idea-013 · 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: an adult with a mature, uncomplicated ileostomy who currently wears a continuous-wear adhesive pouch, and the WOC (wound/ostomy/continence) nurse who trains and supports them.
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, the tag is copied from it and never adjusted here. A [no claim] marker means nothing in the file speaks to the condition at all. See docs/deck-spec.md.
First build. This candidate has never had decks before. At stage: verified, 21 claims — 2 verified, 15 unconfirmed, 2 refuted, and 2 more unconfirmed write-backs from the other two lenses' own slides. Nothing in the file yet speaks to whether anyone wants this.
Would have to be true: There would have to be a substantial population of adults with a mature, standard (non-surgically-reconstructed) ileostomy who are currently dissatisfied enough with continuous-wear adhesive pouching — leakage, peristomal skin irritation, bulk — to seek an alternative collection interface.
Where it stands: The population exists in a wide, unsourced range: 725,000-1,000,000 Americans living with any ostomy (colostomy, ileostomy, or urostomy — not ileostomy-specific) and roughly 100,000 new ostomy surgeries a year [claim 5: unconfirmed]. The dissatisfaction side is more specific but equally unresolved: reported leakage incidence of 18%-76% across published studies, roughly 37% of those with leakage reporting it weekly, and over 81% of those with leakage also reporting peristomal skin irritation [claim 6: unconfirmed]. Neither claim carries a resolvable primary source in this file — claim 5 has no dataset behind it and claim 6 cites no PMID.
What would settle it: A primary epidemiological dataset (CDC/NHANES or a CMS claims-based prevalence study) broken out by ostomy type for claim 5; named PMIDs for the pooled leakage-incidence studies behind claim 6, which literature-detail could then read.
If it's false: There is no addressable population and this candidate and the rubric's TAM factor (Slide 3 of the viability deck) fail together — desirability and viability share this one number.
Would have to be true: The patient would have to self-insert an intraluminal valve at the stoma orifice daily (or per manufacturer instructions), and self-remove it, rather than simply applying an adhesive wafer and pouch — a meaningfully more hands-on daily task than the product it replaces.
Where it stands: This is the candidate's own central, explicitly flagged assumption, now carried as a formal claim after this deck's write-back: adults with a mature ileostomy would have to be willing to learn and perform this daily self-insertion/self-removal in exchange for reduced pouch bulk and reduced adhesive-related skin exposure [claim 15: unverified]. The file's own design-rationale note calls this out by name before any claim existed for it: "there is no connector and no primary research behind that belief in this repo." The nearest mechanism precedent — a 1980 Silastic-tube-and-balloon indwelling valve studied in 14 patients, "continuous and voluntary control ... without untoward local or systemic effects" — describes daily handling analogous to a continent-ileostomy catheter, but in patients who had already undergone continent-ileostomy surgery with a failed nipple valve, not this candidate's standard-ileostomy population [claim 11: unconfirmed].
What would settle it: Structured interviews or a small acceptability study with adults who have a mature, standard ileostomy — not the continent-ileostomy-surgery population the nearest literature analog describes.
If it's false: The device has no user. Everything downstream of this slide — training, belief, adherence — is conditional on this one behavior change being acceptable at all.
Would have to be true: A WOC nurse or other prescribing clinician would have to be willing to train and support a patient on self-insertion/self-removal of an intraluminal device, and a DME supplier or payer would have to be willing to source and bill for a product with no established billing code of its own.
Where it stands: The clinician half is now a formal claim: WOC nurses and other prescribing clinicians would have to be willing to train and support patients on this device rather than treating it as an added training and liability burden relative to conventional pouching [claim 16: unverified]. The payer/DME half is a viability-lens question this deck defers to rather than duplicates — see the viability deck's Slide 2: no HCPCS code distinct from the existing A4361-A4438 adhesive-pouch category exists for a device of this shape [claim 18: unverified], and the established billing category itself is only confirmed to exist for the conventional pouching system, not for this device [claim 7: unconfirmed].
What would settle it: Interviews with WOC nurses on training burden and liability comfort for an indwelling, patient-managed device; the HCPCS/coding question is settled where the viability deck names it.
If it's false: The consent chain breaks at the point of prescription even if the patient would want the device — the same failure shape the file's own competitor read (claim 3, Ampa Medical's InterPoc) has not yet had to answer either, since no FDA status was found for it.
Would have to be true: The daily burden of self-insertion and self-removal, any mucosal/skin exposure at the retention collar, and whatever the patient pays out of pocket would have to be less costly to them than the leakage and adhesive-related skin irritation the device replaces.
Where it stands: The device side of this cost is named but not measured. Valve occlusion by particulate effluent, leakage past the valve seal, and skin/mucosal irritation at the retention collar are all named as possible failure modes by the Generator's own reasoning, none characterized by bench or animal study because no prototype exists [claim 13: unconfirmed]. What the patient would pay is not in the file at all — no price, cash-pay amount, or copay figure appears anywhere [no claim]; the closest adjacent figure is the DMEPOS commodity rate for conventional pouching supplies, which the viability deck's Slide 1 covers and which this deck defers to rather than restate.
What would settle it: A bench/prototype occlusion-and-leak-rate study (feasibility deck Slide 5); a stated price or reimbursement model, which no claim in this file currently supplies.
If it's false: A patient who tries the device and finds the collar irritating or the valve occluding has every incentive to revert to the pouching system they already know works — which is exactly what Slide 6 below would need to observe.
Would have to be true: A patient or their WOC nurse would need to see it work — reduced leakage episodes, less skin irritation, or a colleague's/peer's experience — early enough in a trial period to keep using it rather than reverting to pouching.
Where it stands: No clinical evidence for this device or its mechanism exists in the file at all — it has no prototype and no bench or animal data [claim 13: unconfirmed]. The only mechanism precedent, the 1980 Silastic-tube/balloon study, reports a favorable outcome (14 patients, continuous voluntary control, no adverse effects) [claim 11: unconfirmed], but in a population (failed continent-ileostomy nipple valve) explicitly different from this candidate's intended standard-ileostomy population — the file itself frames it as "mechanism precedent, not a regulatory predicate," and the same distinction applies to clinical belief. Formalized in this deck's write-back: patients who currently experience leakage and skin irritation would have to find the valve-and-cap interface preferable to their pouch beyond an initial trial, enough to sustain continued daily use rather than reversion [claim 17: unverified].
What would settle it: A pilot acceptability/tolerability study in the actual target population (mature, standard ileostomy) — the same design as the 1980 study, run on the population this candidate actually targets rather than the one that study used.
If it's false: The product never crosses the trial-to-habit threshold, and the adherence-driven parts of the design rationale (reduced bulk, reduced skin exposure) never get observed in practice.
Would have to be true: A small number of structured conversations with WOC nurses and ileostomy patients would have to return a consistent signal on three questions at once: would a patient try daily self-insertion, would a nurse train them on it, and would either group accept the device past the novelty period.
Where it stands: No primary research of any kind exists in the file — no connector in this repo reaches patient- or clinician-preference questions, and none was attempted. The three conditions this conversation would test are now individually on record as claims 15, 16, and 17 (all unverified), rather than living only as prose in this deck.
What would settle it: WOC nurse and patient interviews or a small preference/acceptability study — the single highest-yield unspent step for this candidate, since it resolves Slides 2, 3, and 5 in the same conversation.
If it's false: The idea is a mechanism argument (non-absorptive valve vs. the competitor's absorptive intraluminal device, claim 3) built without ever asking the population it targets whether they would use 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.
Structural note: the only verified claims in this file at all are a CFR classification (claim 2) and a repo-state check that no ostomy dossier exists (claim 14) — neither is about anyone wanting the thing. Consistent with the rubric's own gap, nothing here scores desirability; this deck's near-total reliance on unconfirmed and freshly unverified write-backs is what that gap looks like on one candidate.
If only one thing from this chair could be checked: whether adults with a mature, standard ileostomy would be willing to learn and perform daily self-insertion and self-removal of an intraluminal stoma valve, in exchange for reduced pouch bulk and reduced adhesive-related skin exposure [claim 15: unverified].
Every other slide on this deck is downstream of it. If patients will not accept daily self-insertion, the WOC-nurse training question (Slide 3), the belief question (Slide 5), and the cost question (Slide 4) never get asked in practice — and the file's own design-rationale note names this as an assumption it is carrying, not a fact it has established, before any claim existed to carry it.
Naming it is not a recommendation, a gate, or a kill. It is the answer to "check what first."