, Boston Scientific Clonmel IMDA has been very proactive in recognising, embracing and accelerating the need for change in the Medical Device sector. The changes are wide and varied including the Medical device tax in the US, price erosion at an unprecedented rate globally, stiffer regulation, the MDD in Europe and finally access to Emerging Markets to name but a few. Understanding and leveraging the changes to our advantage is what will create the next opportunity for companies in Ireland. R Identifying opportunities in 2014 John Power Colum Honan The only way opportunities can be consistently realised is by having an ecosystem that positions the Irish Medtech sector as a leader in all three elements of medical product creation i.e. technological, commercial and clinical leadership. In a globally competitive market sector, this is easier said than done, but it is a goal we must always strive to achieve. Over the past 25 years Ireland has built a strong reputation in the development of processes, technologies and people. We must leverage our strength to ensure we stay ahead of the curve in terms of delivery of next generation technologies and products, and bring them to market in the most cost-effective and efficient means possible. Managing Director and CEO, Aerogen Senior Director of Operations, Neurovascular Stryker Ireland James Winters Plant Manager, DePuy Ireland The medtech sector globally is going through a period of unprecedented change and in order to continue to take advantage of these opportunities, we must truly understand and even preempt our end-customers REAL needs; positioning ourselves as solutions providers globally. 12 IMDA Annual Review 2013 Ethics IMDA Code of Ethical Business Practice is mandatory The IMDA Code of Ethical Business Practice became mandatory for members on 1 January 2013 following approval at the IMDA AGM in December 2012. Complaints procedure and sanctions were agreed and ratified at the IMDA AGM 2013. T hese guidelines will provide guidance on the interactions of IMDA members with individuals (including physicians, nurses, technicians and research co-ordinators) or entities that purchase, lease, recommend, use or prescribe IMDA members’ medical devices. The last meeting in 2013 of IMDA’s Code of Ethical Business Practice panel members was held in Ibec on 26 November. It was attended by: Liam Downey, former chairperson of the Health Service Executive; Stuart Margetson, consultant in commercial litigation and dispute resolution, Matheson; Siobhán O’Daly, network development manager, NCSM Ireland, Irish Heart Foundation; and Professor W. Arthur Tanner, RCSI council member; IMDA’s Code of Ethical Business Practice chair, Bill Doherty, Cook Medical; and IMDA board member, Phil Watson, Steripack. Aline Lautenberg, general counsel, director legal & compliance, Eucomed gave the panel an update on a number of topics including Eucomed’s compliance panel, Eucomed’s compliance network’s objectives for 2014, an update on Eucomed’s white paper on medtech companies sponsoring healthcare professionals to attend third party medical education conferences, and on Eucomed’s conference vetting system, which is available at: www.ethicalmedtech.eu/ conference-vetting-system/ objective IMDA Annual Review 2013 Ethics website IMDA’s dedicated Code of Ethical Business Practice website provides comprehensive information and relevant updates on the code and on compliance activities. A full overview of the Code including complaints procedure and sanctions are available at: www.imda.ie/ethics 13 Sales and marketing Always on-message: Promoting medtech sector in 2013 Key PR messages for medtech sector outlined Having a unified approach to PR reinforces the points we need to get across in our communications. Using a common hymn sheet brings clarity to our messages and repeated exposure to a common message helps it to be assimilated. IMDA’s boardled PR Taskforce, under the chairmanship of Bill Doherty (Cook Medical) has developed and validated three key messages for the sector: • raising awareness of the medical technology sector in Ireland using facts, figures and testimonials. Audiences: general public, parents and other key stakeholders; • promoting and reinforcing the many rewarding career opportunities in the med tech sector. Audiences: parents, teachers, students and the general public; and • promoting the European regulatory system as an essentially good system which is fit for purpose, while understanding that elements can be improved. Audiences: the Irish Government, EU Commission, Parliament and Council, patients/ patient bodies and the general public. 14 Pictured at the launch of the IMDA Skillnet Sales & Marketing Programme, were (L-R): Pauline O’Flanagan, IMDA Skillnet; Christine Domegan, NUI Galway; Dr Kieran Conboy, NUI Galway; Noreen Fitzpatrick, Skillnets Ltd; Sinead Keogh, IMDA; Brian Clarke, Zeus Industrial Products; and Mary Greaney, NUI Galway. Conversion programme for sales and marketing The Irish medtech sector needs highly skilled technical sales and marketing people to promote the technologies and devices developed here to a global market. The IMDA Skillnet, in conjunction with NUIG and BioInnovate, has developed a level-8 programme to enable engineers, technicians, scientists, nurses, medical professionals, business, arts, and language professionals to make a smooth transition into technical sales, marketing or business development, and to hit the ground running in their new roles. The first sales and marketing conversion programme started in September 2013 and ran until December. The 13 participants were available for medtech internships in the Galway area. The programme was developed in conjunction with IMDA’s Sales and Marketing working group under the chairmanship of Brian Clarke, Zeus Industrial Products. HSE Procurement IMDA in conjunction with Grant Thornton hosted a workshop on HSE Procurement on 30 April in Galway. The HSE has an annual budget of over €13 billion, which is the country’s largest public sector spend. John Swords, head of procurement at the HSE, provided an overview of the marketplace; profile of key suppliers; trends; competitive process; and the HSE’s expectations and value for money considerations. IMDA Annual Review 2013 Career Zoo 2013 Career Zoo 2013 was Ireland’s largest career event for professionals and graduates seeking new opportunities and new challenges. IMDA was an official partner of the event in 2013, at which a number of global medical technology companies exhibited for the first time. IMDA’s Director Sinead Keogh presented about careers in the medtech sector at the event in September. Busy year in press and media relations Young Scientist Exhibition The BT Young Scientist & Technology Exhibition was as bustling and interesting as ever in 2013 and IMDA and PharmaChemical Ireland hosted a joint stand at the show for the seventh time. BT estimates that more than 65,000 students have entered 31,000 projects to the competition since it was launched in 1965. Vitalograph and Labs Are Vital demonstrated the value of medical technology on the stand to students, parents and teachers alike. Pictured at the BTYS 2013 were: Michael Donoghue, Vitalograph, based in Clare, demonstrating lung function testing with Sharon Higgins, director IMDA, and her children Jake and Amy Higgins from Co. Clare. 2013 was a very busy year in terms of media relations and PR. The revisions to the MDD are very significant for the industry and we pulled out all the stops to make sure we got our message across. IMDA issued a steady stream of press releases in 2013 and arranged media interviews with key spokespeople in the national and international media, both to promote Ireland as a centre of excellence in medtech and to get our message heard on EU MDD revisions. We achieved substantial coverage in all the national broadsheets and in a significant number of business publication and regional papers. Highlights include the Sunday Business Post, Irish Times, Irish Examiner, Clinica, EMDT, Med-Tech Innovations, Medical Plastics News and Silicon Republic. ted s li s ie n a p m o c 6 7 e on our interaccttoivr medtech se day map – Join toto by logging on www.ibec.iea/p0/ MedTechM IMDA Annual Review 2013 15 Quality and regulatory Patients must come first in MDD revisions Proposals to revise the Medical Devices and In Vitro Diagnostics directives have been one of the main industry talking points throughout 2013. The European Parliament and the Council of Ministers are discussing proposals from the EU Commission and taking soundings from stakeholders throughout Europe. It is clear that increased oversight is on its way and the IMDA is making your voice heard in the discussions. T hroughout 2013, IMDA and Eucomed have worked hard to ensure that the industry’s voice is heard at EU level and to ensure that the unfortunate failings of a tiny number of companies aren’t allowed to sway the entire agenda for an industry that has operated to the most stringent standards for many decades. The European regulatory system has been used as the basis for the regulatory framework in Japan, Canada and Australia, among others, because of the effective way it delivers life-saving technologies in a timely fashion, without compromising patient safety. Respected academics and researchers have shown that life-saving technologies become available to European patients three to five years earlier (on average) than in the United States, and patient safety does not suffer. Pictured at the IMDA QA/RA Forum were (L-R): John Brennan, Eucomed; Theresa Jeary, BSI; Dr Áine Fox, IMDA; Robbie Walsh, Boston Scientific and Chair, IMDA Quality & Regulatory Forum; and John Kilmartin, Medtronic. 16 IMDA Annual Review 2013 Change is necessary, delay is not IMDA and the medtech industry welcome the majority of the changes that have been proposed. The industry has repeatedly called for more transparency, improved monitoring (including unannounced audits) and greater stakeholder involvement. The industry’s main concern is that the Commission’s proposed Article 44, which deals with “scrutiny procedure”, could lead to delays of months or even years in bringing new technologies to the market. Intensive round of meetings and submissions Since the initial proposals were published in September 2012, IMDA have engaged in an intensive round of meetings with EU Commission representatives, MEPs, the Department of Health and Children and government representatives. A plenary vote in the European Parliament in October 2013 on draft revisions to the MDD has created a basis for constructive dialogue and submissions on further improvements to the draft regulations. Mairead McGuinness MEP, a member of the European Parliament’s committee for environment, public health and food safety (ENVI), informed the audience at the 2013 CEO Forum in December of the European IMDA’s five key messages on MDD and IVD revisions The IMDA’s position on the MDD & IVD revisions have been distilled into five key messages which are described in full on IMDA’s website and promoted by IMDA’s PR Taskforce. 1. The Irish medical technology industry welcomes changes to MDD & IVD Directives; aspects of the current system need meaningful enhancement that will deliver greater safety and transparency. 2. The MDD Revision proposals as currently drafted threaten patient access to innovative therapies. 3. Ireland’s position as a global centre for medtech innovation is at risk. 4. Medtech sector’s vital contribution to the Irish economy is under threat. 5. Any potential future changes to funding and resourcing of the medical devices regulatory framework need to be appropriate, sustainable, nonbureaucratic and transparent. IMDA strongly favours a centralised European system whereby a single fee is collected annually from all 28 member states. QA/ RA Forum November 2013 Speakers – back row (L-R): Robbie Walsh, Boston Scientific; Tom Healy, Vitalograph (Ireland) Ltd.; Declan Brogan, Medtronic; John Kilmartin, Medtronic; James Hoade, Merit Medical; front row (L-R): Dr Áine Fox, IMDA; Caroline Murphy, Teleflex; and Susan McMonagle, Boston Scientific. Parliament’s views on the Revision which aims to ensure the best possible outcome for patients. IMDA’s Regulatory Steering Committee, led by Committee Chair John Kilmartin (Medtronic) on behalf of IMDA will continue to make our case in the strongest possible terms. Regular scheduled meetings with Irish Medicines Board and FDA The IMDA Regulatory Steering Committee meets quarterly with senior members of the IMB to discuss sectoral issues of mutual interest and to head off any potential future conflicts. Members of the committee also meet senior FDA officials every two years, within the Centre for Devices and Radiological Health, Devices and In Vitro Diagnostics and with AdvaMed officials. Directives, where IMDA members received updates on the status of the regulations, IMDA QA/RA Forum the legislative process and major milestones as well as IMDA’s Quality & Regulatory updates on important shorter Forums are held twice yearly and term measures including notified represent important face to face body oversight, unannounced networking events for QA/RA audits and clinical evaluations. specialists in the medtech sector in Ireland, under the guidance of the Chair Robbie Walsh, Global Access 2014 Boston Scientific. A key theme of the 2013 Forum meetings IMDA’s biennial QA/RA were the revision of the Medical Conference (the “Global Access” IMDA Annual Review 2013 conference series) plays a critical part in the development and formulation of the future strategy of Ireland’s medtech industry and will be held again in 2014. This important forum enables stakeholders from across the US, EU and global locations to discuss and better understand global regulatory developments. The conference has gained an exceptional reputation as one of the best across the EU. 17 Sales andfor Working marketing our members What IMDA does for YOU Ibec is YOUR organisation and in 2013 we worked tirelessly to protect your interests and address your business priorities. IMDA has the resources, the experience and the expertise to make sure your voice is heard at the highest level, and to influence the decisions that affect our businesses and our lives. No other organisation exercises more influence or operates as effectively. In the past year In 2013, Ibec and IMDA met with ministers, MEPs, EU commissioners, government agencies and departments to promote the medtech agenda and secured a number of important policy wins: • representations by IMDA and Ibec have achieved a more balanced and favourable approach to European regulation of medical devices and IVDs. This intensive campaign will continue into 2014 and beyond; • influenced a successful outcome from the review of the R&D tax credit scheme; • developed and championed a medtech position on apprenticeship models; • achieved positive changes to capital gains tax for entrepreneurs and a more positive environment for start-ups; • lobbied for agreement on EU’s €70 billion Horizon 2020 programme 18 and organised a joint conference with Enterprise Ireland. • promoted priority status for medical devices, diagnostics and manufacturing in the Science Foundation Ireland funding call; • established the Academic Forum as a formal programme of increased collaboration with Higher Education Authorities; • devised and launched the IMDA/Deloitte Business Foresight Model to deliver best-quality industry foresight for members; • launched the IMDA Code of Ethical Business Practice to support positive engagement with clinicians and promote the highest ethical standards; and • secured more than €700K in state funding for training programmes designed to meet the specific needs of our members. Giving you access to policy-makers at the highest level IMDA meetings with Enterprise Minister Bruton and with Department Secretaries in Finance and Health A delegation from the Board of IMDA met with Minister Richard Bruton on 13 February to seek action on a range of issues affecting the medtech sector. Agenda items included: roll-over tax relief for capital gains tax, R&D tax credit for key employees, the cost of health insurance for employers, revisions to the Medical Device Directive and In-vitro Devices Directive, regional aid guidelines, collective bargaining rights and clinical trials infrastructure. We also met with the secretaries general of the Departments of Finance and Health in March and April. Department of Health Clearing House The Department of Health Clearing House, established in late 2012 is chaired by the Department’s Secretary General and provides for structured IMDA Annual Review 2013 engagement between the department, Ibec and IMDA. Engaging with EU Commission on removing barriers to trade in India A delegation from IMDA met with Marjut Hannonen, adviser to European Trade Commissioner Karel De Gucht, on 23 April to make the case for a joint EU-USA intervention to reverse cuts of up to 62% to the reimbursement price for drug-eluting coronary stents proposed by the Indian Government. The delegation also recommended adding a transparency requirement to medical device pricing under the EU-India free trade agreement. International reach, highest level influence Our memberships of Eucomed and the European Diagnostic Manufacturers Association (EDMA), our close ties with AdvaMed in the US, in addition to Ibec’s membership of BUSINESSEUROPE support our international engagement and enhance our ability to influence policy decisions at the highest levels. Ibec: representing your interests emphatically IMDA pre-budget submission Ibec’s pre-budget submission is an important element of the process of framing the budget. As a clear and responsible voice representing industry and employers, Ibec’s submissions carry great weight and play an important role in shaping government policy. IMDA has a substantial input into the overall Ibec submission, and also makes its own submission on behalf of the medtech industry. Ibec continues to fight for Irish business, representing its interests in the most emphatic manner possible. Our experience, influence and ability is unrivalled and the results we have achieved speak for themselves. Danny McCoy, CEO Ibec Economy and taxation IMDA addressed six key challenges facing the medtech industry in its submission: 1. No increases in employment costs: Although Ireland’s labour cost competitiveness has improved in recent years, average wages here remain higher than in many competitor countries. IMDA is also concerned about the substantial rise in medical insurance premiums. 2. R&D Tax Credit Scheme: The scheme should be improved to attract more mobile investment to Ireland. 3. Access to credit for SMEs: A state-backed enterprise or investment bank could provide much-needed credit to start-ups and SMEs. IMDA met all the major financial institutions to outline the specific needs of the medtech sector. 4. Capital Gains Tax and Entrepreneur’s Relief: Ireland’s entrepreneur relief scheme is uncompetitive compared to the UK and CGT has increased from 20% in 2008 to 33% in 2013. The Government should rule out further increases to CGT and CAT, or reduce the CAT threshold. 5. Energy costs: IMDA supports Ibec’s recommendation to develop a financial instrument to mitigate the competitive disadvantage faced by firms when Irish electricity costs are higher than the EU average. 6. Employee Share Schemes: Imposing PRSI and the Universal Social Charge on employee share schemes adds unwelcome complexity and imposes an administrative burden that far outweighs the modest revenue generated. These schemes should be encouraged and facilitated to attract key talent. • Convinced government to reduce the budgetary adjustment by €600 million and drop some planned tax hikes; • Defended our 12.5% corporation tax regime at home and abroad; and • Worked directly with the OECD to help it appreciate the structure of globalised business in Ireland and the implications of international tax reform. Business costs • Influenced government to drop plans for a €50 million packaging levy and a statutory sick pay scheme; and • Saved €50 million in electricity costs by resisting suggested tariff changes. Wider business environment • Promoted education reforms that have seen a 58% increase in students taking higher level maths; • Promoted Irish business interests throughout the Irish EU presidency; • Advanced negotiation of the Transatlantic Trade and Investment Partnership (TTIP); and • Lobbied strongly to delay (at least) the proposed general Data Protection Regulation. Employment issues • Played a pivotal role in retaining Ireland’s voluntarist approach to collective bargaining; • Exercised significant influence on the review of the Industrial Relations Act; • Secured a more equitable government approach to insolvent pension schemes; and • Successfully resisted statutory sick pay proposals. Ibec services to members Ibec delivers world-class training and a range of services in human resources, industrial relations, employment law, health & safety and management consulting, all on a not-for-profit basis and all specifically designed to meet the changing needs of our members. Our approach is responsive, commercially-minded and customer-centred. We are here to help you and represent your business and commercial interests. IMDA Annual Review 2013 19 IRDC and Academic Forum More R&D by more companies Expansion of the R&D tax credit was an important win for the IMDA, Ibec and for Ireland. R&D and innovation are the lifeblood of the medtech sector and retaining this important tax benefit underlines Ireland’s commitment to the industry. I MDA’s IRDC Working Group, under the Chair of John Reid, Abbott Diagnostics and Ibec lobbied strongly throughout 2013 to ensure that the R&D Tax Credit Scheme was retained on terms favourable to the Irish medical technology sector. We are pleased to report that these vitally important tax credits were not only retained but enhanced in Budget 2014. Ibec and IMDA conducted our own research to substantiate our recommendations and submitted research findings from 33 IMDA companies to the Department of Finance as part of our pre-budget submissions. As part of the consultation process, Fergal O’Brien, Ibec’s Chief Economist, presented an IMDA webinar in conjunction with Ernst & Young in May to give an overview of our 20 findings and recommendations and to address the practical administrative issues involved in claiming the credit. The positive influence of IMDA representations The IMDA and Ibec representations influenced several positive changes to the scheme, including: increasing the outsourcing limit from 10% to 15%, phasing out the “base year” calculation, and increasing the volume basis from €200,000 to €300,000. Given the importance of innovation to the medtech sector, it is not surprising that 70% of IMDA companies cited the R&D tax credit as a key factor their location decisions. IMDA companies participating in the tax credit scheme IMDA Annual Review 2013 IMDA Academic Forum The IMDA Board-led Academic Forum, under the chairmanship of John O’Dea (Crospon) was established and held its first meeting on 7 October 2013 in Dublin. The need for a forum of this type was outlined in our Statement of Strategy as a means of analysing activities within the academic bodies that are beneficial to the medtech community, and of identifying the courses and educational infrastructure that would be useful to colleges as medical technology advances and innovation continues. On the IMDA’s invitation, the presidents of 17 Irish third-level colleges appointed representatives to the IMDA Academic Forum and 16 of these nominees and 11 IMDA company representatives attended the first meeting. Among the themes that emerged from the discussions were the potential for reciprocal placements between academia and industry, the importance of responsiveness and understanding, and the ever-changing nature of manufacturing technology. Future forum meetings will foster increased collaboration between the medtech sector and academia. Separate to the Academic Forum, IMDA has engaged with a wide range of institutions during the year, including: NUIG, UL, WIT and DCU. We held members’ evenings at NUIG and UL. 2013 also saw the launch of the inaugural Medtech Academic Award which was presented to UL for a collaborative project with Cook Medical in December 2013. Pictured above (L-R): Brendan Gaffney Boston Scientific; Sinead Keogh, IMDA; Colm O’Dowd, Vornia; Sonia Ramirez-Garcia, DePuy Ireland; and Fergal Donnelly European Commission. have 70 – 90% more R&D activity than non-participants, with an annual net benefit of €390 - €595 million. In addition, 62% of IMDA respondents reported job creation due to the credit and 67% cited the measure as a key factor in job retention. Horizon 2020 Conference, a €70 billion research fund IMDA and Enterprise Ireland jointly hosted a major conference to examine the ways in which member companies can benefit from European funding under the Horizon 2020 programme, a €70 billion research funding programme running from 2014 to 2020, the successor to the FP7 programme.120 industry leaders attended the conference in Galway on 18 September. identified at a workshop hosted in May: • the clinical focus is widening, seeking support from pre-treatment right through to rehabilitation. Solutions which enable better clinical service design and on-going patient support is the way forward; • reimbursement is becoming increasingly linked to proof of compliance, and payers now require more evidence to support compliance; • commercial models will continue to evolve and payment for outcomes will become a reality in many sectors. At the more complex end of the spectrum, drugs, devices, diagnostics and data communication will combine and be integrated to enable reimbursement to be based on outcomes in individual patients; and • health Technology Assessment, and evidence gathering product pilots and trials are becoming increasingly necessary for the adoption of new products, especially those that have higher capital costs than their incumbents. IMDA was an official partner in eHealth Week, held at the Convention Centre, Dublin. The event attracted over 2500 delegates from across the globe and offered an opportunity for industry (large and SMEs) to identify sales potentials, licensing deals and joint ventures in the eHealth space. Future trends in medtech R&D examined to deliver best industry foresight The IRDC Working Group explored the use of ICT by medical technology companies to meets some of the key emerging business trends and international procurement models. The following are some of the major trends Pictured above (L-R): Liam Brown, Enterprise Ireland, Fergal Donnelly European Commission, Sinead Keogh IMDA and Ciaran Duffy Enterprise Ireland. IMDA Annual Review 2013 21 both innovative Irish companies and the wider health system. More importantly, it holds the potential to improve how we manage and treat patients. The HIH is supported by Ibec and a number of Ibec Sectors including IMDA. Pictured (L-R): Brian Harrison, Science Foundation Ireland; John Reid, Abbott Diagnostics Longford; Sinead Keogh, IMDA; Brendan Hogan, Aerogen. The US Device Tax SFI identifies key areas for medtech sector Enhancing the clinical research landscape in Ireland Science Foundation Ireland (SFI) has identified medical devices, diagnostics and manufacturing competitiveness as key priority areas for Ireland. IMDA has worked closely with SFI and HEI’s over the past year and has endorsed the Medtech Centre proposal led by NUIG and the Manufacturing Competitiveness proposal led by UCD and Tyndall. At present, clinical investigations for medical devices cannot be conducted without making multiple applications to ethics committees. The IMDA believes these applications are wasteful of time and resources and has met with the Department of Health, HRB, and HIQA with a view to streamlining the process. IMDA called for HIQA to be nominated as the central oversight body for medtech ethics committees in Ireland. IMDA welcomed the announcement of the Health Innovation Hub which supports collaboration between Health and Enterprise – and ultimately job-creation. The HIH demonstrator project based in University College Cork is led by Professor John Higgins who informed the sector about the initiative at IMDA’s member’s evening in September at NUIG. He outlined how this initiative has great potential to benefit Enacted in 2010 as part of the Patient Protection and Affordable Care Act, IRC Section 4191 imposes a tax on the sale of certain medical devices. Beginning on January 1, 2013, manufacturers, producers and importers are required to remit a 2.3% excise tax on the sale of medical devices. Companies that manufacture produce or import taxable medical devices within the US are liable to pay the tax. IMDA jointly hosted a webinar with Grant Thornton to hear first-hand about current expectations of companies with respect to the tax. R&D Tax Credit For many years, Ireland’s low corporate tax rate and attractive R&D tax credit scheme have made Ireland a desirable location for inward investment. Other countries, however, keen to attract R&D investment have recently improved their incentives. The UK has introduced the patent box regime, Finland has new R&D incentive and France, Spain and the Netherlands have improved their R&D reliefs. Against this background, it is vital that Ireland’s R&D tax credit system is maintained at a level that can continue to attract highly mobile R&D investment. The recent review of the R&D tax credit scheme by the Department of Finance led to some positive changes in the Finance Act 2014. The outsourcing limit has been raised from 10% to 15%, and the volume limits have increased from €200,000 to €300,000 in the calculation of the base year spend. These welcome changes, along with continuing efforts to streamline the audit process and provide early certainty on credit entitlements will further strengthen our position as one of the most attractive locations for foreign investment. Contact us: Ken Hardy Partner, KPMG Ireland & EMA R&D Incentives Practice Leader +353 1 410 1645 [email protected] 22 Brian Thornton Tax Partner, KPMG Galway +353 9 153 4634 [email protected] IMDA Annual Review 2013 Investments Medtech investments in 2013 Advant Medicalis set to invest €2.4m in a major development programme at its Galway plant, with the company planning to create 34 jobs over the next three years. Aerogen is to licence out its nebuliser technology to Dutch electronics giant Philips. The deal will add a further 20 R&D posts at its headquarters in Galway, bringing the total workforce to 80. Becton, Dickinson and Company has invested €3.5 million in its Drogheda plant. The investment is in new equipment to manufacture state-of-theart safety needles to protect healthcare workers and patients from medical sharps injuries. Caragh Precision has continued to invest in technology and have purchased a number of high spec milling, machining and turning machines from Mori-Seiki and Hermle. These investments are a significant boost to Caragh’s capacity and capabilities. Cook Medical’s new state-ofthe-art R&D innovation centre is now open for business at its plant in Limerick. A €10m investment by Cook Medical was supported by IDA Ireland. DePuy Synthes Companies plans to expand in Cork with a $36 million investment in an R&D programme which will create 38 high-quality positions. Medtronic opened a new Customer Innovation Centre in Galway, providing state of the art facilities for physicians and Medtronic engineers to develop new therapies. The new CIC cost €7.7 million and was supported by IDA Ireland. M&V Medical Devices created 10 jobs and announced that it expected to double its turnover by the end of 2013. The announcement coincided with the move to a new state-of-the art premises in Athlone and an upgrade to new CNC turning machines. NeuroTronik has closed a $13.1 million funding round, led by Hatteras Venture Partners. Other major investors include Synergy Life Science Partners, Mountain Group Capital, and Lord Baltimore Capital. The medical technology industry continued to invest in Ireland in 2013. IMDA members announced significant investments during the year, creating high quality jobs and bringing new skills and expertise to Ireland. PQ ByPass Inc. has raised an investment of $15 million, co-led by Irish venture capital firm, Seroba Kernel Life Sciences, along with USA-based Ascent Biomedical Ventures. The Irish operation of PQ Bypass will initially employ a team of R&D engineers and clinical affairs experts. ProTek Group has acquired Ireland-based AP Design, specialists in new product development for medical device companies. ProTek Medical is one of Ireland’s leading medical device contract manufacturers. Teleflex Incorporated acquired LMA International N.V. in 2012 in a deal worth €199 million. In 2013 the LMA Business Unit was transferred to the Teleflex international headquarters in Athlone, establishing Global Sales, Marketing and R&D in Athlone. Vistakon Ireland plans to invest over €100 million in expanding its manufacturing operations and create 100 new highly-skilled jobs in Limerick. The 18 month construction phase will also create 200 temporary positions VistaMed has opened a new €7.5M extension to its plant in Carrick-on-Shannon, more than doubling its size. It includes state-of-the-art precision extrusion and catheter assembly cleanrooms along with R&D and laboratory facilities. VistaMed expects to reach 250 employees by year end. Zenith Adhesive Components, established in 2012, was recently designated a High Potential Start Up (HIPSU) by Enterprise Ireland and has received funding. The company employs 15 staff. Nypro Healthcare revealed plans to establish a state-ofthe-art facility in Waterford. The announcement will create more than 200 jobs manufacturing complex respiratory and injection devices. IMDA Annual Review 2013 23 Operational excellence Operational Excellence in action 01 Operational Excellence (Op Ex) Taskforce The OpEx Taskforce meets quarterly, with ad hoc meetings of the People & Resources, MÓR™ Benchmark Model, and Mentoring/Partnering subgroups. Meetings usually include a plant tour of the hosting site. Bernie Reynolds of Coviden chaired the taskforce in 2013 Can we have some MÓR™ please? IMDA’s very own MÓR™ benchmarking tool is on its way to achieving standard certification status as a means for companies to measure their capabilities against their peers and competitors. The MÓR™ Benchmark Model was developed in its entirety by members of the IMDA Op Ex Taskforce and it uses gap analysis based on lean principles to identify opportunities and shortcomings in a company’s manufacturing systems, and IMDA’s Operational Excellence (Op Ex) Taskforce has been very active on your behalf during 2013. Headline achievements include advancing the MÓR™ Benchmark Model towards standard certification, making the case for a newly structured National apprenticeship programme and promoting lean mentoring and lean leadership. 02 suggest the next steps to be taken. So far, more than 80 companies have completed training on the model and have reported very favourably on its efficacy and ease-of-use. Major studies on manufacturing in Ireland The Long Term Vision and Strategic Plan for Manufacturing in Ireland report and the Forfás Study on Future Skills Needs for Manufacturing will play an important role in deciding where government resources are allocated and which supports will be provided into the medium term future. The Op Ex group fed into this report by conducting a survey of members to identify any skills gaps. IMDA also met with Forfás, IDA Ireland and NSAI to introduce the MÓR™ model and demonstrate its suitability as a benchmarking model for the National Step Change Initiative. Although MÓR™ was developed with 03 IMDA members in mind, it is not sector-specific and can be used in virtually any industry. The National Step Change Initiative, outlined in Forfás’ “Making it in Ireland, Manufacturing 2020” report seeks to facilitate access to a common suite of advisory services, benchmarking tools, peer networks and in-firm training. funded advanced level apprenticeships; •multi-sectoral representation on the governance of apprenticeship; • 60-80% workbased training for all apprenticeships; IMDA National Apprenticeship Programme submission • increased capital investment in high tech sectors; and The Op Ex Taskforce developed the IMDA’s submission to the consultation process on the National Apprenticeship Programme. IMDA’s comprehensive recommendations were aligned with Ibec’s overall submission, and included the following key recommendations: • creating a “centre of excellence” or “lean academy” to provide hands-on learning opportunities for medical device development and production. • dual-level manufacturing apprenticeship, with 100% state-funded operator level apprenticeships and 85 - 95% state- Lean Mentoring programme launched IMDA’s Lean Mentoring programme was launched in December 2013, following a comprehensive consultation and planning process by the Op Ex Taskforce. The Lean 01 Pictured at the launch of the MÓR™ Benchmark Model were (L-R): Padhraic McGinn, Nypro Healthcare (vice-chair IMDA Op Ex Taskforce); Pauline O Flanagan, Life Sciences Skillnet; Alan Nuzum, Skillnets; and Adrienne McDonnell, IMDA. 02 Pictured at the launch of the Lean Mentoring Programme in University Limerick, were (L-R): Stephen Creaner, Waters Technologies, with Eddie Kiely, Lake Region Medical – New Ross; and Sinéad Keogh, IMDA. 03 Pictured at the Lean Leadership Programme in Beaumont Hospital were (L-R): Damien Moloney, Cambus Medical; Annabelle Normile, Abbott Vascular Clonmel; Adrienne McDonnell, IMDA; and Padhraic McGinn, Nypro Healthcare (Vice-Chair IMDA Op Ex Taskforce). 24 IMDA Annual Review 2013 mentoring programme is designed to allow companies at a relatively advanced stage of lean manufacturing to mentor companies that are less advanced. The pilot programme will see Lake Region Medical mentoring Waters Technologies, and Siemens Healthcare Diagnostics mentoring Bellurgan Healthcare. Both partnerships will report to the IMDA Op Ex Taskforce in February 2014. Lean Leadership The MÓR™ Benchmark Model The MÓR™ Benchmark Model (meaning ‘great’ in Irish), funded by IMDA Skillnet and developed by the IMDA’s OpEx Taskforce is a self-assessment tool that allows member companies to measure themselves in several aspects of lean manufacturing, enabling them to progress on their lean journey. The model is easy to use and helps companies assess performance, identifies areas to implement improvements, with the overall aim of achieving industry recognition. Main aspects of the model 01 Main screen where company inputs their core company information and navigates the workbook. 02 MÓR™ Worksheet is the tool used to identify the areas of focus & support available to the company to achieve their goals. Programme is a hit with members Following the pilot lean leadership programme last year, a comprehensive review took place to improve the programme. A number of tenders were received and the Op Ex Taskforce vetted all applications, with Lean Business Systems, winning the contract. Held in University of Limerick and Beaumont Hospital, the main focus was to ensure that practical application of lean processes played a significant part of the programme, with the value of MÓR™ model to be understood by members. Initial feedback has been extremely positive. The implementation of the MÓR™ model, was the final assessment and impact of the model will unfold in early 2014, when the eight-day programme comes to an end. 03 Assessment Modules Seven individual categorised sheets where a user performs their main self-assessments. 04 A visual report providing oversight to the MÓR™ scores vs target. Benefits: n Self-assessment tool that allows companies monitor progress without excessive cost or resources; n Very comprehensive; n Very useful at identifying knowledge gaps on Lean; n Creates a clear action plan to measure progress; n Will increase employee’s level of knowledge regarding Operational Excellence and how assessments are conducted. IMDA Annual Review 2013 25 Skills and knowledge Skills today, opportun Influencing Government Skills Policy – National Apprenticeship Programme The IMDA submission to the consultation process on the National Apprenticeship Programme has contributed to the policy deliberations in this important area. The IMDA’s comprehensive and detailed recommendations can be viewed on page 28. IMDA is delighted to say that a significant number of our recommendations have been included in Minister Bruton’s Review of Apprenticeships Report published on 21 January 2014. The full IMDA position available at: www.ibec.ie/0/ApprenticeshipReview. IMDA Academic Forum Established The IMDA Academic Forum held its first meeting on 7 October 2013 in Dublin. (See page 18 wfor details). PhD in Biomedical and Regenerative Medicine (BMERM) This programme, jointly delivered by NUI Galway, UL and UCC, has established itself as a leading international graduate programme and includes an industry mentorship scheme which matches each student with an industry mentor who will advise and guide the student. IMDA support the mentoring process. 26 BioInnovate Programme IMDA continues to support BioInnovate Ireland as an industry partner. This inter-institutional fellowship programme, modelled on the prestigious Bio Design programme at Stanford University is offered by NUI Galway, RCSI, UL, DCU and UCC. Fellows have access to Ireland’s leading academic researchers, facilities and full access to teaching hospitals, as well as a chance to identify medical device development opportunities and receive direction from industry mentors and serial entrepreneurs. Leadership in Action IMDA’s Medical Devices and Diagnostics Future Leadership Programme has been running for eight years with its popularity increasing every year. The eight day programme is aimed at senior to middle management in the medical devices and diagnostics sector in Ireland. It is fully accredited by the Institute of Leadership and Management (ILM). IMDA Skillnet delivers for sector The availability of key skills and provision of industry-specific, high-quality, cost-effective training has been identified as a key driver for success under IMDA’s current Statement of Strategy 2012-2015. The IMDA Pictured at the launch of the IMDA Skillnet Manufacturing Operations Programme were (L-R): Noreen Fitzpatrick, Skillnets Ltd.; Mike Farrell, Siemens Healthcare Diagnostics (IMDA Op Ex Taskforce); and Pauline O’Flanagan, IMDA Skillnet. led a strong training agenda under the guidance of Chairman Padraic Broderick, Transitions Optical. Skillnet has grown substantially over the past number of years. We listened closely to our members’ requirements and we created training programmes to meet your needs. The results are impressive. Between 2008 and 2013 the Skillnet programme secured state funding of €1.63 million to develop key skills and expertise for your businesses. Government funding for the IMDA Skillnet will increase by 32% in 2014 to €403K (out of a total budget of €696K). The network was awarded “Best Jobseeker Initiative” at the Irish Institute of Training and Development (IITD) National Training Awards 2013. All jobseeker training programmes are 100% state funded. Special thanks to the IMDA Skillnet Steering Committee, who have IMDA Annual Review 2013 Conversion programmes Sales and Marketing Conversion Programme The Sales and Marketing Conversion Programme started in August 2013 and ran for 12 weeks followed by a 6-month internship through -Job Bridge (see page 12). Upskilling programmes Innovation in Cardiovascular Design and Orthopaedic workshop The IMDA Skillnet launched the very successful Innovation in Cardiovascular Design programme in April, designed by IMDA’s IRDC Working Group and the National University unities tomorrow Pictured at the IITD Annual Awards 2013 in Killashee House, Naas were (L-R): Award Winners for Best Job Seeker Initiative, Dr Áine Fox, IMDA; Pauline O’Flanagan, IMDA Skillnet; Noreen Fitzpatrick, Skillnet Ltd; James O’Neill, IITD President; Sharon Higgins, Ibec; Adrienne McDonnell, IMDA; and Michelle Reinecke Quain, IMDA Skillnet. Pictured at the Cardiovascular Device Design Programme, 23-25 April,, Croi House, Galway were (L-R): Dr Faisal Sharif, National University Hospital Galway; Sinead Keogh, IMDA; Marcia Gallagher, Medtronic; Louise Maloney, Abbott Vascular; and Pauline O’Flanagan, IMDA Skillnet. Results speak for themselves The IMDA Springboard Programme IMDA Skillnet 2013 In July 2013, the IMDA Springboard was awarded €293K (bringing the total to €581K) to continue its excellent work with candidates seeking to transition into the Medtech sector. Target Actual % Member companies 50 83 166 Employed Trainees 825 1038 126 IMDA Springboard Quality Engineers Conversion Programme Unemployed Trainees 136 132 97 Employed Training Days 3123 3991 128 Unemployed Training Days 1380 5011 363 The Certificate in Quality Engineering and Diploma in Management Programme that commenced in September 2013 made 32 engineers available for internship in January 2014. The programmes will provide a further 30 engineering interns in May 2014. In two previous engineer conversion programmes, 78% of participants were recruited into jobs in the high tech sector following the programmes. The programme greatly shortens the transition cycle for engineers, technicians, scientists and medical professionals entering the Medtech sector. Hospital Galway (NUHG). A second programme took place in September 2013. The 3-day programmes were run in conjunction with consultants from the NUHG and were attended by 48 participants from 19 IMDA member companies. A similar workshop on orthopaedic devices was run with Cappagh Hospital with 59 participants. Manufacturing Operations Programme IMDA Skillnet designed a new FETAC level 5 Manufacturing Operations programme, launched in November 2013. This included training in communications, quality, cGMP, health & safety and environment, cleanroom, and continuous improvement. The 15 candidates can seek employment in the medtech sector either directly or via an internship. IMDA Annual Review 2013 27 Irish Medical Technology CEO Forum CEO Forum 2013 The Irish Medical Technology CEO Forum is a firm staple in the annual medtech calendar. Nearly 350 senior industry leaders came together for the 7th annual medical technology CEO forum and awards. The 2013 event was a fast-moving and engaging discussion of the issues facing the industry right now, and a look into the future to prepare ourselves for what’s in store. 28 T he 2013 Irish Medical Technology CEO Forum was jointly hosted by Enterprise Ireland, IDA Ireland and IMDA. It took place in the Radisson Blu, Galway on 12 December 2013 and it was followed by a gala dinner and the Med Tech Awards. The IMDA Annual General Meeting and a mid-term strategy review session were scheduled to coincide with the forum and the awards. All in all, a long and busy day in Galway. The event itself is ambitious in its scope and is authoritative in terms of speakers, content and debate. Mark Little, CEO and founder of Storyful introduced and moderated a very interesting debate on the themes of leadership and managing change. We are grateful to our platinum sponsors KPMG, our gold sponsors Creganna-Tactx Medical and SteriPack, and our silver sponsors Bank of Ireland and IMDA Skillnet. IMDA Annual Review 2013 Stay true to your core business but expand and differentiate. Demand change and embrace it. Hank Kucheman, Director of Hill Rom and former Global CEO of Boston Scientific After the IMDA AGM and the Mid-term Strategy Review, the first session of the day got underway with a thoughtprovoking presentation by Hank Kucheman. Hank outlined how the convergence of a series trends is acting as a disruptor in the industry and creating a number of opportunities. If current trends persist, healthcare spending will double by 2050, leading some economies to spend 20-30% of GDP on healthcare. Our current business models won’t be fit for purpose in this new world and partnerships with nonhealthcare companies will be the key to growth for many. Value-based healthcare trends are driving investment away from treatment and towards prediction and monitoring. The implementation of new technologies and approaches will provide synergistic upstream and downstream additions to medtech’s core business models. Medtech’s approach should be coordinated and sophisticated Mairead McGuinness, MEP Mairead McGuinness MEP is a member of the Environmental, Public Health and Food Safety Committee and was shadow rapporteur (or co-author) of the European Parliament’s report on the Commission’s proposals on MDD revisions and she gave a very clear and forthright account of the current state of play. Following the European Parliament’s plenary vote in October 2013, the legislative process has entered a crucial negotiation phase. Ireland’s tax codes: absolutely transparent, compliant and consistent Brian Thornton, Tax Partner, KPMG Brian presented on the key points of the debate that is taking place on how multinational businesses should pay tax on profits. He gave the background to the Base Erosion and Profit Sharing (BEPS) project, currently being driven by the OECD. Ireland has featured in this debate because of our strong track record in attracting overseas investment and our history of competitive corporation tax rates that goes back to the 1950s. It is crucially important for the medtech industry that our simple and transparent corporate tax system is maintained. Brian explained how the current rules originated, outlined what is happening in practice, and gave the Irish Government policy on the matter, along with a projection of how the debate is likely to develop. It’s an important debate for Ireland, for the Irish medtech industry and for the global economy. Exiting the bailout with momentum and purpose Leadership, innovation, disruption Danny McCoy, CEO Ibec Kieran Drain, CEO Tyndall National Institute Danny McCoy outlined how post-bailout Ireland is poised for an exceptional period of growth and prosperity. Ireland has exited a troika programme with its reputation enhanced and its economic fundamentals strengthened. The resolute efforts of citizens and the determination and resourcefulness of Irish business have created a commercial environment that will allow us to exit the bailout with momentum and begin a period of emphatic growth. Low borrowing costs and renewed investor confidence will help us in the immediate post-bailout period but we need to innovate and to compete. We must be more ambitious in the goals we set for ourselves and industries like medtech will have to lead the way. Danny challenged the industry to set its ambitions ever higher, assuring the forum that Ibec and IMDA would assist in any way possible. Kieran Drain, CEO of the Tyndall Institute kicked off a fascinating panel discussion by examining the links between medtech and academia and looking at the potential for collaborative R&D. Hank Kucheman, Danny McCoy, Brian Thornton and Mairead McGuinness joined in a wideranging discussion of the issues facing our industry and business in general. “It’s important to realise that even if your product works better than anything else on the market, if there isn’t a clinical cost saving, nobody will buy it.” John O’Dea, CEO Crospon, IMDA Chair 2013 IMDA Annual Review 2013 29 Benson Smith’s five key characteristics of leadership 1.Emotional credibility Trustworthiness. 2.Active persuasion Ask people, don’t tell them. 3.Cognitive expression Understanding the other person’s perspective. 4.Work Orientation Finishing, getting the job done. 5.Internal initiative Motivation, the drive to succeed. Plotting a strategic course in a sea of ambiguity Benson Smith, Chairman, President & CEO, Teleflex Benson Smith spoke about medtech in an uncertain environment and outlined how increased utilisation of medical devices combined with increasing cost pressures is creating a situation that could only be addressed by improved innovation. Most of Teleflex’s focus is on innovation and new products and he gave two compelling examples of recent innovations in catheters. In the US, per capita healthcare costs in the US for 65 – 70 year olds Platinum sponsor 30 are fully seven times higher than they are for 55 – 65 year olds and 10,000 people cross into the over-65 age bracket every day. He said we should favour opportunities that will still exist in 5, 10, or 15 years’ time. Managing change in global medtech Peter Walsh VP Global Operations, Cardiac and Vascular Group, Medtronic Peter Walsh is uniquely positioned to comment on the Irish medtech sector from an international perspective, having run Medtronic’s Galway operation until 2003 when moved to the USA to take up a global operations role. Given Peter’s experience, his views on how Ireland is positioned in the global medtech industry were extremely interesting. Given the decreasing emphasis on corporate tax, and the increased emphasis on labour costs and manufacturing costs, Ireland is doing well to maintain at present levels and we will need to innovate if we are to achieve growth. Countries like Costa Rica and Mexico are catching up very fast and they are modelling themselves on Ireland. We have to stay ahead. Although we excel in attracting R&D projects, we cannot afford to lose manufacturing jobs. We must ask ourselves “what is best in class and do we meet the criteria? If we continue to pursue global best practice as a new target, then Ireland can continue to thrive in this sector. Creating a tsunami of consumer disruption Johnny Walker, President, Health Founders Johnny Walker is an Australiantrained interventional radiologist and a serial entrepreneur. He gave a highly engaging presentation on Jinga Life, a mobile, digital cloud-hosted, personalised electronic health monitoring system with integrated 60 second video messaging tool (HealthSnap). Johnny says that 92% of the people who accompany the patients he treats are female, and we need to recognise the importance of the role that (by and large) mothers play in family healthcare. Jinga Life seeks to create a tsunami wave of disruption driven by the female gatekeepers and custodians of their family’s well-being. An SME perspective on launching a new product on growing and scaling a business and on the challenges businesses face as they strive to achieve scale. One of the most useful questions an entrepreneur can ask is: Can we become THE [insert as appropriate] company? If you don’t think you can become a market leader in your chosen field, you should probably think again about which field to enter. It’s important to realise that even if your product works better than anything else on the market, if there isn’t a clinical cost saving, nobody will buy it. CEOs, no matter what their background should be prepared and able to sell their product. It takes time to get your business established, and time costs money so you need have enough funding to stay on the runway long enough to eventually take off. Low risk companies are more likely to survive, to grow organically and to create jobs. Unfortunately these companies aren’t always attractive to venture capitalists. Any SME in the medtech sector introducing new products needs to have a relentless focus on breakeven. It isn’t fun but once you achieve breakeven, options start to open up. John O’Dea, CEO Crospon, IMDA Chair 2013 John O’Dea spoke from a leadership perspective Gold sponsors IMDA Annual Review 2013 Silver sponsors Medical Technology Industry Excellence Awards 2013 Gongs, glitz and glamour The 7th Annual Medical Technology Industry Excellence Awards took place in Galway on 12 December, just after the CEO Forum. A packed ballroom in the Radisson Blu watched the brightest and the best of medtech and academia pick up their prizes and accept the plaudits of their peers. T ransformations can be amazing to behold. In what seemed like the blink of an eye, the erstwhile sober-suited and sensibly-shod delegates to the CEO Forum were back downstairs dressed up to the nines in a display of the sartorial and crispin arts that would take the sight from your eye. The ballroom too, was transformed from conference seriousness to drinks-anddinner-mode with candles, flowers and crystal. Even the mood was transformed from business to social mode and everyone was in high spirits and looking forward to the awards. A good night was in store. The awards were jointly hosted by Enterprise Ireland, IDA Ireland and IMDA, with a total of nine companies and academic institutions shortlisted. The Winner of Medical Technology Industry Company of the Year Award 2013, John Power, CEO, Aerogen. awards recognise and reward best practice in the medical technology sector and are keenly contested and anticipated. On the shortlist for the overall Medical Technology Company of the Year Award were: Abbott Diagnostics (Longford); Aerogen; Medtronic; and Nypro Healthcare Ireland. The shortlist for the Medical Technology Academic Award, encompassing the Emerging Medical Technology award was as follows: Arann Technologies; BioInnovate Ireland; Galway-Mayo Institute of Technology; National University of Ireland Galway; and University of Limerick. IMDA Annual Review 2013 31 01 03 Medical Technology Company of the Year: Aerogen Aerogen scooped the overall Medical Technology Company of the Year for its project ‘Leading the World in Acute Care Aerosol Drug Delivery’. Aerogen has developed a world leading aerosol technology that enables critical drugs to be delivered directly to the lungs via a nebuliser. Aerogen’s products are now used in Intensive Care Units in more than 60 countries around the globe, providing optimum care to the most critically ill patients. Including pre-term babies. One million patients have already benefited from the superior performance of Aerogen products. John Power, CEO & Managing Director accepted the award, thanking his team for their hard work, expertise and commitment and said that whereas he was the one that accepted the award, it was won by the team, not by him. 32 02 04 Abbott Diagnostics (Longford) won the Silver award in this category. Runners up were, Medtronic and Nypro Healthcare Ireland. Medical Technology Academic Award: University of Limerick The University of Limerick won the Medical Technology Academic Award for an innovative project in partnership with Cook Medical, supported through the Enterprise Ireland Innovation Partnership Programme. Scientists and engineers from the University of Limerick and Cook Medical invented a new metal alloy that will make medical devices inside the body more visible under X-ray; an industry-academia collaboration that will benefit patients worldwide. NUIG won the Silver award in this category. Runners up were BioInnovate and Arann Technology. 05 Medical Technology Outstanding Contribution Award The prestigious Medical Technology Outstanding Contribution Award was given to Dr Jim Browne, President of NUIG. Jim has been one of the most vociferous and active promoters of the medtech sector in Ireland over the past 25 years. IMDA Annual Review 2013 The Seventh Annual Medical Technology Industry Excellence Awards 2013 which was jointly hosted by the Irish Medical Devices (IMDA), Enterprise Ireland and IDA Ireland. 01 Tom Kelly, Enterprise Ireland and Sinead Keogh, IMDA, present John Power, CEO, Aerogen, with the trophy for Medical Technology Industry Company of the Year Award 2013. 02 Stefan Molitor (centre) with his colleagues from Abbott Ireland Diagnostics Division, Longford, who won the Silver Medical Technology Company of the Year Award. 03 Pictured receiving the Medical Technology Outstanding Contribution Award was Dr Jim Browne, President of NUI Galway (2nd from left) with (L-R) Sinead Keogh, IMDA; Tom Kelly, Enterprise Ireland; and Andrew Vogelaar, IDA Ireland. 04 Abhay Pandit, NUI Galway, who won the Silver Medical Technology Academic, encompassing the Emerging Medical Technology Award. 05 Dr Seamus Browne; Dr Tofail Syed; Dr Mary Shire, all of University Limerick, with Bill Doherty, Cook Medical (Vice-Chairman IMDA). IMDA events in 2013 06 01 02 04 03 05 06 07 01 Pictured (L-R): Dr Áine Fox, IMDA; Rosaleen Burke, Boston Scientific; Tom Healy, Vitalograph; Audrey Hobson, Teleflex Medical; Deirdre Kennedy, Covidien, Athlone. 02 Pictured at the IMDA Skillnet Orthopaedic Programme were (L-R): Pauline O Flanagan, IMDA Skillnet; Gavin McGowan, Irish Medicines Board; Laura Flanagan, DePuy Ireland; Prof. O’Byrne, Cappagh Hospital; and Lorraine Eagleton, Advant Medical. 03 Delegates at Medical Devices and Diagnostics Future Leadership Programme 2013- 014. 04 Pictured at the IMDA Skillnet Cardiovascular Programme, was Dr Faisal Sharif demonstrating a device used for full-procedural simulation of a wide range of cardiovascular procedures. 05 Pictured at the the Medtech Industry Awards 2013 were (L-R): Teresa Glynn, Marcia Gallagher and Elaine Boyle, all from Medtronic. 06 IMDA members celebrating Aerogen’s Gold Award for Medical Technology Company of the Year Award 2013. 07 Bernard Collins, Life Med; Michael Gilmore, 4 Tech; Adrienne McDonnell, IMDA; Phil Watson, SteriPack; and Sean O’Sullivan, Seabrook Technology Group. To find out more about IMDA events, visit: www.imda.ie/events IMDA Annual Review 2013 33 In conclusion Growth begins again and gathers momentum It is likely that 2013 will be remembered as the year that Ireland’s economic recovery began in earnest. I believe that this recovery will gain momentum throughout 2014 and that we are now at the beginning of what will prove to be an exceptional period of growth in the Irish economy. The business community played a leading role in this emerging recovery and we must be careful now to embrace it, nurture it and manage its development. I t is clear that 2013 was an exceptional year for jobs. The economy added 60,000 jobs during the year, including high value jobs in medtech. This upward trend looks set to continue as Ibec’s Business Sentiment Surveys and Hiring Expectations Index predict further spectacular employment growth. Our exit from the troika programme, upgrades from the ratings agencies and the general increase in business confidence have contributed to this recovery. Ibec has adjusted its GDP growth forecast upwards to 2.8% for 2014. Increased global demand will help our already strong exports reach our predicted growth rate of 4% in 2014. Ibec fought hard to champion the business conditions that would allow this recovery to take place, including business elements that are very important to IMDA members. We scored significant wins in not just retaining, but enhancing, the R&D tax credit scheme, and achieved positive changes in capital gains tax for entrepreneurs and a more positive environment for start-ups. We convinced the government to drop planned tax hikes and to reduce the scale of budgetary adjustment by €600 million. We vindicated and defended our 12.5% corporation tax at home and abroad, and we resisted government plans for a statutory sick pay scheme. It is difficult to overstate the importance of the medtech sector and IMDA’s role in Ireland’s economic recovery. Ireland needs to see exceptional performance from our high growth industries if we are to achieve the growth targets we have set ourselves. I want to take this opportunity to acknowledge and thank the IMDA team directed by John O’Dea and Bill Doherty for all their hard work in 2013. I also want to thank all IMDA members for their support and participation. Good luck and prosperity to all in 2014. Danny McCoy CEO Ibec Valedictory comments from Sharon Higgins, Ibec Head of Sectors Friendships forged and memories shared with colleagues over 14 years makes it very difficult to leave IMDA after such a long and happy period. However, as I move to a new role in Ibec, it is clear that IMDA is in safe and capable hands and that the sector is in good shape. I only wish to thank all the members with whom I have worked, the boards of directors, the executive, the working groups and taskforces that have worked so hard to establish Irish medtech so prominently on the global map. I look forward now to working with you in my capacity as Ibec Head of Sectors over the coming years. 34 IMDA Annual Review 2013 IMDA membership 2013 If you are interested in becoming an IMDA member in 2014, please contact [email protected] or visit www.imda.ie 3M Ireland A Abbott Ireland Abbott Ireland, Diabetes Care, Donegal Abbott Ireland, Diagnostics, Longford Abbott Ireland, Diagnostics, Sligo Abbott Ireland, Nutrition Division, Sligo Abbott Ireland, Vascular Division, Clonmel Abbott Laboratories Ireland Abbott Medical Optics, Wesport Abbott Medical Optics, Dublin Abbott Nutrition, Finisklin, Sligo Accellent Acorn Regulatory Advant Medical Aerogen Limited AIB Bank Alcon Laboratories Ireland Alere International Allergan Pharmaceuticals Ireland Alpha Precision Amcor Flexibles, Sligo AMS Medical Systems Anecto ANSAmed, a Vention Medical Company Apica Cardiovascular APS Materials Inc ArcRoyal Arthur Cox Solicitors Audit Diagnostics Avenue Mould Solutions B B Braun Hospicare Bank of Ireland Group Bausch + Lomb Ireland Baxter Healthcare SA BD Medical Beckman Coulter Ireland Inc. Bellurgan Precision Engineering Bio Medical Research Bioclin Research Laboratories BlueBridge Technologies Boston Scientific, Clonmel Boston Scientific, Cork Boston Scientific, Galway ByrneWallace Solicitors C Cambus Teoranta Cappella Medical Devices Caragh Precision Charles River Laboratories Preclinical Services Ireland ClearStream Technologies Complete Laboratory Solutions Cook Medical Covidien Covidien Diagnostic Plant, Dublin Covidien European Customer Care Centre & Commercial Group, Dublin Covidien Medical Devices, Athlone Covidien Medical Devices, Galway Covidien Medical Supplies Plant, Tullamore Covidien Principal Executive Office, Dublin CPL Creagh Medical Ltd Creganna-Tactx Medical Croom Precision Medical Crospon D Deloitte DePuy Ireland DiaSorin Ireland DQS Ireland l Lake Region Medical, New Ross Lake Region Medical International R&D Centre, Galway Life Science Recruitment Lifewave Europe M M & V Medical Devices Mainstay Medical Marvao Medical Devices Medtronic Ireland Merck Millipore Mergon Healthcare Merit Medical Metal Improvement Company Moll Industries Ireland N E EnBIO EY Euromedic Ireland F Filtertek - An ITW Medical Company Finesse Medical Fort Wayne Metals Ireland Fountain Healthcare Partners Fresenius Medical Care G Goodman Medical Ireland Grant Thornton Hanna Moore & Curley, European Patent and Trade Mark Attorneys Natus Nicolet Ireland Limited Nelipak Holdings Ireland Ltd neoSurgical Limited Netcare Wellness Neuravi Neuromod Devices NeuroTronik Nypro Healthcare, Bray Nypro Healthcare, Waterford O K KCI Medical Kelpac Medical KPMG KPW Print Ulster Bank Utah Medical Products V W R Johnson & Johnson Vision Care U P I J Takumi Precision Engineering Tcoag Technopath Teleflex Medical Europe - Athlone Teleflex Medical Europe - Limerick Tornier Orthopedics Ireland Transitions Optical Oceana Therapeutics Olympus Biotech (Ireland) Omega Teknika / Chefaro Ireland Outsource Technical Concepts Harmac Medical Products Hollister U L C Homecare Medical Supplies Hospira i360 Medical IBM Ireland Innovative Polymer Compounds T Vascular Solutions Zerusa Vistamed Vitalograph Vivasure Medical Vornia VWR International Perfecseal Inc Phardiag PharmabioServ Phillips-Medisize Ireland Prospectus Strategy Consultants ProTek Medical Proxy Biomedical H Siemens Healthcare Diagnostics Manufacturing SOTA Prosthetics and Orthotics (SSE) Specialised Sterile Environments SteriPack Stryker Ireland, Carrantuohill, Cork Stryker Orthopaedics, Limerick Stryker Instruments, Cork Stryker Neurovascular, Cork SurgaColl Technologies Symmetry Medical Inc Synecco Synergy Health Ireland SysComm Project Management RDJ Glynn ResMed Sensor Technologies RR Donnelley GTS S S3 Group SA Partners Lean Consultancy Sanmina SCI Ireland Seabrook Technology Group Sealed Air Nelipak Sealpack Seroba Kernel Life Sciences Shannon MicroCoil IMDA Annual Review 2013 Waters Technologies Ireland Welch Allyn William Fry Solicitors X X-Bolt Orthopaedics Y Young Microbrush Z Zenith Adhesive Components Zeus Industrial Products Ireland Zimmer Orthopedics Manufacturing 35 Irish Medical Devices Association 84/86 Lower Baggot Street Dublin 2 T: + 353 (0)1 605 1500 E: [email protected] W: www.imda.ie Ibec Head Office 84/86 Lower Baggot Street Dublin 2 T: + 353 1 605 1500 E: [email protected] W: www.ibec.ie/membership Galway Ross House Victoria Place Galway T: + 353 91 561109 E: [email protected] W: www.ibec.ie/west Cork Knockrea House Douglas Road Cork T: + 353 21 4295511 E: [email protected] W: www.ibec.ie/cork Limerick Gardner House Bank Place Charlotte Quay Limerick T: + 353 61 410411 E: [email protected] W: www.ibec.ie/midwest Donegal 3rd Floor, Pier One Quay Street Donegal Town Donegal T: + 353 74 9722474 E: [email protected] W: www.ibec.ie/northwest Waterford Waterford Business Park Cork Road Waterford T: + 353 51 331260 E: [email protected] W: www.ibec.ie/southeast Brussels Avenue de Cortenbergh 89, Box 2 B-1000 Brussels BELGIUM T: + 32 (0)2 512.33.33 F: + 32 (0)2 512.13.53 E: [email protected] W: www.ibec.ie/europe