Table 1

IVD product development and implementation activities by phase

	Phase 0	Phase 1	Phase 2	Phase 3	Phase 4
	Concept and research	Product feasibility, definition and planning	Design, development and transfer to manufacturing	Validation, regulatory approvals and first launch	Post-launch surveillance and stable operations
Main questions to be answered	What is the healthcare need? Is there an opportunity to address the need? Is there a business case for investment?	Is it feasible to develop a product that meets the key requirements? How much will it cost to launch the product? How long will it take? Can the risks to development be mitigated? Is there still a business case for investment?	Does the final product design meet all requirements? Can the product be manufactured and sold? Is there still a business case for investment?	Does the final product meet clinical performance requirements and requirements of the intended user? Is there demand for the product? Are we ready to launch?	Is the product meeting safety, quality and performance requirements? Do we need to make changes to the product or to its method of delivery? Are we making enough money to be profitable?
Marketing and sales activities	Identify healthcare need(s) Identify and understand key country stakeholders Conduct market research Work with R&D to create product concept(s) Build business case Prepare financial model	Finalise user requirements document Develop marketing and sales plan Develop global access plan Update business case and financial model	Update marketing and sales plan Update global access plan Update business case and financial model	Execute marketing and sales plan Finalise global access plan Execute first product launch in-country	Ongoing customer support, training and quality monitoring Continue expanding the market and product sales
Research and development, manufacturing, regulatory and legal activities	Select technologies that support product concept Establish proof of concept	Develop TPP and define critical product requirements Show technical feasibility against key product requirements and specifications Prepare development plans (R&D, clinical, regulatory, manufacturing, quality, etc.) Conduct initial risk assessment Review/address IP	Complete product optimisation, including prototype evaluations and lock the design Perform verification studies Prepare manufacturing and quality control procedures Update development plans Risk management and analysis Review/address IP	Conduct clinical validation studies and prepare submissions for regulatory approval Obtain regulatory approvals	Scale-up manufacturing Optimise distribution and supply chain Complete regulatory approvals and registrations in other countries
Policy and advocacy activities	Initiate communication with policy makers, procurers and funders	Develop policy-maker, procurer and funder engagement plans	Update and execute engagement plans Align product offering with policy, procurement and funding guidelines	Execute engagement plans Align product offering with policy, procurement and funding guidelines Support inclusion of diagnostic product in WHO recommendation and country guidelines	Continue to support inclusion of diagnostic product in country guidelines

IP, intellectual property; IVD, in-vitro diagnostics; TPP, target product profile.