idea-016 · viability 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 investor, and the operator who has to make a per-procedure consumable sold into veterinary practices add up to a business with no third-party payer anywhere in the chain.
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-016.md — the number is the claim's position in its ## Claims list, the tag is copied from it and never adjusted here. A [no claim] marker means nothing in the file speaks to this. No number appears here that is not in a claim, and there is no ask slide. See docs/deck-spec.md.
Would have to be true: The veterinary practice's consumable budget would have to buy the kit as stock, and the pet owner's own wallet would have to settle it at the front desk as part of an ear-flush line item — with no third-party payer contributing anything at any point.
Where it stands: That is the file's own market-structure assertion: there is no CPT code, HCPCS code, LCD, NCD or other US third-party payer code for a veterinary procedure, the practice is the direct purchaser and the owner is the ultimate payer, out of pocket [claim 14: unconfirmed]. Insurance is not a second budget — roughly 6-7 million insured pets in North America against a US dog-and-cat population on the order of 150 million [claim 15: unconfirmed]. The file is explicit that this cannot be confirmed with the instruments here: cpt is AMA-licensed and returns unverifiable, hcpcs and coverage have no local cache in this environment, and a miss in a human code set is the wrong universe rather than evidence about veterinary coding [claim 13: unconfirmed].
What would settle it: The primary NAPHIA State of the Industry report, human-attached — one free document, and the only thing that moves the insurance leg. For the pass-through half, a veterinary practice-management price list showing what an ear-flush line item currently bears; licensed, and no connector reaches it.
If it's false: There is no alternative budget to fall back on. If the owner will not bear the cost, the practice stops stocking the kit, and the whole revenue model is a single link long.
Would have to be true: Code existence, payment amount and coverage policy would each have to land — except that in this lane the honest condition is the inverse: all three would have to be permanently absent, and the business would have to be built to not need any of them.
Where it stands:
cpt, missing local caches for hcpcs and coverage
[claim 13: unconfirmed].
What would settle it: Nothing, on the code and coverage legs — there is no code to find, and the file scores Factor 2 as a structural floor rather than pending research. The NAPHIA report settles the insurance leg; the payment leg only moves with real distributor and practice pricing.
If it's false: if some veterinary reimbursement referent did exist, Factor 2's floor would be wrong in the candidate's favour. Nobody should wait on that — the business case has to close on per-procedure consumable margin alone.
Would have to be true: Population x disease rate x in-clinic flush share x price would have to multiply to a market worth a sales motion — with each factor named separately, because a headline number here would be four assumptions in a trench coat.
Where it stands:
market connector returns unverifiable for market-size claims by
construction.
What would settle it: The primary Banfield State of Pet Health report for the rate leg — free, one document, human-attached. A licensed veterinary practice-management dataset (VetSuccess/Vetsource or equivalent) for flush share, per-practice volume and consumable pricing — real money. APPA or AVMA ownership sourcebooks for the population leg — licensed.
If it's false: TAM below 2/5 is an automatic kill in the rubric. It has not fired — TAM is blank, not scored below floor — but two of its three legs are unsourced by the file's own admission, and blank is not the same as clear.
Would have to be true: The sequence before the first invoice would have to be tooling a moulded dual-lumen disposable and running a bench programme — with no regulatory submission to fund, staff or wait on — and the unit cost at volume would have to leave a margin under the price the practice will actually pay.
Where it stands: The regulatory half is the one genuinely settled thing in this file. 21 CFR 807.65(b) exempts a manufacturer of devices to be used solely for veterinary purposes from establishment registration, retrieved verbatim [claim 1: verified], and 807.20(a), 807.81(a) and 814.1(a) each scope their duties to devices intended for human use, so an animal-only device has no US premarket submission of any kind [claim 2: verified]. What no claim in the file carries is a cost or a calendar figure — the Stage 2 row says so itself. This deck puts the consequence on record rather than estimating it: that the dominant pre-launch cost and calendar item is therefore the cadaveric and benchtop programme in claims 9 and 24, not regulatory work [claim 32: unverified], and that the manufactured cost has to leave a gross margin after distributor discount at the assumed price [claim 29: unverified]. The one live regulatory cost risk is the label boundary: a medicated or therapeutic variant would engage FDA CVM's new-animal-drug apparatus instead [claim 3: unconfirmed].
What would settle it: Contract-manufacturer quotes for a moulded coaxial dual-lumen disposable with an inline relief valve and a graduated trap, at volume; and a costed cadaveric temporal-bone protocol from a veterinary teaching hospital. Neither is connector-reachable — both are human-attached estimates.
If it's false: If COGS will not fit under $12-25 with a distributor discount on top, the price has to rise against an incumbent the file calls nearly free [claim 16: unconfirmed], and the desirability deck's Slide 4 cost condition gets harder rather than easier. Factor 7's 3/5 is an inference from claims 1-2 with no costed plan behind it, and would not survive a quote that came back high.
Would have to be true: Something other than being first would have to stop an existing veterinary-consumables manufacturer from shipping the same catheter the quarter after it appears in a distributor catalogue.
Where it stands: The file's own answer is that nothing does. The Generator identifies no technical barrier to copying, and all three proposed levers — a published bench dataset, a size-matched tip family, distribution — are unbuilt rather than merely unmeasured [claim 21: unconfirmed]. Lever (a) is precisely the study the literature does not contain [claim 9: unconfirmed]. Lever (c) is a distributor listing, which was in no claim and is now on record [claim 30: unverified]. And the lane's structural regulatory advantage does not reach IP at all: 35 U.S.C. 271(a) reaches making, using, offering to sell or selling without reference to species [claim 17: unconfirmed]; no patent or FTO search of any kind was performed, and the patent connector resolves a specific number rather than searching prior art, so there was nothing to invoke [claim 18: unconfirmed]; the position that the base mechanism is old art is explicitly an assumption, not a search result [claim 19: unconfirmed].
What would settle it: A USPTO/Google Patents search against the four targets the file names — OtoPet-USA, Nupur Technologies, Stryker/InterPulse pressure-controlled pulsed lavage, and ENT irrigation-suction handpieces. Analyst hours, free. A clearance opinion needs outside counsel and real money. For the channel, conversations with category managers at the national veterinary distributors.
If it's false: FTO blocked is the rubric's only automatic kill regardless of every other score, and this file has neither cleared it nor tripped it — the field is a hole, not a clearance, and "no refuted FTO claim" must not be read as freedom to operate. Short of a blocking patent, the softer failure is that the moat is distribution only, which a consumables incumbent already has and this candidate does not.
Would have to be true: The category would have to be genuinely open — and the reason no existing veterinary or ENT consumables maker has already shipped a single-use pressure-limited dual-lumen ear catheter would have to be something other than that it isn't worth shipping.
Where it stands: The named field is OtoPet-USA's veterinary "Earigator" irrigation-and- suction console — capital equipment this candidate is deliberately positioned beneath on price — and Nupur Technologies' human system of the same name; no single-use pressure-limited dual-lumen veterinary catheter was identified [claim 20: unconfirmed]. The file is careful about what that absence is worth: it is a missed web-search hit, not white space, and the two refuted sub-results inside the claim answer only whether a US human 510(k) exists under those applicants, which is not what the claim asserts. The competitor that actually matters is the incumbent technique — a red rubber catheter and syringe, nearly free [claim 16: unconfirmed]. One fact cuts against the candidate on barriers to entry: the frontmatter's human-use counterfactual is wrong and the file records it as such — the human ear-irrigation analog is product code OGQ, Class I under 21 CFR 880.6960 and exempt from premarket notification, not 21 CFR part 874 [claim 4: refuted]. Stated plainly: a human ENT or hospital-consumables maker crossing into a veterinary-labelled version of this device faces no premarket barrier on either side of the line. (The refutation hits the NOT-LIVE counterfactual row only; the launch route rests on claims 1-2, both verified — see the feasibility deck's Slide 3.)
What would settle it: OtoPet-USA and veterinary distributor catalogue pricing for the console — free desk research. A distributor catalogue sweep for any existing single-use pressure-limited irrigation catheter. A primary practice survey to settle the incumbent technique's actual share.
If it's false: If such a kit is already on a distributor's shelf, the differentiator is gone and Factor 8's 3/5 is generous. If the console is cheaper or more entrenched than the "positioned beneath it" premise assumes, the price ceiling in claim 12 moves down and Slide 4's margin condition tightens.
Would have to be true: There would have to be a next test that costs a document and an afternoon rather than a funded bench programme.
Where it stands: Two free primary documents move the two largest market legs, and both are named in the claims' own notes as one-document fixes: the Banfield State of Pet Health report for the disease rate [claim 5: unconfirmed], and the NAPHIA State of the Industry report for the insurance leg [claim 15: unconfirmed]. The patent search against four named targets is free analyst hours and carries kill-level stakes [claim 18: unconfirmed]. The expensive items are the licensed practice-management dataset behind flush share and per-practice volume [claim 11: unconfirmed], [claim 31: unverified], and the bench programme behind the safety number [claim 9: unconfirmed].
What would settle it: A human attaching two free PDFs, and an analyst running four named patent searches. None of the three requires a connector this repo does not have.
If it's false: If those two reports do not carry the figures the claims attribute to them, the TAM decomposition loses its rate leg and the payer picture loses its only quantified element, with no cheap substitute behind either.
Every condition above with nothing verified behind it — the [no claim] markers, plus the unverified claims this deck itself put on record. Read this slide first.
Of the seven condition slides above, only Slide 4 has any verified claim behind any part of it, and what claims 1 and 2 establish is permission to sell without a submission — not that anyone will buy. Every money question on this deck is unconfirmed or unverified.
If only one thing from this chair could be checked: whether any live, enforceable US patent covers pressure-limited irrigation with coaxial aspiration in a way this device cannot design around [claim 18: unconfirmed].
It is chosen over TAM deliberately. TAM is blank and every leg of it needs either a licensed dataset or a human-attached report, and the file states plainly that no instrument here will ever close it [claim 13: unconfirmed]. FTO is the opposite: free to check, a few hours against four already-named targets, and the only factor in the rubric carrying an automatic kill regardless of every other score. It is also the one place where this lane's structural advantage is simply absent — the veterinary exemption buys nothing against 35 U.S.C. 271(a) [claim 17: unconfirmed] — and if it goes the wrong way, every number on Slide 3 becomes moot. The feasibility deck's Slide 7 reads the same question as a design constraint.
Naming it is not a recommendation, a gate, or a kill.