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Annual CEO Forum and pilot mentoring Programme for entrepreneurs launched Welcome to the winter edition of the IMDA Update newsletter 2014. In this edition we provide an overview of the key measures delivered by Government in Budget 2015 and other pertinent topics of interest for the sector. It was encouraging to see some reforms to the R&D tax credit announced in Budget 2015 in addition to the enhancements to the IP regime, including the introduction of the knowledge development box, and the special assignee relief programme (SARP). This will make Ireland a more attractive location for investment. With this in mind IMDA’s Business Foresight Strategy Taskforce launched its “Attracting Corporate Investment Playbook” in October, to support medtech companies who are looking at new investment opportunities within their own organisations. In Budget 2015 there were also some welcomed modest improvements to the Employment Investment and Incentive Scheme (EIIS) and the Seed Capital Scheme. We were disappointed however with the failure to reform Ireland’s Capital Gains Tax – which we felt was a lost opportunity for Government to support serial entrepreneurship within our industry. IMDA and Enterprise Ireland jointly launched an Entrepreneurship mentoring programme this October. Hopefully, this programme will grow the sector and our economy by facilitating opportunities for start-ups to learn from the experience of larger indigenous and multinational companies. We would like to sincerely thank all involved. Discussions are continuing with the Irish Government to ensure they are keenly aware of the importance of the medtech sector to the Irish and European economy. Top on our agenda is the revision of the Medical Devices and In-Vitro Diagnostics Directives. We are determined that the changes in the way our business is regulated must be as balanced as they are effective. Most recently, IMDA’s Skillnet have been approved a budget of 728K, of which 440k is government funding for 2015. This increase (9% on 2014) in funding is a direct result of the excellent performance of the network and the commitment of the Steering Group over the year. We look also forward to the imminent Apprenticeship Call, and welcome the establishment of the Apprenticeship Council - an initiative we believe will support the development of new skills for the sector. Recent months also saw the Government investment for the SFI CURAM Centre for Research in Medical Devices, which will support Ireland as a centre for medtech innovation. We are delighted to be back in Limerick for the 8th Annual Medtech CEO Forum & Awards, jointly hosted by Enterprise Ireland, IDA Ireland and IMDA and taking place on the 11 December. The CEO Forum is one of the largest gatherings of medtech professionals in Ireland, with goals of sharing insights on global trends and new and innovative ways of doing business. Congratulations to the companies that have been short-listed for this year’s medtech awards. The standard of competition remains high as always and shows how flexible and innovative companies from this sector continue to be in this very competitive global environment. Finally, I want to take this opportunity to thank Donal Balfe, vice chair of IMDA, our Board members as well as all the chairs and vice chairs and members of all of our working groups and taskforces for committing tirelessly on behalf of the industry to identify opportunities for the sector. 2015 will mark the end of IMDA’s current strategy and the dawn of a new direction. As the medical technology industry continues to undergo rapid transformative changes, as well as imposing policy challenges, there could not be a more important time for you to get involved in developing the next phase for medtech in Ireland. Regards Bill Doherty Cook Medical IMDA Chairman Building capabilities and entrepreneurship in medtech IMDA Update December 2014 Issue 41 www.imda.ie Contents Page 02/03 What will the budget mean for 2015? Ibec Regional Business Summit & AGMs New Irish patent court good for SMEs, foreign investment Page 04/05 IMDA and Enterprise Ireland launch medtech-specific Pilot Mentoring Programme for Entrepreneurs IMDA sponsors young medtech entrepreneur at international science fair IMDA Skillnet has secured provisional grant aid of 440,200 to develop skills in medtech Page 06/11 Design for Medical Technologies – IMDA Skillnet Programme Insights from Global Leaders in medtech to be shared Medical Technology Industry Excellence Awards 2014 IMDA Playbook for Growing the mandate of multinational entities in Ireland Lean Mentoring - Interested in participating in the programme? Page 12/15 Events and Training Sector News

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Annual CEO Forum and pilot mentoring Programme for entrepreneurs launched

Welcome to the winter edition of the IMDA Update newsletter 2014. In this edition we provide an overview of the key measures delivered by Government in Budget 2015 and other pertinent topics of interest for the sector.

It was encouraging to see some reforms to the R&D tax credit announced in Budget 2015 in addition to the enhancements to the IP regime, including the introduction of the knowledge development box, and the special assignee relief programme (SARP). This will make Ireland a more attractive location for investment. With this in mind IMDA’s Business Foresight Strategy Taskforce launched its “Attracting Corporate Investment Playbook” in October, to support medtech companies who are looking at new investment opportunities within their own organisations.

In Budget 2015 there were also some welcomed modest improvements to the Employment Investment and Incentive Scheme (EIIS) and the Seed Capital Scheme. We were disappointed however with the failure to reform Ireland’s Capital Gains Tax – which we felt was a lost opportunity for Government to support serial entrepreneurship within our industry.

IMDA and Enterprise Ireland jointly launched an Entrepreneurship mentoring programme this October. Hopefully, this programme will grow the sector and our economy by facilitating opportunities for start-ups to learn from the experience of larger indigenous and multinational companies. We would like to sincerely thank all involved.

Discussions are continuing with the Irish Government to ensure they are keenly aware of the importance of the medtech sector to the Irish and European economy. Top on our agenda is the revision of the Medical Devices and In-Vitro Diagnostics Directives. We are determined that the changes in the way our business is regulated must be as balanced as they are effective.

Most recently, IMDA’s Skillnet have been approved a budget of €728K, of which €440k is government funding for 2015.

This increase (9% on 2014) in funding is a direct result of the excellent performance of the network and the commitment of the Steering Group over the year.

We look also forward to the imminent Apprenticeship Call, and welcome the establishment of the Apprenticeship Council - an initiative we believe will support the development of new skills for the sector. Recent months also saw the Government investment for the SFI CURAM Centre for Research in Medical Devices, which will support Ireland as a centre for medtech innovation. We are delighted to be back in Limerick for the 8th Annual Medtech CEO Forum & Awards, jointly hosted by Enterprise Ireland, IDA Ireland and IMDA and taking place on the 11 December. The CEO Forum is one of the largest gatherings of medtech professionals in Ireland, with goals of sharing insights on global trends and new and innovative ways of doing business.

Congratulations to the companies that have been short-listed for this year’s medtech awards. The standard of competition remains high as always and shows how flexible and innovative companies from this sector continue to be in this very competitive global environment.

Finally, I want to take this opportunity to thank Donal Balfe, vice chair of IMDA, our Board members as well as all the chairs and vice chairs and members of all of our working groups and taskforces for committing tirelessly on behalf of the industry to identify opportunities for the sector.

2015 will mark the end of IMDA’s current strategy and the dawn of a new direction. As the medical technology industry continues to undergo rapid transformative changes, as well as imposing policy challenges, there could not be a more important time for you to get involved in developing the next phase for medtech in Ireland.

Regards

Bill DohertyCook MedicalIMDA Chairman

Building capabilities and entrepreneurship in medtech

IMDA Update December 2014

Issue 41www.imda.ie

Contents

Page 02/03

What will the budget mean for 2015?

Ibec Regional Business Summit & AGMs

New Irish patent court good for SMEs, foreign investment

Page 04/05

IMDA and Enterprise Ireland launch medtech-specific Pilot Mentoring Programme for Entrepreneurs

IMDA sponsors young medtech entrepreneur at international science fair

IMDA Skillnet has secured provisional grant aid of €440,200 to develop skills in medtech

Page 06/11

Design for Medical Technologies – IMDA Skillnet Programme

Insights from Global Leaders in medtech to be shared

Medical Technology Industry Excellence Awards 2014

IMDA Playbook for Growing the mandate of multinational entities in Ireland

Lean Mentoring - Interested in participating in the programme?

Page 12/15

Events and Training

Sector News

Given the recent improvements in GDP, the Government was right to abandon €2 billion adjustment and to focus on getting the deficit below the 3% mark. In doing so, the budget will support business and consumer confidence.

The income tax reform package is a major positive for the domestic economy. The higher rate cut and band increases are well targeted at the labour market and will help the incentive to work. The major disappointment is the continued discriminatory tax treatment of the self-employed. The abolition of the unfair pension levy is welcome.

When it comes to attracting FDI, the new international tax package reflected the concerns of business and achieved an appropriate balance between reform and enhancement. The changes to the residency rules had been flagged in advance and it was positive to see a sensible transition period provided. The enhancements to the IP regime, including the introduction of the knowledge development box, the R&D tax credit and the special assignee relief programme are welcome. This will make Ireland a more attractive location for investment and removes uncertainty.

Improvements to the Employment Investment and Incentive Scheme (EIIS) and the Seed Capital Scheme are positives for indigenous businesses. There is also a modest improvement in the 2015 Exchequer capital investment budget. The importance of putting more private finance to work for investment was stressed and there may be further commitments on new PPP projects.

The Government has delivered a sensible budget. It will be positive for jobs and growth and will help us push on with the recovery in 2015. We look forward to working with you over the coming months.

Mary-Rose BurkeDirector of Policy and Corporate Affairs

What will the budget mean for 2015?

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IMDA Update December 2014

Issue 41www.imda.ie

Mary Rose Burke, Director of Policy and Corporate Affairs

MedTech Europe decides to phase out direct sponsorship of physicians at third party congress. MedTech Europe (Eucomed and EDMA), the industry association representing medtech in Europe are currently reviewing their combined codes of ethical business practice. The code provides guidelines on interactions between Industry and Health Care Professionals (HCP’s). The current model of direct sponsorship of passive attendance of Healthcare Professionals (HCPs) to third party organised conferences is a model which is questioned by judicial authorities, HCPs and more generally the public as it carries an inherent compliance risk of a unilateral benefit to HCPS. Thus, Medtech Europe believe that phasing out direct sponsorship while at the same time swiftly introducing stricter rules for indirect sponsorship is the best way forward for our industry in the long run. In turn, they recommend respective memberships to phase out direct sponsorship of Healthcare Professionals to third-party organised conferences over a three-year period with view to ending all such sponsorships by 1 January 2018. In addition, stricter self- regulation of indirect sponsorship activities is already being developed to come into force at the same time.

IMDA’s Code of Ethical Business Practice is aligned to the Eucomed Code; therefore, our the IMDA Code of Ethical Business Steering Committee will review the revisions and adaptation proposed by Eucomed and ensure that the new compliance environment is consistent with IMDA’s The IMDA Compliance Steering Committee and Code of Ethics external panel met on the 18 November to discuss the Irish position in light of changes as an EU level. At this meeting the panel made the decision to revise our current code to firstly ensure that total independence and autonomy are given to the panel regarding final decisions on complaints. It was agreed that our Steering Committee should work on developing the Irish Industry’s position with regard to the Eucomed position on Direct Sponsorship. As a member of IMDA you are automatically signed up to the IMDA Code of Ethical Business Practice.

For more information visit www.imda.ie/ethics

Medical Devices Directive & In Vitro Diagnostics Directive revisions require a balanced approach The final texts for the Revision of the MDD and IVDD must still be agreed upon by the Council, European Parliament and Commission. IMDA met most recently with the Department of Health and the Regulator on 20 October to discuss ongoing Member State negotiations on the Commission Proposals in Council. IMDA will continue to engage at both a national and European level to promote a balanced approach.

European guidelines on interactions between industry and Health Care Professionals (HCP’s) currently under review

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IMDA Update December 2014

Issue 41www.imda.ie

Ibec CEO Danny McCoy and the Leadership team met with members recently at the Regional Business Summit & Annual General Meetings.

Members were updated on the outlook for domestic and international markets as well as emerging pay trends. The Protected Disclosures Act 2014 was also reviewed along with the key issues associated with the Workplace Relations Bill 2014.

Ibec’s Head of National & Regional Policy and Chief Economist Fergal O’Brien updated members on Ibec’s regional policy agenda, “As we enter the next phase of economic recovery and begin to see improved trading conditions in the regions, a strong voice for business in the regional and national debate will be more important than ever.

The regional distribution of the recovery remains very uneven and Dublin has been the primary focus of new job creation to date. Ibec’s Regional Executive Committees have a key role to play in terms of driving a strong business agenda and helping to ensure that all the regions experience more meaningful business and employment recovery next year.”

Ibec Regional Business Summit & AGMs

Pictured at the Ibec South-East Regional AGM were (l – r): - Danny McCoy, CEO Ibec; AnneMarie Cosgrave, Medite Europe Ltd; and Paudie O’ Connor, Boston Scientific Clonmel.

Pictured below at the Ibec West AGM were (l – r): - Sinéad Keogh, IMDA, Frank Cashman, Anecto; and Liam O’Donoghue, Ibec.

Pictured left (l –r):- Danny McCoy Ibec’s CEO, presents Michael O’Reilly, Phillips- Medisize, and out- going President of Ibec’s North West Region, with a token of appreciation at the Ibec North West AGM.

Pictured left at the Ibec Mid-West & Kerry AGM were (l – r): - Oonagh France,Cook Medical; Adrienne McDonnell, IMDA; Ambrose Downey, McKesson Ireland; and Carla Di Benedetto, Cook Medical

Ibec, recently welcomed Government’s decision to establish a local division of international patent court in Ireland. Ibec and IMDA has pushed for this to provide greater security for Irish SMEs as well as help Ireland better compete for foreign direct investment. Ibec Senior Executive for Government, Enterprise and Regulatory Affairs Aidan Sweeney said: “This will help us to better react to future developments in the global R&D environment as well as develop new clusters of high value-add activity here. Some of our competitors such as Finland, Denmark, the Netherlands and Belgium have already established local divisions. This move will help Ireland compete and encouraging companies to relocate their research activities and IP portfolios here.

New Irish patent court good for SMEs, foreign investment

“This move should provide particular comfort to SMEs who are increasing their rate of patenting but haven’t yet been exposed to litigation. A local division can be seen as a type of a national insurance policy in the overall roll-out of single European patent system. During the seven-year transitional phase, this route will allow an in-depth analysis of the overall operation of the Unified Patent Court, strengthen our hands in negotiation, as well as enabling a detailed assessment of the operation of the court structures. For more information visit: www.ibec.ie

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IMDA Update December 2014

Issue 41www.imda.ie

IMDA sponsors young medtech entrepreneur at international science fair

Pictured above: Young Entreprenuer, Edel Brown (middle) explains how her innovation ‘Free Feet’ works to (l – r) Adrienne McDonnell, IMDA; John O’Dea, Crospon; and Frank Keane, Vitalograph.

Young entrepreneur showcases “Free Feet” technology at IMDA Members Evening

Edel Browne, founder of Free Feet presented her technology at IMDA’s Members Evening, on the 02 October in Limerick. Free Feet is a visual cueing system which I designed to treat gait freezing in Parkinson’s disease (PD). Edel won the Best Individual Project at the BT Young Scientist competition in 2013 for the medical device Free Feet.

IMDA sponsored Edel’s participation at the London International Youth Science Forum (LIYSF). LIYSF is a two week residential event held in Imperial College London. Edel is a first year Biotechnology student in NUI Galway.

IMDA and Enterprise Ireland launch medtech-specific Pilot Mentoring Programme for Entrepreneurs

On the 2nd October, Minister of State at the Departments of Education and Skills Damien English TD launched the first bespoke Medical Technology pilot Mentoring programme, which was developed jointly by IMDA and Enterprise Ireland.

As part of the programme four high-potential start-ups in medtech are mentored by experienced professionals over a six month period. The companies participating in the pilot phase are CEO’s from Dublin based Incereb and ClearSight Innovations and CEO’s from Cork based AventaMed and PMD solutions. The mentors have been chosen because of their expert knowledge and the specific needs of the mentee companies. Leaders from Galway based Aerogen, Natus Manufacturing Ltd and Creganna-Tactx Medical and Dublin based Vascular Solutions have been selected as mentors.

Already some of the mentors and mentees have been introduced and commenced the process of working with each other. One of the participating companies in the pilot programme is PMD Solutions. PMD, a medical device company is based in the Rubicon Centre, Cork. PMD has developed RespiraSense, a solution to the global need for a comprehensive breathing rate monitor. PMD Solutions has received regulatory approvals (CE Mark) to sell RespiraSense across the European market and is forecasting to enter 10 countries across two continents serving 6000 beds by the end of Q1 2015. Sean Langan, Managing Director of Natus Nicolet, is acting as mentor to PMD, and working closely with Myles Murray, CEO, PMD to internationalise RespiraSense. Commenting on the opportunity, Myles Murray says, “Working with Sean allows a start-up such as PMD to leverage the knowhow and resources of a multinational and a seasoned executive to quickly establish a framework to engage with distributors on a global scale”.

Sean Langan provides the mentors perspective, saying, “Working as part of the IMDA/EI mentor programme is a great way to in some small way help start-up Irish Indigenous companies make it on a global scale. Myles and the PMD solutions team are a great example of the talent that exists in Ireland. In addition, the hard work ethic and passion to succeed, with limited resources, is admirable for any multinational to observe. This is an excellent initiative and one that should be expanded in order to build a stronger support network that will better serve Irish start-up’s.”

Pictured at the launch of the IMDA/Enterprise Ireland Pilot Medtech Mentoring Programme were (l – r): - Brian O’Neill, Enterprise Ireland; Sinéad Keogh, IMDA; with Jim Roche, Incereb; and John Power, Aerogen.

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IMDA Update December 2014

Issue 41www.imda.ie

IMDA Skillnet has secured provisional grant aid of €440,200 to develop skills in medtech

Ibec group, SFA presents to EU Parliament on “Supporting Innovative Start-Ups and SMEs”

IMDA Skillnet have been approved for 2015 on a budget of €728K, of which €440K is government funding (9% increase on 2014), even though Skillnets overall funding for 2015, as published on budget day, remains the same as 2014, €15.69m.

This increase in funding is a direct result of the excellent performance of the network and the commitment of the Steering Group over the past two years. The network has been successfully led by Pauline O’Flanagan and her team including Michelle Reinecke-Quain and Enda Dempsey.

There is also an additional provisional grant of 100K which may be made available during 2015 subject to funding availability. IMDA’s Skillnet has developed over 30 niche programmes over the past 8 years (NFQ level 5 – 9). Recently, two new programmes were launched; Design for Medical Technologies will help companies integrate excellent design early into the product development process and Software Quality Assurance analysts will provide much needed software skills for the sector. In 2015, IMDA Skillnet will also launch an MSc in Medical Technology Regulatory Affairs.

The availability of key skills and provision of industry specific, high quality, cost-effective training has been identified as a key driver for success under IMDA’s current Strategy. Since 2008 the IMDA Skillnet has been extremely successful in developing niche bespoke programmes in direct response to industry needs. IMDA would like to take this opportunity to thank Pauline, Michelle and Enda and most importantly the IMDA Skillnet Steering Committee for their support and dedication to the application and oversight process.

We look forward to working with our members in the coming months with regard the development and delivery of the medtech industry’s training needs.

80% of the medtech sector in Ireland are SMEs.

On the 3rd December, the Small Firms Association (SFA), the Ibec sector group that represents small business in Ireland, presented to the EU Parliament Committee on Industry, Research and Energy on “Supporting Innovative Start-Ups and SMEs”.

• SMEs are the driving force of Europe • Small Business Act must be improved and implemented by Member States • Enhanced funding options needed

The Director of the Small Firms Association, Patricia Callan, in her presentation stated that: “Irish SMEs are certainly the driving force in Europe, but despite much progress, the “think small first principle” and the Small Business Act has not been implemented fully in many member states”.

Callan commented: “We welcome the fact that the EU has now moved to a more growth oriented mandate as we believe that enabling business to establish and flourish, will drive forward economic growth and allow the tax revenues to be raised for Governments across Europe to redistribute, achieving their social aims. Prolonged austerity measures have held Europe back. To achieve real progress however, it is critical that the European institutions put small business at the heart of policy-making and really implement the “think small first principle” prior to the introduction of regulation.

Callan welcomed the recent announcement by the Junker administration of an additional 300bn investment programme, “which in addition to the COSME and Horizon funds, should support innovative SMEs by providing them with much needed funds. It is vital that these financial support programmes are targeted at small companies and that communications are improved in informing small companies in Ireland and all member states on what supports are available to them. The key metric for these programmes should be actual draw-down and utilisation by SMEs.”

“In addition to improving the availability and increasing the number of delivery platforms of finance to SMEs, it is essential that the focus on cutting red tape, promoting access to international markets and stimulating entrepreneurship are retained whilst broadening out the Small Business Act priorities to including supporting training for entrepreneurs and their staff. 50% of all Irish start-ups fail in the first 5 years. Studies show that improving management capacity in small business can reduce that failure rate by half. Time and money are barriers to small business owners undertaking training and the EU has a key role to play in supporting small companies to overcome these barriers”.

In conclusion, Callan stated that “The EU does now clearly recognise that SMEs are its driving force; what is now required is that it implements mechanisms to put them firmly in the driving seat”.

Pictured at the Launch of the Biopharma Conversion Programme in IDA Ireland, Athlone on 30th Oct 2014, were (l – r): - Back row: Ray Bowe, IDA Ireland, Helen Brennan, IDA Ireland, Chris Forsdyke, PPD Athlone, Matt Moran, Pharma Chemical Ireland, Lorraine Danaher, DSP, Killian O Driscoll, NIBRT, Des Henry, DSP, Caroline Tiercelin, PPD Athlone, Pauline O Flanagan, IMDA Skillnet Front row: Trish Breen Skillnets Ltd., Caitriona Bracken, DSP

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IMDA Update December 2014

Issue 41www.imda.ie

Design for Medical Technologies – IMDA Skillnet Programme

Companies – hosting an internship adds value

Pictured at the launch of the Design for Medical Technologies programme at the IMDA members evening in the University of Limerick on 2 October 2014 (l to r): - Áine Fox, Senior Executive, IMDA; Professor McCutcheon, Vice President Academic & Registrar, UL; Dr Ann Ledwith, Director, Continuing & Professional Education, UL; John Mugan, Creganna-Tactx Medical; Pauline O Flanagan, Network Manager, IMDA Skillnet

Pictured at the launch of the Design for Medical Technologies programme at the IMDA members evening in the University of Limerick on 2 October 2014 L to R - Áine Fox, Senior Executive, IMDA; John Mugan, Creganna-Tactx Medical; Pauline O’ Flanagan, Network Manager, IMDA Skillnet; David Tallon, Stryker

The Design for Medical Technologies programme was launched at the IMDA members evening in the University of Limerick on 2 October 2014.

The impact of design on medical technology innovation cannot be underestimated and a huge opportunity exists for Irish medtech companies, to upgrade their design engineering capabilities, and develop a world-class design engineering reputation for Ireland.

This new industry led programme will help companies to integrate good design into the product development process from the very outset and to properly exploit the advantages this approach will bring. The course has been developed by industry experts who are familiar with the challenges and imperatives of medtech design engineering. This innovative offering for the sector will address Design Thinking, Design for Six Sigma, Human Factors and Innovation and Technology Transfer and provide a series of guest and industry expert lectures.

The University of Limerick programme in collaboration with NCAD and UCD will be delivered in a block format based over two semesters with face to face contact on 3 days per month starting on 11 February 2015 until December 2015.

The availability of suitably skilled professionals for the sector is key to the growth and development of the ecosystem here. IMDA would like to thank all their member companies who have supported internships. Without company support, we would not be in a position to provide these valuable internships for graduates. By participating in the programme, your organisation will:

• Give an unemployed person the opportunity to gain relevant work experience;

• Access potential future employees;

• Enhance the performance of your organisation by offering an internship to motivated individuals with enthusiasm and a passion for developing their careers;

• Bring in fresh talent, fresh ideas and new thinking and

• Access newly trained interns with recent skills sets or skilled workers that add real value to your organisation.

INTERNSHIPS AVAILABLE!

• IMDA Springboard Quality Engineer NFQ Level 8 Programme 5 interns available from 5th January 2015!

• Medical Software Quality Assurance NFQ Level 8 interns available from 19th January 2015!

• IMDA Skillnet Certificate in Bioanalytics, NFQ level 9 graduates available 19th January 2015

• IMDA Springboard Quality Engineer NFQ Level 8 Programme 6 interns available from 11th May 2015!

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IMDA Update December 2014

Issue 41www.imda.ie

Insights from Global Leaders in medtech to be shared

8th Annual Irish Medical Technology Industry CEO Forum Jointly hosted by Enterprise Ireland, IDA Ireland and IMDA, the Irish Medical Technology CEO Forum year after year, attracts a stellar line-up of compelling speakers that includes some of the worlds most senior and in-demand medtech executives.

We anticipate many opportunities to learn from the vast experience and acute insight of the global leaders on the conference panel, and from our counterparts on the conference floor. We will explore the means by which companies based in Ireland can achieve leadership in global healthcare markets and examine the skills and mind-sets we need to acquire in order to reach this goal. It is an intellectually rigorous event, very fast-moving and it develops themes at a high level.

This year’s conference has several intertwining themes, all of which are influenced by the inexorable impetus towards change that is central to the nature of the medtech sector. So many factors coalesce to drive change in our industry, and to compound the rate of change. The industry is constantly developing new technologies and new treatments, regulation and compliance issues are ever-changing, and the cost of healthcare due to chronic disease will continue to be a challenge for governments globally. This year’s conference is organised around the following themes:

Evolving business models in global medtech. How the industry is embracing value-based innovation and backing up its effectiveness with hard evidence.

Partnering with others to create value. Partnerships with other companies and collaboration with healthcare professionals stimulates innovation.

Finance and competitiveness. Now that the double Irish is coming to an end and BEPS is gaining traction, how will Ireland fare in the new global tax environment?

Entrepreneurship. More than 80% of Ireland’s 300 medtech companies are SMEs. How can we foster and encourage entrepreneurship in the sector?

There are eight speakers scheduled throughout the day, with broadcaster and journalist Matt Cooper acting as moderator for the event and the discussions. The speaker line-up includes some of the world’s leading business people. The distinguished conference panel is as follows:

• M. Kem Hawkins, President, Cook Group Incorporated, one of the largest privately owned companies in the world, will speak about creating value and driving growth where expectations are higher and budgets are constrained.

• Donald Spence, Chairman and CEO, Lake Region Medical, will give his insights on becoming the partner of choice for the world’s leading medtech brands.

• Liam Kelly, Vice-President Americas, Teleflex, will provide the Teleflex perspective on future opportunities in medtech.

• Malcolm Bell, Managing Director, Technopath Manufacturing, will give an Irish SME perspective on working with partners to develop, manufacture and commercialise technology for a global market.

• Suzanne Durdevic, Senior Director, General Counsel, EMEA, Boston Scientific, will give her unique perspective on the evolving compliance debate and its impact on the medtech business model.

• Brian Thornton, Tax Partner KPMG, will outline what’s next for Ireland post BEPS and in the wake of the double Irish.

• Danny McCoy, CEO Ibec, will set out the immediate priorities and future expectations for Irish business.

• Daniel O’Mahony, Partner, Seroba Kernel Life Sciences, Seroba Kernel Life Sciences will outline the global venture capital funding landscape

The event is aimed at developing the vision, capability and expertise at the most senior level in the sector in Ireland. Along with Enterprise Ireland and IDA Ireland, IMDA look forward to welcoming you to the Medtech CEO Forum in the Strand Hotel, Limerick on 11 December! Visit www.imda.ie/ceoforum

Platinum Sponsor

Gold Sponsors

Silver Sponsors

Thank you to our Sponsors

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IMDA Update December 2014

Issue 41www.imda.ie

Medical Technology Industry Excellence Awards 2014

Incereb Ltd

Incereb Ltd was founded in 2010 and is based at the Synergy Centre in the Institute of Technology, Tallaght; Incereb develops brain monitoring sensors designed for infants at risk of seizure and neurological impairment in maternity and neonatal intensive care units. The products are designed to be used with minimal training and will significantly reduce the time taken to set up the neonate for EEG and CFM monitoring.

‘To be shortlisted for the IMDA awards, and to be recognised by our peers for our achievements is a huge honour for Incereb, especially as we are about to launch our first product. In 18 months, from a standing start, we have progressed to CE certification, sourced funding, staff, clinical expertise and manufacturing capability, all in Ireland, thanks largely to the medial device cluster which exists here. There are very few countries in the world where this could be achieved, and is something we are very proud of.’ Jim Roche, CEO, Incereb

Neuromod Devices

Neuromod Devices was founded in 2010 and is based in Nova UCD, Dublin. Neuromod Devices has developed mutebutton™, a new self-administered tinnitus treatment which is designed to gradually reduce chronic tinnitus symptoms. The company will be launching their product in Ireland in December, with a wider European launch in 2015.

“We are delighted to be finalists in the Annual Medical Technology Industry Excellence Awards. As a company, Neuromod Devices is approaching a significant milestone with the launch of our first product, the mutebutton™ tinnitus treatment across Europe.” Padraig Rushe, Chief Commercial Officer, Neuromod Devices

PMD Solutions

PMD Solutions is a medical device company based in the Rubicon Centre, Cork. PMD has developed RespiraSense, a solution to the global need for a comprehensive breathing rate monitor. RespiraSense is the premier product emerging from PMD’s novel respiratory sensor platform. RespiraSense has been specifically designed to be a patient worn wireless solution that continuously and accurately monitors respiratory rate with a single application, from admittance to discharge. PMD Solutions has received regulatory approvals (CE Mark) to sell RespiraSense across the European market and is forecasting to enter 10 countries across 2 continents serving 6000 beds by the end of Q1 2015.

“The Medical Technology Industry Excellence Awards stand out as Ireland’s leading recognition of the best the medtech industry has to offer. PMD being considered as part of this prestigious award is an honour for the entire team. Our vision is to establish RespiraSense as the industry standing in breathing rate monitoring by 2020. To have the recognition as a finalist in the Medical Technology Industry Excellence award is like receiving a flag of quality that PMD and its team will bring forward as we internationalise RespiraSense.” Myles Murray, CEO, PMD Solutions

Shortlist announced for Medical Technology Industry Excellence Awards 2014

The shortlists have been announced for the 2014 Medical Technology Industry Excellence Awards. The awards are jointly hosted by Enterprise Ireland, IDA Ireland and the Irish Medical Devices Association (IMDA), and were keenly contested, with large numbers of entries competing in each category. The ultimate winners will be announced at the gala awards dinner

following the Medtech CEO Forum on 11 December in the Strand Hotel, Limerick. Criteria on which the entries are judged includes: strategic vision, demonstrated quality of products and services, marketing and innovation, professional development of staff. Awards will be presented to company of the year; emerging company of the year; academic contribution to innovation and best medtech clinical innovation. The Clinical Innovation Award is hosted by Cleveland Clinic and Enterprise Ireland. For more information visit www.imda.ie/awards

EMERGING MEDICAL TECHNOLOGY COMPANY OF THE YEAR

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IMDA Update December 2014

Issue 41www.imda.ie

Medical Technology Industry Excellence Awards 2014

Abbott Vascular, Clonmel

Abbott is a global health care company with a significant presence in Ireland. Of its 11 sites in Ireland, 6 are manufacturing sites. Abbott Vascular established in 1998, is a centre of excellence for the manufacture of medical devices, and is the world’s leader in drug-eluting stents. Abbott Vascular’s products are exported to more than 100 countries around the world, and are used in the treatment of vascular disease. The Clonmel facility produces the stents and the delivery systems used to introduce the stents into the body. The facility has been recognised for world class performance across all facets of Operational Excellence.

“Our journey to performance excellence has been a conscious and collaborative effort that has been ongoing since 2004. We have built on the capabilities that existed at the site, and have strategically invested in employee engagement and development. Our experience of operational excellence is akin to the best team sport – the end goal is to have everyone working together, in a synchronised effort, to achieve a common purpose. Like any winning team, engagement fosters stamina, supporting the long-term sustainability of the site”William Boxwell, Site Director

DePuy Synthes

DePuy Synthes Ireland, based in Cork, since 1997 and manufactures knee, hip and shoulder joints for the global market. The company employs more than 700 people. The company was awarded the highest level of recognition, ‘The Shingo Prize for Operational Excellence’.

“Achieving the ‘The Shingo Prize’ is great recognition for the work that we have completed to date but our focus on Operational excellence does not stop now that we have achieved this milestone, if anything we need to re-new our efforts, build on what we have already achieved and continue to prepare ourselves to serve the millions of patients we serve on an annual basis.

Having this focus and achievement recognized through being shortlisted as a finalist for the Medical Technology Company of the Year further validates our strategy and is great recognition of the incredible work and commitment our staff demonstrate on a day to day basis in terms of meeting our patient’s needs.”James Winters, Plant Manager, DePuy Synthes Nypro Healthcare

Nypro Healthcare

Nypro Healthcare Ireland is the strategic European location for the Drug Delivery & Diagnostics group within Nypro Healthcare. Nypro’s Device Development Support group has partnered with market leaders Glide Pharma to develop an innovative new solid-dose auto-injector device. Their lean, risk focussed design

and development partnership with Glide Pharma has led to further business being awarded for clinical production.

Nypro Healthcare believes that their depth and breadth of technical skill set and design capability ensures the continuous flow of design and development projects to final manufacture, essential to sustaining their future business pipeline.

“Nypro Healthcare is now a world leader in medical device design, development and manufacturing. Employing over 450 staff at our two Irish sites in Bray and Waterford with the former site being the location of our European centre of design excellence, where experience and expertise turn ideas into large scale production reality”.Derek Fenlon, Director, Device Development Support, Europe, Nypro Ireland.

Stryker Ireland

Stryker has built a significant research and development competency and continued to expand its manufacturing operations in Ireland through a combination of investment in leading edge technology and strategic acquisitions. Stryker has over 2,200 employees across four sites in Cork and Limerick and has recently announced plans to construct a new 44,000 ft2 Surgical Innovation Centre in Cork.

Stryker’s Ireland operations play a significant role in enabling the company’s continued business growth through strong partnerships with the commercial divisions across our global network. Key to our success in supporting this network and building sustainable business growth are our talented workforce, a track record of innovation and a relentless focus on quality and customer experience.

Recent examples include:

• First company world-wide to automate Knee Femoral manufacturing • Establishment a ground-breaking, robust production-capable Additive Manufacturing Technology

• Development of an award winning Graduate Program to grow talent for the future

“Being shortlisted for the Medical Technology Company of the Year is a great testament to the dynamic and innovative Stryker workforce in Ireland. To enable Stryker to continue to make healthcare better, our Ireland operations continue to receive strong investment, which creates further expansion in the product base and the development of innovative products, manufacturing methods and new technologies”.Aidan O’Shea’s, Vice President, Ireland Operations, Stryker

MEDICAL TECHNOLOGY COMPANY OF THE YEAR

IMDA Update December 2014

Issue 41www.imda.ie

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Cork Institute of Technology

The Cork Institute of Technology’s Medical Engineering Design and Innovation Centre (MEDIC) was established in 2008 and is Ireland’s only academic research centre certified to the international standard for medical device design. The MEDIC recently developed the Tympanostomy Tube (grommet) Device, a safer, cheaper and more convenient single-use device which places a pre-loaded grommet into the eardrum in under one second. It was tested by MEDIC, supported by Enterprise Ireland, and brought to the market by AventaMed, a CIT spin-out company.

“MEDIC finds the best clinical ideas, matches them with the best academic and technical minds and brings them through a strict industry-standard Product Development Process within a world-class research environment. We then push them out to suitable commercialisation vehicles - all within an ISO13485 certified environment’ Daithí Fallon, Head MEDIC

Galway Mayo Institute of Technology

Galway-Mayo Institute of Technology (Gmedtech Centre): we are team of researchers with a unique capacity for designing and developing Invitro simulators, replicating parts of the human anatomy. These simulators are used for medical device design and feasibility studies, but more importantly they can help diagnose cardiovascular and pulmonary related diseases such as aneurysms and lung cancer. They are important training platforms for clinicians and medical device professionals.

“GMIT is delighted Dr Paul Fahy and the Gmedtech research team have been shortlisted for this prestigious award. Our biomedical research centre in partnership with leading clinicians at University Hospital Galway (UHG) are working together to provide safe training platforms for clinicians and medical professionals”.Dr. Patrick Delassus, GMedTech Centre Director

Trinity College Dublin

The Trinity Centre for Bioengineering (TCBE) is a key research centre in Trinity College. The Centre has five research themes: Regenerative Medicine, Biomaterials, Musculoskeletal Research, Cardiovascular Systems and Neural Engineering.

TCBE provides a structure to bring bioengineers, basic scientists and clinicians together to focus on important clinical needs. TCBE and RCSI/Beaumont Hospital identified a need to address inhaler adherence in asthma and COPD and developed the Inhaler Compliance Assessment (INCA) system. An extensive clinical validation of the INCA system has involved over 800 patients.

“The INCA system is a great example of translational science in action – Clinician Respiratory Consultant Prof. Richard Costello of Beaumont Hospital / RCSI collaborated with Engineer Scientist Prof Richard Reilly of TCBE to develop the INCA system. This technical solution was translated back to the bedside in partnership with Vitalograph, a leading respiratory device company with a base in Ireland”.Dr. Gordon Elliott, Case Manager Biomedical Science, Trinity College Dublin

A Seminar for Ibec members

The New Companies Act will take effect in June 2015 and will affect almost all companies in Ireland. There are implications that directors in particular need to be aware and need to prepare their companies for.

Overall the Act is about simplifying and codifying company law and making it more user-friendly and effective. It means private companies will now adopt a simpler constitution and also that customers can now assume a company has the necessary authority to do business. The Act sets out for the first time the duties of Irish company directors. Notably it requires an audit committee and an annual directors compliance statement for larger companies.

It is a key piece of legislation and it is important to understand the changes that will affect you and your business. Ibec is holding this seminar to inform member companies of the changes and what they will need to do to comply with it by June 2015.

Ibec will host a free half-day seminar to explain the implications of the new Companies Act for members on 15 and 23 January in Ibec, Dublin.

For more information contact: Miranda Hunter-Nolan on 01-605 1573 or [email protected]

Adjusting to the new Companies Act

Medical Technology Industry Excellence Awards 2014 ACADEMIC CONTRIBUTION TO INNOVATION IN THE MEDICAL TECHNOLOGY SECTOR

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IMDA Update December 2014

Issue 41www.imda.ie

BUSINESS FORESIGNT MODEL IMPLEMENTATION

IMDA Playbook for Growing the mandate of multinational entities in Ireland

Lean Mentoring - Interested in participating in the programme?

Pictured at the Launch of the IMDA Playbook for Growing the mandate of multinational entities in Ireland, were (l –r): - Tony Kennedy, Teleflex; Adrienne McDonnell, IMDA; and Bill Doherty, Cook Medical

As part of the implementation of IMDA’s Business Foresight Strategy, a key strategic initiative of providing members with information on how to attract Foreign Direct Investment into their existing sites in Ireland was requested by our membership.

At the IMDA Members Evening, Tony Kennedy, VP of Manufacturing EMEA with Teleflex Medical presented a compelling case study on utilising the R&D environment in Ireland, and provided audiences with an understanding in tax planning.

The IMDA Operational Excellence Taskforce launched the lean mentoring programme in late 2013.

The aim of this programme was to leverage the extensive knowledge and experience of member companies with mature lean processes, to assist other member companies who are at an earlier stage of their lean journey.

The Lean Mentoring Programme has already developed two very strong partnerships with both sides of the partnership benefitting from the programme. The IMDA are now on a drive to create more partnerships in this programme.

This programme will further grow the lean network already well-established within the IMDA and ensure the further development of the MÓRTM model as THE model for lean development. Bellurgan have been mentored by Siemens since the inception of the Lean Mentoring programme and have begun utilising the MÓRTM model on site with the help of Gerry McNamee, Siemens Healthcare Diagnostics.

“Bellurgan would like to take this opportunity to thank the team from IMDA who put the programme together and thank both Siemens and in particular Gerry McNamee for his support to date. It has been great having the insight and experience of a Lean mentor practicing in a real business environment to help guide us on our Lean journey.”Suzanne Carroll, Managing Director, Bellurgan Precision Engineering Ltd

The model provides a framework that companies can instantly use to progress in their lean journey and will be launched as a standard by year-end. For more information please contact: [email protected]

IMDA welcomes the Government’s establishment of the Apprenticeship Council to oversee the development of new apprenticeships across a broader range of occupations. IMDA have set up an apprenticeships taskforce that have already begun the development of a first of its kind medtech apprenticeship.

Tony Donohoe head of Education & Social Policy, Ibec has been appointed to the council and stated, “The current apprenticeship system, which is limited to 26 occupations, does not reflect the broad skill needs of the Irish economy. A new model has the potential to boost skill levels across the economy and help get people into quality, sustainable jobs. It is vital that companies are involved in both the design of curricula and in the delivery of programmes. This will ensure the continuing relevance of qualifications in a rapidly changing labour market.

“On-going economic changes require a flexible system, where the terms of the apprenticeship depends on the needs of the specific sector. The Council provides a structure to create new apprenticeships rapidly, and to react to emerging needs and target resources towards sectors with high potential for growth.”

Pictured from (l –r): - Sinéad Keogh, Director IMDA, with Lean Mentoring Participants, James Browne and Stephen Creaner from Waters Technologies, with Dermot Doherty, IMDA Executive.

IMDA Update December 2014

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Events and Training

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Pictured at the Sterility Assurance Forum, in Athlone were: - (l to r) Áine Fox, IMDA; Richard Cowman, Synergy Health (Forum Chair); David O’Sullivan, DePuy Synthes; Olivier Vrain, Synergy Health; Caroline Murphy, Teleflex Medical.

IMDA Sterility Assurance Forum, 11 November 2014, Athlone The second meeting of IMDA’s newly established Sterility Assurance Forum of was held in the Hodson Bay Hotel, Athlone on 11 November. Forty sterility assurance and QA/RA professionals attended the event. A series of formal presentations were interspersed with member company case studies providing a comprehensive overview of sterility assurance standards and encouraged active engagement from participants in the development of relevant standards currently undergoing review.

Updates were provided on ISO11135:2014 and other regulatory standards. Case studies were presented by DePuy Synthes, ArcRoyal and Covidien on parametric release and gamma. An update on ASTM International (American Society for Testing and Materials) an international standards organisation that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services rounded off the day’s proceedings. The Forum will meet again during Q2 2015.

Teleflex to help Ireland’s workforce get healthier Athlone’s Teleflex has become the first company to sign up for Ireland’s first Workplace Wellbeing Day, which will take place on Friday, 27 March 2015. The medical devices company is one of the event’s champions whose work in the area of workplace wellbeing will be used to encourage and assist other companies to participate in this new initiative.

National Workplace Wellbeing Day is supported by Ibec. Healthy workplaces and workforces have also been identified as a priority area under Healthy Ireland, the national framework to improve health and wellbeing across the population. The nationwide campaign aims to help improve employee health through promoting effective wellbeing initiatives targeted at better nutrition and physical activity in workplaces around Ireland.

Companies are being asked to put a special focus on wellbeing on the day through promoting existing and new initiatives available in their workplace as well as hosting special events for staff. Further details of how companies can get involved are available at www.nhfireland.ie

Pictured at the launch of the National Workplace Wellbeing Day initiative, were (l – r): - Karen Duffy HR Co-Ordinator, Teleflex; Danny McCoy, CEO, Ibec; Kate O’Flaherty, Director, Health and Wellbeing Programme, Department of Health; and Miriam Doolan, HR Specialist, Teleflex.

Pictured below at the Sterility Assurance Forum, in Athlone were (l – r):- Shaun McGinley, Covidien; Suzanne Butler, Boston Scientific; Richard Cowman, Synergy Health; Pauline O’Flanagan, IMDA Skillnet; John Cunniffe, Covidien.

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IMDA Update December 2014

Issue 41www.imda.ie

Swords Site Hosts Future Leaders from One Young World In October, Siemens Healthcare Diagnostics in Swords, Ireland, hosted a breakout session for more than 40 delegates from the One Young World conference in Dublin.

One Young World is a catalyst for action to address critical global issues, with the added goal of inspiring the brightest young people from around the world, empowering them to make lasting connections that create positive change.

The Swords DX site’s participation in the One Young World event was a great opportunity to showcase the site’s employees and products for a vibrant global audience. The delegates, ages 18 – 30, were taken on a guided tour of the plant emphasizing three areas of focus, instrument refurbishment, blood screening, and youth development programs. A lively panel discussion followed, centering around the recent introduction of a new initiative: the first dual learning traineeship for production operators in Ireland, in partnership with the Irish Medical Devices Association’s (IMDA) Skillnet training network.

The Swords traineeship is an opportunity for individuals who are young, unemployed, or new to the work force to develop a career in the growing med tech sector in Ireland. Both Siemens and the med tech sector will benefit from developing highly-skilled operators.

The panel hosted a lively interactive discussion with the delegates on the benefits of the Siemens approach to youth development and training in the national and international context. (l – r): Mike Farrell (Head of Production, Siemens HC DX Swords), Martin Hottass (Head of Skills Management, Siemens North West Europe), Philippa Taaffe (Head of Human Resources, HC DX Swords), Dr. Sinéad Keogh (Director of Irish Medical Devices Association), unknown delegate.

The organisers utilised existing med tech training structures in partnership with the IMDA Skillnets, and then supplemented this training with a structure that was developed in partnership with Siemens NWE colleagues who have substantial experience in this field. Swords provides a paid traineeship period of two years with the site covering all costs.

As a result, the first “dual learning” apprenticeship-style program for operators in Ireland was launched in October 2013, and is now feeding into a national apprenticeship review currently underway in Ireland. According to Swords Head of

Production Mike Farrell, “Our young people become more employable, our workforce more enthusiastic and knowledgeable, and our society benefits through reduced youth unemployment.”

For more information on the training program, please contact [email protected]

NOTICE: IMDA AGM – get involved! IMDA’s Annual General Meeting for all members of the IMDA/Ibec will take place 5.30p.m. (directly after the Medical Technology Industry CEO Forum) in the O’Brien Suite on the 6th Floor, Limerick Stand Hotel.

We look forward to your support and attendance. To book your place visit: www.imda.ie/events

Sinéad Keogh, IMDA Director (2nd from right) with IMDA’s Board members pictured at the IMDA Members Evening on 2nd October in University of Limerick (r – l): - Damain Finn, Bausch & Lomb; Phil Watson, SteriPack; Frank Keane, Vitalograph; Patricia Smith, BMR; Bill Doherty, Cook Medical; Barry Comerford, Cambus Medical; John Power, Aerogen; Sinéad Keogh, IMDA; and Tony Kennedy, Teleflex Medical.

IMDA Update December 2014

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Events and Training

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Paula O’Brien, Training Supervisor at Lake Region, New Ross talks about the value of rolling out

Continuous Improvement in Manufacturing QQI Award NFQ Level 5 programme In June 2012, Lake Region Medical’s operation in New Ross Co. Wexford achieved the distinction of becoming the first medical device manufacturing plant in Europe to achieve the prestigious Shingo accreditation. This achievement was subsequently honoured by the Irish Medical Devices Association when they crowned Lake Region Medical as Ireland’s Medtech Company of the year for 2012. Anxious to build on the momentum and enthusiasm of their employees, the company looked at how they could increase their internal operational excellence capabilities. The ideal program would have to meet the following criteria:

• Provide a new layer of C.I expertise rather than expanding programs already in place at Lake Region Medical.• Have a practical application.• Deliver a recognized qualification.• Be cost effective.

After reviewing many options, the Continuous Improvement in Manufacturing, QQI Award at NFQ Level 5 provided by the IMDA Skillnet was selected. As this was a national level 5 certification, there was a requirement to first train five internal facilitators who would be responsible for delivering the seven CI training modules. The internal facilitators selected were already experienced in C.I. with some already holding a Lean Manufacturing qualification.

Their training was delivered at Lake Region Medical over two days using a combination of class based, videos & web based teaching aids. Ten employees including team leaders, trainers and back office support staff were selected as the first wave of trainees. Each of the seven CI modules: Introduction to Continuous Improvement, Value Stream Mapping, 5S & Visual Management, Problem Solving, Control of Variances, TPM and Sustaining Progress were delivered by the internal facilitators in two hourly sessions each week over a seven week period. This was followed, a week later, with a written exam.

The next phase of the course required each trainee to carry out a workplace C.I. project incorporating the lean tools & techniques e.g. Problem Solving, SMED & TPM and on completion write up a portfolio detailing the learning outcomes. For most of the trainees the challenge of leading a project and writing such a comprehensive report was alleviated by the fact that they were partnered with one of the internal facilitators who was always on hand to offer support and direction.

The timeline between training on the first module to the project report submission was aggressive, however necessary in order to make the gap between learning in the classroom and implementing in the workplace as short as possible. All ten of our 2013 CI students passed with seven of them achieving distinction level. This year we have had another ten successfully complete the course (nine at distinction level) with another group scheduling to commence training in December. In fact, such has been the success of this training program that we now have a waiting list of employees wanting to participate & our goal is to qualify 20 employees per year going forward.

The course has certainly met the criteria set out originally. It has provided a new layer of expertise at the team leaders and supervisor level within Lake Region Medical which helps to embed continuous improvement into the DNA of the company while also providing this key group with additional skills to drive the company forward.

One unexpected dividend from the course was the personal development of the internal facilitators. The fact that some of them were mentoring people outside of their own departments helped to forge strong working relationships which will last long after the QQI award is attained. Finally, the blended learning format of the programme lends to a very cost effective method of certifying our people.

“ The course detail was excellent and gave me a true understanding of CI and lean principles. Now when errors occur, I look at them as ‘turning mistakes into opportunities for improvement’ both at work and at home. Having the QQI level 5 qualification gives me greater confidence in my own ability as well as changing other people’s perceptions of how much more I can contribute.”Kate Moore, Assembly Supervisor, Lake Region New Ross

Pictured at the IMDA Skillnet Presentation Ceremony of QQI Level 5 Awards in “Continuous Improvement in Manufacturing” in Lake Region, New Ross were (l –r): - Dr Sinéad Keogh, Director IMDA, Noreen Fitzpatrick, Skillnets, John Harris, VP Operations Lake Region, Pauline O Flanagan, IMDA Skillnet, and graduates.

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Teleflex committing to expansion of jobs at Athlone site

On 29 October, Minister for Jobs, Enterprise and Innovation Richard Bruton TD announced that Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, has confirmed its intention to create more than 100 high-skilled positions over the next three years at its Athlone, Ireland office.

Since the creation of the Athlone site in 2007, Teleflex has grown to employ more than 150 people who support the Company’s growing business in Europe, Middle East, Africa (“EMEA”), Asia Pacific and India. Teleflex is one of the top 160 companies by revenue in Ireland, and the Athlone site recently was accredited as one of the best workplaces in Ireland by the Great Place to Work Institute.

Aerogen Awarded as Exporter of the Year

On 25 November Aerogen, an Irish- headquartered medical device company and drug delivery product innovator has won the award for Exporter of the Year at the annual Export Industry Awards. Aerogen was recognised for exporting 99% of its multi-award winning products in 2014 and achieving 30% growth in exports year on year since 2008. The company’s products are now used in hospitals in over 70 countries worldwide, providing optimum care to the most critical patients from pre-term babies to adults.

Aerogen was chosen from 11 overall winners of individual categories at the awards ceremony, which took place in the Convention Centre, Dublin on Friday 21st November, after winning the award for Life Sciences Exporter of the Year. The Export Industry Awards recognise emerging exporters as well as established indigenous exporters of manufactured goods and services across all sectors.

Seabrook Technology Group celebrates the expansion of Operations across North America

Manufacturing software specialist company Seabrook Technology Group were delighted to announce the expansion of its US operations in California, USA with the Mayor of Dublin, California, Tim Sbranti.

Sean OSullivan, CEO and founder of Seabrook Technology Group, said: We are delighted with the opening of the new office. While we already have operations on the East Coast and in the Mid-West, this expansion to California showcases our success since our expansion into North America just over two years ago. For me, the new office symbolizes the success we are having at Seabrook. We are overwhelmed with the welcome we have received here in California.

NeuroTronik Limited - Series A Second Tranche Funding

NeuroTronik Limited has closed on the second tranche of its 2013 Series A financing. This funding results from the excellent progress made thus far in the development of the technology, therapy, and company. NeuroTronik is developing a novel neuromodulation therapy, for use in hospitals, to treat acute heart failure syndrome. Having successfully deployed the therapy in canines and having achieved a positive initial therapy signal in humans, this funding tranche is deployed to demonstrate the therapy in humans during 2015.

Series B Preferred Stock financing is slated immediately thereafter. That financing is designed to resource commercial system development, clinical trials, market approval, and initial commercialization in Europe.

Sector News

IMDA Update December 2014

Issue 41www.imda.ie

Creganna-Tactx Medical to Acquire Precision Wire Components

On 29 October, Creganna-Tactx Medical, a global provider of medical device outsourcing solutions, announced that it has entered into a definitive agreement to acquire Precision Wire Components LLC (PWC), specialists in wire processing for the medical device industry. The combined company will be known as Creganna Medical and brings together two respected brands with market leading positions in the design, development and manufacture of Minimally Invasive Devices.

The acquisition will strengthen Creganna’s global footprint, enhance its technical capabilities and deepen customer partnerships. PWC’s manufacturing facilities in Tualatin, Oregon and Heredia, Costa Rica will be added to Creganna’s global foot-print in the United States, Europe and Asia. PWC will complement Creganna’s existing solutions for minimally invasive delivery and access devices through the addition of wire component and coiling technologies. Customers will benefit from working with a single proven partner, offering a wider set of solutions, capable of serving their needs both globally and locally.

Board Members

William Boxwell Abbott Vascular

John S Power Aerogen

Damain FinnBausch & Lomb

Dr Patricia Smith Bio Medical Research

Paudie O’ConnorBoston Scientific Clonmel

Barry Comerford Cambus Medical

Board Members

John O’Dea Crospon

James Winters Depuy Ireland

Phil Watson Steripack Ltd

Tony KennedyTeleflex Medical

Frank Keane Vitalograph (Ireland) Ltd

Who we are

Upcoming IMDA Events

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IMDA Executive Team

Dr Sinéad KeoghDirector

Dr Áine FoxSenior Executive

Adrienne McDonnellExecutive

Dermot DohertyExecutive

Fiona HarrisonExecutive Support

Dr Enda DempseyIMDA Skillnet/Springboard Executive

Pauline O’ Flanagan IMDA Skillnet Manager

Michelle Reinecke-QuainExecutive Support for IMDA Skillnet

IMDA Update

IMDA Chair

Bill Doherty Cook Medical

IMDA Vice-Chair

Donal BalfeCovidien

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Irish Medical Devices Association84-86 Lower Baggot Street, Dublin 2

Telephone: + 353 1 6051529Facsimile: + 353 1 6381529

Website: www.imda.ieTwitter: @IMDAIrishMedTec

Op Ex Conference Call 8 January 2015

Design for Medical Technologies Programme11 February - December 2015

Op Ex T/F Quarterly Meeting12 February 2015

IMDA Board Meeting 3 March 2015

Digital Marketing for Medical Technology Companies5 March 2015

Op Ex T/F Quarterly Meeting, Limerick2 April 2015

Manufacturing Conference 29 April 2015

IMDA Board Meeting6 May 2015

IMDA Members Evening, Galway6 May 2015

Op Ex meeting24 September 2015

Op Ex meeting19 November 2015

IMDA Board Meeting16 October 2015

IMDA Members Evening, Cork6 October 2015

IMDA Board meeting10 December 2015

IMDA AGM10 December 2015

Medical Technology Industry CEO Forum & Awards, Galway10 December 2015

December 2014Issue 41www.imda.ie