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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

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Tb diagnostics r d not just technology

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
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



New diagnostics a common perception
New Diagnostics: A Common Perception

Product Development

Technology Development

Validation studies

Cost efficient

Clinical trials

Biomarkers

Specimen collection

Rapid turnaround

Sensitivity and specificity

Dx ACCESS

Implementation

Service and Support


Bd product development process

Concept

Definition

Development

Qualification

Implementation

Support

Advocacy and Policy

Set Up

Customer Requirements

Customer Voices

Validation Units

Product Specifications

Verification Units

Product Requirements

Laboratory Strengthening

Business Voices

Operational Requirements

Training

Process Specification

Process Validation

Process Requirements

Regulatory

Service/Repairs

Manufacturing Engineering Prototypes

Pilot Manufacturing

Pricing

BD Product Development Process


Tb diagnostics r d design challenges
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
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
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



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