idea-010 · desirability deck
Every slide states a condition that would have to be true, then reports where it stands using the candidate file's own claim and its own confidence tag. A deck never upgrades a tag, invents a number, or recommends anything, and there is no ask slide.
The chair: the user. The heart-failure or nephrology prescriber deciding whether to go up a dose step this morning, the medical assistant who has to get the drop out of the finger, and the patient whose arm the alternative needle goes into.
How to read this: every slide is a condition, not a conclusion. A bracketed reference points into knowledge-base/candidates/idea-010.md — the number is the claim's position in its ## Claims list and the tag is copied from it, never adjusted here. [no claim] means nothing in the file speaks to the condition at all. See docs/deck-spec.md.
One number to read correctly before anything else: the candidate carries a Verified Composite of 60/100 computed over Factor 1 alone, which is 15% of rubric weight. It is a renormalisation, not a verdict — 85% of the rubric contributes nothing in either direction, and no factor in the rubric scores whether a user wants this at all. That is why this deck exists, and it is why every condition below rests on unconfirmed or unverified claims.
Would have to be true: An adult with chronic heart failure or CKD, in an outpatient visit where the prescriber wants to start or uptitrate a RAASi or MRA, would have to be in a clinic where that decision today waits on a venous draw sent to an outside laboratory and a result that arrives after the patient has gone home.
Where it stands: The clinical premise is stated and unchecked in both halves. Fear of hyperkalemia is claimed to drive underdosing, discontinuation and failure to reinstate RAASi and MRAs, with cessation rates of roughly 34.7% and 52.8% at one year after a hyperkalemia diagnosis taken from a secondary source [claim 20: unconfirmed]; the monitoring cadence that makes an in-visit result valuable — baseline, ~2 weeks, ~1 month, periodically — comes from a guideline summary rather than the guideline [claim 21: unconfirmed]. The population figures in the file (HF and CKD prevalence) are explicitly aggregator-grade and flagged as not a TAM input and not to be multiplied by anything [claim 19: unconfirmed]. Nothing in the file establishes that the send-out-and-wait workflow is what these clinics actually do today [no claim].
What would settle it: The primary papers behind the cessation figures and the ACC/AHA and KDIGO guideline text itself, read by a human and attached as manual citations — the file's own gap analysis names exactly this and notes no primary paper or guideline was read. Then a workflow audit at a handful of named HF and nephrology clinics: where does the potassium specimen physically go today, and how long until the prescriber sees it.
If it's false: If clinics already have same-visit potassium — a benchtop analyzer on site, or a lab courier that returns results within the visit — the moment this product is designed for does not exist and Factor 6's clinical premise loses its purpose. It would not make the device wrong; it would make it unnecessary.
Would have to be true: The prescriber would have to change the RAASi or MRA dose in the visit, on the fingerstick number, rather than ordering a confirmatory central-lab draw and deferring the decision anyway.
Where it stands: The file records this as an assumption in those words, and says outright that if it fails "the value proposition dies while the device works" — there is no connector for clinician behaviour and no primary research behind it; connectors adoption is unverifiable by design [claim 28: unconfirmed]. The file's own unresolved-claims section names this the most valuable primary research in the file. A second behaviour is now on record through this deck and equally unbacked: what the prescriber does when the strip suppresses a result rather than reporting one [claim 31: unverified].
What would settle it: Structured interviews with twenty US outpatient HF and nephrology prescribers against a specific vignette — an in-band potassium on a fingerstick strip, a patient in front of them, a dose step available — asking not whether they like the idea but what they would write. A published preference study would substitute; adoption cannot.
If it's false: Factor 6's premise survives and the product still fails. The device becomes a screening step that generates a confirmatory venous draw instead of replacing it, which adds cost and workflow to the visit while removing nothing — and Slide 4's cost argument inverts.
Would have to be true: The clinic as an institution would have to obtain and hold a CLIA Certificate of Waiver and absorb the quality-control, documentation and operator-competency burden that comes with insourcing a test — and the medical assistant or nurse at the chair would have to be able to get an adequate drop out of the finger.
Where it stands: The certificate willingness is recorded as an assumption, with the file noting that the certificate rules are CMS facts but the willingness is not [claim 29: unconfirmed]. Whether the device could ever be waived at all runs through the FDA Dual 510(k) and CLIA Waiver by Application pathway, which is structurally unconfirmable here — no connector reads FDA guidance documents [claim 8: unconfirmed]. The operator question is on record only through this deck [claim 32: unverified], and it is not a soft one: heart-failure and CKD patients are disproportionately edematous, cool-peripheried and frequently lanced, and finger-milking to raise a drop is the classic cause of the very hemolysis the device must then reject [claim 22: unconfirmed]. The payer, who is the other party that has to say yes, is the viability deck's Slide 1 and 2 [claim 14: unconfirmed].
What would settle it: The CMS CLIA Certificate of Waiver requirements and the waived-test QC obligations, read by a human; a survey of HF and nephrology practice managers on whether they hold a waiver today and what stopped them. For the operator half, a small collection study in an ordinary clinic measuring first-attempt adequate-volume rate by staff role, in the actual patient population rather than in healthy volunteers.
If it's false: The buying unit disappears. A device that only high-complexity CLIA sites can run is sold to hospital laboratories, which is a different product, a different customer and a different price — and the professional-POC launch indication that the whole regulatory narrowing was designed around loses its point.
Would have to be true: The patient would have to accept an extra fingerstick and the clinic an extra few minutes of staff time, in exchange for actually avoiding the separate lab trip — not in addition to it.
Where it stands: Patient acceptance of the additional stick is an assumption in the file with no primary research behind it [claim 30: unconfirmed]. The harder half is new on this deck: this device reports potassium and creatinine only, and if the titration visit still needs the rest of a metabolic panel the venous draw happens anyway and nothing is saved [claim 33: unverified]. What the patient pays out of pocket cannot be stated at all — no claim in the file carries a price; the price leg of TAM is bounded above by an unverified CLFS allowable and below by an unquantified strip COGS, and asserts no number [claim 17: unconfirmed]. Whether any coverage restriction lands on the patient is an unexamined gap rather than an absence of restrictions [claim 15: unconfirmed]. And the invalid-result case costs the patient a second stick or the lab trip regardless [claim 23: unconfirmed].
What would settle it: A patient-preference study in a RAASi-titrating population, or a published one attached by a human. For the panel question, an audit of what is actually ordered at HF and nephrology titration visits — a claims or EHR order-set extract, which answers it directly. For the money, the CMS Clinical Laboratory Fee Schedule file plus a Tier 3 strip-cost estimate; the viability deck holds that inequality.
If it's false: The value exchange collapses into pure addition — a stick plus a draw plus a wait — and Factor 3's reachable-share assumption [claim 18: unconfirmed] is being applied to a switch nobody has a reason to make.
Would have to be true: A prescriber would have to see capillary-versus-venous potassium agreement demonstrated in their population — outpatient, non-dialysis, on RAASi — before titrating on the number.
Where it stands: No such evidence is claimed anywhere in the file, and the requirement itself is on record only through this deck [claim 34: unverified]. What the file does carry cuts the other way and is the reason the requirement is sharp: capillary sampling lyses red cells, hemolysis releases intracellular potassium, and falsely elevated potassium is the named reason a strip-based fingerstick potassium meter plausibly does not already exist [claim 22: unconfirmed]. The device's own answer to that is suppression rather than correction, so what the clinician experiences is not a wrong number but a missing one [claim 23: unconfirmed]. No guideline mention, no professional-society position and no comparative study is claimed [no claim].
What would settle it: A human reading, at full text, the published capillary-versus-venous potassium literature — the Stage 0 literature scan logged to knowledge-base/signals/log.md on 2026-08-25 names specific records and is explicitly a pointer carrying no confidence tag, so it evidences nothing here and cannot be cited as agreement or as disagreement. Note also that the published work that scan points at sits in dialysis and non-US primary-care populations, which is not this indication. Definitive answer is the candidate's own paired method-comparison study.
If it's false: Adoption requires generating the evidence first, which moves a several-hundred-patient comparison study from post-launch marketing into the pre-revenue critical path and lands directly on Factor 7 [claim 26: unconfirmed].
Would have to be true: In the first handful of real clinics, a majority of titration visits would have to end in a dose decision made on the strip result, with the fraction of attempts that produce no usable result low enough that staff keep reaching for the meter.
Where it stands: Both halves are unbacked. The dose-decision half is the file's own headline assumption [claim 28: unconfirmed] and its suppressed-result variant is this deck's [claim 31: unverified]. The usable-result half is the file's failure-mode consequence claim, which states plainly that a device voiding one draw in four is not clinically usable however accurate it is on the rest [claim 23: unconfirmed] — and the file also states that no connector in this repo can reach that number, because it is bench physics on a device that does not exist [claim 22: unconfirmed].
What would settle it: Two cheap things, in this order. (1) Twenty prescriber interviews on the vignette in Slide 2 — days, not months, and it can be run before a single strip is built. (2) A human reading the published capillary-versus-venous literature at full text for reported hemolysis and rejection rates. Neither is a connector call; adoption returns unverifiable by design and must not be cited as having checked anything.
If it's false: The desirability case is decided before any engineering is funded — which is the point of running these two first, and the reason they sit ahead of the bench work on the feasibility deck.
Every condition above with nothing verified behind it. That is all six of them. The candidate has six verified claims and every one is a regulatory database fact — a CFR section, two product codes, two 510(k) records. Not one verified claim in this file speaks to a user.
adoption is
unverifiable by design.
Read the shape, not the count. Four of these now carry claim numbers only because this deck put them there this morning, tagged unverified — that is an assumption made visible to the Verifier, not an assumption resolved. The rubric scores no factor for whether a user wants the thing, so a desirability deck resting entirely on unconfirmed and unverified is the expected result and is information about the pipeline as much as about this idea.
If only one thing from this chair could be checked: whether an outpatient heart-failure or nephrology prescriber will actually change a RAASi or MRA dose within the visit on a fingerstick potassium result, instead of ordering a confirmatory venous draw and deferring [claim 28: unconfirmed].
It is chosen over the two conditions that look bigger. The hemolysis physics [claim 22: unconfirmed] decides whether the device can exist, but it is bench work no agent here can do and it is the feasibility deck's load-bearing condition. The margin inequality [claim 14: unconfirmed] decides whether the business works, and it is the viability deck's. This one decides whether either matters: a device that performs perfectly and is followed by a confirmatory draw every time has delivered nothing to anyone, and unlike the other two it can be checked by talking to twenty people before any capital is committed.
Naming it is not a recommendation, a gate, or a kill. It is the answer to "check what first."