About Orivise
Independent IVD Feasibility & Technical Risk Advisory
Orivise was built to solve a recurring problem in diagnostics
Teams generate data, but aren’t always clear what decision that data is meant to support. As a result, programmes slow down, costs increase, and technical risk compounds.
We provide independent technical input to help teams step back, define the right questions, and make confident early-stage decisions before committing to full development.
Identify the Problem
Many diagnostics programmes enter development without validated technical foundations.
This leads to:
Unstable or non-reproducible assays
Late-stage redesign
Delays in regulatory readiness
Misaligned investor expectations
Analyse & Solve
We apply a structured approach to evaluate and resolve:
Assay feasibility & architecture
Immunoassay development
Bioconjugation & reagent strategy
Analytical performance
Technical risk (ISO 14971)
Development readiness & transfer
Make the Right Decision
We provide independent technical judgement to answer:
Is this assay truly feasible?
Where are the hidden risks?
What is driving performance issues?
Are you ready for development or transfer?
Dr. Pompi Hazarika
IVD Consultant & Founder, Orivise
Independent IVD advisor specialising in early-stage feasibility and technical risk assessment.
20+ years’ experience across UK, Germany, and India | 1000+ citations
Experience
Previously held roles within global diagnostics organisations including Thermo Fisher Scientific and The Binding Site.
Early-stage feasibility and new product development
Assay architecture (ELISA and particle-based systems)
Biochemistry-driven assay and reagent design
Transition into design-controlled environments (IVDR / ISO 13485)
Led immunoassay development and R&D programmes, including team leadership within regulated environments.
Perspective
Early technical decisions determine cost, timelines, regulatory outcomes, and product success.
Many IVD programmes generate significant data without clearly defining the decisions that data is meant to support.
Orivise provides structured, independent technical judgement to help teams decide what to pursue, refine, or stop before committing to development or capital.
Who This Is For
Start-ups, R&D teams, and investors navigating critical technical decisions in early-stage IVD development.
Ready to make a confident technical decision?
If you're working on an early-stage assay or evaluating a new diagnostic concept, Orivise provides the clarity you need to move forward.