idea-013 · human · US
An external, patient self-inserted and self-removed one-way valve and; low-profile drainable cap, seated at the stoma orifice and mucocutaneous junction, for; use by adults with a mature (post-healing, uncomplicated), non-surgically-reconstructed; ileostomy, as an alternative to continuous-wear adhesive ostomy pouching systems for the; collection and periodic voluntary evacuation of ileostomy effluent in a home setting.
Back in research. The gate sent it there with 7 of 9 factors verified; nothing for you to decide yet. No department has been asked. 2 of 29 claims verified, 2 refuted. Nobody has yet written down what it rests on.
What this is, who it is for, and what it is coded to — in plain language, no rubric vocabulary. Someone who has never opened this repo should be able to read this and know what the product is.
In the Wrap's one-paragraph version, written for someone who has not opened the file. Domain: none linked
No business case yet, so nothing here says who writes the cheque. /business-case idea-013 builds one.
What this idea rests on that is not yet known, in the order this idea's own decision queue puts it: worst if false first, cheapest to settle first inside that. The first row is open; open any other for what would settle it.
This idea is unassessed, so nobody has yet named the few things it rests on. Until then, the gaps below are the rubric factors that are unscored or carry an open question. /assess idea-013 replaces this list with the real one.
Why it scored what it did: Claims 1, 2, 10 — no cleared predicate for this exact device shape found; two Class I exempt analogs (876.5030, 876.5900) whose plain-language scope does not squarely match this device; De Novo (De Novo classification request) carried as most-likely route
What would settle it: Free eCFR/openFDA classification and 510(k) (premarket notification)/De Novo searches can narrow the pathway. An FDA (US Food and Drug Administration) pre-submission (Q-sub) would settle it for good, at the cost of consultant fees and a multi-month FDA queue.
Why it scored what it did: claim 7unconfirmed — an established DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) billing category (A4361 (a HCPCS code for a supply)–A4438) exists for conventional pouching-system components, but no HCPCS (Healthcare Common Procedure Coding System) code was found for a valve-based collection-interface device of this shape
What would settle it: A free CMS (Centers for Medicare & Medicaid Services) HCPCS/DMEPOS lookup confirms no code exists yet. A coding consultant's opinion on miscellaneous-code (A9999) billing vs. a new-code petition costs consultant fees, plus months for CMS to rule on a petition.
Why it scored what it did: Claims 5, 8 — 725k–1M Americans living with an ostomy (any type, not ileostomy-specific) and a ~$586.6M US market-research estimate (aggregator source, not primary data)
What would settle it: Free CMS DMEPOS claims-volume data for A4361–A4438 gives a volume floor. A primary ileostomy-specific epidemiological dataset (e.g. a licensed CMS claims study) would need a paid report to replace the current UOAA/aggregator figures.
Why it scored what it did: Claims 8, 9 — US Patent 11,395,757 B2 ("Continent ostomy valve and method of use") is live and recently issued, a named potential blocker whose claims scope was not read; adjacent sensor-patent art (claim 9unconfirmed) appears not to bear on this…the rest of this reasoning
valve mechanism
What would settle it: A PatentsView claims-scope/assignee/expiration read on US 11,395,757 B2, once an API key is provisioned (free once set up). A formal FTO (freedom to operate) opinion from patent counsel costs several thousand dollars and is the real settler.
Why it scored what it did: No claim in this file addresses defensibility (manufacturing complexity, trade secret, switching cost, fast-follower barrier) — left blank rather than guessed
What would settle it: A manufacturing-complexity assessment of the valve+cap assembly, plus a check of how fast continent-ileostomy-catheter analogs got copied post-clearance — both consultant-time costs, not connector-checkable.
Why it scored what it did: Claims 11, 13 — a 1980 published silastic-tube/balloon indwelling valve analog reported safe/well-tolerated in 14 patients (different design, small n, abstract-level only); no bench or animal evidence exists for this specific valve+cap…the rest of this reasoning
design, and no prototype exists
What would settle it: A full-text read of PMID (PubMed identifier) 7457715 (free, via PubMed). A bench prototype/testing plan is the real settler, costing contract-engineering time — a Stage 7 diligence item, not available yet.
Why it scored what it did: Claims 1, 2, 10, 13 (inferred) — regulatory pathway is genuinely unresolved between a Class I exempt analog and a De Novo route, and no bench/prototype work has begun, so cost and timeline are both open-ended pending which route applies
What would settle it: Outcome of an FDA pre-submission (Q-sub) to resolve pathway; a contract-engineering estimate for prototype/bench-validation cost and calendar time
Why it scored what it did: Claims 3, 4 — two adjacent competitor products identified (Ampa Medical's InterPoc, an absorptive intraluminal device in pilot study, no FDA status found; Coloplast's Heylo, a leak-sensor accessory, UK/NHS-reimbursed only, no US status…the rest of this reasoning
found) — active adjacent space, no direct competitor for this exact valve+cap shape identified
What would settle it: A fresh openFDA 510(k)/De Novo search for any newly cleared stoma-valve device, plus a clinicaltrials.gov check on InterPoc's trial stage — both free, quick lookups.
Why it scored what it did: No claim addresses this — it depends on the operator's own portfolio composition, not a primary source this repo's claims can carry
What would settle it: An internal portfolio review classifying this as hero bet vs. cash-generative spoke against current holdings — not a connector-checkable item
Seven chairs, each answering from its own field. The verdict, and the first condition it set.
Not convened. No department has stated a position on this idea yet — a normal state, not a defect. /round-table idea-013 asks all seven.
Only verified counts toward a score. A low count is usually a statement about the tooling — an absent data file, an unset key — rather than about the idea.
2 claim(s) the Verifier found to be false — a refuted claim is a finding, and the loop owes each one an answer.
<the single piece of evidence that would move this candidate most, what it would cost, and who would have to do it. Take it from the Scores table's "What would settle it" column — this is a selection from that gap analysis, not a new judgement. One sentence.>
Nothing is waiting on a decision. The next move above is work, not a choice.
Only verified counts toward a score. A low count is usually a statement about the tooling (an absent data file, an unset key) rather than about the idea.
PATENTSVIEW_API_KEY
unset) — an absence of a search result is not freedom to operate, and this must not be
read as "clear."
To finish it:
domains: — run /research**Cheapest next test:** is still the unfilled _template.md placeholder — name the test, or the criterion checks nothingNo human review is recorded. Shortlisting, legal and clinical sign-off and capital allocation are Tier 3: no agent in this repo makes or simulates one.
Runs only after a human shortlists the idea.
No loop record: nobody has written down what this idea rests on or convened a department on it. That is a normal state, not a defect. /front-end-loop idea-013 opens one.
Nobody has yet written down what this idea rests on and what it would cost to be wrong. Unassessed is a state, not a low score. /assess idea-013 adds it.
Click any step to see what it holds for this idea. donecurrentloopinghuman only
## Wrap section, as writtenThe packet a human reads. See docs/wrap-spec.md. This section says nothing about whether the idea is good — it says the file is finished enough to be read, and names what to do next. Filling it in advances no candidate and approves nothing.
The one-paragraph version. What this is, who it is for, and what it is coded to — in plain language, no rubric vocabulary. Someone who has never opened this repo should be able to read this and know what the product is.
What would have to be true. One line per lens, quoted verbatim from that deck's load-bearing condition. Do not summarise or re-rank them.
Cheapest next test: <the single piece of evidence that would move this candidate most, what it would cost, and who would have to do it. Take it from the Scores table's "What would settle it" column — this is a selection from that gap analysis, not a new judgement. One sentence.>
Where the evidence actually stands. State the coverage plainly, including what is blocked on tooling rather than on a finding — a missing CMS cache file and an unset PATENTSVIEW_API_KEY are not evidence that a code or a patent does not exist. Run python3 engine/scripts/wrap_status.py --candidate idea-XXX for the numbers.
| Factor | Score | Why | What would settle it |
|---|---|---|---|
| Regulatory pathway | 2 | Claims 1, 2, 10 — no cleared predicate for this exact device shape found; two Class I exempt analogs (876.5030, 876.5900) whose plain-language scope does not squarely match this device; De Novo carried as most-likely route | Free eCFR/openFDA classification and 510(k)/De Novo searches can narrow the pathway. An FDA pre-submission (Q-sub) would settle it for good, at the cost of consultant fees and a multi-month FDA queue. |
| Reimbursement pathway | 1 | claim 7unconfirmed — an established DMEPOS billing category (A4361–A4438) exists for conventional pouching-system components, but no HCPCS code was found for a valve-based collection-interface device of this shape | A free CMS HCPCS/DMEPOS lookup confirms no code exists yet. A coding consultant's opinion on miscellaneous-code (A9999) billing vs. a new-code petition costs consultant fees, plus months for CMS to rule on a petition. |
| TAM | 2 | Claims 5, 8 — 725k–1M Americans living with an ostomy (any type, not ileostomy-specific) and a ~$586.6M US market-research estimate (aggregator source, not primary data) | Free CMS DMEPOS claims-volume data for A4361–A4438 gives a volume floor. A primary ileostomy-specific epidemiological dataset (e.g. a licensed CMS claims study) would need a paid report to replace the current UOAA/aggregator figures. |
| FTO / IP | 2 | Claims 8, 9 — US Patent 11,395,757 B2 ("Continent ostomy valve and method of use") is live and recently issued, a named potential blocker whose claims scope was not read; adjacent sensor-patent art (claim 9unconfirmed) appears not to bear on this…the rest of this reasoningvalve mechanism | A PatentsView claims-scope/assignee/expiration read on US 11,395,757 B2, once an API key is provisioned (free once set up). A formal FTO opinion from patent counsel costs several thousand dollars and is the real settler. |
| Moat / defensibility | — | No claim in this file addresses defensibility (manufacturing complexity, trade secret, switching cost, fast-follower barrier) — left blank rather than guessed | A manufacturing-complexity assessment of the valve+cap assembly, plus a check of how fast continent-ileostomy-catheter analogs got copied post-clearance — both consultant-time costs, not connector-checkable. |
| Mechanism & clinical risk | 2 | Claims 11, 13 — a 1980 published silastic-tube/balloon indwelling valve analog reported safe/well-tolerated in 14 patients (different design, small n, abstract-level only); no bench or animal evidence exists for this specific valve+cap…the rest of this reasoningdesign, and no prototype exists | A full-text read of PMID 7457715 (free, via PubMed). A bench prototype/testing plan is the real settler, costing contract-engineering time — a Stage 7 diligence item, not available yet. |
| Capital intensity & time-to-revenue | 2 | Claims 1, 2, 10, 13 (inferred) — regulatory pathway is genuinely unresolved between a Class I exempt analog and a De Novo route, and no bench/prototype work has begun, so cost and timeline are both open-ended pending which route applies | Outcome of an FDA pre-submission (Q-sub) to resolve pathway; a contract-engineering estimate for prototype/bench-validation cost and calendar time |
| Competitive intensity | 3 | Claims 3, 4 — two adjacent competitor products identified (Ampa Medical's InterPoc, an absorptive intraluminal device in pilot study, no FDA status found; Coloplast's Heylo, a leak-sensor accessory, UK/NHS-reimbursed only, no US status…the rest of this reasoningfound) — active adjacent space, no direct competitor for this exact valve+cap shape identified | A fresh openFDA 510(k)/De Novo search for any newly cleared stoma-valve device, plus a clinicaltrials.gov check on InterPoc's trial stage — both free, quick lookups. |
| Strategic fit & portfolio balance | — | No claim addresses this — it depends on the operator's own portfolio composition, not a primary source this repo's claims can carry | An internal portfolio review classifying this as hero bet vs. cash-generative spoke against current holdings — not a connector-checkable item |
To finish this packet:
domains: — run /research**Cheapest next test:** is still the unfilled _template.md placeholder — name the test, or the criterion checks nothingSource file: knowledge-base/candidates/idea-013.md
Nothing on this page is a recommendation. Shortlist review, legal and clinical sign-off and capital allocation are human-only decisions, and no agent in this repo may make or simulate one. This is a compilation of what the candidate file says.
_shared/plain-language.md