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IMSTA’S 2015 ANNUAL CONFERENCE
making it happen enabling change in healthcare
Prof. Deirdre McNamara
Developing Medical Devices in a Healthcare Environment
25/03/2015
Trinity College Dublin, The University of Dublin
IMSTA’S 2015 ANNUAL CONFERENCE
 “A new funding model, Implementing clinical
pathways, Integrating system wide care. Can
the MedTech Industry help make this happen?
“
 Funding
Cost reduction / Cost effectiveness
 Clinical Pathways
Optimal patient care / outcomes / development &
translation
System integration
Technology / eMedicine /
Developing Medical Devices in a Healthcare Environment
 Industry enables health care system performance,
access, quality and sustainability
 Collaboration and a partnership approach to
efficient healthcare solutions can make it happen
 Here to help healthcare providers with the most
clinically and cost effective diagnostic and
therapeutic solutions. “Two way street”
Trinity College Dublin, The University of Dublin
Medicine and the Patient
Intuitive Medicine
•Highly trained
expensive
professional
•Intuitive
Experimentation
•Pattern
Recognition
Empirical Medicine
•Evidence Based
•Data shows one
way better than
the other
Precision Medicine
•Diagnosed
precisely
•Predict
treatment effect
Traditional Medicine Technological Enabler
IMSTA’S 2015 ANNUAL CONFERENCE
Trinity College Dublin, The University of Dublin
IMSTA’S 2015 ANNUAL CONFERENCE
The Focus In Medical Research
Heart Disease Cancer Immunology Neurosciences Molecular Medicine Genomics
Bench
Bedside Precision Medicine at the Point of Care
Medical
Technology
Understanding
Functional
Aspects to
Disease
Trinity College Dublin, The University of Dublin
Research and Development
Research & Development
SME
Successful Indigenous - Contract Manufacture & Design
Multinationals - Manufacture
FDI
IMSTA’S 2015 ANNUAL CONFERENCE
Trinity College Dublin, The University of Dublin
200
Companies
25,000
Jobs
€7.2 billion
Exports
Building Ireland’s Smart Economy
A Framework for Sustainable Economic Renewal
Trading and Investing in a Smart Economy
A Strategy and Action Plan for Irish Trade, Tourism and Investment
Commercial Success In Medical Technology In Ireland
2010
IMSTA’S 2015 ANNUAL CONFERENCE
Trinity College Dublin, The University of Dublin
Product Life Cycle
Clinical
&
Scientific Testing
Concept
Prototype
Preclinical
Clinical
Manufacturing
Marketing
Commercial
Use
Obsolescence
Involving
Clinicians
&
Other
Healthcare
Professionals
IMSTA’S 2015 ANNUAL CONFERENCE
Trinity College Dublin, The University of Dublin
Industry, Academia & Healthcare
Patient Driven
Innovation
Centres Where
Healthcare is
Delivered
Biotechnology
Sector
Universities and
College
Commercial
Entities
Hospitals
Patients Homes
Health Care
Centres
IMSTA’S 2015 ANNUAL CONFERENCE
Trinity College Dublin, The University of Dublin
Patient Driven Innovation in Gastroenterology
Clinicians
Bioengineers
Physicists
Other
Professionals
Gastroenterology
&
Endoscopy
•Identify needs
•Design
•Translating innovations
•High quality research programs
•Research hub for innovations from
outside group
•Opportunities to develop, adapt and
apply devices in a quality research
environment
IMSTA’S 2015 ANNUAL CONFERENCE
Trinity College Dublin, The University of Dublin
www.medicine.tcd.ie/tagg/
We are a multidisciplinary research and clinical team
comprising Gastroenterologists, Surgeons, Medical
Physicists, Nutritionists, Nurses, Engineers, Scientists
and Allied Health Professionals working
collaboratively at the Adelaide & Meath Hospital
incorporating the National Children’s Hospital
(AMNCH) and St James’s Hospital Dublin with Trinity
College Dublin.
The TAGG Research Centre is affiliated with Trinity
Health Ireland (THI).
Our vision is of excellence and innovation in service
delivery and research in gastroenterology.
Trinity College Dublin, The University of Dublin
– TAGG principal investigators (PIs) collaborate with
national and international colleagues across Europe,
North America, Canada and Ireland as well as with small
and medium sized enterprises (SMEs) and Industry
partners.
– Local Collaborations
• Life Sciences Interface, Tyndall National Institute – Dr.
Karen Twomey
• National Cancer Registry Ireland – Dr. Linda Sharp & Nick
Clarke
• BioInnovate Ireland – Dr. Mark Bruzzi
• EndoVe – Mitamed, Dr. Kevin Soden
• Endodex Ltd – Ms Katrina Bradley
• Vasorum Ltd – Dr. Jim Coleman
IMSTA’S 2015 ANNUAL CONFERENCE
TAGG Medical Device & Innovation Hub
Trinity College Dublin, The University of Dublin
Product Life Cycle
Concept
Prototype
Preclinical
Clinical
Manufacturing
Marketing
Commercial
Use
Obsolescence
Involving
Clinicians
&
Other
Healthcare
Professionals
IMSTA’S 2015 ANNUAL CONFERENCE
Trinity College Dublin, The University of Dublin
EndoFlip Discovery
IMSTA’S 2015 ANNUAL CONFERENCE
Trinity College Dublin, The University of Dublin
IMSTA’S 2015 ANNUAL CONFERENCE
New Applications: FLIP in UOS
Trinity College Dublin, The University of Dublin
IMSTA’S 2015 ANNUAL CONFERENCE
New Applications: FLIP in the Lower GI Tract
Trinity College Dublin, The University of Dublin
IMSTA’S 2015 ANNUAL CONFERENCE
New Applications: FLIP in the Lower GI Tract
Probe No. MODEL Catheter
Diameter
No. of CSA
Measurements
Maximum Bag
Diameter
CSA Measurement
Length
No. of
Patients
Studies
Bag Pressure
Probe 1 EMF-325N
(modified)
2.5mm 16 25mm 75mm 4 Yes
Probe 2 Custom ICV
Probe
2.29mm 12 19mm 55mm 2 Yes
Trinity College Dublin, The University of Dublin
IMSTA’S 2015 ANNUAL CONFERENCE
Medical Device Innovation
The shape we're in: 10
facts about Irish
obesity
“As a nation, we're
getting fatter to the
point of a crisis. It's
especially prevalent
among older people,
according to a new
report”
Trinity College Dublin, The University of Dublin
Obesity Endoscopic Management System
IMSTA’S 2015 ANNUAL CONFERENCE
Trinity College Dublin, The University of Dublin
Product Life Cycle
Clinical
&
Scientific Testing
Concept
Prototype
Preclinical
Clinical
Manufacturing
Marketing
Commercial
Use
Obsolescence
IMSTA’S 2015 ANNUAL CONFERENCE
Trinity College Dublin, The University of Dublin
HSE figures show lengthening hospital waiting lists
Leo Varadkar admits figures will get worse but promises hospital activity will be ramped up ‘subject to
finance being available’
HSE figures show delayed discharges, at 835, were a major problem back in November; the persistence
of high numbers of delayed discharges after Christmas was a major contributory factor behind the trolley
crisis
Health Care Innovation
IMSTA’S 2015 ANNUAL CONFERENCE
Trinity College Dublin, The University of Dublin
IMSTA’S 2015 ANNUAL CONFERENCE
Health Care Innovation
Trinity College Dublin, The University of Dublin
• Developing medical devices in a healthcare
environment is feasible and beneficial
• Involvement of teaching hospitals in trials of
devices and drugs is paramount to market
success
• Performing device trials in hospitals is not
straight forward and needs technical input
from engineers and scientists as well as
clinicians and other healthcare professionals
• TAGG model offers great opportunity as a
gateway to deliver better products for more
effective and economic patient care
• Industry and executive buy in “show me the
money”
Conclusions
IMSTA’S 2015 ANNUAL CONFERENCE
Trinity College Dublin, The University of Dublin
IMSTA’S 2015 ANNUAL CONFERENCE
Medical Device & Innovation Team Leaders
Barry McMahon
Stephen Bligh
Contact Details:
www.medicine.tcd.ie/tagg/
sbligh@tcd.ie
Conclusions
Thank You

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Prof. Deirdre Mc Namara, Assoc. Professor Gastroenterology & Director TAGG Research Centre, TCD

  • 1. IMSTA’S 2015 ANNUAL CONFERENCE making it happen enabling change in healthcare Prof. Deirdre McNamara Developing Medical Devices in a Healthcare Environment 25/03/2015
  • 2. Trinity College Dublin, The University of Dublin IMSTA’S 2015 ANNUAL CONFERENCE  “A new funding model, Implementing clinical pathways, Integrating system wide care. Can the MedTech Industry help make this happen? “  Funding Cost reduction / Cost effectiveness  Clinical Pathways Optimal patient care / outcomes / development & translation System integration Technology / eMedicine / Developing Medical Devices in a Healthcare Environment  Industry enables health care system performance, access, quality and sustainability  Collaboration and a partnership approach to efficient healthcare solutions can make it happen  Here to help healthcare providers with the most clinically and cost effective diagnostic and therapeutic solutions. “Two way street”
  • 3. Trinity College Dublin, The University of Dublin Medicine and the Patient Intuitive Medicine •Highly trained expensive professional •Intuitive Experimentation •Pattern Recognition Empirical Medicine •Evidence Based •Data shows one way better than the other Precision Medicine •Diagnosed precisely •Predict treatment effect Traditional Medicine Technological Enabler IMSTA’S 2015 ANNUAL CONFERENCE
  • 4. Trinity College Dublin, The University of Dublin IMSTA’S 2015 ANNUAL CONFERENCE The Focus In Medical Research Heart Disease Cancer Immunology Neurosciences Molecular Medicine Genomics Bench Bedside Precision Medicine at the Point of Care Medical Technology Understanding Functional Aspects to Disease
  • 5. Trinity College Dublin, The University of Dublin Research and Development Research & Development SME Successful Indigenous - Contract Manufacture & Design Multinationals - Manufacture FDI IMSTA’S 2015 ANNUAL CONFERENCE
  • 6. Trinity College Dublin, The University of Dublin 200 Companies 25,000 Jobs €7.2 billion Exports Building Ireland’s Smart Economy A Framework for Sustainable Economic Renewal Trading and Investing in a Smart Economy A Strategy and Action Plan for Irish Trade, Tourism and Investment Commercial Success In Medical Technology In Ireland 2010 IMSTA’S 2015 ANNUAL CONFERENCE
  • 7. Trinity College Dublin, The University of Dublin Product Life Cycle Clinical & Scientific Testing Concept Prototype Preclinical Clinical Manufacturing Marketing Commercial Use Obsolescence Involving Clinicians & Other Healthcare Professionals IMSTA’S 2015 ANNUAL CONFERENCE
  • 8. Trinity College Dublin, The University of Dublin Industry, Academia & Healthcare Patient Driven Innovation Centres Where Healthcare is Delivered Biotechnology Sector Universities and College Commercial Entities Hospitals Patients Homes Health Care Centres IMSTA’S 2015 ANNUAL CONFERENCE
  • 9. Trinity College Dublin, The University of Dublin Patient Driven Innovation in Gastroenterology Clinicians Bioengineers Physicists Other Professionals Gastroenterology & Endoscopy •Identify needs •Design •Translating innovations •High quality research programs •Research hub for innovations from outside group •Opportunities to develop, adapt and apply devices in a quality research environment IMSTA’S 2015 ANNUAL CONFERENCE
  • 10. Trinity College Dublin, The University of Dublin www.medicine.tcd.ie/tagg/ We are a multidisciplinary research and clinical team comprising Gastroenterologists, Surgeons, Medical Physicists, Nutritionists, Nurses, Engineers, Scientists and Allied Health Professionals working collaboratively at the Adelaide & Meath Hospital incorporating the National Children’s Hospital (AMNCH) and St James’s Hospital Dublin with Trinity College Dublin. The TAGG Research Centre is affiliated with Trinity Health Ireland (THI). Our vision is of excellence and innovation in service delivery and research in gastroenterology.
  • 11. Trinity College Dublin, The University of Dublin – TAGG principal investigators (PIs) collaborate with national and international colleagues across Europe, North America, Canada and Ireland as well as with small and medium sized enterprises (SMEs) and Industry partners. – Local Collaborations • Life Sciences Interface, Tyndall National Institute – Dr. Karen Twomey • National Cancer Registry Ireland – Dr. Linda Sharp & Nick Clarke • BioInnovate Ireland – Dr. Mark Bruzzi • EndoVe – Mitamed, Dr. Kevin Soden • Endodex Ltd – Ms Katrina Bradley • Vasorum Ltd – Dr. Jim Coleman IMSTA’S 2015 ANNUAL CONFERENCE TAGG Medical Device & Innovation Hub
  • 12. Trinity College Dublin, The University of Dublin Product Life Cycle Concept Prototype Preclinical Clinical Manufacturing Marketing Commercial Use Obsolescence Involving Clinicians & Other Healthcare Professionals IMSTA’S 2015 ANNUAL CONFERENCE
  • 13. Trinity College Dublin, The University of Dublin EndoFlip Discovery IMSTA’S 2015 ANNUAL CONFERENCE
  • 14. Trinity College Dublin, The University of Dublin IMSTA’S 2015 ANNUAL CONFERENCE New Applications: FLIP in UOS
  • 15. Trinity College Dublin, The University of Dublin IMSTA’S 2015 ANNUAL CONFERENCE New Applications: FLIP in the Lower GI Tract
  • 16. Trinity College Dublin, The University of Dublin IMSTA’S 2015 ANNUAL CONFERENCE New Applications: FLIP in the Lower GI Tract Probe No. MODEL Catheter Diameter No. of CSA Measurements Maximum Bag Diameter CSA Measurement Length No. of Patients Studies Bag Pressure Probe 1 EMF-325N (modified) 2.5mm 16 25mm 75mm 4 Yes Probe 2 Custom ICV Probe 2.29mm 12 19mm 55mm 2 Yes
  • 17. Trinity College Dublin, The University of Dublin IMSTA’S 2015 ANNUAL CONFERENCE Medical Device Innovation The shape we're in: 10 facts about Irish obesity “As a nation, we're getting fatter to the point of a crisis. It's especially prevalent among older people, according to a new report”
  • 18. Trinity College Dublin, The University of Dublin Obesity Endoscopic Management System IMSTA’S 2015 ANNUAL CONFERENCE
  • 19. Trinity College Dublin, The University of Dublin Product Life Cycle Clinical & Scientific Testing Concept Prototype Preclinical Clinical Manufacturing Marketing Commercial Use Obsolescence IMSTA’S 2015 ANNUAL CONFERENCE
  • 20. Trinity College Dublin, The University of Dublin HSE figures show lengthening hospital waiting lists Leo Varadkar admits figures will get worse but promises hospital activity will be ramped up ‘subject to finance being available’ HSE figures show delayed discharges, at 835, were a major problem back in November; the persistence of high numbers of delayed discharges after Christmas was a major contributory factor behind the trolley crisis Health Care Innovation IMSTA’S 2015 ANNUAL CONFERENCE
  • 21. Trinity College Dublin, The University of Dublin IMSTA’S 2015 ANNUAL CONFERENCE Health Care Innovation
  • 22. Trinity College Dublin, The University of Dublin • Developing medical devices in a healthcare environment is feasible and beneficial • Involvement of teaching hospitals in trials of devices and drugs is paramount to market success • Performing device trials in hospitals is not straight forward and needs technical input from engineers and scientists as well as clinicians and other healthcare professionals • TAGG model offers great opportunity as a gateway to deliver better products for more effective and economic patient care • Industry and executive buy in “show me the money” Conclusions IMSTA’S 2015 ANNUAL CONFERENCE
  • 23. Trinity College Dublin, The University of Dublin IMSTA’S 2015 ANNUAL CONFERENCE Medical Device & Innovation Team Leaders Barry McMahon Stephen Bligh Contact Details: www.medicine.tcd.ie/tagg/ sbligh@tcd.ie Conclusions