ORIVISE SERVICES
Services aligned to critical diagnostic decision points.
Independent technical advisory for early-stage diagnostics and IVD teams where assay chemistry, feasibility, risk and development readiness affect funding, investment or commercial translation.
For Founders, Scale-ups & SMEs
Feasibility review, technical risk assessment, troubleshooting and development-readiness support before further product development investment.
For Investors & Innovation Funders
Pre-investment technical due diligence, data room review, assay feasibility assessment and independent challenge of technical claims.
For Academic Labs, Biohubs & Spin-Outs
Translation-focused feasibility input, grant work-package support, evidence-gap analysis and commercially credible development planning.
PILLAR 01 · TECHNICAL DECISIONS
Independent scientific insight to inform critical decisions.
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For teams that need an independent view of whether an assay concept is technically credible and ready to progress.
What's assessed
- Assay architecture and detection format
- Reagent compatibility and protein stability
- Formulation and conjugation strategy
- Analytical performance and data quality
- Technical assumptions and evidence gapsTypical outcomes
- Clear recommendation: proceed, refine or pause
- Evidence-gap analysis
- Prioritised next steps
- Stronger technical basis for development or fundingBest for
Founders, spin-outs and innovation teams deciding whether an early assay concept is ready to progress to structured development. -
For teams facing assay variability, reagent instability, weak signal or persistent performance problems.
What's assessed
- Aggregation, precipitation and conjugation efficiency
- Purification recovery and buffer effects
- Reagent variability and performance drift
- Signal-to-noise and background interference
- Run-to-run and lot-to-lot variabilityTypical outcomes
- Root-cause hypotheses and structured problem map
- Targeted experimental direction
- Practical troubleshooting plan
- Reduced iteration through clearer problem definitionBest for
Teams facing variability, weak signal, reagent instability, bioconjugation uncertainty or reproducibility problems. -
For teams preparing to move from feasibility into structured development, transfer or scale-up.
What's assessed
- Reproducibility and robustness evidence
- Reagent scalability and lot-to-lot risk
- Stability assumptions and transfer dependencies
- Development assumptions and technical file gaps
- Alignment with regulated development expectationsTypical outcomes
- Readiness assessment: what's mature, what's uncertain
- Defined technical gaps before transfer or scale-up
- Prioritised actions to improve readiness
- Clearer path toward formal development planningBest for
Teams preparing for transfer, scale-up, structured development or CDMO engagement, particularly 3–6 months before planned handover. -
For academic labs, biohubs, university spin-outs and funder-facing projects.
What's assessed
- Feasibility plan and technical rationale
- Evidence gaps and development assumptions
- Translational work-package structure
- Technical risks for grant or funder review
- Commercial and development-readiness logicTypical outcomes
- Stronger feasibility and translation narrative
- Clearer technical work packages
- Better-defined development milestones
- Improved readiness for funders, TTOs and industry partnersBest for
Academic labs, TTOs, biohubs and translational teams preparing for funding, spin-out, accelerator or industry-partner discussions. -
Independent assessment for investors and funding organisations evaluating early-stage diagnostics opportunities.
What's assessed
- Scientific mechanism and assay chemistry
- Evidence quality and claims versus data
- Manufacturability and development assumptions
- Reproducibility, scalability and data-room gaps
- Technical assumptions behind the investment caseTypical outcomes
- Technical due diligence memo
- Red-flag findings and material risks
- Prioritised questions for founders
- Clear view: proceed, investigate further or pauseBest for
Investors, angels, venture partners, accelerators and funding organisations evaluating early-stage diagnostic opportunities before committing capital. -
Senior diagnostics and R&D judgement on a flexible basis, without a full-time hire.
What this covers
- Technical strategy and programme-level decisions
- Investor and partner preparation
- Development planning and milestone prioritisation
- Independent challenge of assay development plans
- Support for disciplined, development-ready working practicesTypical outcomes
- Senior technical judgement at key moments
- Clearer development priorities
- Better-prepared investor or partner discussions
- Earlier identification of riskBest for
Early-stage teams needing senior diagnostics experience at key decision points but not yet ready for a full-time scientific or R&D leadership role.
PILLAR 02 · R&D PERFORMANCE
More efficient R&D and better use of resources.
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Identify where time, effort and resources are being lost
Structured review of how R&D work is planned, executed and reviewed: identifying inefficiencies, decision bottlenecks and process gaps that slow progress.
- How experiments are designed, prioritised and recorded
- Where decision-making creates delay
- Processes, tools and documentation practices -
Implement agreed changes and build sustainable practices
Practical support to implement improvements: helping new processes and working practices stick rather than revert.
- Implementing new processes and working practices
- Supporting teams through the transition period
- Building habits that make improvements sustainable
PILLAR 03 · R&D CAPABILITY
Senior expertise to build product-ready teams.
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Experienced product-development judgement without a full-time hire
Senior R&D advisory on a flexible retained basis: technical leadership at key moments without the overhead of a permanent role.
- Technical strategy and programme-level decisions
- Investor and partner preparation
- Establishing disciplined, compliant development practices -
Build confidence in regulated product development
Mentoring, coaching and capability development for scientists who need to work effectively in a regulated product development environment.
- Identifying the capability gaps holding the team back
- Practical training in product development practice
- Understanding design control, QMS and IVD regulation
WHEN TO ENGAGE ORIVISE
Engage at the moments where technical uncertainty becomes commercial risk.
Before investor discussions, grants or major development investment
Build a credible, defensible technical story. Identify what the evidence actually supports before claiming readiness.
During investment, acquisition, grant or partner evaluation
Identify hidden technical debt before capital is committed. Understand what the data room actually shows.
3–6 months before CDMO transfer, scale-up or formal development
Prevent costly transfer failures and rework. Establish what needs to be addressed before the next stage.
When assay performance issues stall programme progress
Unblock development and restore technical momentum with structured root-cause analysis.
ORIVISE READINESS FRAMEWORK · ORF-001
Technical Decisions engagements are structured through Define, Prove, Develop and Advance, with evidence assessed in four categories rather than misleading numerical scores.
Clarify the technical question, intended use and the decision the evidence must support.
Assess existing data, assay architecture, reagent strategy and performance claims.
Identify risks and gaps that could create rework or failed transfer at a costlier stage.
Recommend prioritised actions with clear conditions for progression, refinement or pause.
Not sure which service fits?
Start with a 30-minute discovery call focused on the decision you are trying to make.