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The Industry Vision
                Session S 1.4 Roundtable


The importance of innovative technologies in healthcare
                  COCIR’s viewpoint

                    Nicole Denjoy
                COCIR Secretary General
                                           25 May, Barcelona (Spain)
COCIR
What is COCIR?
• It represents the industry leading
  voice in Europe and beyond for:
   • Medical Imaging,
   • Health ICTs,
   • Electromedical Industry.




                                       June 17, 2009, page 3
COCIR Member Companies
COCIR National Trade Associations


   Belgium                 Hungary                 Italy               UK




         Spain                       Netherlands             Finland        Netherlands




France           Germany              Sweden               Turkey           Germany
COCIR’s focus:
                  improve market access

• Provide COCIR’s members with competence towards policy
  makers in Europe and outside
• Contribute to sustainability of healthcare systems through
  integrated care approach
• Promote Research and Innovation as a key enabler for
  economic growth
• Drive global regulatory convergence (registered once,
  accepted everywhere)
• Optimise use of International standards
• Push for national and regional deployment (eHealth)
• Pro-active in Green Technology (Eco-Design)
Strategic Global Presence




                IMDRF




                        June 17, 2009, page 7
Challenges
Challenges




         1   35 million deaths from chronic disease


         2   60% of all deaths result from chronic
             disease

         3   Deaths from chronic disease will increase by 17% by 2015

     2              17.5mm
                                                 Chronic disease deaths
                                                 Worldwide




                                       7.6mm

                                                      4.1mm
                                                                        1.4mm


             Cardiovascular diseases    Cancer          Chronic          Diabetes
                                                  respiratory disease
Societal health challenges


•   An ageing population
•   Growing prevalence of
    chronic diseases
•   A declining labour force
•   Rising health care costs




                               June 17, 2009, page 10
Challenges for our Industry

• Highly regulated industry (under revision!)
• Lack of harmonisation in regulatory
  framework globally & insufficient use of
  international standards
• Various HTA & reimbursement systems in EU
• Still fragmented business in eHealth
• Lack of proper research funding &
  insufficient use of structural funds in health

                                        June 17, 2009, page 11
The industry cannot solve alone some key
             challenges faced by innovations

•   Investment and research are associated with high risks
     Toward personalized medicine (niche markets) versus ROI
     Innovative technologies to be integrated into a new, not yet defined
      Healthcare System paradigm

•   Low speed of adoption of new technologies with derived
    clinical and economic benefits
     New role of diagnostic & reimbursement issues
      (biomarkers, companion diagnostic,…)

•   Lack of standards to accelerate research and defragment
    the market (globally)
     Need for large clinical trials led by Clinical/Scientific experts groups
      (e.g: AD taskforce, EORTC,…) supported by EC/EMA to validate new
      medical practices to be reimbursed



                                                                        June 17, 2009, page 12
Proven successes

    2 examples
Innovation in Medical Devices …
              support improving outcomes in Cardiology



                                                  US Life Expectancy at Birth
                                                           1950-2000
                                            80
                                            75
                                            70

                Cancer         Heart        65
                                                 1950 1960 1970 1980 1990 2000
                               Disease

                 Heart         Cancer        5 out 7 years gained due
                 Disease                    to better heart care


                                                             Sources: NCHS,
                                                                Cutler 2006


“Around 70% of the survival improvement in heart attack
mortality is a result of changes in technology.”
Cutler & McClellan, 2001

                                                                  June 17, 2009, page 14
Innovation in Medical Devices …
                             support improving outcomes in Oncology
                      Prostate cancer deaths                               Breast cancer deaths                          Colorectal cancer deaths
                 60                                                  45                                             45




                                                  Per 100K females
Per 100K males




                                                                                                     Per 100K pop
                                                                                                                                 Deaths down 4.9%
                 40                                                  30                                             30

                                                                                     Breast                                      Male
                                Prostate
                 20                                                  15                                             15
                                                                                                                                 Female
                         Deaths down 4.1%                                        Deaths down 3.5%                                   Deaths down 4.5%
                  0                                                   0                                              0

                      1975     2003        2008                           1975      2003      2008                       1975    2003        2008

                 • Prostate cancer mortality continues to fall: screening, PSA
                 • Breast cancer mortality decreased 3.5%: first drop in 20 years
                 • Colorectal cancer 5yr survival: 10% late stage; 90% early detection

                      “The decline in cancer has little to do with improvements in late stage
                         treatment...but more to do with screening, earlier detection and
                                                     treatment."
                                      Prof. Gordon McVie, European Institute of Oncology, Milan
                                                                                                                                        June 17, 2009, page 15
Opportunities
Medical Imaging innovations can turn
         societal challenge into growth
• Yesterday
    Patient stratification
    Patient monitoring

• Tomorrow
    Early diagnosis
    Targeted treatment selection
    Minimally invasive treatment
    Treatment efficacy monitoring

                               Better quality & access to healthcare

                               Lower healthcare cost
 INNOVATIONS
                               Quicker recovery of patients, quicker
                               return to daily activities
                               Economic Growth
                               (incl. jobs in EU for global markets)
                                                          June 17, 2009, page 17
Medical Imaging sector is strong in Europe…

• 3 of the global medical imaging industrial leaders are
  headquartered in Europe, with strong R&D presence in
  Europe
• Strong academic presence and Intellectual Property in
  Europe can be leveraged for innovation (Patents registered
  in 2010: 39% European, 26% US, 18% Japan and 5%
  China and Korea)




                                                     June 17, 2009, page 18
Leverage the Power of Health ICT

                                                                                           Hospital
                                                               Government   Polyclinic
•   Healthcare IT and eHealth  proven high clinical and
    societal value

•   Telehealth  linking patients with care providers                Home
                                                                                    Central
                                                              Pharmacy              Patient’s

•   IT infrastructure  ensure that systems derive maximal                           EHR

    value from medical technology (Cloud computing)
                                                                                 Laboratory
•   IT connectivity through IHE (Integrating the Healthcare
    Enterprise)  improving quality and reducing cost

•   More investment in eHealth  best-practice clinical
    pathways / patient’s mobility throughout Europe




                                                                                    June 17, 2009, page 19
Technology is advancing fast…..
        Diagnostics               Biotech & Genomics              IT & bioengineering
•   Faster, accurate imaging      •   Targeted therapy        •   eHealth/Telemedicine
•   Molecular imaging             •   Proteomics/DNA          •   Mobile solutions
•   Miniaturisation/portability   •   Biomarkers              •   BioSensors
•   Point of Care diagnostics     •   Rapid screening tools   •   Computer Aided Diagnostics
•   Therapy selection/monitor     •   Vaccine development     •   Patient monitoring




                                                                              June 17, 2009, page 20
BUT…change is slow

 Needpolicies that facilitate disease
management approaches:

  o Focus on disease risk stratification, prevention & screening
    programmes
  o Encourage ‘best practice’ patient centric processes
  o Health ICT solutions to drive quality, safety and efficiency,
    and telemedicine
  o Encourage more integrated care delivery
  o Use of regulatory & procurement to accelerate uptake of
    proven technologies

                                                       June 17, 2009, page 21
Two COCIR initiatives:
1. PPP in Research and Innovation
2. More effective PPP models: key best
   practices on integrated care at
   hospital level


                                  June 17, 2009, page 22
1. PPP for Research & Innovation
• Create an industry driven public-private partnership (PPP)
  to accelerate Research and Innovation
• Together with Academics, Research Centers and Public
  Authorities
• Join forces with other industry sectors (pharma, cosmetics,
  etc….)

… in the context of “Horizon 2020” objectives of the
               European Commission

The third objective, 'Societal challenges' will see €31.7
billion allocated to tackling the major issues affecting
the lives of European citizens, including Health,
demographic change and wellbeing (€8.6 billion – up
from €6.1 billion in FP7).


                                                            June 17, 2009, page 23
Benefits for European Commission
              and Member States
• Better quality and lower cost healthcare for the most
  important disease areas in EU and globally
    Acceleration of efficient technology uptake, increasing ROI of
     investments in healthcare technologies
• European Industrial and Scientific leadership
    Prioritization of R&I in line with the industry needs to tackle
     major global societal challenges
    Better leverage of technology and clinical research outputs
    PPP collaboration leads to better insights to jointly address future
     problems
• Growth
    Jobs creations derived from innovations commercialization
    Indirect economic benefits of better management of chronic
     diseases


                                                               June 17, 2009, page 24
2. Hospital Of Today (HOT)
    What you plan Today will remain optimal Tomorrow




 A COCIR Initiative to maximize
investments at hospital level on
      integrated solutions


                                                       June 17, 2009, page 25
Characteristics of a PPP
PPP has a number of characteristics which differentiates it from more traditional
forms of contracting between the public and private sectors:

1.   Long term –Typically contracting period of 25 – 30 years. Over this period of time the private sector will
     operate and maintain the facility.
2.   Transfer of risk – certain financial, technical and operational risks are passed to the private sector for the
     duration of a PPP contract.
3.   Limited recourse finance – the financing within the Special Purpose Vehicle (SPV) is secured against the
     project cash flows rather than the balance sheets of the SPV’s shareholders.
4.   Payments over life of PPP contract– the Procuring Authority pays an annual Unitary Charge to the private
     sector once service delivery has commenced (or in the case of toll funded projects payments are made by the
     users of the service).
5.   Private sector ownership – the private sector usually owns the asset for the duration of the contract. Upon
     completion of the contract term, ownership of the asset can be transferred to the Procuring Authority.
6.   Involves a range of partners – a number of private sector entities come together to form a consortium to
     deliver the project.




26                                                                                                      June 17, 2009, page 26
Alternative Model PPP
                  De-couple Infrastructure from Technology

                               Government
                               Hospital
     Managed                                          Building
     Service                                          Concession
      Technology
                                              Consortium
      Partner
•   Construction Company
     – Turnkey DBFMO model to provide infrastructure on 20 – 30 years lease basis



    Design                 Build                 Finance               Maintain     Operate
•   Equipment Technology Partnership
     – Via a Managed Service based on Service Model and Service Level Agreement
     – Providing flexibility in 10 – 15 years term



                                                                                    June 17, 2009, page 27
Valencia Region South
                             Integrated Patient Care System



- Full integrated patient care
- No waiting lists
- Patient has free choice to choose
  hospital
- 600 € per capita, per year


                                             Capitated payment
   Property refund to
   Valencia
   Government




Public and free healthcare
services                                  Controlled Project


                                                                 June 17, 2009, page 28
What we need….
Innovative technology will enable
                       a shift in care
              •   Focus on acute conditions         Focus on acute & long term conditions
              •   Hospital centred                  Community centred
              •   Physician dependent               Team based
              •   Episodic, reactive care           Integrated preventive care
              •   Passive patient                   Knowledgeable patient
              •   Slow uptake of technology         Localised integrated high tech solutions
              •   Budget silos                      Fund continuum of care


                  Hospital                    Community                        Home
                                              clinic
Utilization




                                   PRESENT                          FUTURE




                  High                        Acuity                                   Low
                                                                                 June 17, 2009, page 30
Importance of prevention & personal
    initiative for healthier and more active lifestyles



• Industry strongly supports government policies
  and educational programs that encourage
  individuals to make informed choices and take
  personal initiatives for leading healthier and
  more active lives




                                                June 17, 2009, page 31
Collaborative partnership approach…



• Non-communicable diseases are multi-factorial
  in nature, thus requiring a multi-stakeholder
  and horizontal approach to ensure healthier
  and informed life-styles
• Effective strategies must involve all levels of
  government as well as all key stakeholders




                                            June 17, 2009, page 32
Expectations to foster an innovation-
     friendly environment in Europe


1.Establish a mechanism to ensure a robust evaluation of
innovations during the product-development cycle

2.Enable rapid access to market for innovative products
and services with added value

3.Adopt a clear strategy at EU level to support innovations

4.Access to further financing Research and Development
investments

5. Better leverage the use of Structural Funds for Health



                                                     June 17, 2009, page 33

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Denjoy, Nicole - The importante of innovative technologies in healthcare. COCIR’s viewpoint

  • 1. The Industry Vision Session S 1.4 Roundtable The importance of innovative technologies in healthcare COCIR’s viewpoint Nicole Denjoy COCIR Secretary General 25 May, Barcelona (Spain)
  • 3. What is COCIR? • It represents the industry leading voice in Europe and beyond for: • Medical Imaging, • Health ICTs, • Electromedical Industry. June 17, 2009, page 3
  • 5. COCIR National Trade Associations Belgium Hungary Italy UK Spain Netherlands Finland Netherlands France Germany Sweden Turkey Germany
  • 6. COCIR’s focus: improve market access • Provide COCIR’s members with competence towards policy makers in Europe and outside • Contribute to sustainability of healthcare systems through integrated care approach • Promote Research and Innovation as a key enabler for economic growth • Drive global regulatory convergence (registered once, accepted everywhere) • Optimise use of International standards • Push for national and regional deployment (eHealth) • Pro-active in Green Technology (Eco-Design)
  • 7. Strategic Global Presence IMDRF June 17, 2009, page 7
  • 9. Challenges 1 35 million deaths from chronic disease 2 60% of all deaths result from chronic disease 3 Deaths from chronic disease will increase by 17% by 2015 2 17.5mm Chronic disease deaths Worldwide 7.6mm 4.1mm 1.4mm Cardiovascular diseases Cancer Chronic Diabetes respiratory disease
  • 10. Societal health challenges • An ageing population • Growing prevalence of chronic diseases • A declining labour force • Rising health care costs June 17, 2009, page 10
  • 11. Challenges for our Industry • Highly regulated industry (under revision!) • Lack of harmonisation in regulatory framework globally & insufficient use of international standards • Various HTA & reimbursement systems in EU • Still fragmented business in eHealth • Lack of proper research funding & insufficient use of structural funds in health June 17, 2009, page 11
  • 12. The industry cannot solve alone some key challenges faced by innovations • Investment and research are associated with high risks  Toward personalized medicine (niche markets) versus ROI  Innovative technologies to be integrated into a new, not yet defined Healthcare System paradigm • Low speed of adoption of new technologies with derived clinical and economic benefits  New role of diagnostic & reimbursement issues (biomarkers, companion diagnostic,…) • Lack of standards to accelerate research and defragment the market (globally)  Need for large clinical trials led by Clinical/Scientific experts groups (e.g: AD taskforce, EORTC,…) supported by EC/EMA to validate new medical practices to be reimbursed June 17, 2009, page 12
  • 13. Proven successes 2 examples
  • 14. Innovation in Medical Devices … support improving outcomes in Cardiology US Life Expectancy at Birth 1950-2000 80 75 70 Cancer Heart 65 1950 1960 1970 1980 1990 2000 Disease Heart Cancer 5 out 7 years gained due Disease to better heart care Sources: NCHS, Cutler 2006 “Around 70% of the survival improvement in heart attack mortality is a result of changes in technology.” Cutler & McClellan, 2001 June 17, 2009, page 14
  • 15. Innovation in Medical Devices … support improving outcomes in Oncology Prostate cancer deaths Breast cancer deaths Colorectal cancer deaths 60 45 45 Per 100K females Per 100K males Per 100K pop Deaths down 4.9% 40 30 30 Breast Male Prostate 20 15 15 Female Deaths down 4.1% Deaths down 3.5% Deaths down 4.5% 0 0 0 1975 2003 2008 1975 2003 2008 1975 2003 2008 • Prostate cancer mortality continues to fall: screening, PSA • Breast cancer mortality decreased 3.5%: first drop in 20 years • Colorectal cancer 5yr survival: 10% late stage; 90% early detection “The decline in cancer has little to do with improvements in late stage treatment...but more to do with screening, earlier detection and treatment." Prof. Gordon McVie, European Institute of Oncology, Milan June 17, 2009, page 15
  • 17. Medical Imaging innovations can turn societal challenge into growth • Yesterday  Patient stratification  Patient monitoring • Tomorrow  Early diagnosis  Targeted treatment selection  Minimally invasive treatment  Treatment efficacy monitoring Better quality & access to healthcare Lower healthcare cost INNOVATIONS Quicker recovery of patients, quicker return to daily activities Economic Growth (incl. jobs in EU for global markets) June 17, 2009, page 17
  • 18. Medical Imaging sector is strong in Europe… • 3 of the global medical imaging industrial leaders are headquartered in Europe, with strong R&D presence in Europe • Strong academic presence and Intellectual Property in Europe can be leveraged for innovation (Patents registered in 2010: 39% European, 26% US, 18% Japan and 5% China and Korea) June 17, 2009, page 18
  • 19. Leverage the Power of Health ICT Hospital Government Polyclinic • Healthcare IT and eHealth  proven high clinical and societal value • Telehealth  linking patients with care providers Home Central Pharmacy Patient’s • IT infrastructure  ensure that systems derive maximal EHR value from medical technology (Cloud computing) Laboratory • IT connectivity through IHE (Integrating the Healthcare Enterprise)  improving quality and reducing cost • More investment in eHealth  best-practice clinical pathways / patient’s mobility throughout Europe June 17, 2009, page 19
  • 20. Technology is advancing fast….. Diagnostics Biotech & Genomics IT & bioengineering • Faster, accurate imaging • Targeted therapy • eHealth/Telemedicine • Molecular imaging • Proteomics/DNA • Mobile solutions • Miniaturisation/portability • Biomarkers • BioSensors • Point of Care diagnostics • Rapid screening tools • Computer Aided Diagnostics • Therapy selection/monitor • Vaccine development • Patient monitoring June 17, 2009, page 20
  • 21. BUT…change is slow  Needpolicies that facilitate disease management approaches: o Focus on disease risk stratification, prevention & screening programmes o Encourage ‘best practice’ patient centric processes o Health ICT solutions to drive quality, safety and efficiency, and telemedicine o Encourage more integrated care delivery o Use of regulatory & procurement to accelerate uptake of proven technologies June 17, 2009, page 21
  • 22. Two COCIR initiatives: 1. PPP in Research and Innovation 2. More effective PPP models: key best practices on integrated care at hospital level June 17, 2009, page 22
  • 23. 1. PPP for Research & Innovation • Create an industry driven public-private partnership (PPP) to accelerate Research and Innovation • Together with Academics, Research Centers and Public Authorities • Join forces with other industry sectors (pharma, cosmetics, etc….) … in the context of “Horizon 2020” objectives of the European Commission The third objective, 'Societal challenges' will see €31.7 billion allocated to tackling the major issues affecting the lives of European citizens, including Health, demographic change and wellbeing (€8.6 billion – up from €6.1 billion in FP7). June 17, 2009, page 23
  • 24. Benefits for European Commission and Member States • Better quality and lower cost healthcare for the most important disease areas in EU and globally  Acceleration of efficient technology uptake, increasing ROI of investments in healthcare technologies • European Industrial and Scientific leadership  Prioritization of R&I in line with the industry needs to tackle major global societal challenges  Better leverage of technology and clinical research outputs  PPP collaboration leads to better insights to jointly address future problems • Growth  Jobs creations derived from innovations commercialization  Indirect economic benefits of better management of chronic diseases June 17, 2009, page 24
  • 25. 2. Hospital Of Today (HOT) What you plan Today will remain optimal Tomorrow A COCIR Initiative to maximize investments at hospital level on integrated solutions June 17, 2009, page 25
  • 26. Characteristics of a PPP PPP has a number of characteristics which differentiates it from more traditional forms of contracting between the public and private sectors: 1. Long term –Typically contracting period of 25 – 30 years. Over this period of time the private sector will operate and maintain the facility. 2. Transfer of risk – certain financial, technical and operational risks are passed to the private sector for the duration of a PPP contract. 3. Limited recourse finance – the financing within the Special Purpose Vehicle (SPV) is secured against the project cash flows rather than the balance sheets of the SPV’s shareholders. 4. Payments over life of PPP contract– the Procuring Authority pays an annual Unitary Charge to the private sector once service delivery has commenced (or in the case of toll funded projects payments are made by the users of the service). 5. Private sector ownership – the private sector usually owns the asset for the duration of the contract. Upon completion of the contract term, ownership of the asset can be transferred to the Procuring Authority. 6. Involves a range of partners – a number of private sector entities come together to form a consortium to deliver the project. 26 June 17, 2009, page 26
  • 27. Alternative Model PPP De-couple Infrastructure from Technology Government Hospital Managed Building Service Concession Technology Consortium Partner • Construction Company – Turnkey DBFMO model to provide infrastructure on 20 – 30 years lease basis Design Build Finance Maintain Operate • Equipment Technology Partnership – Via a Managed Service based on Service Model and Service Level Agreement – Providing flexibility in 10 – 15 years term June 17, 2009, page 27
  • 28. Valencia Region South Integrated Patient Care System - Full integrated patient care - No waiting lists - Patient has free choice to choose hospital - 600 € per capita, per year Capitated payment Property refund to Valencia Government Public and free healthcare services Controlled Project June 17, 2009, page 28
  • 30. Innovative technology will enable a shift in care • Focus on acute conditions  Focus on acute & long term conditions • Hospital centred  Community centred • Physician dependent  Team based • Episodic, reactive care  Integrated preventive care • Passive patient  Knowledgeable patient • Slow uptake of technology  Localised integrated high tech solutions • Budget silos  Fund continuum of care Hospital Community Home clinic Utilization PRESENT FUTURE High Acuity Low June 17, 2009, page 30
  • 31. Importance of prevention & personal initiative for healthier and more active lifestyles • Industry strongly supports government policies and educational programs that encourage individuals to make informed choices and take personal initiatives for leading healthier and more active lives June 17, 2009, page 31
  • 32. Collaborative partnership approach… • Non-communicable diseases are multi-factorial in nature, thus requiring a multi-stakeholder and horizontal approach to ensure healthier and informed life-styles • Effective strategies must involve all levels of government as well as all key stakeholders June 17, 2009, page 32
  • 33. Expectations to foster an innovation- friendly environment in Europe 1.Establish a mechanism to ensure a robust evaluation of innovations during the product-development cycle 2.Enable rapid access to market for innovative products and services with added value 3.Adopt a clear strategy at EU level to support innovations 4.Access to further financing Research and Development investments 5. Better leverage the use of Structural Funds for Health June 17, 2009, page 33