Medical Devices for The Non-Communicable Diseases Agenda Nicole Denjoy

Transcription

1 Medical Devices for The Non-Communicable Diseases Agenda Nicole Denjoy DITTA Chair COCIR Secretary General 2 nd WHO Global Forum on Medical Devices Geneva, Switzerland Plenary session 3 on Sunday 24 November 2013

2 DITTA - the Global Diagnostic Imaging, Healthcare IT, and Radiation Therapy Trade Association DITTA is a global organization representing Industry Associations of Manufacturers around the world DITTA was officially incorporated in 2012 as a non-profit trade association in the United States after more than 12 years of existence

3 DITTA: 6 Operational Groups DITTA Task Forces RPS UDI MSW MDSAP ENVI GRP

4 Our Technology: a Greater role to play at Global Level! Our Industry leads in state-of-art advanced technology and provides integrated solutions covering the complete care cycle

5 Challenges million deaths from chronic disease in % of all deaths result from chronic disease 2 3 Deaths from chronic disease will increase by 17% by mm Chronic disease deaths Worldwide 7.6mm 4.1mm Cardiovascular diseases Cancer Chronic respiratory disease 1.4mm Diabetes

6 Why the focus on Non-Communicable Diseases? 1. NCDs are contributing to 50% of global disability 2. In 119 out of 165 countries analyzed coronary heath disease are in the Top 3 leading causes of death Economic implications: Over the next 2 decades NCDs will represent 48% of the global GDP Policy developments will be required

7 Innovation in Medical Devices Diagnostics Biotech & Genomics IT & bioengineering Faster, accurate imaging Molecular imaging Miniaturisation/portability Point of Care diagnostics Therapy selection/monitor Targeted therapy Proteomics/DNA Biomarkers Rapid screening tools Vaccine development ehealth/telemedicine Mobile solutions BioSensors Computer Aided Diagnostics Patient monitoring

8 Innovation in Medical Devices support improving outcomes in Cardiology US Life Expectancy at Birth Cancer Heart Disease Heart Disease Cancer 5 out 7 years gained due 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 8

9 Per 100K males Per 100K females Per 100K pop Innovation in Medical Devices support improving outcomes in Oncology Prostate cancer deaths Breast cancer deaths Colorectal cancer deaths Deaths down 4.9% 40 Prostate 30 Breast 30 Male 20 Deaths down 4.1% 15 Deaths down 3.5% 15 Female Deaths down 4.5% 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 9

10 Breast Cancer Care Cycle Diagnosis of Recurrence Detection of Residual Disease Therapy Evaluation PET/CT New markers Screening Diagnosis Therapy Selection Staging CTMRI Radiation Treatment Optical Functional Marker Mammography In-vitro test F-Angiogenesis PET Predisposition Proteomics Mammography Genomics Ultrasound BRCA 1,2 MR Risk Profiling Microarray PET/CT Functional marker CT MR PET/CT Nuclear Med Microarray PACS Electronic Health Record Medication Management Exist Today Emerging Research and Technologies

11 Changing Role of Healthcare Imaging Trend: Minimal invasive procedures (i.e. more gentle methods for the elderly) more images for guiding Therapies than Diagnostic procedures Trend: Increasing number of IVD tests Imaging tells the where Request for Screening: One-third of all cancers could be cured if detected and treated early earlier detection followed by less costly treatment / therapy Trend: Personalized Medicine Biomarker research & imaging to characterize disease fundamentals

12 Medical Imaging Evolution 80s Mainstream 90s Mainstream 00s Mainstream Next Mainstream X-Ray-based Anatomical Imaging: XR, CT Ultrasound CT, MR, US Anatomical Imaging Digital Xray Anatomical Positioning (Registration) of Functional Imaging: PET/CT, MR Molecular Imaging + Molecular Therapeutics + Molecular Diagnostics Emerging Emerging Emerging Emerging MR Anatomical Imaging (Tissue Visualization) Functional Imaging MR, PET MR Spectroscopy (Characterization) Anatomical Registration of Molecular Imaging Molecular Therapeutics, Diagnostics & DI Image-guided Gene Therapy

13 Leverage the Power of Healthcare IT 1. Healthcare IT and ehealth proven high clinical and societal value Government Polyclinic Hospital 2. Telehealth linking patients with care providers Pharmacy Home Central Patient s EHR 3. IT infrastructure ensure that systems derive maximal value from medical technology (Cloud computing) Laboratory 4. IT connectivity improving quality and reducing cost

14 Driving better access to healthcare, with maximum safety and quality in a cost-efficient and affordable way Access To Healthcare Smart use of technology to provide better access to healthcare and avoid inequalities Next page, see an example of use of Health ICT Better Safety & Quality 1. Avoid medical errors 2. Drive CT dose Optimisation 3. Provide Excellent image quality 4. Ensure reliability 5. Expand life cycle of equipment through smart maintenance Affordability & Cost Efficiency 1. Use integrated solutions and use technology to connect through center of excellence 2. Maximize use equipment through its entire life cycle 3. Taylored solutions based on country environment

15 Better access to healthcare e.g. Telehealth solutions Home Repository Care Provider Blood Pressur e Device Scale Bluetooth connectio n Manual measureme nt entry DSL / POTS / 3G Secure databas e Monitor and review patient data Analyse data Careplan delivery

16 Utilization Innovative technology enables a shift in care Focus on acute conditions Hospital centred Physician dependent Episodic, reactive care Passive patient Slow uptake of technology Budget silos Focus on acute & long term conditions Community centred Team based Integrated preventive care Knowledgeable patient Localised integrated high tech solutions Fund continuum of care Hospital Community clinic Home PRESENT FUTURE High Intermediate Low

17 Technology affordability everywhere: A Concrete Initiative for Medical Imaging Equipments GOOD REFURBISHMENT PRACTICE (GRP) Extending Life of Medical Devices and Contributing to Recycling Economy

18 GRP a GLOBALLY accepted Golden Standard GRP PROCESS GRP is currently a synonym for manufacturer refurbishment. Used medical devices re-shipped to the manufacturer and processed to restore safety and performances as when new (including all relevant updates) GRP is not touching the regulatory scope for medical imaging devices. GRP and RESOURCE EFFICIENCY Refurbishment is a form of re-use of whole equipment. It extend the lifetime of the medical equipment, ensuring at the same time that safety and performances when the equipment was new are maintained (or even improved). Refurbishment prevents equipment to be wasted, saves resources and energy needed for the manufacturing of new equipment. INDUSTRY INITIATIVE Recognizing the importance of refurbishment from the perspective of business and environment and as a tool to meet up-coming requirements on energy and resource efficiency COCIR, JIRA and MITA published in 2009 the GRP paper. GRP is now a globally accepted approch to access to affordable technology

19 Call for attention to public authorities to benefit from innovation 1. Innovative technology and healthcare has to be seen as long-term investment 2. Member States with support of WHO can drive implementation and uptake of innovative and essential technology 3. Healthcare authorities should translate faster innovation from research to market 4. Public procurement and reimbursement systems should incentivise innovative technologies and IT connectivity

20 Besides Technology, crucial elements for success: 1. Constant education to ensure proper use of evolving technologies 2. Appropriate Healthcare Workforce and combined with technology (e.g. telehealth) 3. Invest in technology for sustainable healthcare systems through long term investment 4. Don t forget equipment maintenance to ensure maximum safety and performance over time

21 7 Recommendations to tackle NCDs 1. Proactive steps should be taken by all governments to implement a monitoring framework 2. Prevention strategies and implementation of early diagnosis and treatment should be prioritized 3. Active promotion of educational and public health awareness of the modified risks associated with NCDs 4. Provision of universal health coverage should be the global norm 5. Developmment of clinical guidelines and public policies 6. Increase investment of primary care infrastructure 7. «Invest to save» would save more lives and improve health outcomes

22 Conclusions 1. Multistakeholder approach: Industry is part of the solution and forces need to be combined with all other key stakeholders 2. Primary and Secondary Prevention: Paradigm shift needed towards a more preventive, patient-centered care to decrease NCDs 3. Supportive Regulatory System: Predictable, cost-efficient regulatory processes (follow developments of IMDRF and AHWP) 4. Short & Long term investment: Deployment of innovative healthcare & ICT technologies is crucial for sustainability of healthcare systems

23 All together we need to Think Global, Act Local THANK YOU!