Early-stage IVD feasibility & technical judgement

Clarity Before Commitment in IVD Development

Independent technical judgement to help diagnostics teams decide what’s worth pursuing, fixing, or stopping - before committing to development.

Orivise is a specialist technical consultancy supporting start-ups, spin-outs, and growing diagnostics teams in early-stage assay development-across feasibility, bioconjugation strategy, and development readiness.

We combine deep assay science expertise with proportionate IVDR and ISO 13485 design-control awareness to bring clarity to technical risk and early development decisions - reducing the likelihood of costly downstream rework.

Most development delays don’t come from lack of effort, but from unclear early decisions.

Where Orivise adds value

Before feasibility is clear

You have a promising concept but uncertainty remains around whether it will work in practice.

When results are inconsistent

Assay performance lacks reproducibility, and the underlying causes are unclear.

Before committing to scale

You need confidence in your approach before progressing further into development.

How we support

  • Feasibility and Risk Clarity

    Understand whether your concept is viable and what risks matter most.

  • Assay & Bioconjugation Troubleshooting

    Identify root causes and define practical paths to improve performance.

  • Development Readiness

    Ensure early work is robust, transferable, and aligned before scaling.

We provide independent, senior technical judgement at the point where decisions matter most before significant time and cost are committed.

Need clarity on whether your assay is ready to move forward?

Why Orivise

  • Focused on early-stage decisions not lifecycle consulting

  • Deep expertise in assay development and bioconjugation

  • IVDR-aligned, proportionate design-control thinking

  • Independent, senior technical judgement

How We Work

Orivise provides focused, project-based technical advisory at key points in early-stage development, centred on feasibility, risk, and development readiness.

Engagements are intentionally short and tightly scoped, designed to bring clarity to critical decisions without introducing unnecessary complexity or regulatory burden.

Founder Snapshot

Led by Dr Pompi Hazarika, a technical consultant with deep experience in assay development, bioconjugation, and early-stage IVD development.

Her work focuses on feasibility, design-control thinking, and development readiness - supporting teams in making clear, confident technical decisions within IVDR- and ISO 13485-aligned environments.

Get in Touch

If you are developing an assay or IVD concept and need clear, independent technical judgement at an early stage, we’d be happy to discuss whether Orivise is the right fit.