Transforming to shape the medtech landscape of the future

Transcription

1 Irish Medical Devices Association Transforming to shape the medtech landscape of the future Looking at the challenges, real opportunities and beyond in 2015

2 Contents Mission element 01 Driving significant agenda items in the industry vision Industry vision Ireland will be a global leader in innovative patient-centred medical technology products and solutions Strategic themes 1. Ecosystem development 2. Industry foresight 3. Entrepreneurship 4. IMDA services to members Mission element 02 Providing services, support and information which will add value to members businesses The Irish Medical Devices Association (IMDA) promotes and supports an environment that encourages the sustainable development and profitable growth of multinational and indigenous medical technology companies. 3 Foreword 4 A message from our 2014 Chairman, Bill Doherty 5 A message from our incoming Chairman, Donal Balfe 6 The objective assessment: Strategy implementation and the Business Foresight Model 8 Pilot mentoring programme for medtech companies to accelerate growth 10 Put it to the Board 13 Medtech in the media 14 Codes, compliance and ethical considerations 16 World-class medtech QA/RA event in Galway 18 MDD and IVD revision negotiations ongoing 20 IMDA is here to represent YOU, your business and your interests 22 Ibec is your strategic partner 23 Medtech investment continues to grow 24 Collaboration, benchmarking and innovation 26 Operational Excellence 28 The big picture 29 At the forefront of regional policy 30 Solutions, services and skills 32 A new type of manufacturing apprenticeship 33 Irish Medtech CEO Forum Medtech Awards bring out the best 38 IMDA events IMDA membership listing 2014 Copyright Irish Medical Devices Association, 2015.

3 A warm welcome to the Irish Medical Devices Association Annual Review of 2014 As 2014 morphs seamlessly into 2015 and we wonder where the time went, it is appropriate to take a look back over the year and reflect on what was a very busy year for IMDA. Before looking back, I want to thank Bill Doherty, our outgoing Chairman for his sterling work and steadfast dedication throughout the year. Bill was always available throughout the year and put a great deal of time and energy into meetings, conference calls, policy documents, presentations, position papers and all of the myriad other things that are part of the job of being IMDA Chair. It was a pleasure to work with Bill and with Donal Balfe, our incoming Chairman, to whom I wish to extend a very warm welcome. We look forward to working with Donal and with James Winters, the incoming Deputy Chair, during Liam Kelly could only stay a while in the Vice Chair as the IMDA Board Effect kicked in and he was promoted to the US in Teleflex before the end of his tenure. I would also like to thank each of the individual board members who contributed so much during 2014 and all of the steering group and taskforce members who give so freely of their time and talents to further the common good in their industry. These members are the backbone of the entire association and the driving force that has impelled IMDA into its position as one of Ireland s leading business associations. Thanks again and keep up the good work. The MDD and IVD revisions featured significantly throughout the year. IMDA endeavoured to ensure that our politicians really understood the importance of these future regulations to Ireland and the imperative to articulate and gather support for the Irish position at the highest level in Europe also saw amendments agreed to IMDA s Code of Ethical Business Practice, and 2015 will see further adaptations on the code in line with changes across Europe. During 2015, we need to devise a new strategy document to follow on from the work done on our strategy statement. This strategy has resulted in many positive initiatives and developments and it has served the industry well. The membership will play a critical role in ensuring that its successor will be as ambitious, as well-informed and as insightful as the original. We encourage you to get involved in the process. During a review of Ibec sectors, it became very apparent that there are strategic synergies between a number of sectors within Ibec which could be further harnessed through simple restructuring. The outcome of the review will have some very positive implications for IMDA members, from an expertise, resource and a strategy realisation perspective. From February 2015, a new Ibec sector structure will be created called Medtech & Engineering. Medtech & Engineering will comprise of four trade associations; IMDA representing Medical Technologies and three Engineering Sectors including Plastics Ireland, Irish Engineering Enterprise Federation and Federation of Aerospace Enterprise. We look forward to working with you over the coming year and realising the added value this new approach will bring to you all. I want to finish by thanking my colleagues on the IMDA executive team for their hard work and dedication throughout Much of the team s work goes on in the background and isn t always seen by the members but the executives work very hard all year long to provide services, assistance and support. Ibec and the IMDA team is always available to our members. I look forward to seeing as many of you as possible in Dr Sinéad Keogh Director, IMDA Director of MedTech & Engineering Sectors, Ibec Introducing the IMDA team Dr Áine Fox Senior Executive Adrienne McDonnell Executive Dr Enda Dempsey Network Executive Pauline O Flanagan Network Manager Michelle Reinecke-Quain Network Administrator IMDA Annual Review

4 INTRODUCTION A message from our 2014 Chairman, Bill Doherty, Executive Vice-President Cook Medical Although it has been a busy and varied year for me as IMDA Chairman, a single element stands out clearly in my mind as the most important business of the year and the area on which we focused a great deal of our attention. That element is, of course, the revision of the MDD and IVD Directives. It involved considerable time and effort in negotiations, representations and lobbying that went on both in the background and in public. Over the past three years, the proposed legislation has been making its way from the EU Commission to the floor of the European Parliament to a point where the outgoing parliament voted on a draft of the proposals before the elections in May IMDA was steadfast in conveying the message that although we welcome very many things in the proposed legislation, the industry is very concerned about the scrutiny procedures which have been mooted but not yet defined. IMDA, Eucomed and the national associations believe that the strengthened system of oversight by independently assessed Notified Bodies is working well and is a robust system that is fit for purpose. IMDA members know that patient safety comes before all other considerations but we do not believe that patient safety, promotion of innovation and a transparent, predictable oversight procedure must be mutually exclusive concepts. After the vote in the European Parliament, the proposed revisions went to the Council of Ministers and the Italian Presidency which has just ended made a tremendous effort to get agreement between the 28 member states but failed to do so. Latvia now holds the EU Presidency and we await their proposals with interest. I believe that the cost of regulation will become more of a talking point in The increased level of oversight requires resources and time and it is adding cost to the system. Industry advocates that future funding of the regulatory framework for medical technologies in Europe needs to be appropriate, sustainable and demonstrate benefits to both the Regulator and the regulated. Future funding of the framework should be considered in light of supporting innovation and SME s, the lifeblood of the sector in Ireland and Europe. A single transparent and predictable pan-european system for funding regulatory activities will benefit the sector and safeguard Europe s global competitiveness. All things considered, the prognosis for the Irish medtech sector remains good. Medtech companies are still performing well, R&D is continuing to grow and the recent strengthening of the R&D tax credit should help the case for more investment in Ireland. The Capital Gains Tax issue remains important for entrepreneurs and for Irish SMEs and start-ups. The question of ethical engagement with healthcare professionals is still a controversial one and public demand for transparency in this remains undiminished. Sunshine acts have been passed in France and Finland and they look likely to be introduced in other jurisdictions. It is incumbent on our industry to tackle this issue before a solution is imposed on us by others. The issue is not going to go away and we would prefer to see a pan-european regime in place than have to deal with reporting every clinician interaction to 25 or more different authorities. I want to finish up by thanking Donal Balfe for his support as Vice-Chair and to wish him every success as Chair for the coming year. I also wish to thank Liam Kelly for his work in the first six months as Vice Chair before his promotion in Teleflex necessitated his move to the US. As always, the IMDA executive team, the steering committees and the sub-committees achieved a great deal throughout the year and I want to express my gratitude for their sterling work and dedication. Bill Doherty Executive Vice-President Cook Medical 4 IMDA Annual Review 2014

5 A message from our incoming Chairman, Donal Balfe, VP Manufacturing Europe and Asia, Medtronic This year will be an important one as the revision of the Medical Devices and IVD Directives is expected to come to a conclusion. We will continue to work with key stakeholders to ensure that they understand the industry position as the political and legislative process unfolds. Ireland, with its strong medical technology expertise and reputation, can play a central role in developing the proposals at a European Level. I believe that opportunities exist for enhanced collaboration between our industry and physicians. The physicianindustry relationship is key for the realisation of ideas and innovation. IMDA s mandatory Code of Ethical Business Practice gives us clear guidance in this area and offers a robust ethical framework for all interactions so members can understand how to proceed appropriately with collaborations. As technology becomes commonplace in our everyday lives, there is a shift towards consumer technology companies making inroads in medicine. We are seeing a shift from hospitals to patient centric care, at home and in the community, enabled by advanced technology. With its strength in software and ICT, Ireland is uniquely placed to harness and leverage the opportunity for convergence between these industries. IMDA has always encouraged entrepreneurial activity and new businesses but we need to speak clearly in support of our entrepreneurs, and make sure our voice is heard. SMEs and start-ups are the lifeblood of this industry. Neighbouring jurisdictions have moved in recent years to make their tax codes more amenable to risk-takers and innovators. We believe Ireland should work to make our tax codes as welcoming as possible to entrepreneurs. We are supportive of the government s draft knowledge box proposals and through Ibec we will set out the medtech position in the formal consultation process outlined by the Department of Finance. In early 2015, Medtech Europe launched a Medtech Value Campaign.. The campaign aims to raise the profile and understanding of the industry in Europe and educate stakeholders about the contribution our industry makes in transforming the health system and patients lives. Early diagnosis and improved monitoring allow for more effective treatments which lower the cost of hospitalisation. Medtech limits the use of ineffective, unnecessary treatments and provides personalised care so that healthcare professionals and governments are better informed about the effectiveness of certain therapies on specific patients. As Chairman, I am looking forward to working with the Board and members in developing a national programme to support this important initiative. One of the key milestones of the campaign is to support the very first EU Medtech Week, which will take place from the June I encourage all members to get involved. In April this year IMDA and Ibec sectors will host the Manufacturing to Win on the World Stage event in Galway. Ireland has built a strong reputation in manufacturing over the past 30 years however, with global competitiveness and downward price pressures, companies are looking at new strategies to rapidly adapt their intellectual and physical infrastructures to exploit changes in technology. Manufacturing is changing it s becoming faster, much more responsive to changing global markets and closer to customers. Reflecting on Ireland s success in manufacturing, this conference aims to celebrate its current achievements and highlight the path down which Ireland must steer in order to remain competitive. As Chairman, I am looking forward to welcoming our members to Dublin for the first time next December for our annual Medical Technology CEO Forum and Awards event. We have held excellent events around the country over the years and it will be good to see how the capital measures up. I m also looking forward to members evenings in Cork and in Sligo this year. It s good to get around the country and see what s happening in other parts. I want to thank Bill Doherty for his sterling work throughout last year on behalf of all our members. I also want to thank Liam Kelly, whose seat I took when he was promoted in Teleflex and departed for the US. I look forward to working with James Winters and all of the board members, the committees and working groups and with the IMDA Executive who work so tirelessly on our behalf. I look forward to seeing as many of you as possible throughout Donal Balfe VP Manufacturing Europe and Asia Medtronic As 2015 gets underway and we approach the closing stages of our statement of strategy, one of the most important jobs facing the IMDA board is to review our progress to date and agree a new four-year strategy. We must be clear in our vision for the association and our industry and set out the steps we can take over the next four years to realise that vision and its associated goals. I look forward to working with the IMDA Board, IMDA s Working Groups and the broader membership on developing our new strategy for the coming years. IMDA Annual Review

6 STRATEGY The objective assessment Strategy implementation and the Business Foresight Model STRATEGY IMPLEMENTATION The IMDA Statement of Strategy provides a framework against which to assess our progress, and contains objectives which we work to achieve. We are now coming to the end of our strategy and it is encouraging to see the growth and development of the sector as a whole, exporting 8bn in product and employing more than 27,000 people. Over the last three years more than 2,000 jobs have been announced by the sector and many new startups have been established. As the four-year lifespan of this strategy comes to an end we are pleased to report significant progress. Some objectives have been achieved outright and substantial progress has been made towards completing other goals. This annual review reports on the work done and the progress we have made. Below are just some highlights of our strategic objective achievements in We look forward to working on a new strategy statement throughout this year. Entrepreneurship The Entrepreneurship Taskforce, under the chairmanship of Frank Keane (Vitalograph) launched a dedicated mentoring programme for start-ups with Enterprise Ireland to support entrepreneurship in the sector. Access to finance and funding sources was identified as a potential problem for entrepreneurs and IMDA was an active media partner in the IN³ Medical Device 360 conference which included a range of workshops and break-out sessions on financing new and existing businesses. We presented to a Joint Oireachtas Committee to advocate enhanced investment incentives for SMEs and we developed and promoted the industry position on seed and venture capital as part of an Enterprise Ireland consultation. Ecosystem development The benefit of a well-structured and cohesive industry approach was seen this year in our representations on MDD and IVD revisions. The entire medtech ecosystem united to present a cogent argument against excessive regulation and oversight of our industry. The industry launched a comprehensive public relations and lobbying campaign on several fronts with industry members, strategic partners and other stakeholders working together for the common good. Working in partnership like this reinforces the bonds of mutual interest and makes our industry stronger. Services to members Providing high quality services to members is the fundamental reason IMDA exists. The organisation is here to serve, represent and promote the medtech sector in Ireland and to do what is necessary to ensure its development and growth. Throughout this annual review, you will see how IMDA has: n represented the industry, giving voice to its members; n provided timely, relevant information and acted as a focal point for action and debate; n supported the development of skilled employees and attracted high quality graduates to the industry; n provided opportunities for collaboration, experience sharing and networking. Industry Foresight More than ever, companies need to anticipate what is coming down the track, and they need reliable, accessible intelligence on which to base projections and forecasts. IMDA s Industry Foresight Taskforce, chaired by John Harris (Lake Region Medical) made significant progress in this area. In 2013, IMDA and Deloitte jointly published a Business Foresight Model for Ireland, designed to provide a menu for medtech companies, from which they can select the elements that best suit their individual circumstances. The strategy is intended to enable industry leaders in Ireland to share knowledge, discuss the impact of changing business models and prepare for the future. The business model is set out under the following themes: n overview of market trends; n strategies and business models to meet the challenges; n strategic initiatives to respond to challenges; and n key strategies for businesses in Ireland 6 IMDA Annual Review 2014

7 IMPLEMENTATION OF BUSINESS FORESIGHT MODEL Employee Engagement - Getting the best from your team IMDA s seminar on Rethinking Employee Engagement Models held on 11 July 2014 in the Strand Hotel Limerick was a great success and served to amplify a discussion that has been underway for quite a while. A distinguished panel of speakers from a range of large and small companies shared their unique experience and insights into how they have approached employee engagement to drive business priorities forward. Companies are measuring employee engagement very differently today than they were even five years ago. An integrated, holistic and real-time approach to monitoring and measurement is the key to motivating younger, more dynamic and motivated workforces. IMDA brings thought leaders together to discuss rising health insurance costs More than 70% of IMDA member companies currently provide health insurance for their employees. Over the past few years, the industry has seen substantial increases in health insurance premiums and the associated costs have become very unpredictable. This is a serious concern for the medtech sector. IMDA, supported by IMDA Skillnet, held a discussion and debate, on 9 April in Athlone 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 attended. As a consequence, Ibec formally responded to the government submission The Path to Universal Healthcare: outlining concerns for business including the medical technology sector. A revised roadmap is expected to be delivered by Minister Varadkar over the course of Growing the mandate of multinational entities in Ireland As part of the implementation of IMDA s Business Foresight Strategy, members asked for information on how to attract Foreign Direct Investment into their existing sites in Ireland. At the IMDA Members Evening in the University of Limerick on 2 October, Tony Kennedy, VP of Manufacturing EMEA with Teleflex Medical presented a compelling case study on utilising the R&D environment in Ireland, and gave the audience an overview of tax planning. 01 Pictured at the IMDA Health Insurance Workshop (l r) were: John O Dwyer, VHI; Nicola Gilmartin, Abbott Ireland; Eoin O Neill, Aviva Healthcare; Sinéad Keogh, IMDA; and Liam Sloyan, Health Insurance Authority. 02 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 Pictured below at the IMDA Employee Engagement Event, were: William Boxwell, Abbott Vascular, Sinéad Keogh, Director, IMDA, Elaine O Neill, BMR; and Keith O Connor, 3M. IMDA Annual Review

8 ENTREPRENEURSHIP Pilot mentoring programme for medtech companies to accelerate growth In 2012, IMDA launched its four year strategy from , with one of the key pillars being entrepreneurship. A strategic vision at the time was to collaborate with Enterprise Ireland to develop an innovative and new approach to mentoring by utilising experts in the medtech industry through mentor-mentee partnerships a bespoke medtech mentoring programme. We are delighted to say, that this new medtech pilot programme is up and running, with four mentors who were paired with four identified HPSU s (High Potential Start Up) companies. These start-ups, identified by Enterprise Ireland, felt they would benefit from an assigned mentor, are sharing their experiences and challenges over the course of a six month period, with the overall aim of improving their business. IMDA invited companies to put forward their expression of interest in becoming a mentor. Key to the programme is that a mentor does not necessarily have to be the CEO of an organisation; it can be an expert in an area of expertise required by the mentee organisation. The programme was launched by Damien English TD, Minister of State at the Department of Education and Skills in October The scheme aligns with the Government s Action Plan for Jobs and Ibec s An Ireland That Works. A mentorship to support commercialisation Both Incereb and Aerogen develop therapies that are used in the neo-natal intensive care unit. Jim Roche explained that the programme came at a very appropriate time for Incereb, given that the company was preparing for its launch into the European market. John Power of Aerogen had been through this process before and was perfectly positioned to provide guidance on the path ahead. According to Jim, the medical devices sales process is complex. The whole process can be shortened considerably with some judicious introductions. If you want to shorten the initial sales process, companies like Aerogen who have the experience and knowhow are hugely important part of your business network, I m grateful to this programme for providing same. John Power of Aerogen knows that the road to commercialisation in medtech is not a straight road or a simple one. The process will weed out those who haven t got the staying power, deep enough pockets or possibly even the right products. I ve been on this road before and I am delighted to be able to help Jim in any way I can. Established medtech companies should give the next generation a helping hand if possible. It s the right thing to do. A mentorship to accelerate sales Myles Murray of PMD Solutions says that acceleration is the first word that comes to mind when he thinks about the mentoring programme. His work with Sean Langan of Natus Nicolet has added urgency and impetus to the drive for sales and Sean s expertise and experience helped PMD Solutions to set up an international distributor agreement in a matter of days, rather than weeks or months. Sean Langan is very clear on what he saw as PMD Solutions main objective. The company needs sales now. The RespiraSense system is sufficiently well developed for them to get out there and start to sell it. Medtech start-ups can easily focus too much on product tweaks and making everything absolutely perfect. There comes a point when you have to say, the product is ready now. Myles was very receptive to these ideas and immersed himself in the drive for customers. A mentorship to support product development Ronan Byrne of ClearSight Innovations is a serial entrepreneur and an experienced CEO. Ronan explained that ClearSight Innovations needed expertise in product development and design, and we needed an experienced product development expert to guide us through the process of scaling up for production, miniaturising from prototype, reducing costs and the myriad of other details involved in moving into the production phase of the project. John Mugan of Creganna-Tactx 8 IMDA Annual Review 2014

9 Medical provided that expertise. He immediately started to show us what we needed to do and how to do it. I couldn t even hazard a guess at how much time he has saved us. John Mugan was delighted to be able to help. Product development is an area I know well. I have been through the process several times now and I have learned a lot from each project. Collaboration is one of the great side benefits of associations like IMDA. Networking, dialogue and conversations between companies lead to opportunities like this mentoring programme. I was very happy to help in any way I could A mentorship to develop a distribution model Olive O Driscoll of AventaMed was partnered with Liam Mulloy of Vascular Solutions Zerusa. They met for the first time in December 2014 at the Medtech CEO Forum in Limerick and got to work straight away. AventaMed s new device can insert an ear grommet in less than one second, without the need for general anaesthetic. So far, Liam and Olive have been concentrating on preparing to bring a distributor on board. Liam Mulloy says that the product is one of those devices for which everyone can immediately see the demand and its application. AventaMed is fortunate, not having to explain at length why the product is necessary. Olive and John Vaughan are an experienced team and very impressive. I m very happy to be able to give them the benefit of my experience in securing distribution and formulating deals. Olive O Driscoll appreciates the value of being able to call on Liam s experience and having him at the end of a phone if necessary. Skype calls allow them to talk face to face at short notice. Olive looks forward to continued contact. Liam has been a great help so far. Even though we are in the early stages of our mentoring programme, we have already benefitted from Liam s expertise and experience. We anticipate even more benefits as we move towards distribution and commercialisation. It s clear that this pilot programme has been successful. It has proved itself to be a valuable aid in promoting entrepreneurship in the sector and to expedite commercialisation of new products by the participants. We will review progress in due course and make a plan to move on from this worthwhile pilot programme. IMDA SPONSORS YOUNG MEDTECH ENTREPRENEUR AT INTERNATIONAL SCIENCE FAIR Young entrepreneur showcases Free Feet technology at IMDA Members Evening Edel Browne, founder of Free Feet presented her technology at the IMDA s Members Evening, on 2 October in Limerick. Free Feet is a visual cueing system 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). Edel is a first year Biotechnology student in NUI Galway. Pictured above is Young Entreprenuer, Edel Brown (middle) explaining how her innovation Free Feet works to (l r) Adrienne McDonnell, IMDA; John O Dea, Crospon; and Frank Keane, Vitalograph. 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. IMDA Annual Review

10 IMDA BOARD Q&A Put it to the Board It s question time for the IMDA Board members. We asked each of the IMDA Board members to give us their thoughts on some of the main issues facing the industry. REGULATION How important are the Revisions of the EU Medical Device and Diagnostic Regulation in Europe? The MDD revisions and IVD are hugely important. The EU has an opportunity to establish a regulatory regime that will benefit both the patient and the industry. Everyone is keen to see that the right decisions are made but it is also important that decisions are made soon and that a level of certainty is established. Bill Doherty Cook Ireland How will evolving global regulations shape the future medtech business model? As companies look to emerging markets, it is becoming apparent that there is an increasing regulatory workload which resembles Europe as it was in the pre-ce mark era. Registration procedures are starting to more closely approximate approval procedures, and seeking approval to market in new large markets such as Brazil and Russia has become extremely challenging. Companies looking to grow into these marketplaces will need to plan for a longer and more costly journey. John O Dea Crospon GLOBAL COMPETITIVENESS What changes does Ireland need to make in order to continue to attract new medtech investments in the future? The medtech sector in Ireland needs to continue to innovate and keep our focus on the changing needs of our ultimate customers, the end-users. We must be cost-competitive in all things. Lean manufacturing and process control can contribute but macro factors like the taxation code have a big impact on labour costs and competitiveness. Irish labour costs are 16% higher than the EU average and 30% higher than in the UK, our biggest competitor. We must be vigilant and not allow recent hard-won competitiveness gains to be eroded. Tony Kennedy Teleflex INNOVATION Will the convergence of big data analysis and constant monitoring by consumer wearables, apps etc. lead to smartphone companies (for example) entering the medtech sector? It is inevitable that the quantified-self movement will continue apace, as consumers are understandably very interested in monitoring their own health. Not surprisingly, consumers are expressing concern about data security around their personal health parameters and how that data could/might be used. It is likely that smartphone companies and others collecting healthcare parameters will see opportunities to enter the medtech sector perhaps through acquisition or partnerships and it will be prudent to watch this space closely, opening a dialogue with them at the earliest opportunity. Dr Patricia Smith Bio Medical Research 10 IMDA Annual Review 2014

11 TAXATION What will be the impact of the changing BEPS rules around the Double Irish for the Irish medtech sector? How can the Irish Government continue to compete? It s probably too early to say what the ultimate impact of the demise of the Double Irish will be, but I think the initial reaction will be more muted than some have predicted. As the G8 and G20 get more serious about BEPS, the international taxation playing field will likely level somewhat and Ireland s non-tax strengths as an investment location will carry even more weight. Donal Balfe Medtronic Budget 2016 will be announced in Oct 2015, what should be prioritised for the medtech sector? High personal taxes are the most damaging taxes for growth. In the next series of budgets the focus needs to be on reducing Ireland s reliance on personal taxes if we are to remain internationally competitive. This does not just apply to the challenge of attracting highly-skilled people into Ireland but primarily to job sustainability for middle-income earners who have shouldered most of the austerity burden over the last five years. Marginal income tax thresholds should be increased to raise the entry point to the top rate of income tax, a salary of 33,800 is far too low for the marginal rate to apply. Damain Finn Bausch + Lomb To encourage entrepreneurs and their investors to take the risk we need Capital Gains Tax back at 20%. To encourage experienced staff to join early stage companies we need Employee Share Option Plans to be treated under Capital Gains rather than Income Tax. These two measures would hugely improve the entrepreneurial environment in Ireland. John Power Aerogen ENTREPRENEURSHIP Do you think the mentoring programme launched by IMDA this year will continue into the future? Judging by the feedback from the participants in this year s programme, I will be extremely surprised if the programme doesn t continue, and even expand. Both mentors and mentees were very pleased with the process and the positive outcomes. I think mentorship schemes like this are one of the key networking benefits of a trade association like IMDA. OUTSOURCING / PARTNERSHIP Should medtech companies partner to create value? As medical devices become more complex and hybrid devices include software, pharmaceutical elements and more sophisticated processes, it will be necessary for many manufacturers and device developers to collaborate with other specialists. In the early adoption stage of new technologies, no single company can do everything so some level of collaboration is a positive thing. John Harris Lake Region Medical Frank Keane Vitalograph IMDA Annual Review

12 IMDA BOARD Q&A SKILLS DEVELOPMENT What skills can you see being in most demand in three years time? And why? The skills that will be in most demand in three years time will be engineering skills combined with a stronger focus on statistical problem solving and data analytics. As our industry continues to evolve and our customer s expectations continue to grow, our ability to maximize every opportunity to make life changing products as effectively as possible will be paramount to our future success. James Winters DePuySynthes (Ireland) Will new skill needs emerge in medtech over the next three years? It s sometimes tempting to look a little too far into the future. Yes, I believe there will be demand for big data analysts and composite device software quality assurance engineers, but, as always, there will be a strong demand for design, process, automation and mechanical engineers. In short, there will be many skills in demand. IMDA Skillnets and IMDA Springboard is working hard to ensure the next generation of operatives, engineers and executives has the skills and experience our industry needs. Paudie O Connor Boston Scientific What are the benefits of a dual-level National Apprenticeship Scheme? Having gone through the Apprenticeship Scheme myself in the 80s, I can really see the benefits, and in particular the benefits of the dual-level approach. IMDA has been clear in our submission to the Department of Education and Skills that this approach is required to create opportunities for companies to recruit new apprentices and up-skill existing employees. The system will assist companies in many industry sectors to recruit apprentices in specific areas to meet their demands, and allow individuals to progress their careers in a safe, cost effective and flexible manner. The pilot programme that was introduced with the help of IMDA Skillnet in Siemens Healthcare Diagnostics in Swords has been extremely positive. I am confident, once our proposal is approved, Cambus Medical will avail of the newly devised apprenticeship programme, for both new and existing employees. Barry Comerford Cambus Medical Would a revised National Apprenticeship Scheme be of benefit to the Irish medtech sector? I believe it would be of great benefit. IMDA has proposed a two-tier manufacturing apprenticeship scheme which would allow certain sectors (including medtech) to structure training programmes which meet industry requirements and are responsive to changing needs. We have also called for a Centre of Manufacturing Excellence to be established, which would be available to apprenticeship, undergraduate and executive learning programmes. William Boxwell Abbott Vascular How is the IMDA supporting members as the pace of change in the industry accelerates? As always, IMDA is promoting a progressive, competitiveness agenda for its members. This year, IMDA worked hard to develop and further progress the industry position on a number of fronts, including the Medical Devices and IVD Directive revisions, the expansion of the IMDA Code of Ethical Business Practice and the reform of the current apprenticeship model. The IMDA working groups continue to deliver tools for the benefit of members, e.g. the MÓR Model, which is already proving very useful and work, is under way to develop a similar model for best-in-class product development which is such a key activity for our industry. Philip Watson SteriPack Group IMDA SERVICES TO MEMBERS 12 IMDA Annual Review 2014

13 RAISING MEDTECH PROFILE Medtech in the media IMDA s PR Taskforce was proactive in 2014 across a range of media platforms, including; TV, radio, print and events to raise the profile of the medtech sector amongst key stakeholders. Key messages included communicating the size, scale and economic contribution the industry makes to the Irish economy and the many rewarding career opportunities. Top on the agenda was promoting the industry position on the revision of Medical Devices and IVD Directives. In 2015, we look forward to promoting the impact medtech innovation brings to patients and the overall health system as a whole. IMDA Annual Review

14 COMPLIANCE Codes, compliance and ethical considerations Throughout the course of 2014, IMDA has been keeping abreast of European-wide discussions on compliance. MedTech Europe, the alliance of European medical technology industry associations, is currently reviewing the Eucomed and EDMA codes of ethical business practices, to combine them into one code which will, in turn, have implications for the IMDA s code. Four work streams within the compliance network at Medtech Europe have spent a number of months reviewing the various aspects, namely: Transparency; Events; Promotional Activities; and Clinical Activities. This process is continuing into 2015 with the various work streams working on the finer details of the code. IMDA is conscious that our own Code of Ethical Business Practice is aligned with Eucomed s code and will therefore need to be updated later this year once the new Eucomed code is published. Compliance with the IMDA code is mandatory for members and we urge member companies to make sure their voices are heard during this critical time of change across Europe. It is important that we build a strong compliance network so that IMDA can voice Irish industry s view at European level. Company and industry association representatives gathered at the annual global compliance conference last May in Barcelona to discuss compliance developments globally. Delegates learned about a number of new developments, including the decision by EDMA and Eucomed to review aspects of collaboration between companies and healthcare professionals (HCPs). Medtech companies collaborate with Pictured at the Global Compliance Conference in Barcelona in May were: Bill Doherty, IMDA Chairman (Cook Medical); Aline Lautenberg, Eucomed; Adrienne McDonnell, IMDA; and Serge Berlesconi, EDMA, Eucomed&Medtech Europe. 14 IMDA Annual Review 2014

15 Supported by Guidelines on Interactions with Healthcare Professionals Code of Ethical Business Practice HCPs in various ways, one of which is through industry support of medical education by means of direct sponsorship of HCPs to attend thirdparty 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 varying transparency and disclosure requirements. MedTech Europe has began a comprehensive consultation process with HCP organisations and other stakeholders at European and national levels to work towards a new framework that reflects today s reality while ensuring HCP s continued access to the training and education they need. On 4 July, IMDA participated in a Medtech Europe round-table discussion with European CEOs to discuss how industry support for medical education should reflect changes in today s healthcare and compliance landscapes. MedTech Europe decides to recommend phasing out direct sponsorship of physicians at third party congresses During the European MedTech Forum held in Brussels last October, the board of MedTech Europe (Eucomed and EDMA), recommended the phasing out of direct sponsorship while simultaneously introducing stricter rules for indirect sponsorship. It was proposed that this change would be phased in over a three year period. Formal approval for this recommendation will be sought in November If this recommendation is then ratified, direct sponsorship of HCPs to third-party organised conferences would end on 1 January In addition, stricter self-regulation of indirect sponsorship activities is being developed and would take effect at the same time. IMDA as a member association of Eucomed has a role to play in voicing Irish industry opinions on this important topic. The IMDA Code of Ethical Business Steering Committee will review the proposed revisions and seek to formulate a position vis-à-vis the recommendations which will then be presented to the IMDA Board. The IMDA Compliance Steering Committee and Code of Ethics external panel met on 18 November 2014 and ratified a change approved by the board giving the panel full independence and autonomy regarding decisions and sanctions to be applied in the event that a complaint is upheld by the panel. As a member of IMDA, companies are automatically signed up to the IMDA Code of Ethical Business Practice. For more information visit IMDA Annual Review

16 INTERNATIONAL REGULATORY INSIGHT World-class medtech QA/RA event in Galway IMDA s biennial Global Access Conference was held in Galway on 10 and 11 September. The conference marked the definitive Irish event for medtech QA/RA professionals during This event was extremely well attended with a comprehensive schedule of presentations and Q & A sessions, all covering a lot of ground in a remarkably short time. After an introduction by the conference director, Áine Fox, Senior Executive, IMDA, Bill Doherty, Executive Vice President, EMEA Cook Medical Ireland and IMDA Board Chair introduced the conference s keynote speakers. Keynote addresses Aurélien Perez, EU Commission, spoke about the EU Regulatory framework for medical devices and current developments under same. Aurélien explained how progress in reassessing the functioning of Notified Bodies (NBs), including mandatory joint assessments by at least two Competent Authorities had led to significant improvement in market surveillance activities. Pat O Mahony, Chief Executive of the Health Products Regulatory Authority (HPRA) spoke of the need to balance patient safety with industry s need for timely market access. European patients have access to innovation almost three years faster than US patients and all parties wish this situation to continue. He urged the industry to engage with Regulatory Science Ireland (RSI), a new network of interested parties from academia, industry and government agencies committed to the development of an integrated Irish response to the Global Regulatory Science effort in the fields of research, education and knowledge sharing. China, India and the U.S. regulatory changes on the ground Chair John Kilmartin, Senior Director RA, Medtronic Ireland and IMDA s Regulatory Steering Committee Chair introduced the first session on global regulatory developments. Huang Yiwu of the Shanghai Municipal Food and Drug Administration spoke about the three legislation systems in China and outlined how China s medical device regulations were revised under Decree No. 650 of the State Council on 1 June The new regulations comprise eight chapters and 80 articles. Praveen Kumar, Director of RA, Quality and EHS of Medtronic India informed delegates that the market for medical devices is growing significantly in India and the regulatory system will be significantly altered within 18 months when the Drugs and Cosmetics (Amendment) Bill 2013 is transposed into law. Mike Ryan of the FDA s Center for Devices and Radiological Health outlined a wide range of product change scenarios and specified the appropriate type of supplement in each case. He explained the difference between Annual Reports and 30 Day Notices and showed how to determine which submission type would apply to a particular product change. He also outlined the differences between Special and Traditional 510 (k)s. Regulatory challenges and opportunities in emerging markets Robbie Walsh, Director, Regulatory Affairs, Boston Scientific chaired an informative session which gave industry perspectives on regulation across global jurisdictions. Tim Missios, Director of RA International, Boston Scientific, gave an overview of the changing regulatory systems in Argentina, Columbia, Peru, Ecuador, Venezuela, Guatemala and Costa Rica, and a detailed review of the situation in Brazil, the biggest and most important market in the region. Enrico Schuur, Director RA, Medtronic International, covered Central and Eastern Europe, a vast area with a combined population of 380 million people across 25 jurisdictions. He explained how inconsistent regulations and customs requirements can cause difficulties for distributors. He also touched on cultural aspects of doing business in Russia and the Slavic states. Stephen Hendrikx, Manager RA International, Merit Medical, presented on the practical considerations of product registrations in Russia. The recently introduced Resolution 1416 has imposed significant testing and certification requirements. Russia s long term aim is that 80% of its state procured medtech should be manufactured domestically. Dominik Reterski, VP Regulatory Affairs, EMEA, Covidien, spoke in detail about the widely varied regulatory systems in countries that ranged from oil-wealthy Gulf States to developing nations in Africa and covered Saudi Arabia and Egypt in some detail. Gerardine Finn, VP Regulatory Affairs, Medtronic gave an overview of RA management from her perspective in a major multinational. She emphasised the need for collaboration 16 IMDA Annual Review 2014

17 between producers, distributors and regulators, calling for increased harmonisation in regulatory standards. EU Commission and Authorities address impact of changing regulatory requirements for manufacturers Tom Healy, RA / Quality Manager Vitalograph, chaired a session examining trends in QA/RA, auditing and compliance. Beth Staub, VP Global RA & QA, Stryker, highlighted how trends in pre and post market activity were affecting the industry. Beth provided insights into the barriers to medical device quality and spoke about FDA s Case for Quality Initiative. Luc Cayuela, Auditor, Food and Veterinary Office, Directorate General Health and Consumers, EU Commission, explained the system that pertains since October 2013 whereby Notified Bodies (NBs) are subject to joint assessment by an EU Commission Joint Assessment Team and national experts from two Competent Authorities. Every NB will be jointly assessed at least once every five years. Lorraine Nolan, Director of Human Products Authorisation and Registration, HPRA, gave the HPRA s perspective on involvement in joint assessments of NBs. Since 2013, HPRA has participated in seven joint assessments. Jayanth Katta, Product Specialist & Certification Manager, Medical Devices, BSI spoke on BSI s approach to unannounced audits. BSI assessment teams usually consist of one QMS assessor and one product technical specialist. Typically an audit lasts one day for SMEs and two days for very large manufacturers. Manufacturers should be prepared for an unannounced visit and should have a competent deputy primed and ready any time the QA/RA manager is off site. Key sectoral trends assessed by industry experts John Kilmartin, Senior Director RA, Medtronic Ireland, chaired the final seesion of the conference. Tom Healy, RA / QA Manager, Vitalograph (Ireland) Ltd, presented on software as a medical device. He described a complex set of standards that applied to different types of software and identified IEC as being the key standard to aim for as it is on the FDA s Recognized Consensus Standards list, and it is harmonised in Europe and in Canada. Medtech QA/RA Conference IMDA Annual Review 2014 Jesús Rueda, Director Regulatory Affairs, European Diagnostics Manufacturers Association, set out the expected impact of the proposed EU regulations on in vitro diagnostics. An ISO Standard (via ISO/ TC 212) setting out clinical evidence and implementation recommendations is anticipated. Jay Crowley, VP, UDI Solutions and Services at USDM Life Sciences presented on Unique Device Identification (UDI), which gives each device and product a unique identifier which allows it to be traced to its manufacturer. Jay outlined UDI challenges, opportunities, timelines and public health benefits. Sinéad Keogh, Director, IMDA, officially closed the conference, thanking the speakers,organisers, IMDA s Regulatory Steering Committee and delegates for contributing to such a successful conference. A special word of thanks was extended to event Gold Sponsors, Boston Scientific and Medtonic and Silver Sponsors, NSAI, EtQ Ltd., IMDA Skillnet and Med- Tech Innovation. 01 Robbie Walsh, Director Regulatory Affairs, Boston Scientific; Caroline Dore Geraghty, Chief Clinical Evaluator, NSAI; Maria Carleton, Operations Manager, Human Products Authorisation and Registration, HPRA; Tom Healy, QA/RA Manager, Vitalograph Ltd.; Áine Fox, Senior Executive, IMDA; John Kilmartin, Senior Director Regulatory Affairs, Medtronic Ireland and Chair IMDA Regulatory Steering Committee. 02 Sinéad Keogh, IMDA Director; Bill Doherty, IMDA Chair; Aurélien Perez, European Commission Directorate-General for Health and Consumers and Pat O Mahony, Chief Executive, HPRA. 03 Huang Yiwu, Chief Officer, Medical Device Registration Department, Shanghai Municipal FDA; Pat O Mahony, Chief Executive, HPRA; Aurélien Perez, European Commission Directorate-General for Health and Consumers and Áine Fox, Senior Executive, IMDA. 17

18 QUALITY AND REGULATORY AFFAIRS MDD and IVD revision negotiations ongoing 2014 was another busy year in the QA/RA sphere and a significant year in terms of future regulatory change. As in the recent past, the MDD and IVD Revisons featured strongly but there was a lot more happening too. Negotiations on MDD and IVD Revision are ongoing Following a year of intensive lobbying, discussion and analysis, the Medical Devices (MDD) and the In-Vitro Diagnostic Medical Devices (IVD) Regulations are still at a draft stage. The medical technology industry in Ireland and in Europe has been vocal over the last two years since the Commission s proposals on Regulations for medical devices and IVD s were first published (26 September 2012), in stating that it wants a clear, predictable and effective regulatory system specifically tailored for medical devices that ensures the highest level of safety for patients. The regulatory system should also facilitate timely access to the latest innovative technologies, ensure the trust of its stakeholders and the sustainability of national healthcare systems and, importantly, keep R&D and innovation in Europe Legislative negotiations on the dossiers are entering a third year and European Parliamentary Rapporteurs have since 5 November 2014 been mandated to enter into negotiations with Council with the aim of reaching agreement on the proposals. Industry is calling at this time for a swift as possible adoption of thought-through regulations which uphold the philosophy and principles of the Commission proposals. Some concerns for industry continue to be debated including the proposed scrutiny mechanism for certain high risk medical devices, clinical investigations and re-processing of single use medical devices. Although there are some policy differences between member states, it is hoped that these differences are not insurmountable. IMDA, fellow national associations throughout Europe and Eucomed will continue to maintain open and frequent dialogue with key stakeholders and policy makers. The industry s system of oversight has already been strengthened by the introduction of mandatory and unannounced site inspections by Notified Bodies (NBs) and increased supervision of NBs, including joint assessment by at least two Competent Authorities. These developments have been welcomed by the industry. As negotiations move towards possible conclusion during 2015, it is more than ever apparent that a balanced and appropriate regulatory framework that protects patients and world class innovation in the medtech sector will be vital if the sector is to achieve its full potential in Europe during the term of the current European Parliament and Commission and beyond. IMDA establishes a Sterility Assurance Forum The newly established IMDA Sterility Assurance Forum met twice during This forum is a means by which sterility assurance and QA /RA professionals from Irish medtech companies can share their expertise and experience and keep themselves up to date on developments in the area. Fifty sterility assurance and quality / regulatory professionals from across 28 IMDA member companies attended the first meeting of the forum in Athlone on 16 April The meeting was a mix of formal presentations and lively breakout sessions on topics including sterilisation validation documentation, load configuration and maintenance of a validated process. The event included a detailed update on standards, draft ISO11135 and on the MDD Revision s impact on sterilisation. The second meeting was held in Athlone on 11 November, with 40 sterility assurance and QA / RA professionals in attendance. ISO was discussed again and members presented case studies on parametric release and gamma. The meeting concluded with an update on ASTM International (American Society for Testing and Materials), an international standards organisation that develops and publishes voluntary consensus technical standards for many materials, products, systems, and services. The next forum meeting is scheduled to take place during Q IMDA Annual Review 2014

19 Almost 100 delegates attend IMDA s Quality & Regulatory Forum IMDA s Quality & Regulatory Forum had its largest ever attendance of almost 100 QA/RA professionals when it met in Limerick on 28 May The National Standards Authority of Ireland (NSAI) gave an informative presentation on risk management and Commission Recommendation 2013/437/EU Annex III from the perspective of a Notified Body. The forum discussed recent developments with respect to unannounced audits. Naturally, the MDD/ IVD Revision was discussed with an update on the current status of negotiations. The meeting concluded with reports and discussion on UDI implementation in practice. Representing your interests IMDA s Regulatory Steering Committee was very active throughout the year. We held a number of significant meetings and contributed to many representations on QA/ RA issues. Among the key meetings held during 2014 were meetings with An Taoiseach Enda Kenny TD, Minister for Health, Leo Varadkar TD and Pat O Mahony, Chief Executive of the Health Products Regulatory Authority. 01 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); Áine Fox, IMDA. 02 Pictured at the IMDA Skillnet event were: Michelle Reinecke-Quain, IMDA Skillnet & Springboard Administrator with Laura Flanagan, DePuy Synthes. 03 Pictured at the Sterility Assurance Forum, in Athlone were: Áine Fox, IMDA; Richard Cowman, Synergy Health (Forum Chair); David O Sullivan, DePuySynthes (Ireland); Olivier Vrain, Synergy Health; Caroline Murphy, Teleflex Medical. 04 Enda Dempsey, IMDA; 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. 05 Pictured at the IMDA Sterility Assurance Forum were: Sean Hanley, Boston Scientific; Caroline Murphy, Teleflex Medical Ltd; Richard Cowman, Synergy Health Ireland Ltd; Áine Fox, IMDA. 06 Pictured at the Sterility Assurance Forum in Athlone were: Shaun McGinley, Covidien; Suzanne Butler, Boston Scientific; Richard Cowman, Synergy Health; Pauline O Flanagan, IMDA Skillnet; John Cunniffe, Covidien. IMDA Annual Review

20 REPRESENTING YOUR INTERESTS IMDA is here to represent YOU, your business and your interests Throughout the past year we have worked long and hard, whether behind the scenes or out in front to make sure that Irish medtech gets the very best representation, assistance and services available. Nothing less is acceptable. IMDA and Ibec have the resources, the experience and the expertise to make sure your voice is heard and that your opinions count. No other organisation can guarantee the same levels of access, influence and results. Here are some highlights from the past year. IMDA met with ministers, government agencies and departments throughout 2014 to promote the medtech agenda and secure a number of important policy decisions to enable sustainable growth in the sector. The revision of the Medical Devices and IVD Directives were top of IMDA s agenda during the year. We also engaged in campaigns during the year that resulted in the introduction of a knowledge development box, enhancements to the taxation rules governing IP and the removal of the base year for the purposes of the R&D tax credit. IMDA made the following representations in its Budget Submission 2015: 1. Capital Gains Tax should recognise and reward medium and high risk investments. The medtech sector has many serial entrepreneurs who have launched multiple products and founded multiple companies. Capital Gains Tax (CGT) in Ireland no longer favours high risk investments by indigenous entrepreneurs. Only one in five technology investments achieve commercial success and the Irish taxation regime should recognise this. Ireland is competing for investment with jurisdictions that are significantly more investmentfriendly than us. IMDA will continue to promote a more favourable CGT regime for Budget Certainty for R&D tax credit scheme. The R&D tax credit scheme is a cornerstone of Ireland s enterprise policy and has been a significant factor in the success of the medtech sector. Recently, a degree of uncertainty has emerged about the scheme s continued operation and the terms on which it will apply. This uncertainty is damaging to business confidence and risks undermining Ireland s broader enterprise policy objectives. IMDA called for a timely policy decision and outlined the terms that would facilitate sustained growth and employment in the medtech sector. It was encouraging to see enhancements to the scheme in Budget 2015 and the removal of the base year calculations. 3. Reform the Employment and Investment Incentive Scheme (EIIS). Some progress towards reforming the EIIS was made in Budget 2014 by removing the restrictions on EIIS relief for high earners for a period of three years. Budget 2015 should add to this progress. IMDA recommends rebranding the scheme to give it a renewed sense of purpose, dropping the employment R&D restriction and targeting non-traditional investors. 4. Employee financial involvement. Imposing employee PRSI and Universal Social Charge on employee share schemes has introduced a level of complexity and an administrative headache that far outweighs the relatively modest revenue potential. The tax treatment of share schemes in Ireland is much less attractive than in neighbouring jurisdictions. 5. A balanced approach to MDD and IVD Revisions. Making every effort to get MDD and IVD Revisions right must be a top priority for Ireland. 20 IMDA Annual Review 2014

21 Representing you and your interests On representation n We lobbied the European Parliament and the European Commission, promoting our position on a pan-european approach to funding the future regulatory framework. n We initiated a series of meetings with An Taoiseach, the Minister for Health and the Minister for Jobs Enterprise & Innovation to promote a number of important policies outlined in IMDA s budget submission. n Hosted the four largest health insurers in Ireland to discuss the unsustainable rising cost of health insurance in Ireland. Contributed to the Ibec submission to government on universal healthcare. On funding and business development n Secured 732,351 in government funding for IMDA Skillnet and Springboard networks to develop much-needed programmes across lean, quality and innovation for the sector. n We launched a Level 9 programme to develop design skills for the sector. n Presented to the joint Oireachtas committee to advocate for enhanced investment incentives for SMEs. n We developed and promoted the industry position on seed and venture capital. n IMDA and Enterprise Ireland launched a dedicated mentoring programme for start-ups to support entrepreneurship in the sector, a key initiative under our strategy. n IMDA developed a playbook help companies with overseas parent companies to demonstrate the benefits of investing in Ireland and to make the case for locating additional projects here. We also developed a programme to encourage increased employee engagement in medtech companies. n We met with the Department of Education to promote our position on developing new apprenticeships. n Piloted a new apprenticeship scheme for medtech to support skills development within the sector. On networking and events n Jointly hosted the eighth annual CEO Forum and Awards programme with Enterprise Ireland and IDA Ireland. n Hosted the fifth biennial international regulatory symposium, Global Access, to keep the industry fully briefed on global regulatory trends. n Hosted networking evenings for members in Limerick and Athlone. On raising the sector s profile n We were active on TV and radio and in print to promote the value of the medtech sector. n We re-launched the Irish medtech map, highlighting the scale and diversity of the sector in Ireland. n We developed a new sentiment survey to capture key statistics and information about the medtech sector for the purpose of increasing its profile. n Promoted careers in medtech through a number of forums such as the BT Young Scientist and Career Zoo. John Brennan, Eucomed Director Regulations and Industrial Policy; Sinéad Keogh, Director, IMDA, An Taoiseach, Enda Kenny, Joe Almeida, Advamed Chairman, Covidien President and CEO; Steve Ubl, Advamed CEO at Government buildings on 08 September IMDA Annual Review

22 YOUR STRATEGIC PARTNER Ibec is your strategic partner Posterity will record 2014 as a turning point for Ireland. Through Ibec s flagship campaign, An Ireland that works, we ve been successful in influencing the policy and business environment, delivering a number of tangible gains for our members and for society as a whole, including the following: 1. Ibec successfully campaigned to reduce tax rates. Reducing the marginal tax rate to 40% in Budget 2015 gives households almost 500 million in new spending power and helps employers to increase wages without adding to labour costs. 2. Ibec successfully campaigned to stop pension levy on private pensions. This unfair tax on the savings of you and your employees was abolished in Budget Ibec successfully lobbied to prevent proposed changes to our voluntarist approach to collective bargaining. This retains a positive industrial relations climate for you and your business. 4. Ibec successfully campaigned for increased focus on maths and science to support business demand for high level ICT talent. This has resulted in an 11 percentage point increase in the participation rate at higher level Leaving Certificate maths. 5. Ibec successfully lobbied for more capital investment in infrastructure, expanded JobsPlus and reform of the apprenticeship scheme. This resulted in 210 million for infrastructure projects and an expansion of the JobsPlus scheme giving employers greater access to talent. 6. Ibec successfully lobbied for a redesign of our international tax offering. Positive measures in Budget 2015 include a new knowledge development box ; enhancement of the R&D tax credit and improved personal tax rules for ex-pat workers. These will provide certainty to foreign companies operating in Ireland and enhance our attractiveness for mobile investment. We were first out of the blocks in predicting 2014 growth would exceed expectations and in 2015 we expect growth of 4.5% and employment figures to return to 2009 levels. However, while the economy is moving in the right direction, we remain acutely aware of the challenging trading conditions, legacy costs and wage pressures that continue to confront many of our members, particularly those solely reliant on the domestic economy. We still have a very long way to go. This year we will again be seeking to address the key issues that affect everyone who works so hard to succeed in business in this country. We need to secure increased investment in capital infrastructure; facilitate the tentative recovery in the consumer economy and ensure that the economic upswing is experienced in all sectors and regions across the country. As always, our professional expertise remains at your disposal and we welcome your involvement. Danny McCoy CEO, Ibec 22 IMDA Annual Review 2014

23 INVESTMENT Medtech investment continues to grow The Irish medtech sector has continued to grow strongly in 2014 and some major investments and developments were announced by IMDA members and by the industry in general. This sustained investment has generated many valuable high-tech jobs and confirmed Ireland s place at the forefront of the global medical device industry. Some of the headline announcements are listed below. AbbVie Inc officially opened its recently expanded facility in Sligo with the creation of 175 highly skilled jobs. This site will be involved in commercialising and manufacturing pipeline products for liver disease, oncology and women s health. Becton, Dickinson and Company has revealed plans for a 16m investment in new equipment for its Drogheda site. This will result in 20 new jobs being brought to the region and will increase the production portfolio for the plant. Clearstream Technologies has finalised the 50,000 square foot expansion of its Enniscorthy facility. This will enable the company to accommodate an additional 200 jobs on top of its current workforce of 410, and allow the plant to add new products to its portfolio. Embo Medical, a HPSU that focuses on minimally invasive embolization technology, has secured 3m in seed-funding from the AIB Seed Capital Fund syndicate, creating 10 jobs. Irrus Investments, HBAN s Medtech Business Angel Syndicate, Western Development Commission and Enterprise Ireland were the other major investors. Ethicon Biosurgery Ireland, part of the Johnson & Johnson Family, has planned an 80m, 60,000 square foot manufacturing facility. This will lead to the creation of over 270 permanent and 150 temporary jobs in the Limerick area. Filtertek Ireland, an ITW company, is set to bring its total workforce to 100 by adding 35 new jobs. The positions will be a mix of machine operators, moulding technicians, engineers, quality technicians and production supervisors. Hollister Incorporated has committed an 80m investment to their facility in Ballina, Co. Mayo. This has previously added extra manufacturing R&D processes to the site. To date, Hollister employs over 500 people. Nelipak Healthcare Packaging, which established itself in Ireland in 1995 after the acquisition of Plasmedics, has announced an increase of 10 in its permanent workforce, bringing its headcount up to 86 people. Stryker Corporation will be investing in a 44,000 square foot cutting-edge surgical Innovation Centre that will focus on the R&D for product design and process development. This complex will have simulated operating rooms and surgical environments, allowing surgeons and engineers to evaluate new ideas and technologies. The facility is expected to be completed in Q Teleflex Incorporated plans to significantly boost its EMEA operations in Athlone with the announcement that over 100 high-skilled positions will be generated in the next three years. VistaMed opened a new 35,000 square foot expansion in its Carrick-on-Shannon manufacturing facility. Up to 125 jobs are expected to be generated as a result of this investment. West Pharmaceuticals Services revealed plans to invest 100m in a new facility in Waterford that will produce packaging components for insulin injector cartridges and other high quality products. This will eventually lead to the creation of jobs. IMDA Annual Review

24 INNOVATION Collaboration, benchmarking and innovation To combat increased competition in the global medtech market, many companies are seeking to differentiate themselves through innovation. As Ireland moves increasingly towards a knowledge based economy, innovation and collaboration have the potential to generate significant benefits, from reducing cost to securing marketplace advantage with innovative products and services. Collaborating with our academic partners During 2014, members of IMDA s Innovation, Research, Development and Commercialisation (IRDC) working group met with representatives from the APT Centre, AIT and the AMBER Centre at the CRANN Institute, Trinity College Dublin to discuss innovative materials research currently on going. Working group members also met with REMEDI on Stem Cell research and potential impact on manufacturing and clinical development. The group received timely updates on the CÚRAM centre, SFI Industry Academia Partnerships and Knowledge Transfer Ireland during 2014 Working Group meetings. 24 IMDA Annual Review 2014

25 Developing a best practice model to support product development in Ireland World-class manufacturing and operational excellence are globally recognised hallmarks of the medical device and diagnostics sector in Ireland and critical to the sector s continued success. However, product development has been identified as an area in which Ireland can further raise the bar, providing long term benefits to industry in sustaining the sector as the global medtech manufacturing landscape shifts towards lower-cost jurisdictions. It is clear that there is a huge opportunity for Irish product development leaders to share successful and innovative tools with each other helping to successfully benchmark and build a world-class product development reputation in this country. Members of IMDA s IRDC working group, having agreed a strategic scope for the initiative, will during 2015 further develop the proposed model in conjunction with leading product development experts. The development phase of the initiative is funded by IMDA Skillnet and will comprise ongoing consultation with IMDA members. There is a wealth of product development expertise across Irish medtech companies which can and should be harnessed to benefit the sector nationally. Bridging the design skills gap During 2015, engineers from across Ireland will embark on a new design programme developed by industry for industry, accredited by the University of Limerick and delivered in association with UCD and NCAD. The course presents a unique opportunity to develop future skills needs in design, identified by the industry as crucial for future growth of the sector. Significantly, the programme will develop the next generation of highly skilled design engineers for the Irish medtech sector. The launch of the Design for Medical Technologies course coincides with the Irish Design 2015, a year long initiative identified in the 2014 Action Plan for Jobs which aims to encourage investment in design and design skills across multiple sectors as a key component of competitiveness and innovation and to promote Ireland s design reputation internationally. New Irish patent court good for foreign investment and SME s On 13 November 2014 the Government officially announced that it would establish a local division of the Unified Patent Court (UPC) in Ireland. Ibec welcomed Government s decision as this development will provide greater security for Irish SME s as well as help Ireland better compete for foreign direct investment. Establishment of the local division of the UPC will also help Ireland better react to future developments in the global R&D environment as well as develop new clusters of high value-add activity in the country. Several of Ireland s competitors for mobile investment, among them, Finland, Denmark, the Netherlands and Belgium have already established local divisions. The move will help Ireland compete internationally and encourage companies to relocate their research activities and IP portfolios here. The Unitary Patent is expected to come into force in late 2015/2016, allowing Government time to establish the local division of the UPC, dependent on a successful national referendum. R&D tax credits The R&D tax credit scheme is crucial aspect of Ireland s innovation policy and key to driving innovation and investment in R&D in this country. Positive measures in Budget 2015 included enhancement of the R&D tax credit which will enhance Ireland s attractiveness for mobile investment. In its pre-budget submission, Ibec called for a credit lite R&D tax credit model for SME s to enable such companies to more fully engage with the credit scheme. Ibec also addressed the issue of uncertainty for companies availing of the scheme. The removal of the 2003 base year from the R&D tax credit scheme was a key win in Budget Additionally, a new knowledge development box regime is expected to be introduced by 2016 at the latest following public consultation. IMDA s Academic Forum The mission of the IMDA Academic Forum is to foster the cohesive interaction of the medical technology industry with the academic community in Ireland. This Forum was established to address issues of shared strategic importance in medical technologies existing within both the academic community and industry. IMDA s Academic Forum met in May 2014 where models of engagement across academia and industry were discussed in light of results from IMDA s National MedTech Skills Survey. The Forum discussed convergence technologies and the role of the pharmacist/ pharmacy skillsets in the medtech industry. There were also updates from CURAM and the Irish Centre for Advanced Manufacturing. Breakout sessions addressed models of academic/industry engagement in apprenticeship curriculum development and the ability of current academic offerings to address current skills gaps and future skills needs. Pictured at IMDA s Academic Forum were: 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. 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 were: Áine Fox, Senior Executive, IMDA; John Mugan, Creganna-Tactx Medical; Pauline O Flanagan,Network Manager, IMDA Skillnet; and David Tallon, Stryker. IMDA Annual Review

26 ENHANCING MANUFACTURING CAPABILITIES Operational Excellence In 2014, the IMDA s very active Operational Excellence Taskforce worked on a number of projects, including the further development of the MÓR TM Model; the rollout of their third Lean Leadership Programme and initiating planning process for IMDA s inaugural Global Manufacturing Conference, which will happen in Lean Mentoring Programme goes from strength to strength The IMDA Operational Excellence Taskforce launched the lean mentoring programme in late This programme aims to leverage the knowledge and experience of member companies with mature lean processes, to help members who are at an earlier stage of their lean journey. The mentoring relationship is based on implementing the MÓR TM Benchmark model in the mentored company while giving guidance and setting out a realistic roadmap based on the mentor company s experience. Two strong partnerships have already emerged from the Lean Mentoring Programme; n Siemens Healthcare Diagnostics and Bellurgan Precision Engineering; and n Lake Region Medical and Waters Technology. Each of the four participating companies have reported significant benefits. We are delighted to be in a mentoring partnership with Lake Region Medical. They have been extremely supportive to us on our lean transformation journey and their help has been of a very high quality. By far the main benefit to Waters from this partnership was the peerto-peer interactions between personnel at both sites. Sharing experiences of embarking on lean gave us the confidence to fully embrace our programme, said James Browne, Lean/6- Sigma Programme Manager, Waters Technology 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, said Suzanne Carroll, Managing Director, Bellurgan Precision Engineering Ltd. IMDA is now on a drive to create more partnerships in this programme, and we are currently accepting expressions of interest for new mentoring relationships. Sinéad Keogh, Director IMDA, with Lean Mentoring Participants, James Browne and Stephen Creaner from Waters Technologies, with Dermot Doherty, IMDA Executive. 26 IMDA Annual Review 2014

27 Lean Mentoring Case Study Waters Technologies partnership with Lake Region Medical In 2013, IMDA selected Lake Region Medical to mentor Waters Technologies through its transition to lean manufacturing. Lake Region Medical appointed Eddie Kiely, Director of Operations & Logistics as the main mentoring contact. Many benefits accrued to Waters Technologies: n Key representatives from Waters Technologies visited Lake Region to see lean techniques in action; n Lake Region trained and supported Waters in launching a structured problem solving and A3 reporting programme; n Sub-networks were established between the two companies to share best practices; n Lake Region was generous in sharing its past experience; n Lake Region visited Waters Technologies to help with lean benchmarking exercises and with implementing the IMDA MÓR TM Model. IMDA has developed a Lean Mentoring guidance document to help guide mentor-mentee relationships. The booklet outlines the benefits of the programme and provides information on how to get involved. This guidance document will help to grow the already well-established lean network within the IMDA. It will also ensure the further development of the MÓR TM model as THE model for lean development. A case study of the Lake Region Medical and Waters Technology Pilot Lean Mentoring Programme will be delivered at IMDA s upcoming manufacturing conference Manufacturing to Win the World Stage in April 2015, in Galway. MÓR Model working its way towards an Industry standard The MÓR model which was developed by members of IMDA s Operational Excellence Taskforce allows members to highlight and address gaps in their lean manufacturing capabilities. Although the model was developed by IMDA members, it is not sector specific and can be used in any industry. The MÓR Model has begun its journey from a tool to an industry standard. The MÓR subgroup met with a number of interested parties and joined with SA Partners who delivered a sold out MÓR model workshop in Galway on 15 September The subgroup has also acquired the services of two consultants who are tasked with the progressing of the MÓR model from tool to standard. A national rollout of the overall MÓR model standard and award criteria is planned for Q Sinéad Keogh, IMDA: Theresa Moloney, Boston Scientific; Barry Storan, Teleflex; and John Quirke, SA Partners IMDA Annual Review

28 EU AND INTERNATIONAL RELATIONS The big picture 2014 was a year of significant change and renewal in the European Parliament and Commission prioritising medtech reimbursement on the EU Agenda. Ibec, working with the IMDA and other sectors, launched a policy campaign entitled, A European Union that Works highlighting Irish business priorities to the new European Parliament and Commission. The first strand of the campaign highlighted Ibec priorities for the European Parliament at a St Patrick s week reception, hosted with Sean Kelly MEP, in Brussels and at the European Parliament offices in Dublin. The second strand of the campaign, aimed at the Commission, was presented to its Secretary General, Catherine Day, at a high level briefing in Brussels in December. Ibec business priorities were also presented to the Head of Commission Dublin office, Barbara Nolan and to EU member state ambassadors based in Dublin. The Ibec priorities papers have been widely distributed to key stakeholders in Brussels and Dublin. Ibec s campaign asks the European Parliament and Commission to understand and respond to the needs of business. This is essential if Europe is to return to a path of strong economic growth and employment. For example, an appropriate EU regulatory framework that protects patients and worldclass innovation in the medical technology sector is essential. The Commission s new work programme is important to the future direction of Europe and reflects many of our business priorities. On the topic of medical technology the Commission has been invited to ensure that future funding for medical technologies across Europe is appropriate, sustainable and demonstrates benefits to both the regulator and the regulated. Efficient and sustainable reimbursement of medical technologies across Europe is also critical. IMDA and Ibec, with the support of its Brussels office, will continue to advocate Irish business priorities at EU level in International trade policy 2014 was a busy year for trade policy. The EU continued in its negotiations on free trade agreements with Singapore, Vietnam, Japan and the USA. The agreement with Canada was finalised and is currently being tidied up before going through an approval process. Although at a much slower pace, with fewer developments, the negotiations with Malaysia, India, Thailand and Mercosur (Argentina, Brazil, Paraguay, Uruguay and Venezuela) all continued. Ibec continues to emphasise the strategic importance of trade, and to support the current negotiations and trade liberalisation policies in general. We are working with our partners to ensure that the details of any trade deals promote economic growth for companies in Ireland. Work with other European business organisations is vital as the European Commission is the lead negotiator for all these negotiations. As Chair of BUSINESS EUROPE s US Network, Ibec s Pat Ivory is well placed to lead on business interests with our European business organisation counterparts and in April, Pat participated in the senior business delegation visit to Washington to meet with the US Trade Representative (Mike Froman), members of Congress, officials from the relevant departments, the White House and Christine Lagarde from the IMF. Emmett Devereux, Director of Quality and Regulatory Affairs, 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. 28 IMDA Annual Review 2014

29 REGIONAL POLICY At the Ibec West AGM were: Sinéad Keogh, IMDA; Frank Cashman, Anecto; and Liam O Donoghue, Ibec. 02 At the Ibec South-East Regional AGM were: Danny McCoy, CEO Ibec; AnneMarie Cosgrave, Medite Europe Ltd; and Paudie O Connor, Boston Scientific Clonmel. 03 At Ibec s Making the West Work were: Sinéad Keogh, IMDA; John Power, Aerogen; Bernie Turley, Goodman Medical; and Mary-Rose Burke, Ibec. 04 At Ibec s Making the Mid-West Work were: Mairead Crosby, Ibec, Mark Nolan, Dromoland Castle, Bill Doherty, Cook Medical, Maria Hinfelaar, LIT, Kevin Molloy, Electric Ireland and Danny McCoy, Ibec. 05 At the Ibec Mid-West & Kerry AGM were: Oonagh France,Cook Medical; Adrienne McDonnell, IMDA; Ambrose Downey, McKesson Ireland; and Carla Di Benedetto, Cook Medical. 06 Danny McCoy, CEO Ibec presents Michael O Reilly, Phillips-Medisize, and outgoing President of Ibec s North West Region, with a token of appreciation at the Ibec North West AGM. 07 At Ibec s Making the South- East Work were: Paudie O Connor, Boston Scientific, Michelle Walsh, Ribworld, Pat McLoughlin, Abbott Vascular, and Danny McCoy, Ibec. At the forefront of regional policy The medical technology sector in Ireland is geographically spread across all corners of the island. Representation at a regional, national and international level is important for the sustained and continued growth of the sector here. In 2014, a new regional policy team was appointed within Ibec. The team consisting of Fergal O Brien, Head of Regional & National Policy and Helen Leahy, Senior Regional Coordinator along with the respective Ibec Regional Directors are working closely with members to ensure the delivery of a strong regional business agenda. The key driver of regional policy issues in each region is the Ibec Regional Executive Committee (REC). The REC is made up of senior business leaders in the region. The role of the Ibec REC is to shape, guide and lead business policy priorities for each region and to ensure that all national policy developments have an appropriate regional balance. Each REC president sits on Ibec s Regional Presidents Council and on our National Council. The Regional Presidents Council provides an important forum to develop and expand upon all regional issues. It also ensures that policy priorities for the regions are reinforced in Ibec s national focus. In May and June 2014, Ibec ran a series of regional seminars during which senior business leaders from each region gathered to explore local opportunities for jobs and growth. Key priorities emerging from the series formed the basis for the REC programme of activity for These key regional priorities include the promotion of infrastructure investment in the regions along with skills development and facilitating employer engagement with the education providers in the region. Ibec will be hosting a series of Regional Skills events throughout May Due to recent retirements from the committees, a number of vacancies have arisen. Any Ibec members interested in discussing membership of the Regional Executive Committees can get in touch with any member of the Ibec regional policy team for further information. IMDA Annual Review

30 UPSKILLING MEDTECH PROFESSIONALS Solutions, services and skills Throughout 2014, IMDA Skillnet and IMDA Springboard have delivered high-quality, cost-effective training to IMDA members and developed bespoke programmes for the Irish medtech sector, upskilling existing employees, training new entrants and providing jobseekers with useful and marketable skills. In 2015, IMDA Skillnet received a 9% increase in the state-funded element of its budget, even though the central Skillnets budget remained static. This is a testament to the success of the IMDA programmes thus far. As the contracting body for IMDA Skillnets and IMDA Springboard, we are constantly exploring new ways to augment the services we provide to our members. Pauline Flanagan and her team (which includes Michelle Reinecke-Quain and Enda Dempsey) have done a great job on our behalf. Here follows a summary of some of the initiatives that we have been involved in over the year. Responding quickly to identified skills shortages in the medtech sector Understanding the needs and skills gaps in the Medtech sector is a crucial component in the successful operation of IMDA Skillnet. In March, an extensive survey was conducted targeting chief executives and HR officers. Several key trends emerged; n 81% of companies are hiring engineers n 59% are specifically seeking quality and validation engineers n 51% are seeking design or development engineers n 46% are seeking regulatory affairs personnel Based on these results and close consultation with the industry, IMDA developed a bespoke Level 9 Design for Medical Technologies programme which launched in February A Masters in Regulatory Affairs is prioritised for development in IMDA Springboard, for a third consecutive year was awarded funding to deliver the Certificate in Quality Engineering and a Diploma in Management. This course promotes crossover from traditional engineering roles to the hi-tech, hi-precision and highly regulated working environment associated with medtech/pharma. To date more than 180 jobseekers have enrolled and 85% of these have secured employment or an internship in the industry. Convergence of technologies will require new skillsets Developing Software Quality Assurance Skills for the Medtech Sector As more and more connected health and computerised medical devices are developed, this is creating surge in demand for software engineers to ensure the information and programs installed on these products meet the sector s stringent regulatory standards. IMDA Skillnet partnered with the Lero Institute in the University of Limerick, to develop a NFQ 01 Pictured at the IMDA Springboard 2014 launch on 15 Sept 2014 were: Michelle Reinecke-Quain, Ibec; Simon Jege and Gordan Flewitt, Global Business Institute; with 28 students who were starting a 15 week conversion programme Certificate in Quality Engineering Level 8 and Diploma in Management Level 6 in the University of Limerick. 02 Pictured at the launch of the pilot Higher Certificate in Medtech Engineering (NFQ Level 6) programme at Galway-Mayo Institute of Technology (GMIT) were: Dr Paul Fahy, GMIT; Jerzy Leonczyk, Accellent; David O Connell, Covidien Tullamore; Noel Joyce, Transitions Opticals; and Padraic Broderick, Transitions Opticals IMDA Annual Review 2014

31 level eight Medical Software Quality Assurance programme. Graduates of this programme undertook the internationally recognised ISTQB exam and are capable of creating and executing test cases and tracking software issues from diagnosis to resolution and assuring the quality of developed software. Biopharma skills development Nineteen job seekers successfully completed the 2014 IMDA Skillnet Biopharma conversion programme. This was a collaboration between Skillnets Ltd, National Institute for Bioprocessing Research & Training (NIRBT), Pharmaceutical Product Development, Ireland (PPD), the Department of Social Protection and IDA Ireland. Ten students have already started three-month paid placements in Athlone and Brussels. The remainder of students will start their placement in March and April Surgeons deliver niche training to develop innovation and design skills Design Innovation for the Orthopaedic Sector The teaching facilities in Cappagh Hospital allow for direct observation of live knee and hip replacement surgery. This event, which IMDA Skillnet has been running for a number of years, showcases the impact medical devices have on the lives and health of real patients. The Q&A session afterwards with the surgeons and nurses is invaluable, as it permits direct feedback to companies about their products. Design Innovation for the Cardiovascular Sector This three-day seminar was developed two years ago by IMDA to enhance the understanding of cardiovascular anatomy, physiology and pathophysiology among medtech engineers and researchers. The course covered cutting edge technologies in a series of interactive lectures and live transmissions of heart surgery. Real-time feedback from the surgeons encouraged delegates to develop innovative solutions to previously unresolved medical issues. Focus on upskilling production operators and technicians Continuous Improvement in Manufacturing NFQ level 5 The IMDA Skillnet continues to certify operatives at level five in Continuous Improvement in Manufacturing. The course gives participants a thorough understanding of lean principles which they can apply to their daily tasks. Its flexible, blended learning format is cost effective and can be delivered at a time and pace to suit participants business needs and shift patterns. It has provided a new layer of skills and expertise at team leader and supervisor level in Lake Region Medical and has helped to embed continuous improvement into the DNA of the company and drive the company forward Paula O Brien, Lake Region Medical, New Ross. Higher Certificate in Medtech Engineering QQI Level 6 Consultation with industry leaders revealed a skills gap in the newly evolving complex manufacturing processes, IMDA Skillnet partnered with GMIT to design a bespoke medtech engineering course. Eighteen students from five member companies participated in the programme, upskilling in areas such as metrology, industrial automation, metal forming processes and electrical technologies. Phase two of the programme is planned for February 2015 and 22 people from 11 companies are already signed up. Developing the medtech leaders of tomorrow Futures Leaders Programme The Future Leaders Programme, now in its ninth year, is highly popular with executives who wish gain an insight into all aspects of the medical device industry. The course is divided into eight modules with expert consultants delivering workshops and lectures on current developments in their area. The course is fully accredited by the Institute of Leadership and Management (ILM). 7 Habits of highlyeffective people IMDA Skillnet hosted a pilot personal development class in March 2014 using the principles defined by Stephen R. Covey. This interactive workshop sought to identify our own strengths and weaknesses with the aim of maximising our potential. 03 Pictured below at the Live Knee Surgery Event in Cappagh Hospital were: Christian Walsh, Stryker Orthopaedics; Enda Dempsey, IMDA; Mike Mohally, Symmetry Medical; and Professor John O Byrne, Cappagh Hospital. 03 IMDA Annual Review

32 APPRENTICESHIPS A new type of manufacturing apprenticeship In late 2013, IMDA made a submission to the Department of Education and Skills on the review of the National Apprenticeships Model for Ireland. IMDA s submission recommended expanding the existing infrastructure to support industry-relevant apprenticeship programmes while broadening the scope of traditional apprenticeships to include medtech and other growth sectors, thus creating an identifiable national career-path model. A dual-level manufacturing apprenticeship was a fundamental component of this submission, along with the creation of a Centre of Manufacturing Excellence to support this model. The Government took a significant step in addressing the needs of the Industry with the publication of the apprenticeship model review in January Since its publication, IMDA has been in close consultation with the Department of Education and Skills through the Ibec Education & Skills Committee and IMDA s Academic Forum. Using IMDA s initial proposal, the members established the Apprenticeships Taskforce, under the able guidance of board member Barry Comerford, CEO, Cambus Medical, with input from representatives from the operational excellence and skills & knowledge working groups. The taskforce has fine-tuned a dual-level pilot apprenticeship programme, which Siemens Healthcare Diagnostics in Swords originally introduced for production operatives in October This dual learning apprenticeship, was developed in partnership with IMDA Skillnet, and has different entry points for jobseekers and experienced operatives. A one-year level five award in manufacturing operations is available and a two-year level six award in mechanical engineering. The programme was piloted with two production trainees who are now well on their way to becoming top class medical technology production operatives at Siemens Healthcare Diagnostics. Feedback from the production team leaders has been extremely positive. Towards the end of June 2014, the Department of Education and Skills put an implementation plan in place, in preparation for a call for proposals later in the year which will be submitted to SOLAS in early In preparation for this call, IMDA surveyed its membership to corroborate the strong industry need and commitment to engage with the proposed new apprenticeships model. In late 2014, Ibec and IMDA welcomed the government s establishment of the Apprenticeship Council to oversee the development of new apprenticeships across a broader range of occupations. Tony Donohoe, Ibec s Head of Education & Social Policy, has been appointed to the council. It is Ibec s view that the current apprenticeship system, which is limited to 26 occupations, does not reflect the broad skill needs of the Irish economy, and that a new model would boost skill levels and help get people into quality, sustainable jobs. Tony Donohoe stated, that the involvement of industry in both the design of curricula and in the delivery of programmes is vital, to ensure the continuing relevance of qualifications in a rapidly changing labour market. IMDA has been extremely fortunate to have an enthusiastic, dynamic and committed Apprenticeship Taskforce which has worked tirelessly to produce a robust proposal in advance of the 2015 call for proposals by the council for pilot apprenticeships. On 15 January 2015, the Apprenticeship Council invited proposals for new apprenticeships. The proposal process for new apprenticeships commenced on 16 January 2015 and will remain open for submissions until 31 March IMDA Annual Review 2014

33 INDUSTRY FORESIGHT Irish Medtech CEO Forum 2014 The eighth annual Irish Medtech CEO Forum was held in the Strand Hotel, Limerick on 11 December A stellar line-up of global medtech executives presented at the event, giving the delegates the benefit of their vast experience and their compelling insights into the future direction of the global medtech industry. The forum is jointly organised by IMDA, Enterprise Ireland and IDA Ireland and it is attended by senior medtech executives. Business journalist and broadcaster Matt Cooper was moderator for the event and he introduced Bill Doherty, IMDA Chair, Executive Vice-President, EMEA Cook Medical Ireland, who kicked off with an overview of the medtech industry in Ireland and an outline of the challenges and opportunities facing the industry. He set out the intertwining themes of this year s conference, with the central question of creating value through partnership at its core. Bill introduced his company president, Kem Hawkins as the first keynote speaker. Kem Hawkins, President Cook Group Incorporated, President Cook Incorporated, gave an inspiring presentation on the history and ethos of Cook Medical and related the story of how Cook Medical grew from the smallest of start-ups in Bill and Gayle Cook s spare bedroom to the largest privately held medical device company on Earth. He described how a chance meeting with Dr Charles Dotter at a Radiological Society meeting in Chicago changed the course of Bill Cook s life and started an enduring partnership that led to the development of minimally invasive medical techniques. Kem outlined the importance of its Irish operations to the Cook organisation and praised Ireland s focus on education and training which has enabled our preeminent role in global medtech. He Pictured at the eighth annual Irish Medtech CEO Forum were: Bill Doherty, Executive Vice-President, Cook Medical; Sinéad Keogh, IMDA Director; and Kem Hawkins, President Cook Group Incorporated, President Cook Incorporated. IMDA Annual Review

34 INDUSTRY FORESIGHT Kem Hawkins President Cook Group Inc. Susanne Durdevic Senior Director General Counsel Europe Boston Scientific Brian Thornton Partner KPMG Galway Sharon Higgins Head of Sectors Ibec singled out the positive work in promoting Ireland as a place to do business, by IDA Ireland. Susanne Durdevic, Senior Director, General Counsel Europe at Boston Scientific gave a hard-hitting presentation on ethics in the medical device industry and pulled no punches in calling for stricter standards and adherence to a rigorous code. She was clear in her view that ethics is doing the right thing, even when no one is looking and that grasping the nettle of more rigorous voluntary ethical standards now will pay dividends in the long run. She argued that change is inevitable and that the industry should take the opportunity to develop its own code and decisions around ethics. ould. She singled out sponsorship of healthcare professionals to passively attend third-party conferences as an issue which needs consideration. She has been sharing this message at every opportunity and urging industry leaders to find a consensus on this important topic for the benefit of the industry as a whole. Brian Thornton, Partner, KPMG Galway spoke about tax issues and competitiveness in Ireland. Brian set out the background to Ireland s tax regime, emphasising the stability, consistency, transparency and predictability of Ireland s tax codes since the foundation of the state. Brian explained the government s proposals for a knowledge development box which will make our taxation structure even more attractive to owners and developers of intellectual property of all descriptions. International competition is intensive for foreign direct investment and Ireland needs to compete not only with our neighbours but with the entire global community. The born global label that is often applied to medtech companies reflects how mobile international investment can be. In the post BEPS (Base Erosion Profit Sharing) environment, Brian believes that Ireland is well positioned to continue to attract high quality foreign direct investment. Sharon Higgins, Head of Sectors, Ibec gave a compelling account of the strong recovery that s underway in the Irish economy and of the strong fundamentals that underpin this recovery. Our GDP growth rate remains the fastest in Europe. Sharon set out Ibec s business priorities for the coming year and outlined its work to foster and encourage this growth and specified some of the initiatives Ibec has taken to support the medtech sector in particular. Ibec s future expectations for the Irish economy are very positive. Over the past decade, hard lessons have been learnt, hard decisions have been taken, and the hard work that was done is standing us in good stead. Our restored competitiveness has been hard won and we need to fight now to retain that competitiveness. Lake Regional Medical was recently acquired by Accellent, and in a somewhat unusual scenario, Accellent, the acquirer, was the one who changed its name to Lake Region Medical. This merger is an acutely pertinent example of partnering to create value and chimed exactly with the central theme of this year s conference. Donald Spence, Chairman and Chief Executive Officer, Lake Region Medical described the vetting process both companies went through, and how they looked at each other s corporate culture as closely as they looked at the balance sheets. He PLATINUM SPONSOR GOLD SPONSOR 34 IMDA Annual Review 2014

35 Donald Spence Chairman and CEO Lake Region Medical Liam Kelly Executive Vice President & President The Americas Teleflex Inc. Daniel O Mahony Partner Seroba Kernel Life Sciences Malcolm Bell Managing Director Technopath Manufacturing strongly advised against ever buying a company that is in-fighting internally. Together the new company is stronger than they were individually but the successful union took a great deal of foresight and planning. Personal and corporate integrity are becoming ever more important in business. Today s business environment requires closer collaboration between companies and the ability to inspire trust in other individuals is a crucial element of doing business. Word gets around very quickly when there is a breach of trust, howsoever caused. Liam Kelly, Executive Vice President and President The Americas, Teleflex Inc. started the year as Vice Chair of the IMDA board but a promotion to Teleflex s Head Office in Wayne, Pennsylvania forced him to step down from the IMDA board. Liam s new position in the US has given him a unique perspective on the American market and he analysed the US demographics, showing that the population is growing and ageing as Americans live longer. As the baby boomer generation starts to hit 65 years of age, demand for healthcare and the cost of that healthcare is set to rise sharply as health spending increases six-fold over the age of 65. Every year the US spends $315 billion treating heart disease and stroke alone out of a total healthcare spend of $3,8 trillion. Group purchasing organisations (GPOs) and Independent Delivery Networks (IDNs) can often have huge spending power and are an important vector into the US healthcare system. GPOs and IDNs can prove to be the path of least resistance for many market entrants, although they are usually very cost conscious. They will typically look at cost reduction, risk sharing, improved efficiencies and evidence based outcomes. Seroba Kernel is a venture capital firm that specialises in life sciences investments. The firm operates on a pan- European basis seeking out and investing in emerging healthcare technologies. Daniel O Mahony, Partner Seroba Kernel Life Sciences explained how Seroba Kernel s current fund, its second life sciences fund, closed in January 2009 with 75 million in capital committed to investments in Ireland, the UK and Western Europe. Five of its investments are in the medtech sector including two where the initial underlying innovation was developed in the USA. Seroba Kernel looks for products that emerge from novel concepts and address clear unmet clinical needs.. They prefer companies with well-advanced prototype products, solid plans and a clear route to market. The firm bases its funding decisions on medical need, market opportunity, product differentiation, development timelines and the strength and experience of the management team Malcolm Bell, Managing Director, Technopath Manufacturing explained that Technopath has grown to become a leading pioneer in in-vitro diagnostic controls and clinical diagnostic testing. Technopath began with three employees in Limerick s Tait Business Centre, selling and distributing clinical diagnostics and food technology sectors products before expanding into the medical and pharmaceutical sectors. Malcolm gave an excellent account of the challenges faced by smaller companies in a sector that has many large and well-resourced multinationals competing for many of the same contracts. Smaller companies must be more flexible, more innovative and more nimble in order to prosper in this environment. SILVER SPONSORS Corporate Banking IMDA Annual Review

36 RECOGNISING MEDTECH EXCELLENCE Medtech Awards bring out the best The annual medtech awards were held after the CEO Forum in Limerick on 11 December in Limerick and provided an opportunity to recognise, promote and reward best practice across the sector. Medtech Company of the Year Padhraic McGinn, General Manager, Nypro Healthcare, accepted the Medtech Company of the Year Award to great applause and said: Everyone at Nypro Healthcare Ireland is delighted to have won this award. It is very gratifying that the hard work and dedication of the entire Nypro team has been acknowledged by the prestigious judges. This has been a fantastic year for Nypro as we expanded our operations across two world class sites in Bray and Waterford, employing over 450 colleagues. Our partnership with Glide Pharma on the solid dose auto-injector has been extremely successful and we anticipate further growth in this area. We believe that our depth and breadth of technical skills and design capability ensures the continuous flow of design and development projects to final manufacture, essential to sustaining our future business 36 pipeline. Receiving this award will help the company in our quest for new markets and new revenues. Runner-up, Medtech Company of the Year William Boxwell, Site Director, Abbott Vascular, said Abbott is honoured to be recognised with this award, it is truly a crowning achievement in an outstanding year for our company in Ireland. It is a tribute to decade of hard work and commitment by one of the best teams in medical devices, working together toward a common purpose. To be the first company in Europe to achieve the Shingo Prize for Operational Excellence was a great achievement and now to be recognised by the sector in Ireland, is very humbling. Shortlist: Abbott Vascular, DePuySynthes (Ireland), Nypro Healthcare, Stryker Emerging Medtech Company Neuromod Devices won the emerging company award as it launched its new selfadministered tinnitus treatment device, mutebutton, in Ireland. Neuromod Devices was founded in 2010, and is based on-campus in UCD. Tinnitus is often described as a persistent ringing in the ears and the new mutebutton device is designed to gradually reduce chronic tinnitus symptoms by enabling the brain to distinguish between real and illusory sounds. The treatment is based on Neuromodulation, a branch of medicine that uses sensory stimulation to manipulate the brain s ability to learn and re-learn, an ability known as Neuroplasticity. The product s UK launch is expected in Q Padraig Rushe, Chief Commercial Officer, Neuromod Devices, accepted the award on behalf of his team, saying: IMDA Annual Review 2014 It is an honour to be awarded the Emerging Company of the Year, especially in Ireland where we have such a thriving medical technology sector. We appreciate the ongoing support of IMDA, Ibec and agencies like Enterprise Ireland which enable global innovation in Ireland and help to position Irish companies for global success. We are truly honoured. Shortlist: Incereb Ltd, Neuromod Devices, PMD Solutions

37 Sharon Higgins, Head of Sectors, Ibec receiving the Outstanding Contribution to the Medtech Industry Award from Bill Doherty, IMDA Chairman. 02 Nypro Healthcare, Padhraic McGinn, Plant Manager, Nypro Healthcare who won the Overall Medical Technology Company of the Year Award 2014 (2nd from right), with the award were: Tom Kelly, Head of Manufacturing and Competitiveness, Enterprise Ireland; Sinéad Keogh, Director, IMDA, the Ibec Group representing medtech; and Barry Heavey, Head of Life Sciences Division, IDA Ireland. 03 Abbott Vascular, were awarded the Silver prize for the Medical Technology Company of the Year 2014, at Medical Technology Industry Awards, jointly hosted by Enterprise Ireland, IDA Ireland and IMDA, the Ibec group representing the Medical Technology sector. Pictured receiving the award was: William Boxwell, Plant Manager, Abbott Vascular Clonmel (2nd from right), with Barry Heavey, Head of Life Sciences Division, IDA Ireland; Tom Kelly, Head of Manufacturing and Competitiveness, Enterprise Ireland; and Sinéad Keogh, IMDA. 04 Cork Institute of Technology received the Award for Contribution to Academic Innovation in Medical Technology Industry Neuromod Devices, were awarded Emerging Medical Technology Company of the Year Pictured are: Barry Heavey, Head of Life Sciences Division, IDA Ireland and Padraig Rushe, Chief Commercial Officer. Medtech Academic Award Cork Institute of Technology s Medical Engineering and Design Innovation Centre (MEDIC) won the medical technology academic award, for their pioneering work, based at CIT s Bishopstown Campus. MEDIC recently developed the Tympanostomy Tube (grommet) Device, a safer, cheaper and more convenient single-use device which places a pre-loaded grommet into a patient s eardrum in less than one second. This device was conceived, designed, prototyped, patented and tested by MEDIC. It is now manufactured in Ireland, supported by Enterprise Ireland, and brought to the market by AventaMed, a CIT spin-out company. Daithi Fallon, Head of MEDIC, accepted the award on behalf of the entire MEDIC team, saying: We are absolutely delighted to win this prestigious award and for our work to be recognised in this way. MEDIC has been on the innovation and commercialisation trail since well before it became part of the common language of the third-level sector. We have brought industry standard discipline into the research lab by building a team of highly experienced engineers and innovators and I want to thank all of my MEDIC colleagues as well as CIT and Enterprise Ireland for all their support. Shortlist: Cork Institute of Technology, Galway-Mayo Institute of Technology, Trinity College Dublin Outstanding Contribution to the Medtech Sector The Outstanding Contribution to the MedTech Sector, voted for by the IMDA Board was awarded to former IMDA Director, Sharon Higgins, Head of Sectors at Ibec. She was appointed Director of IMDA in 2000 and guided IMDA Annual Review 2014 the association over the next 13 years during an era of unprecedented growth and development. Sharon was singled out for her ability to establish relationships, and secure political support both nationally and internationally, leading to positive policy developments that shaped and propelled the sector forward. A true believer in the value of working together, Sharon was aptly recognised for her personal contribution to what was a fledgling Irish medtech sector in 2000 to its preeminent position today as one of the top five emerging global hubs. 37

38 Some IMDA events during Pictured at the BTYS Exhibition 2014 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. 02 Pictured at IMDA s Networking Members Evening in Athlone AIT were: Barry Comerford, Cambus Medical; Donal Balfe, Covidien (IMDA Vice-chair); Sinéad Keogh, IMDA; and Fergal O Brien, Ibec. 03 Pictured at Global Access were: Ger Finn, Vice President Regulatory Affairs, Medtronic; Praveen Kumar, Director Regulatory Affairs, Quality & EHS (South Asia), Medtronic; Enrico Schuur, Director Regulatory Affairs, Medtronic International. 04 Pictured at the IMDA Employee Engagement Event were: Sinéad Keogh, IMDA; James Winters, DuPuy Synthes; Diarmuid Marrinan, Deloitte Consulting; Donal Molloy, EMC; and Mary Connaughton, Ibec. 05 Áine Fox, Senior Executive, IMDA; David Kimes, Division Vice President, Global Quality Assurance, Abbott Diagnostics; and Beth Staub, Vice President, Global RA/QA, Stryker Corporation. 06 Pictured are the winning team from Nypro Healthcare Ireland who took home the Medtech Company of the Year Award at the recent Medtech Awards. 38 IMDA Annual Review 2014