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Irish Medical Devices Association is a business sector within IBEC www.imda.ie

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.

Vision: Ireland will be a global leader in innovative patient-centred medical technology products and solutions

n Ireland will be a globally significant medical technology hub and the location of choice for the industry due to our expertise and pro-business environment;

n Irish medical technology products and solutions will be major contributors to global healthcare and the global economy.

Mission: IMDA’s mission is to shape and deliver the industry vision by:

n driving significant agenda items in the industry vision;

n providing services, support and information which will add value to the businesses of our members.

Contents03 Foreword

04 A personal message from our outgoing Chairman

05 Plotting the course: Strategy progress report

08 Twitter Q&A with the IMDA Board

10 How IMDA represents you

12 Ecosystem development: Collaborating from concept to commercialisation

14 The medical technology ecosystem: Real people, real benefits

15 Code of Ethical Business Practice becomes mandatory

16 Sales and marketing: Sharing best practice and building the future skills pipeline

17 Spreading the good news about Irish medtech

18 Working towards a balanced regulatory environment

20 Skills and knowledge: Futureproofing our industry

21 Life Sciences Skillnet: Boosting competitiveness

22 Operation excellence: Trailblazing the way forward

24 Irish Medical Technology Industry CEO Forum 2012

26 Medical Technology Industry Excellence Awards 2012

27 Events 2012

28 Investment news 2012

29 Medtech in Ireland by numbers

30 Address from Danny McCoy, Director General, IBEC

31 IMDA member listing

Dr Sinead KeoghSenior Executive

Dr Áine FoxExecutive

Adrienne McDonnellExecutive

Fiona HarrisonExecutive Assistant

Pauline O’FlanaganNetwork Manager

Michelle Reinecke-Quain Network Administrator

FOrewOrD

A warm welcome to the Irish Medical Devices Association’s 2012 Annual review.

Introducing the IMDA team

While the medical device and diagnostic industry in

Ireland remains a vibrant growth sector, it will continue to evolve rapidly over the next 5 to 10 years, creating new opportunities and challenges. Increasing economic pressures, emerging markets, an ageing population, patient-empowering technologies and an ever-increasing need for business model innovation are accelerating the pace of change across the sector like never before. While Ireland already plays a leading role in the global medical technology industry, we need to continue to strengthen and advance this leadership position and look at how we can further develop our distinctiveness.

With that in mind, we have crafted a strategic approach to steer us towards an exciting future for the Irish Medical Devices Association (IMDA) and our member

companies. Our Statement of Strategy 2012–2015 was launched in February 2012 and under the exceptional leadership of our outgoing Chairman Paraic Curtis (Boston Scientific), we hit the ground running to develop an implementation plan and progress key objectives under each of our four strategic pillars: Industry foresight, ecosystem development, entrepreneurship and services to members. You can read our strategy progress report on page five and we continue to receive very positive feedback from our members.

I wish to pay tribute to the tremendous work done by Paraic throughout the year in steering the course and taking our strategy to the next level. I look forward to working with our new Chairman John O’Dea (Crospon) and I welcome Bill Doherty (Cook Medical) as our new Vice Chair. I also wish to pay special

tribute to each of the IMDA board members for their commitment, skills and energy and I know you will join me in thanking them for generously giving of their time to support the growth of our sector.

While we continue to make excellent progress on our strategic objectives, it is worth reiterating that delivering high-quality services to our member organisations is the backbone of the IMDA’s strategy and underpins everything we do. Our membership currently stands at close to 180 companies. We work in four key ways to serve our member organisations:

n As a representative voice of the industry, we focus on understanding the industry’s issues, developing positions and ensuring that the voice of the industry is made clear to government and relevant agencies at both national and international level.

n We provide members with information that is timely and appropriate to their businesses across a wide range of topics.

n We support the development of skilled and adaptable people as well as attracting graduates to the sector.

n We work to provide an environment for sharing of best practice and peer to peer networking.

To each of our member organisations, I encourage you to ensure that you are getting the best out of the services we have to offer. To our members, partners and allied organisations, we wish you a prosperous 2013 and we look forward to working with you to strengthen and advance the leading role our country already plays in the global medical technology industry.

Sharon Higgins, Director, IMDA

IMDA ANNuAL REVIEW 2012 3

A PERSONAL MESSAGE FROM OuR OuTGOING CHAIRMAN

Introducing the incoming IMDA Chairman John O’Dea, CeO, Crospon

” As Chairman of IMDA for 2013, I’m looking forward to working with the Board to progress the objectives in our four-year strategy. We are one year into the plan at this stage and excellent progress has been made on a number of fronts. Some new tasks will begin over the course of 2013. Of particular interest to me is the work that we will be starting with the third-level sector regarding the introduction of entrepreneurship modules in final-year engineering courses. I also look forward to heading the IMDA delegation to meet with senior representatives of the FDA, which always proves to be a useful meeting and exchange of views.”

The medical technology sector is a key part of the Irish economy

and a key driver of national economic growth. As illustrated in our enlightening infographic on page 29, we employ 25,000 people and export over €7.3 billion worth of product each year.

We also know, however, that globally the industry is evolving at an incredible pace and this is impacting enormously on the sector in Ireland. Without doubt, this presents some challenges but it also provides terrific opportunities.

As Chairman of the IMDA for 2012, I’m very happy with the progress we have made under each of the four pillars of our new Statement of Strategy 2012–2015, as described in detail on page five. I am also extremely pleased with the progress made by all the working groups, taskforces and steering committees across the IMDA who have worked tirelessly over the course of the year to achieve our aims.

As I reflect on my year as Chairman, I wish to highlight a few items to give you a flavour of the scope and extent of the work of the IMDA.

n While medtech companies are no strangers to innovation, the current IMDA strategy recognises that it is now time to use those innovative strengths to revisit the business model itself. In conjunction with Deloitte, we have developed a comprehensive medtech

business foresight model for Ireland, described in detail on page five.

n The European Commission’s proposals for regulation on medical devices have the potential to significantly change the industry landscape in Europe. Throughout 2012, the IMDA has been actively involved in representing the sector’s view as a very strong voice in Europe, as outlined on page 18.

n We have a consistently high-performing medical technology sector based here in Ireland, with an exceptionally strong foothold on a worldwide scale. This is a story that needs to be told and throughout 2012 the IMDA has been telling that story more robustly and with purpose. You can read more about our many initiatives on page 17.

n Operational excellence is front and centre in maintaining our strong culture of manufacturing. This year, we created a new industry-driven national operational excellence framework to support companies. This is called the MÓR™ Benchmark Model and it is described in detail on page 22.

n Training and education is another major theme for us. An example of our efforts in that area is our Life Sciences Skillnet programme which has trained 842 employee trainees and delivered almost 2,700 training days, as outlined on page 21.

As my tenure as Chairman draws to a close, I want to extend my sincere thanks to my fellow board members who gave me enormous guidance throughout the year. And on behalf of the IMDA, I wish to thank our colleagues in the many Government agencies and departments who continue to work with us to allow the industry in Ireland to thrive.

Paraic Curtis Vice President, endoscopy Division for eMeA, Boston Scientific

4 IMDA ANNuAL REVIEW 2012

PlOTTIng THe COurSe: STrATegy PrOgreSS rePOrT

imda sTaTemenT of sTraTegy 2012-2015

On 1 February 2012, the IMDA’s Statement of Strategy 2012–2015 was launched in the Merrion Hotel, Dublin. The IMDA Board subsequently established a number of focused taskforces to progress key objectives set out under the four strategic pillars: Industry foresight, ecosystem development, entrepreneurship and services to members.

Industry foresight

Business foresight modelThe medical technology industry globally is evolving at an incredible pace. Never before has the call for innovative technologies been so great or the pressure on healthcare budgets so acute. While medtech companies are no strangers to innovation, our current strategy recognises that it is now time to use those innovative strengths to revisit the business model itself. Only then can we best position ourselves to respond to global developments and trends in a rapidly changing health ecosystem.

Specifically, our current strategy identifies the need to influence the strategic development of IMDA member organisations by providing foresight into the complex business models being used throughout the industry and global supply chain. To achieve this, Deloitte was selected to partner with the IMDA to develop a deeper understanding of these

Strategic objective Influence the strategic development of IMDA member organisations by delivering best-quality industry foresight.

High level strategy

continued overleaf


complex business models and their impact on Irish-based medical technology companies.

Following months of in-depth research and expert analysis, the IMDA and Deloitte have jointly published a draft document which sets out a Business Foresight Model for Ireland. In preparing the document, we were keenly aware that one size does not fit all and that business model innovation most likely requires experimenting with multiple different approaches to figure out which ones work best. Furthermore, as companies seek to reach an increasingly diverse customer base, they will likely need not one business model, but many. The end point may well be a portfolio of business models that address the needs of different customer segments.

The Business Foresight Model is therefore designed to provide a menu for any medical technology company

to pick and choose from, depending on the nature of the company. The Model is set out in easy-to-navigate tabular format under the following themes:

n an overview of major market trends;

n strategies and business models to meet the challenges;

n a menu of strategic initiatives to proactively develop responses to the challenges;

n key strategies that Irish and Irish-based organisations should consider.

Over the next 18 months, the IMDA will hold strategy review groups with member companies to share trends and ideas, ultimately enabling them to incorporate leading-edge strategy themes into their local business plans and prepare for a thriving future.

Ecosystem development

Public imageTimes are turbulent yet we have a consistently high-performing medical technology sector based here in Ireland, with an exceptionally strong foothold on a worldwide scale. This is a story that needs to be told and against the backdrop of our current strategy, we have been telling that story more robustly and with purpose.

For example, the IMDA, Enterprise Ireland and IDA Ireland have come together with technology news service Silicon Republic

to launch a national and international PR campaign to heighten awareness of our dynamic and successful medical technology sector. The campaign included the development of a medical technology microsite on the Silicon Republic website, the inclusion of sector-related news stories in Silicon Republic’s weekly ezine and promotion of events through Silicon Republic’s various social media channels. Since the microsite was launched, over 40 positive medtech articles and interviews have been generated.

Code of ethicsThe IMDA is deeply committed to upholding the integrity of the industry and thus ensuring that sufficient safeguards are in place. Our Code of Ethical Business Practice is comprehensive in its commitment to high ethical standards and was unanimously adopted at the Annual General Meeting on 13 December 2012. Adherence to the code is now compulsory and binding for all IMDA member

organisations. For more information, see page 15.

IRISH MEDICAL DEVICES ASSOCIATION

STATEMENT OF STRATEGY 2012-2015

Irish Medical Devices Association is a business sector within IBEC

www.imda.ie

Strategic objective Strengthen and future-proof the medtech ecosystem to safeguard the sustainable development of the industry in Ireland

IMDA ANNuAL REVIEW 20126

Entrepreneurship

nurturing entrepreneurshipAs the pace of change accelerates, a culture of entrepreneurship is integral to the continued growth of the sector in Ireland. Together with Enterprise Ireland, National university of Ireland, Galway and Trinity College Dublin, we have been examining how to maintain and strengthen

a more positive and supportive environment for entrepreneurial activity in Ireland. Throughout the latter half of 2012, this joint taskforce has been reviewing existing literature and conducting telephone interviews to assess knowledge gaps common to medical device entrepreneurs. The gaps, which include lack of experience and access to finance have been identified and summarised. The taskforce is currently developing a practical framework to bridge these gaps through increasing knowledge, improving education and setting up a mentoring programme.

Services to members

Delivering real value to membersDelivering high-quality services to member organisations is the backbone of our strategy and underpins everything we do.

Throughout the rest of our 2012 Annual Review, we are proud to update you on our work:

n as a representative voice of the industry;

n to provide members with timely, relevant information across a wide range of topics;

n to support the development of skilled and adaptable people as well as attracting graduates to the sector;

n to provide an environment for sharing of best practice and peer to peer networking.

Strategic objective enable medical device entrepreneurs to access the expertise of experienced IMDA members.

Strategic objective Influence the strategic development of IMDA member organisations by delivering best-quality industry foresight.

Implementation of the IMDA Statement of Strategy 2012-2015


TwITTer Q&A wITH THe IMDA BOArDAs the pace of change in the medical technology sector accelerates, IMDA board members examine key trends and consider how the IMDA is assisting medical technology companies across Ireland.

# Major developments 2012

# Key challenges 2013

A major development of 2012 was undoubtedly the Eu Commission’s publication of the draft revision of the Medical Devices Directive. This will alter the regulatory landscape in Europe.

BIll DOHerTy EXECuTIVE VICE PRESIDENT COOK MEDICAL

The continued recession in the Eu and its affect on Government spending will translate into more cost pressure in the national health systems of member states.

PHIl wATSOn CEO, CAPPELLA MEDICAL DEVICES

While productivity improvements have been made by the industry in Ireland over recent years, it is critical that we continue to promote a culture of manufacturing and operational excellence, in order to remain competitive.

wIllIAM BOxwell SITE DIRECTOR, ABBOTT VASCuLAR

The new draft Medical Devices Directive in Europe was a major development, as well as the ongoing activities related to former commissioner Dalli’s drive for enhanced controls of Notified Bodies.

JOHn O’DeA CEO, CROSPON

The need to make healthcare costs more sustainable has become even more apparent. Now more than ever, innovation and innovative thinking are required to deliver better healthcare to more people, more efficiently.

DeS O’leAry GENERAL MANAGER, DIASORIN

There is no doubt that cost reduction combined with growing one’s business represent two of the biggest challenges facing companies in our sector.

JOHn HArrIS VICE PRESIDENT OuS OPERATIONS, LAKE REGION MEDICAL

We are increasingly seeing a convergence that’s blurring the lines between health IT and medical technology, and it is becoming very clear that we need to embrace business model innovation to respond.

PArAIC CurTIS VICE PRESIDENT, ENDOSCOPY DIVISION FOR EMEA, BOSTON SCIENTIFIC

A key challenge facing Irish medtech in the next few years is the shortage of suitably qualified graduates. A more strategic and coordinated approach amongst third-level institutes is needed.

FrAnK KeAne GENERAL MANAGER VITALOGRAPH


For news and updates, follow the IMDA on Twitter

@IMDAIrishMedTec

# IMDA supporting industry

# Seizing emerging opportunities

The training offered to members by the IMDA represents excellent quality at terrific value.

DOnAl BAlFe VICE-PRESIDENT COVIDIEN

The IMDA provides an excellent programme of events, enabling members to access the experience, knowledge and insights of peers to promote best practice and adapt to the changing environment.

COluM HOnAn SENIOR DIRECTOR OF OPERATIONS – NEuROVASCuLAR, STRYKER IRELAND

The IMDA team calls upon the broad capability of IBEC and related Government resources to provide members with the most up-to-date and relevant analysis of European and international medtech business news.

JOHn POwer MANAGING DIRECTOR AND CEO, AEROGEN

We must now embrace the emerging markets and expand our businesses in these countries. They have tremendous growth opportunities and the necessary financial resources to grow their markets.

MICHAel O’DOnOVAn CEO AND MANAGING DIRECTOR AuDIT DIAGNOSTICS

As well as China and Brazil, we should recognise that there are opportunities in South East Asia, Turkey, Russia and India. We must develop R&D and key opinion leader partnerships in these markets to maximise growth potential.

lIAM Kelly EXECuTIVE VICE PRESIDENT TELEFLEX MEDICAL

The IMDA’s thorough understanding of the current and potential future state of the industry ensures that its members are positioning themselves appropriately for the future.

JAMeS wInTerS PLANT MANAGER DEPuY IRELAND

By actively connecting peers and developing business linkages, IMDA activities provide a vital platform from which the Irish medtech sector can collaboratively address the challenges and realise the potential opportunities ahead.

Helen ryAn CEO, CREGANNA TACTX MEDICAL

Excellent research is being carried out in our universities and hospitals and stronger linkages between the research community and the manufacturing base would enhance Ireland’s reputation for innovation.

BrIAn THOrneS CEO, X-BOLT ORTHOPAEDICS

By underpinning our medtech innovations with locally relevant clinical and health economic outcome data, we can rapidly build our international market share. The IMDA is helping Irish medtech to firmly establish these competencies.

PATrICIA SMITH CEO, BIO MEDICAL RESEARCH


As your representative voice for the medical technology sector in Ireland, the IMDA focuses on understanding the industry’s issues, developing positions and ensuring that the voice of the industry is made clear to government, relevant agencies and other stakeholders at both a national and international level.

Revision of the Medical Devices Directives

On 26 September 2012, European Commission proposals for a Regulation on medical devices and a Regulation on in vitro diagnostic medical devices were published. The proposals are currently undergoing legislative scrutiny at European Parliament and Council level and are expected to be adopted in 2014.

While the medical device industry unanimously agrees that an overhaul of Europe’s regulatory framework is necessary to improve the system, it is feared that the proposed “scrutiny procedure” could lead to delays of months or even years for certain high-risk medical devices.

We have been working hard to ensure that the proposal amendment process will provide the best outcome for patients and industry. Top of our agenda is to protect innovation and patient safety, and to ensure that the Eu continues to benefit from a rapid and safe progression to market of new medical devices.

We have held many high-level meetings throughout

2012 and will continue to work closely with MEPs and other relevant stakeholders on this critically important issue. For much more detailed information on the proposals and our lobbying activities, see page 18.

Welcome developments in 2012

As your representative voice for the medical technology sector in Ireland, the IMDA continued to collaborate closely with Government, relevant agencies and many other stakeholders throughout 2012, as illustrated by the table on the opposite page. Good progress was made across a number of arenas including regulatory affairs, skills, access to finance, clinical access and the research environment. For example:

n Health Innovation Hub Demonstrator Project Minister for Jobs, Enterprise and Innovation, Richard Bruton TD and the Minister for Health, Dr James Reilly TD launched the Health Innovation Hub Demonstrator Project which will bring together

the health system, enterprise and academia in an environment where new ideas can be developed. IMDA actively supported calls for the Hub via the Life Sciences Alliance and warmly welcomed its launch.

n Clinical access One of the key barriers identified by industry relates to the challenges presented by multiple applications to ethics committees for medical device clinical trials. IMDA has met with the Department of Health to communicate the importance of the prioritisation and passing of the Health Information Bill. This Bill will establish the Health Information and Quality Authority (HIQA) as the supervisory and support authority for the 13 recognised ethics committees in Ireland. We are also actively advocating for a Centralised Ethics Committee to evaluate all medical device and diagnostic studies in Ireland.

HOW IMDA REPRESENTS yOu


life Sciences Alliance

The Life Sciences Alliance was established in January 2010 and brings together high-level representatives from industry, the Department of Jobs, Enterprise and Innovation, the enterprise development agencies, the healthcare system and the research and academic communities. IMDA director Sharon Higgins represents medtech interests on the Alliance.

Department of Health Clearing House

Established in late 2012, the Clearing House is chaired by Dr Ambrose McLoughlin, General Secretary of the Department of Health and allows for structured engagement between the Department of Health and IBEC, including IMDA. Issues addressed to date include the revision of the medical devices directives and the much-delayed Health Information Bill and its impact on ethics approval.

Pre-budget submission 2013

In advance of the budget each year, the IMDA recommends actions on areas of concern to the medtech sector. Key items in the IMDA’s pre-budget submission 2013 called for no increase in labour costs; no further increase in the marginal income tax rate; and the strengthening of the R&D tax credit.

Quarterly meetings with Irish Medicines Board (IMB)

The IMDA continued to actively represent the medtech sector to the Irish Medicines Board (IMB) via regular communications and quarterly liaison meetings. Recent meetings have focused on the revision of the medical devices directives and the possible introduction of fees to fund IMB activities.

Department of Jobs, enterprise and Innovation’s Manufacturing Forum

IMDA Board member James Winters (Depuy) was appointed to the Manufacturing Development Forum, established by the Department of Jobs, Enterprise and Innovation in 2012. The Forum will assist the Government in identifying the needs of manufacturing enterprises and progressing a transformation agenda.

Forfás research Prioritisation

The IMDA represented the medtech sector in research undertaken by Forfás to establish priority areas of focus for the allocation of publicly-funded research and development. This has resulted in medical device research being prioritised at Government level.

Forfás expert group on Future Skills needs

The IMDA has had ongoing engagement with Forfás as part of the consultation process on future skills needs in manufacturing.

eucomed The IMDA is an active member of Eucomed, the European medtech industry association. Eucomed’s mission is to improve patient and clinician access to modern, innovative and reliable medical technology. Directly and indirectly, Eucomed represents 22,500 designers, manufacturers and suppliers of medical technology.

The european Diagnostic Manufacturers Association (eDMA)

The IMDA is also an active member of EDMA, the European Diagnostic Manufacturers Association. EDMA is the industry association that represents the interests of over 500 companies that are engaged in the research, development, manufacturing and distribution of in vitro diagnostic products across Europe.

AdvaMed The IMDA is an associate member of AdvaMed, whose member companies produce nearly 90% of the healthcare technology purchased annually in the united States and more than 50% purchased annually around the world.

n Access to funding IMDA has had discussions with all major banks about the needs of the medtech sector in Ireland. There is a general understanding amongst banks of opportunities in the sector, but not always of the route to market. Discussions have helped to heighten that understanding. We have also worked with venture capitalists at an Irish and European level to increase awareness of the sector here and the opportunities available.

n Supporting SMes IMDA and Eucomed, the European medical technology industry association, joined leaders from European healthcare and the European Commission to call for concrete measures to close the gaps that hinder healthcare innovation through the adoption of SME-friendly regulation and simpler reimbursement policies. IMDA Director Sharon Higgins is Chair of the Eucomed SME Taskforce.

A snapshot of IMDA member representation in 2012


COLLABORATING FROM CONCEPT TO COMMERCIALISATION

ecosysTem developmenT

The whole is greater than the sum of its parts and as the ecosystem diagram on page 14 illustrates, there are many parts contributing to the success of the medical technology industry in Ireland. Throughout 2012, the IMDA’s Innovation, research, Development and Commercialisation (IrDC) working group continued to bring together the many members of the medical technology community.

Chaired by Darragh Colgan of Boston Scientific with John Reid of Abbott Diagnostics in the position of Vice Chair, the IRDC Working Group plays a very important role in nurturing strong, cross-sectoral collaboration and engages with academia, clinicians, development agencies, Government and convergent industries as it works towards an ever-stronger medtech ecosystem. Another core function of the group is to encourage the sharing of best practice among medical technology companies. Throughout 2012, particularly good progress was made in the areas of academic engagement, convergence and clinical engagement.

Academic engagementThe IRDC Working Group engages with third-level institutions to develop collaborative relationships for the commercialisation of medtech products and services. The group also works to ensure that the

correct policies are in place to fund medical technology research, thus supporting the development of the sector.

During 2012, the IMDA hosted academic workshops which included presentations on key research taking place at the Centre for Research on Adaptive Nanostructures and Nanodevices (CRANN) in Trinity College Dublin and at the Materials Research Institute in Athlone Institute of Technology.

The Report of the Research Prioritisation Steering Group (Forfás) was published in March. The IRDC Working Group carried out a full consultation with IMDA member organisations in advance of its submission to the report and IRDC members participated in working groups across key thematic areas. Several significant recommendations were made across a number of the priority areas identified in the report, including:

n medical devices;

n connected health and independent living;

n diagnostics;

n manufacturing competitiveness (a theme significantly enhanced by the IRDC Working Group);

n processing technologies and novel materials;

n innovation in services and business processes.

ConvergenceGlobally, the medtech sector is increasingly seeing a convergence that’s blurring the lines between health IT and traditional medical devices. A range of patient-empowering technologies has the potential to vastly change healthcare delivery and service delivery. Against this backdrop, the IMDA was involved in a number of key initiatives on the theme of convergence and connected health throughout 2012.

Hosted by Convergence Ireland, the IRDC Working Group jointly led a

pioneering conference entitled Harnessing Ireland’s potential for healthcare and information technology, which provided a forum for medical technology, ICT, software and telehealth companies to explore Ireland’s unique potential for the commercialisation of healthcare ICT products and services. With over 280 delegates in attendance, it was widely agreed that strategic partnerships and connecting stakeholders across the ecosystem are critical to harnessing the revolutionary potential of connected health. Key findings from the conference included the need to understand new business models and commercialisation pathways.

Clinical engagement In conjunction with the Irish Clinical Research Infrastructure Network (ICRIN), the IMDA’s Clinical Trials Taskforce (chaired by John Kilmartin of Medtronic) hosted an international


conference to exploit key strengths of the Irish clinical research infrastructure. The conference, entitled Ireland: A location of choice for medical technology clinical investigations, brought together world-class health research stakeholders including industry, academia, healthcare providers and Government organisations. The conference provided an overview of current medical technology clinical investigations taking place and capabilities across the six clinical research facilities.

Key recommendations include:

n the establishment of a coordinating infrastructure to navigate researchers and companies through the clinical investigation process in Ireland;

n the need to embed research, development and commercialisation into the culture of the health system;

n the coordination of medical technology ethics committees in Ireland, and as such the prioritisation of the Health Information Bill;

n the promotion of clinical investigation to the patient population and the development of patient registries.

The IMDA were also involved in other programmes which engaged the clinical community including the annual Informa conference Clinical Evaluations and Investigations for Medical Devices.

Clinical programmes developed by the IRDC Working Group on designing orthopaedic and cardiovascular devices have become firm fixtures on the medtech clinical landscape and provide a unique opportunity for industry to foster collaborations with local clinical specialists across therapeutic areas of strategic importance to the sector in Ireland.

Strategic thinkingIn light of the change in emphasis of the overall IMDA strategy (see page 5), the IRDC Working Group also felt it was opportune to assess the value proposition of the group and revisit its priorities. A strategy day was held in late 2012 and five key objectives for the group emerged:

1. Emerging trends – impact and opportunities The objective of this theme is to provide an understanding of global trends and to ensure that industry can respond appropriately from an R&D perspective.

2. Knowledge sharing A practical approach to knowledge sharing will be developed, whereby a set of priority areas will be identified each year with an accompanying programme of events.

3. Funding mechanisms, capabilities and IP This theme is related to knowledge sharing but identifies a specific set of topics to build members’ competences and capabilities through an ongoing programme of events.

4. Entrepreneurship While it was agreed that the needs of entrepreneurs should pervade all other strategy themes, a specific set of actions will also be explored including mentoring supports.

5. Ecosystem development Because the priority areas for understanding and influencing the ecosystem will change year on year, it was agreed that the best approach was to carry out an annual review of the ecosystem to identify a prioritised list of issues.

01 Pictured in June at the Convergence Ireland Conference on harnessing Ireland’s potential for healthcare and information technology, held in Dublin, were (l-r): George MacGinnis, PA Consulting; Sharon Higgins, IMDA; and Tom Wilmering, Covidien. 02 Pictured in September at the IMDA/Irish Clinical Research Infrastructure Network (ICRIN) jointly-hosted conference “Ireland: A location of choice for medical technology clinical investigations”, held in Dublin, were (l-r): John O’Dwyer, NSAI; Siobhan Gaynor, ICRIN; John Kilmartin, Medtronic; Frank Van Leeuwen, Medtronic; Sinead Keogh, IMDA; and Fionnuala Gibbons, ICRIN. 03 Also pictured at the Convergence Ireland Conference were (l-r): Tom Healy, Vitalograph; Sinead Keogh, IMDA; Michael Martin, Irish Software Innovation Network; and Jim O’Donoghue, S3.


reAl PeOPle, reAl BeneFITS

The medical Technology ecosysTem

The patient“ Receiving two knee replacements in 2009 and 2011 dramatically improved my quality of life. I am completely pain-free and can once again go for a walk and play a round of golf without even thinking about it. However, when I suffered a major heart attack in October 2012, the insertion of two drug-eluting stents saved my life. I used to say that I owed my quality of life to a medical device. Now, I owe my life to one.”

Hans Droog, 63, Limerick


CODe OF eTHICAl BuSIneSS PrACTICe BeCOMeS MAnDATOry

proTecTing The indusTry

Adherence to high ethical standards is critical to guaranteeing access to modern, innovative, reliable medical technology and a culture of integrity across the industry. IMDA board member Bill Doherty (Cook Medical) tells us about the Code of ethical Business Practice, which became mandatory for all IMDA member organisations on 1 January 2013.

ethical collaboration

Appropriate support of scientific

and educational conferences

legitimate consulting agreements with HCPs

Provision of educational grants

and charitable donations

Provision of modest hospitality and gifts

unethical collaboration

Inappropriate support of conference events

Questionable consulting agreements

with HCPs

grants or charitable donations with

strings attached

excessive hospitality or lavish gifts

We as an industry have a responsibility to both patients and to healthcare providers and the healthcare system. The long collaborative tradition between the medical technology industry and the healthcare profession has produced groundbreaking treatments which have transformed healthcare and patient quality of life. However, it is widely recognised that medical technology companies and the healthcare profession are entering a new era in terms of how they deal with each other. The IMDA is taking a leadership role in protecting a culture of integrity and ethical business practices across the medtech industry in Ireland.

Eucomed, the European organisation representing the medical technology industry, published their Code of Ethical Business Practice, which has been many years in the making and reflects the values and the norms that we as an industry should follow. IMDA, as a member association of Eucomed, has adopted this Code and over the past year, we have been busy providing guidance and information to members about the Code.

The Code is now mandatory for all members of the IMDA. It is not meant to restrict or hamper how companies do business with healthcare systems but instead it sets expectations and norms concerning the conduct of business and our

interaction with healthcare professionals.

The Code of Ethical Business Practice is comprehensive in its commitment to high ethical standards. It governs all interactions between medical technology companies and healthcare professionals and it is supplemented by detailed guidelines which clarify and distinguish between appropriate and inappropriate activity, examples of which are illustrated below.

IMDA is committed to the Code and we look forward to working with our members and other stakeholders to oversee its continued implementation.

enforcing the codeAny complaints about the conduct of any company under the Code or about interactions between industry and healthcare professionals in general should be submitted to IMDA with the appropriate documentation. This will then be forwarded to an independent compliance panel for review.

Full details about the Code are available on the IMDA website at www.imda.ie/ethics


Sharing best practice n In March, over 50

IMDA members attended a workshop on repositioning and rebuilding a company to drive global sales. Led by Andrew Jones (former CEO of ClearStream Technologies), this thoroughly informative one-day workshop showcased the evolution of ClearStream and

mapped out the background to a story of true survival through the repositioning and rebuilding of the company.

n In September, over 20 IMDA member companies attended a workshop on accessing high-growth markets. The workshop, which took place in SteriPack, Co Offaly, featured

SHArIng BeST PrACTICe AnD BuIlDIng THe FuTure SKIllS PIPelIneAs the pace of change accelerates, there is pressure on medtech companies to revisit their sales, marketing and market access functions to address the different needs of customer segments. with Caolan Bushell (Mergon Healthcare) as Chair and Brian Clarke (Zeus Industrial Products) as Vice Chair, the IMDA’s Sales and Marketing working group is helping companies to adapt.

sales and markeTing

Pictured in October at the Executive Management Sales Programme, held in Galway, were Tobi Laczkowski, ZS Associates; Sinead Keogh, IMDA; Colm Flood, SteriPack; Maura Leahy, Creganna-Tactx Medical; and Caolan Bushell, Mergon Healthcare.

The Medical Technology Sector Map is now online and interactive.

Visit www.imda.ie to update your company’s details.

updates on doing business from a cultural perspective in Malaysia, China, Singapore, India and Thailand.

n In October, over 20 IMDA member companies attended a sales workshop for managers with responsibility for planning and implementing business development and sales strategies within their organisation. Supported by IMDA’s Life Sciences Skillnet, the two-day workshop included topics such as the development of high-impact strategies to accomplish company goals.

Addressing international sales and medical marketing skills gapsIn conjunction with the Life Sciences Skillnet, the Sales and Marketing Working Group has also developed a conversion programme for international sales and medical marketing, which will include industry placements. Recruitment will take place during summer 2013, and the programme will commence in September.


The Public Image Taskforce has been promoting the vibrancy and dynamism of the sector in Ireland on a national and international scale and the following offers a flavour of the wide-ranging initiatives undertaken in 2012.

n In conjunction with Enterprise Ireland and IDA Ireland, the IMDA came together with Ireland’s technology news service Silicon Republic to launch a national and international PR campaign to heighten awareness of the medtech sector in Ireland. The campaign also includes the development of a medical technology microsite at www.siliconrepublic.com/medtech. In excess of 40 medtech-related editorials have been

featured on the microsite. Silicon Republic attracts more than 260,000 unique visitors per month. Approximately 50% of this website traffic is based outside Ireland.

n A PR campaign was conducted around the sixth annual Medical Technology Industry Excellence Awards, resulting in significant coverage of the sector across Ireland, the uK and Europe. Media partners included European Medical Device Technology (EMDT), Medtechinsider, Med-Tech Innovation and Silicon Republic. A review of editorials is available at www.imda.ie/awards.

n The Medical Technology Industry Excellence Awards provide an

opportunity to capture, reward and promote best practice across the sector both nationally and internationally. Fourteen company profile videos have been developed and uploaded to the IMDA YouTube channel and awards website over the past two years. These videos have received more than 6,000 hits to date and showcase Ireland as a global centre for medical technology.

n In conjunction with PharmaChemical Ireland, the IMDA hosted a stand at the 2012 BT Young Scientist & Technology Exhibition. Cook Medical and Labs are Vital participated on the stand and the event attracted close to 50,000 students, teachers and parents over three days.

n The IMDA has partnered with Smart Futures to develop a sector-specific media campaign to raise the profile of careers in medtech. The campaign, which began in September 2012, is aimed at second-level students. Ten IMDA members have provided company profiles for the website www.smartfutures.ie, which also features an on-line careers fair and competitions. Overall website traffic averaged at 500 visits a day during the peak, with a total of 62,000 hits in 2012.

n The Ireland by Numbers medical technology video, which highlights statistics about the sector in Ireland, attracted in excess of 2,500 hits on YouTube throughout 2012.

SPREADIng THE gooD nEWS ABouT IRISH MEDTECH Times are turbulent yet we have a consistently high-performing medtech sector in Ireland. The IMDA’s board-led Public Image Taskforce, chaired by Bill Doherty of Cook Medical, has been telling this story more robustly and with purpose.

public image

Pictured in Trinity College Dublin at the launch of STEM Careers Week and the Smart Futures Campaign were (l-r): Minister Sean Sherlock, TD; Dr Sinead Keogh, IMDA; and Dr Graham Love, DSE.

Pictured at the BT Young Scientist Exhibition 2012 were students Luka Murray and Glen Hogan from Kilbride National School, Clonee, Co Meath with (l-r): Sinead Keogh, IMDA and Meurisse Leahy, Cook Medical.


WORKING TOWARDS A BALANCED REGuLATORY ENVIRONMENTTimely access to the best available medical technology while protecting patient safety is at the core of the IMDA’s regulatory policy and lobbying activities. This work is spearheaded by the IMDA’s regulatory Steering Committee with John Kilmartin (Medtronic) in the position of Chair.

With the publication in September of the Eu

Commission’s proposal for future regulation of medical devices, it is no surprise that the revision of the Medical Devices Directives (MDD) continued to be a key priority for the IMDA throughout 2012.

Various stakeholders agree that the current European regulatory system provides a high level of patient safety, availability of latest technology solutions, appropriate costs and timings and a strong innovation capability. However, the medical device industry unanimously agrees that an overhaul of Europe’s regulatory framework is necessary to improve the system that has been the world’s fastest in providing life-saving technologies to patients without

compromising safety. The MDD Revision

proposals, which are currently undergoing legislative scrutiny, contain elements which have been strengthened including:

n more rigorous designation and audit of Notified Bodies;

n more vigilance and coordination between national surveillance authorities;

n more traceability;

n clearer requirements for clinical evidence;

n increased regulation of reprocessing of single-use devices;

n more harmonised guidance and relevant stakeholder involvement;

n and clearer roles and responsibilities for economic operators.

While industry broadly welcomes the proposals, it expresses concern over Article 44 which calls for a mechanism for scrutiny of certain conformity assessments. This process will delay the final approval by Notified Bodies by a minimum of 60 days and happens after the Notified Body has finished the evaluation. Industry strongly feels that the scrutiny procedure is an unnecessary bureaucratic addition.

The medical device industry and associated trade organisations, including IMDA, are working to ensure that the proposal amendment process will provide the best outcome for patients and industry and ensure that innovation and patient safety are not threatened. Industry ultimately wants to ensure that the Eu continues to benefit from a rapid and safe

progression to market of new medical devices.

Throughout 2012, the IMDA held many high-level meetings and continues to work closely with MEPs and other relevant stakeholders on this critically important issue.

Since the proposals were published in September, Europe’s medical technology trade associations met on 27 November in Brussels to discuss a united response. Following on from this meeting, members of the IMDA’s Regulatory Steering Committee and executive team met with six Irish MEPs (Marian Harkin, Mairead McGuinness, Nessa Childers, Phil Prendergast, Séan Kelly and Pat the Cope Gallagher) along with parliamentary assistants and a representative from Ireland’s Health Attaché.

At this meeting IMDA articulated the industry’s

“ Industry ultimately wants to ensure that the eu continues to benefit from a rapid and safe progression to market of new medical devices.”

regulaTion


position, stating that most of the recommended measures proposed by the European Commission are welcomed as they improve patient safety, do not unnecessary delay patient access to life-saving medical technologies and do not hamper innovation. The IMDA highlighted, however, that industry has strong concerns with regard to the scrutiny procedure as it is in grave danger of driving the system towards a centralised approach of pre-market authorisation, similar to the FDA approach in the united States. As a result of this meeting, Irish MEPs came away with a heightened understanding of the medical device industry’s position on the MDD Revision, particularly with regard to the scrutiny procedure.

In the months ahead and throughout Ireland’s

forthcoming presidency of the Eu, IMDA will continue to liaise with MEPs and other relevant stakeholders on this issue. Revision of the MDD has been identified as a priority area for the Department of Health and is expected to be adopted before the European Parliamentary elections in 2014.

01 Pictured at the European Parliament in June 2012 were (back row l-r): Bill Doherty, Cook Medical; Eoghan Ó Faoláin, IMDA; Donal Balfe Covidien; John Kilmartin, Medtronic; Emmett Devereux, Cook Medical; with (front row l-r) Sharon Higgins, IMDA; and Mairead McGuinness MEP. 02 Pictured in October at the Quality and Regulatory Forum, held in Dublin, were (l-r): Dr Áine Fox, IMDA Executive; Robbie Walsh, Director of Regulatory Affairs Europe, Boston Scientific; and Pam Mackey, Manufacturing Quality Manager, Bausch+ Lomb. The Quality and Regulatory Forum covered topics of interest to the quality and regulatory community including the highly topical revision of the Medical Devices Directives. 03 Pictured in Galway at the IMDA Global Access 2012 Dinner were: (l-r) Sarah Roarty, who presented a patient’s story on behalf of her daughter Clara, who has Angelman’s Syndrome; Nessa Childers, MEP; and Sharon Higgins, Director, IMDA.

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Amid relentless technological innovation and fierce global competition, the IMDA is working hard to ensure that the medical technology sector continues to be equipped with the right level of skills and expertise to meet the challenges of a rapidly changing industry.

armed with the knowledge that innovation, technology

management and entrepreneurship will play a key role in the future of our industry, the IMDA is spearheading and supporting a wide range of initiatives to ensure that Ireland retains its global reputation for a highly educated and talented workforce.

BioInnovate Ireland

The IMDA is the industry partner to BioInnovate Ireland, a fellowship programme modelled on the prestigious Biodesign Programme offered at Stanford university, California. Bioinnovate academic partners include the National university of Ireland, Galway, university of Limerick, Dublin City university and university College Cork.

BioInnovate is a multidisciplinary training programme to support innovation in the medical devices sector. Two elite

multi-disciplinary fellowship teams are recruited annually with each team composed of four high-calibre fellows from either a medical, engineering, business or technical graduate background. The teams focus on a specific clinical area, identifying unmet needs, inventing solutions to meet those needs, and mapping a route to commercialisation. For physicians to be involved in this process is brand new.

The 2011/12 teams focused on cardiovascular disease and initially came up with 400 ideas from their observations. Eventually two projects came to the fore – a vascular support device for grafting and technology to improve vascular embolism. Both projects are being funded by Enterprise Ireland to be developed further.

Structured PhD programme in Biomedical engineering and regenerative Medicine IMDA is also an industry supporter of the structured PhD programme in Biomedical Engineering and Regenerative Medicine (BMERM). This four-year programme is delivered by a core partnership of academic institutions

(National university of Ireland, Galway; university of Limerick and university College Cork) linked with a wider consortium of national and international institutions. BMERM combines a PhD research project with a practical learning programme, resulting in a unique learning experience for the student due to its combination of outstanding research and clinical and industrial interaction.

Quality engineering training for jobseekers

Following a detailed proposal, the IMDA secured funding from Springboard to train 60 unemployed engineers for 12 weeks and place them on a six-month internship in the life sciences sector. One cohort of 30 students began training in the university of Limerick in September 2012 and the second cohort will start in January 2013.

Springboard is an initiative, managed by the Higher Education Authority on behalf of the Department of Education and Skills, under which certain groups

of unemployed people can pursue a course of higher education and training on a part-time basis in an area of current or future skills need. The IMDA Springboard programme was developed specifically to enable unemployed engineers and technicians of traditional disciplines to convert to the medical device and pharmaceutical sectors.

Strategic trainingIMDA, with support from the Life Sciences Skillnet, continued to provide key strategic training to the sector throughout 2012 with many industry programmes held throughout the year. These included:

n the Medtech Future Leadership Programme;

n viewing of live knee surgery at Cappagh National Orthopaedic Hospital;

n designing cardio-vascular devices;

n sales and marketing (see page 16 for more information);

n Lean leadership (see page 23 for more information).

FuTuREPROOFING OuR INDuSTRY

skills and knoWledge


Pauline O’Flanagan, network Manager of the life Sciences Skillnet, tells us how the IMDA’s life Sciences Skillnet continues to expand its offering and boost business competitiveness through training, upskilling and professional development programmes.

BOOSTIng COMPeTITIVeneSS

life sciences skillneT

our manufacturing base is funda-mental to the medtech sector

in Ireland and will always underpin our strong global foothold. Operational excellence is front and centre in maintaining our culture of manufacturing and is critical to the continued success of the sector. This is why the core function of the IMDA’s Life Sciences Skillnet is to provide invaluable support to manufacturers in their bid to remain competitive. However, our offering also goes a great deal further with programmes in quality control, technical skills, and research and development – as well as highly strategic sector-specific programmes for middle and senior management.

Over the past five years, we have distributed in excess of €1.3 million of Government funding towards the cost of training to the life sciences sector. In 2012, we trained 842 employed trainees and delivered 2,682 training days.

In a significant development, we are now a FETAC approved centre

and since validating our Continuous Improvement in Manufacturing award (FETAC level 5), we have certified 212 trainees working at operative level across eight multinational and indigenous companies.

In addition to Continuous Improvement training, other in-company training being delivered includes the unique Behavioural Based Quality Programme; Leadership Development; Certified Lead Auditor Training; and Quality Engineer Training accredited by the American Society for Quality.

An overview of other important developments from 2012 includes the following:n In collaboration with

the IMDA’s Operational Excellence Taskforce, the Skillnet continued to enhance and roll out the MÓR™ Benchmark Model, as outlined in detail on page 22.

n Also in collaboration with the Operational Excellence Taskforce, the Skillnet developed a Lean Leadership programme in

conjunction with Cardiff university. The first of its kind, the programme is described in detail on page 23.

n The Skillnet brought 32 trainees to the Toyota Lean Management Centre in Deeside, Wales. This workshop provided superb practical insight into the Toyota Way, the Toyota Production System and Toyota Lean tools and techniques.

n As described on page 16, international sales skills have been identified as a skills gap within the medical technology sector in Ireland. In response to this, 20 Life Sciences Skillnet members attended an intensive, hands-on, two-day workshop, which was developed in conjunction with international thought leaders.

n From August 2011 to May 2012, the Skillnet coordinated a conversion training programme for 25 unemployed engineers. These trainees were qualified in the traditional disciplines of civil, mechanical and electrical engineering and the programme provided the trainees with an opportunity to secure the skills and experience necessary to work in the medical device and pharmaceutical sectors. The Skillnet is very proud to report that 78% of trainees went on to secure employment and a second programme commenced in July 2012.

Pictured below at the graduation ceremony for the Life Sciences Skillnet’s Engineers Conversion Programme were (l-r): Noreen Fitzpatrick, Skillnets Ltd; Pauline O’Flanagan, Life Sciences Skillnet; Professor Declan McCormack, DIT and David Murray, Intern at Bluebridge Technologies.

21IMDA ANNuAL REVIEW 2012

TRAILBLAzING THE WAY FORWARDOur core manufacturing base is fundamental to the medtech sector in Ireland and will always underpin our strong global foothold. The IMDA has a deep understanding of the importance of operational excellence in maintaining and enhancing our manufacturing presence.

chaired by Mike Farrell of Siemens Healthcare Diagnostics,

the role of the IMDA’s Operational Excellence (Op Ex) Taskforce is to promote and strengthen the value of best-in-class manufacturing operations as a key part of Ireland’s overall economic development strategy. The year got off to a good start when the Government’s Action Plan for Jobs 2012 articulated a clear commitment to manufacturing in Ireland and elaborated on the range of initiatives and supports that will be put in place to demonstrate this commitment. IMDA board member James Winters (DePuy) was also appointed to the Manufacturing Development Forum, which was established to assist the Government in progressing a transformation agenda in this area.

2012 was subsequently a very busy year for the Op Ex Taskforce and exciting developments were made in identifying and promoting the appropriate processes, structures, policies and supports required to facilitate an ever-stronger culture of manufacturing and operational excellence.

MÓr™ Benchmark Model With support from the Life Sciences Skillnet, the IMDA has created a pioneering industry-driven operational excellence framework to support companies. Aptly named MÓR™ (meaning “great” in Irish), the benchmark model was pre-launched in early 2012 and has been rolled out in a number of IMDA member companies to an excellent reception.

Devised by the IMDA’s Op Ex Taskforce under the guidance of Chair Mike Farrell (Siemens Healthcare Diagnostics), Vice Chair Bernie Reynolds (Covidien) and taskforce member Cathal O’Reilly (DePuy Ireland), the MÓR™ Benchmark Model 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 and ultimately achieve a competitive advantage. As well as pointing towards appropriate resources and areas of expertise, this exceptional tool also allows members the opportunity to benchmark themselves against other companies.

operaTional excellence

“ As the first medical device manufacturer in europe to be awarded the global Shingo Bronze Medallion accreditation for operational excellence, lake region Medical endorses the IMDA’s MÓr™ Benchmark Model as a highly interactive and user-friendly tool which enables Irish companies to identify the greatest barriers to becoming a world class operation as well as detailing the steps required to overcome them. At lake region Medical, we are using the MÓr™ Benchmark Model to plot our journey towards a successful Shingo Prize challenge in 2015.”John Harris, Vice President of OuS Operations, lake region Medical

Pictured above (l-r) were: Padhraic McGinn, Nypro Healthcare; Marie Bourke, Forfás; Bernadette Reynolds, Covidien and Vice Chair of IMDA’s Op Ex Taskforce; Con Gregg, Consultant to Forfás on Future Skills Needs Study in Manufacturing; Mike Farrell, Siemens and Chair of IMDA’s Op Ex Taskforce; and Adrienne McDonnell, IMDA Executive.


realising opportunities and maintaining growth. IMDA members and executives played a key role in these workshops.

Conclusions arising from the workshops included the following:

n New models for organising manufacturing need to be understood and embraced.

n Digital technologies will continue to “disrupt” and need to be mastered.

n Collaboration will enable us to compete better.

n Responding increasingly quickly to customers’ needs will be a key uSP and will have implications for work practices.

n Adjacent possibilities offer prospects for significant new product and service opportunities.

n Embracing organisational change and upskilling is vital.

Throughout 2012, the Op Ex Taskforce has fed into the national policy development activity under Forfás.

Future Skills Needs in Manufacturing in IrelandDovetailing into the Long Term Vision and Strategic Plan for Manufacturing in Ireland, is the Forfás study by the Expert Group

on Future Skills Needs to identify a range of important skills-related issues for the sector. An extensive programme of company interviews, workshops and stakeholder consultations took place to deepen the understanding of the issues and identify actionable education and training solutions that can be pursued through relevant policies. IMDA conducted a member’s survey to understand the skills gaps that exist in the industry, the results of which showed gaps in the availability of computer, quality/validation and mechanical engineers. This data has been shared with Forfás along with a number of other key recommendations by the Op Ex Taskforce including:

n the creation of a national apprenticeship programme;

n continuation of funding for the engineers conversion programmes by Springboard and the Life Sciences Skillnet;

n the creation of a centre of excellence to provide practical application opportunities for Lean improvement projects

n continued support via the Life Sciences Skillnet for the IMDA Lean Leadership Programme (see below).

Driving operational excellence through lean leadershipThe IMDA’s Op Ex Taskforce also developed an innovative Lean Leadership Programme in conjunction with Cardiff university, entitled Driving Operational Excellence through Lean Leadership. The first of its type, the eight-day programme was funded by Life Sciences Skillnet and incorporated a three-day immersed practical approach to learning at Abbott Diagnostics, Longford.

Influencing post-graduate programmes The need for engagement between industry and academia was highlighted by a member survey in late 2011, which indicated a large amount of member organisations are sending employees abroad for training in lean manufacturing. In early 2012 the IMDA’s Op Ex Taskforce met with key third-level institutions across Ireland to discuss their offerings in lean manufacturing at both masters and postgraduate level with a view to tailoring course content to industry needs. Initial feedback is very positive, with both university College Cork and university of Limerick enhancing their courses to reflect IMDA members’ recommendations. A new postgraduate diploma has also been approved in Waterford Institute of Technology.

Throughout 2012, a series of workshops were held in Dublin, Cork and Galway to train members on how to implement the model. Once training has been received, members can then download the model from the IMDA website.

The model provides a holistic diagnostic tool to help companies create a leaner business culture through the application of various tools. Furthermore the model was developed with the internationally recognised ”Shingo Award” in mind, and so supports companies embarking on the Shingo Award route. The model’s unique features centre around its process-oriented approach, and a novel “heat map” summary that identifies areas requiring focus and suggests the appropriate lean tools to apply. This enables companies to strategically align themselves with their overall business objectives. Testament to the model’s value is the fact that it is already being sought after by members’ international sites. The IMDA is currently working on some exciting developments to build on the model’s potential as a first-rate mentoring resource and independent auditing tool, and we look forward to updating you throughout 2013.

representing the industryThe Op Ex Taskforce has been heavily involved in representing IMDA members in two Forfás studies:

A Long Term Vision and Strategic Plan for Manufacturing in IrelandAs part of the consultation and strategy development process, Forfás hosted a number of consultation workshops with manufacturing companies. The aim of these workshops was to collectively discuss the future of manufacturing in Ireland in the context of global trends and drivers, and to identify opportunities and challenges faced by manufacturing companies in


IRISH MEDICAL TECHNOLOGY INDuSTRY CeO FOruM 2012Hosted by the IMDA, enterprise Ireland and IDA Ireland, the sixth annual CeO Forum focused on the evolving face of global healthcare and how Ireland can continue to strengthen and advance its leadership position. The day, which has become a firm fixture in the calendar for Ireland’s medtech thought leaders, was packed with inspiring presentations, open-minded debate and opportunities to meet old friends and new.

setting the tone and introducing delegates to many of the day’s

recurrent themes was keynote speaker David Pierce, Senior Vice President and President of Endoscopy at Boston Scientific. under the overarching narrative that the medical devices industry is in a dynamic period of change, Pierce walked the audience through the ensuing challenges and opportunities, from the global economic crisis through to emerging markets and unmet clinical needs. A consistent patient-centric culture, an aligned sales model and a value proposition that extends beyond the device were the core facets of Pierce’s presentation. ”And innovation will always rule the day,” he concluded.

With the scene set, Kieran Devery and Lorraine Griffin from Deloitte took to the stage to present the joint IMDA/Deloitte business foresight model, detailing how companies can evolve their business models to respond to many of the

global developments and trends outlined by Pierce. The business foresight model is described in detail on page six.

IBEC’s Chief Economist Fergal O’Brien presented a refreshingly balanced analysis of the current state of the economy, highlighting that the domestic economy has stabilised and is poised for recovery. Delegates learnt that 85% of austerity has been delivered and that Ireland has regained substantial labour cost competitiveness over recent years. O’Brien also stressed that exports achieved another record performance in 2012 and that Ireland remained on the path of export-led growth.

Concluding the opening session was IMDA’s outgoing Chairman Paraic Curtis, who provided some powerful insights into the value proposition of medical devices from the customer’s perspective. Curtis also updated delegates on the IMDA’s Statement of Strategy 2012-2015, which is detailed on page five.

The second session of the day focused on the critical success factors

involved in growing and rapidly scaling a medical technology business and Kevin Conroy, president and CEO of Exact Sciences Corporation, was first to take to the podium. Conroy imparted invaluable advice on how to successfully capitalise a company while in turnaround or rapid-growth mode by detailing his experiences at Third Wave Technologies and Exact Sciences. Having successfully turned both of these deeply troubled companies around, he advised delegates to focus on one thing that really matters. ”If you have more than three priorities, you really have none,” he stressed.

Helen Ryan, CEO of Creganna-Tactx Medical shared a true Irish success story, charting the inspiring evolution of Creganna-Tactx from start-up right through to becoming the global multinational that it is today. Transformation with a clear

vision and strategy emerged as a key theme, with Ryan also speaking about the importance of getting the right people on board, and having a little bit of fun along the way!

Ted Brombach and John “Yogi” Spence, managing partners at XMS Capital, focused on the things you always wanted to know about fundraising but were afraid to ask. At the core of Brombach’s and Spence’s presentation was the belief that capital is not scarce but vision is, and they subsequently focused their talk on how to present your vision in the right way to attract capital. Echoing Conroy, simplifying and focusing your “ask” was a key piece of advice dispensed by the duo.

The session concluded with a robust panel discussion, which focused on the trade-off between venture capital and other sources of funding.

“Innovation will always rule the day” “If you have more than three priorities, you really have none”


IRISH MEDICAL TECHNOLOGY INDuSTRY CeO FOruM 2012

“Prepare to embrace change”

The final session of the day featured three companies that

have successfully managed market challenges, as well as deep-rooted change from within their respective organisations.

First up was Frank O’Regan, Vice President of Global Operations at Bausch & Lomb, who informed delegates of the huge change undergone by Bausch & Lomb in Waterford following its acquisition by Warburg Pincus in 2007. O’Regan focused on the opportunities that can present themselves through innovation and change, and stressed the importance of getting on with the hard decisions.

Conor Hanley is Managing Director of ResMed Ireland, which acquired BiancaMed (a spin-out of uCD) in

2011. Hanley spoke in very real-world terms about the importance of connected health, and described how the sophisticated ecosystem in Ireland was key to ResMed’s decision to acquire BiancaMed.

The final speaker of the day was Pauline Oakes, Director of Operations at C.R. Bard, who spoke about the evolution of ClearStream from its establishment in 1996 until it was acquired by Bard in 2011. Overnight, ClearStream went from being a small company to being part of a large multinational organisation and Oakes gave an honest insight into key learnings over the previous year. “Prepare, communicate and prepare to embrace change,” she advised. A fitting conclusion to a day with the theme of change at its very core.

Gold sponsors

Silver sponsors

01 Pictured at the CEO Forum were (l-r) Brian O’Neill, Manager of Lifesciences, Enterprise Ireland; Kevin Conroy, President and CEO, Exact Sciences Corporation; Helen Ryan, CEO, Creganna-Tactx Medical; John ‘Yogi’ Spence and Ted Brombach, Managing Partners, XMS Capital; Chris Coburn, Executive Director, Cleveland Clinic Innovations; and Daniel O’Mahony, Partner, Seroba Kernel Life Sciences. 02 David Pierce, Senior Vice President and President, Endoscopy, Boston Scientific. 03 (l-r) Paraic Curtis, Chairman, IMDA and Vice President, Endoscopy Division for EMEA, Boston Scientific; Kieran Devery and Lorraine Griffin, Deloitte; Fergal O’Brien, Chief Economist, IBEC; and David Pierce, Senior Vice President and President, Endoscopy, Boston Scientific. 04 (l-r) Barry Heavey, Global Head of Life Sciences, IDA Ireland; Frank O’Regan, Vice President, Global Operations, Bausch + Lomb; and Pauline Oakes, Director of Operations, C.R. Bard.

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MeDICAl TeCHnOlOgy InDuSTry exCellenCe AwArDS 2012

lake region Medical won the prestigious title of Irish Medical Technology Company of the year 2012 and Technopath Manufacturing were honoured with the title of emerging Medical Technology Company of the year at the sixth annual Medical Technology Industry excellence Awards. The awards were jointly hosted by enterprise Ireland, IDA Ireland and the IMDA.

lake Region Medical is an original development manufacturer of

minimally invasive devices and components with clinically-focused product innovations. It is an industry expert in developing and marketing medical devices to meet unique clinical challenges for stimulation therapy, cardiovascular,

neurovascular, and peripheral vascular applications.

Technopath Manufacturing is a privately held company that manufactures products for a number of multinational in-vitro diagnostic companies. Its products monitor the quality of hospital laboratory blood tests and prevent the reporting of incorrect results, thus ensuring optimal patient care.

Also on the night, DePuy Ireland received the Silver Medical Technology Company of the Year Award, while Stryker Ireland and Hollister were highly commended. neoSurgical received the Silver Emerging Medical Technology Company of the Year Award, while i360 and APICA Cardiovascular were highly commended.

01 Pictured at the Medical Technology Industry Awards 2012 were (l-r): Sharon Higgins, Director, IMDA, Joseph Fleischhacker, CEO, Lake Region Medical; John Harris, Vice President of Operations, Lake Region Medical; and Barry O’Leary, CEO, IDA. Lake Region Medical won the title of Irish Medical Technology Company of the Year. 02 (l-r) Malcolm Bell, CEO, Technopath Manufacturing and Brian O’Neill, Lifesciences Manager, Enterprise Ireland. Technopath Manufacturing won Emerging Medical Technology of the Year. 03 Liz Keane, DePuy Ireland, with the silver award for Medical Technology Company of the Year. 04 John O’Shaughnessy was honoured with the prestigious Medical Technology Outstanding Contribution Award. O’Shaughnessy is one of the original trailblazers for the medical device sector in Ireland with thirty years’ experience across a number of disciplines including top level general management, senior operations and commercial management. 05 (l-r) Sharon Higgins, Director, IMDA and Barry Russell, CEO, neoSurgical. neoSurgical won the silver award for emerging medical technology company of the year.

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eVenTS 201201 Pictured in October at an intensive two-day Executive Sales Programme, held in Galway, were (l-r): Mick McEnroe, Harmac Medical; Sinead Keogh, IMDA; Brian Chapman, ZS Associates; Joan McCabe Creganna-Tactx Medical; Garett Coady, BlueBridge Technologies and Michael O’Reill, Phillips-Medisize. 02 Pictured in September at the IMDA Lean Leadership Programme in Galway were (l-r): Sean Kelly, Abbott Diagnostics; David McKernan, Teleflex Medical; Pauline O’Flanagan, Life Sciences Skillnet; John Bicheno, LERC; Suzanne Carroll, Bellurgan Precision Engineering; and Fred O’Brien, Siemens Healthcare Diagnostics. 03 Pictured at the IMDA’s Global Access 2012 conference, held in Galway, were (l-r): Ann O’Connor, Irish Medicines Board (IMB); John Kilmartin, Medtronic and Chair of IMDA’s Regulatory Steering Committee; Robbie Walsh, Boston Scientific and Chair of IMDA’s Quality and Regulatory Forum; and Eoghan Ó Faoláin, IMDA Executive. 04 Pictured in October at the IMDA Future Leadership Programme in Limerick were (l-r): Patrick Redmond, Siemens Healthcare Diagnostics Manufacturing; Sharon Higgins, Director IMDA; and John Lynam, Thomas International. 05 Also pictured at the IMDA Future Leadership Programme were (l-r): Catherine Connolly, Boston Scientific; Dermot Doherty, IMDA Intern; and Joanne O’Flaherty, Boston Scientific. 06 Pictured in October at the IMDA’s Quality and Regulatory Forum held in Dublin, were (l-r): Thomas Breslin, Regulatory Affairs Manager, EMEA, Covidien; Mark Mullaney, Regulatory Affairs Manager, Merit Medical; Gert Boss, Head of Regulatory and Clinical Affairs Medical Devices, BSI; and Audrey Hobson, Director of Regulatory Affairs, EMEA, Teleflex Medical. 07 Pictured in September at the IRDC Working Group’s Polymer Workshop at Athlone Institute of Technology were (l-r): Joe Dowling, Bausch + Lomb Ireland; Richard Cowman, Synergy Health; John Reid, Abbott Diagnostics and Vice Chair of the IRDC Working Group; Sinead Keogh, IMDA; and Clem Higginbotham, Athlone Institute of Technology. 08 Pictured in February at the IRDC Working Group meeting at CRANN, Trinity College Dublin were (l-r): Professor John Boland, CRANN; Dr Chris Keely, CRANN; and Darragh Colgan, Boston Scientific and Chair of the IRDC Working Group. 09 Pictured in March at the Irish Institute of Training and Development Awards Ceremony were (l-r): Pauline O’Flanagan, Life Sciences Skillnet Network Manager; Denise Marron, President of the Irish Institute of Training and Development (IITD); Noreen Fitzpatrick, Skillnets Programme Support Manager; and Eoghan Ó Faoláin, IMDA Executive. 10 Pictured in University of Limerick in November were Hilda Mulvihill, Stryker Orthopaedics and Sharon Higgins, Director, IMDA with students from the structured PhD programme in Biomedical Engineering and Regenerative Medicine. 11 Pictured at the Irish Medical Technology Industry Excellence Awards were the finalists for the Emerging Company of the Year (l-r): Derek Young, CEO, i360; Malcolm Bell, CEO, Technopath Manufacturing (Winner); Brendan Cunniffe, Business Development and Barry Russell, CEO of neoSurgical (Silver Award). 12 Also pictured were (l-r): Pat O’Malley, Hollister ULC and finalist for Medical Technology Company of the Year 2012 with Andrew Vogelaar, Head of Medical Devices, IDA. 13 Also pictured at the Awards were (l-r): Dave Tallon, Stryker Ireland and finalist for Medical Technology Company of the Year with Andrew Vogelaar, Head of Medical Devices, IDA.

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InVeSTMenT newS 2012The medical technology sector in Ireland remains vibrant and dynamic, as borne out by the following announcements in 2012.

Cambus Teo is to create 35 new jobs following the 50% acquisition of the company by global medical device company Helix Medical. As part of that arrangement, Helix Medical agreed to provide expansion funding to the Galway company for further development.

Cook Medical’s Irish operation is to invest up to €16.5 million over four years creating 12 highly skilled positions in research and development activities at its Limerick site. This investment is supported by IDA Ireland.

Delcath Systems, Inc. opened its European Headquarters in Galway. Delcath is the developer of the Hepatic CHEMOSAT® Delivery System, a device used in a new therapeutic approach for patients with cancers in the liver.

Diaceutics is to create 20 new jobs, which will be housed in the Incubation Centre in Dundalk Institute

of Technology, and will focus on the further development, support and sale of its personalised medicine software.

lynch Medical Supplies (lMS) announced a significant investment in a new central headquarters facility in Swords, Co Dublin. The company, which currently employs sixteen people, has seen continuous annual growth of approximately 25% year on year.

Mainstay Medical is to move its head office and executive leadership to Dublin from its Minnesota base in the uS. The company raised €15.3 million in funding to help advance its medical device to treat lower back pain. The Series B financing round was led by Fountain Healthcare Partners, the life science-focused venture capital fund headquartered in Dublin

Merit Medical Systems announced the creation of 200 new jobs over five years

at the official opening of its new €20 million Galway facility. The investment is supported by IDA Ireland.

nypro Healthcare announced that it will open a new medical device development centre at its facility in Bray, Co Wicklow, creating 100 high-quality jobs. This brings Nypro’s total Irish workforce to 460.

resMed announced that it is to expand its research, development and innovation facility at its operation in NexusuCD, the innovation partnerships centre at university College Dublin. Fifty jobs will be created, with the support of IDA Ireland.

Stryker Ireland announced that twenty new research and development jobs are to be created as part of a uS$30 million investment by medical devices player Stryker Instruments at its facility in Carraigtwohill, Co Cork.

Surgacoll, a spin-out of the Royal College of Surgeons in Ireland (RCSI), closed a €2 million syndicated investment round involving AIB Seed Capital Fund, Harmac Medical Products, Enterprise Ireland and a number of private investors. The company was set up to commercialise research into tissue regeneration and create products to surgically treat diseases of the bone. Technopath Manufacturing announced the creation of 40 new jobs on the back of a €3 million investment to scale their manufacturing capability and drive export activity. The investment was supported by Enterprise Ireland.

VistaMed announced the creation of 79 jobs at its medical devices plant as part of a €7.2 million investment in research and development. Enterprise Ireland is supporting the investment.

“ A key part of my plan to get jobs and growth back into the economy again is to target sectors where Ireland has distinct advantages and the potential for large-scale jobs growth. life sciences and medical devices are sectors where we have built up very substantial strength over a period of many years: the challenge now is to build on that to achieve the jobs growth we need.” richard Bruton, Minister for Jobs, enterprise and Innovation


medTech in ireland by numbers


There is no doubt that 2012 was a challenging year for Ireland, for europe and for the global economy. global economic growth has slowed having been hampered by a number of factors including the ongoing uS fiscal negotiations and the eurozone debt crisis. However, it is important not to let this story overshadow the progress made by Irish and european business over the past 12 months.

despite the difficulties, 2012 was another record year for exports

and there are increasing signs of stabilisation in the rest of the economy. As Ireland takes over the reins of the Eu presidency, IBEC and the Irish Medical Devices Association (as a business sector within IBEC) remain convinced that our fundamental business model remains strong and we are on a path to recovery.

That is why in April 2012, IBEC launched the Driving Ireland’s Recovery campaign, as part of our ongoing effort to put the views and priorities of business at the very top of the national agenda. The campaign sets out how to address the key challenges facing the country and the central role business must play. It provides an economic roadmap to achieve growth and informed all our key activity during the year such as championing a yes vote in the Fiscal Stability Treaty referendum; opposing ill-conceived plans

that would add to business costs; leading the calls for more radical and speedy reform of the public sector; and making the case for meaningful reform of our education system.

At the heart of this campaign is our ambition that Ireland can grow by 3-4% per annum over the coming decade. If Ireland is to achieve this, we will need all sectors of the economy to perform strongly and to match the success of the medtech sector over the past number of years. As we have witnessed throughout this review of IMDA’s activities, medtech has become one of Ireland’s most important sectors, responsible for over €7.3 billion in exports and employing 25,000 people. It has demonstrated tremendous flexibility and resilience.

However, there is no doubt that the industry is facing mounting pressures with greater competition from low-cost manufacturing economies alongside the ever-increasing focus on

global healthcare expenditure. While Ireland has retained its strong manufacturing base, we are seeing increasing complexity in the industry and a stronger focus on R&D. This focus on R&D will be vital if the medtech sector is to compete vigorously in the global economy. The recent findings of the European Commission’s 2012 R&D Investment Scoreboard, which shows Ireland as one of the top 10 Eu countries for industrial R&D investment, is to be welcomed.

It is clearly evident that the medtech sector, led by IMDA, has demonstrated tremendous ambition, both in Ireland and globally. The IMDA’s current strategy has set out an exciting and dynamic vision for the medical technology sector, alongside a range of comprehensive measures to support this vision. The continued development and implementation of the strategy is crucial to continuing and enhancing the success of the medtech sector.

Finally I wish to acknowledge that the current IMDA strategy has been spearheaded to date by outgoing IMDA chairman and recently-elected IBEC board member Paraic Curtis of Boston Scientific, and I look forward to the expertise and valuable insight that Paraic will bring to the IBEC board.

Danny McCoyDirector general, IBeC

On Friday 11 May 2012, the Irish Medical Devices Association was joined by Minister for Finance, Michael Noonan TD at the Cook Medical facility in Limerick. The group said a Yes vote was necessary to help Ireland’s exporters continue driving economic growth.

ADDreSS FrOM DAnny McCOy, DIreCTOr generAl, IBeC

in conclusion


3M Ireland

AAbbott Ireland Diabetes Care, Donegal Abbott Ireland Diagnostics Division, LongfordAbbott Ireland Diagnostics Division, SligoAbbott Ireland Nutrition Division, Ballytivnan, SligoAbbott Ireland Vascular Division, ClonmelAbbott Laboratories Ireland Abbott Medical Optics, WestportAbbott Nutrition, Finisklin, SligoAccellentAcorn RegulatoryAdvant MedicalAerogenAIB BankAlcon Laboratories IrelandAlere InternationalAllergan Pharmaceuticals IrelandAlpha PrecisionAmcor Flexibles SligoAMS Medical Systems Anecto ANSAmed, a Vention Medical CompanyApica CardiovascularAPS Materials IncArcRoyalArgutus MedicalArthur Cox SolicitorsAudit Diagnostics Avenue Mould Solutions

BB Braun Hospicare Bank of Ireland GroupBausch + Lomb Baxter Healthcare SABD MedicalBeckman Coulter Ireland Inc.Bellurgan MedicalBio Medical Research Bioclin Research LaboratoriesBiomedical Diagnostics InstituteBlueBridge Technologies Boston Scientific ClonmelBoston Scientific CorkBoston Scientific GalwayByrneWallace Solicitors

CCambus TeorantaCappella Medical DevicesCaragh PrecisionCharles River Laboratories Preclinical Services IrelandClearStream TechnologiesClinical CabinetsComplete Laboratory SolutionsCook MedicalCork Institute of TechnologyCovidienCovidien Diagnostic Plant, DublinCovidien European Customer Care Centre & Commercial Group, Dublin Covidien Medical Devices, AthloneCovidien Medical Devices, GalwayCovidien Medical Supplies Plant, TullamoreCovidien Principal Executive Office, DublinCPLCreagh Medical Creganna Tactx MedicalCroom Precision MedicalCrospon

DDeloitte & ToucheDePuy IrelandDiaSorin Ireland

eEnBIOErnst & YoungEuromedic Ireland

FFiltertek – An ITW Medical CompanyFinesse Medical Fleming Medical Fort Wayne Metals IrelandFresenius Medical Care

gGoodman Medical IrelandGrant Thornton

HHarmac Medical ProductsHollister u L CHospira

Ii360 Medical LimitedIBM IrelandInnovative Polymer Compounds

JJohnson & Johnson Vision Care

KKCI ManufacturingKelpac MedicalKPMGKPW Print

lLake Region Medical, New RossLake Region Medical International R&D Centre, GalwayLife Science RecruitmentLifewave Europe

MM & V Medical DevicesMainstay Medical LimitedMarvao Medical DevicesMedtronic Merck MilliporeMergon HealthcareMerit Medical Metal Improvement CompanyMoll Industries Movement Industrial Design

nNational university of Ireland GalwayNatus Nicolet IrelandneoSurgicalNetcare WellnessNeuraviNypro Healthcare

OOceana Therapeutics O’Flynn MedicalOlympus BiotechOmega Teknika/ Chefaro IrelandOutsource Technical Concepts

PPerfecseal IncPhardiagPharmabioServ Phillips-Medisize IrelandPro Tek MedicalProspectus Strategy ConsultantsProxy Biomedical

rRDJ GlynnRR Donnelly Global Turnkey SolutionsRSM Farrell Grant Sparks

SS3 GroupSA Partners Lean ConsultancySanmina SCI IrelandSeabrook Technology GroupSealed Air NelipakSealpackSeroba Kernel Life Sciences Shannon MicroCoil Siemens Healthcare Diagnostics Manufacturing SOTA Prosthetics and Orthotics (SSE) Specialised Sterile Environments SteriPack Stryker Ireland, Carrantuohill, Cork Stryker Ireland, LimerickSurgaColl TechnologiesSymmetry MedicalSyneccoSynergy Health IrelandSysComm Project Management

TTakumi Precision EngineeringTcoag Teleflex Medical Europe – AthloneTeleflex Medical Europe – Limerick Tornier Orthopedics Transitions Optical

uulster Bank university of Limerickutah Medical Products

VVascular Solutions zerusa Vitalograph Vivasure MedicalVolex Europe VWR International

wWaters Technologies IrelandWelch AllynWilliam Fry Solicitors

xX-Bolt Orthopaedics

yYoung Microbrush

Zzeus Industrial Productszimmer Orthopedics Manufacturing

If you are interested in joining IMDA please contact: [email protected] or visit: www.imda.ie

2012 IMDA MeMBer lIST


COrK

Knockrea House Douglas Road

Cork

PHONE + 353 (0)21 429 5511 EMAIL [email protected]

SOuTH eAST

Confederation House Waterford Business Park Cork Road Waterford


MID-weST

Gardner House Bank Place

Charlotte Quay Limerick


weST

Ross House Victoria Place

Galway


nOrTH weST

3rd Floor Pier One Quay Street

Donegal Town


IBeC eurOPe

Avenue de Cortenbergh, 89 Boite 2 1000 Bruxelles,

Belgium


www.ibec.ie/europe

IrISH MeDICAl DeVICeS ASSOCIATIOn

Confederation House 84/86 Lower Baggot Street Dublin 2 PHONE + 353 (0)1 605 1529 FAX + 353 (0)1 638 1529

EMAIL [email protected] www.imda.ie

Irish Medical Devices Association is a business sector within IBEC

www.ibec.ie

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