Table 2. Planning processes for product development.

Output	Objective	Stakeholders responsible for definition
Use-cases	• Requires understanding of program workflow; infrastructure; resources to identify needs, preferences, limitations for implementation • Define link between phase of program and criteria, with implications of diagnostics-based decision • Frame epidemiological/biological characteristics • Identify stakeholders (data users, test implementers, policy, payors)	• Programs/implementers • WHO STH program guidelines or recommendations With input from: • Research (laboratory, epidemiology, field)
TPP	• Requires defined use-case • Define “must-have” criteria for a diagnostic to meet program needs for each use-case • Assess feasibility of meeting TPP requirements via landscape of existing research/methods/technologies/available patient specimens • Define evaluation criteria and methods for assessing new products and regulatory pathway • Account for cost-effectiveness, scalability, manufacturability	• Programs/implementers • Research • Product development With input from: • WHO STH program guidelines or recommendations • Regulatory
Product development pathway	• Requires use-case and TPP • Define regulatory pathway • Define requirements in accordance with existing or new STH program policies/guidelines/recommendations • Define pathway for translating existing reagents/methods into prototype • Define verification criteria that prototype meets TPP to lock/freeze design • Define validation criteria to evaluate adherence to TPP in actual operating conditions • Define product launch plan • Define payors/donors for program’s diagnostic infrastructure • Define user-support, quality assurance, monitoring, supply chain requirements • Define manufacturing and distribution plans	• Research • Product development • Regulatory • WHO STH program guidelines or recommendations With input from: • Country programs • Representatives from Ministries of Health • Program donors • Implementing nongovernment organizations

Abbreviations: STH, soil-transmitted helminth; TPP, target product profile.