Irish Medical Devices Association Yearbook 2011 - FAEI · Irish Medical Devices Association...

Irish Medical Devices Association

Yearbook 2011Driving innovation through collaboration

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

250 The number of medtech companies in Ireland

50 The percentage of indigenous Irish medtech firms

11 Of the world’s top 13 medtech companies, 11 are located in Ireland

33 The percentage of the world’s contact lenses manufactured in Ireland

7.2 The value of Irish medtech exports in 2010

5 The number of clinical research facilities translating knowledge into patient care

25,000 The number of people employed in the industry

50 The percentage of ventilators worldwide in acute hospitals that are Irish made

30million

billion

The number of people with diabetes that rely on an injectable device manufactured in Ireland

No1 Ireland’s global ranking for inward investment jobs

By NumbersMedtech in Ireland

Proven track record • High productivity • Supportive fi scal infrastructure Skilled and educated workforce • ‘Can do’ attitute • Signifi cant cluster

To view and share a short, upbeat video capturing the success of the medical technology sector in Ireland, see www.imda.ie/0/MedtechIrelandNumbers

This video was developed in association with IDA Ireland and Enterprise Ireland.

FOREWORDSharon Higgins, director, IMDA

To our members and friends,

A warm welcome to the Irish Medical Devices Association’s 2011 Yearbook.

Throughout 2011, the medical technology sector in Ireland remained a bastion of strength compared to other industry sectors, as illustrated by the encouraging facts and fi gures on the opposite page. In weathering the global economic downturn, we have become more productive and competitive, and our industry will undoubtedly be a key driver of Ireland’s export-led growth in coming years. But the future is not without its challenges. Global healthcare expenditure is coming under mounting strain, and the industry in Ireland is under ever-increasing pressure to build on its reputation for producing high-end, clinically superior products and solutions that add proven economic value.

Given our existing capacity to adapt, we are well placed to address these challenges. As an industry, innovation has always been at the heart of what we do. But the future will demand a different kind of innovative thinking from all stakeholders across the medical technology sector.

And it is innovative thinking that is at the core the IMDA’s new four-year strategy, which was an integral part of our work in 2011. Under the leadership of our outgoing chairman, Gerry Mc Donnell (Stryker), we are now armed with a strong, clear vision of where we need to be and how we can best get there. I wish to acknowledge Gerry’s tremendous work as chairman, and thank him for his clear thinking, proactive leadership and availability throughout the year. I look forward to working with our new chairman, Paraic Curtis (Boston Scentifi c), who has also been a key driver of the strategy development process, and I welcome John O’Dea (Crospon) as our new vice-chair. I would also like to pay a special tribute to each of the IMDA board members who have given us their time, skills, energy and enthusiasm over the years.

In addition to presenting you with our new strategy, our Yearbook summarises our key achievements on priority areas in 2011, taking in operational excellence, convergence, marketing, regulation and skills development. And underpinning all our work throughout the year was our continued commitment to integrated, collaborative relationships across all medtech stakeholders, including Government departments, development agencies, the clinical community and regulators.

To our member organisations, I encourage you to ensure that you are getting the best out of the high-quality services the IMDA has to offer. To our members, our partners and our allied organisations, we look forward to working with you in 2012 towards an ever-stronger ecosystem for our industry to fl ourish. As always, the IMDA stands ready to help you as you navigate your way forward.

CONTENTS

Foreword 3

STRATEGIC THINKING

A note from our outgoing chairman 4

IMDA Statement of Strategy 2012-2015 5

Thought leaders: Q&A with the IMDA Board 8

IMDA: WORKING FOR YOU

IMDA: The voice of the medical technology industry 10

IBEC: Delivering for the medical technology sector 12

Protecting the industry: Code of Ethical Business Practice 13

Nurturing collaboration: Innovation, research, development and commercialisation 14

Spreading the good news: Marketing medtech 15

Mapping the medical technology sector in Ireland 16

Evolution not revolution: Ensuring safe, smart and effi cient regulation 18

Operational excellence: A new model for Ireland 19

Staying at the cutting edge: Skills and knowledge 20

Boosting competitiveness: IMDA’s Life Sciences Skillnet 21

UP-TO-DATE: NEWS AND EVENTS

Conference report: Irish Medical Technology Industry CEO Forum 2011 22

Medical Technology Industry Excellence Awards 2010 24

Medical Technology Industry Excellence Awards 2011 25

An outstanding contribution 26

Investment monitor 2011 27

Photo review 2011 28

Meet the team 30

IMDA member listing 31

IMDA Yearbook 2011 | 3

A NOTE FROM OUR OUTGOING CHAIRMAN

Introducing the IMDA Statement of Strategy 2012-2015Our strategic approach and plan has served us well over the past four years. There have been many successes to be proud of, in particular our signifi cant contribution to the recovery that is now underway in Ireland. The growth of our industry in recent times is testament to that contribution and as an export-led economy, it has never been more important that we lead from the front. You should all be very proud of the role that your business and this industry are playing on the path to recovery.

as mid-2010 when we collected as much information and input as possible from our members and other interested parties. Along with analysis of best quality market insight and assistance from a wide variety of sources, we crafted a strategic approach to steer us towards an exciting future for the IMDA and our members.

Our approach is broad and bold in its intent, but we are confi dent that it caters for the many and varied requirements

That stated, we need to recognise that our industry is changing rapidly. The industry trends outlined in the above table show that our continued success will depend more than ever on our ability to adapt.

It was within this context we embarked on the development of the next phase of our strategic plan. It began as early

of our members now and into the future. Through our strategic objectives and actions, we are also reaching out to those who wish to be involved in the creation of a dynamic and exciting future for the medical technology industry in Ireland, and I encourage you all to take full advantage of that opportunity.

4 | IMDA Yearbook 2011

Paraic Curtis, vice president, endoscopy division for EMEA, Boston Scientifi c, assumed chairmanship of the IMDA on December 8th 2011:

‘In 2011 we put huge work into developing a comprehensive and ambitious set of strategic objectives and actions to guide our work in the forthcoming years. The success of the strategy now requires a commitment to the implementation of the actions it recommends. During my tenure as chairman, I intend to determine the specifi cs required to execute the strategy profi ciently, and develop a working implementation plan. To take the strategy to the next level, I look forward to engaging with those who have the energy and skills required to build an even more innovative and successful medical technology sector in Ireland.’

INTRODUCING THE INCOMING IMDA CHAIRMAN

G CHAIRMAN

Gerry McDonnell,vice president and general manager, Stryker Ireland

MEDTECH INDUSTRY TRENDS

Global healthcare pressure The need to demonstrate the cost/benefi t of product

Increased competition The need to restructure

Industry complexity Intense collaboration becoming a major feature of the industry

The industry shift up the value chain Talent acquisition and retention key

Emerging Markets, emerging products and emerging systems Ageing population, need for new products and new markets

Intersection of healthcare and information technology Innovation across boundaries becoming important

IMDA STATEMENT OF STRATEGY 2012-2015

Strategy snapshot: Vision, mission and high-level strategyVision

Mission

High-Level Strategy


IRELAND WILL BE A GLOBAL LEADER IN INNOVATIVE PATIENT-CENTRED MEDICAL TECHNOLOGY PRODUCTS AND SOLUTIONS

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

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

IMDA’S MISSION IS TO SHAPE AND DELIVER THE INDUSTRY VISION BY:

Driving signifi cant agenda items in the industry vision

Providing services, support and information which will add value to the businesses of our members

STS RATEGIC AA THEMESS 1. Ecosystem Development

2. Industry Foresight3. Entrepreneurship4. IMDA Services to

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1. Ecosystem developmentUnder the ecosystem development pillar, the IMDA will focus on strengthening and future-proofi ng the medtech ecosystem in order to safeguard the sustainable development of the industry in Ireland. The broadest and most far-reaching of the four pillars, the actions have been broken up into two strands: the overall medtech ecosystem and the entrepreneurial environment.

To strengthen and future-proof the overall medtech ecosystem, IMDA will:

promote integrated and collaborative relationships across medtech stakeholders in the national and, as appropriate, global ecosystem;

identify and infl uence supportive policy development at a national and international level;

understand and infl uence where appropriate the complex business models being used throughout the global supply chain and their impact on Irish-based medical technology companies;

be the voice of the medical technology industry in Ireland.

To strengthen and future-proof the entrepreneurial environment, IMDA will:

maintain a positive and supportive environment for entrepreneurial activity;

address existing barriers facing medical devices entrepreneurs;

ensure engineers receive essential start-up education at third level;

ensure ongoing availability of experienced mechanical engineers;

promote a culture of commercialisation in universities;

attract leading international clinicians in the development and validation of Irish medical technology products and solutions.

2. Industry foresightWith huge transformation taking place in the medical technology sector, the industry foresight pillar is about driving our future, and infl uencing the strategic development of IMDA organisations by delivering best-quality industry foresight.

To achieve this, IMDA will:

develop a deep understanding of the complex business models being used throughout the industry and global supply chain, and their impact on Irish-based medical technology companies;

establish appropriate forums to enable industry thought leaders in Ireland to share knowledge, discuss the impact of changing models and where relevant, prepare for the future;

identify critical competencies and skills needed to align with new business models;

if and when appropriate, take steps to advocate for and infl uence a new business environment.

3. EntrepreneurshipNurturing entrepreneurs and developing a strong culture of entrepreneurship is critical to the future success of medtech in Ireland. To this end, the IMDA will enable medical devices entrepreneurs to access the expertise of experienced IMDA members.

This will be done by:

identifying and assessing knowledge gaps common to medical devices entrepreneurs;

identifying a network of experienced IMDA members prepared to bridge those knowledge gaps;

developing a practical framework whereby medical devices entrepreneurs and prospective entrepreneurs can avail of mentoring supports from experienced


IMDA STATEMENT OF STRATEGY 2012-2015

Strategic Themes and ActionsIN WORKING TOWARDS ITS VISION OF IRELAND AS A GLOBAL LEADER IN INNOVATIVE PATIENT-CENTRED MEDICAL TECHNOLOGY PRODUCTS AND SOLUTIONS, THE IMDA WILL FOCUS ON FOUR STRATEGIC PILLARS OVER THE COMING YEARS: ECOSYSTEM DEVELOPMENT, INDUSTRY FORESIGHT, ENTREPRENEURSHIP AND SERVICES TO MEMBERS.

IMDA members, with established ethical guidelines to ensure trust and confi dentiality on both sides.

4. Services to membersThe fourth pillar is about delivering real value to members, by providing high-quality services that will impact positively on their business performance.

To achieve this goal, IMDA will:

be the voice of the medical technology industry in Ireland;

actively connect peers to develop business links, address business concerns, exchange views and promote best practice;

engage with members to discuss their needs and aspirations and provide industry-specifi c, high-quality, cost-effective training;

provide members with access to expertise, knowledge and insight across a broad suite of business-specifi c topics;

communicate to political stakeholders, the media and the general public the value of medical technology to patients and the economy;


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reinforce industry integrity and high ethical standards through the operation and adoption of the Irish Medical Technology Code of Ethical Business Practice;

continue to support and promote a culture of manufacturing excellence.

5. ImplementationIn 2012, the IMDA will focus on determining the specifi cs required to execute the strategy profi ciently, and will develop a working implementation plan to take the strategy to the next level.

The IMDA’s Board, working groups, taskforces and executive team will work closely with our strategic partners to develop the implementation plan and to deliver the objectives of our strategic vision effectively.

IMDA member organisations actively participated in the development of this plan and we are committed to continuing this participatory approach. Any comments on the strategic plan or on any aspect of IMDA’s work are very welcome and can be sent via [email protected].

To order your copy of the full IMDA Statement of Strategy 2012-2015, call the IMDA on +353 1 605 1500


THOUGHT LEADERS:

Q&A WITH IMDA BOARDIMDA board members discuss the current state and future prospects of the medical technology sector in Ireland.

How will the IMDA’s new statement of strategy 2012-2015 assist medical technology companies in Ireland?

Strengthening and future-proofi ng the medical technology ecosystem is a very important objective of the strategy. If we are to establish Ireland as a leading cluster and go-to place for startups, integrated and collaborative relationships across all medtech stakeholders are vital. Increasingly stronger linkages are being fostered between industry and universities but while progress has been made in the area of clinical engagement, there is still some way to go.

Bill Doherty

Des O’Leary,GENERAL MANAGER, BIOTRIN INTERNATIONAL

In your opinion, what are the key trends emerging in medtech?

Keith McCracken,

DIRECTOR OF EUROPEAN OPERATIONS,PERFECSEAL

The entrepreneurship pillar stands out for me in the new strategy. Nurturing a culture of entrepreneurship will be critical to the future of the industry in Ireland and will ensure that we stay at the cutting edge. In broader terms, the IMDA has well-informed policies which get the the attention of Government. The group has a detailed understanding of the changing needs of the industry and the many different layers of the ecosystem that supports the medical devices sector in Ireland.

John O’Dea

Refl ecting on the last 15 years of medtech in Ireland, there has been huge transformation. Developments have also thought us that it is important not to always be comfortable with the status quo. The IMDA’s new strategy 2012 to 2015 anticipates the needs of the industry over the next 15 years and sets out a clear vision of where we need to be and how we can best get there.

Paraic Curtis

Paraic Curtis,

VICE PRESIDENT ENDOSCOPY DIVISION FOR EMEA, BOSTON SCIENTIFIC

New products are being developed for new markets, as the industry responds to the demographic developments posed by an ageing global population. Furthermore, the sector is increasingly catering for global emerging markets like China. These trends represent signifi cant growth potential for the sector over the coming years, and bode well for the future.

Des O’Leary

The medtech sector is evolving at an incredible pace. New technologies are transforming manufacturing processes, and radical new paradigms are being developed in order to meet the need for reduced costs and most importantly, increased responsiveness. Improved responsiveness is vital if we are to to maximise quality, effi ciency and speed to market.

Keith McCracken

John O’Dea,

CEO,

CROSPON

Bill Doherty,

EXECUTIVE VICE PRESIDENT, COOK MEDICAL

The industry today is experiencing a rapidly increasing demand for high-end, high-value products and services. To remain competitive, we must retain our strong manufacturing base through the development and application of world-class manufacturing and supply chain techniques. We also need to demonstrate considerable adaptability and fl exibility to compete in the new-world environment where change continues to come at us, wave after wave.

Colum Honan


In these changing times, how can the medical technology sector in Ireland seize emerging opportunities?

What does the IMDA offer medical technology companies in Ireland?

While we, as an industry in Ireland, are improving our research capabilities and evolving from just ‘development’ to ‘research and development’, more needs to be done. Excellent research is being conducted in our hospitals and universities and we should focus on commercialising the potential output of this research. Stronger linkages between the research community and the manufacturing base would benefi t both and would enhance Ireland’s reputation for innovation.

Colin Henehan

If we are to remain competitive, we have to play to our strengths, and a culture of manufacturing excellence is what gives us the edge over other up-and-coming medical technology hubs such as Singapore. It is critical that we have a renewed focus on manufacturing, and the Government needs to signal a clear commitment to the role of manufacturing in the Irish economy.

Helen Ryan

The global business environment in which the medical technology sector operates is rapidly changing and if we are to continue to compete internationally, we have to continually focus on innovation, including business model innovation. Only through innovation and innovative thinking can the sector in Ireland do what it has to do: deliver better healthcare to more people, more effi ciently.

Michael O’Donovan

The IMDA has a thorough understanding of the industry in Ireland and is very successful at pulling together the broader medtech community to give it one cohesive voice. The group also does a great job at promoting the sector through effective PR and marketing, and communicating to members that they are part of a progressive vibrant industry.

Donal Balfe

The IMDA offers an excellent service in that it moves beyond the specifi cs of one company and provides a comprehensive, yet succinct overview of the bigger picture. The organisation offers a wealth of knowledge and foresight to member organisations, and continually strives to put in place all the necessary elements to allow the industry in Ireland to thrive.

John Harris

An important aspect of the IMDA’s work is the support it provides to indigenous industry. The structure of the IMDA allows for informal mentoring between more established companies and those getting off the starting blocks, and enables people to develop their contacts. It offers companies a chance to meet and network, and brings like-minded people together. This is quite a unique setup and I encourage members to take advantage of the opportunities it offers.

John Power

Donal Balfe,

VICE-PRESIDENT, COVIDIEN

John Power,

MANAGING DIRECTOR AND CEO, AEROGEN

Colin Henehan,SITE DIRECTOR, ABBOTT NUTRITION MEDICAL DEVICES (SLIGO)

Michael O’Donovan,CEO AND MANAGING DIRECTOR, AUDIT DIAGNOSTICS

Colum Honan,GENERAL MANAGER,BAUSCH & LOMB IRELAND

Helen Ryan,CEO, CREGANNA-TACTX MEDICAL

John Harris,

VICE PRESIDENT OUS OPERATIONS, LAKE REGION MEDICAL HOLDINGS LIMITED

IMDA: The voice of the medical technology industry

The IMDA works tirelessly on your behalf to strengthen the medtech ecosystem and safeguard the sustainable development of the industry in Ireland. This requires the IMDA to work closely with several Government departments and agencies, and participate on a range of national and international high-level groups.

Life Sciences Alliance

The Life Sciences Alliance was established in January 2010 and brings together high-level representatives from industry, the Department of Enterprise, Jobs and Innovation, the enterprise development agencies, the healthcare system as well as the research and academic community. It is chaired by Dr Paul Duffy, vice president of manufacturing, Pfi zer Ireland and Singapore. IMDA director Sharon Higgins represents medtech interests on the Alliance along with IMDA board members Paraic Curtis of Boston Scientifi c and Michael O’Donovan of Audit Diagnostics.

The IMDA has directly contributed to the considerable progress made by the Alliance to date which includes:

• enhanced collaboration resulting in a coordinated approach to the development of the life sciences sector. Collaboration on events has also increased considerably through events such as the Science Foundation Ireland/IMDA research showcases, and the Health Research Board/IMDA clinical research event;

• the launch of the BioInnovate Ireland Fellowship Programme. This is a national, inter-institutional initiative which involves clinicians, industry and academia (For more information, see page 20);

• feeding into the Government Jobs Strategy which is expected to be published in January 2012;

• feeding into the National Research Prioritisation Exercise conducted by Forfás (more information below);

• the re-establishment of the Convergence Council within the context of the Alliance (more information below).

Convergence Council

The convergence of technology and services will be a major driver of new product development in the coming years and all of the policy arms of the Government are prioritising convergence. It is against this backdrop that the Convergence Council was re-established. Chaired by IMDA director Sharon Higgins, the Convergence Council comprises representatives from industry associations, relevant Government departments and agencies, and academia. Specifi cally, the group has been developing workshops and materials under six key themes and the 2011

programme focused on drug/device combination products, resulting in a very successful conference to explore Ireland’s unique potential for the commercialisation of drug, device and biologic combination products. (For more information, see page 14.)

Research Prioritisation Exercise

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. IMDA industry representatives participated on the working groups on Health, Wellbeing and Ageing and Innovative Processes for Enterprise.

Intellectual Property Implementation Group

IP capability continues to be a key issue for medical device and diagnostic companies, with an urgent need to make changes to the way we exploit intellectual property arising

IMDA PRE-BUDGET SUBMISSIONOn November 14th 2011, the IMDA presented its pre-budget submission to Richard Bruton TD, Minister for Enterprise, Jobs and Innovation.

In addition to presenting the Minister with the IMDA’s new Statement of Strategy 2012-2015, the IMDA recommended actions on areas of concern to the medical technology sector in Ireland, including the urgent need to:

• enhance our taxation regime for intellectual property;

• improve the R&D tax credit offering by increasing the fl exibility of the subcontracting limit;

• embed R&D and commercialisation within the objectives and culture of the health System.

The IMDA also took the opportunity to outline concerns about possible changes to the IMB’s fee structure, and updated the Minister on the revision of the EU regulatory framework for medical devices.


Pictured at the second steering group meeting of the European Innovation Partnership on Active and Healthy Ageing in Brussels in September were John Dalli, EU Commissioner for Health and Consumer Policy, and Sharon Higgins, IMDA director.

from research in our institutions. An Intellectual Property Implementation Group, comprising technology transfer practitioners and industry representatives from diverse sectors, was charged with implementing recommendations to improve the return on IP. With the work of the Intellectual Property Implementation Group nearly complete, IMDA are monitoring the progress of the Group and are keen to see its outputs published.

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.

Eucomed SME Taskforce

In January 2010, Eucomed established an SME Taskforce to determine the size of the medical technology industry and identify the specifi c challenges and opportunities that SMEs in Europe face. IMDA director Sharon Higgins was appointed chair of the group.

The Taskforce has achieved some important milestones to date. A survey was conducted among national industry associations in twelve countries including Germany, UK and France. The Taskforce is now working together with the European Commission to make small but powerful changes identifi ed by SME’s that will go a long way towards increasing their innovation potential. These include a coordinated and transparent programme of market surveillance; a smarter, faster regulatory process; easier access to EU R&D funds; and the provision of information about market access and distribution channels.

European Innovation Partnership on Active and Healthy Ageing

As part of the collaborative work with the European Commission outlined above, IMDA director Sharon Higgins was invited to sit on the high-level steering group on the Pilot European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) to represent the views of SMEs. An exciting and powerful initiative, it is the fi rst time

in Europe that all the stakeholders are joining forces at this scale to commit to advancing innovation in active and healthy ageing.

In November 2011, the Strategic Implementation Plan of the EIP on AHA was adopted, setting out a common vision and a set of operational priority actions to address the challenge of ageing through innovation. The next steps will be for the European Commission and stakeholders to work together on making this plan a reality.

AdvaMed

The IMDA is an associate member of AdvaMed, whose member companies produce nearly 90 per cent of the health care technology purchased annually in the United States and more than 50 per cent purchased annually around the world. In September 2011, the Advamed 2011 Medtech conference was attended by three senior IMDA executives. The conference brought together international policy-makers, experts, and insiders for critical dialogue on the current challenges and future direction of the medtech sector.

Other high-level interactions in 2011 included:

• many formal and informal meetings with key stakeholders around the revision of Medical Devices Directives (MDD) including Richard Bruton TD, Minister for Jobs, Enterprise and Innovation; Michael Noonan TD, Minister for Finance; Nessa Childers, MEP; and Pat O’Mahony, chief executive at the Irish Medicines Board. (For more information on the MDD recast, see page 18);

• quarterly meetings with the Irish Medicines Board at dedicated industry liaison meetings;

• a private lunch with Tom Donohue, president of the US Chamber of Commerce in Washington at the invitation of the American Chamber of Commerce;

• discussions with the board of Forfás on opportunities to enhance the medtech ecosystem in Ireland;

• meetings with the HSE to discuss procurement processes;

• individual meetings with fi nance directors in the pillar banks to discuss fi nance for industry.

IN 2011, THE IMDA EXECUTIVE TEAM:

conducted over 90 on-site meetings with member companies to learn more about the issues affecting you;

held 99 cross-sectoral working group meetings;

engaged in 64 meetings with Government departments, state agencies and regulators.



ADDRESS FROM DANNY MCCOY, DIRECTOR GENERAL, IBEC

IBEC: Delivering for the medical technology sectorAt the opening of 2011, the Irish business community highlighted the inherent strengths of the Irish economy, and through IBEC provided the business perspective of the Irish economic story. Despite the focus on the fi scal and banking crises we argued that the fundamental business model was strong and that this would lead Ireland on a path to recovery.

Twelve months on, I am pleased that this has been proved correct. Irish business responded quickly to the challenges and found new opportunities. In 2011, Ireland saw a return to economic growth. This growth, underpinned by our extraordinary export performance, is all the more impressive given the ongoing uncertainty across Europe. The lack of a fi nal resolution to the eurozone crisis is hampering the ongoing ability of business, both here and across Europe, to fully emerge from the global recession. It is unclear whether the package of measures agreed in December 2011 will prove suffi cient to address the lack of confi dence in the eurozone, but unless a full and comprehensive response is agreed, business will not be able to fully realise its growth potential. IBEC believes that the EU27 must put in place the necessary mechanisms to communicate a clear vision of a strong, vibrant and dynamic Europe in which to invest, live, work and do business.

Over the last 12 months, Ireland has slowly and surely addressed many of the challenges facing our economy. In March the Government completed the recapitalisation programme for the banks, we have met our fi scal targets under the EU/IMF programme and most importantly, we have seen international perceptions of Ireland improve considerably.

In 2011, the theme of IBEC’s CEO conference was ‘Going for Growth’, at which delegates recognised the need to build on our impressive performance in the export-led sectors of the economy. At the heart of our export-led recovery has been the performance of the medical devices sector. Recent improvements in the R&D tax regime as well as improvements to schemes to attract foreign talent are welcome developments, and through its new Statement of Strategy 2012-2015, the IMDA has crafted a set of comprehensive strategic

objectives and actions to build an even more successful and innovative medical devices sector.

One of IBEC’s key priorities for the year ahead is to support measures that will stimulate our domestic economy. A return to strong growth will increase investment, support employment and reduce the debt burden on business and families. However, the ongoing economic uncertainty is proving a drag on our potential growth, and the short-term outlook for the eurozone economy remains exceptionally challenging. Even so, the fundamentals of the Irish economy have improved signifi cantly in recent years, and when external conditions improve again the economy is likely to expand at a pace well ahead of our main trading partners.

Through its new Statement of Strategy

2012-2015, the IMDA has crafted a set of

comprehensive strategic objectives and actions to build an even more

successful and innovative medical devices sector.


UNETHICAL COLLABORATION

Inappropriate support of conference events

Questionable consulting agreements with HCP’s

Grants or charitable donations with strings attached

Excessive hospitality or lavish gifts

ETHICAL COLLABORATION

Appropriate support of scientifi c and educational conferences

Legitimate consulting agreements with HCP’s

Provision of educational grants and charitable donations

Provision of modest hospitality and gifts

Minster for Health, James Reilly, TD, launching the Code of Ethical Business Practice.

Figure 1: Examples of ethical and unethical collaboration.

PROTECTING THE INDUSTRY:

CODE OF ETHICAL BUSINESS PRACTICE Developed by the IMDA in conjunction with IMSTA (who represent medtech supply companies), the Code of Ethical Business Practice for the Irish medical technology industry was launched by Minister for Health, Dr James Reilly TD in June 2011.

The full text of the Code of Ethical Business Practice is available at www.medtechethics.ie or from the IMDA at [email protected]

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 with the appropriate documentation, which can be found at www.medtechethics.ie. This will then be forwarded to a compliance panel for review.

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. Chaired by Bill Doherty of Cook Medical, the IMDA’s Code of Ethics Working Group is deeply committed to ensuring that suffi cient safeguards are in place to uphold the integrity of industry.

The Code of Ethical Business Practice for the Irish medical technology industry 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 outlined in Figure 1.

Committing to the code Members have been invited to commit to this code on

a voluntarily basis for an 18-month introductory period which began in July 2011 and will end on December 31st 2012.

During this introductory period, members commit to follow all processes relating to the Code, but the results of these processes will be non-binding.

From January 1st 2013, adherence to the Code will be compulsory and binding as a condition of IMDA membership.

For medical technology companies, interacting with healthcare professionals is a key component of their day-to-day activities. The medical technology industry in Ireland is committed to ensuring that its collaboration with HCPs adheres to the highest ethical and professional standards.

Bill Doherty, executive vice-president, Cook Medical and chair of the Code of Ethics Working Group

Conference on converging in IrelandAt a conference hosted by the Convergence Council (see page 11) in May, over 200 delegates learned about the importance of convergence to the Irish economy, and the value of collaboration between Ireland’s pharmaceutical, biotechnology and medical technology sectors. Specifi cally, the theme of the conference was how to best harness Ireland’s unique potential for the commercialisation of drug, device and biologic combination products.

In her closing keynote address at the conference, IBEC president Julie O’Neill said, ‘Ireland is uniquely positioned to become a world leader in developing convergent technologies. Healthcare practitioners are increasingly looking for effi ciencies in every stage of patient care, and Irish companies are putting the foundations in place now to integrate many technologies to streamline healthcare processes’.

Following on from the success of this conference, the IMDA, the Irish Software Innovation Network and ICT Ireland are currently preparing for a conference on connected health in 2012 in association with the Convergence Council partners.

Key actions on clinical investigations presented to Richard Bruton TD, Minister for Enterprise, Jobs and InnovationIn recent years, there has been much enhancement of the clinical research infrastructure in Ireland, including the establishment of the Health Research Group; protected research time in clinicians’ contracts; the establishment of clinical research centres; standardised ethics consent forms across the 13 recognised ethics committees; parallel review; and the establishment of the Irish Clinical Research Innovation Network.

In September 2011, the IMDA hosted a forum in Galway to allow companies to discuss current opportunities and challenges for conducting clinical investigations in Ireland. A position paper was subsequently produced identifying actions to improve the clinical research environment, and was presented to Minister Bruton as part of the IMDA’s pre-budget submission. Recommendations included the establishment of a dedicated medical device ethics committee and the appointment of an executive director with responsibility for R&D within the HSE.

Medical technology competence centre proposal A joint initiative between Enterprise Ireland and IDA Ireland, competence centres are resourced by highly-qualifi ed researchers associated with academic institutions who are empowered to undertake market-focused strategic R&D for the benefi t of industry. IMDA believes that a medical technology competence centre would greatly enhance the medtech innovation ecosystem by serving as a networking hub for the initiation of collaborations between researchers and industry. The IMDA’s initial application has progressed to the second stage, and it is now working with a number of stakeholders to develop the proposal further.

Chaired by Martin Cassidy of Beckman Coulter, the IMDA’s Innovation, Research, Development and Commercialisation (IRDC) Working Group is focused on nurturing strong cross-sectoral collaboration, as illustrated by the following selection of 2011 highlights.


Pictured at the Convergence Conference on May 13th in Dublin were (l–r): Sean Gorman, secretary general at the Department of Jobs, Enterprise and Innovation; Sharon Higgins, IMDA director; and David Liu, vice president, Operational Readiness & Convergence Technology, Johnson & Johnson.

NURTURING COLLABORATION:

INNOVATION, RESEARCH, DEVELOPMENT AND COMMERCIALISATION

Medical technology in Ireland by the numbers is a short, upbeat viral which captures the success of the sector in Ireland through meaningful, compelling facts and fi gures. It is available to view and share at www.imda.ie/0/MedtechIrelandNumbers

Medtech Quarterly is a newsletter that analyses quarterly industry surveys, invariably highlighting strong confi dence in the Irish medical technology sector. The newsletter also summarises the many and varied medtech investment announcements for each quarter. (See page 27 for a review of 2011 investment announcements.)

Medical Technology Sector Map profi les over 250 companies within the industry by location, size and category. Developed in conjunction with government development agencies, a tailored version of the map is available overleaf for your perusal

Careers promotion, highlighted on page 20, is also an important activity of the Marketing Working Group which supported the BT Young Scientist Exhibition and the IBEC/Institute of Guidance Counsellors Annual Careers Conference in 2011.

IMDA/Royal Academy of Medicine Joint Commercialisation Forum In January 2011, top researchers from the Section of Bioengineering of the Royal Academy of Medicine came together in Galway to showcase exciting, industry-specifi c biomedical research taking place in several universities.

Medtech industry experts share R&D best practice In April, over 60 medical technology companies gathered in Galway to participate in an IMDA seminar to share best practice in R&D among industry leaders. Hosted by Boston Scientifi c, the workshop was the third in a series of business excellence seminars developed by the IMDA.


Pictured at the Joint Commercialisation Forum in January 2011 in Galway were (l-r): Martin Cassidy, Beckman Coulter and chair of the IRDC Working group; Nathan Quinlan, NUI Galway; Sinead Keogh, IMDA; Darragh Colgan, Boston Scientifi c and incoming chair 2011; and Mark Bruzzi, NUI Galway.

Pictured at the Business Excellence Seminar in Galway on April 8th were (l-r): Darragh Colgan, global VP of process development at Boston Scientifi c; Rakhi Baj, technical project leader at Abbott Diagnostics; Sinead Keogh, IMDA; and Richard Gribbons, innovation and commercial director at Caragh Precision.

Pictured at the launch of Medical technology in Ireland by the numbers were (l-r): Incoming chair of the Marketing Working Group Caolan Bushell of Mergon Healthcare; outgoing chair Teresa Glynn of Medtronic; Sinead Keogh, IMDA; and Brian Clarke, Zeus Industrial Products.

In these challenging times, a culture of partnership is critical to the future of the medical technology sector. Fostering a spirit of collaboration and promoting integrated relationships across all medtech stakeholders is the focus of the IMDA’s Innovation, Research, Development and Commercialisation Working Group.

So much positivity surrounds the medical technology sector in Ireland. Through the IMDA’s Marketing Working Group, we want to spread the good news and continue to reinforce Ireland’s positive business environment internationally. Initiatives such as the Medical Technology Industry Excellence Awards provide a great opportunity to capture and showcase industry excellence here.

Martin Cassidy, director, global program management, Beckman Coulter and chair

of the IRDC Working Group

Teresa Glynn, senior communications manager, Medtronic and chair of the IMDA

Marketing Working Group

Chaired by Teresa Glynn at Medtronic, the IMDA’s Marketing Working Group has been busy developing a range of exciting materials to promote the vibrancy and dynamism of the medical technology sector in Ireland. The group also oversees the annual Medical Technology Industry Excellence Awards.

SPREADING THE GOOD NEWS

Marketingmedtech

Pictured (l-r rear): Ian Purdy, Boston Scientifi c; Robbie Walsh, Boston Scientifi c (incoming chair IMDA QA/RA Forum); Eoghan Ó Faoláin, IMDA; Emmett Devereux, Cook Medical (outgoing chair IMDA Regulatory Steering Committee); John Kilmartin, Medtronic (incoming chair IMDA Regulatory Steering Committee) (l-r front): Christine Brooker, Abbott (outgoing chair IMDA QA/RA Forum); Audrey Hobson, Telefl ex Medical Europe.


EVOLUTION NOT REVOLUTION

Ensuring safe, smart and effi cient regulationThe revision of the Medical Devices Directives (MDD) continued to dominate the IMDA’s regulatory policy and lobbying activities throughout 2011. This work is spearheaded by the IMDA Regulatory Steering Committee, with Emmett Devereux of Cook Medical in the position of chair.

CURRENT STATUS

With the European Commission’s impact assessment on the MDD revision now concluded, it was confi rmed in September 2011 by DG SANCO that two texts are likely to be proposed in Q2 2012.

The fi rst text will be the horizontal recast of the three medical device directives (the Active Implantable Medical Device Directive, the Medical Devices Directive and the IVD Directive), while the second will be the technical revision of the IVD Directive. It also appears the Commission will seek to replace these Directives with Regulations (thus eliminating the need for transposition into national law by member states).

Of the four options that had been under consideration, it appears that just two remain. These are a new division within the European Medicines Agency (EMA) and a new division within the European Commission’s Joint Research Centre (JRC).

IMDA POSITION

The IMDA has been reviewing in detail the implications of the two policy options outlined, but is strongly of the view that the basic principle of the option adopted must enhance patient safety, while retaining rapid access to the latest high quality medical technologies. European patients benefi t from the latest in safe technology nearly two years ahead of their US counterparts and this competitive advantage must be preserved.

The IMDA favours strengthening the three crucial components in the regulatory framework in Europe, namely coordination, science and policy advice. The IMDA believes the resources required to do this can ideally come from within the Commission from DG SANCO, supported by JRC. The JRC could play a crucial role in key areas, from auditing Notifi ed Bodies to ensure a comparable high level of quality

across the EU through to providing expert policy advice in medical technologies to support evidence-based decision making and legislation.

ACTION

The IMDA has been heavily involved in shaping the national and European industry position regarding the MDD revision, and has had many formal and informal meetings with key stakeholders throughout the year. These include Richard Bruton TD, Minister for Jobs, Enterprise and Innovation; Michael Noonan TD, Minister for Finance; Nessa Childers, MEP; Pat O’Mahony, chief executive at the IMB; as well as senior representative within the Department of Health.

Ireland will assume the EU Presidency in January 2013 for a period of six months, and given the timing, the revision of the MDD has been identifi ed as a priority area for the Department of Health.

IMDA Quality and Regulatory Forum

In May, over 60 quality and regulatory representatives attended the IMDA QA/RA Forum in Galway. Topics discussed at the forum included key issues on quality system audits; managing the interaction and performance of different Notifi ed Bodies; and recent FDA auditing trends among others.

The IMDA’s Regulatory Steering Committee is working hard to ensure that any future legislative framework for medical devices continues to guarantee rapid access to safe medical technology while safeguarding innovation. Evolution, not revolution, needs to be the approach adopted.

Emmet Devereux, director of quality and regulatory affairs, Cook Medical and chair of the IMDA’s Regulatory Steering Committee

IMDA Yearbook 2011IMDA Yearbook 2011 | 19

OPERATIONAL EXCELLENCE

A NEW MODELFOR IRELANDChaired by James Winters of DePuy, the IMDA’s Operational Excellence (OpEx) Taskforce has developed an exciting new model for operational excellence in Ireland, enabling members to harness expert knowledge and improve competitiveness.

In May 2011, an expanded Operational Excellence Taskforce met for the fi rst time to discuss a new two-year strategy and work plan. The dynamic group set about crafting a programme of work around the following key themes:

1. Developing a standard operational excellence benchmark model

2. Devising a formal mentoring programme

3. Improving operational excellence skill set and resources

It was also agreed that communicating and promoting the benefi ts of operational excellence would be a core part of the group’s remit, underpinning its work across the three themes listed above.

1. OPERATIONAL EXCELLENCE BENCHMARK MODEL

Following months of tireless work by members of the OpEx Taskforce in consultation with software experts, the Operational Excellence Benchmark Model was launched at the Irish Medical Technology CEO Forum in December 2011. Developed with funding from the Life Sciences Skillnet, the standardised benchmark model is a novel self-assessment and diagnostic tool that defi nes operational excellence as it applies to the medical technology sector. An extremely valuable tool, it enables members to benchmark themselves against other companies, and avail of tailored resources and expertise on their lean journey.

During 2012, a series of workshops will be organised to train members on how to implement the model. Once trained, members will be able to download the model from the IMDA website www.imda.ie

2. FORMAL MENTORING PROGRAMME

The group is currently fi ne-tuning elements of an operational excellence mentoring programme, which will begin piloting early in 2012. Six IMDA member companies will be chosen to take part, and each company will be assigned a mentor from another member company who will share their lean experiences and visit with them over the course of a year to monitor progress. The objective of the mentoring programme is to transfer knowledge and

experience to the mentee site, enabling them to become self-suffi cient after 12 months.

3. OPERATIONAL EXCELLENCE SKILL SET AND RESOURCES

During 2011 a member survey was issued to determine the current level of expertise in lean manufacturing in Ireland. The survey identifi ed a number of gaps, enabling the OpEx Taskforce to devise a meaningful offering of operational excellence training to meet members’ needs. In conjunction with Cardiff University, the group has already begun to develop a bespoke Lean Leadership Programme. Crucially, this will incorporate the practical element of lean manufacturing — a major gap highlighted by the member survey.

The vision of the Operational Excellence Taskforce is that Ireland will be recognised as the global leader in operational excellence in the medical devices and diagnostics supply chain industry.

James Winters, plant manager, DePuy and chair of the Operational

Excellence Taskforce

Pictured at the Irish Medical Technology Industry CEO Forum 2011 were members of the IMDA’s Operational Excellence Taskforce (l-r): Pauline O’Flanagan, Lifesciences Skillnet; Sean O’Sullivan, Seabrook Technology; Joan McCabe, Creganna Tactx Medical; James Winters, DePuy (chair); Adrienne McDonnell, IMDA; Bernadette Reynolds, Covidien (vice-chair); and Pauric Gillespie, CareFusion.

Figure 1: A screengrab of the Operational Excellence Benchmarking Model


STAYING AT THE CUTTING EDGE

SKILLS ANDKNOWLEDGE

BioInnovate Ireland

As an industry supporter of BioInnovate Ireland, IMDA was delighted to co-launch this exciting new fellowship programme in August 2011. A multidisciplinary training programme to support innovation in the medical devices sector, it is modelled on the prestigious Biodesign programme offered at Stanford University. The initiative is being offered by NUI Galway, RCSI, UL, DCU and UCC, and the eight selected fellows are offered a unique opportunity to:

• experience an intensive clinical immersion in our teaching hospitals;

• identify potential medical device development opportunities;

• avail of the expert advice, direction and guidance from dedicated industrial mentors and serial entrepreneurs.

The IMDA is currently developing a series of industry-led modules to be delivered to the fellows on subjects including regulatory affairs, reimbursement strategy, and intellectual property.

Medtech Engineers Conversion Programme

In October, Joan Burton TD, Minister for Social Protection, launched an innovative internship programme to retrain 25 unemployed engineers to work in the high-tech medical devices and pharmaceutical sectors. Prior to a six-month placement in a medical technology company, the candidates also completed eight weeks of highly targeted training.

The IMDA is delighted to support these internships and to provide the engineers with a chance to develop their experience and secure future employment.

Strategic training

IMDA, with support from the Life Sciences Skillnet, continued to provide key strategic training to the sector throughout 2011 with many industry programmes held throughout the year. These included:

• medtech future leadership programme;

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

• international strategic medical marketing programme (in conjunction with faculty members from UCLA);

• designing cardiovascular devices.

Career matters

IMDA continues to promote the medtech sector to second and third level students with a view to encouraging the uptake of STEM subjects (science, technology, engineering, and mathematics). In January, the IMDA hosted a stand at the BT Young Scientist Exhibition to promote careers in medtech companies, with Covidien and Abbott Ireland also participating.

In November, Pharmachemical Ireland hosted the Institute of Guidance Counsellors Annual Careers Conference on behalf of IBEC. Gary O’Connell from Seabrook Technology Group represented the medical technology sector at this important forum.

IMDA also presented at numerous third level career events in Trinity College Dublin, University of Limerick, University College Cork and NUI Galway.

Investment by multinational companies in Ireland has been underpinned by our highly skilled and educated workforce. The IMDA’s Skills and Knowledge Working Group is supporting the continuous development of skilled and adaptable people, as well as attracting graduates to the sector by increasing their awareness of the wonderful career opportunities in medical technology.

Nicola Gilmartin, compensation and benefi ts manager, Abbott Ireland and chair of the IMDA’s Skills and Knowledge Working Group

(1) Pictured (l-r): Ian Quinn, non-executive Chairman and founder of Creganna-Tactx Medical; Wagar Aziz, BioInnovate fellow; Kevin Moore, BioInnovate fellow; and Eoghan Ó Faoláin, IMDA executive.

(2) Pictured (l-r): Eoghan Ó Faoláin, IMDA executive; Joan Burton TD, Minister for Social Protection; Killian O’Beirne, intern; Padhraic McGinn, senior operations manager, Nypro Ireland; and Ruth Lloyd, human resources manager, Nypro Ireland

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Chaired by Nicola Gilmartin of Abbott Ireland, the objective of the IMDA’s Skills and Knowledge Working Group is to ensure that Ireland retains its global reputation for producing highly employable graduates.

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With operational excellence critical to the continued success of the medical technology sector in Ireland, the IMDA’s Life Sciences Skillnet is providing invaluable support to manufacturers in their bid to remain competitive.

Over the past four years, the IMDA’s Life Sciences Skillnet has distributed in excess of €1million of Government funding towards the cost of training to the life sciences sector. The network has directly trained in excess of 2000 trainees nationally, with 500 specifi cally trained in Continuous Improvement (CI) skills.

A snapshot of important 2011 development includes:

In Sept 2011, the Life Sciences Skillnet became a FETAC approved centre. This exciting achievement allows the industry-led network to continue to upskill sector employees and offer highly targeted FETAC awards as part of the National Framework of Qualifi cations (NFQ). One such course is the new FETAC 5 in Life Sciences Manufacturing Operations. As a result of FETAC requirements, the network has implemented its own quality system which will safeguard a continued high standard of training and assessment to member companies.

The Skillnet also supported the development of an exciting new Operational Excellence Benchmark Model. Incorporating a template that can be used by both MNC’s and SME’s alike, the standardised benchmark model is a novel self-assessment and diagnostic tool that defi nes operational excellence as it applies to the medical technology sector. For more information, see page 19.

As a result of increased compliance requirements from international regulatory bodies, a continued focus on current Good Manufacturing Practices (cGMP) is critical to the life sciences sector. In response to this, the Skillnet has developed a new two-day programme entitled Behaviour Based Quality (BBQ). This programme has been specifi cally commissioned and developed by the network, and is the fi rst of its kind in the world.

For more information on the wide variety of programmes offered by the Life Sciences Skillnet, see www.lifesciencesskillnet.ie

The Life Sciences Skillnet is funded by member companies and the Training Networks Programme, an initiative of Skillnets Ltd. funded from the National Training Fund through the Department of Education

and Skills.

The Life Sciences Skillnet encompasses companies from the medical devices, pharmaceutical, biopharmaceutical, and food and drink sectors. The combined number of employees in the life sciences sector is over 100,000 people directly and an additional 158,000 indirectly. In 2011, Padraic Broderick of Transitions Optical took over as chair of the Life Sciences Skillnet Steering Committee.

Since its inception, the network has developed a suite of bespoke training materials on life sciences manufacturing. This includes a novel training technique to deliver blended learning across multiple sites simultaneously (thus reducing costs and adding increased fl exibility for both employers and trainees) along with an online e-learning package, which provides companies with even more fl exibility and complete control over training.

Pictured are (l-r): Eoghan O’Faolain, IMDA; Pauline O’Flanagan, Life Sciences Skillnet Network Manager; Padraig Broderick, Transitions Optical and chair of the Life Sciences Skillnet Steering Committee.

BOOSTING COMPETITIVENESS

IMDA’S LIFE SCIENCES SKILLNET

Life Sciences Skillnet by the numbers

€1 million: Government funding distributed over the past four years;

2000: The number of people directly trained by the network;

500: The number of people trained in Continuous Improvement skills.

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CONFERENCE REPORT:

IRISH MEDICAL TECHNOLOGY INDUSTRY CEO FORUM 2011

Global trends and Ireland’s strategic repsonseKicking off the opening session was the fi rst of two stimulating keynote addresses by global opinion leaders in medtech. Scott Ward, president of Raymond Holdings, began his presentation with his thoughts on the importance

Mr Ward wrapped up by describing the implications of these global trends for Irish medtech, and reiterating the importance of winning the innovation competition through the creation of a supportive medtech ecosystem. ‘The best way to manage the future is to invent it,’ he concluded, quoting personal computing pioneer Alan Kay.

Delegates were also presented with a ‘pulse of the industry’ by Leo Gribben, associate partner with Ernst & Young, who outlined a solid fi nancial performance in 2011. Echoing Mr Ward, however, Mr Gribben did point to a ‘new normal’ for medtech. ‘This is an environment where companies face a confl uence of risks and challenges: heightened regulatory

of leadership, innovation and innovative thinking in weathering adversity and changing times. Mr Ward then took delegates through global ‘megatrends’ infl uencing the medtech sector from demographic changes through to the economic crisis and regulatory uncertainty, before exploring environmental infl uence on innovation outlined in Figure 1.

scrutiny, a fundamentally different funding environment and a rapidly changing customer base,’ he commented.

Director of sectors at IBEC, Pat Delaney, provided an overview of the Irish economy in the wake of Budget 2012, asserting that while the domestic economy remains fragile, export performance has held up very well to date. Mr Delaney highlighted that we can have an export-led recovery, and stressed that Ireland is a fantastic place to do business.

Outgoing IMDA chairman Gerry McDonnell concluded by presenting the IMDA’s new strategy 2012-2015, as described on page 5.

Innovation, collaboration and the need to embrace change were the recurring themes of the 2011 Irish Medical Technology CEO Forum – themes that were presented and debated against a backdrop of optimism, inclusiveness and open-minded thinking. The Forum was hosted by IMDA, Enterprise Ireland and IDA Ireland.

CURRENT FOCUS FUTURE OPPORTUNITY

1. Unmet medical needs 1. Unmet medical needs

2. Chronic disease 2. Safety, effi cacy and effi ciency

3. Safety and effi cacy 3. Less invasive and less hospitalisation

4. Price premium 4. Reduce diagnostic, imaging or follow-up requirements

5. Cost of goods sold 5. Lower cost and higher volume

6. Developed markets 6. Medtech to the masses

7. Leverage infrastructure 7. Increase patient access

8. Target medical specialty 8. Leverage convergence

9. High-touch education and support 9. Ease of use and intuitive design

10. Novel technology 10. Reduce support requirements

Figure 1: Environmental infl uence on innovation


The perfect storm – innovation during global healthcare system reformThe second keynote speech of the day was given in session 2 when Dr Richard Stack, president of Synecor LLC, took to the stage. Dr Stack gave a succinct overview of the current state of the medical technology industry in the US, and what this means for Ireland. He spoke in depth of the demise of venture capital and how unpredictable and expensive regulatory processes are jeopardising America’s position in medtech innovation.

Dr Stack charted the opportunities for medtech in private mergers and acquisitions, and described the Synecor paradigm. Commenting on Synecor’s shift to domicile new companies outside the US, Dr Stack gave strong hints that this could be very good news for Ireland, with Synecor very close to locating 10 new companies here. ‘Ireland is the perfect place at the perfect time to emerge from the perfect storm,’ he concluded. A fi nal decision on the location of the 10 new Synecor companies will be made during 2012.

This was followed by a robust and enlightening panel discussion on the challenges and opportunities of innovating in the current climate, chaired by Brian O’Neill of Enterprise Ireland. Along with Dr Stack, panellists included Ian Quinn, chairman of BioInnovate Ireland (and founder/chairman of Creganna-Tactx); Derek Young, CEO of i360 Medical (RCSI-CIST); Barry Russell, CEO and founder of neoSurgical Ltd; and colorectal surgeon Mr Paul Neary. Much of the discussion centred on the importance of clinical engagement and a conduit for clinicians’ ideas; promoting a culture of entrepreneurship and venture capital investment; the need for a clear Government commitment to manufacturing in Ireland; and the importance of an appropriate regulatory system.

Business model developmentThe fi nal session of the day was chaired by Dave Shananhan of IDA, and focused on strategies for redeveloping business models to cope with the changing healthcare landscape. David Toohey, president of business operations at Alere took delegates through a worked example of strategically

integrated supply chain management at Alere. James Winters, plant manager at DePuy Cork presented an exciting new model for operational excellence in Ireland, described on page 19. Carlo Webster, business development executive at Tyndall gave an overview of work being carried out at Tyndall and where the future lies for disruptive technologies. Daniel O’Mahony of life sciences venture capital fi rm Seroba Kernel was tasked with giving the fi nal presentation of the day on assessing and securing knowledge and IP opportunities, and fi ttingly concluded with an overview of why Ireland is one of the largest medtech hubs in Europe, and a great place to invest in medtech.

An industry poised to embrace changeCentral to debate and discussion throughout the day was the acknowledgement that medtech needs to undergo fundamental transformation to ensure the sustainability of the sector, and that innovative thinking is the way forward. It was also made clear that the boundaries between medtech stakeholders are beginning to blur and that a culture of partnership and collaboration is critical. In his closing remarks, outgoing IMDA chairman Gerry McDonnell sounded an upbeat note, refl ecting the positive mood of the day: ‘We have the capability. We have the desire. It is now up to us to embrace global emerging opportunities and realise the true potential of the medtech sector in Ireland.’


Pictured at the 2011 Irish Medical Technology CEO Forum in Limerick on December 8th were: (l-r) Leo Cribben, associate partner, Ernst & Young life sciences transaction advisory team; Scott Ward, president of Raymond Holdings; Gerry McDonnell, vice president/general manager, Stryker Ireland; and Pat Delaney, director of sectors, IBEC.

Also pictured were (l-r): William N. Starling, chief executive offi cer, Synecor, LLC and general partner of Synergy Life Science Partners, LP; Gerry McDonnell, vice president/general manager, Stryker Ireland; and Sharon Higgins, IMDA director.

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MEDICAL TECHNOLOGY INDUSTRY EXCELLENCE AWARDS 2010 & 2011

Identifying Excellence / Rewarding People


Since 2007, the Irish Medical Technology Industry Excellence Awards have seen leading companies compete and be recognised for their innovations resulting in the development of new and exciting products and services. Jointly hosted by the Irish Medical Devices Association, Enterprise Ireland and IDA Ireland, the Awards have gone from strength to strength and provide a valuable opportunity to share and showcase best practice across the medical technology sector in Ireland.

“I am delighted and honoured to accept this award on behalf of the Cappella team. The design and testing of a medical stent is a complex process and I commend each member of the team that brought Sideguard from concept to reality. This award of excellence from the Irish Medical Devices Association, Enterprise Ireland and IDA Ireland is wonderful recognition of our work.”

Michael Gilmore Cappella vice president of engineering,

clinical and regulatory affairs

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With three categories in total, the other worthy awards winners on the night were:

Innovation, Research, Development and CommercialisationGold: Crescent DiagnosticsSilver: dabl

Manufacturing and Operational ExcellenceGold: DePuy IrelandSilver: Creganna-Tactx

Emerging Company of the YearGold: CapellaSilver: Sota Orthopaedics

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Irish Medical Technology Industry Awards 2010The 2010 Awards saw Galway-based Cappella honoured with the prestigious title of Medical Technology Company of the Year 2010 and Emerging Company of the Year 2010. Established in Galway in May 2005 and now employing more than 30 staff, Cappella won both awards for creating an innovative solution for the treatment of complex coronary artery disease. Cappella’s Sideguard is a next-generation, self-expanding sidebranch stent which offers cardiologists a straightforward, effective solution that focuses on treating the sidebranch of diseased coronary arteries fi rst, rather than the main vessel. Medical device companies large and small had failed repeatedly in their efforts to provide a device to address this major unmet opportunity in cardiology, and the market is estimated by Cappella to be worth circa $1 billion.


Irish Medical Technology Industry Awards 2011

Limerick-based Cook Medical won the title of Irish Medical Technology Company of the Year at the 2011 Awards for adopting a business model which saw the company upskill its manufacturing from producing FDA Class II medical devices to Class III medical devices and for becoming the shared service centre for Europe.

Cook Medical in Ireland is the global manufacturer of the Zilver® PTX® Drug-Eluting Peripheral Stent; the fi rst drug eluting stent in the world approved for use in the superfi cial femoral artery (SFA). This combination therapy

gives sometimes limb-saving and life-saving patency to blocked SFA arteries succumbing to peripheral arterial disease which affects 27 million people across Europe and North America and is responsible for more than 200,000 amputations per year. Zilver® PTX® clinical trials have shown it greatly improves peripheral arterial disease with much better patient outcomes.

Commenting on the win, Bill Doherty Executive vice president, EMEA Cook Medical said, ‘Winning an Irish Medical Industry Technology Excellence Award is a tremendous recognition of Cook Ireland’s leading role in the global production of the Zilver PTX Drug-Eluting Stent. The Limerick plant has embraced the challenge of manufacturing a Combination Class III device and now exports this innovative

and sometimes life-changing product to nearly 40 countries worldwide. With over 200 medical device companies in Ireland it is an honour to win such a prestigious award and demonstrates the strength of the medtech sector in Ireland.”

Galway-based Aerogen Ltd won the Silver Medal award for adopting a strategy which effectively leveraged its core technology across new and expanded sectors of its international hospital medical device business.

Wexford-based Lake Region Medical won the Bronze Medal award, for adopting a business model which improved quality, effi ciency and safety.

n (A) Pat Burke, Cook Medical (B) Julie Sinnamon, Enterprise Ireland and John Power, Aerogen (C) John Harris Lake Region Medical and Sharon Higgins IMDA (D) Brian O’Neill, Enterprise Ireland and John Elwood, KCI Ireland (E) Ken McClannon, Nypro Healthcare; Dave Shanahan, IDA Ireland; Conor Mulcahy, Nypro Healthcare; and Noel Kelly, Nypro Healthcare (F) Dave Shanahan, IDA Ireland and Brian Casey, Stryker NSE Division.

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OUTSTANDING CONTRIBUTION AWARDS

AN OUTSTANDING CONTRIBUTION TO MEDICAL TECHNOLOGYThe IMDA Medical Technology Outstanding Contribution Award 2010 recognises an individual who has made a signifi cant contribution to the development, growth and success of the medical technology sector in Ireland. Selected by the IMDA Board, nominations are received from across the membership of IMDA, and the award recognises the person’s contribution to the sector as a whole, rather than to any one company or organisation. In 2010, the inaugural award was bestowed on Bernard Collins, CEO, Lifemed and in 2011, Ian Quinn, non-executive Chairman and founder of Creganna-Tactx took the honour.

Ian Quinn, non-executive chairman and founder of Creganna-Tactx Medical

Operating in three continents and employing 1,200 staff worldwide, Creganna-Tactx Medical is ranked among the Top 10 global providers of outsourced designed and manufacturing services and is Ireland’s largest indigenous company in the medical devices sector. Having founded Creganna in 1980, Ian served as CEO until 2005 when he transitioned to the role of chairman to direct the strategic development of the company.

Ian is chairman of the Advisory Board for the BioInnovate Fellowship. Modelled on Stanford University’s Biodesign Programme, Ian was a catalyst in bringing the programme to Ireland, working tirelessly to generate linkages with Stanford University and securing industry support for this important initiative.

Ian also serves on the Board of the Tyndall National Institute, and recently served on the advisory panel of the Research Prioritisation Initiative under the auspices of the Minister for Enterprise, Trade and Employment. He also serves on the Board of the Galway Prostate Cancer Institute, a research led initiative exploring innovative oncology treatments.

Ian is married with three children and lives in Creganna, Co Galway. His personal interests include running and athletics and he has completed marathons and triathlons both competitively and for charitable causes.

Bernard Collins, CEO, Lifemed Consulting

Bernard Collins is a seasoned businessman with 30 years of international management experience. Having worked in the past with Baxter and Boston Scientifi c, one of the highlights of Bernard’s career was establishing Lifemed Consulting to promote growth and partnership in life science companies. Bernard continues to be a major infl uential fi gure in the medtech sector as an investor, chairman and non-executive director of several medical device companies. He is a non-executive director of Heartsine, Haptica, AnsaMed, Proxy Biomedical, and Aerogen Ireland Ltd/ Aerosurge Ireland Ltd, Vysera, InterMed Precision, and Creagh Medical. He is also a non-executive director of IDA Ireland and a member of the advisory board of Delta Partners Venture Capital Co.

Bernard is chairman of VHI Healthcare and VivaSure Medical, as well as being a member of the National Competitiveness Council. He is also chairman of Cancer Care West, the largest cancer patient support centre in Ireland which in 2007 opened Inis Aoibhinn, a residence for patients undergoing radiotherapy treatment at University Hospital Galway. Bernard also served as a chairman of the IMDA.

Bernard is married to Dubliner Liz and they have three children, Gareth, Susan and Ben. They also have three grandchildren. A former rugby player, he was also a handy squash player and is now a fi ne golfer who plays a low single-fi gure handicap.

Bernard Collins (right) accepting his award from 2010 IMDA chairman, Pat Gallagher of Baxter Healthcare.

Ian Quinn (left) accepting his award from outgoing IMDA chairman Gerry McDonnell of Stryker Ireland.

IMDA Yearbook 2011

Investment monitor 2011The medical technology sector in Ireland remains vibrant and dynamic, as borne out by the following selection of investment announcements in 2011.


Alere is establishing its International Business Service Centre in Galway and creating 100 jobs over four years.

Allergan has chosen Ireland as the location for a $10 million manufacturing investment, specifi cally for the manufacture of its newest medical technology, SeriScaffold.

Apica Cardiovascular has secured a €3.75 million investment from two venture capital companies including Irish company Seroba Kernel Life Sciences.

American Medical Systems Holdings will invest €4.6 million to establish a manufacturing operation in Athlone, resulting in the creation of 50 new jobs. This investment is supported by IDA Ireland.

Audit Diagnostics has merged with polish-based company PZ Cormay.

Bausch & Lomb is midway is through a $100 million investment at its plant in Waterford, with the creation of approximately 100 jobs at various times during the different phases of the project.

Boston Scientifi c set aside $37 million on overseas R&D at its facility in Clonmel. This investment is partially supported by a grant from IDA Ireland.

ClearStream Technologies will create 70 new jobs over the next three years as part of an expansion plan which is supported by Enterprise Ireland.

Covidien announced plans to invest up to €25 million in six separate R&D projects in Ireland, all focused on the area of respiratory technology .

Crescent Diagnostics has secured €1.5m in funding to support the development of an analyser that can test for osteoporosis.

Delcath is to establish its European headquarters in Galway, with jobs created in marketing, sales and logistic support.

Goodman Medical Ireland is expanding its Galway site, creating up to 115 new jobs and investing €1.1 million.

Harmac is making a signifi cant investment in an expansion of its facility, creating 100 new jobs over the next fi ve years.

Kelcourt Plastics is establishing a new medical tubing manufacturing operation in Tullamore, creating 55 new jobs over fi ve years

Lynch Medical Supplies announced a signifi cant investment in a new central headquarters facility in Swords.

Metal Improvement Company is to establish a new facility in Galway, initially create 20 technical manufacturing jobs, with a further 20-30 jobs planned by 2015.

MuteButton secured a €200,000 investment from Enterprise Ireland to accelerate large-scale clinical trials of its tinnitus treatment device, enabling the company to grow its staff to 20 by 2013

NeoSurgical secured a 1.6 million syndicated investment led by Kernel Capital comprising investments by the Bank of Ireland MedTech Accelerator Fund, Enterprise Ireland and a number of private investors.

Telefl ex Medical OEM announced that it intends to expand its manufacturing capability and create up to 80 new jobs

Veniton acquired Ansamed, an Irish company specialising in medical tubing for catheters. Ansamed will establish a strategic presence for Vention in Ireland and serve as a base for further European and International expansion.

VistaMed announced that 79 medtech jobs are to be created as part of a €7.2m investment in research and development. Enterprise Ireland is supporting the investment.

Zeus Industrial Products is investing €10m in an expansion of its Donegal facility, creating 75 new manufacturing jobs over three years.

‘We chose the Galway operation for our future growth and development due to our dedicated and proactive workforce, the support of IDA Ireland, our strong supplier network and the positive experiences we have had of doing business in Ireland since 2004.’

President Takehito Yogo, Goodman Co., Ltd

“Ireland provides the key elements we needed — a talented workforce, a pro-business environment and good prospects for success, as evidenced by the large cluster of healthcare companies operating so well from Ireland.”

David Toohey, president of business operations at Alere


Photo (1)

Pictured at the IMDA Members evening in May were (l-r): Sharon Higgins, director, IMDA; Prof Terry Smith, vice president for Research at NUI Galway; Dr. Alan Ahearne, lecturer in economics in the Cairnes School of Business Economics at NUI Galway; Gerry McDonnell, outgoing chairman of the IMDA and VP and general manager, Stryker Ireland.

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Pictured in January at the 2011 BT Young Scientist Exhibition were (front row l-r): Kim Prylowski, Koni Dudzik and Olivia Duff from St Patrick’s Secondary School, Bray, Wicklow with (back row l-r) Sinead Keogh IMDA; Dara Power, Abbott Diagnostics; and Kelly Sheanon, Covidien

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Pictured in November at the Institute of Guidance Counsellors Annual Careers Conference, were (l-r): Eilish Coakley, president of the Institute of Guidance Counsellors; Gary O’Connell, Seabrook Technology Group; and Sinead Keogh, IMDA

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Pictured at the IMDA’s operational excellence workshop on product lifecycle management in Bausch & Lomb, Waterford in April were (l-r): Sean O’Sullivan, Seabrook Technology Group; Mark Kilroy, Telefl ex Medical Europe; Kevin Meehan, Bausch & Lomb; Adrienne McDonnell, IMDA; and Colum Honan, Bausch & Lomb

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Pictured at an IMDA symposium on Health Technology Assessment in Galway in January were (l-r): Richard Phillips, Medtronic; Sinead Keogh, IMDA; Thomas Breslin, Covidien; Martin Flattery, HIQA; Maura Leahy, Creganna Tactx; and Jan Benjamin Pietzsch, Stanford University.

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Pictured are quality and regulatory representatives who attended the IMDA Quality and Regulatory Forum in Galway in May.

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ok 2011

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PhotoReview2011


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Pictured at the annual Healthcare Cup in Athenry Golf Club in September were (l-r): Peter Walsh, vice president of global operations at Medtronic; Chris McNamara, quality technician III at Boston Scientifi c; and Sinead Keogh, IMDA.

Photo (8)

Pictured at the IMDA programme ‘Designing Cardiovascular Devices Begin with the Body in Mind’ in the Radisson Blu Hotel in September were (l-r): Amanda Creane, IMDA intern; Dr Michael Drues, president of Vascular Sciences, Grafton, Massachusetts; and Antoinette McTigue, Ansamed.

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Pictured at the IMDA Members Evening in May were (l-r): Jerry Kiely, Telefl ex Medical; Bill Doherty, Cook Medical; John Humphreys, Filtertek; and John Farragher, Cambus Teoranta.

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Pictured at the IMDA Members Evening in May were (l-r): John Kilmartin, Medtronic; Frank Cashman, Anecto; and Dermot O’Connell, Ulster Bank.

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Pictured at the IMDA Members Evening in May were (l-r): Eoghan O’Faolain, IMDA; John Curran, KPW Print; Denis Healy, Metal Improvement Company.

Photo (12)

Pictured at an orthopaedic and trauma surgery programme in April, were (l-r): Colin Stanley, Stryker Orthopaedics; Sheila Murphy, DePuy Johnson & Johnson; Sinead Keogh, IMDA ; and Mr John O’Byrne, RCSI. The programme was hosted by the IMDA and delivered by a team of surgeons from Royal College of Surgeons in Ireland and Cappagh National Orthopaedics Hospital.

IMDA Yearbo

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The executive team at the Irish Medical Devices Association (IMDA) is thoroughly committed to providing high-quality services to our memer organisations as we work towards an ever-stronger medtech ecostystem for our industry to fl ourish.

Here for you

Adrienne McDonnellEXECUTIVE

Phone: + 353 1 605 1677Fax: + 353 1 638 [email protected]

Adrienne is responsible for marketing; events management; publications; communications; and operational excellence.

Sharon HigginsDIRECTOR


Sharon is responsible for the IMDA Board; chief reps; external relations; profi le; global business services; Code of Ethics; and the Convergence Council.

Sinead KeoghSENIOR EXECUTIVE


Sinead is responsible for medtech sector marketing; innovation, R&D and commercialisation.

Eoghan Ó FaoláinEXECUTIVE


Eoghan is responsible for quality and regulatory affairs; skills and knowledge; and the Life Sciences Skillnet.

Fiona HarrisonEXECUTIVE ASSISTANT

Phone: + 353 1 605 1529Fax: + 353 1 638 1529fi [email protected]

Fiona is responsible for membership and general enquiries.


IMDA member listing3M Ireland

Abbott Medical Optics, WestportAbbott Laboratories IrelandAbbott Ireland Diabetes Care, DonegalAbbott Ireland Diagnostics Division, LongfordAbbott Ireland Diagnostics Division, SligoAbbott Ireland Nutrition Division, Ballytivnan, SligoAbbott Nutrition, Finisklin, SligoAbbott Ireland Vascular Division, ClonmelAccellentAcorn RegulatoryAdvant MedicalAerogenAIB BankAlcon Laboratories IrelandAlere InternationalAllergan Pharmaceutical IrelandAmcor Flexibles SligoAMS Medical SystemsAnectoANSA MedApica CardiovascularAPS Materials IncArcRoyalArthur Cox SolicitorsAudit DiagnosticsAvenue Mould Solutions

B Braun HospicareBank of Ireland GroupBausch & Lomb IrelandBaxter Healthcare SABD PenelBeckman Coulter Irl IncBeckman Coulter BiomedicalBellurgan Precision EngineeringBio Medical ResearchBioclin Research LaboratoriesBiomedical Diagnostics InstituteBiotrin InternationalBlueBridge TechnologiesBoston Scientifi c CorkBoston Scientifi c GalwayBoston Scientifi c ClonmelByrne Wallace

Cambus MedicalCappella IncCaragh PrecisionCareFusion Manufacturing IrelandCharles River Laboratories Preclinical ServiceClearStream TechnologiesClinical CabinetsCook MedicalCork Institute of TechnologyCovidienCovidien Medical Devices, AthloneCovidien Medical Devices, GalwayCovidien Medical Supplies plant, TullamoreCovidien European Customer Care Centre & Commercial group, DublinCovidien Principal Executive Offi ce, Dublin

Covidien Diagnostic plant, DublinCPLCreagh MedicalCreganna Tactx MedicalCroom Precision MedicalCrospon

Deloitte & ToucheDePuy Ireland

EnBIO

Filtertek BVFinesse MedicalFleming MedicalFoireann BDSFort Wayne Metals IrelandFresenius Medical Care

Goodman Medical IrelandGrant Thornton

H2 ComplianceHarmac Medical ProductsHollister U L CHospira

IBM IrelandInnovative Polymer CompoundsIrema Ireland

Johnson & Johnson Vision Care

KCI ManufacturingKelpac MedicalKompass Regulatory ServicesKPMGKPW Print

Lake Region MedicalLife Science Recruitment

M & C Stokvis IrelandM & V Medical DevicesMarvao Medical DevicesMedtronicMerck MilliporeMergon HealthcareMerit MedicalMetal Improvement CompanyMoll IndustriesMovement Industrial Design

National University of Ireland GalwayneoSurgicalNeuraviNypro Healthcare

O’Flynn MedicalOlympus BiotechOmega Teknika/Chefaro IrelandOutsource Technical Concepts

PerfecsealPhardiagPharmabioServPhillips-Medisize IrelandPro Tek MedicalProxy Biomedical

RDJ GlynnRR Donnelly Global Turnkey Solutions

SA Partners Lean ConsultancySeabrook Technology GroupSealed Air NelipakSealpackSeroba Kernel Life SciencesShannon MicrocoilSiemens Healthcare DiagnosticsSOTA Prosthetics and OrthoticsSPS International(SSE) Specialised Sterile EnvironmentsSteriPackStryker Ireland - LimerickStryker Ireland - Cork OperationsStryker Ireland - Innovation CentreSymmetry MedicalSyneccoSynergy Health

Takumi Precision EngineeringTcoagTech Group EuropeTelefl ex EngineeringTelefl ex Medical EuropeTornier OrthopedicsTransitions Optical

Ulbrich Precision MetalsUlster BankUniversity of LimerickUtah Medical Products

Vascular Solutions ZerusaVitalographVolex EuropeVWR InternationalVysera Biomedical

Welch AllynWilliam Fry Solicitors

X-Bolt Orthopaedics

Young Microbrush

Zeus Industrial ProductsZimmer Orthopedics Manufacturing

E&OE

CORK

Knockrea HouseDouglas Road

Cork

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

SOUTH EAST

Confederation HouseWaterford Business Park

Cork Road Waterford


MID-WEST

Gardner HouseBank Place

Charlotte Quay Limerick


WEST

Ross HouseVictoria Place

Galway


NORTH WEST

3rd Floor Pier OneQuay Street

Donegal Town


IBEC EUROPE

Avenue de Cortenbergh, 89Boite 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 1500 FAX + 353 (0)1 638 1500

EMAIL [email protected] www.imda.ie

IMDA is a business sector within IBEC

www.ibec.ie

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