Monograph Companion — Structured Self-Assessment
A practical companion to the monograph, applying its framework to a simplified project case.
This tool provides a functional completeness assessment of a diagnostic system, applied to a specific project, including both current state and funded development.
It is designed to simplify the monograph into practical questions without pretending to replace detailed product, regulatory, commercial, or financial analysis. Because apparently humans insist on wanting usable things.
Answer for one specific project or offering. If a partner provides a function, answer based on the combined offer.
Stage 1 of 4 — Product & Evidence
The monograph starts from the product itself. Before anything else, the project must exist as a system, have a defined clinical role, and show evidence that the results matter in care.
Q1 — System
Is this product available as a complete and industrialised analytical system suitable for the intended point of use?
Think in terms of the actual usable system: instrumentation, reagents, software, workflow, and the level of standardisation needed for the intended setting.
Q2 — Clinical indication
Is this product used within defined clinical pathways to support patient care decisions?
The question is not whether the technology is interesting. It is whether the product has a defined place in care where its result informs a decision.
Q3 — Clinical evidence
Is clinical evidence in place showing that this product’s results change patient management?
This is about evidence that links product output to clinical action. Technical performance alone does not satisfy it.
Stage 2 of 4 — Institutional Authorisation
These conditions determine whether a product can be authorised and paid for. They are not internal preferences. They depend on outside institutions that move on their own timelines, because of course they do.
Q4 — Regulatory
Is a regulatory pathway in place for this product with the ability to obtain approval?
Consider whether the path is defined for the product and whether the organisation or combined offer has the capability to execute it credibly.
Q5 — Test payment
Is there a viable pathway for this test to be paid for in routine use, whether by reimbursement, out-of-pocket payment, or another mechanism?
The question is whether payment logic exists in practice for routine use, not whether someone hopes a payer will eventually agree.
Stage 3 of 4 — Deployment Capability
This is where products stop being ideas on slides and start colliding with supply, compliance, service, placement, and customer-facing reality.
Q6 — Supply, service, and compliance
Is supply, service, and operational compliance capability in place to deploy this product at clinical standards?
This includes the ability to supply, maintain, and support the product compliantly in the intended setting, not merely to ship a prototype and hope for the best.
Q7 — Customer interface and placement model
Is capability in place to access customers, deploy the product, and support its use, including customer interface and financing or placement models where applicable?
This includes the commercial interface with customers, deployment support, and any financing or placement logic needed to make the offer work in practice.
Stage 4 of 4 — Capital
Capital is not a decorative line in a strategy deck. It determines whether the crossing can survive long enough for any of the other conditions to matter.
Q8 — Financing the crossing
Is financing secured to carry this product through the whole crossing?
Assess whether funding is secured across development, regulatory work, initial market deployment, and the period before real revenue arrives.