idea-013 · feasibility 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: engineering — the people who would have to design, bench-test, manufacture, and produce the evidence a reviewer will ask for, for a device that does not yet exist as a prototype.
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 this. See docs/deck-spec.md.
First build. No prototype exists for this device. Every slide below is read against that fact.
Would have to be true: A soft, flanged, one-way (duckbill/slit) silicone valve, sized to the individual stoma, would have to seat at the stoma orifice/mucocutaneous junction (not advanced into the proximal small bowel), retained by a low-profile external collar, passing effluent into a small external cap the patient empties several times a day — for use only by adults with a mature, uncomplicated, non-surgically-reconstructed ileostomy.
Where it stands: This is the candidate's own mechanism and intended_use frontmatter, restated as a spec rather than a claim — no claim in the ## Claims list independently verifies the mechanism description itself, since no prototype exists to test it against [no claim]. What is checkable is the population restriction: the intended use deliberately excludes continent/Kock-pouch reconstructions and newly-created or complicated stomas, a scope decision the file states explicitly as a design choice to avoid confounding both safety and the regulatory story, not something any connector confirms or refutes.
What would settle it: A written device requirements specification with quantities (valve opening pressure, effluent flow rate, retention-collar dimensions) — none of which exist in this file yet; a first physical prototype.
If it's false: Every downstream slide is moot — there is no device to bench-test, classify, or manufacture.
Would have to be true: The one-way valve would have to reliably contain ileostomy effluent (higher volume and lower viscosity than colostomy output) without occluding on particulate matter, without leaking past the seal, and without irritating the stoma mucosa/peristomal skin at the retention collar — over daily use, for an extended period, without the bowel-obstruction or retained-foreign-body risk a device advanced into the bowel would carry.
Where it stands: Named explicitly as the Generator's own unsourced mechanism reasoning, not sourced to any study: valve occlusion by particulate effluent, leakage past the valve seal, and skin/mucosal irritation at the retention collar are all flagged as possible failure modes, "none of which have been characterized by any bench or animal study, because none has been performed; this device does not yet exist as a prototype" [claim 13: unconfirmed]. The one mechanism precedent in the literature — a Silastic tube with a circumferential balloon providing a leakproof seal, studied in 14 patients with "continuous and voluntary control ... without untoward local or systemic effects" — is a different valve design (balloon retention, not a duckbill/slit valve) in a different population (post-continent-ileostomy-surgery patients with a failed nipple valve, not this candidate's standard-ileostomy target) [claim 11: unconfirmed].
What would settle it: Bench testing of a prototype valve against synthetic or ex vivo ileostomy effluent for occlusion rate and seal integrity; the full text of PMID 7457715 (currently only abstract-level via literature-detail, which cannot itself resolve a confidence tag) for whatever mechanism detail it carries.
If it's false: The device's core differentiation from the absorptive competitor (Ampa Medical's InterPoc [claim 3: unconfirmed]) — a different failure-mode profile rather than a superior one — does not hold, and the mechanical valve carries its own unmitigated risk profile instead of a better one.
Would have to be true: Whichever regulatory route actually governs this device would have to be known, because it sets the entire build spec — performance-standard testing, biocompatibility, human-factors work, and whether any clinical evidence is required at all.
Where it stands: Three routes remain open and pull toward different build specs. 21 CFR 876.5030 (continent ileostomy catheter) is Class I, exempt from 510(k), but whether its scope extends to a standard (non-surgical, non-Kock-pouch) ileostomy — rather than post-surgery continent-ileostomy drainage — is unresolved by the regulation text itself [claim 1: unconfirmed]. 21 CFR 876.5900 (ostomy pouch and accessories) is verified Class I, exempt, and confirmed to match this device's external cap/reservoir component specifically — but not the valve-insert, the device's novel and higher-risk element [claim 2: verified]. A third route the frontmatter's device_class field never carried is now in play: 21 CFR 876.5980 (the classification governing the historical Waters Ileostomy Valve, K813585), Class II, not exempt — meaning full 510(k) submission, not simple registration [claim 12: refuted] — see the viability deck's Slide 6 for what this refutation does and does not settle. If none of the three fits cleanly, De Novo is the frontmatter's own fallback, carrying its own performance-data and special-controls burden.
What would settle it: An FDA pre-submission (Q-sub) — the single act that would resolve which build spec applies; a direct FDA classification-database query for indwelling stoma-valve devices generally, which no connector call run so far has performed as a landscape search (the patent/classification/510k connectors here answer named-item queries, not open searches for a device type).
If it's false: If the Class II route governs, the biocompatibility, bench, and human-factors evidence burden is materially larger than either Class I exempt analog implies, and the build timeline the viability deck's Slide 4 has no claim to price would lengthen further.
Would have to be true: The valve-and-collar assembly would have to seal reliably across the range of individual stoma sizes and anatomies it is meant to fit, since the device is described as "sized to the individual stoma" rather than one-size-fits-all — the single component most likely to determine whether the mechanism (Slide 2) holds in practice.
Where it stands: No claim in the file speaks to stoma-size variability, fitting tolerance, or how many valve sizes a manufacturer would need to stock [no claim]. This is a narrower, more specific version of the general mechanism uncertainty already carried by [claim 13: unconfirmed] — named here separately because it is the one variable a bench study could isolate first, before testing occlusion or effluent handling.
What would settle it: A stoma-anatomy sizing study (even a small cadaveric or clinical measurement series) to set the size-range requirement before any valve tooling is cut.
If it's false: A device that fits only a narrow anatomical range needs either a large SKU count (a manufacturing-cost problem, Slide 6) or a custom-fit process (a cost and time-to-revenue problem the viability deck's Slide 4 already flags as unpriced).
Would have to be true: A bench rig would have to demonstrate acceptable occlusion rate, seal integrity under realistic effluent volume/viscosity, and retention-collar tissue compatibility before any animal or human study could be considered — and no agent in this repo is positioned to greenlight that next step regardless.
Where it stands: None of this exists. The file states plainly that none of the named failure modes "have been characterized by any bench or animal study, because none has been performed; this device does not yet exist as a prototype" [claim 13: unconfirmed]. This is also exactly the Stage 7 diligence gap the file names for itself: "the Factor 6 gap a Stage 7 bench-evidence plan would need to close."
What would settle it: A defined bench-test protocol (occlusion challenge with simulated effluent, seal-integrity/leak testing, cytotoxicity/biocompatibility screen per the applicable ISO 10993 battery once the regulatory route in Slide 3 sets the requirement) — none of which is scoped in this file yet.
If it's false: There is no basis to propose an animal study, and per the trust-tier rule this repo enforces structurally, no agent here would propose one regardless of what a bench study showed.
Would have to be true: The silicone valve and low-profile cap would have to be manufacturable and sterilizable (or safely patient-reprocessable) at a unit cost compatible with DMEPOS-scale reimbursement, with a shelf life suitable for a daily-use home item, and usable correctly by a patient at home without clinician supervision after initial training — not in a hospital or clinic, the environment most human-factors evidence in this space assumes.
Where it stands: Nothing in the original claim set addressed this at all — the Scores table's Moat/defensibility and Capital-intensity rows are both left blank rather than guessed, and no manufacturing, sterilization, shelf-life, or home-use human-factors claim existed prior to this deck. Formalized in this deck's write-back as two separate conditions: that the device could be manufactured, sterilized (or safely patient-reprocessed), and shelf-life-rated at a DMEPOS-compatible unit cost [claim 20: unverified], and that a patient could be trained to correctly size, self-insert, and self-remove the valve at home without clinician supervision after initial training, without mucosal trauma, stomal stenosis, or misplacement [claim 21: unverified]. The second condition is the feasibility-side counterpart to the desirability deck's Slide 2 (willingness) — this slide asks whether they can do it safely, that one asks whether they will.
What would settle it: A manufacturability/DFM review of the valve+collar+cap assembly against a target unit cost; a formative human-factors study in a home-like setting, not a clinical one, per FDA human-factors guidance for the applicable device class (Slide 3).
If it's false: Either the unit economics never work under DMEPOS-scale pricing (a viability-lens consequence, Slide 4 of that deck), or the device is unsafe for genuinely unsupervised home use and the intended use would have to add a supervision requirement it does not currently carry.
Would have to be true: No live, enforceable patent would have to cover a non-absorptive one-way mechanical valve seated at the stoma orifice and retained by an external collar — or, if one does, a design workaround would have to exist that does not compromise the mechanism described in Slide 1-2.
Where it stands: Genuinely unexamined, not clear. US Patent 11,395,757 B2, "Continent ostomy valve and method of use," is live and recently issued, and the Generator itself did not read its claims scope [claim 9: unconfirmed] — both patent-connector calls attempted failed because PATENTSVIEW_API_KEY is unset in this environment, a missing credential rather than a finding that the patent is clear. A body of adjacent patent art was located but named as clustering around leak-sensing (the Coloplast Heylo competitive space) rather than valve mechanics [claim 10: unconfirmed] — but that reading itself rests on an unread patent corpus and no specific patent numbers, so it cannot be upgraded past unconfirmed either. An absence of a search result here is not freedom to operate, and must not be read as an open field.
What would settle it: Provisioning PATENTSVIEW_API_KEY and re-running patent 11395757 / patent US11395757B2 for claims scope, assignee, and expiration; a formal FTO clearance opinion from patent counsel, which no connector in this repo can substitute for.
If it's false: If US 11,395,757 B2's claims read broadly enough to cover a non-absorptive valve at the stoma orifice, the mechanism in Slide 1-2 would need to design around it or this candidate does not have a buildable, unencumbered version of its own core idea.
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 one verified claim this deck can lean on, [claim 2: verified], covers only the external cap/reservoir component under an existing exempt classification — it says nothing about the valve-insert, which is this device's actual novelty and actual risk.
If only one thing from this chair could be checked: which regulatory route actually governs this device — Class I exempt under 21 CFR 876.5030 or 876.5900 (partial coverage only), or Class II under 876.5980 or a De Novo grant [claim 1: unconfirmed], [claim 2: verified], [claim 12: refuted].
This is the single most consequential open question in the file, by the Verifier's own assessment of the finding that produced it (a real Class II predicate, Waters Ileostomy Valve K813585, contradicting the frontmatter's "no predicate found" premise). It sets the build spec for every other slide on this deck: whether biocompatibility and bench testing alone suffice or a full 510(k) submission with performance data is required, and therefore what Slide 5's bench program has to prove before anything else can move. It is also the condition the viability deck's capital-to-first-dollar slide names as the reason it cannot price a timeline at all.
Naming it is not a recommendation, a gate, or a kill.