Table 4. Our classification system for classifying diagnostic candidates into phases.
| Broad
categories provided by Policy Cures Research |
Stage | Our classification
system |
TRL
equivalent |
MRL
equivalent |
Short
descriptor |
Description of stage | Milestone at
end stage |
Status of risk
assessment |
Status of data | Status of quality
management system |
|---|---|---|---|---|---|---|---|---|---|---|
|
Early
Development |
Selection and
Validation |
Concept | 1 | -- |
What is the
idea? |
Technical concept
(whether innovative mechanism or unique integration of proven concepts) is under investigation. |
Concept
design, preliminary data |
Technical risks,
manufacturing risks, business risks not yet fully known. |
Preliminary
data on low n evaluations may be available, likely in academic publication in technical journal, or equivalent. Data collected in an academic and/ or prototyping laboratory. |
Not applicable |
| Feasibility | 2–4 | 1–2 | Can it work? | Prototype
development with all necessary system components designed and shown to meet specifications |
Feasibility
study data |
All key risks
are known and no data exist to suggest they cannot be addressed. |
Feasibility study
complete, and data indicate that product specifications can be met. Where relevant, manufacturing process data suggests design is manufactural reproducibly. |
Development is
under a quality management system; MRD and PRD ("TPP") exist in draft form. |
||
|
Late
Development |
Development | Early Development | 5–7 | 3–4 |
Can it give
the same result every time? |
Final system design
specifications complete ("design lock") and novel manufacturing processes established. |
MRD and
PRD |
Risk register
complete under mature quality system |
"Alpha" product
in a mature production environment meets design specifications in laboratory testing. |
MRD and PRD
are final, product is under design control |
| Late Development | 5–7 | 5–7 |
Can it be
manufactured and work every time? |
Final commercial
product produced on pilot (or final) manufacturing line |
Verification
data |
Technical file
complete other than clinical validation. |
"Beta" product
meets product specifications and is ready for validation. Verification plan exists and verification meets requirements. |
Technical file
("dossier") begun |
||
| Clinical Trials |
Regulatory
Trials |
Validation | 8–9 | 8–9 |
Does it work
as intended in the hands of customers? |
Clinical testing in
settings of use. |
Validation
study data ("regulatory trial") |
Technical file
for regulatory submission, including clinical data complete. Product meets specifications. |
Validation study
complete. Product meets specifications. |
Technical file
("dossier") complete |
| -- | On Market | Commercialization | -- | 10 |
Is it a
business? |
Customer use after
regulatory clearance. |
-- |
Abbreviations: TRL, Technology Readiness Level; MRL, Manufacturing Readiness Level; MRD, Market Requirements Document; PRD, Product Requirements Document; TPP, Target Product Profile