Table 3.

Elements required for product launch

Item	Description
Policy, guidelines and product registration	Officially decide to adopt the diagnostic intervention and develop practice guidelines to inform the implementation process; legally approve products that meet the required quality, safety and efficacy standards.
Site selection and health facility infrastructure	Select clinical sites per product rollout strategy to optimally integrate the new product into workflows; update health facilities to meet product installation and operational requirements.
Financing, procurement and supply and distribution logistics	Identify secure sources of funding to cover procurement, implementation and maintenance costs; define forecasting and ordering processes and identify suppliers; identify, coordinate and monitor key players in the supply and distribution process.
Quality management system	Establish laboratory or health facility quality management system relevant to the diagnostic test that covers personnel training and supervision, record keeping, equipment service and maintenance plan and corrective-action and preventive-action procedures.
Monitoring, reporting and evaluation	Define key performance indicators to monitor the implementation process; modify patient and other administrative registers to accommodate new reporting requirements and metrics; support streamlined collection, storage, auditing and communication of data.