idea-015 · human · US
For fitting by a licensed clinician and subsequent wear by the patient, as a; removable intravaginal support device to reduce the symptoms of stage II or stage III; anterior-compartment or apical pelvic organ prolapse in adult women who have elected; non-surgical management; not indicated for the treatment of stress urinary incontinence, not; indicated for stage IV or procidentia, and not a substitute for surgical repair.
Still being built — 7 of 8 wrap criteria met; nothing for you to decide yet. No department has been asked. 9 of 56 claims verified, 4 refuted. Nobody has yet written down what it rests on.
A reusable medical-grade silicone ring-with-support pessary containing a ratcheting internal band whose outer supporting diameter the fitting clinician sets, and locks, at any point across a continuous range spanning the standard ring-pessary size ladder. A failed or uncomfortable fit is corrected by re-adjusting the same device within the same visit rather than by withdrawing it and trying the next discrete size from a stocked fitting set, and the set diameter is readable off the device so it can be recorded in the chart and re-set at follow-up. Insertion, removal, cleaning and wear are otherwise those of a conventional ring pessary. One SKU replaces a multi-size fitting inventory.
In the mechanism, as the candidate file states it — the plain-language paragraph in ## Wrap has not been written yet. Domain: none linked
No business case yet, so nothing here says who writes the cheque. /business-case idea-015 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-015 replaces this list with the real one.
Why it scored what it did: Claims 1, 3, 4, 5. intended_use: is stated, so this factor is scorable. Scored on the assumption that 884.3575 / HHW is read to cover a mechanically-set diameter. Pulled down from 4 by claim 2unconfirmed (510(k) (premarket notification)-vs-exempt unresolved) and claim 5unconfirmed…the rest of this reasoning
(no cleared adjustable-diameter predicate, so a De Novo (De Novo classification request) reading is live). Note claim 5unconfirmed is absence-of-evidence over a non-exhaustive search, not confirmed absence.
What would settle it: An openFDA device/classification lookup on product code HHW — settles the class and the premarket-notification exemption flag in one call, near-zero cost. Opening the K190277 (an FDA 510(k) clearance number) clearance letter and the four candidate K-numbers confirms…the rest of this gap analysis
whether a real adjustable-mechanism predicate exists.
Why it scored what it did: Claims 6, 7, 8, 11. Scored as "codes plausibly exist," not "pathway exists": A4561 (a HCPCS code for a supply)/A4562 and CPT (Current Procedural Terminology) 57160 are asserted active, which is better than most candidates, but the ~$69-89 device allowed amount (claim 11refuted) is a hard ceiling on a…the rest of this reasoning
device that bills once, claim 7unconfirmed puts a DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) supplier channel in the way, and margin at that payment is only assumption claim 24unconfirmed — an assumption, not evidence. No coverage policy was checked at all.
What would settle it: The CMS (Centers for Medicare & Medicaid Services) DMEPOS fee-schedule file for A4561/A4562 and the PFS (physician fee schedule) relative-value file for 57160 — both free downloads, one lookup each. A DME MAC (durable medical equipment Medicare administrative contractor) LCD (local coverage determination)/policy-article search for pessary coverage criteria is the missing coverage half.
Why it scored what it did: Claims 10, 11, 12, 13. All three TAM (total addressable market) components are the candidate's own unsourced guesses (10 and 12 say so explicitly). Taken at face value the arithmetic is thin: ~50-200k fittings × ~$69-89 × 30-50% addressable ≈ low single-digit $M of…the rest of this reasoning
Medicare device revenue, once per patient on a reusable SKU. claim 13unconfirmed (2.9% symptomatic POP prevalence) sizes the disease, not the billable device market. Sits at the 2/5 kill floor.
What would settle it: CPT 57160 Medicare Part B (Medicare Part B) allowed-services volume from the CMS Physician & Other Practitioners utilization data via this repo's procedures volume lookup — cheap, and it fixes the one component with a real source. Price comes from the…the rest of this gap analysis
same DMEPOS file as Reimbursement; addressable share has no primary source and needs commissioned practice-level research.
Why it scored what it did: Claims 16, 17, 18. Not an honest blank: claim 16verified names US 11,865,033 as live-looking, directly adjacent art that already steered the design away from a collapse-for-removal feature, and claim 18unconfirmed records that **no landscape search was run…the rest of this reasoning
on the locking mechanism itself** — the core novelty's FTO (freedom to operate) field is unexamined, not clear. claim 17verified (US 6,189,535 expired) is minor comfort on a different concept. Scored low for unexamined blocking risk, not scored as blocked — that call needs verified claims.
What would settle it: Pull the issued claims, assignee of record, legal status and maintenance-fee state for US 11,865,033 from USPTO (United States Patent and Trademark Office)/Patent Center — one lookup. The ratcheting-lock landscape needs a commissioned professional FTO search; that is a paid,…the rest of this gap analysis
multi-week item and the single most expensive gap in this file.
Why it scored what it did: Claims 5, 18, 20, 21. The moat is one mechanical ratchet-and-lock on an otherwise commodity silicone ring, with no filed application recorded and no landscape work (claim 18unconfirmed) to say what is even patentable. Claims 20 and 21 put third…the rest of this reasoning
parties (3D-printed patient-specific pessaries, Reia) on the same trial-and-error fitting problem. Regulatory exclusivity is nil on a 510(k)/exempt route.
What would settle it: A patentability opinion on the locking mechanism, which falls out of the same commissioned search as FTO — no extra search cost, added attorney time.
Why it scored what it did: Claims 14, 15 establish the problem is real (56-80% initial fitting success; 30-50% 12-month discontinuation), and mechanical support of a prolapsed compartment is an incumbent mechanism, so plausibility is high. Held at 3 by assumption…the rest of this reasoning
claim 23unconfirmed — that in-visit re-adjustment beats the next discrete size — which is the central clinical bet and has no data behind it, and by assumption claim 25unconfirmed, cleaning validation and lock retention on a reusable mechanical joint. Both are assumptions and are not scored as evidence.
What would settle it: Retrieve the actual fitting-success and discontinuation papers via PubMed (claims 14, 15 name no confirmed PMID (PubMed identifier)) — cheap. claim 23unconfirmed can only be settled by a prospective comparative fitting study; claim 25unconfirmed by a bench cleaning-validation and…the rest of this gap analysis
ISO (International Organization for Standardization) 10993 biocompatibility protocol on a real joint.
Why it scored what it did: Claims 1, 2, 6. Silicone moulding plus a mechanical joint, no expected clinical trial on a substantial-equivalence argument about geometry and materials, and an existing DMEPOS code to bill against — this is a cheap, fast route to first…the rest of this reasoning
dollar by medtech standards. The spread is wide: claim 2unconfirmed's exempt route would make entry registration/listing plus QSR, while a De Novo reading (claim 5unconfirmed) would add years. claim 25unconfirmed's cleaning-validation burden is the main hidden cost.
What would settle it: Same openFDA HHW classification lookup as Regulatory — it collapses the exempt-vs-510(k)-vs-De Novo spread that drives this factor. A contract-manufacturing quote on the ratcheting mechanism would settle the cost side and also test…the rest of this gap analysis
assumption claim 24unconfirmed.
Why it scored what it did: Claims 4, 20, 21, and the predicate_or_analog incumbents (CooperSurgical/Milex, Bioteque, ConTIPI/ProVate K190277). A crowded, commoditised, low-price category with named development-stage entrants attacking the same fitting problem from…the rest of this reasoning
other directions. No adjustable-diameter competitor was identified (claim 5unconfirmed), which is the only thing holding this above 1.
What would settle it: An openFDA product-code sweep of HHW plus a ClinicalTrials.gov pull on NCT04275089 (a ClinicalTrials.gov registration number) — both cheap, and together they confirm the incumbent field and Reia's actual status.
Why it scored what it did: Reads as a cash-generative spoke, not a hero bet: existing codes, modest ceiling, short path. Structurally distinct from idea-001's continence lane by the deliberate SUI (stress urinary incontinence) exclusion (indication-scope note). Held at 3 because domains: is…the rest of this reasoning
deliberately empty — no dossier covers pelvic organ prolapse, so this candidate has no in-house domain evidence base behind it, and that named absence is itself a gap.
What would settle it: A human portfolio call, plus commissioning a POP domain dossier so a later candidate in this area inherits an evidence base — dossier work is a Scout-lane item, not a lookup.
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-015 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.
4 claim(s) the Verifier found to be false — a refuted claim is a finding, and the loop owes each one an answer.
No cheapest next test written yet — /wrap idea-015 names one.
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.
Run 2026-09-29 on the Stage 4 Verified Composite (35/100 unscaled, 7/9 factors), verified claims only.
coverage claim and no device-code payment is verified. The factor shows that a
clinician gets paid to fit a pessary, not that this device gets paid for.
unconfirmed). There
is no 'ratchet' hit in the pessary class. The one confirmed US grant nearby is US
10,687,977 B1. No family's legal status or claim scope is known. Swept but not read by
counsel is not blocked.
stage: stays
verified, awaiting Stage 6. Clearing the gate is not an approval. It means no
verified evidence yet says the candidate should be killed, not that it is de-risked.
patent-status pass on claims 47–53 and the rescore:
To finish it:
domains: — run /researchNo 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-015 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-015 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 would have to be true.
Cheapest next test:
Where the evidence actually stands.
| Factor | Score | Why | What would settle it |
|---|---|---|---|
| Regulatory pathway | 3 | Claims 1, 3, 4, 5. intended_use: is stated, so this factor is scorable. Scored on the assumption that 884.3575 / HHW is read to cover a mechanically-set diameter. Pulled down from 4 by claim 2unconfirmed (510(k)-vs-exempt unresolved) and claim 5unconfirmed…the rest of this reasoning(no cleared adjustable-diameter predicate, so a De Novo reading is live). Note claim 5unconfirmed is absence-of-evidence over a non-exhaustive search, not confirmed absence. | An openFDA device/classification lookup on product code HHW — settles the class and the premarket-notification exemption flag in one call, near-zero cost. Opening the K190277 clearance letter and the four candidate K-numbers confirms…the rest of this gap analysiswhether a real adjustable-mechanism predicate exists. |
| Reimbursement pathway | 3 | Claims 6, 7, 8, 11. Scored as "codes plausibly exist," not "pathway exists": A4561/A4562 and CPT 57160 are asserted active, which is better than most candidates, but the ~$69-89 device allowed amount (claim 11refuted) is a hard ceiling on a…the rest of this reasoningdevice that bills once, claim 7unconfirmed puts a DMEPOS supplier channel in the way, and margin at that payment is only assumption claim 24unconfirmed — an assumption, not evidence. No coverage policy was checked at all. | The CMS DMEPOS fee-schedule file for A4561/A4562 and the PFS relative-value file for 57160 — both free downloads, one lookup each. A DME MAC LCD/policy-article search for pessary coverage criteria is the missing coverage half. |
| TAM | 2 | Claims 10, 11, 12, 13. All three TAM components are the candidate's own unsourced guesses (10 and 12 say so explicitly). Taken at face value the arithmetic is thin: ~50-200k fittings × ~$69-89 × 30-50% addressable ≈ low single-digit $M of…the rest of this reasoningMedicare device revenue, once per patient on a reusable SKU. claim 13unconfirmed (2.9% symptomatic POP prevalence) sizes the disease, not the billable device market. Sits at the 2/5 kill floor. | CPT 57160 Medicare Part B allowed-services volume from the CMS Physician & Other Practitioners utilization data via this repo's procedures volume lookup — cheap, and it fixes the one component with a real source. Price comes from the…the rest of this gap analysissame DMEPOS file as Reimbursement; addressable share has no primary source and needs commissioned practice-level research. |
| FTO / IP | 2 | Claims 16, 17, 18. Not an honest blank: claim 16verified names US 11,865,033 as live-looking, directly adjacent art that already steered the design away from a collapse-for-removal feature, and claim 18unconfirmed records that **no landscape search was run…the rest of this reasoningon the locking mechanism itself** — the core novelty's FTO field is unexamined, not clear. claim 17verified (US 6,189,535 expired) is minor comfort on a different concept. Scored low for unexamined blocking risk, not scored as blocked — that call needs verified claims. | Pull the issued claims, assignee of record, legal status and maintenance-fee state for US 11,865,033 from USPTO/Patent Center — one lookup. The ratcheting-lock landscape needs a commissioned professional FTO search; that is a paid,…the rest of this gap analysismulti-week item and the single most expensive gap in this file. |
| Moat / defensibility | 2 | Claims 5, 18, 20, 21. The moat is one mechanical ratchet-and-lock on an otherwise commodity silicone ring, with no filed application recorded and no landscape work (claim 18unconfirmed) to say what is even patentable. Claims 20 and 21 put third…the rest of this reasoningparties (3D-printed patient-specific pessaries, Reia) on the same trial-and-error fitting problem. Regulatory exclusivity is nil on a 510(k)/exempt route. | A patentability opinion on the locking mechanism, which falls out of the same commissioned search as FTO — no extra search cost, added attorney time. |
| Mechanism & clinical risk | 3 | Claims 14, 15 establish the problem is real (56-80% initial fitting success; 30-50% 12-month discontinuation), and mechanical support of a prolapsed compartment is an incumbent mechanism, so plausibility is high. Held at 3 by assumption…the rest of this reasoningclaim 23unconfirmed — that in-visit re-adjustment beats the next discrete size — which is the central clinical bet and has no data behind it, and by assumption claim 25unconfirmed, cleaning validation and lock retention on a reusable mechanical joint. Both are assumptions and are not scored as evidence. | Retrieve the actual fitting-success and discontinuation papers via PubMed (claims 14, 15 name no confirmed PMID) — cheap. claim 23unconfirmed can only be settled by a prospective comparative fitting study; claim 25unconfirmed by a bench cleaning-validation and…the rest of this gap analysisISO 10993 biocompatibility protocol on a real joint. |
| Capital intensity & time-to-revenue | 4 | Claims 1, 2, 6. Silicone moulding plus a mechanical joint, no expected clinical trial on a substantial-equivalence argument about geometry and materials, and an existing DMEPOS code to bill against — this is a cheap, fast route to first…the rest of this reasoningdollar by medtech standards. The spread is wide: claim 2unconfirmed's exempt route would make entry registration/listing plus QSR, while a De Novo reading (claim 5unconfirmed) would add years. claim 25unconfirmed's cleaning-validation burden is the main hidden cost. | Same openFDA HHW classification lookup as Regulatory — it collapses the exempt-vs-510(k)-vs-De Novo spread that drives this factor. A contract-manufacturing quote on the ratcheting mechanism would settle the cost side and also test…the rest of this gap analysisassumption claim 24unconfirmed. |
| Competitive intensity | 2 | Claims 4, 20, 21, and the predicate_or_analog incumbents (CooperSurgical/Milex, Bioteque, ConTIPI/ProVate K190277). A crowded, commoditised, low-price category with named development-stage entrants attacking the same fitting problem from…the rest of this reasoningother directions. No adjustable-diameter competitor was identified (claim 5unconfirmed), which is the only thing holding this above 1. | An openFDA product-code sweep of HHW plus a ClinicalTrials.gov pull on NCT04275089 — both cheap, and together they confirm the incumbent field and Reia's actual status. |
| Strategic fit & portfolio balance | 3 | Reads as a cash-generative spoke, not a hero bet: existing codes, modest ceiling, short path. Structurally distinct from idea-001's continence lane by the deliberate SUI exclusion (indication-scope note). Held at 3 because domains: is…the rest of this reasoningdeliberately empty — no dossier covers pelvic organ prolapse, so this candidate has no in-house domain evidence base behind it, and that named absence is itself a gap. | A human portfolio call, plus commissioning a POP domain dossier so a later candidate in this area inherits an evidence base — dossier work is a Scout-lane item, not a lookup. |
To finish this packet:
domains: — run /researchSource file: knowledge-base/candidates/idea-015.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