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 a soft silicone valve and a retention collar for a living stoma, prove on a bench that they seal and do not clog, make them at scale for daily home use, and assemble the evidence an FDA (US Food and Drug Administration) reviewer would ask for.
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. See docs/deck-spec.md.
Rebuild, 2026-09-29. Rebuilt after the Verifier's second pass. What changed for this chair: the continent ostomy valve patent now resolves bibliographically (claim 9unconfirmed), and the earlier feasibility write-backs (claims 20 and 21) are now unconfirmed — no connector reaches manufacturability or patient handling. The device still does not exist as a prototype. This build appended claims 28 and 29.
Would have to be true: For an adult with a mature, standard ileostomy at home, the device would have to pass effluent one way through a stoma-sized silicone valve into a flush external cap, hold it without leaking between emptyings, drain on demand, and be inserted and removed by the patient daily. The quantities that turn this into a spec — stoma size range, effluent volume and viscosity, reservoir capacity, emptying interval, opening pressure — are blanks.
Where it stands: The function is the file's own intended-use statement and mechanism, not a claim. The failure modes it would have to design against are the Generator's own reasoning, about a device with no prototype claim 13unconfirmed. How often the cap would have to be emptied, day and night, is a desirability assumption on record, unchecked claim 22unverified. No claim carries any of the quantities listed above [no claim].
What would settle it: A published characterisation of ileostomy output volume and consistency, entered as a claim with a PMID (PubMed identifier) so literature-detail can run it; stoma-size distribution data from the same source or from a WOC nurse survey. Only then can reservoir capacity be a number.
If it's false: If ileostomy output cannot be held in a low-profile reservoir for an interval patients accept, the "low-profile" half of the design fails and the device becomes a pouch with extra parts — desirability Slide 4 collapses with it.
Would have to be true: A duckbill or slit valve in soft silicone would have to open under normal ileal output pressure, close against backflow, and not be occluded by particulate effluent over a full day of wear. The opening and closing pressures it would have to hit are not in the file.
Where it stands: Occlusion by particulate effluent and leakage past the seal are named as uncharacterised failure modes; no bench or animal work has been done claim 13unconfirmed. The one precedent is a different mechanism — a Silastic tube with a circumferential balloon, in 14 patients with a failed continent-ileostomy nipple valve — reported to give continuous, voluntary control without adverse effects, read from the abstract only claim 11unconfirmed. Nothing in the file carries a pressure, a flow rate or an occlusion rate [no claim].
What would settle it: A full-text read of PMID 7457715 (free, via PubMed) for whatever pressures and failure data it reports; then a bench flow rig with simulated ileostomy effluent of graded viscosity and particulate load.
If it's false: A valve that clogs or leaks back is the single failure a patient would notice first. Factor 6 (Mechanism and clinical risk) stays unscoreable and the Stage 7 bench list has nothing to measure against.
Would have to be true: The device would have to fall under a Class I, 510(k) (premarket notification)-exempt classification — so that general controls, biocompatibility and labelling are the build spec — rather than under a Class II (FDA device class II) route that adds performance data and a premarket submission, or a De Novo (De Novo classification request) that adds whatever special controls FDA writes.
Where it stands: The exempt reading is on record, unchecked claim 28unverified. The continent-ileostomy catheter regulation exists, is Class I and exempt, and describes a device the patient inserts periodically — for a surgically created ileal pouch; whether it reaches a standard ileostomy is an FDA judgement claim 1unconfirmed. The ostomy pouch regulation is Class I and exempt and verified, but reaches the external cap only, not an indwelling valve claim 2verified. Against both, an "ileostomy valve" was cleared by 510(k) in 1982 under product code KNT, now Class II under 21 CFR (Title 21 of the Code of Federal Regulations) 876.5980, not exempt, with no readable indications for use claim 12refuted. The frontmatter carries De Novo as the most likely route; no claim confirms any of the three.
What would settle it: An FDA pre-submission (Q-sub) naming K813585 (an FDA 510(k) clearance number) and 876.5980 alongside 876.5030 and 876.5900, as the Scores table's regulatory row says. python3 -m connectors regulation 876.5980 would add the current text of the third route — cheap, and not yet run for its scope.
If it's false: If the route is Class II or De Novo, the build spec gains performance testing and human-factors validation before any sale, and the capital line on viability Slide 4 grows with it. The whole evidence plan on Slide 5 is sized by this answer.
Would have to be true: A low-profile external retention collar, with no adhesive wafer, would have to keep a soft valve seated at the stoma orifice through walking, sitting, sleeping and peristalsis, without dislodging and without effluent tracking past the seal onto the skin.
Where it stands: On record from this deck, unchecked claim 29unverified. The failure modes it has to avoid — leakage past the seal, skin and mucosal irritation at the collar — are named but not characterised claim 13unconfirmed. Whether a patient could seat it correctly every day without trauma or misplacement is a separate assumption adoption cannot answer claim 21unconfirmed. No claim carries any retention force, stoma-shape range or seal pressure [no claim].
What would settle it: A bench fixture with compliant stoma models spanning a stoma-size range (to be sourced, Slide 1), cycled through simulated movement and output, measuring dislodgement force and leak-past-seal. The step after that is Tier 3 and outside this deck.
If it's false: Without adhesive, the collar is the only thing between effluent and skin. If it cannot seal, the device reintroduces leakage — the problem that motivated it — and every slide on the desirability deck answers the wrong question. This is the component most likely to be the reason the idea does not work.
Would have to be true: Before any animal or patient is involved, a bench rig would have to show the valve opening and closing within a specified pressure window, an occlusion rate under graded particulate load, retention and leak-past-seal performance on stoma models, and material biocompatibility for mucosal contact. The acceptance thresholds are not in the file.
Where it stands: None of it exists: no prototype, no bench study, no animal study claim 13unconfirmed. The seal-and-retention condition is on record claim 29unverified. No claim sets an acceptance threshold for any of these measurements [no claim].
What would settle it: A bench-evidence plan written at Stage 7 by the Diligence Lead, with thresholds taken from whichever route Slide 3 lands on; contract-engineering time to build the rigs. Whether anything moves past the bench is a Tier 3 decision; no agent in this repo greenlights an animal study.
If it's false: If the bench cannot show sealing and non-occlusion, there is nothing to take further, and Factor 6 has no evidence to score.
Would have to be true: A silicone valve and cap would have to be manufacturable, sterilised or validated for patient reprocessing, and shelf-stable as a daily-use home product at a unit cost that fits ostomy-supply reimbursement — and an adult patient would have to learn to size, insert and remove it at home without supervision or injury.
Where it stands: Manufacturing, reprocessing, shelf life and unit cost are an assumption no connector reaches claim 20unconfirmed; the reimbursement ceiling that unit cost has to fit under is about $2-$5 allowed per unit for the candidate codes (viability Slide 2) claim 18unconfirmed. Unsupervised patient handling without mucosal trauma, stomal stenosis or misplacement is an assumption adoption cannot answer claim 21unconfirmed. Whether the valve is single-use or reusable is not stated anywhere in the file [no claim].
What would settle it: A design-for-manufacture review and a cost-of-goods estimate from a silicone moulding contractor once a design exists (human, paid); a formative usability study on a non-functional model with ileostomy patients (human).
If it's false: If the device cannot be made for less than supply-rate reimbursement, the viability deck has no margin; if patients cannot seat it safely alone, the intended use ("patient self-inserted") is wrong and the route on Slide 3 changes with it.
Would have to be true: No live, enforceable patent would have to cover a one-way valve seated at a standard ileostomy's orifice with an external retention collar — or, if one does, a design-around would have to exist that still seals.
Where it stands: US 11,395,757 B2, "Continent Ostomy Valve and Method of Use", exists, filed 2019-08-30, naive expiry 2039-08-30; its in-force status, grant date and claims are unread, and the patent lookup is dates only, never an FTO (freedom to operate) finding claim 9unconfirmed. The adjacent leak-sensor patents are cited without numbers, so nothing could be looked up claim 10unconfirmed. The 1981 indwelling valve is published art claim 11unconfirmed. Whether this design could itself be patented is on the viability deck claim 27unverified. No patent search on valve-at-stoma mechanics beyond one named number has been run [no claim].
What would settle it: Reading the claims of US 11,395,757 B2 (a human act, or a connector that returns claim text); then an FTO opinion from patent counsel, which is Tier 3 legal work and costs several thousand dollars, per the Scores table.
If it's false: If US 11,395,757 B2 reads on a stoma-orifice valve and cannot be designed around, the Stage 5 "FTO blocked" condition applies — naming that is not proposing it — and the mechanism on Slide 2 is off the table until 2039 at the naive date.
Every condition above with nothing verified behind it. The only verified claim cited (claim 2verified) covers the external cap's classification, not the valve. Read this slide first.
regulation 876.5980 (cheap).
If only one thing from this chair could be checked: whether a low-profile external retention collar, without an adhesive wafer, can hold a soft silicone one-way valve seated at the stoma orifice of a mature ileostomy through normal daily activity and peristalsis without dislodgement and without effluent leaking past the valve seal claim 29unverified.
Why this one: the route (Slide 3) decides how much evidence has to be built, but the seal decides whether there is a device to build evidence for. If the collar cannot hold without adhesive, the product reintroduces the leakage it was meant to remove, and the route, the patent and the manufacturing questions stop mattering. It is also checkable on a bench, before any person or animal is involved.
Naming it is not a recommendation, a gate, or a kill.
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