Medical Devices for The Non-Communicable Diseases Agenda Nicole - - PowerPoint PPT Presentation
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 DITTA - the Global Diagnostic
2nd WHO Global Forum on Medical Devices Geneva, Switzerland Plenary session 3 on Sunday 24 November 2013
Nicole Denjoy
DITTA Chair COCIR Secretary General
Manufacturers around the world
in the United States after more than 12 years of existence
DITTA Task Forces RPS UDI MSW ENVI MDSAP GRP
Our Industry leads in state-of-art advanced technology and provides integrated solutions covering the complete care cycle
Cardiovascular diseases Cancer Chronic respiratory disease Diabetes 17.5mm 7.6mm 4.1mm 1.4mm
Chronic disease deaths Worldwide
36 million deaths from chronic disease in 2008
2
60% of all deaths result from chronic disease Deaths from chronic disease will increase by 17% by 2015
1 2 3
IT & bioengineering
Biotech & Genomics
Diagnostics
June 17, 2009, page 8
Heart Disease Cancer Cancer
US Life Expectancy at Birth 1950-2000 65 70 75 80 1950 1960 1970 1980 1990 2000
“Around 70% of the survival improvement in heart attack
mortality is a result of changes in technology.”
Cutler & McClellan, 2001 Sources: NCHS, Cutler 2006
5 out 7 years gained due to better heart care Heart Disease
June 17, 2009, page 9
15 30 45 15 30 45 20 40 60
“The decline in cancer has little to do with improvements in late stage treatment...but more to do with screening, earlier detection and treatment."
Breast Deaths down 3.5% 1975 2003 2008 Per 100K males Deaths down 4.1% Prostate cancer deaths Colorectal cancer deaths Breast cancer deaths Prostate 1975 2003 2008 Per 100K females Male Female Per 100K pop Deaths down 4.9% Deaths down 4.5% 1975 2003 2008
Therapy Evaluation Detection of Residual Disease Therapy Selection Staging Diagnosis Screening Predisposition Diagnosis of Recurrence Exist Today Emerging Research and Technologies
Genomics BRCA 1,2 Risk Profiling Mammography Ultrasound MR CT MR PET/CT Nuclear Med Proteomics PET/CT Functional marker Microarray PACS Electronic Health Record Medication Management Optical Functional Marker CTMRI Radiation Treatment F-Angiogenesis PET Mammography In-vitro test PET/CT New markers Microarray
(i.e. more gentle methods for the elderly) more images for guiding Therapies than Diagnostic procedures
Imaging tells the ‘where’
cancers could be cured if detected and treated early earlier detection followed by less costly treatment / therapy
Biomarker research & imaging to characterize disease fundamentals
Emerging
MR Anatomical Imaging (Tissue Visualization)
Emerging
Functional Imaging MR, PET MR Spectroscopy (Characterization)
‘90s Mainstream
Anatomical Imaging
Emerging
Anatomical Registration
Molecular Therapeutics, Diagnostics & DI
‘00s Mainstream
Anatomical Positioning (Registration) of Functional Imaging: PET/CT, MR
Emerging
Image-guided Gene Therapy
Next Mainstream
Molecular Imaging + Molecular Therapeutics + Molecular Diagnostics
‘80s Mainstream
X-Ray-based Anatomical Imaging: XR, CT Ultrasound
Central Patient’s EHR Home Pharmacy Laboratory Polyclinic Hospital Government
clinical and societal value
providers
derive maximal value from medical technology (Cloud computing)
reducing cost
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
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
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
Home Care Provider Repository
patient data
Bluetooth connectio n Manual measureme nt entry
Secure databas e
DSL / POTS / 3G Blood Pressur e Device Scale
Focus on acute & long term conditions Community centred Team based Integrated preventive care Knowledgeable patient Localised integrated high tech solutions Fund continuum of care
Utilization
Hospital Home Community clinic
Intermediate
FUTURE
Low High
PRESENT
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. GRP PROCESS
synonym for ‘manufacturer refurbishment’.
devices re-shipped to the manufacturer and processed to restore safety and performances as when new (including all relevant updates)
touching the regulatory scope for medical imaging devices. INDUSTRY INITIATIVE Recognizing the importance
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
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
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
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