A time of change; new EU regulations and new EU code of ethical business practice on the horizon

I am delighted as Chair of IMDA, to welcome you to the ‘new look’ IMDA Update. It has been an incredibly busy year so far for the Medtech sector. I would firstly like to acknowledge both Liam Kelly, Teleflex Medical whose recent promotion to VP Americas for Teleflex has seen him move to the US, and step down as vice-chair of IMDA, and secondly to Donal Balfe, Covidien, who has taken over Liam’s position as vice-chair. On a personal note, I wish Liam every success and thank him for his contribution to IMDA, and look forward to working with Donal over the coming months.

We are currently in a time of change, with the pending adoption of new regulation on the Medical Devices and In-vitro Diagnostics Directives, and recent European parliament elections having just taken place. This was a topic of significant discussion when the IMDA Board met with the Secretary General of the Department of Health & Children in February, and subsequently the CEO of IMB in April, among many other keys issues for the Medtech industry. In fact, our largest quality and regulatory conference ‘Global Access 2014’ is only a few months away, and will be an ideal opportunity for industry members to convene and discuss the challenges that lie ahead. We look forward to seeing you there on the 10 & 11 September in the Radisson Blu Hotel, Galway!

Across Europe there is also a changing landscape with regard to compliance. Earlier this month IMDA participated in a Medtech Europe Round-table discussion with CEO’s of the various European jurisdictions on the future framework of industry support to medical education that reflects changes in today’s healthcare and compliance circumstances. I encourage all members to ensure you are engaged with IMDA by having a compliance representative nominated onto our compliance mailing list. At this time of change it is important for Medtech companies to stay abreast of compliance, particularly in light of the on-go-ing discussions on the Code across Europe.

In May, a delegation from Ibec and IMDA addressed the Joint Oireachtas Committee on Jobs Enterprise and Innovation to communicate specific views of the Medtech sector with respect to access to finance for SME’s. IMDA also made a submission as part of the Public Consultation on the Future Focus of the Seed and Venture Capital Scheme (2013- 2018).

On the skills front, IMDA have completed our Annual Skills Survey, to reveal a significant number of vacancies across the engineering functions. IMDA have also been granted funding for the third year in succession for a bespoke conversion programme for quality engineers under the Springboard initiative.

IMDA and Enterprise Ireland have built a framework for a new approach to mentoring as a pilot initiative for our industry – we are looking for a number of mentors with expertise in various areas of the business, so that we can build a mentor network to provide support and advice to Medtech companies. I would like to encourage all my fellow Medtech colleagues to participate in this programme and promote the SME community here in Ireland.

Finally, I look forward to many companies working with IMDA to foster growth opportunities through the many working group initiatives on policy issues, training or networking events over the coming months. Have a healthy and successfully summer.

Regards

Bill DohertyCook Medical

IMDA Update June 2014

Issue 39www.imda.ie

Contents

Page 02/03

Industry calling for balanced approach to revision of the Medical Devices and IVD Directives

EU-US Transatlantic Trade and Investment Partnership – what this means for Medtech

IMDA Progress on the new Apprenticeship Model

Page 04/05

IMDA Submission on Seed & Venture Capital

New mentoring programme for start-ups

Surveying and bridging current skills gaps in the Medtech sector

Page 06/07

New IMDA Sterility Assurance Forum established

IMDA Best Practice in Product Development

IMDA’s Academic Forum

Page 08/09

Medtech conversion programme for quality engineering IMDA’s members Evening

Medtech conversion programme for quality engineering

An Ireland that works - Ibec regional breakfast seminars

Page 10/11

Medical Technologies Pilot Mentoring Programme

Sector News

Industry continues to call for a clear, predictable and effective regulatory system specifically tailored for medical devices that ensures the highest level of safety for patients, timely access to the latest innovative technologies, the trust of its stakeholders, the sustainability of national healthcare systems and keeps R&D and innovation in Europe.

The European Parliament voted on its first reading of the draft legislation on the revisions of EU Medical Devices Directives (MDD) and in vitro Diagnostics Directive (IVDD) on 2 April 2014.

Five important issues have emerged as key concerns for the sector:

• Revisedclinicalrequirements-IMDArecommendsthatthe Council of the European Union to closely adhere to a device-specific approach, setting clear, attainable and scientifically valid clinical requirements for devices

• Introductionofapre-market‘scrutiny’procedure- IMDA recommends that the Council of the European Union replaces the European Commission’s proposed Article 44 ‘scrutiny’ procedure with a ‘Reinforced Control Procedure’ that is applicable to all Notified Bodies certified by authorities to approve new high risk class III devices and built into an upgraded notified body approval system

• Restrictionofhazardoussubstances-IMDArecommends that the Council of the European Union supports the European Commission’sproposalontheuseofhazardoussubstances in medical devices

• Re-useofsingle-usedevices-IMDArecommendsthatthe Council of the European Union supports the European Commission’s proposal on the re-use of single-use devices

• TransitionperiodforIVD’s-IMDArecommendsthatthe Council of the European Union supports the European Commission’s proposal for a transition period of 5 years

‘Trilogue’ negotiations are expected to commence in September and the outcome of these negotiations should lead to the final legislative texts for medical devices and IVD’s. The next phase in the legislative process for these technical and complex proposals is crucial. Whilst shorter term adoption of the legislative proposals is desirable, industry advocates that a rushed ‘political’ compromise must be avoided and the final agreement must strikethe appropriate balance between maintaining the strengths of the current European regulatory framework whilst addressing aspects of the current system that need enhancement. Whilst early 2015 continues to look more likely for adoption of the new Regulations, it is certainly clear that the debate is still finely balanced. IMDA through Ibec’s Brussels office will continue its advocacy at a European level as the new Parliament and Commission enter office over the coming months.

Industry calling for balanced approach to revision of the Medical Devices and IVD Directives

2

IMDA Update June 2014

Issue 39www.imda.ie

Company and Trade Association Representatives from the Medtech industry gathered at the Annual Global Compliance Conference on 20 – 22 May, in Barcelona to discuss Compliance across the world.

Attendees were advised of a number of new developments, the most topical subject currently under discussion being the decision by the EDMA and Eucomed to revise their respective Codes of Ethics regulating the collaboration between companies and healthcare professionals (HCPs). Medtech companies collaborate with HCPs in various ways, one of which is through industry support of medical education by means of direct sponsorship of HCPs to attend third-party medical conferences as delegates.

The European compliance landscape is changing rapidly, with some countries regulating HCP sponsorship with measures ranging from partial to full bans, while others have opted for various levels of transparency and disclosure requirements. Medtech Europe has therefore began a comprehensive consultation process with HCP organisations and other relevant stakeholders at European and national levels to work towards a new framework that reflects today’s reality while ensuring HCPs continued access to the training and education they need.

On the 4 June, IMDA participated in a Medtech Europe Roundtable discussion with CEO’s of the various European jurisdictions to further discuss the future framework of industry support to medical education (at conferences) that reflects changes in today’s healthcare and compliance landscapes. IMDA’s Code of Ethical Business Practice is aligned with Eucomed’s Code, and compliance with the IMDA Code is mandatory for members. It is envisaged that an updated version of the Eucomed Code will be approved in Q4 2014.

Code of Ethical Business Practice – changes looming across Europe

Pictured at the Global Compliance Conference in Barcelona in May were (l - r): - Bill Doherty, IMDA Chairman (Cook Medical); Aline Lautenberg, Eucomed; Adrienne McDonnell, IMDA; and Serge Berlesconi, EDMA, Eucomed & Medtech Europe.

3

IMDA Update June 2014

Issue 39www.imda.ie

The Transatlantic Trade and Investment Partnership (TTIP) is a trade agreement that is presently being negotiated between the European Union and the United States.

TTIP aims to remove trade barriers in a wide range of economic sectors to make it easier to buy and sell goods and services between the EU and the US. On top of cutting tariffs across all sectors, the EU and the US want to tackle barriers behind the customs border – such as differences in technical regulations, standards and approval procedures. These often cost unnecessary time and money for companies who want to sell their products on both markets.

The Department of Jobs, Enterprise and Innovation have engaged Copenhagen Economics to undertake a study on the impact in Ireland of the EU-US Transatlantic Trade and Investment Partnership. The final report which is due around July will identify key areas of interest and quantify the magnitude of the impact. Their analysis will also help inform the Irish negotiating position in the discussions.

The Medtech sector has set out key priority areas for the Medtech industry as follows:

• SingleAuditofMedicalTechnologyManufacturerQuality Management Systems;

• SingleHarmonizedStandardforMarketingApplication Format and;

• UniqueDeviceIdentification.

IMDA Progress on the new Apprenticeship Model

In January 2014 the Government published the review of apprenticeship training in Ireland.

Since its publication IMDA have been in consultation with Phil O Flaherty, Department of Education & Skills at both the Ibec Education & Skills Committee and at the IMDA Academic Forum.

The Department of Education & Skills have indicated that they expect to have an implementation plan in place by the end of June with a call for proposals to follow later in the year.

Through the recent Medical Technology Skills Survey, IMDA have defined the needs of Industry and intend to submit a pilot apprenticeship proposal to SOLAS, via the newly formed IMDA Apprenticeships Working Group.

Ibec are urging the Department of Education & Skills to move quickly on implementation. This new model has the potential to make apprenticeships more attractive as a progression routes for trainees and meet skills requirements of business.

On 10 April, Ibec launched ‘A European Union that Works’, this document sets out the business priorities for the incoming European Parliament and stresses the important role Irish MEP’s will have in shaping law and policy and giving Ireland a strong voice in Europe.

This document which was widely circulated to approximately 3000 stakeholders provides a specific recommendation under the theme of ‘Smarter Regulation’ stating that ‘the European Parliament should work with the Council and Commission to ensure that a balanced and appropriate regulatory framework which protects patients and world-class innovation in the medical technology sector is adopted’.

‘A European Union that Works’ is part of a wider Ibec campaign, ‘An Ireland that Works,’ which sets out the business priorities for the next phase of Ireland’s economic recovery. Ibec will produce a more detailed policy & sectoral document aimed at the new Commission during the Autumn. IMDA will input into this document addressing key topics for the Medtech sector including the MDD/IVD revision, a European funding framework and procurement.

EU-US Transatlantic Trade and Investment Partnership – what this means for Medtech

Ibec sets out business priorities for the next European Parliament

Pictured at the Brussels launch of ‘A European Union that Works’ were (l – r):- Emmett Devereux, Cook Medical (IMDA Regulatory Steering Committee member); Ambassador Tom Hanney, Deputy Perm Rep to the EU; Sean Kelly, MEP and Pat Ivory, Head of EU and International Development, Ibec.

4

IMDA Update June 2014

Issue 39www.imda.ie

Promote the Medtech industry in Ireland - Pilot Mentoring programme

IMDA and Enterprise Ireland have developed an innovative and new approach to mentoring by utilising experts in the Medtech industry through mentor-mentee partnerships. This Medtech Pilot Programme is looking for mentors to be paired with identified SMEs. The High Potential Start Up (HPSU) companies, who feel they will benefit from an assigned mentor, will share their experience and challenges over the course of a six month period (2 hours per month), with the overall aim of improving their business.

At this point, IMDA are inviting companies to put forward their expression of interest in becoming a mentor for this Medtech-specific programme. A mentor can be an expert in their field and can also be a representative of their company. Mentoring can increase small businesses capabilities in selected business areas by providing the support and guidance of experienced practitioners or mentors in various areas of the business.

More action needed to improve credit flow to SMEs

As part of a delegation from Ibec, John O’Dea, CEO Crospon & IMDA Board member addressed the Joint Oireachtas Committee on Jobs Enterprise and Innovation on 13 May, to communicate specific views of the Medtech sector with respect to access to finance for SME’s.

Ibec and IMDA stated that more action was needed to ensure that SMEs had access to the credit they needed to run and expand their businesses. Irish companies continue to pay relatively high interest rates on bank loans and credit conditions for non-financial enterprises and businesses remain tight. While some steps have been taken to improve matters business in Ireland is still too reliant, by international standards, on traditional banking which accounts to 94% of total SME finance.

To address the problem, Ibec have called on government to enhance tax-based investment schemes and the venture capital environment, as well as introduce state-backed capital funds. At the committee we called for:

• Roll-out significant state backed enterprise financing: we need to address gaps in financing growth for business, especially for SMEs and start-ups.

• RebrandingoftheEIISandtargetingnon-traditionalinvestors: the EIIS needs to focus on investing in SMEs, and the employment or R&D restrictions should be dropped.

• Enhance the seed capital scheme: the share holding period must be reduced and more information should be provided through LEOs and other available avenues.

• Reform capital gains tax: changes are needed to support enterprise investment over speculative activity and improve competitiveness of offering.

New mentoring programme for start-ups Seeking mentors to support start-ups!

IMDA Submission on Seed & Venture Capital

In IMDA’s recent submission to Enterprise Ireland on the Future Focus of the Seed and Venture Capital Scheme (2013-2018), we have voiced that funding gaps currently exist for the Medtech sector at early, growth and expansion stages.

It is noteworthy that take-up of the seed capital scheme has fallen in value terms in recent years. This scheme is likely to expandinsizeastheeconomyrecoversbut growth will be limited unless a number of issues are addressed.

IMDA have noted that there a particular funding gap for start-up companies around the 5 year mark. Venture capital tends to be abundant for mature companies, but there is very little available during the early to middle stages once the seed money has been consumed. Due to this issue, mid-stage companies are often under- valued when being sold. This is a global trend and not just specific to Ireland. IMDA made a number of observations;

• Informationonentitlementsunderthe scheme is not reaching individuals starting a new company and should be prioritised through the new LEO system.

• Theperiodoverwhichthesharesmust be held (3 years) is excessively long given the high risk of company failure in their early years.

• Abetterapproachwouldbetojudgea business on it growth potential, not on its current profit/equity.

IMDA have also voiced the need for a funding mechanism that supports lower risk or smaller market type enterprises. This cohort can often be neglected and is representative of many start-ups in Ireland particularly in the sub-supply base. In fact 50% of the Medtech sector in Ireland are sub-supply. The full IMDA submission can be viewed on the IMDA website.

The Medtech skills survey, conducted in March, was based on the responses of chief executives and HR officers of companies employing around 11,000 in the Irish Medtech sector.

Notably, the survey indicated that:

• 81% of companies are currently hiring engineers;

• 59% are specifically seeking quality and validation engineers;

• 51% are seeking design or development engineers;

• 46% are seeking regulatory affairs candidates.

Oversight of current and future skills needs within the industry is critical to inform government skills policy and to communicate career opportunities to potential graduates. IMDA’s 2013/2014 Springboard programme will specifically enable 60 unemployed engineers and technicians of traditional disciplines to convert to the life sciences sector.

Surveying and bridging current skills gaps in the Medtech sector

IMDA meetings with the Secretary General of the Department of Health & Children

5

IMDA Update June 2014

Issue 39www.imda.ie

Design capabilities to be improved for the Medtech sector in Ireland.

IMDA Skillnet, have successfully developed and secured funding for, an industry led masters (NFQ Level 9) for technical design engineers and scientists in order to enhance capabilities in design and new product introduction.

A number of IMDA IRDC working group members have commenced work on development of this innovative programme for the sector in Ireland.

The concept of ‘Technology Readiness Levels’ has been exploited to organise course content and a preliminary programme has been developed. Delivery of the programme is projected by October/ November 2014.

IMDA Board meet with CEO of IMB A delegation comprising of members of IMDA’s Regulatory Steering Committee and IMDA Board met with Pat O’Mahony, CEO, IMB and IMB colleagues on the 22 April. The background to funding and resourcing of medical device oversight in Ireland and Europe were discussed as well as the industry position on the MDD and IVD Directives.

IMDA’s Board met with Dr. Ambrose McLoughlin Secretary General of the Department of Health & Children on 13 February. IMDA’s Board was updated on current activities within the Department including the establishment of new Hospital Trusts. Discussions also featured around the MDD/IVD Directive Revision, HSE procurement, the research infrastructure, ethical oversight and health insurance.

IMDA brings thought leaders together to discuss rising health insurance costs

Over 70% of IMDA member companies currently provide health insurance for its employees.

Over the past number of years, the industry has seen substantial increases in health insurance premia and the market has become very unpredictable with respect to rising costs. Our members have told us this is unsustainable and a serious concern for the Medtech sector. IMDA held a discussion and debate about current health insurance models and what the future holds for health insurance in Ireland.

Representatives from the Health Insurance Authority, the major insurers; VHI, Aviva, Laya Healthcare and GloHealth and health insurance experts from Towers Watson, Aon and Mercer were present.40 IMDA members also attended the session on the 9 April, Athlone, supported by IMDA Skillnet, and consequently, Ibec formally responded to the Government Submission on Universal Healthcare “The Path to Universal Healthcare:” outlining concerns for business including the medical technology sector.

Pictured at the IMDA Health Insurance Workshop (l – r) were: John O Dwyer, VHI; Nicola Gilmartin, Abbott Ireland; Eoin O Neill, Aviva Healthcare; Dr Sinéad Keogh, IMDA; and Liam Sloyan, Health Insurance Authority

(L to R): -Melissa White, Bausch & Lomb; Paul Burke, Medtronic; Ann O’Connor, Bausch & Lomb; Margarite Foran, Stryker; Emmett Devereux, Cook Medical (IMDA Regulatory Steering Committee); Pam Mackey, Bausch & Lomb ( IMDA Quality & Regulatory Forum Vice-chair); Robbie Walsh, Boston Scientific ( IMDA Quality & Regulatory Forum Chair); Dr. Áine Fox, IMDA.

(L to R): Dr. Enda Dempsey, IMDA; Dr. Áine Fox, IMDA; Tom Healy, Vitalograph Ltd (IMDA Regulatory Steering Committee); Anne Cantwell, Stryker; Micheal Noone, Tcoag; Fidelma Sheerin, Stryker; Pauline O’Flanagan, IMDA Skillnet.

Almost 100 quality & regulatory professionals attend IMDA Quality & Regulatory Forum

IMDA Best Practice in Product Development

6

IMDA Update June 2014

Issue 39www.imda.ie

IMDA’s Quality & Regulatory Forum met in Limerick on 28 May. Almost 100 quality and regulatory professionals from across the country were in attendance at the event, the largest meeting of the Forum to date.

NSAI provided meeting participants with a Notified Body perspective on risk management and Commission Recommendation 2013/437/EU Annex III. A number of senior industry representatives facilitated a discussion on unannounced audits and member company experience of same which was followed by an update on the MDD/IVD Revision.

The meeting also addressed member company approaches to UDI implementation.

Fifty sterility assurance and quality/ regulatory professionals from across 28 IMDA member companies attended the inaugural meeting of IMDA’s newly established Sterility Assurance Forum of was held in the Sheraton Hotel, Athlone on April 16th.

The meeting included a series of formal presentations interspersed with lively breakout sessions on sterilisation validation documentation requirements, load configuration requirements and maintenance of a validated process among others. The event covered an update on sterilisation related standards and impact of the MDD Revision on sterilisation as well as an update on draft ISO11135. Following a very successful inaugural meeting, IMDA’s Sterility Assurance Forum is expected to meet again towards the end of 2014 with a meeting agenda once more informed by member feedback.

New IMDA Sterility Assurance Forum established

Pictured above at the IMDA Sterility Assurance Forum (l – r) were: - Sean Hanley, Boston Scientific; Caroline Murphy, Teleflex Medical Ltd; Richard Cowman, Synergy Health Ireland Ltd; Dr. Áine Fox, IMDA.

World-class manufacturing and operational excellence are globally recognised hallmarks of the medical device and diagnostics sector in Ireland.

However, product development has been identified as an area of opportunity for Ireland. Irish Medtech companies, particularly SMEs, continue to face challenges accessing best practice product development tools and would benefit enormously from an easy access product development toolbox.

IMDA’s Board mandated the establishment of a ‘best practice in R&D/ product development’ taskforce to drive development of a ‘best practice in R&D model’ for the Medtech sector. The taskforce have drafted a scope document following an exchange of views and detailed discussion on what a future best practice model in the area of R&D/ product development might look like. A formal workshop to further develop strategy for delivery of the model is envisaged during Q3 2014.

Global Access is among the largest medical technology industry conferences in Ireland.

Established in 2006 and organised by the Irish Medical Devices Association, a business sector within Ibec, the 5th Global Access conference will take place on 10/11th September 2014 at the Radisson Blu Hotel, Galway.

In 2012, the biennial conference brought together almost 200 participants including policy makers and representatives of the global Medtech industry and was widely cited as a resounding success.

Global Access is once again being tailored to the medical devices and in vitro diagnostics industry’s needs in 2014. Global Access 2014 will address how our industry is adapting to a changing regulatory landscape globally. Critical trends which influence our industry will be discussed throughout the conference including new European legislation, regulatory trends across global jurisdictions and the future of regulation in supporting innovative technologies.

This year’s event will host key international speakers, including senior representatives from; the European Commission, the Irish Medicines Board, US Food and Drug Administration, Shanghai FDA,ANVISA(BrazilianRegulator),CorporateQA/RADirectorsand VP’s. The conference will cover recent developments and trends related to quality regulations worldwide including perspectives from across Europe, USA, South America, China, Russia and the Middle East. Global Access 2014 will, as in previous years, provide ample opportunity for networking and discussion with industry peers.

Visit: www.imda.ie for conference updates and a link to the dedicated conference website.

7

IMDA Update June 2014

Issue 39www.imda.ie

IMDA’s Academic Forum IMDA’s Academic Forum comprised of representatives from all the third-level institutes and industry met on the 13 May to discuss finding of the survey and a number of topics including curriculum development, industry placements, SFI funded research centres and new delivery models through apprenticeships.

Pictured from l-r: John O Dea, Crospon, Dermot Doherty, IMDA Lucy O Keefe, Nypro Healthcare, Daithi Fallon, Cork Institute of Technology and Dr Denis Dowling, University College Dublin

The IMDA Operational Excellence Taskforce launched the lean Mentoring programme at the IMDA members evening in October 2013.

The basis of the lean mentoring relationship is to accelerate the Op-Ex deployment throughout IMDA companies with the incorporation of the MÓRTM model. There are currently two lean mentoring relationships in operation, the first between Siemens Healthcare Diagnostics and Bellurgan and the second between Lake Region Medical and Waters Technology.

Nine months since its inception and relationships between the companies have developed far beyond what was originally envisaged with wide ranging benefits for both the mentee and the mentor.

“ We really see this partnership as a win-win situation for both our sites. Well done and thank you to the IMDA for facilitating this programme.”James Browne, Lean/6-Sigma Programme Manager.

IMDA are currently developing new lean mentoring relationships and expressions of interest are being accepted. If you are inter-ested in participating in the lean mentoring programme or require more information please contact dermot.doherty@ibec.ie.

Lean Mentoring Programme going from strength to strength

At the Presentation Ceremony of FETAC 5 Awards in “Continuous Improvement in Manufacturing” Pictured l – r): - Liam Curley, Site Director, Paul Martin, Adrian McMorrow, Abbott Diabetes Care, Michelle Reinecke-Quain, Michael Loftus, Pauline O Flanagan, IMDA Skillnet, and graduates.

IMDA Skillnet launches Medtech Engineering programme in response to evolving Medtech sector needs

8

IMDA Update June 2014

Issue 39www.imda.ie

On 3rd June IMDA Skillnet, launched a pilot Higher Certificate in Medtech Engineering (NFQ Level 6) programme at Galway-Mayo Institute of Technology (GMIT).

The programme was developed in response to an industry wide consultation which found that manufacturing will play a crucial role in our economic recovery. As the Medtech manufacturing environment becomes more complex, there is a requirement for new skill sets. The programme will include metrology, industrial automation, metal forming processes and electrical technologies, and will run over 16 weeks at GMIT.

Pictured at the launch were (l – r): - Dr Paul Fahy, Galway-Mayo Institute of Technology; Jerzy Leonczyk, Accellent; David O’ Connell, Covidien Tullamore; Noel Joyce, Transitions Opticals; and Padraic Broderick, Transitions Opticals.

BT Young Scientist In January, IMDA and PharmaChemical Ireland came together for the sixth consecutive year with a stand at the BTYS Exhibition 2014 to urge students to consider careers in science and engineering. Pictured were Bryan Deeny, Design engineer, Stryker, demonstrating keyhole surgery using innovative medical technology instruments and cameras developed and produced by Stryker to students James Liffey (aged 8) and Ellen Liffey (aged 11) with Adrienne McDonnell, IMDA.

Responding to national demand for quality engineers across Ireland’s medical technology sector, Ibec’s IMDA, have been granted funding for the third year in succession for a conversion programme for quality engineers by the Higher Education Authority (HEA) Springboard initiative.

This hugely successful programme gives engineers and science graduates the additional skills needed to help them find jobs. Over the past two years 120 jobseekers have completed the IMDA programme.

Following the completion of the 2013 programme;

• 48% of participants secured employment in the high-tech sector;

• 13% of participants were on internship placements, and;

• 4% went on to further study or lost interest and

• 35% are currently seeking employment.

To find out more about IMDA Springboard opportunities, visit www.imdaspringboard.ie

BioInnovate Ireland announced its new Fellowship teams for 2014 at the end of year symposium In addition, the programme announced a new collaboration with the Mayo Clinic in which a Fellowship team will engage in clinical immersion at the Mayo clinic.

BioInnovate Ireland is a medical technology innovation training programme, modelled on the Biodesign programme offered at Stanford. The BioInnovate Programme is based on the recruitment of multi-disciplinary teams, consisting of up to four high-calibre Fellows, which include medical, engineering, business and science graduates.

Medtech conversion programme for quality engineering

Pictured left: - Pauline O Flanagan, IMDA Springboard, Sinead Keogh, IMDA, Edward Seery (Job Bridge Intern) Nypro Ireland, Ruth Lloyd, Nypro Healthcare

9

IMDA Update June 2014

Issue 39www.imda.ie

Pictured above: - Barry Comerford, Cambus Medical; Donal Balfe, Covidien (IMDA Vice-chair); Dr Sinéad Keogh, IMDA; and Fergal O’Brien, Ibec.

Pictured below were: Frank Keane, Vitalograph; Adrienne McDonnell, IMDA; and Des Forde, Verus.

IMDA’s members evening takes place at AIT

70 people attended IMDA’s Networking Members Evening on the15 May at Athlone AIT, to hear thoughts on how global Medtech companies are preparing for an innovation makeover, presented by Patrick M Heslin, PwC and Ibec’s Chief Economist, Fergal O’ Brien who provided an overview of “An Ireland that works” campaign that maps out the key priorities for business.

Pictured left at the Ibec’s ‘Making the South-East Work’ were (l -r): - Paudie O’ Connor, Boston Scientific, Michelle Walsh, Ribworld, Pat McLoughlin, Abbott Vascular, and Danny McCoy, Ibec

Pictured right at Ibec’s ‘Making the West Work’ were (l - r): -were (l - r): - Sinéad Keogh, IMDA; John Power, Aerogen; Bernie Turley, Goodman Medical; and Mary-Rose Burke, Ibec.

An Ireland that works - Ibec regional breakfast seminars

“An Ireland that works” Ibec regional breakfast seminars sponsored by Electric Ireland, were held in Cork, Letterkenny, Galway, Waterford and Limerick. Our priorities are to reduce the tax burden, have better government, invest in the future, extend Ireland’s global reach and promote enterprise and entrepreneurship. Thanks to all IMDA members who participated in the regional roadshows.

Follow the discussion @Ibec_irl #Irelandworks Pictured below at Ibec’s ‘Making the Mid-West Work’ were (l - r): - Mairead Crosby, Ibec, Mark Nolan, Dromoland Castle, Bill Doherty, Cook Medical, Maria Hinfelaar, LIT, Kevin Molloy, Electric Ireland and Danny McCoy, Ibec.

Compliance Mailing listIMDA are currently building our compliance network and have requested all members provide us with the key contact in your organisation for Compliance/Ethics, so that we can add them to our Compliance mailing list and ensure they are kept abreast of pertinent information regarding Ethical Business Practices for the Medtech Sector.

Please revert to: Adrienne McDonnell, IMDA Executive, on 01-605 1655 or adrienne.mcdonnell@ibec.ie with the relevant individuals name and contact details.

Medical Technologies Pilot Mentoring ProgrammeLending your expertise to promote the Medtech Industry in Ireland

10

IMDA Update June 2014

Issue 39www.imda.ie

The IMDA and Enterprise Ireland have teamed up to deliver an innovative and new approach to Mentoring.

We have developed a unique Medical Technologies Pilot Mentoring programme which will enable client and member organisations to progress on their companies to achieve scale-up swifter, by utilising experts in the Medtech industry through mentor-mentee partnerships.

About the programme:This Medtech Pilot Programme is looking for four mentors to be paired with four identified SME’s (i.e. 4 mentors and 4 Mentees). We have developed a unique Medical Technologies Pilot Mentoring Programme which will enable SME’s to accelerate scale-up by utilising experts in the Medtech industry through mentor-mentee partnerships. A primary mentor will be allocated to each High Potential Start Up (HPSU), with a mentor network to provide support if required in other areas of the business where necessary.

At this point, IMDA are inviting companies to put forward their expression of interest in becoming a mentor for this Medtech-specific programme. The programme will commence in July 2014, with the official launch in October 2014.

Mentors are: senior executives in business who volunteer to help client companies work through their value proposition, product differentiation, sales and marketing strategy, management gaps or funding requirements.

Why mentoring?Mentoring can increase small businesses capabilities in selected business areas by providing the support and guidance of experienced practitioners or mentors in these areas.

Benefits for Mentor –

• OpportunitytocontributetoenhancingtheMedical Technologies Industry in Ireland;• InsightsintoSMEchallengesandnewtechnologies;• Peertopeernetworking;• Personaldevelopmentopportunity;• ThismayfitintothecompanyCSRprogramme.

NOTE: It is recommended that the Mentor Company provide a maximum of 5 meetings (2 hours a month) time-commitment level.

Benefits for Mentee – • Mentoringcanacceleratethescalingupofyour company. • Enhancethedevelopmentofinternalresourcesby developing their ability throughout their organisation; • Provideshandsonexperienceandknowledgesharing;• Subsidised2.5dayprogrammeonFinancial Capabilities for SME’s specific to Medical Technology Industry.

Some areas that can be supported by this mentoring programme in terms of company development:

• Moretargetedsalesandmarketing;Expansioninto new export markets; Improved production and logistics;• Strategicbusinessplanning;Staffdevelopmentand team building; Better management and financial systems; • Attractingoutsideinvestment;Managementsuccession.

ConfidentialityMutual trust, openness and confidentiality form the basis of the relationship between a Mentor and a company. Every Mentor signs a strict confidentiality agreement as part of the programme, before taking on assignments and will not discuss mentees business with third parties without mentees express permission.

Confidentiality works both ways: a Mentor will discuss relevant past experiences and insights with the mentee with the expectation that such information with be treated with upmost confidentiality and discretion. • Mentorsshouldindicateiftheyarecurrently participating in any other mentoring initiatives.

For further details contact:Adrienne McDonnell, IMDA Executive, 01-6051655 or Adrienne.mcdonnell@ibec.ie

Bumper seed investment set to fast track commercialisation of innovative X-Bolt hip fracture fixation product to the global export market

X-Bolt Orthopaedics, an innovative hip fracture fixation company based in Dublin, has completed an equity investment round of €1.8million. The funding round was led by the AIB Seed Capital Fund, co-managed by Enterprise Equity Venture Capital. The investment syndicate also included knowledgeable private investors with backgrounds in Medtech and medical practice. The seed investment is set to advance FDA approval of the X-Bolt product in the US and fast track commercialisation of the product to the global export market.

Seabrook Technology Group announces the opening of its second US Office in California

Manufacturing software specialist company Seabrook Technology Group has announced the expansion of its US operations by opening an office in Dublin, California. The opening of the second office in the USA reflects Seabrooks success in that country, and indeed globally, over the past 18 months.

Medical-device firm Mainstay aims to raise up to €23m in IPO

Irish medical-device maker Mainstay Medical, which makes devices to alleviate lower back pain, is planning to raise up to

€23m via a dual-listing on the Irish Stock Exchange and the Euronext exchange in Paris. The flotation will value the company at around €128m. The company has operations in Ireland, Australia and the US.

NeuroTronik Announces $13.1 Million Series A Preferred Stock Financing

June 13, 2013 NeuroTronik Limited and NeuroTronik, Inc. today announced closing on a $13.1 million Series A Preferred Stock Financing. The funding is led by Hatteras Venture Partners of Durham, NC. Other major investors include Synergy Life Science Partners, Mountain Group Capital, and Lord Baltimore Capital. The investor group also includes other financial and industry participants. Now joining the NeuroTronik Board of Directors are Douglas Reed, M.D., Hatteras Venture Partners, and Mudit K. Jain, Ph.D., Synergy Life Science Partners.

Cook Medical Introduces EchoTip ProCore Endobronchial Ultrasound Needle

Limerick, Ireland Cook Medical is introducing the first endobronchial ultrasound (EBUS) needle in Europe that can acquire histological samples. Researched, designed and manufactured in Limerick, Ireland, The EchoTip ProCore Endobronchial Ultrasound Needle gives physicians the ability to retrieve both cell and tissue samples from lymph nodes or tumors in the pulmonary area.

US medical device maker Medtronic has agreed to buy Dublin-based Covidien for $42.9 billion.

Medtronic is the world’s largest stand-alone medical device maker with a market value of over $60 billion, while Covidien makes devices used in a range of surgical procedures.

Postmarket surveillance study in Japan confirms benefits of Cook Medicals Zilver PTX stent

Limerick, Ireland - May 29, 2014 One-year follow-up data from 907 Japanese patients who received the Zilver PTX drug-eluting stent showed positive results in keeping open the superficial femoral artery (SFA). The postmarket surveillance (PMS) study, designed to evaluate the stents performance in real-world patient use, was presented at the 2014 Euro PCR meeting.

Advant Medical Acquires Injection Moulding Company, Wayglen

Advant Medical has announced the acquisition of Ireland based Wayglen, a specialist injection moulding provider. Advant Medical is a global provider of contract manufacturing and packaging solutions to the medical device industry. The company manufactures Class I, II and III minimal invasive and implantable devices. Advant supports a broad range of customers including start-ups, SMEs and Multinationals through the product life cycle from concept through to commercialisation.

VistaMed to create 125 new jobs on back of €7m investment

Irish med devices company VistaMed is to create 125 new jobs in Carrick-on-Shannon and Roosky as part of a €7m investment. VistaMed is the leading Irish catheter and extrusion provider to the global medical device industry and a Helix Medical joint venture partner. The €7m investment is supported by the Department of Jobs, Enterprise and Innovation through Enterprise Ireland.

Sector News

11

IMDA Update June 2014

Issue 39www.imda.ie

IMDA Chair

Bill Doherty Cook Medical

Board Members

William Boxwell Abbott Vascular

John S Power Aerogen

Damian FinnBausch & Lomb

Dr Patricia Smith Bio Medical Research

Paudie O’ConnorBoston Scientific Clonmel

Barry Comerford Cambus Medical

James Winters Depuy Ireland

John HarrisLake Region Medical Ltd

Phil Watson Steripack Ltd

Colum HonanStryker Ireland

Frank Keane Vitalograph (Ireland) Ltd

IMDA Executive Team

Dr Sinéad KeoghDirector

Dr Áine FoxSenior Executive

Adrienne McDonnellExecutive

Dermot DohertyExecutive

Fiona HarrisonExecutive Support

Dr Enda DempseyIntern

Pauline O’ Flanagan IMDA Skillnet Manager

Michelle Reinecke-QuainExecutive Support for IMDA Skillnet

Who we are

Upcoming IMDA Events

12

IMDA Update

IMDA Vice-Chair

Donal BalfeCovidien

FOLLOW IMDA on

Why not follow us on Twitter? Twitter: @IMDAIrishMedTec

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

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

Website: www.imda.ieTwitter: @IMDAIrishMedTec

Re-thinking Employee EngagementStrand Hotel, Limerick11 July

IMDA Member EveningLimerick2nd October

Financial Capabilities for SME2 September & 16 September

Global Access 2014, Quality & Regulatory Conference 2014Radisson Hotel, Galway 10-11 September

Medtech CEO Forum & Awards Strand Hotel, Limerick 11 December 2014