pipeline-devices

Methodology inspired by publicly taught medtech pipeline frameworks; all text is an original paraphrase.

Defaults

Parameter	Default Value	Rationale
asset_scope	all disclosed devices	Full-pipeline enumeration first
stage_lens	feasibility + pivotal	Design-iteration stages, not drug-phase labels
reimbursement_aware	true	Value framed against coverage paths, not raw approval
post_market_scan	true	Obligations and surveillance state surfaced
value_frame	risk-adjusted	Modeled value = unadjusted peak x POS, both shown

Preflight

Run canonical pre-flight per contracts/preflight.md. Propagate X-Agentii-Trace per contracts/x-agentii-trace-header.md. Confirm ticker resolution via search_companies before asset queries.

Triggers

• "Analyze [ticker]'s device pipeline."
• "What is in [ticker]'s feasibility and pivotal portfolio?"
• "Where is each of [ticker]'s devices in its design cycle?"
• "Which of [ticker]'s programs are approaching submission?"
• "What RWE studies support [ticker]'s devices?"
• "What post-market obligations does [ticker] carry?"
• "Risk-adjust [ticker]'s device pipeline."
• "What is the next catalyst for each of [ticker]'s devices?"
• "How does [ticker]'s device pipeline compare to peers?"
• "Which device classifications (PMA/De Novo/510(k)) map to [ticker]'s pipeline?"
• "Map [ticker]'s devices by clinical stage and indication."
• "What does [ticker]'s pipeline say about its reimbursement path?"

Production Grounding

• Device stage ladder: feasibility (first-in-human, small N) → pivotal (registrational) → submission (PMA / De Novo / 510(k)) → post-market. Devices iterate through design versions; design freezes and iteration cycles are the pipeline milestones, not drug-style phases.
• Pivotal design varies by classification: PMA demands the highest evidence bar, De Novo novel classification, 510(k) equivalence — the pipeline's value path depends on the expected track.
• RWE studies (registries, claims analyses) increasingly support coverage and label expansion; treat them as pipeline assets with their own timelines.
• Post-market obligations (surveillance studies, MDR reporting) shape long-term liability and the re-approval path.
• Reimbursement-aware framing: pipeline value assumes a coverage path; an asset without one is discounted.
• Grounding detail lives in references/knowledge-frameworks.md.

Data Source Priority

1. get_company_devices / search_universe_devices — asset inventory from the med universe.
2. search_clinical_trials / get_clinical_trial — study stage, design type, status, enrollment.
3. get_device_decision — decision history and upcoming decisions per device.
4. Knowledge layer: search_knowledge_entries for framework grounding.

Methodology

Retrieval Scope

structured_only

Retrieval Strategy

1. Pull asset inventory (get_company_devices), cross-check the universe (search_universe_devices).
2. Enrich per asset with study records (search_clinical_trials) — stage, design type, status-diff.
3. Pull decision history and upcoming dates (get_device_decision).
4. Flag post-market obligations and RWE study presence per asset.
5. Size each asset (peak x POS); ground in knowledge entries.

Temporal Scope

See frontmatter temporal_scope block. Device development and post-market windows span years; history may reach back 8-12 quarters.

Tool Allowlist

See frontmatter allowed_tools.

Protocol

1. Asset enumeration
2. Stage and design-cycle mapping
3. Decision-track alignment
4. Post-market and RWE overlay
5. Risk-adjusted synthesis

Modes

• Phase scan (default): all devices by stage with next catalyst and expected track.
• Design cycle: design-iteration state, freezes, and submission readiness.
• Post-market: obligations, surveillance state, and RWE support.

Tool Fallbacks

Failure	Fallback
get_company_devices empty	search_universe_devices by company or indication; annotate coverage_gap
No trial rows	Mark stage undisclosed; do not guess pivotal vs feasibility
No decision history	Flag the submission track unknown; state both possibilities
Knowledge tools empty	Proceed with structured data only

Output File

{ticker}/{YYYY-MM-DD_HHMM}_pipeline-devices_{affix}.md

Output Structure

1. Executive Summary — pipeline stance in 2-3 sentences
2. Asset Table — stage, design type, expected track, next catalyst
3. Design-Cycle Read — iteration state, freezes, submission readiness
4. Post-Market & RWE — obligations, surveillance, registries
5. Risk-Adjusted Sizing — peak x POS with reimbursement framing
6. Coverage Gaps — missing records, undisclosed stage, degraded modes

Error Handling

Error	Fallback
Stage unknown	Mark "undisclosed"; do not guess
Classification ambiguous	State the evidence-bar difference across tracks
No catalysts found	Say so explicitly; note the pipeline may be early-stage

Memory Load

See contracts/memory-load.md.

Snapshot

See contracts/snapshot-synthesis.md.

Final Summary (TUI)

Include ### Key Citations block with 0-10 clickable /v/ URLs.

References

• contracts/citation-and-memory.md
• contracts/output-frontmatter-schema.md
• contracts/memory-load.md
• contracts/snapshot-synthesis.md
• contracts/preflight.md
• references/knowledge-frameworks.md