idea-007 · 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: the engineers who have to put a foreign body under a cat's skin for years and have an owner access it at a kitchen table.
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-007.md — the number is the claim's position in its ## Claims list, the tag is copied from it and never adjusted here. A [no claim] marker means nothing in the file speaks to the condition at all. See docs/deck-spec.md.
What changed since the 2026-08-24 build — the SUB precedent this deck twice called "located by title, never read" has been read, and it is the most useful engineering evidence in the file [claim 32: unconfirmed], [claim 33: unconfirmed]. Human implanted-port infection rates arrived alongside it [claim 34: unconfirmed], [claim 35: unconfirmed], as did a verified classification for the human analog [claim 36: verified]. Rebuilt from the file, not patched.
Would have to be true: A fenestrated diffuser would have to sit in the subcutaneous space with a septum port at a defined, palpable, non-interscapular site, and deliver a fixed volume per session through a metered owner-operated giving set — no hanging bag, no free needle.
Where it stands: No volume, rate or septum specification is stated as a claim [no claim], so this deck states none. The human analog is now regulatorily identified: implanted vascular access ports are Class II under 21 CFR 880.5965, product code PXK [claim 36: verified] — which gives a standards map, not an obligation. One oddity in that map is worth noting rather than over-reading: no 510(k) clearances or recalls are recorded in openFDA under PXK for the scanned window [claim 37: unconfirmed], which is a structural null about how that code is used rather than evidence that human ports are unregulated or trouble-free.
What would settle it: The existing feline port products' instructions for use [claim 3: unconfirmed] for the volumes and rates already in clinical practice; standard subcutaneous fluid protocols for feline CKD as the dose target; the PXK standards battery [claim 36: verified] adopted voluntarily.
If it's false: There is no spec, and — as with every veterinary candidate here — no regulator will supply one [claim 2: verified].
Would have to be true: The mechanical part would have to be routine, and it largely is; the biological part is the product.
Where it stands: The oncologic premise remains deliberately unasserted and unresolved [claim 13: unconfirmed], with the case report [claim 4: unconfirmed] and the injection-site sarcoma entity [claim 5: unconfirmed] as its context. What the SUB read establishes is that "the mechanical part is routine" was too generous. In 95 SUB devices across 66 cats, chronic device mineralization occurred in 19-50% of devices and chronic urinary tract infection in 3-33% of cats, varying with flush protocol [claim 32: unconfirmed]. Implanted ports in this species foul, at rates that would be commercially fatal if they transferred. Whether they transfer is the open question and it is answerable by reading: SUB carries urine, and mineralization in a urinary device may be a urine-chemistry phenomenon rather than an implant-surface one. A subcutaneous fluid port carries crystalloid, not urine.
What would settle it: A human reading PMID 40011049 for whether mineralization tracked urine composition or implant surface and dwell time — the single most decisive hour available on this candidate, because it determines whether [claim 32: unconfirmed] is a warning about this product or about a different application. Then a prospective feline case series with multi-year follow-up for the oncologic endpoint; nothing shorter answers that, and nothing in this repo substitutes.
If it's false: The device causes, at some rate, the disease that veterinary oncology in this species is most alert to — and the design lever the candidate is built around does not work.
Would have to be true: Nothing forces anything — so the evidence plan would have to be self-imposed, and it would have to be long.
Where it stands: Veterinary-only manufacturers need not register establishments or list devices with FDA [claim 2: verified], and the premarket exemption itself rests on text no connector here can read [claim 1: unconfirmed]. The human counterfactual is now precisely identified — Class II, 21 CFR 880.5965, product code PXK [claim 36: verified] — which is the most useful thing a voluntary evidence plan can be built against, since it names the regulation whose standards battery a reviewer would have demanded.
What would settle it: The human implanted-port standards (ISO 10993 biological evaluation, implant-specific series) adopted voluntarily as the specification, anchored on [claim 36: verified]; regulatory counsel on what labelling claims are defensible without premarket review.
If it's false: The risk is not a blocked pathway but an unforced one, and this candidate is the clearest case in the repo where the absence of a gatekeeper is a safety question rather than a cost saving.
Would have to be true: A low-fouling surface would have to measurably reduce chronic tissue reaction in a cat, over years — not in a bench assay, in the animal.
Where it stands: Unbacked [claim 24: unconfirmed], and the week's evidence made it both more urgent and better specified. Urgent, because the only long-term feline implanted-port data available shows fouling in 19-50% of devices [claim 32: unconfirmed] — the exact failure class this surface chemistry is supposed to address, occurring at a high rate in the nearest comparable product. Better specified, because the same literature shows the incumbent successfully engineering a different failure mode out across generations: kinking from 15.5% to 0%, with 90-day survival rising from 75% to 94% [claim 33: unconfirmed]. That is proof that iteration works in this device class, and also proof that the incumbent iterates.
What would settle it: Explant histopathology from a staged case series — chronic inflammatory infiltrate and capsule characteristics at defined intervals — which is a surrogate; only long follow-up settles the endpoint itself.
If it's false: The material claim is marketing, the moat is a commodity port [claim 11: unconfirmed], and the safety argument reverts to site choice alone.
Would have to be true: Septum durability, flow behaviour and infection control would all have to be characterised on the bench before a cat is implanted.
Where it stands: All three are this deck's write-back and all came back unconfirmed [claim 25: unconfirmed], [claim 26: unconfirmed], [claim 27: unconfirmed] — bench claims about unbuilt hardware that no connector here reaches. The infection condition now has benchmarks to design against, from the human side: 0.05 catheter-related bloodstream infections per 1,000 catheter-days across 37,763 catheter-days [claim 34: unconfirmed], and early port infection in 1.2% of 1,714 placements with 0.2% port-related 30-day mortality [claim 35: unconfirmed]. Those are the numbers a clinician-accessed port achieves. This device would be accessed by an untrained owner in a home, several times a week, for years — so they are a floor to be measured against, not a rate to be assumed.
What would settle it: Bench cycling of the septum to the implied access count; flow and back-pressure testing in a subcutaneous tissue model; a sterility protocol tested with untrained users rather than technicians, against [claim 34: unconfirmed] as the benchmark.
If it's false: The failure modes that end the product are mundane — a leaking septum, a fluid pocket, an infected port — and they arrive long before the oncologic question is answered. The SUB record says exactly this: its documented problems are mineralization and infection [claim 32: unconfirmed], not tumours.
Would have to be true: A sterile implantable device plus a consumable giving set would have to be manufacturable, implantable by an ordinary practice, and operable by an owner at a kitchen table.
Where it stands: Owner operation is unbacked [claim 19: unconfirmed], [claim 27: unconfirmed], and general-practice placement is unbacked [claim 18: unconfirmed]. The SUB literature suggests the ongoing-management burden is real: mineralization rates varied with flush protocol [claim 32: unconfirmed], which means device longevity depends on maintenance technique — and the maintenance here would be performed by an owner rather than a technician. Port removal and revision remain absent from the file as a defined procedure [no claim].
What would settle it: A contract-manufacturing quote against a defined implant spec; a usability study with real owners; an explant/revision procedure defined and tested.
If it's false: Unit economics and complication rates move together in the wrong direction, and the consumable revenue [claim 21: unconfirmed] never materialises because the ports come out.
Would have to be true: An implanted subcutaneous port with a metered owner-operated giving set would have to be buildable around whatever the established implanted-port manufacturers hold.
Where it stands: Never asked [claim 28: unconfirmed] — unexamined, not clear. The SUB manufacturer is now better evidenced as an active, iterating device developer in this exact species and anatomy [claim 33: unconfirmed], which makes it the obvious assignee to start from and raises rather than lowers the prior that live art exists.
What would settle it: A patent landscape on implanted subcutaneous ports, low-fouling implant coatings and metered delivery sets; expiry checks; then counsel. Note that the patent connector is the one tool in this repo that sees veterinary products honestly, because patents do not respect the human/veterinary labelling boundary [claim 15: unconfirmed].
If it's false: Automatic kill under the Stage 5 gate — and on a candidate whose only other barrier to entry is tooling [claim 12: unconfirmed], the patent position is the whole defence.
Every condition above with nothing verified behind it. Two verified claims exist [claim 2: verified], [claim 36: verified] and both concern regulatory classification rather than device behaviour.
If only one thing from this chair could be checked: whether the material and siting choices actually reduce chronic inflammatory reaction, and therefore sarcoma risk, in a cat over years [claim 24: unconfirmed], [claim 13: unconfirmed].
It is the candidate's central premise, it is deliberately unasserted in the file, and it is the only condition on any of these three decks whose resolution takes years rather than weeks. Every commercial argument assumes it; nothing tests it short of the case series.
The last build named the SUB literature as the nearest cheap proxy and noted nobody had opened it. It has now been opened, and it did not settle the oncologic question — it raised a nearer one. Implanted feline ports mineralize in 19-50% of cases [claim 32: unconfirmed], varying with flush protocol, and that is a fouling problem arriving years before any tumour would. So the sequence has changed: before anyone funds a multi-year oncologic follow-up, someone should read PMID 40011049 closely enough to say whether that mineralization is a urine phenomenon that does not transfer to a crystalloid port, or a surface-and-dwell-time phenomenon that does. That is an hour of reading standing in front of a multi-year study.
What happens after that evidence is a Tier 3 decision — an animal study is exactly the thing no agent in this repo greenlights, and this candidate's central question cannot be answered without one.
Naming it is not a recommendation, a gate, or a kill.