idea-019 · desirability 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 user. An adult with Parkinson disease, multiple system atrophy or pure autonomic failure whose day is limited by how long they can stay upright; the spouse or carer who would put the garment on them each morning; the neurologist or autonomic specialist who would have to write a DME (durable medical equipment) order instead of, or next to, a prescription for a pill.
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-019.md: the number is the claim's position in its ## Claims list, and the tag is copied from that claim as it stands at build time, never adjusted here. A [no claim] marker means nothing in the file speaks to the condition at all. Where another lens holds a condition, this deck points at that deck rather than restating it. See docs/deck-spec.md.
What the file looks like from this chair. Strong on the literature, thin on the user. The research lane has put verified, adjacent evidence on record — drug persistence, compression-garment non-use, binder tolerability, guideline mentions — and none of it is about this device, about home use, or about a posture-triggered garment worn every upright period of the day. Every statement about what a patient, carer, prescriber or supplier would do is unconfirmed, and the Verifier has recorded each as unanswerable without primary research. The rubric scores no factor for whether a user wants this, so that gap shows in no score.
One thing changed under this chair since the last build: the money. The compressor family is paid as a one-time purchase, not a monthly rental claim 117refuted, so what the patient pays arrives as one share of one purchase (Slide 4).
Would have to be true: A material share of adults with symptomatic neurogenic orthostatic hypotension due to primary autonomic failure would have to be poorly served by the drugs they can be given today — limited by supine hypertension, stopped for lack of benefit, or never started — so that a device fills a gap a neurologist already recognises rather than competing with a pill that works.
Where it stands: The population is partly evidenced. In Parkinson disease, pooled OH (orthostatic hypotension) prevalence is 33% (neurogenic 26%, symptomatic about 20%), with 24.9-28% the file's own US-scoped range claim 22verified. Supine hypertension, the harm the design trades against, is common: 30.4% across alpha-synucleinopathies, 46.5% in MSA (multiple system atrophy) with OH claim 82verified. The drug side cuts both ways.
How many remain symptomatic after non-pharmacologic measures, which is the intended use's own population, has no figure; the condition is held in the viability deck, Slide 4 claim 141unverified. Whether prescribers treat zero supine exposure as a reason to change prescribing is a separate, unevidenced preference claim 30unconfirmed.
What would settle it: Human-attached droxidopa and midodrine labels from Drugs@FDA (US Food and Drug Administration) or DailyMed — claims 61 and 62 are unconfirmed only because no drug-label connector exists. Then structured interviews with autonomic specialists on what share of their nOH (neurogenic orthostatic hypotension) patients are drug-limited, and by what. No connector reaches that.
If it's false: If the drugs serve most patients adequately, this is a second-line product for a residual group no claim sizes. Addressable share (claim 24unconfirmed) shrinks, and the design rationale, zero supine exposure, solves a problem prescribers do not rank highly.
Would have to be true: An adult with Parkinson disease, MSA or PAF (pure autonomic failure), often with tremor, rigidity or camptocormia, would have to put on, charge and wear a powered abdominal garment during every upright period of every day, for months, rather than abandoning it after the first weeks.
Where it stands: Nothing establishes this for a powered garment or for sustained home use. It is on record as an assumption claim 28unconfirmed, as is all-day tolerance of the set pressure claim 39unconfirmed. The adjacent verified evidence is mixed at best.
What would settle it: Device-logged wear time in a home-use study, the design stated in claim 99unconfirmed. Before that, a literature sweep for dropout reasons in the other binder studies.
If it's false: Every other slide in every deck becomes moot. The device works only while worn, a study-day benefit (claim 73verified, in the feasibility deck) never reaches a patient's Tuesday, and addressable share (claim 24unconfirmed) collapses to the adherent fraction, which no claim sizes.
Would have to be true: A neurologist or autonomic specialist would have to write a DME order and carry the prior-authorisation documentation for a device in an indication they now manage with midodrine and droxidopa; a caregiver would have to be there every morning to don the garment for a patient who cannot; a DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) supplier would have to stock, fit and bill it; and Medicare would have to pay (held in the viability deck).
Where it stands: None of the four is evidenced.
What would settle it: Prescriber interviews or a preference study (the adoption connector returns unverifiable by design). Caregiver data from the posted baseline characteristics of the binder trials, or a caregiver survey. Calls to two or three DMEPOS suppliers already billing E0650 (a HCPCS code for durable medical equipment)-E0652. All human acts.
If it's false: No prescriber, no order. No caregiver removes the most impaired patients — plausibly those with the worst symptoms — from addressable share (claim 24unconfirmed). No supplier leaves the manufacturer enrolling as one itself (claim 125unconfirmed, viability deck) or with no channel.
Would have to be true: The patient would have to accept sustained abdominal pressure during every upright period without discomfort, breathlessness, reflux or skin irritation bad enough to stop; a controller and garment worn under everyday clothing outside the home; and a coinsurance share of a one-time purchase, or the full price where nothing pays.
Where it stands:
What would settle it: Tolerance: a multi-week home-use study with device-logged wear and adverse-event capture (claim 99unconfirmed). Visibility: a prototype worn by a handful of patients with a structured debrief. Money: a Verifier run on 42 CFR 414.210(a) for claim 138unverified, then patient interviews on a stated one-time amount once the code is known.
If it's false: A garment taken off outside the house covers only part of the day that matters, undercutting the upright-standing-time goal and the symptom endpoint a pivotal study would measure (claim 100unconfirmed, feasibility deck). If the coinsurance is refused, the Part B channel delivers fewer placements than its population arithmetic implies.
Would have to be true: A patient who has already tried an elastic abdominal binder — cheap, and already named by guidelines — would have to prefer the powered, posture-triggered device strongly enough to switch, despite its charging, weight and cost.
Where it stands: The sharpest desirability question in the file, and unconfirmed claim 132unconfirmed.
The comparator is real and endorsed: a GRADE-based review gives abdominal binders a strong recommendation among non-pharmacological measures claim 78verified, and the EFNS guideline lists elastic binders in initial management claim 79verified. That binders are widely sold as general garments is not confirmed claim 4unconfirmed.
The evidence on whether more engineered compression adds anything is not encouraging for the premium product. In 13 adults with nOH, 10 mmHg applied before rising blunted the standing drop, and raising compression to maximal tolerance once standing added nothing claim 77verified. The only posture-triggered analog reached about 11 mmHg against about 8 mmHg for a passive binder, in healthy volunteers claim 86verified.
What would settle it: A home crossover in which the same patients wear an elastic binder and a posture-triggered prototype, with stated preference and device-logged wear as outcomes. A Stage 7 customer-discovery item; no connector reaches it.
If it's false: The market becomes the patients for whom an elastic binder fails, and no claim sizes them. The viability deck's moat loses its most obvious differentiator, and a claim-stripped version of the hardware (claim 127unconfirmed, viability deck) competes with a commodity it cannot beat on price.
Would have to be true: The patient would have to feel a reduction in orthostatic symptoms within the first weeks of home use large enough to keep going, and the prescriber would have to see a sham-controlled symptom result for automated abdominal compression, not only the existing guideline endorsement of passive binders.
Where it stands:
What would settle it: For the prescriber, NCT03482297 (a ClinicalTrials.gov registration number)'s results, posted or published; its PI is on the registry record (claim 6verified), so a direct enquiry is a human act. For the patient, symptom change at two and four weeks in the home-use study (claim 99unconfirmed).
If it's false: Without a sham-controlled result, the prescriber conversation rests on one small manually activated crossover and claim 29unconfirmed gets harder. If patients feel nothing early, Slide 2's abandonment risk is realised in the first weeks — and under the purchase model, after Medicare has already paid for the controller once.
Would have to be true: In a single-arm home-use study of at least 20 adults with symptomatic nOH due to primary autonomic failure, over at least four weeks, compression would have to be active for most device-detected upright time and fewer than one in five would discontinue for discomfort, breathlessness, reflux or skin injury; wear time collapsing after the first week is the observation that falsifies this deck.
Where it stands: Nothing has been run with this device, which does not exist claim 8unconfirmed. The study design is on record as the clinical chair's condition claim 99unconfirmed. The file cannot say what such a study costs or how long it takes [no claim].
What would settle it: The study, which needs a prototype and so sits downstream of the feasibility deck's bench slides. Cheaper and earlier: 10-20 structured interviews with patients who have tried a binder and their carers, and 10-20 with prescribers, aimed at claims 28, 29, 130, 131 and 132. Human-run customer discovery; no connector does it.
If it's false: If wear collapses, Slides 2 and 4 fail together and the value case has no user under it. That is a question for the human in Stage 6, not a verdict here.
Every condition above with nothing verified behind it that supports it. Almost every one carries a claim number, so a short [no claim] list is not good news; the honest measure is that every behavioural condition on this deck rests on unconfirmed, and the Verifier has recorded each as unanswerable without primary research.
Slides 1 and 6 are the only ones where a verified claim bears directly on the condition, and on Slide 6 the verified part is class 2 or about passive binders. The verified claims on Slides 2 to 5 are adjacent context — other garments, study days, other indications, and the payment category — and do not support those slides' conditions. The shape of this list is information about the pipeline: the rubric scores nothing on this chair.
If only one thing from this chair could be checked: whether adults with Parkinson disease, MSA or PAF would actually wear and operate a powered abdominal garment during every upright period, day after day, for months claim 28unconfirmed.
It is this one, not prescriber willingness or price, because it sits underneath both. A prescriber will not keep ordering a device patients take off. Under the purchase model Medicare pays for the controller once, so abandonment does not cost the supplier a rental stream — it costs the patient their one paid device in its useful lifetime, and the prescriber their confidence. The symptom benefit a pivotal study would try to show exists only for the hours the garment is on. The verified adjacent evidence leans against easy adherence: stockings rejected over donning and stigma, mixed views on abdominal compression, and no real-life change in sit-to-stand frequency after a week of binder use. None of it is about this device, which is why it is still a question.
Naming it is not a recommendation, a gate, or a kill. It is the answer to "check what first."
_shared/plain-language.md