hh-health-ai/healthcare-equity/device-diligence

Device & Regulatory Diligence

Deep regulatory and technical diligence: product profile, manufacturing, IP, FDA pathway and history, diagnostics regulation, and therapy–test coupling. Eight workflows, each a prompt in ${CLAUDE_PLUGIN_ROOT}/skills/device-diligence/references/prompts.md — pick by question:

Execution rules

1. Choose the workflow(s) from the table, load the prompt, and gather primary sources first: FDA databases via web research (Drugs@FDA, 510(k)/PMA/De Novo databases, warning letters), the Clinical Trials connector for supporting studies, PubMed for published validation data.
2. Ground pathway and development-stage judgments in ${CLAUDE_PLUGIN_ROOT}/references/fda-pathways-fto.md and ${CLAUDE_PLUGIN_ROOT}/references/device-development-checkpoints.md (includes the human-factors gate). For drug CMC, translate per the manufacturing row of references/evidence-translation-clinical.md: CMC progress moves launch probability, timing, yield, capacity, and capital — not patient demand or share.
3. For legal-adjacent outputs (FTO), state the analysis is an investment-diligence screen, not a legal opinion, and note that definitive FTO requires patent counsel.
4. End each workflow with the EVIDENCE BRIEF block (layer: regulatory; competitive for TPP/CDx where share-relevant). Route label/coverage consequences to adcom-label and cms-reimbursement; route pathway timelines to catalyst-calendar; route COGS/margin deltas to healthcare-equity model-valuation.

Combination products & delivery-format changes

For IV→SC conversions, autoinjector/PFS launches, self-administration claims, and device changes on marketed drugs, work from ${CLAUDE_PLUGIN_ROOT}/references/combination-products.md: place the change on the four-domain evidence ladder (HF/URRA · PK bridging 80–125% · clinical · CMC/EDDO, with the Humira-s381 → Repatha precedent range), check device qualification (ISO 11608, aged/shipped verification, PPQ at filing) and the autoinjector deficiency base rates (~10/12 recent BLAs flagged on essential-performance traceability), note that shelf-life/device-change supplements are PAS-clocked dated events, and translate per the "easier administration" evidence row — a format conversion moves initiation/site-of-care/persistence, never efficacy or TAM, and is not a new patient (case C05 rule). Post-launch, hand MAUDE use-error trajectories to the quality-signals skill.