Independent Technical Judgement for Early-Stage IVD Feasibility
Helping early-stage diagnostics start-ups and founders decide what to pursue, fix or stop before committing to development or capital.
Led by Dr. Pompi Hazarika | PhD | Executive MBA Candidate
✔ 20+ years in diagnostics and IVD R&D across early-stage and regulated environments
✔ Immunoassay & bioconjugation expertise
✔ ISO 13485 & IVDR experience
The Decisions That Determine Development Success
Most early-stage IVD programmes fail not due to lack of effort but because data is generated without a clear decision framework, which leads to technical debt, costly rework, and missed milestones.
These decisions typically centre on three critical areas:
Risk
What hidden technical risks could delay your next development or funding milestone?
Regulatory Readiness
Is your data structured to meet IVDR/FDA design-control expectations?
Scalability
Will this assay architecture translate into robust, high-volume manufacturing?
How Orivise Works
Orivise Helps You Make the Right Technical Decision: Before You Commit
Orivise conducts independent technical audits to evaluate feasibility, identify hidden risks, and define the critical path to development readiness.
Define the Decision
Clarify what the data must prove
Audit Existing Data
Review assay performance and evidence
Identify Risks and Gaps
Surface hidden failure points
Assess Feasibility
Determine technical and commercial viability
Recommend Next Steps
Provide a clear, actionable development path
Who We Support at Critical Decision Points
Early-stage IVD Startups & Founders
Validate assay feasibility before committing to development, avoiding costly rework and failed programmes.
VCs & Investment Partners
Independent technical due diligence on assay feasibility and underlying data before committing capital.
Diagnostic CDMOs
Ensure programmes are technically transfer-ready and reduce failure risk.
Strategic R&D Leadership
Resolve persistent assay performance issues and uncover hidden technical risks.
Working on an early-stage IVD programme?
Technical Challenges We Address
We focus on the specific failure points that determine whether a programme progresses or stalls.
Commercial Requirement Alignment
Align assay performance with real clinical and manufacturing requirements not unrealistic targets that waste time and capital.
Assay Failure & Variability Resolution
Identify root causes of variability, instability, and poor reproducibility across lots, operators, or platforms.
Early Feasibility & Go/No-Go Decisions
Assess early-stage data to determine whether a concept is viable, scalable, and worth investment.
Bioconjugation & Reagent Stability Risks
Evaluate instability in conjugation, surface chemistry, and reagents - most common hidden causes of assay failure.
IVDR / Design-Control Readiness
Structure experimental data into a framework aligned with ISO 13485 and IVDR/FDA expectations.
When to engage Orivise
Feasibility unclear, but decisions are approaching
Assay performance below target or inconsistent
Technical risks not fully understood
Data exists, but decision-making is unclear
Flexible Ways to Engage
Select the right engagement based on your stage
MOST TEAMS START HERE
Feasibility & Technical Risk Review
Structured evaluation of feasibility, key risks, and clear next steps
OTHER WAYS TO ENGAGE
Quick Scientific Call
Focused expert input on a specific technical question
Troubleshooting Deep Dive
Targeted root-cause analysis of assay design, reagents, and performance issues
Development Readiness Assessment
Evaluate whether early work is robust and ready for structured development
ONGOING SUPPORT
Fractional Scientific Advisor
Ongoing senior technical input for teams requiring continued guidance
Working on an early-stage IVD programme?
Case Example
Resolving variability in an early-stage immunoassay
Early-stage immunoassay with high variability and unstable performance.
Results not reproducible → blocking development progression.
Insight: Structured review of assay architecture, reagent interactions, and conjugation strategy identified bioconjugation approach as a major instability driver.
Outcome:
Improved reproducibility (CV significantly reduced)
Stabilised assay performance across lots
Clear path to development readiness
Key Questions to Answer Before Committing to IVD Development
Early technical uncertainty can slow development and increase risk. These are the most common questions teams ask before moving forward.
How do I assess the feasibility of my new in vitro diagnostic assay?
Why is my assay not reproducible or showing high variability?
When should we engage an IVD consultant?
What makes Orivise different from other IVD or MedTech consultants?
Led by Dr. Pompi Hazarika - 20+ years’ across UK, Germany and India, including senior IVD feasibility, assay development and NPD leadership in regulated diagnostics environments.
Need expert input on assay feasibility or a technical challenge?