Inferential burden audit for devices, therapeutics, clinical trials and instrument development

Evidence reading for deep tech

Technology readiness is not evidence readiness.

A TRL says what the team has done. It doesn't say what the evidence supports. We audit the record and state what it is entitled to claim.

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01

Burden of evidence

Progress is not a matter of accumulating evidence, but of clearing the right evidence.

Every claim in product development activates a burden, one that the development cycle must clear. NADIR audits these burdens, records whether they have been cleared, and shows which ones remain unresolved and block progression [1].

A diligence report tells you what the team did, what has been demonstrated, and in what environment. It does not tell you which piece of evidence may yet be missing.

02

NADIR-TRL

Most existing instruments read evidence backwards [2]: once the results are in, what do they stand for?

NADIR reads evidence forward. It was developed in cardiovascular medicine, on two large trials of the same hypothesis that returned conflicting results. Twenty pre-defined dimensions cover design and positioning, measurement and analysis. Any evidence that meets the standard clears a burden; study designs are not ranked.

NADIR-TRL is the extension of the original framework into product development. It provides a realistic TRL development stage by addressing the activated and retained burdens; a product may claim to be at a much higher level than the evidence supports.

NADIR-TRL develops not just the audit of the existing burden, but also an inference-driven development map, which targets the activated burden clearance by the path of least resistance, in terms of funding, time and developer effort.

It is at its most useful in complex developments that do not follow a common or traditional pathway, where standard readiness checklists have no template to lean on.

03

Three audits

Three audits from the public domain. Every cell is sourced.

01Activity without movement
Electrochromic space-suit radiatorNASA Game Changing Development · public record

A full-suit variable-emissivity radiator can actively regulate heat rejection during spacewalks [3].

Nd (RADIATOR.heat-rejection @ 2015-08)
= { ∅ | A1 A9 B1r B3 || A3 A4 A7 A8 A10 B1a C2 C6 } · Licensed TRL 3 · NASA TRL 3

Nd (RADIATOR.heat-rejection @ 2016-01)
= { B1r | A1 B3 || A3 A4 A7 A8 A9 A10 B1a C2 C6 } · Licensed TRL 3 · NASA TRL 3

Binding burden: B1r, repeatability of the emissivity measurement (TRL 4). Six months of documented work moved five burdens from activated to cleared. The licensed level did not move, because the one burden that controls level 4 was never discharged.

02One label, two claims
Ejecta STORM lunar-plume instrumentSame hardware · same date · two claims

Claim A: the instrument integrates with a lander and returns usable data under flight conditions. Claim B: the instrument recovers the entire particle-size distribution of the plume [4].

Nd (STORM.integration @ 2024-02)
= { ∅ | ∅ || A3 A4 A7 A8 A9 A10 B1a B1r B3 C6 } · Licensed TRL 6 · NASA TRL 6

Nd (STORM.full-distribution @ 2024-02)
= { A9 | A1 C2 || A3 A4 A7 A8 A10 B1a B1r B3 C6 } · Licensed TRL 4 · NASA TRL 6

Binding burden for claim B: A9, restricted outcome range (level 5): four lasers constrain only part of the distribution. NASA's TRL 6 is correct for the first claim and not for the second.

03Premature level evidence
Anti-inflammatory therapy for atherosclerosisCardiovascular medicine · two published trials

Claim: lowering vascular inflammation reduces cardiovascular events in patients with prior events and residual inflammatory risk. CANTOS tested canakinumab [5]; CIRT tested low-dose methotrexate [6]. Population burdens are active here: this is a claim about patients, read through a measurement.

Nd (CANTOS.events @ 2017-08)
= { ∅ | ∅ || A2 A3 A4 A7 A8 A9 A10 B1a B1r C3 C6 } · Licensed TRL 8 · Claim licensed

Nd (CIRT.events @ registration 2012)
= { A2 | A8 A9 C3 || A3 A4 A7 A10 B1a B1r } · Licensed TRL 4 · Level-8 record commissioned

Nd (CIRT.events @ 2018-11)
= { A2 A8 | ∅ || A3 A4 A7 A9 A10 B1a B1r C3 } · Licensed TRL 4

Binding burden at registration: A2, population mismatch. CIRT enrolled on diabetes or metabolic syndrome as a proxy for inflammatory risk; the claim names inflammation, and the record at registration did not carry the marker. That burden was retained before a patient was enrolled and is the first member of the terminal set. A8, exposure contrast, was carried at registration on rheumatology evidence and failed at interpretation; a second route to the same mismatch. The CIRT evidence is not wrong. A level-8 record was commissioned over an open level-5 burden that was visible in the registration, and that is what the ledger reports.

Code key: A1 information adequacy · A2 population · A3 temporal alignment · A4 historical baseline · A7 construct–measure mismatch · A8 exposure contrast · A9 restricted outcome range · A10 prior pathway · B1a instrument accuracy · B1r measurement repeatability · B3 temporal instability · C2 model specification · C3 analysis set · C6 mechanism interrogation.

04

For funders

An audit before the tranche, not after the pivotal.

What you receive: a concurrent audit of the development plan, run against the record the company holds today. It states the TRL the company claims, the TRL the evidence licenses, and the retained dimension that separates them.

What a diligence memo does not give you: whether the study you are about to fund clears a retained dimension at all; which evidence would move the level further; what the company already holds and is not credited for; and how many attempts each retained dimension has already absorbed, at what cost, and whether it moved.

Every audit element is elaborated and justified, so that any possible discussion can follow.

05

For developers

The development map, before the money is spent.

What you receive: the dimensions your claim activates, which of them the record already clears, and which one holds the next level. With it, the inference-driven development map: the path of least resistance to clearance, in funding, time and developer effort.

What it gives you: credit for evidence you already hold, which a readiness label cannot show; the cheapest evidence that clears the binding dimension, rather than the study everyone expects; and a clearance specification per dimension, the design, the standard it must meet and the check that it did, so the next study is the one that moves the level.

You control the record. You grant access, you see the full audit before it is dated, and you may add evidence to it. It is not a score, not a rating of the company and not a verdict on the team. It is a statement of what your record supports, which is also the document you will be asked for at the next round.

NADIR-TRL provides a unified funder–developer vocabulary, read from both sides of the table: the same twenty dimensions, the same page in both hands. What the funder reads as risk, the developer reads as the next purchase, and both can say why.

An audit is not a verdict. It is guidance: each retained dimension comes with a set of possible clearance suggestions, so funder and developer can discuss the pathway and its implications over the same page.

06

Price structure

Priced by the evidence problem, not by the company.

Audit
€2,000–6,000
one claim, one dated page

The figure depends on how many dimensions the claim activates: a bench measurement claim activates fewer than a clinical outcome claim.

Clearance suggestions
per dimension
beyond the audit

The audit names the binding dimension. Clearance work specifies routes for three to five retained dimensions: for each, the cheapest evidence that meets the standard, the design that produces it, and the check that it did. We suggest the pathway; the company runs it. Further work by the hour.

Cycle support
from €15,000
one product, one development cycle

From the product development plan, we provide the prospective account of inferential burdens, with the planned study checked against the retained dimensions before it is bought. Work beyond the re-audits is by the hour.

Every price is set by two numbers you already know from the audit: claims and dimensions activated. Nothing is charged per company.

Terms

Independence. An audit is fixed and dated before any clearance work is offered, and clearance work does not re-code it. The company sees the ledger and may add evidence to it; it does not negotiate the coding. Audits are double-coded; disagreements are resolved on the record and the resolution is deposited with the audit.

Three parties. The record belongs to the company. The company grants access, sees the audit in full, and may add evidence before it is dated. The funder receives the same page. An audit states what the record supports on a named claim at a named date; it is not a rating of the company, not a recommendation to invest, and not for circulation beyond the parties who commissioned it.

Confidentiality. The record stays with the auditor for the engagement and is not retained afterwards without written agreement. We sign the funder's and the company's confidentiality terms. The justification behind the page is available to the commissioning parties and to no one else.

Who audits. [Name], [title], [institution]. Epidemiologist and trialist; developed NADIR on cardiovascular outcome trials and ran the readiness demonstration on NASA development records. [One line of track record.]

07

Sample audit

A real product. A real record. A different answer.

DERMAE - non-invasive skin-cancer imaging. DAMAE Medical · EU Horizon 2020 · public-record audit [7].

The DERMAE project reported progression from TRL 4 to TRL 6 after preclinical testing and imaging of human skin tumours. NADIR-TRL reaches a different level for the clinical claim.

DERMAE.clinical-diagnosis @ 2015-09Public-record audit · historical

A non-invasive imaging device can support immediate and early-stage skin-cancer diagnosis during clinical examination.

Claimed
6
Project closeout
Licensed
4
For the clinical-diagnosis claim
Gap
2
Evidence generated above the binding burden

Binding dimension: A2, population / intended-use mismatch. Demand: suspicious skin lesions, imaged in situ in patients during the clinical examination. Record: human basal-cell carcinomas and melanomas were imaged only after the dermatologist had removed the tumour. The project report separately identifies direct imaging on the patient, development of the handheld clinical device, and clinical validation as subsequent work.

The technology had moved. The stronger clinical claim had not yet moved with it. What clears the next level: evidence generated in the intended-use frame - lesions imaged in vivo, before excision, under the conditions in which the diagnostic claim will actually be used.

This does not mean the programme's TRL 6 was "wrong". TRL 6 described the maturity of the technology and its preclinical demonstration. NADIR-TRL asks a narrower question: what readiness level does the existing record license for this particular claim?

The gap was temporary, and the record shows it being closed: the project itself named in-patient imaging, the handheld clinical device and clinical validation as the next steps, and the subsequent development delivered them - in vivo imaging is today the product's headline evidence. That is exactly what NADIR-TRL serves: a within-development audit that names the evidence the next stage must produce, while the technology is still moving. Read in 2015, the audit would not have argued with the programme; it would have handed it the map.

Contact

One company.
One week.
One audit you can check.

Give us a portfolio company you are unsure about. We return the audit in five working days; you check it against the record; you decide whether it is worth using on the next one.

Or write directly: [email]

References

[1] [NADIR-TRL framework paper: authors, title, journal or deposit, year, DOI]

[2] [NADIR instrument paper: authors, title, journal, year, DOI]

[3] [NASA Game Changing Development, electrochromic radiator record: report identifier, year, URL] · readiness demonstration deposit, DOI

[4] [Ejecta STORM record: report identifier, year, URL] · readiness demonstration deposit, DOI

[5] Ridker PM et al. Antiinflammatory therapy with canakinumab for atherosclerotic disease. N Engl J Med 2017;377:1119–31.

[6] Ridker PM et al. Low-dose methotrexate for the prevention of atherosclerotic events. N Engl J Med 2019;380:752–62.

[7] European Commission CORDIS, DERMAE project 685041, periodic report, 1 April – 30 September 2015. https://cordis.europa.eu/project/id/685041 - every substantive statement in the audit is traceable to the dated public project record.