About ORIVISE

Independent IVD Feasibility & Technical Risk Advisory

ORIVISE supports early-stage diagnostics and IVD teams at critical decision points where technical uncertainty can affect development progress, funding confidence or investment readiness.

Built on 20+ years of diagnostics R&D experience and strengthened by Executive MBA training, ORIVISE combines deep technical judgement with commercial and strategic thinking.

We help teams step back, define the right technical questions and make clearer decisions before committing major time, funding or development resources.

The ORIVISE Approach

Problems in assay development

Identify the Problem

Many diagnostics programmes generate data before clearly defining the decision that data is meant to support.

This can lead to:

  • Unclear feasibility conclusions

  • Unstable or non-reproducible assays

  • Late-stage redesign

  • Delays in development or investment readiness

Analyse and solve assay problems

Analyse & Solve

ORIVISE applies structured technical judgement across:

  • Assay feasibility and architecture

  • Immunoassay and reagent strategy

  • Bioconjugation and assay optimisation

  • Analytical performance and reproducibility

  • Development-readiness and transfer risk

Decision-tree

Make the Right Decision

ORIVISE helps teams answer:

  • Is this assay technically feasible?

  • Where are the hidden risks?

  • What evidence is missing?

  • What should be refined, paused or progressed?

  • Is the programme ready for development, funding or investor review?

Dr. Pompi Hazarika‍ ‍

IVD Consultant & Founder, ORIVISE

Independent diagnostics and IVD advisor specialising in early-stage feasibility, technical risk assessment, assay troubleshooting and development readiness.

20+ years in diagnostics R&D | PhD, Germany | MSc, IIT India | Executive MBA candidate, UK

ORIVISE combines deep diagnostics R&D expertise with commercial and strategic thinking to support critical development, funding and investment decisions.

Dr. Pompi Hazarika - IVD Consultant and Founder of Orivise Diagnostics Advisory

Experience

Dr. Pompi Hazarika has held roles across global diagnostics organisations, including Thermo Fisher Scientific and The Binding Site, as well as academic institutions including the University of East Anglia and the University of Manchester.

Her experience spans:

  • Early-stage IVD feasibility and new product development

  • Immunoassay architecture, including ELISA and particle-based systems

  • Biochemistry-driven assay and reagent design

  • Troubleshooting, reproducibility and assay optimisation

  • Transition into design-controlled environments aligned with IVDR and ISO 13485 expectations

  • R&D team leadership within regulated diagnostics settings

Perspective

Early technical decisions shape cost, timelines, regulatory readiness and product success.

Many IVD programmes generate significant data before clearly defining the decision that data is meant to support. This can create technical debt, delayed milestones and costly rework later in development.

ORIVISE provides structured, independent technical judgement to help teams decide what to pursue, refine or pause before committing further development time, funding or capital.

Who This Is For

ORIVISE supports early-stage diagnostics start-ups, R&D teams, investors, researchers and university spin-outs navigating critical technical decisions in IVD development.

This includes teams preparing for feasibility review, assay troubleshooting, development-readiness assessment, technical due diligence, grant-led translation or investor discussions.

Not Sure What the Next Technical Step Should Be?

ORIVISE helps founders, researchers, investors and innovation teams step back, assess feasibility, identify hidden risks and make clearer development decisions.