Decision catalogueModality pressure-test
361 language is not a free option on tissue technologies
Decision problem
Which claims stay inside a lighter posture — and which processing moves reclassify risk?
Thesis
Homologous-use and minimal-manipulation arguments must match actual processing, or the regulatory and capital model is fiction.
Tissue and HCTP-adjacent opportunities often underwrite timelines on 361-style framing. The claim test is whether processing steps and intended use still support that posture.
The review asks for a plain map: what is done to the tissue, why homologous use holds, and what commercial claims would force a different path. Donor eligibility, tracking, and quality systems should support the supply story at the claimed scale.
When clinical or performance language outruns homologous-use logic, reclassification risk becomes a pre-term-sheet decision trigger — not a post-close surprise.
Claim map
Must-be-true cuts a Decision Sprint memo would force
- Homologous-use and minimal-manipulation arguments cohere with actual processing
- Donor, tracking, and quality claims support the commercial supply story
- Clinical or performance claims do not quietly imply a heavier regulatory burden than modeled
Decision triggers
Outputs from the claim test that should change the conversation
- Processing steps that break minimal-manipulation assumptions
- Intended use drifting beyond homologous-use framing
- Supply and quality systems underspecified for the claimed scale
Sources
Related in the catalogue
- Prior work · HCTP-regulated tissue technologies
Anonymized account of decision pressure in this modality class.
- Method · graph-backed claim testing
How claims are decomposed, tested against the evidence graph, and turned into decision outputs.
- Identity before mechanism in extracellular vesicle packages
What must be true about vesicle identity and controls before mechanism claims can carry a check?
- Assay performance is not the whole diagnostics investment claim
Do analytical claims, intended use, and path-to-adoption cohere under the stated clock?
Facing this cut on a live $1–10M package?
Scope a Decision Sprint for one opportunity under your deal deadline—claim map, risk register, management questions, and partner briefing.