Demonstrating the downstream value of diagnostics

Diagnostic technologies are advancing rapidly, with AI-driven platforms, multi-omics, and data-rich approaches redefining how disease is detected and managed. The value of a diagnostic is also often indirect; it is realised through its impact on downstream clinical outcomes and resource utilisation. As such, the evidence generated for diagnostics may use intermediate endpoints, test accuracy metrics, or predictive models. This may not translate cleanly into conventional HTA frameworks.

At YHEC, we specialise in generating and synthesising the evidence needed to navigate this environment. Our extensive methodological work in this area enables our team to provide the strategic guidance and technical rigour required to help you articulate the value of your diagnostic. We help you to ask the right questions early, critically explore the evidence landscape, and prepare for scrutiny from a wide array of stakeholders. Our dedicated training courses in health economics and evidence generation also help clients build their internal expertise.

How can YHEC help the diagnostic sector?

We support diagnostic innovators at every stage of the product life-cycle:

During the development of your diagnostic device, strategic evidence planning can impact future success. We help you to:

  • Conduct early reviews to identify unmet needs and disease burden.
  • Conduct care pathway analysis to establish the clinical utility and analytical validity of your diagnostic, identifying its precise role within the clinical pathway.
  • Develop early models to explore the potential economic value of your diagnostic.
  • Conduct gap analysis projects, which involve reviewing the value proposition for a technology and mapping existing evidence against key value messages to inform future evidence generation.
  • Structure clinical evidence plans to anticipate future health technology assessment and payer requirements.

YHEC provides support to:

  • Integrate the patient voice into evidence development by using outcomes research in a meaningful manner.
  • Synthesise your evidence and value story through literature reviews, economic models and statistical analysis.
  • Create compelling value communications that are easy to interpret and resonate with stakeholders
  • Conduct structured expert elicitation where evidence may be limited, incomplete or uncertain.
  • Align your evidence with the expectations of payers, HTA, and other key decision makers.

Preparing your value proposition and market access strategy is important for a successful launch. We work with you to:

  • Anticipate payer expectations for economic models and evidence submissions, considering how to demonstrate the impact on downstream costs and patient outcomes.
  • Adapt global evidence to local HTA requirements, ensuring your submission is relevant and persuasive for specific national and regional contexts.
  • Create defensible HTA submissions that resonate with stakeholders.
  • Prepare for HTA consultations and scientific advice meetings.

After launch, continuous monitoring and evidence generation are important for long-term success. We assist you to:

  • Strengthen your value proposition with real-world data that reflects the lived experiences of patients and clinicians.
  • Prepare for evolving healthcare expectations by embedding considerations of sustainability and equity into your continuous evidence plans.
  • Analyse patient registries and health databases to collect real-world data supporting your diagnostic device, leveraging the real-world evidence to enhance your value messages and communications.

Talk to our expert

To find out more about our work with the diagnostic sector, talk to our expert – Matthew Taylor

A head and shoulders photo of Matthew Taylor sitting in front of a bookcase in his office.