AEGIS
// LIFE SCIENCES
WORKBENCH/PROCESSES/MEDTRONIC-ICM-001/01 STRAT
DECISION OPEN
akira.tanaka@medtronic
STAGE 01 · REGULATORY STRATEGY
Where do we anchor the LINQ-NEXT launch?
⬢ MERIDIAN·regulatory strategy agent·3 viable pathways modeled
DECISION · YOUR CALL
Pick the pathway sequencing strategy.
MERIDIAN modeled three viable strategies for filing across 7 APAC authorities. The choice shapes the entire downstream evidence chain — clinical trial design, dossier sequencing, market access timing. Per policy, anchor selection is non-delegable to the agent. CRO sign-off required to seal.
OPTION B
KFDA-first → Japan secondary
KFDA New HTA accepts lighter predicate evidence. Use Korean approval to support PMDA filing. Cascade outward.
Timeline~11 mo
Evidence burdenLow
Risk profileMedium
OPTION C
Parallel · Japan + Korea
File both anchors simultaneously. Maximum speed. Doubles regulatory team load (14 FTE-weeks). Cascade after PMDA approval.
Timeline~7 mo
Evidence burdenHigh
Risk profileMedium-high
Pick one, then route
MODIFY · DRAFTAdjust Option A within MERIDIAN's modeled parameters
Modifying OPTION A · PMDA ANCHOR. Only parameters MERIDIAN marked as tunable can be adjusted. Strategy core (PMDA anchor logic) cannot be edited — request a new option for that.
PMDA filing window
Month 1 of strategy
no impact
Reliance sequencing
HSA → TGA → TFDA → HK
−1 wk timeline
NMPA local-trial start
Parallel with PMDA
+2 mo NMPA delivery
KFDA filing timing
After PMDA + HSA
−4 wk if Month 5
RA team FTE allocation
Default 8.0 FTE-weeks
within capacity
MERIDIAN · live recomputeTimeline ~9 mo → ~9 moRisk LowNet delta no material change
Pick parameters from each option to compose a new strategy. MERIDIAN will compute the combined timeline and risk profile, then surface the hybrid as Option D for CRO sign-off.
From Option A
AnchorPMDA · Japan
Reliance marketsHSA · TGA · TFDA · HK
KFDA timingLast (month 7)
NMPAParallel local trial
From Option B / C
KFDA timingParallel with PMDA (C)
Evidence approachKFDA HTA-lite (B)
FTE allocation14 FTE-wk (C)
MERIDIAN · live recompute · Option DTimeline ~8 moEvidence burden Medium-highRisk Low-medium
Describe the strategy you want MERIDIAN to model. The agent will run a fresh analysis against current guidance, predicate data, and payer schedules. Estimated turnaround: 4-6 hours. Original three options remain sealed during analysis.
Estimated turnaround: 4-6 hours · receipt-chained · 142 guidance docs re-queried · payer schedules pulled · risk profile recomputed
All modifications receipt-chained · diff vs original preserved · audit-traceable
DECISION SEALEDOption A approved · routed to S. Chen (CRO) for final sign-off
A. Tanaka approved Option A — PMDA anchor with reliance cascade. Routed to Sarah Chen (CRO) for final sign-off. Once Sarah signs, Stage 01 seals and handoff to VECTOR (Stage 02 Clinical Evidence) initiates automatically. SLA: 48h to CRO sign-off, auto-escalates to RA-Council if unsigned.
NEXT STAGE · HANDOFF QUEUEDMERIDIAN prepares packet for VECTOR
FROM
⬢ MERIDIAN
01 · Regulatory Strategy
→
TO
⬢ VECTOR
02 · Clinical Evidence
HANDOFF PACKETPathway map · 7 jurisdictions with anchor/reliance/local-trial designation · Intended use lock · AF detection in adults, 24/7 ambulatory monitoring · Predicate mapping · Reveal LINQ ICM (PMDA 2014, 12-yr post-market data) · Evidence requirements · per-jurisdiction trial design constraints (PMDA Japanese subgroup expectations, NMPA local-CT requirements, KFDA HTA predicate evidence)
Receipt on seal: 091d...4f8a
WORKFLOWMERIDIAN's substages7 of 7 complete · 8 days
▶
D1
D2
D3
D4
D5
D6
D7
D8
Guidance ingestion
7 authorities · 142 documents
DONE
Predicate mapping
Reveal LINQ · 12-yr precedent
DONE
Intended use lock
AF detection · adult population
DONE
Sequencing model
3 strategies · timing + risk
DONE
Strategy gate
A. Tanaka + S. Chen sign-off
GATE
Pathway map seal
7 jurisdictions locked
DONE
Handoff to VECTOR
Stage 02 unblocked
SEAL
Stage ThreadMERIDIAN · LIVE
01 STRAT · 7 events · decision open
MERIDIAN → GATE10 Mar · 14:22
Surfacing pathway sequencing decision. Three viable strategies modeled. Decision is consequential — shapes entire downstream evidence chain across 7 jurisdictions. Per policy POL-STRAT-ANCHOR-V1, anchor selection is non-delegable. Routing to A. Tanaka for L1 approval, then S. Chen for CRO sign-off.
82e1...9b3c · HUMAN GATE
MERIDIAN10 Mar · 13:48
Sequencing model complete. Option A: PMDA anchor, ~9 mo total, low risk. Option B: KFDA-first, ~11 mo, lower evidence burden but higher coordination risk. Option C: parallel Japan+Korea, ~7 mo, highest team load. Recommendation: Option A — PMDA's Reveal LINQ precedent is strongest reliance anchor.
A. TANAKA · RA08 Mar · 11:40
Locking intended use: AF detection in adult population, 24/7 ambulatory monitoring. Pediatric out of scope for first launch. Vyasa, run sequencing model against this.
MERIDIAN07 Mar · 09:15
Predicate device mapped: Reveal LINQ ICM, 2014 PMDA approval, 12-year post-market data. Substantial equivalence pathway viable for PMDA, HSA, TGA, TFDA. KFDA accepts as supporting evidence only.
d52b...0f17
MERIDIAN05 Mar · 16:05
Guidance ingestion complete. 142 documents across 7 authorities. PMDA Class III, HSA-MDB-G009 reliance, NMPA 2021 order, TGA CO-OR, MFDS Notice 2024-58, TFDA pathway, HK MDD VRS.
b71e...4a29