idea-018 · human · US
For prescription home use by skeletally mature adults, to promote osteogenesis; at an established nonunion of a long bone fracture — excluding nonunions of the skull and; vertebrae and tumor-associated nonunions — in which serial radiographs confirm that fracture; healing has ceased for three or more months, as an adjunct to standard fracture management; not indicated for acceleration of healing of fresh or acute fractures, not indicated as an; adjunct to spinal fusion, and not indicated for skeletally immature patients.
Still being built — 7 of 8 wrap criteria met; nothing for you to decide yet. No department has been asked. 17 of 50 claims verified, 1 refuted. Nobody has yet written down what it rests on.
An externally worn, battery-powered coil applies a pulsed electromagnetic field (PEMF (pulsed electromagnetic field)) across the fracture gap of an established long-bone nonunion for a prescribed number of hours per day over a fixed treatment course, with the aim of promoting osteogenesis at a fracture that has stopped healing. The differentiating engineering is not the field: it is a low-profile, garment-integrated coil sized to be worn under clothing, plus an onboard tamper-evident treatment-time log that records actual field-on minutes against the prescribed schedule and exports a compliance report for the prescriber and the DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) supplier's documentation file.
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-018 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-018 replaces this list with the real one.
Why it scored what it did: intended_use is stated, so this is scorable. Claims 1, 2, 5, 6 — if they hold, the launch route is Class II (FDA device class II) 510(k) (premarket notification) under 21 CFR (Title 21 of the Code of Federal Regulations) 890.5870, live since 2026-05-18, and claim 7unconfirmed's narrowing inference keeps the indication inside the…the rest of this reasoning
regulation's own language. Discounted from a 4 by claim 20verified (no 510(k) cleared under 890.5870 was found, and no search was run) — a 510(k) with no predicate is not the cheap pathway this candidate is built on — and by claim 3verified (special-controls text never retrieved, so the evidence burden is unknown). claim 4verified's six-year proposed-to-final gap is a settledness signal, unchecked.
What would settle it: openFDA clearances query on product codes LOF and LPQ with a decision-date window from 2026-05-18, to establish whether any predicate exists — cheap, and it is the first check. Then the eCFR text of 890.5870(b)(2) for the special controls;…the rest of this gap analysis
the claim-7 inference really needs an FDA (US Food and Drug Administration) pre-submission, not a lookup.
Why it scored what it did: Claims 8, 9, 10, 13, 23 — if they hold, this is national coverage under NCD 150.2 (a Medicare national coverage determination number) with an existing HCPCS (Healthcare Common Procedure Coding System) code (E0747 (a HCPCS code for durable medical equipment)), an indication deliberately written to restate the NCD (national coverage determination)'s radiographic nonunion definition, and separate DMEPOS payment.…the rest of this reasoning
Strongest factor in the file. Held off 5 because claim 16verified (price) is an unsourced guess, so the code's existence is not yet a demonstration it pays above cost, and claim 12unconfirmed's policy article A52513 was never opened, so documentation/coverage conditions are unknown. claim 22unconfirmed records that the RAPID coverage-at-authorization lane is forgone.
What would settle it: CMS (Centers for Medicare & Medicaid Services) Medicare Coverage Database record for NCD 150.2 (version and effective date) and LCA A52513; HCPCS quarterly release file for the E0747 descriptor. All free web lookups.
Why it scored what it did: Claims 15, 16, 17 — all three legs are explicitly the Generator's unsourced guesses, so this score is what they would imply, not a finding. Low tens of thousands of E0747 services at low-thousands each puts the US Medicare line in the…the rest of this reasoning
tens of millions: above the 2/5 floor if true, but small, and the narrowing shrinks it on purpose (claim 17unconfirmed's denominator, claim 18verified's forgone E0748 line). The relative-size half of claim 18verified is flagged as belief, not data.
What would settle it: CMS DMEPOS utilization public-use file for E0747 allowed services (pull E0748 in the same query to settle claim 18verified); DMEPOS fee schedule PUF for the purchase allowance. Both free; this is the cheapest high-value check in the file.
Why it scored what it did: Claims 26 and 27: no patent search of any kind was performed and no patent number, family or expiry date is named. Scored as unknown-leaning-neutral for triage only. claim 27unconfirmed's "1970s-80s PEMF art would be expired" is explicitly an…the rest of this reasoning
inference about a class of patents, not a finding, and it says nothing about the modern differentiators — garment-integrated coil geometry and tamper-evident adherence logging — where live art is most likely. Unexamined is not clear; the Stage 5 FTO (freedom to operate) kill cannot fire on this.
What would settle it: A PatentsView or EPO (European Patent Office) OPS assignee search against Orthofix, Zimmer Biomet, Bioventus and Enovis, plus a CPC search on the adherence-logging function. A few hours of analyst time; a real clearance opinion is a paid counsel job.
Why it scored what it did: claim 21unconfirmed is decisive and points down: the 510(k) door opened for every incumbent and entrant on the same day, so the pathway confers no exclusivity. That leaves only the special controls' evidence bar (claim 3verified, content unknown), DMEPOS…the rest of this reasoning
machinery, and the adherence log — whose entire commercial case is claim 30unconfirmed, an explicit assumption, reinforced by claims 28 and 29 (prescriber preference and patient adherence, both assumptions with no source).
What would settle it: Nothing here is settleable by a connector. Read LCA A52513 to see whether device-generated adherence records carry documentation weight, then commission prescriber and DMEPOS-supplier interviews — a paid primary-research line item, not a…the rest of this gap analysis
lookup.
Why it scored what it did: Mechanism plausibility is helped by the class having been marketed for decades (claims 5, 19), but the indication-specific evidence is a named hole: claim 25unconfirmed records that no literature on PEMF in established nonunion was retrieved in…the rest of this reasoning
either direction. claim 24verified pulls down — the TRUST LIPUS trial is recalled as negative in the adjacent fresh-fracture setting — and is itself only the Generator's recollection with no PMID (PubMed identifier), so it is a search handle, not a citation.
What would settle it: A PubMed sweep on PEMF and electrical stimulation in established nonunion, and retrieval of the TRUST trial's PMID to confirm design and result. Free, a few hours.
Why it scored what it did: If claims 1, 2, 5 and 13 hold, this is commodity hardware onto an existing pathway and an existing payment code — fast and cheap by medtech standards. Held at 3 because the two unknowns that set the actual cost both sit on unexamined…the rest of this reasoning
claims: no predicate found (claim 20verified) and special-controls content unretrieved (claim 3verified), either of which could turn a 510(k) into a De Novo (De Novo classification request)-scale evidence programme. claim 22unconfirmed removes the RAPID lane.
What would settle it: Falls out of the Regulatory checks above — the openFDA LOF/LPQ predicate query and the 890.5870(b)(2) special-controls text. No separate work.
Why it scored what it did: claim 19unconfirmed names four entrenched incumbents (Orthofix, Zimmer Biomet, Bioventus, plus Enovis at claim 27unconfirmed) with established DMEPOS distribution, and claim 21unconfirmed says they all gained the same cheap route on the same day. claim 28unconfirmed records…the rest of this reasoning
prescriber preference for incumbent brands as an assumption working against a new entrant. No funding, launch or recall data was retrieved for any of them.
What would settle it: openFDA device recall/enforcement records and 510(k) filings for the named assignees, plus a public-filings or press sweep on recent launches. Free and quick; a licensed market report would be a paid attachment a human must supply.
Why it scored what it did: Left unscored. No claim in this file speaks to portfolio fit — there is no orthopedic/nonunion dossier in knowledge-base/domains/ (see domains: in frontmatter) and nothing records what the current portfolio holds. Scoring this…the rest of this reasoning
would mean inventing the comparison, so the row stays blank rather than guessed.
What would settle it: A human or the Librarian naming the current portfolio position this would occupy (cash-generative spoke vs. hero bet). No external source; internal context this candidate has not been given.
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-018 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.
1 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-018 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.
No gate check recorded yet.
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-018 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-018 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 | intended_use is stated, so this is scorable. Claims 1, 2, 5, 6 — if they hold, the launch route is Class II 510(k) under 21 CFR 890.5870, live since 2026-05-18, and claim 7unconfirmed's narrowing inference keeps the indication inside the…the rest of this reasoningregulation's own language. Discounted from a 4 by claim 20verified (no 510(k) cleared under 890.5870 was found, and no search was run) — a 510(k) with no predicate is not the cheap pathway this candidate is built on — and by claim 3verified (special-controls text never retrieved, so the evidence burden is unknown). claim 4verified's six-year proposed-to-final gap is a settledness signal, unchecked. | openFDA clearances query on product codes LOF and LPQ with a decision-date window from 2026-05-18, to establish whether any predicate exists — cheap, and it is the first check. Then the eCFR text of 890.5870(b)(2) for the special controls;…the rest of this gap analysisthe claim-7 inference really needs an FDA pre-submission, not a lookup. |
| Reimbursement pathway | 4 | Claims 8, 9, 10, 13, 23 — if they hold, this is national coverage under NCD 150.2 with an existing HCPCS code (E0747), an indication deliberately written to restate the NCD's radiographic nonunion definition, and separate DMEPOS payment.…the rest of this reasoningStrongest factor in the file. Held off 5 because claim 16verified (price) is an unsourced guess, so the code's existence is not yet a demonstration it pays above cost, and claim 12unconfirmed's policy article A52513 was never opened, so documentation/coverage conditions are unknown. claim 22unconfirmed records that the RAPID coverage-at-authorization lane is forgone. | CMS Medicare Coverage Database record for NCD 150.2 (version and effective date) and LCA A52513; HCPCS quarterly release file for the E0747 descriptor. All free web lookups. |
| TAM | 2 | Claims 15, 16, 17 — all three legs are explicitly the Generator's unsourced guesses, so this score is what they would imply, not a finding. Low tens of thousands of E0747 services at low-thousands each puts the US Medicare line in the…the rest of this reasoningtens of millions: above the 2/5 floor if true, but small, and the narrowing shrinks it on purpose (claim 17unconfirmed's denominator, claim 18verified's forgone E0748 line). The relative-size half of claim 18verified is flagged as belief, not data. | CMS DMEPOS utilization public-use file for E0747 allowed services (pull E0748 in the same query to settle claim 18verified); DMEPOS fee schedule PUF for the purchase allowance. Both free; this is the cheapest high-value check in the file. |
| FTO / IP | 2 | Claims 26 and 27: no patent search of any kind was performed and no patent number, family or expiry date is named. Scored as unknown-leaning-neutral for triage only. claim 27unconfirmed's "1970s-80s PEMF art would be expired" is explicitly an…the rest of this reasoninginference about a class of patents, not a finding, and it says nothing about the modern differentiators — garment-integrated coil geometry and tamper-evident adherence logging — where live art is most likely. Unexamined is not clear; the Stage 5 FTO kill cannot fire on this. | A PatentsView or EPO OPS assignee search against Orthofix, Zimmer Biomet, Bioventus and Enovis, plus a CPC search on the adherence-logging function. A few hours of analyst time; a real clearance opinion is a paid counsel job. |
| Moat / defensibility | 1 | claim 21unconfirmed is decisive and points down: the 510(k) door opened for every incumbent and entrant on the same day, so the pathway confers no exclusivity. That leaves only the special controls' evidence bar (claim 3verified, content unknown), DMEPOS…the rest of this reasoningmachinery, and the adherence log — whose entire commercial case is claim 30unconfirmed, an explicit assumption, reinforced by claims 28 and 29 (prescriber preference and patient adherence, both assumptions with no source). | Nothing here is settleable by a connector. Read LCA A52513 to see whether device-generated adherence records carry documentation weight, then commission prescriber and DMEPOS-supplier interviews — a paid primary-research line item, not a…the rest of this gap analysislookup. |
| Mechanism & clinical risk | 2 | Mechanism plausibility is helped by the class having been marketed for decades (claims 5, 19), but the indication-specific evidence is a named hole: claim 25unconfirmed records that no literature on PEMF in established nonunion was retrieved in…the rest of this reasoningeither direction. claim 24verified pulls down — the TRUST LIPUS trial is recalled as negative in the adjacent fresh-fracture setting — and is itself only the Generator's recollection with no PMID, so it is a search handle, not a citation. | A PubMed sweep on PEMF and electrical stimulation in established nonunion, and retrieval of the TRUST trial's PMID to confirm design and result. Free, a few hours. |
| Capital intensity & time-to-revenue | 3 | If claims 1, 2, 5 and 13 hold, this is commodity hardware onto an existing pathway and an existing payment code — fast and cheap by medtech standards. Held at 3 because the two unknowns that set the actual cost both sit on unexamined…the rest of this reasoningclaims: no predicate found (claim 20verified) and special-controls content unretrieved (claim 3verified), either of which could turn a 510(k) into a De Novo-scale evidence programme. claim 22unconfirmed removes the RAPID lane. | Falls out of the Regulatory checks above — the openFDA LOF/LPQ predicate query and the 890.5870(b)(2) special-controls text. No separate work. |
| Competitive intensity | 1 | claim 19unconfirmed names four entrenched incumbents (Orthofix, Zimmer Biomet, Bioventus, plus Enovis at claim 27unconfirmed) with established DMEPOS distribution, and claim 21unconfirmed says they all gained the same cheap route on the same day. claim 28unconfirmed records…the rest of this reasoningprescriber preference for incumbent brands as an assumption working against a new entrant. No funding, launch or recall data was retrieved for any of them. | openFDA device recall/enforcement records and 510(k) filings for the named assignees, plus a public-filings or press sweep on recent launches. Free and quick; a licensed market report would be a paid attachment a human must supply. |
| Strategic fit & portfolio balance | — | Left unscored. No claim in this file speaks to portfolio fit — there is no orthopedic/nonunion dossier in knowledge-base/domains/ (see domains: in frontmatter) and nothing records what the current portfolio holds. Scoring this…the rest of this reasoningwould mean inventing the comparison, so the row stays blank rather than guessed. | A human or the Librarian naming the current portfolio position this would occupy (cash-generative spoke vs. hero bet). No external source; internal context this candidate has not been given. |
To finish this packet:
domains: — run /researchSource file: knowledge-base/candidates/idea-018.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