annual general meeting - ibec · 2020. 1. 9. · shannon microcoil shire pharmaceutical siemens...

Annual

2018

GeneralIrish Medtech Association

Meeting

A message from Sinéad Keogh, Director, Medtech and Engineering Sectors, Ibec

Irish Medtech Association Annual General Meeting 2018

We are delighted to celebrate with you another successful year with the Irish Medtech Association. For nearly two decades, as part of Ibec, we’ve worked to promote and support a business environment which ensures the sustainable development and profitable growth of our member companies, both big and small, homegrown or international.

Our agenda is guided by the leadership from the Irish Medtech Board of Industry CEOs and Executive Leaders with strategy implementation coordinated through numerous working groups and taskforces.

This would not be possible without commitment from the association Chair sharing their insight and time generously with the group.

Now, as David Tallon’s tenure comes to an end I would like to thank him for his contribution over the past two years as Vice Chair and Chair of the Irish Medtech Association. I would also like to congratulate Conor Hanley, on assuming the role of Chair and thank him for his work this year as Vice Chair.

In 2018, the Irish Medtech Association continued to not only be a leader in Ireland representing the Irish medtech community, but also internationally as significant contributors to strategic MedTech Europe committees.

With input from our members we developed recommendations and policies that we have advocated for in meetings with Ministers, TDs, MEPS and senior civil servants as the voice of Irish medtech in Ireland and Europe.

At a national level we have called for investment in an advanced manufacturing centre of scale, made recommendations for nurturing entrepreneurship, called for the appropriate

measures to ensure that Ireland’s workforce is equipped for the jobs of the future, as well as advocated for gender leadership in STEM and manufacturing to be a priority.

Our influence continues to also be seen internationally as we identified opportunities and challenges for medtech under Brexit, set out the case for appropriate methods for medtech Health Technology Assessment, and urged authorities to advance a solution to address challenges with the transition time for the Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 to ensure that the regulatory system is ready so that a large number of medical technologies can remain on the market for patients.

As we look towards 2019, we will continue to collaborate with you, our members, and we would like to encourage you to get involved, to have your say in shaping the business supports and policy work which we develop on your behalf.

Thank you.

Sinead Keogh

A message from outgoing Board Chairman, David Tallon, Vice President of Research and Development Stryker Neuro Spine ENT and Navigation


Over the past year, I have been proud to represent the Irish Medtech Association and our members. In this capacity I have worked with the Irish Medtech Association Executive Team and Board to ensure that the work we do takes us on the right path to achieve the sector’s potential and ambition.

The 2018 Medtech Rising CEO Conference and Awards is only one of three flagship events we hosted to share industry foresight, global trends and best practice. I’m delighted to have been given the opportunity to welcome you here in Cork for Medtech Rising. Over the course of two days the event is brings together 30+ speakers over 10 sessions to explore the latest trends in medtech innovation from AI and robotics in surgery, to growing product portfolios with R&D and new business models. Then it culminates in a celebration of the sector’s success with the Irish Medtech Awards 2018.

Looking back, this summer I had the pleasure to address the “New thinking in Enterprise Excellence: Manufacturing Conference” in Galway. Ireland is already a world leader in manufacturing and boasts more than 4,000 businesses which employ more than 230,000 and accounts for nearly a quarter of Ireland’s economic output. But, this event showcased how industry can build on this success by embracing smart factories, 3D printing, data analytics and robotic surgery to deliver better patient outcomes.

More recently, I opened the “Global Access 2018” conference in Galway and at it I warned that Brexit may lead to delays in patient access without the mutual recognition of CE marks and the risk of regulatory divergence. But the immediate concern for industry is for the 32% drop in the number of designated Notified Bodies

in the EU since 2012 which has the potential to disrupt the patient care continuum if the EU does not work with industry to identify practical solutions to solve this serious problem.

Lastly, another important area of engagement and industry foresight this year is the major R&D project to make Ireland a location of choice for innovation. More needs to be done help companies increase the level of sophistication and complexity of their R&D activities here and expand their mandate to include complete product portfolios. We’ve already made strides to identify the challenges and opportunities that must be taken into consideration to ensure we’ve an effective strategy for the industry in years to come.

I wish Conor Hanley, the best for his term. This is a rewarding and important role that lets you shape the future growth of Ireland’s global medtech hub. But this would not be possible without the generosity of the medtech community who collaborate and support each other. Thank you to everyone from the medtech ecosystem their continued hard work and to my colleagues in Stryker.

David Tallon

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A message from incoming Board Chairman, Conor Hanley, CEO, FIRE1


It is a great honour and privilege to become the new Chair of the Irish Medtech Association.

I have enjoyed working with David Tallon this year and want to thank him for his dedication during his term as association Chair.

Each Chair since the association was established in 2000, as part of Ibec, has demonstrated great leadership and taken great care to ensure that we grow every year.

2019 will be no exception and I look forward to working with S3’s John O’Brien, as Vice Chair, to make sure that Ireland’s global medtech hub sees businesses grow in size and across new strategic markets.

Over the course of my career I’ve worked in some of the biggest medtech markets in the areas of chronic diseases, cardiology and connected health. But now as we look to the future, connected health will be both a major contributor to growth and reduce some of the burdens on international health systems, by promoting better care pathways and empowering patients.

With a strong base of global biopharma and ICT companies in Ireland already, we are uniquely placed to assume a leadership role in connected health. But to make our vision a reality we will need the right talent. The Irish Medtech Association and Connected Health Skillnet will continue to play a key role upskilling and reskilling professionals to meet changing industry demands.

Additionally, we must encourage more women to work in manufacturing and STEM as well as tackle barriers to leadership. Diversity and representation are business priorities which will help our companies and industry make better decisions, increase sales and outperform the competition.

I look forward to working with the association and our members in 2019 on these key areas, and much more.

Conor Hanley

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Meet the Board


David TallonStryker

Conor RussellBoston Scientific

Dr Pat DuaneTE Medical

Barry ComerfordCambus Medical

Gary HartnettDePuy Ireland

Tony NearyMedtronic

Conor HanleyFIRE 1

Garrett CoadyBlueBridge Technologies

Padhraig McGinnNypro

Bill DohertyCook Medical

Jackie MurphyAlcon

Evelyn O’TooleCLS

Ciaran CorcoranAbbott

John O’BrienS3 ConnectedHealth

Tom ClarkeWest

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Meet the team


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Dr Sinéad KeoghDirector

Pauline O’FlanaganIbec Medtech and Engineering Skills Programme Manager

Dr Áine FoxSenior Executive

Trish BreenApprenticeship Project Manager

Adrienne McDonnellSenior Executive

Shane BeirneApprenticeships Executive

Ciara FinlayExecutive

Michelle Reinecke-QuainNetwork Executive, Irish Medtech Skillnet

Jennifer McCormackNetwork Executive and Connected Health SkillnetNetwork Manager

Hazel HickeyNetwork Administrator, Irish Medtech Skillnet

In good company


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(SSE) Specialised Sterile Environments3M 4Tech Cardio AbbottAbbvie ABECAcorn RegulatoryAdvant MedicalAerogen Alcon Allergan Amcor Flexibles SligoAmneal PharmaAnecto APS Materials IncAran BiomedicalArrotek Medical Avenue Mouldmaking B Braun Hospicare Bausch + Lomb Baxter Healthcare Beckman Coulter Becton Dickinson Penel Bellurgan Precision Engineering Bemis Heathcare Packaging BlueBridge Technologies Boston Scientific Cambus TeorantaCaragh PrecisionCardinal HealthCenseo Resources Centre for Research in Medical Devices (CÚRAM)Charles River Laboratories ClearStream Technologies Complete Laboratory SolutionsCook MedicalCordis A Cardinal Health CompanyCreagh Medical Creganna Medical

DePuy SynthesDesign Partners DiaSorin DolmenDukane IAS EtQ Filtertek - An ITW Medical CompanyFinesse Medical FiunExFort Wayne Metals Foundry Innovation and Research 1Fountain Healthcare Partners Fund IIFresenius Medical Care Frontend Usability Engineering Goodman Medical Guerbet Harmac Medical Products Hollister Homecare Medical SuppliesHospiraHUYA Global i360 Medical Innovative Polymer Compounds IntegerIntegra LifeSciences Johnson & Johnson Vision CareKCI ManufacturingKeltie KPW PrintLake Region Medical LBS PartnersLife Science Consultants Lifewave EuropeM & V Medical DevicesM&M QualtechMainstay Medical MavensMeddev Solutions Medtronic

In good company


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Merck Millipore Merit Medical Metabolomic DiagnosticsMolex Multivac Natus Manufacturing Nelipak NeuraviNeuromod Devices NeuroTronik NeuVT Nordson MEDICAL Nypro HealthcareObru Plastics OPKO IrelandOptel Group EuropeOrange-Moon Outsource Technical ConceptsPerrigo UK & IrelandPhardiag PhenoxPhillips-Medisize PMD Device SolutionsProcess Automation Solutions Prodent ProTek Medical ProVerum Medical ResMed Sensor TechnologiesRRD Supply Chain SolutionsSanminaSeabrook Technology GroupSealpack Seroba Life Sciences

Shannon MicroCoilShire Pharmaceutical Siemens Healthcare Diagnostics ManufacturingSignum SurgicalSmart ElectronicsSteripack Solutions StrykerSurgaColl Technologies SyneccoSynergy Health

SysComm Project Management TcoagTechnopath ManufacturingTecometTeleflex Medical Tinderpoint Transitions Optical Trinity BiotechUtah Medical ProductsVeryan Medical VistamedVitalograph (Ireland) Vivasure Medical VWR International Waters Technologies Welch Allyn West Wright Medical GroupYoung MicrobrushZenith Adhesive ComponentsZeus Industrial Products Zimmer Zoan BioMed

Welcome to our new members in 2018Avoncourt Packaging, Erba Diagnostics, Intarcia, Lynchs Pharmacy, MKON Enterprises, Neurent Medical, PI Medical (A Prince & Izant Company), Rockfield Medical Devices, Smart Factory Solutions, SteriTrack, TCL Plastics, TechnoPath Distribution

A look back at our 2018 events

Medtech Rising 2017

Award Winners 2017


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Manufacturing Conference


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‘New Thing in Enterprise Excellence’, Galway, 7th June, 220 members in attendance.


Global Access QA/RA Conference, Galway 25th/26th October, 200 members in attendance


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Delivering for our members in 2018


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Realising the potential for Advanced Manufacturing+ The Advanced Manufacturing Working Group

devised a Benchmarking Visit to learn about an Industry-Hospital Innovation Partnership in Additive Manufacturing, with Wales University Hospital and Renishaw’s Miskin Additive Manufacturing Plant, 17 April.

Keeping Operational Excellence at the core+ The Irish Medtech Skillnet Lean Leadership

Programme is now running for its seventh consecutive year, and will commence again in September 2019. This eight day programme equips participants with the skills they need to Drive Operational Excellence Through Lean Leadership. The programme use the MÓRTM Benchmark Model as a central learning tool, to introduce key concepts on Lean thinking and driving overall vision for an organisation of any sector and size.

+ Continuing Mater Lean Academy & Irish Medtech Association’s collaboration, as cited in 2017’s Future of Healthcare Sláintecare Report, our members have buddied up with UCD’s Masters in Healthcare Systems Programme by mentoring students on hospital lean projects. This is aligned to Irish Medtech’s 2016 – 2020 Strategy. The mentoring initiative allows member organisations an opportunity to have a lean expert impart some of their valuable industry experience and gain a unique insight into the problems faced in the hospital setting.

Business growth by focusing on commercial+ The Commercial Working Group have

been working on developing a commercial excellence model, with €50,000 Skillnet funding provided to develop the new Commercial Model. This commercialisation framework will support and guide start-up’s, SME’s and Multinational organisations transition through growth stages of their businesses to increase commercialisation activity out of Ireland.

The new Code of Ethical Business Practice comes into full force+ The Irish Medtech Association was represented

at MedTech Europe’s Global Medtech Compliance Conference in Paris in May 2018. The IMA are ahead of most European Trade Associations in that, we have already ratified and rolled-out the new Code of Ethical Business Practice. Member companies are obliged to adhere to the Code.



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Supporting best practice in sterility assurance+ In 2018, 109 sterilisation, quality and regulatory

professionals engaged with the Sterility Assurance Forum. Members came together to share knowledge, ideas and best practice while expert speakers gave insights on changes to the sterilisation standards/regulatory landscape, new and novel sterilisation techniques and various challenges facing the industry.

Keeping Regulatory and Quality Assurance at the heart of medtech+ Irish Medtech Association/ HPRA Quarterly

Liaison Meetings continued during 2018. Irish Medtech Regulatory Steering Committee members met with HPRA’s Head of Medical Device Unit and Head of Compliance and senior colleagues to discuss issues of importance for the sector including MDR/ IVDR implementations and HPRA developments. 120 members attended a QA/RA Forum on July 5th in Limerick.

A firm focus on the MDR and IVDR through topic specific Task Forces + With a key focus during 2018 on helping

members transition to the new Medical Devices (MDR) and IVD Regulations, the Irish Medtech Association convened 7 task forces comprised of industry RA experts to develop a comprehensive set of new resources to help members navigate the complex IVDR/MDR legislative provisions. The resource document was presented to 120 industry professionals at a QA/RA forum in July. The task forces held a combined 20+ meetings during 2018 with over 50 members involved spanning 20 member companies.

Environmental Health and Safety Forum+ This forum brought together health & safety

professionals to discuss EHS specific issues while sharing industry knowledge and best practice. Areas of focus included behaviour-based safety, manufacturing ergonomics, best practice in management of EHS. The Forum query facility, which consists of 170+ EHS professionals, is a valuable resource for members.

Growing the mandate for R&D+ Growing the mandate for more sophisticated

R&D led out of Ireland has been a key focus during 2018. The Irish Medtech Board have contracted Technopolis consultancy firm to support the development of a roadmap to help companies grow R&D capability in Ireland. The project commenced in August and will be completed over the next 6 months.

Leadership Development Taskforce

+ Ibec’s Medtech and Engineering Leadership Development Taskforce held a special event on ‘The business case for women in leadership: Attracting, retaining and developing talent’ in the Medtronic Customer Innovation Centre Center Galway, with industry leaders Medtronic and Boston Scientific will share their experiences and successful policies in addressing this gender imbalance. Key priorities for the group during 2018 key priorities included development of programmes for senior/middle managers to increase women in leadership; get commitment at CEO level to make gender leadership an industry priority; benchmark diversity in leadership in medtech; and identify best practices for those working manufacturing sectors.



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The Irish Medtech Association Board has met with a number of Government officials, TD’s, MEP’s, Ambassadors and other key stakeholders during 2018 to present its business priorities, calling for;

1. €42 million to establish of an advance discrete manufacturing centre of scale;

2. Build medical device sterilisation (ethylene oxide (EtO)) capacity to protect future medtech investment, which is now being impacted;

3. Ensure patient access to medical technologies post Brexit through mutual recognition of Notified Body CE Certificates issued by UK and the EU and vice versa;

4. Work proactively with authorities (Commission, Competent Authorities to advance a solution to address challenges with the transition time for the Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 to ensure the regulatory system is ready so that a large number of medical technologies can remain on the market for patients;

5. Introduce an incentive scheme for companies to engage with the new 2016 apprenticeship programmes, as model is too costly for employers;

6. Ensure clear separation of regulations between the existing Medical Devices and IVD Regulations from the proposed EU Commission Health Technology Assessment Regulation and introduce appropriate rules and methodologies, which use reliable evidence to demonstrate the full value of technology;

7. Introduce positive policies and financial incentives to nurture entrepreneurship; and

8. Make gender leadership a priority and ensure Government achieves objectives set-out in ‘National Strategy for Women and Girls 2017-2020’ ‘Better Balance for Better Business’.

2018 meetings on policy issues with;

+ Heather Humphreys TD, Minister for Business, Enterprise and Innovation

+ Mairead McGuinness, MEP


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+ Jim O’Callaghan TD, Fianna Fáil spokesperson on Justice

+ David Cullinane TD, Sinn Féin spokesperson on Foreign Affairs and Trade with special responsibility for Brexit

+ Dr Orlaigh Quinn, Secretary General, Department of Business, Enterprise and Innovation

+ Robin Barnett CMG, British Ambassador to Ireland

+ Oireachtas Joint Committee on Joint Committee on Business, Enterprise and Innovation

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Irish Medtech Association hosted three Medtech Brews in conjunction with BioInnovate, in March, May and October, with over 350 attendees

The top policy issues identified by the sector and promoted by the IMA Board

To keep a finger on the pulse of policy developments at international level, Irish Medtech Association executives attended the following MedTech Europe meetings in Brussels during 2018;

+ Compliance network

+ MD and IVD Regulatory Affairs Committees

+ National Association Network

+ Health Technology Assessment Committee

+ Brexit Task Force

Irish Medtech Association executives attended the AdvaMed Medtech Conference on 24/25/26th September in Philadelphia.

During 2018 Irish Medtech Association has co-signed a manifesto prepared by Industry4Europe, which comprises 131 European Industry Trade Associations to have a joint voice with regard to EU elections of the European Parliament and the European Commission next year. The coalition has created a 1-page ‘Manifesto’ which calls for a strong EU industrial /manufacturing strategy and a strong representation of industry in the next Commission.


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Talent development and skills continues to be key priority for the Irish Medtech Association and as such we have dedicated significant resources to ensure we are maximising opportunities to win funding across the various funding agencies on your behalf. These include Skillnet Ireland, SOLAS and the HEA.

Key stats

Irish Medtech SkillnetBy the end of 2018, and with a budget of €1.3 million, the Irish Medtech Skillnet will have trained over 1,500 employed trainees and delivered over 8,000 training days for 150 companies. 25% increase in budget for 2019.

Connected Health Skillnet By the end of 2018, the Connected Health Skillnet will have trained over 270 employed trainees and delivered over 1,700 training days for 104 companies. 100% increase in budget for 2019.

Appren- ticeships At the end of 2018, 170 apprentices were signed up from 60 companies, of which 45% are small and medium enterprises. The sector breakdown is 50% medtech, 4% pharma and 46% engineering.

Talent development and skills at the forefront in 2018


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What’s ahead?

JanuaryR&D mandate workshop

DecemberMedtech Rising, GalwayLean Leadership Programme – Day 5/6

MayManufacturing Apprenticeship

Polymer Apprenticeship

OctoberLean Leadership Programme – Day 2/3

Springboard Cert. in Quality Engineering NFQ Level 8 & Dipl. in Professional Competence NFQ Level 6

Connected Health ForumQA/RA Forum

FebruaryIbec Business Leader’s Conference

Springboard Cert. in Quality Engineering Level 8, & Dipl. in Professional Competence, NFQ Level 6

July

MarchAdditive programme

Fundamentals in Regulatory Affairs for Medical Technologies Brexit Event

AugustSpringboard B.Sc. in Quality & Regulatory Affairs NFQ Level 8

NovemberLean Leadership Programme – Day 4

SeptemberLean Leadership Programme – Day 1Ibec President’s Dinner Manufacturing Apprenticeship Polymer ApprenticeshipMasters in Medical Technology Regulatory AffairsMedical Technology Future Leadership Programme Medical Software Quality Assurance (NFQ Level 8 15 ECTs)

AprilIbec Employment Law Conference Validation Principles and Practices for the Medical Technology Industry Connected Health ForumQA/RA Forum

JuneManufacturing Conference

We look forward to seeing you again at an Irish Medtech Association event

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Ibec Head Office

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Irish Medtech Association

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W: www.irishmedtechassoc.ie

@IrishMedtech

annual general meeting - ibec · 2020. 1. 9. · shannon microcoil shire pharmaceutical siemens...

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