Evaluating and generating evidence for quality-assured diagnostics

Related program: Diagnostics

We facilitate the generation of actionable evidence to advance diagnostic solutions that are context-appropriate and perform as required.

Our evidence-generation capabilities are critical to rigorously evaluating products before advancing development to ensure that useful, high-quality, fit-for-purpose products enter the market.

Formative user research to define requirements for users and contexts of use

In the early development stages, we identify needs and inform specifications for products and systems in order to achieve the desired health impact. The evidence generated is critical to set up product development for success by determining user needs and the product's or system's key functionality.

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Fit-for-purpose clinical evaluation to generate actionable data

Rigorous evaluation of prototypes as they advance and proceed through verification and validation testing is critical to diagnostics development. This evidence drives the creation and refinement of products that are fit for purpose and suitable for end users to use within a health system context.

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Implementation research to ensure solutions are appropriate to both users and health systems

Health systems, the policy environment, and clinical workflows are complex and significantly impact the successful introduction and scale-up of health products. Implementation research during product introduction and scale-up helps to determine how diagnostics can successfully integrate into real-life settings.

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