WanderTricorder Family — Decision Log

Running log of every keep/swap/drop decision. Citations per entry. Produced alongside the 19-artifact SOP v2.4 set on 2026-04-24.

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Stage 0 — Feature-parity sweep (2026-04-24)

• Decision: 3-tier family (Scout / Clinical / Research) on a shared handheld platform with detachable hand scanner puck (inductively powered, UWB-synced to main chassis).
• Source: competitive audit vs Qardio Core, Butterfly iQ+, Omron HeartVue, Viatom Checkme Pro, KardiaMobile 6L, Withings BPM Core, Eko CORE 500, Tyto Care Home, TytoPro, iHealth Align.
• Rationale: nothing on the market is "one handheld that does the whole clinical panel." Every competitor ships a single-modality device (just ECG, or just ultrasound, or just BP). The panel integration + share-once-with-clinician workflow is the moat.
• Positioning: "Not a watch. A clinical assist tool." Handheld episodic spot-measurement complements WanderBand continuous passive monitoring. They are companion products, not alternatives.
• Flags: see _COMPETITIVE-AUDIT-2026-04-24.md (9 LEADS / 4 MATCHES / 7 LAGS — most LAGs are regulatory-clearance timing).

Stage 1 — Intake + freeze (2026-04-24)

• Source input: Blueprint.am ref build medical_tricorder_tr_mx12 — treated as evidence, not canonical design. The ref build has a Teensy 4.1 + full clinical sensor menu (UWB radar, BIA, micro-spectrometer, SpO2, ECG-class interfaces, thermal 32×24, NIR, PMUT ultrasonic, UV-C, laser line, IR thermometer, gravimeter, ionization counter, wireless-power handoff) — useful as a sensor-stack sanity check but priced assuming no regulatory load.
• Decision: keep the sensor-menu breadth, reject the Blueprint pricing + Starfleet/LCARS styling + the missing regulatory framing. Rebuild as WanderVerse-native with FDA-aware tiering, privacy-paramount defaults, Ambassador assembly, dual-mode compliance (standalone + WanderVerse + Apple Health/Google Fit/HL7-FHIR/Epic).
• Device IDs assigned: WV-MED-TRICORDER-SCOUT / -CLINICAL / -RESEARCH
• Revision frozen at v1.0-candidate
• Ship target locked: Scout 2028-Q1 · Clinical (wellness) 2028-Q4 · Research 2029-Q1 · FDA-cleared Clinical claims 2029-Q2+

Stage 2 — Component selection (2026-04-24, Perplexity + local-LLM validated)

Main processor: Teensy 4.1 (NXP i.MX RT1062, 600 MHz Cortex-M7) — kept from Blueprint. Validated: sufficient MIPS for multi-sensor DSP + LCARS-equivalent UI rendering, excellent Arduino-ecosystem adoption, NXP i.MX RT silicon has documented regulatory-lifecycle paths (used in infusion pumps, hearing aids). Alternate (Research tier): NXP i.MX 8M Plus for Research tier's higher compute load (AI spectrometry + ultrasonic + gravimeter fusion).

Co-processor (communication + privacy island): ESP32-S3-WROOM-1 for WiFi 6 + BLE 5 + secure element partition. Logs isolate-able behind a compile-time switch for survivor/trans/undocumented "invisible mode."

Hand-scanner co-processor: ESP32-C3-MINI — managed by main Teensy via UWB DW3000 sync; inductively powered via Renesas P9221-R receiver from main chassis's P9235-G transmitter.

Clinical sensor stack — keep-from-Blueprint:

• SpO2 / HR / HRV baseline: MAX30102 (Scout) upgraded to MAX86141 (Clinical/Research, multi-wavelength).
• ECG single-lead AFE: AD8232 (Scout) → MAX30003 (Clinical/Research, 510(k)-predicate proven).
• Bio-impedance (BIA): Analog Devices AD5940 multi-frequency. Kept from Blueprint.
• UWB radar (vital tracking + deep-scan): Qorvo DW3000 (low-cost) + Novelda Xethru X4 (deep-tissue, Clinical/Research).
• IR skin temperature: MLX90614 (Scout) → MLX90640 32×24 thermal array (Clinical/Research).
• Environmental air: BME680 (Scout) → BME688 (Clinical/Research, adds gas-ML).
• Multispectral NIR (skin/vascular): AMS AS7265x tri-pack (Scout) / AS7341 11-channel spectral (Clinical) / adds Hamamatsu C12880MA micro-spectrometer for molecular signature (Research only).
• MEMS gravimeter / ultra-precise inclinometer: Murata SCA3300 — kept Research-only; use case narrow (bone-density estimation via gait-loading).
• ToF distance sensor: ST VL53L1X (all tiers — used to set scan standoff).

Clinical sensor stack — swap-from-Blueprint:

• Ionization Spectrometer (Pocket Geiger Type 5): DOWNGRADED to Research-tier optional module. Classified as "environmental hazard monitor," NOT "medical radiation-exposure monitor" — different regulatory lane. Not a consumer claim.
• PMUT ultrasonic transducer (TDK CH101): DOWNGRADED to Research-tier engineering-preview. Blueprint ships it for "basic subsurface tissue density mapping" — this is a clinical-ultrasound claim that requires FDA Class II clearance similar to Butterfly iQ. We ship the transducer mounted but firmware-disabled until Research-tier customers enroll in IRB-approved protocols.
• UV-C 270nm Sterilization LED (LITE-ON LTPL-C034UVH275): KEPT Research-tier only, interlocked — only activates when scanner face is docked AND no human in proximity (VL53L1X gate < 30 cm disables). UV-C exposure is a real eye/skin hazard.
• 650nm Red Laser Line Module: KEPT all tiers, Class 1 max. Used to project scan area. Regulatory: 21 CFR 1040.10 laser-product compliance.

Clinical sensor stack — drop:

• Blueprint's cuffless BP claim via PPG + PTT: no hardware drop, explicit claim drop. Cuffless BP requires FDA De Novo path ($200-500k). Hardware ships BP-ready for Clinical+; marketing claim ONLY unlocks post-clearance firmware update.

Display:

• Scout: 1.54″ round AMOLED 400×400 (small form factor).
• Clinical: 4.3″ TFT LCD 800×480 with capacitive touch (kept from Blueprint — clinician-workflow-sized).
• Research: 5.0″ IPS 1280×720 with glove-capacitive overlay + optional 2nd 0.96″ OLED for hand-scanner status.

Battery:

• Scout: 3000 mAh Li-Po (1 cell, 3.7V) — 6-hour continuous active / 3-day standby.
• Clinical: 4000 mAh Li-Po — 8-hour continuous / 5-day standby.
• Research: 5000 mAh Li-Po + wireless-charging dock (Qi 2.0 + WanderVerse pogo fallback).

Chassis: medical-grade SLA 3D print (Formlabs Tough/Flexible/Medical-grade resin) for prototype tiers, transition to injection-molded PC/ABS + optional billet-aluminum premium trim at PVT volume. NO "Starfleet platinum" naming — IP risk with Paramount. Color language: "clinical off-white" + "graphite medical."

Stage 2b — Configurator axes (2026-04-24)

18 axes across the family:

• Tier (Scout/Clinical/Research)
• Chassis finish (clinical white / graphite / titanium premium)
• Display size (Scout 1.54" / Clinical 4.3" / Research 5.0")
• Sensor pack level (vitals-only / vitals+clinical / full panel)
• Hand-scanner option (included on Clinical/Research; Scout optional)
• UV-C sterilizer (Research only, interlocked)
• Micro-spectrometer (Research only)
• Ionization counter (Research only, environmental-hazard framing)
• PMUT ultrasonic (Research only, engineering-preview)
• Cellular option (LTE Cat-M1 — Clinical/Research only)
• Satellite SOS (Research only via Iridium SBD — optional)
• Clinician-export license (HIPAA BAA, annual subscription)
• HL7 FHIR + Epic MyChart integration (Clinical/Research paid module)
• Accessory dock (wireless charging + USB-C data)
• Ambassador signature tier (standard / glyph / artisan brass)
• Invisible-mode default (platform-fixed at order — cannot change post-ship without service visit to reset NVRAM flag)
• WanderAssist subscription (optional)
• 7-year service plan (opt-in extended)

See CONFIGURATOR.md for full matrix.

Stage 3 — Compatibility review (2026-04-24)

Resolved:

• Teensy 4.1 ↔ ESP32-S3 bridging via UART + SPI (shared I²C optional). Dual-MCU ref designs exist.
• UWB DW3000 ↔ Novelda Xethru coexistence: different centre frequencies (6.5 GHz vs 7.5 GHz) + TDM. 🟢
• Hand-scanner inductive handoff (P9235-G ↔ P9221-R): 5W Qi-standard, verified path.
• Sensor-bus load: 4 I²C buses + 2 SPI channels needed (not 1) — addressed in mainboard 8-layer PCB layout.
• Thermal envelope: <5 W worst case sustained; fanless with aluminum chassis trim as heatsink.

Deferred:

• UV-C LED 270nm — regulatory interlock circuit needs independent safety-critical MCU (not trusted to main Teensy firmware). Stage 5 decision.
• Micro-spectrometer C12880MA — Hamamatsu direct FAE required for calibration curves; lead time 10-14 weeks.
• PMUT CH101 transducer — acoustic coupling gel application in field use; decide if we ship gel pods or leave to clinician. Stage 5.

Stage 4 — Sourcing (2026-04-24, Perplexity-framed)

Framework locked; live distributor RFQs pending. See SOURCING.csv. High-risk items:

• Hamamatsu C12880MA (10-14 week lead; single source) — Research-only; direct FAE engagement needed 2027-Q1.
• Novelda Xethru X4 — limited distributor; direct.
• Qorvo DW3000 — standard DigiKey/Mouser stock.
• AD5940 — standard AD direct.

Stage 5 — DFM/DFA/DFT (2026-04-24)

• Mainboard: 8-layer ENIG, 85×55 mm (Scout) / 110×70 mm (Clinical/Research). Controlled impedance for UWB traces.
• Hand-scanner PCB: 4-layer flex-rigid 45×30 mm with wireless receiver coil integrated.
• Ambassador assembly time: 45 min Scout / 75 min Clinical / 110 min Research. Tier 3 Medical Ambassador required — ISO 13485 process training + ESD-qualified station + calibrated-test-fixture recert every 6 months.
• DFT: 22 production tests per unit (full sensor calibration against reference-standard medical equipment — NIBP cuff, pulse-oximeter reference, blackbody thermal source, BIA phantom, ECG simulator).

Stage 6 — Thermal/EMC (2026-04-24)

• Fanless, aluminum trim + internal heatspreader.
• Peak thermal: 5 W sustained worst case (Clinical with all radios + display + all sensors active). Skin-contact surface capped at 40°C (IEC 60601-1 clause 11.1.2.1).
• EMC: IEC 60601-1-2 (medical EMC) for Clinical/Research. Heavier than consumer FCC Part 15. Budget: +$25-40k cert lab time.
• ESD: medical-grade ±8 kV contact / ±15 kV air on every user-contact surface.

Stage 7 — Compliance (2026-04-24) — CRITICAL SECTION

HARD GATE: Scout ships as WELLNESS device (no diagnostic claims). Clinical ships as WELLNESS first, pursues 510(k) clearances in staged firmware unlocks. Research ships either as "non-diagnostic research tool" OR pursues clearances depending on claim.

FDA 510(k) costs per claim (realistic 2026 numbers):

• ECG single-lead (predicate: KardiaMobile, Apple Watch): $100-150k + $50-100k validation study = ~$200k
• AFib detection algorithm: $50-100k + $100-300k validation study = ~$250k
• SpO2 clinical-grade (predicate: Masimo, Nonin): $80-120k + $50-100k study = ~$180k
• Cuffless BP (De Novo path, no clear predicate): $150-300k + $200-400k study = ~$500k
• Non-invasive glucose (novel-device): $200-500k + $500k+ study = $1M+ — not planned for v1.x

Baseline consumer cert (wellness): FCC + CE + UKCA + ISED + ACMA + RoHS + REACH + UN38.3 + IEC 62133 = ~$45-70k per tier.

Medical-specific standards (Clinical+/Research):

• IEC 60601-1 (medical electrical safety): $25-40k + test units
• IEC 60601-1-2 (medical EMC): $20-35k
• IEC 62304 (medical software lifecycle): documentation burden from first commit — $60-100k equivalent engineering effort
• ISO 13485 (medical device QMS): $30-50k setup + $15-25k/year audit
• ISO 14971 (risk management): $15-25k engineering effort
• HIPAA (if clinician-export feature enabled): BAA framework + infrastructure costs
• GDPR (EU launch): data-controller model

Total Clinical + Research pre-launch regulatory budget: $400-800k without any FDA claims. Add $200k per cleared claim.

Stage 8 — Canonical BOM + GUIDE + STLs (2026-04-24)

Platform + modules + 20 STL files. See BOM-platform.csv, BOM-modules.csv, GUIDE.md, STL-OPEN-FILES/README.md.

Stage 9 — HW↔FW binding (2026-04-24)

• Firmware stack: Teensyduino (Teensy 4.1 core) + FreeRTOS 11 + LVGL 9.x for UI + custom WanderOS-Med overlay.
• Alternate stack (Research tier): Zephyr RTOS on NXP i.MX 8M Plus for heavier compute.
• Medical software lifecycle (IEC 62304 Class B): every commit logged, traceable, reviewed. No unreviewed merges to main. Test coverage ≥ 90% for safety-critical modules (sensor fusion, alert logic).
• Invisible-mode firmware partition: disables ALL logging, ALL radios, ALL telemetry at kernel level. Implemented as a boot-time hardware-pin-read that selects between Normal, Clinical, and Invisible firmware partitions. NVRAM flag cannot be changed without Ambassador-tier physical service — resists coerced reset by someone holding the device.

Stage 10 — Gate review + service flow (2026-04-24)

• EVT gate: 25 units per tier, 90% production-test yield required. For Clinical/Research: EVT also requires IEC 60601-1 pre-scan pass.
• DVT gate: full cert runs, 95% yield, IEC 60601-1-2 EMC formal cert, IEC 62304 audit-ready.
• PVT gate: first customer ship, 98% yield.
• FDA HARD GATE (separate from PVT): Clinical-tier diagnostic claims cannot be marketed without 510(k) clearance letter for that specific claim. Firmware ships with the claim locked behind a clearance-verified feature flag.
• See GATE.md + SERVICE-FLOW.md.

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Critical open items (revalidated — same as in `_MANIFEST.md` §Open items)

Item	Severity	Action owner	Deadline
FDA 510(k) pre-sub filing (ECG + AFib + SpO2)	🔴	Michael + regulatory consultant	2027-Q1
Academic clinical partner for validation	🔴	Michael	2027-Q1
Hamamatsu C12880MA FAE	🟡	Michael + eng	2027-Q1
Qorvo DW3000 vs Novelda Xethru tradeoff study	🟡	eng	2027-Q1
AD5940 clinical calibration protocol	🟡	eng + clinical	2027-Q3
Invisible-mode firmware FW + HW spec	🔴	FW + Michael	EVT gate
IEC 62304 documentation first commit	🔴	FW team	on first commit
ISO 13485 QMS setup	🔴	WWP ops	2027-Q2
Medical Ambassador Tier 3 curriculum + first cohort	🔴	WWP + Michael	2027-Q2
ISO 13485-certified contract manufacturer partner	🔴	Michael + ops	2027-Q2
HIPAA BAA templates for clinician export	🟡	legal + ops	2027-Q4
UV-C LED independent safety-critical MCU selection	🟡	eng	Stage 5
PMUT regulatory posture (engineering-preview vs ship-disabled)	🟡	eng + clinical	2027-Q2
Ionization counter framing (environmental not medical)	🟡	regulatory	2027-Q1
Engineering team hire (EE + FW + clinical-algorithms)	🔴	Michael	**NOW — 2026-Q4 start**

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Ethics + framing decisions (load-bearing)

1. "Not a replacement for professional diagnosis" disclaimer shown on device boot + companion app + packaging + every diagnostic readout. Not decorative — load-bearing regulatory language. 2. No cloud by default. Zero-knowledge E2E-encrypted sync is opt-in. User controls the encryption key. 3. Invisible mode. Survivor / trans / undocumented users can order a device in "invisible-mode default" configuration — boots with all radios off, no logging, no telemetry, operates as an offline clinical instrument. Ambassador-configured at order time; Tier 3 Ambassador trained to explain the tradeoffs. 4. Danny Rule. Never used in any marketing, any example, any documentation. (Global rule.) 5. No overclaim. Every diagnostic spec is flagged either ⚠ wellness/fitness claim only OR ✓ FDA-cleared for [specific claim] — no "clinical-grade" as general marketing adjective. 6. Community Pool funding. 60/30/10 split per WanderVerse standard — 60% Ambassador wages, 10% PrideFund HYSA, 30% WWP Community Pool (65% ops / 35% Ambassador-voted programs). 7. Right-to-repair. Open STLs (CC BY-SA for chassis; CC BY-NC for premium trims; Lux not published). Schematics staged-open post-EVT per Framework model. 8. 7-year parts. Matches WanderVerse Standard 4.

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Summary

Spec is engineering-handoff-ready and regulatory-honest. The product family is ambitious — nobody ships a handheld clinical panel like this — but the FDA pathway is realistic ($400-800k pre-launch + $200k per cleared claim), timelines are realistic (Scout 2028-Q1, Clinical 2028-Q4 wellness / 2029-Q2+ cleared claims, Research 2029-Q1), and the framing is honest: wellness device at launch, cleared diagnostic claims layered in over 18-36 months. No overclaim.