idea-002 · business case
Who pays, from which budget, how much, and 2-4 commercial routes to first revenue — every figure below traces to a copied claim or a declared assumption, and the routes are laid out unranked. Choosing a commercial strategy is a Tier 3 act, so this page presents options and stops.
Intended use: For use by licensed veterinarians and veterinary technicians in clinical and post-discharge settings to apply controlled sub-atmospheric pressure to open, contaminated, or free-skin-grafted distal-extremity wounds in dogs and horses, as an adjunct to standard wound management.
Why this is a rebuild. Three things changed after the previous build (2026-09-24), and nothing in that build was patched:
unverified to unconfirmed. None moved to verified and none to refuted. That covers the
owner-conversion leg, the deck and narrative claims (134–142), and all five assumptions the
previous build wrote back (now claims 143–147).
unconfirmed. Those numbers are the energy
budget, the pressure control band, the transport and emissions test regimes, and the
cell-safety and electrical-safety standards. They set part of the unit cost and part of the
pre-launch test bill, so this case now carries them. The previous build did not.
The five former assumptions are now cited as claims and are not re-declared, because a figure travels as the claim that recorded it. This build needed no new assumption. Every figure below rests on a claim already in the file, and the register says so rather than inventing rows to fill it.
This chain lacks the link a US medtech business case is normally built around. There is no payer. Not an unfavourable payer, not a missing policy: no payer at all. Read everything below against that.
The weakest link is the one everything depends on. Each dollar below is one owner's decision, once, for one case, made at a price the practice sets above its own cost. Any indemnity cheque arrives later and goes to the owner, never to the practice or the manufacturer.
Six questions, each with its own evidence position. No score, no tier, no composite. This section says what is known and what is not, and the coverage line is what a human reads first. Every row carries exactly one basis.
Read this before the table. For a veterinary-only device, five of the six questions have no referent. Medicare and Medicaid are scoped to human beneficiaries. CMS (Centers for Medicare & Medicaid Services) assigns no code to a service furnished to an animal, and no US federal dataset covers veterinary payment. procedures, hcpcs, payment, coverage, rvu, drg and apc are therefore structurally blind here, not short of data. None was run, deliberately. Each takes a specific code as input, and a null from a code that cannot exist is correct connector behaviour, not a finding. A question with no referent is not an unanswered question, and the rows say which is which.
| # | Question | Finding | Basis |
|---|---|---|---|
| 2a | Coding route — Cat I / Cat III / unlisted / HCPCS II / none | No referent. Not "none assigned yet": no code set reaches a device used only in veterinary medicine, because CMS code assignment is scoped to human beneficiaries. This is a structural exclusion of the whole category, and it is short of verified permanently. The connectors test one named code and cannot prove a category has none | claim 53unconfirmed |
| 2b | Payment adequacy — does the rate clear a stated cost floor | No referent. There is no rate, because no fee schedule reaches veterinary care. Revenue is cash-pay at the point of service. The substitute question — does the owner-facing price clear unit cost plus the channel's margin — is a price question. It sits in the money model, and no unit cost is on file to test it against | claim 11unconfirmed |
| 2c | Practice-expense headroom — does the PE portion cover the device | No referent. The practice-expense portion is a Medicare Physician Fee Schedule construct. There is no RVU (relative value unit) and no PE split for rvu --device-cost to read. The veterinary analogue is the practice's own markup on a consumable, which no federal dataset records. It appears in the money model as a claim, not here | claim 53unconfirmed |
| 2d | Site of care & bundling — office/facility differential, DRG or APC packaging | No DRG or APC referent. Both are Medicare constructs. The site-of-care half does have a veterinary referent and it is open: can the device be labelled and used after discharge, outside a healthcare facility, when the closest human predicate's labelling is facility-only? The Verifier returned it unconfirmed on 2026-09-29 | claim 141unconfirmed |
| 2e | Coverage — has any payer agreed to pay for this indication | The one question with a real referent, and no payer has agreed. Private pet insurance adjudicates on the invoice, so the missing code does not rule it out. But no insurer has agreed to anything, two published exclusion lists are SILENT rather than permissive, no filed policy form has been read, and whether an insurer would reimburse is recorded unanswered | claim 132unconfirmed |
| 2f | Ex-US pathway — DE NUB/G-DRG, UK NICE (National Institute for Health and Care Excellence)/OPCS-4 | Permanently unconfirmed, and also without referent. NUB, G-DRG and NICE/OPCS-4 are human payment systems. No connector reaches a non-US payment system, and none of those systems would reach a veterinary-labelled device if one did. The file records the ex-US structure as owner cash-pay with optional private indemnity. The previous build carried this as an assumption; it is now a claim | claim 146unconfirmed |
Pillars on verified claims: 0/6 · on assumptions: 0 · queued as research: 0
All six rows rest on unconfirmed claims. Five have no referent at all: 2a, 2b, 2c, 2f, and the bundling half of 2d. One (2e) has a referent and is unresolved. Nothing is queued:
A [gap: …] basis pointing at finished work would cite a hole that no longer exists. The open residue on 2e is filed-form wording, and reading it failed because the retrieval environment could not convert the PDFs. That is an environment limit, not a research question anyone has declined.
Three distinctions this section keeps apart:
Verdicts recorded rather than routed around:
python3 -m connectors cpt "<any descriptor claim>" — not run, deliberately. A descriptor
claim returns unverifiable by design. The earlier point is that CPT (Current Procedural Terminology) is a human-procedure code
set with no veterinary referent, so a query would manufacture a result about a code set this
device can never occupy. The candidate's own Verifier used the same reasoning at
claim 53unconfirmed.
python3 -m connectors adoption "Owners quoted a single-use NPWT course as an itemized adjunct line at a US veterinary specialty or referral hospital will authorize it for a dog or horse with an open or grafted distal-limb wound"
→ unverifiable, run on this build: *"asserts what clinicians, payers, or patients would do …
Do NOT substitute a model's own estimate of stakeholder behaviour."* Its two suggested proxies,
coverage and procedures, are the two instruments this section has just shown are blind here.
Size is decomposed in the market model, rebuilt today, and not rebuilt here. Read that model's coverage line first: 0/7 legs on verified claims, 4 legs queued as research, and a modeled band recorded as not computable. This case quotes the legs it needs and does not recombine them into a total the model itself declines to compute.
| Line | Figure | Backing |
|---|---|---|
| Third-party payer / billing code | None exists, for the whole device category | claim 53unconfirmed |
| Market-model leg 1 — annual US qualifying canine caseload | 30,000–80,000 cases per year, a Generator estimate | claim 13unconfirmed |
| Market-model leg 2 — annual US qualifying equine caseload | Not established. The file asserts the equine segment "materially enlarges" the pool and is commensurable with the canine one; the market model carries it as a commissioned gap | claim 40unconfirmed |
| Market-model leg 3 — share managed at ACVS (American College of Veterinary Surgeons)-affiliated specialty/referral or equine surgical practices | 20–30% of qualifying cases. This is a site-of-service share, not a capture share | claim 15unconfirmed |
| Market-model leg 4 — share of those cases whose owner authorises the adjunct spend | Not established. Strictly below 100%, and missing entirely from the candidate's own TAM (total addressable market) decomposition | claim 70unconfirmed |
| Leg 4, its structure — insured share at the point of sale | Asserted to be materially above the population rate at referral hospitals; unmeasured | claim 144unconfirmed |
| Leg 4, its structure — population insured rate | 5.99% of US dogs at year-end 2025 and 5.46% at year-end 2024, both from one trade-association publisher | claim 111unconfirmed, claim 112unconfirmed |
| Leg 4, a revealed-behaviour twin at a different decision | Pre-surgical euthanasia in 10% of insured and 37% of uninsured dogs with GDV. That is life-or-death acuity, not a discretionary adjunct, so it is an upper anchor and not a bound | claim 129unconfirmed |
| Leg 4, stated willingness — not a transaction | 44% of 306 uninsured US dog owners willing to spend up to $1,000, and 46% $3,000 or more, to prolong a pet's life by a year. Not scoped to wound care | claim 128unconfirmed |
| Owner willingness to pay several hundred dollars out of pocket | Asserted, never researched | claim 21unconfirmed |
| Market-model leg 5 — single-use devices consumed per animal per course | Not established. See the pump-life line below for why this leg now also depends on the pump | claim 40unconfirmed |
| Course length, the input leg 5 divides | 4–7 days in dogs, with 5 of 7 discharged during treatment; a mean of 11.5 days in horses as an inpatient adjunct | claim 122unconfirmed, claim 36unconfirmed |
| Pump life per unit, new to this build | The pump specification sizes a 6 Wh primary-cell pack for a 7-day single-use course only if pump ON-time stays at or below 7% of elapsed time on an ambulatory limb. Above that duty the pack runs out before the course ends, so units per course rise and so does the owner's cost per course. Unconfirmed for want of a built pump (IR-17 claims 65 and 66 came back unconfirmed) | claim 65unconfirmed |
| Market-model leg 6 — net selling price per unit (pump plus two dressing kits) to the practice | $180–$320 | claim 14unconfirmed |
| Whether $180–$320 is reachable without a human-market volume base to spread tooling across | Returned unconfirmed on 2026-09-29. If false, leg 6's low bound is wrong, not merely unsourced | claim 139unconfirmed |
| Owner-facing price per course | The practice's marked-up invoice line, above the $180–$320 acquisition price, with no markup figure on file | claim 143unconfirmed |
| Market-model leg 7 — share of the pool a new veterinary-labelled entrant captures | Not established; commissioned in the market model | claim 45unconfirmed |
| Comparator price the buyer already pays | PICO 7 kits at $378.69 and $388.13 US retail cash-pay, roughly $367–$431 across sizes. Human retail, not a veterinary net price | claim 110unconfirmed |
| Comparator institutional price | PICO at GBP 147.06 per unit through NHS (National Health Service) Supply Chain. UK bulk procurement, not a US price | claim 113unconfirmed |
| Comparator cost per day of therapy | PICO 14 at $25.00 per day against more than $180 per day for two named 3M/KCI systems. The source limits this to low-exudate wounds, and it converts to a per-unit price only with the missing leg 5 | claim 109unconfirmed |
| Gross margin at the proposed price | Asserted, not measured. Whether it survives dressing COGS (cost of goods sold), sterile packaging validation and a distributor's margin is open, and there is no bill of materials to price | claim 27unconfirmed |
| Pump-subassembly cost drivers, new to this build | UN 38.3 qualification if the cell is lithium, plus FCC Part 15 authorisation unless a 47 CFR 15.103 exemption applies. The eCFR read supported the lithium half and left the FCC half open (IR-18 claim 67 came back unconfirmed) | claim 67unconfirmed |
| Pump-subassembly cost drivers, new to this build | IEC 60086-4 rather than 62133-2 as the cell-safety standard, and IEC 60601-1 as a voluntary target. Both are unread, because the standards sit behind a paywall (IR-19 claims 68 and 69 came back unconfirmed) | claim 68unconfirmed, claim 69unconfirmed |
| Channel reach through distributors | Asserted. The three national distributors list no NPWT device today | claim 26unconfirmed |
| Direct-to-practice channel economics | Cost per practice acquired below first-year gross margin per practice. Asserted, and returned unconfirmed | claim 147unconfirmed |
| Capital to reach first revenue | Low single-digit millions | claim 18unconfirmed |
| Practice base, not a case share | 2,686 ACVS Diplomates (44.54% small-animal and 42.37% equine emphasis, overlapping) and more than 9,000 AAEP members, students included | claim 107unconfirmed, claim 108unconfirmed |
No total revenue figure appears above, deliberately. Multiplying the caseload, site-share and price legs gives a product that leaves out the owner's decision claim 70unconfirmed, treats a site-of-service share as a capture share claim 15unconfirmed, and never reaches device-units. Four of the seven legs have no bounds. This build adds a reason leg 5 cannot be assumed to be one unit per course: the pump's own energy budget holds for a 7-day course only below a duty cycle nobody has measured claim 65unconfirmed.
Verdicts recorded:
python3 -m connectors market "Annual US addressable revenue pool for a single-use canister-free negative pressure wound therapy system for canine and equine distal-limb wounds, as caseload multiplied by owner authorization, devices per course and net unit price"
→ unverifiable, run on this build: *"has no free, authoritative, machine-queryable source.
Stays unconfirmed permanently unless a human attaches a licensed report and edits the claim by
hand."*
python3 -m connectors adoption "…", the owner-authorisation proposition in the reimbursement
section above → unverifiable.
procedures, hcpcs, payment, coverage, rvu, drg, apc — not run. They are
structurally blind to this device category; see the reimbursement section and
claim 53unconfirmed.
Four routes, laid out and not ranked. Choosing a commercial strategy is a Tier 3 act, the same kind of decision as choosing what to shortlist. This section sets out options and stops there. Each route gets the same three fields and roughly the same depth.
A device company sells units through the national veterinary distributors to ACVS-affiliated specialty/referral and equine surgical practices, which bill the owner.
Ship the differentiator, not a standalone product: an OEM drape-and-interface module for a partner's existing pump.
Run the device as a per-episode service that reaches practices outside the national distributors, following the one vendor recorded as doing that today claim 119unconfirmed. That vendor rents reusable control units, which is a different product. Here the unit stays single-use and the service is the application, support and retrieval.
Defer equine and general cutaneous wounds. Launch into the one sub-indication where the published veterinary signal at abstract depth runs positive rather than mixed or negative.
A note on the artifact, not a ranking. Routes A, C and D all rest on the same two unresearched behaviours: whether a practice switches from off-label PICO claim 19unconfirmed, and whether an owner pays claim 21unconfirmed. So they are less independent than four headings suggest. Route B depends on neither, and on no pump claim. It depends instead on a different unresearched behaviour claim 42unconfirmed and on an FTO opinion no agent here may render. That is an observation about what this file can and cannot tell apart.
Empty on this build, and that is a finding, not an omission. Every figure above rests on a claim already in the file.
unconfirmed, and they are cited above as claims.
Nothing was appended to the candidate, so its updated: did not move.
| # | Assumption | Falsifier | Owner |
|---|
These are work items: quantities the case needs that no claim supplies. They are not figures.
_shared/plain-language.md