idea-001 · narrative
A synthesis across this candidate's claims, dossier and decks — every statement here traces to something that already exists elsewhere in the knowledge base. A narrative never invents a fact, upgrades a tag, or recommends anything.
How to read this. This is a synthesis, not a new source of truth: every claim it cites carries the tag the candidate file gives it right now, copied not paraphrased, and every line quoted from a deck is quoted verbatim. See docs/narrative-spec.md.
This is a prescription, home-use intravaginal probe that delivers neuromuscular electrical stimulation (NMES) to the pelvic floor while sensing surface EMG for closed-loop biofeedback, aimed at women with stress urinary incontinence (SUI) who have already failed a documented four-week course of pelvic muscle exercise training. The regulatory shape is settled — Class II, 510(k), product code KPI — and a billing code (HCPCS E0740) with a published payment rate already exists for the device category. What remains open runs from clinical mechanism through market economics: whether the coverage policy the intended use was written around actually names the code, whether the EMG-gating engineering the product's own differentiation depends on can be built at all, and whether anyone in the referral chain would prescribe it. Since the last version of this narrative, a business case was added to the candidate file, appending nine further assumptions about unit economics — cost of goods against the payment rate, gross margin, cash pricing, licensing to an incumbent, and whether an EMG-gating module could be added to an already-cleared device without a new 510(k) — every one of them tagged unverified and none yet touched by a Verifier pass.
The device sits in a well-mapped regulatory lane: FDA product code KPI, 21 CFR 876.5320, Class II via 510(k) [claim 1: verified] [claim 2: verified], with the adjacent Class III/PMA route (884.5940) carved away by this candidate's own stated indication rather than merely assumed [claim 2: verified]. The named predicate pool is less clean than the frontmatter first claimed — InControl Medical's InToneMV/InTone clearances exist but their cleared Indications for Use name mixed incontinence, not the stress-only indication this candidate claims, so "usable predicate" is a live regulatory judgment call rather than a closed fact [claim 3: unconfirmed].
The billing story is where the intended use does the most work: it was deliberately written to mirror Medicare NCD 230.8's eligibility language (cognitively intact, failed four-week PME trial) specifically so the coverage argument would restate an existing policy rather than create a new one. HCPCS E0740 exists and its descriptor matches the device category [claim 7: verified], and a DMEPOS payment rate is published — $74.52 [claim 10: verified]. But whether NCD 230.8's actual text supports this candidate's reading of it is refuted by the one connector check that could reach it, with the caveat that the miss traces to a blank cross-reference field in the coverage cache rather than a confirmed absence of the policy [claim 9: refuted] — the load-bearing regulatory-reimbursement question the whole indication was built around is still open, just open in a more specific way. Both Medicare-FFS TAM floors the Scorer originally used were themselves refuted by real utilization data, by wide margins [claim 16: refuted] [claim 17: refuted] — real, sourced volume exists, just an order of magnitude below what was assumed.
On the engineering side, the product's actual differentiator — closed-loop EMG gating on the same probe that is stimulating — is entirely unverified: whether it can be built at all [claim 34: unconfirmed], whether it outperforms open-loop stimulation clinically [claim 33: unconfirmed], and whether the resulting adherence/EMG dataset is a real moat [claim 22: unconfirmed] all rest on claims nothing has checked yet. And on the demand side, the one assumption the desirability deck itself flagged as unchecked — whether prescribers would actually send a patient home with this instead of retaining her in clinic [claim 24: unconfirmed] — sits next to a real, sourced twin from the domain dossier: women already prescribed the cheapest, lowest-friction, no-hardware conservative therapy (plain PFMT) drop off it at high rates, and the one study in the dossier that actually asked why found "forgetting to do the exercises and boredom with the exercises were the factors most strongly related to low treatment adherence" [dossier: stress-urinary-incontinence] — evidence that the underlying behavior is a habit-formation problem regardless of modality, not evidence that this device is the fix.
What is new since the last version of this file is not a change to any of the claims above — none of them moved — but an addition below them. A business case was appended to the candidate on 2026-09-03, and it does not answer the viability deck's revenue-gap question so much as break it into nine separately checkable pieces, every one of them unverified rather than unconfirmed: unverified here means never checked at all, a different thing from a claim a connector has already tried and failed to settle. The nine cover whether a DME-channel launch captures a material share of the E0740 Medicare FFS volume by year 3 [claim 46: unverified], whether the manufacturer's per-unit price is high enough to support a standalone business [claim 47: unverified], whether fully-loaded cost of goods sits below the verified $74.52 DMEPOS rate [claim 48: unverified], whether gross margin at an achievable price and volume supports a standalone rather than subsidized or bundled model [claim 49: unverified], whether practices or patients would pay a cash price not anchored to $74.52 [claim 50: unverified], whether an incumbent would license or integrate the EMG-gating module rather than build it in-house [claim 51: unverified], whether RTM platform revenue accrues in part to the manufacturer rather than solely to the clinician's own CPT billing [claim 52: unverified], whether a direct-to-practice sales channel is affordable without DME/Medicare billing infrastructure [claim 53: unverified], and whether qualifying an EMG-gating module as an OEM addition to an already-cleared device avoids a new full 510(k) for the host device [claim 54: unverified]. Each one names, in the candidate file's own words, that it was "never checked; recorded so the Verifier can see it."
refuted by
the one connector check that reached it, with a real caveat about why [claim 9: refuted]
unverified and none yet
attempted by a Verifier pass: DME-channel share capture by year 3 [claim 46: unverified];
whether the manufacturer's price is high enough to support a standalone business
[claim 47: unverified]; whether cost of goods sits below the $74.52 DMEPOS rate
[claim 48: unverified]; whether gross margin supports a standalone rather than subsidized
model [claim 49: unverified]; whether a cash price unanchored to $74.52 is achievable
[claim 50: unverified]; whether an incumbent would license the EMG-gating module rather than
build it [claim 51: unverified]; whether RTM revenue accrues to the manufacturer at all
[claim 52: unverified]; whether a direct-to-practice channel is affordable without DME
infrastructure [claim 53: unverified]; and whether an OEM EMG-gating add-on avoids a new
full 510(k) for the host device [claim 54: unverified]
All three decks carry source_updated: 2026-09-03, which matches the candidate's current updated: field and is what python3 engine/scripts/check_decks.py --candidate idea-001 checks — it reports all three decks clean (3/3). But every deck's own built: stamp still reads 2026-08-30, and reading their text confirms that date is the honest one: none of the three decks references any of the nine business-case claims (claims 46-54) added to the candidate on 2026-09-03. check_decks.py cannot see that gap — it verifies that a deck's frontmatter stamps agree with the candidate's current ones, not that the deck's prose actually engages with everything the candidate now contains — so this is said here plainly rather than left for the mechanical check to imply it isn't there: the three decks below are a live, mechanically-consistent view of the candidate as it stood after the 2026-08-30 CMS-cache rebuild, not of the file as it stands with the business case attached.
The desirability deck turns on whether anyone in the referral chain will actually prescribe this rather than keep the patient in clinic — the same condition the dossier's PFMT-adherence data speaks to from the opposite direction (people already drop the cheaper option; that's not proof they'd take up a more expensive one).
"whether pelvic floor PTs and urogynecologists will prescribe a home device instead of retaining the patient in clinic" — the load-bearing condition of the desirability deck (built 2026-08-30).
The viability deck turns on the gap between the one verified payment figure for this code and the per-system revenue the TAM assumes — a gap the business case's nine new claims (cost of goods, cash pricing, licensing, RTM revenue capture, channel cost) now name specific, checkable pieces of, without the deck itself having had the chance to fold them in.
"whether a device supplied under a $74.52 DMEPOS allowable, with no coverage determination naming the code, can carry the $350-$700 net revenue per dispensed system the TAM rests on" — the load-bearing condition of the viability deck (built 2026-08-30).
The feasibility deck turns on the one piece of hardware risk everything else assumes away: can the EMG sensing survive being on the same probe as the stimulation at all.
"whether microvolt EMG can be recovered on the same probe that is stimulating, well enough to gate the stimulation in real time" — the load-bearing condition of the feasibility deck (built 2026-08-30).
If the EMG-gating engineering works, NCD 230.8 turns out to cover this device as the intended use was written to assume, and a prescriber sends a patient home with it instead of keeping her in clinic, do the business case's own nine unchecked assumptions — cost of goods measured against the verified $74.52 payment line, cash pricing, licensing, RTM revenue capture, and channel cost — still add up to a standalone device business, or is the unit economics itself the binding constraint that no combination of engineering and adoption success can fix on its own?