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TB DIAGNOSTICS R&D: Not Just Technology. BD Experience with Implementation & Support. Peter Mehlape, General Manager GBC Southern Africa Conference 11th October 2010, Johannesburg. About BD (Becton, Dickinson and Co.). Medical Technology Company $7.5B Offices in 52 countries - PowerPoint PPT Presentation
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TB DIAGNOSTICS R&D: Not Just Technology
Peter Mehlape, General Manager
GBC Southern Africa Conference11th October 2010, Johannesburg
BD Experience with Implementation & Support
About BD (Becton, Dickinson and Co.)
Medical Technology Company
$7.5B
Offices in 52 countries
29,000 employees
Four Areas of Focus
Reducing the spread of infection
Advancing global health
Enhancing therapy
Improving disease management
Africa Presence
120 Employees
Offices in Johannesburg, Nairobi and Accra
Distribution, service and support network
1882 2000
Progress in TB Diagnostics for the Developing World
2010
Future
?
Product Development
Technology Development
Implementation
Service and Support
Biomarkers
Specimen collection
Rapid turnaround
Sensitivity and specificity
Validation studies
Cost efficient
Clinical trials
New Diagnostics: A Common Perception
Dx ACCESS
BD Product Development Process
ImplementationQualificationDevelopmentDefinitionConcept
Customer Voices
Business Voices
Customer Requirements
Operational Requirements
Product Requirements
Process Requirements
Product Specifications
Process Specification
Verification Units Validation Units
Process Validation
Manufacturing Engineering Prototypes
Pilot Manufacturing
Support
Pricing
Regulatory
Laboratory Strengthening
Advocacy and Policy
Service/Repairs
Training
Set Up
TB Diagnostics R&D: Design Challenges
Need for improved laboratory capacity
Roads, electricity, cold chain
Regulatory hurdles
Lack of trained personnel
Patients who need to be treated are not reached
Specimens from non-responding patients need to be referred
Stakeholders have had difficulty routing specimens to the NTRL
Verification of microscopy results and the response to blinded re-checking of smears is incomplete
Used GPS technology to map patient sample collection sites
Created reference network and
ability to gather data
Trained on proper TB specimen collection and transport
More than 1000 patient samples referred and more than 900 sites mapped
BD Example: Uganda Specimen Referral Program
Private Sector Core Competencies
– Public/private and private/private collaboration
• Technology development
• Advocacy
– Project management
• Working with local MoH
– Training and education
• Leverage employee skill-set
• Strengthen healthcare capacity
Implementation and Support
Dx ACCESS
Conclusions
• Effective R&D considers implementation/service up front
– Anything can work in a laboratory or work in the field once – replicability and sustainability is essential
• Incentives should not only be for technology/product development
– Look for incentives on implementation and service as well
• Leverage core competencies of the private sector
– Multi-faceted problems require collaborative approach
Thank You