idea-013 · 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.

Stoma Outflow Valve — viability

The chair: the investor, and the operator who would have to run a daily-use, patient-replaceable ostomy product as a business in the US.

How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-013.md: the number is the claim's position in its ## Claims list and the tag is copied from that line as it stands today, never adjusted here. A [no claim] marker means nothing in the file speaks to the condition. No number appears on this deck that is not in a claim, and there is no ask slide. See docs/deck-spec.md.

Rebuild, 2026-09-29. Rebuilt after the Verifier's second pass, which had the HCPCS (Healthcare Common Procedure Coding System), DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) fee-schedule, utilization and coverage caches available for the first time. That pass put real code descriptors and real Medicare allowed amounts into the notes on claims 7, 8 and 18 — while holding all three at unconfirmed. Those notes change what this deck can say about price, and the tags do not change what it can say about confidence. This build appended claims 24 to 27.

Slide 1 — Who pays, from which budget

Would have to be true: Medicare Part B (Medicare Part B), through the DMEPOS benefit and an ostomy-supply DME (durable medical equipment) supplier, would have to pay for this device (with commercial plans following the same supply codes) — or, failing that, the patient would have to pay out of pocket at a price that supports a specialty product.

Where it stands: The budget line this device would displace is identifiable: conventional pouch supplies sit on the Medicare DMEPOS fee schedule, category OS, with A4416 (a HCPCS code for a supply) (a closed one-piece pouch with barrier and filter) allowed at $3.93 non-rural in the July 2026 release claim 7unconfirmed. Whether patients or payers would pay this device more than commodity supply rates is an assumption the adoption connector cannot answer claim 19unconfirmed. No claim speaks to commercial-payer or Medicaid ostomy benefits, or to cash-pay willingness at any stated price [no claim].

What would settle it: For Medicare, the three questions on Slide 2. For commercial and cash, a human act: payer-policy review by a reimbursement consultant, and a pricing interview round with patients (the desirability deck's Slide 4 interview could carry the question).

If it's false: If neither Medicare DMEPOS nor the patient's wallet will pay above supply rates, there is no revenue line for a specialty device; what it would cost to make is unknown (feasibility Slide 6) claim 20unconfirmed. Factor 2 (Reimbursement) and Factor 7 (Capital to first dollar) both lose their premise.

Slide 2 — The three reimbursement questions

Would have to be true: An existing HCPCS code would have to describe a valve that passes effluent into a drainable cap; its Medicare allowed amount would have to be high enough to carry a specialty device; and a coverage policy would have to allow it for a standard ileostomy.

Where it stands:

Code exists: No code names a device of this shape. The live candidates are A5081 "Stoma plug or seal, any type" and A5055 "Stoma cap"; A5082 and A5083 are restricted to a continent stoma, which the intended use excludes; A4421 "Ostomy supply; miscellaneous" is the fallback. Which code applies is decided only by a PDAC (Pricing, Data Analysis and Coding contractor) coding verification claim 18unconfirmed. The range the file first named as the ostomy category, A4361-A4438, is wrong at its upper bound — A4438 is a nerve-stimulator clip claim 7unconfirmed.
Payment amount: every candidate code is allowed at roughly $2-$5 per unit — A5081 $4.01-$4.72 and A5055 $1.74-$2.05 non-rural claim 18unconfirmed. Whether anyone pays more than that for this device is the assumption on Slide 1 claim 19unconfirmed.
Coverage policy: the cached coverage index names no NCD (national coverage determination) or LCD (local coverage determination) for A4416 or A5081, which is not a denial and not proof no ostomy LCD exists claim 18unconfirmed; whether a coverage policy exists and would reach this device is now on record, unchecked claim 24unverified.

What would settle it: A PDAC coding verification request once a device exists (a human act by the manufacturer); python3 -m connectors coverage run against the DME MAC (durable medical equipment Medicare administrative contractor) ostomy supply LCD by its policy identifier, if a human names it; and a coding consultant's view on A4421 versus a new-code application, as the Scores table's gap analysis already says.

If it's false: If PDAC places it under A5081 or A5055, the device is paid as a few-dollar supply item, and Slide 1's price question is answered against it. If only A4421 fits, payment is set claim by claim and the revenue line is unforecastable. Factor 2 stays below floor either way, which is half of the Stage 5 compound kill condition — naming that is not proposing it.

Slide 3 — TAM, decomposed

Would have to be true: Ileostomy patients (not all ostomy patients) × the share with a mature, uncomplicated, standard ileostomy × the share who would switch × a price above supply rates would have to multiply to a market worth building a specialty channel for.

Where it stands:

Population: 725,000-1,000,000 Americans with any ostomy and about 100,000 new ostomy surgeries a year, from non-primary materials claim 5unconfirmed. No ileostomy-only count is in the file; that it exists in a primary source is on record, unchecked claim 26unverified. The only primary volume in the file is Medicare FFS (fee-for-service): A4416 billed 1,014,232 services across 2,587 beneficiaries, a ratio the Verifier flagged for a unit-definition check before anyone multiplies it claim 8unconfirmed; A5081 billed 43,803 services across 557 beneficiaries claim 18unconfirmed.
Rate / incidence: leakage in 18%-76% of people with an ostomy, no PMID (PubMed identifier) cited claim 6unconfirmed. The share who would switch rests on stakeholder assumptions only claim 17unconfirmed claim 23unverified.
Price: the comparator codes are allowed at about $2-$5 per unit claim 18unconfirmed; this device's price is unknown and no claim carries one [no claim].
Reachable share: no claim [no claim].

The one headline figure, a US ostomy care and accessories market of about $586.6 million in 2025, is a single aggregator estimate the market connector marks unverifiable by design, and other estimates for differently scoped categories range from about $3.5B to $4.3B claim 8unconfirmed. It is not decomposable and is not used here.

What would settle it: An ileostomy-specific prevalence source (CDC/NHANES or a CMS (Centers for Medicare & Medicaid Services) claims-based study, per claim 5unconfirmed's note); a unit-definition check on A4416 in the DMEPOS utilization file's documentation (data/provenance.json names the source); procedures runs over the rest of the roughly 90 ostomy codes to build a Medicare FFS floor; named PMIDs for the leakage range.

If it's false: If the ileostomy-only, mature, standard subset is small, or the switch share is small, Factor 3 (TAM (total addressable market)) cannot clear its 2/5 floor, which is a Stage 5 kill condition on its own. Naming that is naming a question.

Slide 4 — Capital to first dollar

Would have to be true: The sequence before first sale — prototype, bench evidence, biocompatibility and human-factors work, and whichever FDA (US Food and Drug Administration) route applies — would have to be short and cheap enough that a device reimbursed near supply rates can pay it back. The cost and calendar are unknown: no claim in the file carries either.

Where it stands: No cost or timeline claim exists [no claim]. The route that sets both is open. The cheapest reading, that the device fits an existing Class I 510(k) (premarket notification)-exempt classification, is on record from the feasibility deck, unchecked claim 28unverified. The regulation it leans on most is checked but its scope for a standard ileostomy is not claim 1unconfirmed; the pouch classification is verified but reaches only the external cap claim 2verified. Against both, a 1982 "ileostomy valve" clearance sits under a Class II (FDA device class II), non-exempt code the file did not originally consider claim 12refuted. The device does not exist as a prototype claim 13unconfirmed.

What would settle it: An FDA pre-submission (Q-sub) for the route, as the Scores table says; a contract-engineering estimate for prototype and bench cost and calendar. Both are human acts with a fee. No connector returns a cost.

If it's false: If the route is De Novo (De Novo classification request) or Class II 510(k) rather than exempt, the capital line grows while the revenue per unit (Slide 2) stays at supply rates, and Factor 7 scores against a cost nobody has estimated.

Slide 5 — What stops a fast-follower

Would have to be true: Something other than the idea itself would have to stop an incumbent ostomy supplier from copying a silicone valve and cap — most plausibly an issued patent on this specific valve-and-collar design that neither the 2019-filed continent ostomy valve patent nor the 1981 indwelling valve anticipates.

Where it stands: The file carries no claim on moat at all — the Scores table leaves Factor 5 blank [no claim]. The patentability of this design over the two named prior references is on record, unchecked claim 27unverified. The nearest patent, US 11,395,757 B2 "Continent Ostomy Valve and Method of Use", is confirmed to exist, filed 2019-08-30 with a naive expiration of 2039-08-30; its claims have not been read claim 9unconfirmed. The 1981 device is published prior art claim 11unconfirmed. No claim speaks to manufacturing complexity, switching cost or supplier lock-in [no claim].

What would settle it: A human act: a patentability search by patent counsel against US 11,395,757 B2, PMID 7457715 and the KNT product-code art, once a specific design exists. Nothing in this repo can issue that opinion.

If it's false: A mechanical valve and cap with no protectable feature could be copied by any ostomy-supply incumbent that chose to; no claim in the file names who holds the DME channel. Factor 5 would have nothing to score, and Slide 6's field becomes the whole story.

Slide 6 — Who is already there

Would have to be true: No currently marketed US device would have to already offer a valve for a standard ileostomy, and the adjacent leak-alert product would have to leave the dissatisfied pouch user unserved.

Where it stands: The file's premise that no cleared ileostomy valve exists is refuted: the WATERS ILEOSTOMY VALVE, Waters Instruments, K813585 (an FDA 510(k) clearance number), cleared 1982-04-09, product code KNT, Class II under 21 CFR (Title 21 of the Code of Federal Regulations) 876.5980; what it was cleared for cannot be read, as no summary exists for a filing that old claim 12refuted. Whether it is still on the market is on record, unchecked claim 25unverified. The leak-sensor premise is also refuted: Coloplast's Heylo is US-cleared, K252140, 2025-10-06 claim 4refuted. Ampa Medical's InterPoc, an absorbent device advanced into the small bowel, has no 510(k) or De Novo record; its description and pilot outcome have no connector claim 3unconfirmed. No claim speaks to why the large ostomy-supply incumbents have not built a valve product [no claim].

What would settle it: FDA's establishment registration and device listing database for K813585 and product code KNT (no connector in this repo queries it today — a human search, or a new connector); a fresh 510k and denovo search on stoma-valve terms; clinicaltrials.gov for InterPoc, per the Scores table.

If it's false: If the Waters valve or a successor is still listed, there is a direct incumbent and the "no competitor for this exact shape" line in the Scores table's Factor 8 row was never true. If Heylo absorbs the leakage-driven demand, the market in Slide 3 narrows to the bulk-and-skin segment only (desirability Slide 5).

Slide 7 — The cheapest way to find out

Would have to be true: One cheap check would have to move the money question: whether the Medicare codes this device could be billed under pay more than a few dollars a unit, or whether a patient or payer would pay a premium over them.

Where it stands: The first half has already moved, against the premise: the fee-schedule lines for every candidate code are now in claim 18unconfirmed's note, at about $2-$5 allowed per unit claim 18unconfirmed. The second half is the stakeholder assumption that no connector can answer claim 19unconfirmed.

What would settle it: A human act: a short round of conversations with DME ostomy suppliers and with patients on out-of-pocket willingness (combinable with the desirability deck's Slide 6 round), and a coding consultant's read on A4421 as the Scores table's reimbursement row describes.

If it's false: If nobody pays above supply rates, every other slide on this deck is describing a market this device cannot earn from.

Slide 8 — Where this deck outruns the file

Every condition above with nothing verified behind it. The only verified claim cited on this deck (claim 2verified) covers the external cap's classification, not money. Read this slide first.

Medicare, commercial or cash paying above supply rates — claim 19unconfirmed, [no claim] for commercial, Medicaid and cash — payer-policy review and patient pricing interviews (human).
A HCPCS code that fits a valve into a drainable cap — claim 18unconfirmed — PDAC coding verification (manufacturer, once a device exists).
A Medicare coverage policy that reaches the device — claim 24unverified — coverage against a named DME MAC ostomy LCD; a human names the policy.
The ostomy supply category as the file first stated it — claim 7unconfirmed — a restated code range, appended by the Generator.
An ileostomy-only population count — claim 26unverified, with claim 5unconfirmed — a primary prevalence source.
The Medicare volume floor — claim 8unconfirmed — unit-definition check on A4416, then procedures over the remaining ostomy codes.
The leakage rate — claim 6unconfirmed — named PMIDs.
A switch share and a device price — claim 17unconfirmed claim 23unverified, [no claim] for price and reachable share — patient interviews (human).
Cost and calendar to first dollar — [no claim] — contract-engineering estimate and a Q-sub (human, paid).
An exempt route — claim 28unverified — FDA, via pre-submission.
A protectable design — claim 27unverified, [no claim] for any non-patent moat — patent counsel (human, paid).
No marketed direct incumbent — claim 25unverified, against claim 12refuted — FDA registration and listing search (human today).
Why incumbents have not built it — [no claim] — no source in this repo; industry interviews.

After write-back almost every condition here has a claim number, and none of them is verified. That is the honest count for this lens.

Slide 9 — The load-bearing condition

If only one thing from this chair could be checked: whether ileostomy patients or their payer would pay a price for this device high enough to sustain a specialty product, above the roughly $2-$5 per unit Medicare allows for the ostomy codes it could be billed under claim 19unconfirmed claim 18unconfirmed.

Why this one: the second Verifier pass turned the reimbursement question from "no code found" into a concrete number for every candidate code, and that number is a commodity supply price. Population, route and moat only matter if someone pays more than that. It is also the condition a connector will never settle; it takes people.

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

Words on this page19 abbreviation(s) and code(s), with what each stands for — copied from _shared/plain-language.md

21 CFR: Title 21 of the Code of Federal Regulations — the US food-and-drug rulebook; a number after it is one regulation, often the one that classifies a device type
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
A####: a HCPCS code for a supply — one billing code for a supply or an accessory; the letter A and four digits
Class II: FDA device class II — moderate-risk devices, usually cleared by 510(k)
CMS: Centers for Medicare & Medicaid Services — the US agency that runs Medicare, and so decides what Medicare pays for
De Novo: De Novo classification request — the FDA route for a new, lower-risk device with no comparable product to point at; longer than a 510(k), usually needs clinical data
DME: durable medical equipment — equipment a patient uses at home, such as a pump or a stimulator, that Medicare pays for under its own rules
DME MAC: durable medical equipment Medicare administrative contractor — one of the four regional contractors that process Medicare's home-equipment claims and write its local coverage rules
DMEPOS: durable medical equipment, prosthetics, orthotics and supplies — the Medicare benefit and fee schedule that home equipment is paid under
FDA: US Food and Drug Administration — the US regulator that clears or approves a device before it can be sold
FFS: fee-for-service — the traditional form of Medicare that pays per item or service
HCPCS: Healthcare Common Procedure Coding System — the US billing codes for equipment, supplies and some services; a code is how a payer recognises what to pay for
K######: an FDA 510(k) clearance number — the public record of one cleared device; the letter K and six digits
LCD: local coverage determination — a Medicare contractor's rule, valid in its region, saying when something is covered
Medicare Part B: Medicare Part B — the part of Medicare that pays for outpatient care and equipment used at home
NCD: national coverage determination — a Medicare rule, valid everywhere in the US, saying whether and when something is covered
PDAC: Pricing, Data Analysis and Coding contractor — the Medicare contractor that decides which billing code a specific product falls under
PMID: PubMed identifier — the public id of one published medical paper
TAM: total addressable market — how much money the whole market would be worth if every possible buyer bought

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