TB Diagnostics Critical Pathway

Stage-gate process
0

Identify Need

1

CONCEPT & FEASIBILITY

2

DEVELOPMENT

3

LAB AND CLINICAL VALIDATION

Ongoing commercial activities – demand generation, market development, market planning
Can happen in parallel or overlap
4
Regulatory approvals
5
WHO evaluation
6
Country transition to scale (Pre-Launch)
4

REGULATORY APPROVALS

5

WHO EVALUATION

6

COUNTRY TRANSITION TO SCALE PRE-LAUNCH

7

COUNTRY ADOPTION

8

SCALE-UP AND MONITORING

9

IMPACT MEASUREMENT