idea-002 · 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.

Single-use veterinary NPWT for distal-limb wounds — viability

The chair: the investor, and the operator who has to sell a single-use consumable into veterinary practices with no payer behind it and no regulatory barrier in front of a copier.

How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-002.md: the number is the claim's position in its ## Claims list, and the tag is the one that claim carries there, copied and never adjusted here. A [no claim] marker means nothing in the file speaks to the condition. No number appears here that is not in a claim, and there is no ask slide. See docs/deck-spec.md.

What changed since the 2026-09-24 build: the Verifier's 2026-09-29 pass worked the lines this deck and the business case had appended — practice stocking, the second claim-chart, manufacturability at the stated price, practice markup, insured share at specialty hospitals, equine billing, ex-US payment and direct-sales acquisition cost — and every one landed on unconfirmed, most as adoption or market returning unverifiable by design. The Smith & Nephew patent lines were re-run with kind-coded numbers and returned exactly the filing facts already on record, so their tags did not move claim 85unconfirmed, claim 86unconfirmed, claim 87unconfirmed. This rebuild appended claims 150 and 151. Rebuilt from the file, not patched.


Slide 1 — Who pays, from which budget

Would have to be true: The animal's owner would have to pay for the course in cash at the practice — the practice buying the unit and billing it on, with a markup — because no other payer exists; and enough owners quoted that price would have to say yes.

Where it stands: The structure is asserted and reasoned, not checked: no third-party payer code exists for veterinary NPWT (negative-pressure wound therapy) and revenue is owner cash-pay claim 11unconfirmed, and no CMS (Centers for Medicare & Medicaid Services) code or Medicare/Medicaid coverage can structurally reach a veterinary device claim 53unconfirmed. That the practice bills the unit on at a markup is unbacked claim 143unconfirmed, as is owner willingness to pay for this indication claim 21unconfirmed. The share of eligible cases that convert to a paid course once the owner hears the price is a step the file's own TAM (total addressable market) omits claim 70unconfirmed. The adjacent behaviour on record: 57% of small-animal vets report client economic limits on care claim 130unconfirmed; pre-surgical euthanasia 10% insured versus 37% uninsured in a GDV series claim 129unconfirmed; insurance raising owner spending claim 131unconfirmed. In the equine half, whether the device is billed as its own supply line rather than absorbed into a per-day charge is unbacked claim 145unconfirmed. The ex-US equivalent is on record with a jurisdiction the Verifier flagged as mislabelled claim 146unconfirmed.

What would settle it: An owner willingness-to-pay study at referral practices, at this price band and for this indication; practice invoices for comparable single-use adjuncts; equine practice billing samples. No connector here reaches any of it.

If it's false: With no payer, a price owners will not accept is not a reimbursement problem to be worked; it is the end of the demand curve.


Slide 2 — The three reimbursement questions

Would have to be true: Code, payment and coverage would all have to be moot for the owner — and pet insurance, the only third party in the room, would have to be able to pay on an invoiced line.

Where it stands:

What would settle it: A human reads two insurers' full policy documents and asks one directly whether an invoiced NPWT line has been paid; a specialty hospital's own count of insured patients.

If it's false: Every point on the demand curve is unsubsidised, and the owner carries the whole price at the counter.


Slide 3 — TAM, decomposed

Would have to be true: A qualifying caseload, times the share of it reachable at specialty and equine practices, times the share of owners who say yes, times the number of units a course consumes, times a unit price that still leaves margin — each factor separately.

Where it stands:

What would settle it: Veterinary teaching-hospital caseload data; a reading of the 42-horse full text for course length by wound type; a contract-manufacturing quote for margin.

If it's false: TAM is a hard gate on this rubric, and on this candidate it is the factor least likely ever to reach verified — a fact about the pipeline's reach into veterinary markets as much as about the market. Stage 5 reads a blank as unevaluable, not as a kill.


Slide 4 — Capital to first dollar

Would have to be true: Dressing tooling, sterile-packaging validation and one or two prospective case series would have to be the whole bill to first revenue, with no premarket gate — and the omitted items would have to be small.

Where it stands: The premarket half is the best-evidenced thing in the file: the veterinary registration exemption claim 2verified, the 510(k) (premarket notification) duty conditioned on human use claim 48verified, PMA (premarket approval) scoped to human use claim 49verified. The human NPWT special controls, including usability testing, classify human-use devices only claim 99verified. The attribution to CPG 655.100 is still unread claim 1unconfirmed. The cost half is an unpriced estimate claim 18unconfirmed that the file itself says leaves out battery/electrical-safety and biocompatibility qualification claim 52unconfirmed and ground-up drape and interface development claim 58unconfirmed, and may fund pilot rather than production tooling claim 54unconfirmed, claim 61unconfirmed. The pump subassembly brings its own test regimes (feasibility deck, slide 6). The calendar is unbacked claim 41unconfirmed; the two studies are specified claim 46unconfirmed, claim 47unconfirmed; a cheaper canine-graft-only launch is unbacked claim 44unconfirmed.

What would settle it: Contract-manufacturer tooling and packaging-validation quotes; a teaching-hospital budget for the two specified studies; a test-house quote for the pump qualification the estimate omits.

If it's false: The one genuinely cheap thing about this candidate stops being cheap.


Slide 5 — What stops a fast-follower

Would have to be true: The live canister-free absorbent-dressing patents would have to leave this design free to operate, and the fur-compatible drape and limb interface would have to be patentable in their own right — because with no premarket review, patents are the only barrier either way.

Where it stands: The foundational NPWT patents are expired and constrain nobody claim 5verified, claim 6verified. The live layer is named and unread. Three Smith & Nephew patents are in force on a naive term, and the claim-chart against this design is not run claim 64unconfirmed; the claim-1 recitations the file records for them — a wound-contact, transmission and absorbent layer stack with a filtered suction port; a controller that detects at the connector port whether a canister or a canisterless dressing is attached; a backing layer with adhesive over an absorbent layer, with no species limitation — are all unreached by any connector claim 85unconfirmed, claim 86unconfirmed, claim 87unconfirmed. Two more live patents are named with their claim-chart likewise unrun claim 88unconfirmed, claim 90unconfirmed, claim 138unconfirmed; the landscape itself is unsearched claim 7unconfirmed. On this side: the moat is asserted to be the drape chemistry and limb interface, nothing filed claim 16unconfirmed; fast-follower risk is elevated because a copier faces no regulatory delay claim 17unconfirmed, a deduction from the same exemption that makes entry cheap here claim 2verified; supply rests on one adhesive and one converter claim 57unconfirmed. Licensing the module claim 42unconfirmed or running a rental service claim 43unconfirmed instead are unbacked.

What would settle it: Counsel charts the independent claims of the three Smith & Nephew patents, then the other two, against the drape, interface and connector; a prior-art search on fur-compatible adhesive drapes before anything is filed.

If it's false: Either the design is blocked — the one automatic kill on the rubric — or it is free but unprotectable: a commodity consumable in a market with no regulatory barrier to entry.


Slide 6 — Who is already there

Would have to be true: The incumbent would have to be displaceable — and the incumbent is a human single-use device already bought for this use, plus a rental vendor already selling into practices, not an empty field.

Where it stands: The off-label human device is the one in the published veterinary work claim 8verified, claim 10verified, and the candidate names it as what surgeons would have to stop buying claim 19unconfirmed. The distributor shelf showed no NPWT at three national distributors claim 116unconfirmed, claim 117unconfirmed, claim 118unconfirmed — absence-shaped, and contradicted in substance by a direct vendor renting and selling NPWT to practices outside all three claim 119unconfirmed. Whether distributors would carry this unit claim 26unconfirmed, claim 45unconfirmed, whether a direct sales motion pays back per practice claim 147unconfirmed, and whether practices will hold single-use stock and its expiry risk claim 137unconfirmed are all unbacked. On the human side the field is established: KCI claim 71verified, claim 72verified, Accuro claim 94verified, Medela claim 96unconfirmed. The canistered architecture's recall record points at components this design removes claim 37unconfirmed, while pump-side failures remain claim 95unconfirmed, claim 97unconfirmed.

What would settle it: Distributor conversations, not catalogue searches; a price quote from the direct vendor for what a practice pays today; trade-show exhibitor lists.

If it's false: The competitor is already in the building in human packaging, and a rental vendor already owns the relationship this product would need.


Slide 7 — The cheapest way to find out

Would have to be true: A claims-text pull on three named patents, a handful of owner and practice conversations, and one reading of an existing case series would have to move the money questions from assumed to known.

Where it stands: The patent reading list exists and is unread claim 64unconfirmed. The owner's total-bill question is on record — whether the course costs less than the hospital days it replaces claim 150unverified — and the only analog on file is human, UK and n=5, where discharge on single-use NPWT reduced stay by an average of 20.2 days claim 124unconfirmed. The units-per-course question can be bounded from a full text the file already cites claim 36unconfirmed, claim 151unverified.

What would settle it: Counsel on the three patents; practice invoices for the hospitalisation a home phase would shorten; the 42-horse full text for course lengths.

If it's false: Nothing here is false; it is a work order, and each item names its document.


Slide 8 — Where this deck outruns the file

Every condition above with nothing verified behind it — six of seven. The exception is slide 4, whose premarket half is verified and whose cost half is not. Read this slide first.

The verified claims on this deck are the regulatory perimeter claim 2verified, claim 48verified, claim 49verified, claim 99verified, two expired patents claim 5verified, claim 6verified, papers that exist claim 8verified, claim 10verified, and other companies' human clearances claim 71verified, claim 72verified, claim 94verified. Not one is a fact about this market's size, price, channel, margin or payer.


Slide 9 — The load-bearing condition

If only one thing from this chair could be checked: whether a claim-chart comparison of this design against the independent claims of the three live Smith & Nephew canister-free dressing patents finds no infringement, or finds an available design-around claim 64unconfirmed.

Why this one rather than the owner's willingness to pay: an unwilling owner makes a small market; a blocking patent makes no market, and it is the only automatic kill on the rubric. It is also the moat question turned around — with no premarket review claim 2verified, patents are the only barrier in either direction, and the claim-1 language the file records for one of these patents carries no species limitation claim 87unconfirmed. The file knows the patents exist and are in force on a naive term; it knows nothing verified about what they cover. That is a reading task with named documents.

Naming it is not a recommendation, a gate, or a kill.

Words on this page8 abbreviation(s) and code(s), with what each stands for — copied from _shared/plain-language.md
510(k)
premarket notification — the FDA route for a device shown to be as safe and effective as one already on the market; months, no clinical trial as a rule
ACVS
American College of Veterinary Surgeons — the US specialist board for veterinary surgeons
CMS
Centers for Medicare & Medicaid Services — the US agency that runs Medicare, and so decides what Medicare pays for
NHS
National Health Service — the UK's public health service
NPWT
negative-pressure wound therapy — sealing a wound under an airtight dressing and applying gentle suction to help it heal
PICO
population, intervention, comparator, outcome — the four parts of a well-posed clinical question
PMA
premarket approval — the FDA route for the highest-risk devices; years and clinical trials
TAM
total addressable market — how much money the whole market would be worth if every possible buyer bought