Question 1

What is assay feasibility and why does it matter in IVD development?

Accepted Answer

Assay feasibility is the systematic assessment of whether an in vitro diagnostic assay can realistically achieve required analytical performance — including sensitivity, specificity and reproducibility — under practical development conditions. Most IVD programmes that stall do so not because the science lacks promise, but because feasibility assumptions were not tested against a clear decision framework early enough.

Question 2

Why is my immunoassay not reproducible or showing high variability?

Accepted Answer

Immunoassay variability is usually driven by underlying system instability. The most common root causes are inconsistent bioconjugation — where antibody-particle attachment degrades between batches — reagent instability affecting binding characteristics over time, and poorly controlled assay conditions including buffer composition, temperature and incubation timing.

Question 3

What is technical debt in IVD development?

Accepted Answer

Technical debt in diagnostics arises when assay data is generated without a clear decision framework — accumulating unresolved questions and untested assumptions that compound during scale-up, CDMO transfer or regulatory review. It manifests as unexpected variability, failed transfer or the need to repeat characterisation studies.

Question 4

What makes an assay development-ready?

Accepted Answer

An assay is development-ready when it demonstrates stable, reproducible performance across defined conditions and operators, has clearly defined critical parameters, and shows that performance is consistently achievable — not just demonstrated once. The reagent strategy and evidence base must support a clear, costed development plan.

Question 5

When should I engage an independent IVD consultant?

Accepted Answer

The highest-impact timing is before investor discussions, grant applications or major development investment — when assay performance is inconsistent, when preparing for CDMO transfer or scale-up, and when independent technical assessment is required by an investor or partner.

Question 6

How is ORIVISE different from a CRO?

Accepted Answer

ORIVISE provides independent technical evaluation and decision support — not laboratory execution. Where CROs generate data, ORIVISE focuses on ensuring the right questions are being asked of existing data and that decisions are based on robust technical foundations before resources are committed.

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