Frank KeaneVitalograph (Ireland)

Ireland remains the strongest growing economy in Europe, with the latest Quarterly National Accounts highlighting a strong domestic economic recovery in 2015.

Overall growth was up 7.8% in volume terms and 13.5% in turnover terms in 2015, driven by business investment and consumer spending. This is a crucial turning point for the Irish economy and will boost household living standards across the board. However, many parts of the country are still below their pre-crisis levels. That’s why it’s vital for sectors such as medtech to have the right business environment to support a faster recovery in the regions. IMDA’s Board recently met with Secretary General for Health Jim Breslin to discuss medtech growth and how the industry can support better healthcare in Ireland.

IMDA have launched an ambitious strategy for the future: The Global Medtech Hub to ensure Irish companies continue to grow and make the most of exciting new opportunities. Ireland may be a small country, but we’re a big player in the industry with 18 of the world’s top 25 medtech companies located here.

The global medtech industry is expected to reach €475 billion in 2018 and IMDA are working on a number of initiatives to ensure Ireland remain at the forefront internationally, such as the new ICT for Health group. We’ve also developed a new event, Medtech Brew, hosted with BioInnovate, to bring entrepreneurs together to brainstorm, learn from start-up successes and network.

As part of Global MedTech Compliance Conference, which we are co-hosting with AdvaMed and Eucomed, there will be an SME bootcamp and an opportunity for the Irish medtech sector to showcase its talents and thought leadership in the industry. Important changes are happening in Europe with a new code of ethics being agreed by Medtech Europe and IMDA is inviting companies to join its dedicated steering committee.

IMDA have made progress on the new apprenticeships which were announced last year to meet the growing demand for skills in manufacturing which is the second largest employer in Ireland at 159,000. Other initiatives to attract talent into the medtech sector include promoting STEM careers at the BT Young Scientist, engagement in the Smart Futures outreach programme and placements with Ibec’s Global Graduate programme.

Lastly, with progress made during the Luxembourg Presidency, companies must now prepare for the MDR and IVDR legislation which will affect medtech businesses across Europe. IMDA will host a special workshop in May, in Limerick to ensure that medtech business in Ireland are adequately equipped to deal with any potential costs and changes the new regulations will create.

James Winters DePuy Synthes

Irish medtech sector leads the way with 2020 strategy

IMDA Update March 2016

Issue 45www.imda.ie

Contents

Page 02/03Making Ireland a‘Global Medtech Hub’

Changes to code of ethics will impact industry

Next Generation Manufacturing

Abbott Diagnostics named Medtech Company of the Year

MDR and IVDR TrilogueDiscussions - Update

MedTech Europe showcases new model for procurement

Page 04/05Medtech start-ups’ ambition showcased at Galway event

Irish companies showcase opportunities at BT Young Scientist

Get involved: Tell the story of medtech

€7 billion African projects fund accessible to Irish firms

Top tips to support mental wellbeing at work

Workplace WellbeingDay 2016

Page 06/07Events and Training

Members News

Following Medtech Europe’s vote to change its code of ethics, IMDA will update its Code of Ethical Business Practice.

IMDA’s steering committee recently produced an outreach campaign which promotes transparency and responsible behaviour and informs members about the implications of these changes. Notably:

• The introduction of new industry support models for medical education of healthcare professionals;• The phasing out of direct sponsorship of healthcare professionals to attend third-party conferences as of 1 January 2018; and• Defining, securing and framing education grants in order to prevent misuse.

IMDA is now inviting companies to join the Code of Ethics Steering Committee and ensure that a representative is on the mailing list to get the latest updates of major changes with advice on how business can prepare. For more information go to www.imda.ie/ethics

Manufacturing for tomorrow conference Ibec will host a cross-sectoral manufacturing conference on Manufacturing for tomorrow, Thursday, 23rd June in the RDS, Ballsbridge, Dublin 4.

Rapid growth in developing markets, profound changes in demand patterns and the emergence of disruptive technologies are radically changing the manufacturing world and creating exciting opportunities. Patrick Dixon, who is ranked as one of the 20 most influential business thinkers alive today will give a keynote address.For more information please contact, Director of the Irish Manufacturers Association Avine McNally by emailing avine.mcnally@ibec.ie

Next Generation Manufacturing

IMDA Skillnet is supporting a visit to the Fraunhofer Institute Advanced Manufacturing Centres in Stuttgart on 12- 13 April to help members learn from international best practice.

Those attending will have the opportunity to explore the use of new technologies and processes in Advanced Manufacturing with particular emphasis on the two main priority areas identified; Factory 4.0 and Additive Manufacturing.

IMDA have launched an ambitious strategy for 2020: ‘The Global Medtech Hub’. The priorities to ensure Ireland is innovating for future healthcare and economic growth, include:

Drive our future: Identify and influence key areas of focus such as trade barriers, skills needs, and changes to the business environment.Achieve the potential of the cluster: Assist companies utilise the cluster to expand and achieve their potential developing new technologies from concept to market. Use technological innovations to help patients: Facilitate cooperation between sectors such as pharmaceuticals, bio- technology and ICT and realise the potential for advanced, additive and cell manufacturing.Nurture entrepreneurship: Develop policies and conditions to ensure entrepreneurship can thrive, such as facilitating new funding opportunities.

One exciting new area which has the potential to not only create jobs, but also take pressure off our overburdened healthcare system, is connected health. Technological advances are creating new ways for healthcare to deliver better results for patients. IMDA will continue to step-up its activities to support collaboration between industries such as ICT to drive innovation among Irish businesses. An ICT for Health group has already been established with Ibec’s ICT Ireland, the next meeting is the 29 March, in Athlone.

Another important area of focus is the move on value-based healthcare which is revolutionising the commercial model used by healthcare systems across the world. The industry in Ireland must now adapt to these changes, so that it can continue to compete and be a global leader.

Global MedTech compliance conference comes to Ireland AdvaMed, Eucomed and IMDA are jointly hosting the Global Medtech Compliance Conference which is coming to Ireland for the first time and will be held in the Convention Centre Dublin Tuesday 24 -Thursday 26 May 2016. In addition to promoting ethical compliance at the most senior level in the global medtech sector, a special one day SME Bootcamp has been developed. For more information, go to: www.gmtcc.com

2

IMDA Update March 2016

Issue 45www.imda.ie

Making Ireland a ‘Global Medtech Hub’

Changes to code of ethics will impact industry

Pictured (l-r): Conor Russell, Boston Scientific; Sinead Keogh, Director IMDA; and James Winters, DePuy Synthes.

Late last year, the Luxembourg Presidency successfully secured a General Approach for the IVD and MD Regulations and opened informal trilogue negotiations with the EU Commission and Parliament.

Trilogue discussions are now continuing under the Dutch Presidency of the EU, which began on 1 January. The focus will revolve around; scrutiny, genetic testing, CMR chemicals, reprocessing, liability insurance for medical device manufacturers, transitional measures and the validity of certificates, classification and clinical investigations.

The Dutch cautiously hope to finalise the texts by the June.EDMA, Eucomed and national trade associations continue their outreach to policy makers at national and EU level as trilogue negotiations continue. It’s expected that much of the current draft text will be present in finalised legislation.

It is now clear that business processes and systems will be challenged and a robust regulatory-lead response will need to be executed in the face of the new rules. There will likely be substantial costs which need to be planned by businesses and as a wide spectrum of business functions will be impacted, sponsorship at the most senior levels will be necessary to achieve the prioritisation and alignment required for an extensive cross functional preparatory program. IMDA will host a workshop which will focus on preparing this response and who needs to be involved in this. The workshop will be facilitated by EY/ YourEncore and will take place on 18 May in the Radisson Blu Hotel, Limerick.

Mark your diary: Global Access Conference, 26-27 October IMDA’s international QA/RA Global Access Conference is among the largest medical technology industry events in Ireland.

Established in 2006 and organised by IMDA, the sixth Global Access conference will take place on 26 - 27 October 2016 at the Radisson Blu Hotel, Galway. In 2014, the biennial conference brought together almost 200 participants including policy makers, regulators and representatives of the global medtech industry. Global Access is once again being tailored to the medical devices and in vitro diagnostics industry’s needs in 2016.

MedTech Europe showcases new model for procurement MedTech Europe and the Boston Consulting Group aims to develop a new tender assessment system to promote ‘Most Economically Advantageous Tender’ (MEAT).

This project, which was presented at the launch of the IMDA strategy in February, looks at new ways to measure and account for variables other than the lowest price when procuring medtech, notably quality outcomes for patients. IMDA representatives will attend a two-day workshop in March in Vienna, Austria to explore how value-based procurement models and the introduction of a new pilot programme, will be rolled out in Europe.

Abbott Diagnostics named Medtech Company of the Year

3

IMDA Update March 2016

Issue 45www.imda.ie

Abbott Diagnostics Longford were announced as the Medtech Company of the Year at the Irish Medical Technology Industry Awards, jointly hosted by IMDA with Enterprise Ireland and IDA Ireland.

Through the “Becoming World Class” programme, Abbott Diagnostics Longford has developed an organization that is focused on the needs of its customers and a site wide ‘continuous improvement’ culture which has enabled operational excellence. These efforts have improved product quality and delivery while yielding exceptional volume expansion.

Irish Medtech Award Winners 2015

Medtech Company of the Year Award: Abbott Diagnostics Longford; Silver Award Winners: StrykerEmerging Company Award: AventaMedAcademic Contribution to Medtech Award: University of Limerick, Department of Mechanical, Aeronautical and Biomedical EngineeringOutstanding Contribution to Medtech: Barry O’Leary, Former CEO of IDA Ireland

The awards are a fantastic opportunity for both multinational and Irish indigenous companies to display their latest products and services. We would like to thank our sponsors KPMG, Teleflex, SteriPack, AIB and IMDA Skillnet for their support.

Progress on apprenticeships highlights opportunities IMDA and Plastics Ireland are developing three new apprenticeships to meet the demands of these growing sectors as manufacturing in Ireland experiences a surge.

IMDA have now chosen Galway-Mayo Institute of Technology as their lead training provider. Member companies are working together in two sub-groups HR and Technical to determine the employment criteria and apprenticeship training modules. IMDA are now recruiting a project manager. Pauline O’Flanagan, IMDA Skillnet is assuming an oversight role on both projects. This will help to complete the development phase in the hopes of rolling out the programmes in a timely fashion.

MDR and IVDR Trilogue Discussions - Update

Pictured (l - r): John Conlon, Abbott Diagnostics Longford; Tom Kelly, Enterprise Ireland; Sinead Keogh, IMDA; and Michael Lohan, IDA Ireland.

IMDA Update March 2016

Issue 45www.imda.ie

Irish companies showcase opportunities at BT Young Scientist

Medtech start-ups’ ambition showcased at Galway event

IMDA launched a new event for medtech start-ups with BioInnovate. The first Medtech Brew, in Galway saw more than 80 people gathered at the Glasshouse at Electric, in Galway.

There are more than 400 medtech companies in Ireland, but with 8 out of ten medtech companies being either a start-up or an SME it’s vital that we give entrepreneurs the right supports to grow the sector.

“Starting, sustaining, and growing a medtech company” was the theme for the first Medtech Brew which saw successful Irish entrepreneurs ditch powerpoint presentations and get up on a soapbox to chat about their experience. The entrepreneurs were, Ian Quinn, Chairman, Creganna Medical (moderator); Ger Brett, Co-Founder and Chief Executive of Vivasure Medical; Pat O Neill; Founder and Managing Director of Zenith Adhesive Components; and Jim Roche, Founder and CEO of Incereb.

The next Medtech Brew will take place Thursday 12 May, to find out more please email ciara.finlay@ibec.ie

Tax reform needed to encourage entrepreneurship Ibec is calling for the income tax system to treat the self- employed the same as PAYE workers, tax incentives to encourage investment in Irish companies and a simplified R&D tax credit system.

Ireland continues to excel when it comes to attracting multinational; this focus now needs to be applied to supporting indigenous firms. Indigenous firms account for only 43% of GDP and about 15% of our exports, despite making up 98% of the enterprise base. Improvements made to the tax treatment of entrepreneurs in Budget 2016 were important, but were only a start.

The first IMDA Entrepreneurship Working Group meeting will take place on the 12 May 2016 in Galway from 15:00-17:30. Nurturing entrepreneurship is one of the key pillars of our 2020 strategy and the group would be responsible for guiding what policy areas and supports we focus on developing.

The record breaking number of entries at the BT Young Scientist 2016 is part of a larger trend of more students studying towards science, technology, engineering and maths (STEM).

IMDA were delighted to once again host a stand with Pharma- Chemical Ireland to showcase exciting career opportunities in the sector. Cook Medical and Stryker joined the Ibec stand to inspire students to pursue careers in STEM by demonstrating some of the latest medical technology and devices. It’s essential that companies engage in get involved in initiatives such as the BT Young Scientist and Smart Futures. Ibec Global Graduates and Smart Futures will discuss attracting talent at HR and Skills Forum, 24 March, in the Clayton Hotel Galway. To find out about initiatives to attract talent in medtech, please email ciara.finlay@ibec.ie

Get involved: Tell the story of medtechIMDA is inviting member companies to join the PR Taskforce.

We have developed a proposal for promoting the sector and attracting talent. Although the medtech sector here is globally recognised with 18 of the top 25 medtech companies having bases in Ireland, more can be done to raise awareness among the general public and students considering STEM careers. Medtech Europe will provide an update on this year’s exciting plans for Medtech Week which takes place 13-17 June across Europe at the first PR Taskforce meeting. It will take place 8 April, 10.30-2.00 in the Castletroy Park Hotel in Limerick. To find out more, please email ciara.finlay@ibec.ie

€7 billion African projects fund accessible to Irish firms Ibec has announced details of a joint programme with the Department of Foreign Affairs to help Irish companies compete with other European businesses for billions of European Development Funds (EDF). The Winning Business in Africa (WBIA) programme is an online one-stop-shop for companies providing the information and support needed to bid on over 200 projects in Sub-Saharan countries worth €7 billion. You can register online, by visiting www.wbia.ie

4

Pictured (l - r): Paul Anglim, BioInnovate Ireland; Jim Roche, Incereb; Ian Quinn, Creganna Medical; Sinead Keogh, IMDA; and Pat O’Neill, Zenith Adhesive Components.

Pictured: Amy McWey, (left), and Lucy Foley (right) from, Summercove National School; Ruth Kelly Walker, Stryker (second from left); and Ciara Finlay, IMDA.

5

IMDA Update March 2016

Issue 45www.imda.ie

Top tips to support mental wellbeing at work

Workplace Wellbeing Day 2016

Green Ribbon month is an annual campaign in May to get Ireland talking openly about mental health.

Many Ibec member companies have taken the See Change Pledge to make mental health a priority and reduce stigma in the workplace. If you’re interested in promoting mental wellbeing her are six steps to create an open culture around mental health.

1. Training workshops: Take ‘Mental Health in the Workplace’ training for line managers, funded by the National Office for Suicide Prevention.2. Policy overhaul and implementation: See Change has developed a template ‘Mental Health Policy Document’ which you can use.3. Mental health awareness and wellness training: Host mental health awareness training and wellness workshops for staff. Create internal communications campaigns promoting wellbeing in your newsletters, on noticeboards, in the staff canteen or on your organisation’s intranet site.4. In-house mental health promotion: Nominate staff champions to promote wellness and provide information for staff to access with ease. 5. Engage your stakeholders: Organise a stigma challenging activity in your workplace in partnership with See Change and involve local communities and stakeholders.6. Sign the workplace pledge: This is a public statement that your organisation is aiming to tackle mental health stigma and has completed or is in the process of completing the first five steps in the workplace programme.

For further information contact Ibec Senior Executive Kara McGann at kara.mcgann@ibec.ie or click here.

Medtech and Engineering EHS/Forum The second Medtech and Engineering EHS/OHS Forum took place in February which looked at accident identification/prevention and resource management.

Siemens Healthcare provided an overview of their advanced Zero-Harm/Close-Call safety system which records near-miss situations as well as accidents. This theme was continued with a presentation on behaviour based safety which pointed out that 95% of accidents in the workplace are due to employee habits.

Following interest in members, the group was given an update on new EU legislation promoting the Circular Economy and waste management. Baxter Healthcare, previous winners of the Ibec Environmental Award for reducing the total carbon footprint of their intravenous (IV) bag, Viaflo, are an example of what can be achieved. They saved over €700k, per year on one item.

After a successful first year, the Ibec’s Nutrition and Health Foundation (NHF) are leading Ireland’s National Workplace Wellbeing Day on Friday 8 April 2016.

Organisations across the country are expected to participate in day and the inaugural Workplace Wellbeing Awards. According to research only one in three workers takes the recommended level of exercise for a healthy lifestyle each week. Further details are available at www.nutritionandhealth.ie/wellbeing

The MÓRTM suite of services show positive results IMDA Skillnet has trained 190 individuals through the MÓRTM Benchmark Model and Lean Leadership training programmes.

IMDA recently issued a survey to get feedback from members. Two-thirds of respondents said that they had implemented the model and 60% of those who had not yet used it, stated that they intended to in the future. As many as 95% said they would recommend it, 97% said it was a useful guide in identifying gaps to enhance business performance and 83% said they had seen improvements in work.

These survey results were used in the recent application to the Irish Institute of Training and Development (IITD) Awards, where the MÓRTM suite of services were short-listed in the Leadership Development Award category on the 26th February at the Killeshea House Hotel, in Naas.

IMDA Skillnet Medtech Regulatory Affairs Conversion Programme IMDA Skillnet has identified a need for a Level 8 Special Purpose Award in the Fundamentals of Medical Technology Regulatory Affairs to convert employed life sciences personnel to work in specialist roles in the medical technology regulatory affairs function and to upskill medical technology professionals in the regulatory framework in their existing roles.

The new programme will be delivered over 12 weeks or 1 semester. Eligibility will entail a minimum NFQ Level 7 technical qualification plus 2 years medical technology or pharma experience. The programme is expected to commence in September 2016.

Sterility Assurance experts to meet IMDA Sterility Assurance Forum members will meet on April 26 in Athlone. The meeting agenda will feature regulatory and standards updates, a session focusing on alternative sterilisation technologies and also a number of case studies from participating member companies on a range of sterility assurance related topics. To find out more, please contact IMDA Senior Executive Aine Fox by emailing, aine.fox@ibec.ie

WORKPLACE WELLBEING DAY

NATIONAL

WORKING TOGETHER FOR A HEALTHIER FUTURE

IMDA Update March 2016

Issue 45www.imda.ie

6

Events and Training

Pictured at the Irish Medtech CEO Forum, 10 December, Clontarf Castle Hotel, (l - r): John Shiel, Enterprise Ireland; Sinead Keogh, IMDA; Minister Richard Bruton; Donal Balfe, Medtronic; and Michael Lohan, IDA Ireland.

Pictured at the launch of IMDA’s 2016-2020 Strategy: The Global Medtech Hub, 11 February in the Royal College of Physicians, Dublin, (l - r): Padhraic McGinn, Nypro Healthcare; Sinead Keogh, IMDA; David Tallon, Stryker; and Danny McCoy, Ibec.

Pictured right at the Irish Medtech CEO Forum, (l-r): Matt Cooper, journalist; John Power, Aerogen; Bryan Hanson, Medtronic; and Wim Appelo, DePuy.

Olive O’Driscoll (second from the left) receives the Emerging Company Award for AventaMed at the Irish Medtech Excellence Awards, 10 December, Clontarf Castle Hotel. Pictured with (l - r): Tom Kelly, Enterprise Ireland; Sinead Keogh, IMDA; and Michael Lohan, IDA Ireland.

Pictured below left: Medtech Company of the Year Award, Silver Award winners Stryker pictured with Academic Contribution to Medtech Award: University of Limerick, Department of Mechanical, Aeronautical and Biomedical Engineering

Donal Balfe, Medtronic presents the Outstanding Contribution to Medtech Award to Barry O’Leary, Former CEO of IDA Ireland.

Pictured at the IITD Training Awards 2016, IMDA Skillnets received an outstanding achievement award in the Best Back to Employment Category and IMDA were recognised in the Best Leadership Development Initiative category.

Pictured at the BT Young Scientist exhibition promoting medtech careers to students, (l - r): Ciara Finlay, IMDA; Fiona Sheehy, Cook Medical Ireland; and young science enthusiast Lucy Foley from Summercove National School Kinsale.

7

IMDA Update March 2016

Issue 45www.imda.ie

In DePuy Synthes Cork, a new Test Method Centre of Excellence supporting all medical device companies of Johnson and Johnson worldwide has been established.

This laboratory offers a centralized support model to the J&J Medical Device Quality Release labs for test method development, remediation, validation and transfer, primarily focusing on analytical chemistry techniques. Other focus areas include cleaning validation, method lifecycle management and training. The laboratory is equipped with state of the art instrumentation, and a very strong, experienced scientific team in test method development and validation.

TE Connectivity Ltd, a world leader in connectivity and sensors, has announced that it has entered into a definitive agreement to acquire the Creganna Medical group for USD $895 million in an all cash transaction. Creganna Medical is a global leader that designs and manufactures minimally invasive delivery and access devices serving medical device original equipment manufacturers (OEMs). The company, headquartered in Ireland, reported sales of approximately $250 million in 2015 and is a portfolio company of Permira Funds. The acquisition establishes TE as a leading supplier to the fast-growing minimally invasive interventional medical device segment.

AbbVie has been listed among the Top 20 Best Large Workplaces in Ireland for the third successive year at the Great Place to Work Awards in Dublin recently. The opportunity to make a remarkable impact on people’s lives is just one reason employees value working at AbbVie. It was this among a number of other reasons that AbbVie was listed as the 3rd Best Large Workplace in Ireland and the winner of the Employee Development award.

NeuroTronik Limited is a development- stage, venture-backed medical technology company which is pioneering cardiac autonomic nerve stimulation (CANS) therapy to improve clinical and economic outcomes associated with hospitalizations for the treatment of Acute Heart Failure Syndrome (AHFS). NeuroTronik has now achieved all of its Series A development milestones.

The signature deliverable was a Human NeuroCatheter™ Study completed in December 2015. In that study, the Company demonstrated the NeuroTronik therapy in 16 patients. The company has now embarked on a Series B Preferred Stock financing during 2016 to fund the company through CE Mark approval and into early Europe commercialization.

Cook Medical will celebrate 20 years of success in Limerick, where it has grown from a team of less than a dozen people to a staff of over 800. Employees have a range of events to look forward to starting with a special celebration in Limerick this April. Cook plans to continue to invest in their EMEA services, employees, and product development at our facility in Limerick. Cambus Medical, a Freudenberg Medical Joint Venture Company, has announced the launch of an innovative new over-molded Hub & Strain relief solution for Hypotube based catheter shafts commonly used in Percutaneous Transluminal Coronary Angioplasty (PTCA) and other minimally invasive medical devices used in diagnostic and therapeutic interventions.

Cambus Medical’s latest product offering was created in response to market demands for a low risk, rapid response yet cost effective solution to accelerating new MIS catheter development and market launches.

System Label joins Multi-Color Corporation growing portfolio of medical companies. Joining Cashin Print and MCC Drogheda in Ireland, Multi-Color Corporation now have the ability to offer Medical companies their complete solutions from total labelling capabilities to IFUs, booklets, inserts and outserts. MCC are now positioned as the largest medical device supplier in Europe with over 46 facilities across the globe.

Trend Technologies have announced the opening of a new metrology laboratory at their manufacturing facility in Mullingar. The temperature controlled facility has been equipped with the latest Global Performance coordinate measuring machine (CMM) by Hexagon Metrology, an OGP SmartScope, CubePro 3D printer, and a large range of other measuring equipment.

This is great news for Trend’s medtech customers as in-house inspections can be performed in a more timely manner. The development supports and enhances the NPI process and ensures speed to market for new products, whilst guaranteeing their dimensional conformance.

SSE have been awarded three prestigious awards at the Facilities Management Awards- “Excellence in Customer Service” and “Best Cleaning Service Provider” and the ultimate accolade of winning the overall “Facilities Management Service Provider of the Year” award. Also in 2015, SEE won the ‘Women Led Business’ award category at the 2015 Ulster bank Achievers Award for Connacht.

SSE is a facilities management company that’s core business is contract cleaning working with a wide range of clients including the medical device sector and is the only cleaning company in Ireland to have an internationally recognised contamination control training course to ensure the needs of this industry are met.

Seroba Life Sciences is platinum sponsor again this year to the popular ‘Innovation in Medtech’. This conference brings together start-ups and investors from across Europe and beyond and takes place in The Shelbourne Hotel this coming 12 – 14 April. Returning to Dublin for its fourth year, this conference expects an attendance of 300+ Irish, U.S. and European delegates meeting to discuss innovation in medtech.

Acorn Regulatory has seen significant growth, having expanded the range of supports offered to companies building on the existing services with pre-market regulatory strategies and technical file preparation; implementing post-market surveillance and risk management processes; and implementing quality systems. New support recently added include: drug- device combination products, woundcare, IVDs, connected health (including software apps), dermatological creams, vascular implants, endoscopy.

Members News

Frank KeaneVitalograph (Ireland)

Board Members

Donal BalfeMedtronic

Barry ComerfordCambus Medical

Ciaran Corcoran Abbott Diagnostics, Longford

Bill DohertyCook Ireland

Damain FinnBausch + Lomb

Conor HanleyIMDA

Board Members

Tony KennedyTeleflex Medical

Frank KeaneVitalograph (Ireland)

Padhraic McGinnNypro Healthcare

Michael O’ReillyPhillips-Medisize

John PowerAerogen

David TallonStryker

Phil WatsonSteriPack

Who we are

Upcoming IMDA Events

8

IMDA Executive Team

Dr Sinéad KeoghDirector

Dr Áine FoxSenior Executive

Adrienne McDonnellSenior Executive

Ciara FinlayExecutive

Rory McMahonIntern

Pauline O’ Flanagan IMDA Skillnet Manager

Michelle Reinecke-QuainExecutive Support for IMDA Skillnet

IMDA Update

IMDA Vice-ChairConor RussellBoston Scientific

FOLLOW IMDA on Why not follow us on Twitter? Twitter: @IMDAIrishMedTec

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

Telephone: + 353 1 605 1661Twitter: @IMDAIrishMedTec

Website: www.imda.ie

Lean Leadership: First Programme (8 Day Course)26 - 27 April 2016 (UL & Teleflex)17 - 18 May 2016 (Westport Plaza & Allergan)14 - 15 June 2016 (UL)

IMDA Sterility Assurance ForumSheraton Athlone Hotel26 April 9:30 - 15:30

IMDA Skillnet Steering Committee MeetingTBC28 April 9:30 - 14:00

IMDA Board MeetingCork5 May 11:30 - 16:00

IMDA and PharmaChem Ireland Joint Members EveningCork (TBC)5 May 16:30 - 20:30

Ibec Annual Employment Law Conference 2016Croke Park, Dublin12 May 8:30 - 17:00

IMDA Entrepreneurship Working GroupRadisson Blu Galway12 May 15:00 - 17:30

Medtech Brew: IMDA and BioInnovate Glasshouse at Electric, Galway12 May 18:30 - 20:30

IRCA Lead AuditorBallybane Enterprise Centre17 May 8:30 - 17:00

Project Management EssentialsClayton Hotel, Galway19 May 9:00 - 17:00

Medical Polymers and Processing Technology Seminar First Polymer Training Athlone26 May

Statistics with MinitabGalway Technology Centre8 June 9:00 - 17:00

IMDA Skillnet Steering Committee MeetingTBC14 July 9:30 - 14:00

IMDA International QA/RA Global Access ConferenceRaddisson Blu, Galway26 - 27 October

IMDA Board MeetingSligo6 October 11:00 - 16:00

March 2016Issue 45www.imda.ie

IMDA ChairJames Winters DePuy Synthes

Medtech and Engineering IR/HR ForumGalway24 March 10:30 - 15:00

IMDA and ICT Ireland, ICT for Health meetingAthlone 29 March 10:30 - 14:00

Driving Operational Excellence through Lean Leadership (Level 9 on NFQ)University of Limerick5 April 9:00 - 17:00

IMDA PR Taskforce meetingCastletroy Park Hotel, Limerick8 April 10:30 - 14:00

National Workplace Wellbeing Day 2016: A step in the right directionCroke Park, Dublin8 April 8:30 - 14:00

Next Generation Manufacturing Visit to Fraunhofer Institutes for Manufacturing and EngineeringIPA and IAO Fraunhofer Institutes12 April 9:00 - 17:00

Biological Evaluation of Medical Devices, including Chemical CharacterisationBallybane Enterprise Centre, Galway21 April 9:00 - 17:00