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
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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
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CS X-BOLT ORTHOPAEDICS ALERE BLUEBRIDGE TECHNOLOGIES NEOSURGICAL PRESSCO REINSHAW ELECTRONICS SPECIALTY COATING SYSTEMS TECH GROUP IRELAND 3STRATA TECHNOLOGIES AUDA
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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
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UTIONS ZERUSA LIMITED (“VS IRELAND”) VERYAN MEDICAL VYSERA BIOMEDICAL ACCELLENT / STARGUIDE ADVANT MEDICAL ANECTO CAMBUS TEORANTA CARAGH PRECISION CLADA MEDICAL DEVICES CONT
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SOURCE TECHNICAL CONCEPTS SYNECCO ULBRICH PRECISION METALS VIVASURE MEDICAL WAYGLEN EMEDIA SYNCROPHI CLS MEDPHARMA EMBRICON M&Q PACKAGING SPECIALISED STERILE ENVIRNOME
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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
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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
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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
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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
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W: www.ibec.ie/west
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Cork
T: + 353 21 4295511
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Place Charlotte Quay Limerick
T: + 353 61 410411
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3rd Floor, Pier One Quay Street
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T: + 353 74 9722474
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W: www.ibec.ie/northwest
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T: + 353 51 331260
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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]
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