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Nicole Denjoy DITTA Chair
COCIR Secretary General
IMDRF Open Stakeholders Forum Brussels, Belgium
November 13, 2013
Innovation for Safety: Achievements and Challenges
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• DITTA is a global organization representing industry associations of manufacturers around the world
• DITTA, a non-profit trade association, has represented this industry for
more than 12 years
DITTA - the Global Diagnostic Imaging, Healthcare IT, and Radiation Therapy Trade Association
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Member companies manufacture: • medical x-ray equipment • computed tomography (CT) scanners • ultrasound • radiation therapy equipment • nuclear imaging • magnetic resonance imaging (MRI) • medical software • imaging information systems • health IT • radiopharmaceuticals
DITTA - the Global Diagnostic Imaging, Healthcare IT, and Radiation Therapy Trade Association
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• eHealth/Telemedicine • Mobile solutions • BioSensors • Computer Aided Diagnostics • Patient monitoring
IT & bioengineering
• Targeted therapy • Proteomics/DNA • Biomarkers • Rapid screening tools • Vaccine development
Biotech & Genomics
• Faster, accurate imaging • Molecular imaging • Miniaturisation/portability • Point of Care diagnostics • Therapy selection/monitor
Diagnostics
Examples of Innovation
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Example: Imaging in Breast Cancer
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
5
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Manufacture Prototype Commercialize Concept
• User Needs • Design Input/Output • Verification • Validation
End of Life Clinical
Postmarket
Stakeholders are key in providing input on safety: patients, HCPs, regulators, CIOs, etc.
Stakeholder
Product Lifecycle: Continuous Improvement
State-of-art international standards are the foundation to the full product lifecycle
Milestones for Patient Safety focus
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Challenges • Lack of:
• Harmonized regulatory framework • Internationally recognized standards • Common data set for product registration • Common process for postmarket requirements
Regulatory Framework
Patient Access • Impact on time to market (in all geographies) • Access to clinical solutions • Quality of care
• Increase of: • Integrated care • HomeHealth • Aging populations • Non-communicable chronic disease • Patient empowerment • Demands for healthcare
Societal Trends
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An Example Solution – CT Dose • Goal – CT dose optimization
• Stakeholders – patients, physicists, healthcare professionals, equipment designers and manufacturers, regulators, hospital managers, etc.
Joint Task Forces
Commitments
Adoption
• Analyze problem, identify potential root causes, develop solutions
• Implement dose optimization measures , e.g., in standards
• Establish dose management, recording and reporting • Provide extensive multimedia training curricula
• As technology progresses, CT manufacturers provide clinical image quality at lower doses
Innovation
• Continued investment in dose reduction without compromising diagnostic accuracy
• Expand model to other modalities
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Future Trends
• Demand for rapid development of telehealth, mobile health, cloud computing, remote care, etc.
• Protecting patient data and cybersecurity • Software as a medical device
• Integrated technologies (product and services) to cover the continuum of care
Health IT
Integrated Technologies
Global Manufacturing
• Local manufacturing (regulatory pressure, cost of labor, proximity to resources and raw materials)
• Increasingly complex, global supply chain • Ancillary regulation compliance (recycling,
transportation of used parts/waste)
• Building clinical and socio-economic evidence for innovative technologies
Health Tech. Assessment
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Processes and Communication Supporting Safety
• Industry, healthcare professionals (HCPs) and patients
• Technology and intended use • In person, on site, and on-line
• Ongoing support for HCPs/patients • Preventive maintenance programs • Remote diagnostics and upgrades
• In person, letters, on-line alerts • Regulator consultation • Adverse event reporting, recalls
• Product upgrades • Preventive and corrective actions
Training
Improvements
Safety Alerts
Technical Support
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Recommendations to Stakeholders
1. Further harmonize the global regulatory framework
2. Continue promoting active partnering with all stakeholders in the implementation of innovative and safe technologies
3. Increase awareness through shared responsibility in providing effective education
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Innovation for Safety: Achievements and Challenges The Way Forward
THANK YOU !