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Doing Business in Ireland. Sharon Higgins Director IMDA The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress Harvard University 29 March 2007. Why do business in Ireland? Because Ireland has and continues to ‘do the business’ for companies operating here

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Doing business in ireland

Doing Business in Ireland

Sharon Higgins

Director IMDA

The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress

Harvard University

29 March 2007



  • Why do business in Ireland? Congress – 29 March 2007

    • Because Ireland has and continues to ‘do the business’ for companies operating here

  • Don’t take my word for it……

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Trajectory of Ireland’s Economy Congress – 29 March 2007

1988

1997

2004

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


1 000 overseas companies have chosen to invest in ireland as their european base
1,000 overseas companies have chosen to invest in Ireland as their European base

ICT

Pharmaceuticals

Medical Devices

Financial &

International

Services

E-business

Engineering

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Ireland the knowledge economy
Ireland - The knowledge Economy their European base

  • Free and pro business economy especially for foreign business

    • 3rd of 157 (2006 index of economic freedom)

  • A quality education system

    • – 4th of 60 IMD World competitive framework

    • 5th for level of university education attained

  • A dynamic information infrastructure

    • Lowest leased line costs in the OECD

  • Innovation systems

    • Science Technology and Innovation Strategy

    • Science Foundation Ireland

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


‘Ahead of the Curve’ their European base

- Enterprise Strategy Group

Comparative

Advantage

Competitiveness

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007



Medical Technology Companies in Ireland their European base

Abbott Vascular Devices

Accellent

Aerogen (Nektar)

Beckman-Coulter

Bioniche Lifesciences Inc

Boston Scientific

Brivant*

Caragh Meditech*

Contech Medical

Creganna*

Labcoat

Goodman

Medtronic

Merit Medical

Micron Clean*

Nelipak

Tyco (Puritan Bennett)

Ulbrich

Xenith Biomed

Zerusa*

Letterkenny

Perfecseal

Institute of Technology

Boston Scientific (IVT) Medisize (DHC)

Zeus Industrial Products

Northern Ireland

Abbott Diabetes

Moll Industries Ireland

Sligo Institute of Technology

National Tool-making Centre

Abbott - 3 plants

Amcor Flexible

Andrew Medical

Hospira

Lotus Automation*

Pro-Tek Medical*

Sligo

B Braun Hospicare

Charles River

Hollister

Biomedical Diagnostics Institute

Dundalk

Abbott

Cavan

Institute of Technology

Baxter Healthcare - 2 plants

Fort Wayne Metals

The Conway Institute

of Biomolecular and

Biomedical Research

BBE Healthcare

Endura Coatings

ANSAmed*

Innocoll Technologies

Allergan - 2 plants

AMO

Isotron (Gammaster)

Field Boxmore

National Pharmaceutical Biotechnology Centre

Vistamed*

Harmac

Abbott

B Braun

Becton Dickinson

Athlone Optical

Conor Medsystems

Elan

Tyco Mallinckrodt

Utah Medical

Innocoll

Transitions Optical

De Royal

Welch- Allyn

DublinUniversities

Dublin City University

Trinity College

University College

Oakley

National Centre for Biomedical Engineering Science

National Centre for Laser Applications

Athlone

Galway

USCI

Regenerative Medicine Institute (REMEDI)

Georgia Tech Irl.

Institute of Technology

Institute of

Technology

Dublin

DublinInstitutes of

Technology

Blanchardstown

Dublin

Tallaght

National University of Ireland

Steripack*

Institute of Technology

Boston Scientific

Isotron

Midland Bandages*

Tyco Healthcare

Viasys (Intermed))

Cook Ireland

Essilor

J&J Vistakon

Ophtecs

Stryker Howmedica

Teleflex Medical

Rupp & Hubrach

Olympus

Essidev

Vitalograph

Enfer Scientific

Phardiag*

AMO

Bayer Diagnostics

Becton Dickinson

Biotrin Technologies

J&J Consumer

KCI Medical

Nova Science

Nypro Ireland

Omega Teknika

Smith & Nephew

Specialty Coating

Tech Group

Trinity Biotech

Tyco

Biomedical & Environmental Sensor Technology Centre

Oral B

Allergan(Inamed)

Institute of Technology

Biomedical Electronics Centre

Limerick

University of Limerick

Institute of Technology

J & J Cordis

Clearstream*

Abbott Vascular

Boston Scientific

Lake Region

Filtertek

Listal

Carl Zeiss

Waters Corp.

Bausch & Lomb

Institute of Technology

Institute of Technology

Waterford

Piercan

Institute of Technology

Microbrush

Legend :

University College Cork

University, Institute of Technology

Cork

National Microelectronics (Nanotechnology) Research Centre

Speciality / Research Centre

Airports

Alcon J&J DePuy

GE Healthcare Millipore

Audit Diagnostics* Stryker Instruments

Boston ScientificStryker Orthopaedics

Donovan Medical

(Tornier)

IDA Regional Offices

Medical Device Companies

* Indigenous Irish Companies

Equipment & Diagnostics

Hospital Products

Orthopaedic & Implants

Vascular Intervention

Opthalmic / Vision

Allergan (Inamed)

Bio-medical Research

BBE Healthcare

Donovan Medical

J&J DePuy

Stryker Howmedica

Stryker Instruments

Stryker Orthopaedics

Viasys (Intermed)

Abbott

Aerogen

Bayer Diagnostics

Beckman Coulter

Biotrin Technologies

Tyco (Puritan Bennett)

Vitalograph

Welch Allyn

Abbott

Baxter Healthcare

B Braun

Becton Dickinson

De Royal

Hollister

Oral B

Tyco (Sherwood & Mallinckrodt)

Utah Medical

Alcon

Athlone Optical

Bausch & Lomb

Carl Zeiss

Essilor

J&J Vistakon

Oakley

Ophtechs

Rupp & Hubrach

Transitions Optical

Abbott Vascular

Boston Scientific

Brivant

Clearstream

Conormedsystems

Labcoat

Medtronic

Nova Science

USCI

Solution Providers

Pack, Print & Sterilisation

Filtration

Interventional Wire & Tubing

Shared Services

Amcor Flexibles

Field Boxmore

Isotron (Gammaster)

Nelipak

Steripack*

Filtertek

Listal

Millipore

Accellent

ANSAmed*

Contech Medical

Endura Coatings

Harmac

Goodman

Medisize Donegal Healthcare

Pro-Tek Medical*

Vistamed*

Allergan

AMO

Bayer Diagnostics

Baxter Financial Services

Cook Ireland

De Royal

J&J DePuy

Tyco

Welch Allyn

Accellent

Creganna

Fort Wayne Metals

Lake Region

Merit Medical

Teleflex Medical

Ulbrich

Zeus Industrial Products

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Irish medical devices and diagnostics sector employment continues to rise steadily
Irish Medical Devices and Diagnostics Sector their European baseEmployment continues to rise steadily

Source - forfas

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Companies ranked by medical device revenues 2005 us million
Companies Ranked by Medical Device Revenues 2005 (US$, Million)

1 Johnson & Johnson

2 General Electric

  • Medtronic

  • Baxter International

    5 Siemens

    6 Fresenius

    7 Philips

    8 Tyco International

    9 Boston Scientific

  • Stryker

  • B Braun

  • Guidant

  • Zimmer

  • Becton Dickinson

    11 of worlds top 14 in Ireland (7 with multiple locations)

    Red – manufacturing/ R&D MD based in Ireland

    Blue – not manufacturing MD in Ireland

    Pink – since taken over by Abbott/ Boston Scientific

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Irish export markets
Irish Export Markets Million)

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Key success driver global access
Key Success Driver – Global Access Million)

  • Facilitated by..

    • Centers that promote Innovation

    • Convergent Technologies

    • Focus on high value-added activity

    • Competence & Skills to suit future needs

    • A competitive and proactive regulatory environment

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007



Skills & Education Million)

Support for

Business

Innovation

Supportive Regulation

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Regulatory infrastructure challenges

Regulatory Infrastructure Million)& Challenges

European Framework

Global Market



Medical device legislation eu
Medical Device Legislation - EU Congress – 29 March 2007

pacemakers;

implantable infusion pumps;

Inmplantable cardiac defibrillators + related software and accessories

Directive 90/385/EEC

Active Implantable

Medical Devices

S.I. No. 253 of 1994

US, X-ray, heart valves

hip-implants, ECG, EEG,

intravascular catheters, stents, syringes, wheelchairs,

dental materials ...

Directive 93/42/EEC

General Medical Devices

S.I. No. 252 of 1994

Lab analysers, reagents , HIV/hepatitis tests, pregnancy tests,

assays, calibrators, control materials

specimen receptacles ...

Directive 98/79/EC

In-vitro Diagnostic

Medical Devices

S.I. No. 304 of 2001

Medizinprodukte - RichtlinienMedical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Ireland s ca and nb
Ireland’s CA and NB Congress – 29 March 2007

  • Competent Authority

    • The Irish Medicines Board

  • Notified Body

    • The NSAI

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Role of the imb
Role of the IMB Congress – 29 March 2007

  • To authorise the manufacture, preparation, importation, distribution and sale of human and veterinary medicinal products

  • To regulate the post marketing surveillance of medical devices, grant approval for clinical investigations, manage a register of low risk medical devices, monitor Notified Bodies for conformity assessment in Ireland, etc

  • To provide information on medicinal products and medical devices to healthcare professionals

  • To advise the Minister for Health and Children and the Minister for Agriculture and Food, as required

  • To enforce the Regulations made pursuant to the Act

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Imb relationship with industry
IMB - relationship with industry Congress – 29 March 2007

  • Firm but fair

  • IMB/ IMDA Liaison Group

    • Quarterly meetings

    • Two way discussion forum

    • User Fees

    • Guidelines

  • Online registration

  • Vigilance

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


NSAI Congress – 29 March 2007

3,000+ Registered / Certified Firms – Medical ++

Carry out in excess of

6,000

assessments per year

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Regulatory challenges for irish industry
Regulatory Challenges for Irish Industry Congress – 29 March 2007

  • Reach

  • MDD Review

  • E-labelling

  • Risk Management

  • FDA Small business Fees

  • IMB - 2007

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Reach
Reach Congress – 29 March 2007

  • Single system for the registration, evaluation and authorisation of all chemical substances manufactured, imported or used in products or processes in the EU.

  • Companies that manufacture, import or use such substances in excess of one tonne per annum, will be required to register the substance with a central competent authority.

  • A company, if unprepared, could discover that crucial raw materials are no longer available or that the use of the raw material is simply no longer permitted.

  • Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 and Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC were published in the Official Journal on 30 December 2006.

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Reach timelines
Reach - timelines Congress – 29 March 2007

  • 1 June 2007 – REACH enters into force

  • 1 June 2008 – European Chemicals Agency (ECA) in operation and main titles of REACH apply

  • 1 June 2008 – “New” substance registration

  • 1 June 2008 – November 2008 – Pre-registration for phase-in of existing substances

  • November 2010 – 1st phase-in substance deadline*

  • June 2013 – 2nd phase-in substance deadline*

  • June 2018 – 3rd phase-in substance deadline*

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Medical devices directive review
Medical Devices Directive Review Congress – 29 March 2007

  • Changes proposed to

    • Definition – medical purpose

    • Conformity assessment

    • Clinical evaluation requirements

    • Post market surveillance

    • Transparency

    • Co-operation

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Timelines mdd
Timelines MDD Congress – 29 March 2007

  • European Parliament due to vote in plenary on 29 March or during April session (depending on progress)

  • Issues to be overcome:

    • reuse and reprocessing of single-use devices

    • proposed for a ban on hazardous substances in devices

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Bear in mind that
Bear in mind that ….. Congress – 29 March 2007

Markos Kyprianou, European Commissioner for Health and Consumer Protection, at a meeting at the European Parliament on February 27

  • Modernisation of the EU's legislation for medical devices (envisaged for discussion 2008)

  • Reviewing the legal framework on pharmaceuticals

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


E labelling
E-Labelling Congress – 29 March 2007

  • New paragraph proposed in article 11 of Directive 93/42/EEC stating “the Commission may in accordance with the procedures referred to in article 7(2) adopt measures allowing instructions for use to be provided by other means”

  • Not prohibited in IVD legislation

  • Working group in Europe focusing on guidance for IVDs

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


E labelling cont d
E-Labelling, cont’d Congress – 29 March 2007

  • Subgroup has prepared a draft MED.DEV for consideration (drafting group led by Ireland)

  • IMB support moving in this direction under defined circumstances and only for devices for professional use and not at point of care

  • Pilot in Ireland under discussion

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Risk management
Risk Management Congress – 29 March 2007

  • ISO 14971 is being reviewed

  • Expected to be published by April ’07.

  • Currently there are about 190 proposed amendments.

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Fda small business fees
FDA - Small business Fees Congress – 29 March 2007

  • MDUFMA pre-market approval (PMA) application fees for US firms with annual gross sales of US$ 30 million or less do not pay a fee for their first PMA filing

  • Those with gross sales of US$ 100 million or less can receive a reduction of 38% (US$ 98 648).

  • Non-US companies are unable to apply because the current system requires that they submit Federal tax returns to show eligibility

  • Raised with EU Commission – discussions ongoing to address

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Irish medicines board
Irish Medicines Board Congress – 29 March 2007

  • Resources

  • Combination products

  • User Fees

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Irish medical devices association

Irish Medical Devices Association Congress – 29 March 2007


Imda vision
IMDA Vision Congress – 29 March 2007

Ireland; the location of choice for research and development, manufacture and marketing of innovative products in the Medical Device and Diagnostic Sector.

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Imda working structure

R&D Congress – 29 March 2007

HRD

IMDA

Board

Marketing

QA/ RA

SCM

IMDA working structure

81 member companies

IBEC and IMDA Executive Group

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Quality regulatory affairs
Quality/ Regulatory Affairs Congress – 29 March 2007

  • Regulatory Steering Committee

  • Quality Working Group

  • Quality Mailing List

Eucomed

EDMA

Advamed

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


IMDA Congress – 29 March 2007

  • Influence Legislation

  • Training and education

  • Information

  • Network

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Collaboration key to future vision 2020 and mtc convened
Collaboration – key to future Congress – 29 March 2007Vision 2020 and MTC convened

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Reach support available
Reach – Support available Congress – 29 March 2007

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Mdd related legislation
MDD related Legislation Congress – 29 March 2007

  • IMDA RSC

  • Eucomed

  • EDMA

  • Department of Health and Children

  • Irish Medicines Board

  • National Standards Authority of Ireland

  • European Commission

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Clinical trials activity
Clinical Trials activity….. Congress – 29 March 2007

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Training and education
Training and Education Congress – 29 March 2007

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Imagine careers in medical technology
Imagine! Careers in Medical Technology Congress – 29 March 2007

  • 19 Scientists & Engineers describe working in the Med Tech sector. They describe their:

    • Responsibilities

    • Educational Background

    • Products/Services their company makes

    • Tips for success to future graduates

  • Postgraduates in Med Tech (30)

  • Useful CAO/Postgraduate Websites listed

  • Company Lists for School Tours & Graduate placement programs

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


Feel free to contact me at
Feel free to contact me at: Congress – 29 March 2007

Sharon Higgins

Director IMDA

84-86 Lower Baggot Street

Dublin 2

Ireland

++353 1 6051564

++353 87 2313437

[email protected]

www.imda.ie

Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007


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