Heaven Health · Product blueprint for manufacture

Heaven Bio Sync

The Heaven Bio Sync kit for the kitchen counter: a blood-testing machine, Bio Sync Draw, and a supplement dispenser, Bio Sync Dose, working with the Heaven Halo ring. Both plug into an ordinary wall socket and connect to the Heaven Health app. This dossier covers the concept, the rotatable 3D models, the full parts list, how it connects to the app, and a build plan in order for a contract manufacturer.

Dwg no.HBS-000
RevisionA — concept
Date2026-09-23
Unitsmm · °C · µL
AssembliesHD · HC · HS
OwnerHeaven Research Labs
StatusConcept design. Not validated, not for clinical use.
Read this first

Four facts that shape the design

Capillary blood, not a vein draw

People cannot safely put in their own IV line at home, and no regulator will allow it. The fingertip rests on the analyser's light ring, where a single-use sampler cartridge with a retracting lancet fills the sealed disc, targeting about 50 µL. That is enough for a small panel on a microfluidic disc, but not for a full hospital panel.

A small panel done well, not "a lab in a box"

Theranos failed by claiming hundreds of tests from one drop of blood. Version 1 measures about 8 markers using methods that already run reliably on point-of-care analysers. Larger panels go by post or through the blood-centre booking the app already offers.

It is a regulated medical device

A blood test used at home is an in-vitro diagnostic. In the US that means FDA 510(k) or De Novo clearance for home (over-the-counter) use, backed by a lay-user study; home-use clearance makes the test CLIA-waived. In the EU it is an IVDR self-test with a notified body, and in the UK it goes through the MHRA (UKCA). That process, not the hardware, sets the timeline. Expect several years for a new analyser. Licensing a proven point-of-care analyser shortens it a lot.

The dispenser only follows a plan it can check

Dose numbers come from fixed rules with hard safety ceilings, and the member approves every change. Anything flagged, such as starting iron, needs a clinician's sign-off. Luna can explain a plan, but Luna never sets a dose.

Sheet 1 · 3D models

Rotate, explode and identify every part

Open the photo-real 3D build studio ↗
These models show the internal engineering layout. The finished look follows the Heaven Bio Sync concept renders: a white tower with clear canisters and a round fingertip sampler.

Drag to rotate, or use the arrow keys when the view is focused. Use the slider to pull the assembly apart. Click any tag or list item to see what the part is and why it's there. Each part ID matches the parts list further down.

drag · ← → ↑ ↓
Sheet 2 · System

From a drop of blood to today's supplements

flowchart LR
  K1["Sampler cartridge K1
fingertip on the light ring"] --> C1["Sealed test disc C1"] C1 --> HD["Bio Sync Draw
spin · heat · read"] HD -->|"QC pass only"| R["Signed result"] HD -->|"QC fail"| X["No result
retest, nothing guessed"] R -->|"Wi-Fi mTLS, or BLE via phone"| API[("Heaven backend")] API --> REP["Blood report
same shape as /api/blood-test"] REP --> APP["Heaven Health app
trends · Luna explains"] REP --> ENG["Dose-plan engine
fixed rules + ceilings"] ENG --> OK{"Member approves
clinician if flagged"} OK --> HS["Bio Sync Dose"] HS -->|"dispensed / missed"| API API -->|"retest due"| K1

Bio Sync Draw · HD

Size
220 W × 180 H × 260 D mm, about 2.8 kg (ballasted for spinning)
Power
Any 100–240 V kitchen socket through an external 24 V medical power supply. About 25 W during a run, under 1 W on standby (target)
Sample
About 50 µL capillary whole blood from a fingertip (target)
Result
15 minutes or less from closing the tray (target)
Runs when
15–32 °C, 10–85 % RH, level within 2°. Otherwise it refuses to start and explains why
Links
Wi-Fi 6 (2.4 GHz) and Bluetooth LE 5.3
Hygiene
Blood never touches the machine. It stays sealed inside the disc. Wipe clean with 70 % IPA

Bio Sync Dose · HS

Size
About 180 W × 260 H × 160 D mm, about 3 kg (target)
Capacity
10 sealed canisters, roughly 30–40 size-0 capsules each
Accuracy
Two independent count gates, then a weight check in the cup. A miscount goes to the reject bin; a wrong weight keeps the drawer locked and the app is alerted
Outage
48 h of scheduled doses on the backup battery
Child safety
Locked lid that opens from the app or a PIN, plus child-resistant canister caps
Power
The same 24 V supply family as Bio Sync Draw
Sheet 3 · What it measures

Test panel and what each result is allowed to change

Each marker is chosen because a proven point-of-care method exists for it. Roche's cobas b 101 runs lipids, HbA1c and CRP on a spinning disc, and Abaxis's Piccolo uses rotors with dried reagent beads. That supports the disc design, but every assay still needs its own validation.

MarkerMethod on the discStageWhat it can change
25-OH vitamin DFluorescence immunoassay (reader D8)v1Vitamin D3 dose, up to the ceiling
FerritinFluorescence immunoassayv1Iron: clinician gate never started automatically; read alongside CRP
Total cholesterol · HDL · triglyceridesEnzymatic colour change, absorbance (D7). LDL is calculatedv1Omega-3 (EPA+DHA) suggestion. Out-of-range lipids trigger a doctor referral, not a supplement
HbA1c · glucoseImmunoassay / enzymatic absorbancev1No supplement change. Flags and referral only
CRPImmunoturbidimetric absorbancev1Context only: a high CRP freezes ferritin-driven changes
Vitamin B12 · TSHFluorescence immunoassayv2B12 dose. TSH: referral only
Omega-3 index · magnesium · zinc · full blood countDried blood spot card posted to a partner lab, or a blood-centre bookingmail-inArrives as a normal lab report through the existing upload path
Sheet 4 · Bill of materials

Every part, per assembly

Reference parts are real, currently sold components given as starting points. The manufacturer qualifies each one or proposes an equivalent. Click an ID to find the part in the 3D model.

HD · Bio Sync Draw analyser 19 line items

IDPartSpecificationReference / sourceQty
Top shellPC/ABS, UL 94 V-0, 2.5 mm wall, matte texture, resists 70 % IPA and 0.5 % hypochlorite wipesInjection-moulded, custom tool1
Base chassis + ballastPC/ABS base with a 1.2 kg zinc-plated steel plate so the unit can't walk while spinning at 5,000 rpm; 4 silicone feetCustom1
Motorised disc trayGlass-filled PC tray, 150 × 150 mm, Ø132 mm disc pocket, front bezel sits flush with the shellCustom1
Tray stepper + lead screw15 mm PM stepper, M3 lead screw, 60 mm travel, optical end-stop15BY-series linear stepper1
Spindle motor + encoderBrushless outer rotor, 0–6,000 rpm, runout ≤ 10 µm, 1,024-line encoder, damped mount. Spinning separates plasma from cellsmaxon EC flat class · driver TI DRV83161
Disc heater plateAluminium plate with a 24 V 12 W polyimide film heater, 2 × 10 kΩ 1 % NTC, PID-held at 37.0 ± 0.2 °C, 70 °C thermal fusePolyimide film heater · TDK B57861S NTC1
Absorbance read head6 LEDs (405 / 450 / 520 / 590 / 630 / 850 nm) and a 14-channel spectral sensor, reading through the disc's optical cuvettesams OSRAM AS73431
Fluorescence reader365 and 470 nm excitation, long-pass emission filters, SiPM detector for the immunoassay wellsHamamatsu S13360 MPPC1
Main boardReal-time MCU, 16 MB encrypted flash, RTC with supercap, and a secure element holding the device's private signing keyST STM32H743 · Microchip ATECC608B1
Wi-Fi + Bluetooth moduleWi-Fi 6 (2.4 GHz) and BLE 5.3, pre-certified module (FCC / CE / UKCA)Espressif ESP32-C6-WROOM-11
Touch display4.3" IPS, 800 × 480, capacitive, 1.1 mm chemically strengthened cover glass4.3" TFT, medical-grade supplier1
Light ring + start button24 RGB LEDs under an opal diffuser around a capacitive start button. Shows progress, then green, amber or redWS2812-class LEDs1
Power board + DC inletLocking 24 V DC inlet, eFuse, reverse-polarity protection, 5 V / 3.3 V buck regulators, separate motor railTI TPS25940 eFuse1
External medical power supply100–240 V AC in, 24 V 60 W out, IEC 60601-1 2 × MOPP, Class II. IEC C8 lead with UK / EU / US plugs, so it works in any kitchen socketMean Well GSM60B241
Environment + level sensorsTemperature and humidity (refuses to run outside 15–32 °C) and an accelerometer (refuses to spin if tilted more than 2°)Sensirion SHT45 · ST LIS2DW121
Tray interlockHall sensor and magnet. The spindle can't start unless the tray is closed and latchedTI DRV50321
Speaker28 mm, 1 W, for spoken step-by-step prompts and alertsGeneric1
Disc identity readerNFC reader for the disc tag plus a 2D camera for the printed lot code, giving two independent ways to reject an expired or reused discST ST25R39161
Optics gantryMachined 6061 aluminium bridge that holds D7 and D8 at a fixed read radius, with alignment dowelsCNC, custom1

HC · Test disc + sampler (single use) per test

IDPartSpecificationReference / sourceQty
Disc bodyØ120 × 5 mm optical-grade COC, two moulded halves, 12 radial channels, 10 read cuvettes plus 2 on-board control wellsTopas COC 5013, custom tool1
Plasma separation chamberSpinning pushes the cells to the outer wall and plasma siphons into the metering channels, so no filter membrane is needed. One well is fed before separation and keeps whole blood, because HbA1c is measured inside red cellsMoulded into C1—
Freeze-dried reagent beadsOne dried bead per assay well, stable at room temperature. Includes 2 control beads that must read in range, or the whole test is voidedContract reagent manufacturer12
Foil sealPierceable aluminium/PET laminate, heat-sealed moisture barrierCustom laminate1
Identity tag + lot codeAuthenticating NFC tag holding the lot calibration curve, expiry date and a single-use flag, with a printed 2D code as backupNXP NTAG 424 DNA1
Sample inlet + capHinged snap cap. The inlet only accepts the sampler cartridge one way roundMoulded1
Waste chamberAbsorbent pad sealed inside the disc, so no liquid ever leaves itCellulose pad1
Fingertip sampler cartridgeSingle-use cartridge that seats in the light-ring pad: a retracting lancet and a capillary channel that fill the disc inlet, target about 50 µL. Buy an already-cleared lancet mechanism under a supply agreement and design the cartridge around it rather than inventing onePartner-sourced lancet + custom channel1
Return / disposal pouchSealed biohazard pouch for the used disc and sampler cartridge. The needle retracts, so nothing sharp is exposedUN3373-style pouch1

HS · Bio Sync Dose dispenser 17 line items

IDPartSpecificationReference / sourceQty
Base housingPC/ABS lower body, 200 × 100 × 200 mm, holding the electronics, load cell and drawerCustom tool1
Smoked lid + solenoid lockTinted PC dome that locks shut and opens only from the app or a 6-digit PIN (child-resistant)12 V latching solenoid1
Carousel plateØ150 mm POM plate with 10 bays and indexing notchesCustom1
Supplement canisters40 cc clear Tritan tube, desiccant in the cap, tamper seal. Filled and sealed at the factory by the supplement partner, and never refilled by handCustom + partner fill10
Carousel stepperNEMA 14 stepper with home sensorADI TMC2209 driver1
Canister readerNFC reader that identifies each canister's product, strength, lot and expiryST ST25R39161
Singulation wheelPocket wheel that releases one unit at a time, with swappable inserts for size 00 / 0 / 1 capsules and tabletsCustom POM1
Singulator motorN20 geared DC motor with encoderGeneric1
Drop chuteSmooth PC chute into the cupCustom1
Dual count gatesTwo independent IR break-beam pairs that must agree on the countGeneric IR emitter/receiver pairs2
Reject flap + binA count mismatch diverts to a sealed reject bin before the cup; a wrong cup weight (S13) keeps the drawer locked and alerts the appMicro servo1
Dose cup drawerRemovable cup. A presence sensor records when the dose is takenCustom1
Load cell100 g single-point load cell with a 24-bit ADC that checks the cup weight matches the expected units; a mismatch keeps the drawer lockedTI ADS12321
Main boardWi-Fi + BLE MCU, secure element, RTCEspressif ESP32-S3-WROOM-1 · ATECC608B1
Backup battery2S Li-ion 18650 pack with BMS, keeping doses on schedule for 48 h without mainsIEC 62133 certified cells1
Humidity guardHumidity sensor and a replaceable desiccant bay. Alerts before supplements degradeSensirion SHT451
Status display + buttonSmall display showing today's dose, with a single "dispense now" buttonGeneric1
Sheet 5 · Heaven Health app

How the machines connect to the app

The analyser's result lands in the same blood-report format the app already uses for uploaded lab PDFs. Trends, biomarker history and Luna's explanations work without new result screens. What's new is pairing, the guided test and today's dose.

Pairing (once)

1
In the app, the member chooses Add Bio Sync Draw or Add Bio Sync Dose. This reuses the Bluetooth onboarding pattern from the Halo ring
2
The app sends the Wi-Fi details and a one-time claim token over BLE
3
The device proves its identity with the certificate in its secure element, and the backend binds it to that member
4
From then on the device uploads directly over Wi-Fi. If Wi-Fi is down, it relays through the phone over BLE and keeps an encrypted queue until the upload is confirmed

The guided test in the app

1
Checks: fasting if needed, disc in date, room temperature OK
2
A short video on warming the hand and resting a fingertip on the light ring
3
Load a disc and a sampler cartridge, rest a fingertip on the light ring, and it counts down
4
The result appears in the app, and the member confirms it before it feeds any dose change
5
Disposal: the used disc and sampler cartridge go into the sealed pouch
EndpointStatusRole
POST /api/bio-sync/devices/claimnewBinds a device certificate to the signed-in member
POST /api/bio-sync/resultsnewChecks the signature, the device binding, that the disc hasn't been used before and that its lot isn't recalled, then writes a blood report
POST /api/blood-test/confirm/:reportIdexistsMember confirms the result, exactly as for uploaded lab PDFs
GET /api/blood-test/reports · /trendsexistsHistory and charts light up automatically
GET /api/biomarker-trendsexistsTrend analysis and prediction
POST /api/optimize-supplementsexistsLuna-assisted reasoning. It may explain a plan but must not be the source of a dose number
POST /api/bio-sync/dose-plannewFixed-rules engine: confirmed report + health profile + current stack → proposed plan inside the ceilings
POST /api/bio-sync/dose-plan/:id/approvenewMember approval, with clinician co-sign when flagged. Produces the signed plan
GET /api/bio-sync/dispenser/:deviceId/plannewDispenser pulls the signed plan and refuses anything unsigned
POST /api/bio-sync/dispenser/:deviceId/eventsnewDispensed, taken, missed and rejected events. These feed adherence and the streak
GET /api/supplement-vendorsexistsCanister refills are ordered from verified vendors

Result record the analyser uploads example

{
  "deviceId": "HD-7F3A91",
  "discSerial": "C1-260917-000482",
  "lot": "L26-0917", "lotExpires": "2027-03-17",
  "collectedAt": "2026-09-23T07:12:04Z",
  "sampleType": "capillary_whole_blood",
  "qc": {
    "discTempC": 37.1, "levelDeg": 0.6,
    "volumeOk": true, "hemolysisIndex": 0.04,
    "onboardControls": "pass"
  },
  "results": [
    { "code": "VITD25OH", "value": 22.4, "unit": "ng/mL", "method": "FIA" },
    { "code": "FERRITIN", "value": 38,   "unit": "ng/mL", "method": "FIA" }
  ],
  "signature": "<ECDSA P-256 from ATECC608B>"
}

Integrity rules the firmware and backend enforce. If any QC check fails, results is empty and the app shows "Retest" with the reason. There are no partial results and no estimated values. The app never shows a marker the disc didn't measure. A used disc serial is rejected by both the tag and the server. The app bills a test only once a result has passed QC.

Sheet 6 · Dosing safety

Hard ceilings the dispenser cannot exceed

Supplements come in fixed strengths, so "balancing" means choosing how many units of each canister to dispense. The engine works to the adult tolerable upper intake levels, always uses the stricter of the US NIH Office of Dietary Supplements and EFSA figures (EFSA's are lower for zinc, magnesium, B6, selenium and copper, and EFSA's 2024 safe level of 40 mg for iron), and dispenses automatically only up to half of that limit.

NutrientAdult upper limit (stricter of US NIH ODS and EFSA)Automatic ceilingRule
Vitamin D3100 µg (4,000 IU)50 µg (2,000 IU)Above that needs a clinician. Retest vitamin D after 8–12 weeks before any further change
Iron40 mg (EFSA)0 mgclinician gate never started automatically. Low ferritin with a high CRP means "see a doctor"
Zinc25 mg (EFSA)12 mgPair with copper if the course runs past 8 weeks
Magnesium (supplemental)250 mg (EFSA)125 mgBlocked if the profile lists kidney disease
Vitamin B612 mg (EFSA)6 mgUses the stricter EFSA figure
Selenium255 µg (EFSA)100 µgNever automatic if a multivitamin canister already contains it
Vitamin A (preformed)3,000 µgnot dispensedExcluded: pregnancy risk
Copper5 mg (EFSA)2 mgOnly alongside a long zinc course, and never with a copper-containing multivitamin
Omega-3 (EPA+DHA)5 g (FDA)2 gBlocked with anticoagulants unless a clinician co-signs

Also enforced: each nutrient changes at most once per retest cycle. A result outside the plausible range prompts a retest, not a dose change. Pregnancy, anticoagulants, kidney disease and listed prescription drugs all route the plan to a clinician. Totals are summed across every canister, including multivitamins, before any ceiling is checked. Canisters are identified by NFC, so a misplaced canister is refused rather than dispensed.

Sheet 7 · Build plan

Step-by-step, for the manufacturer

Development runs in gated phases, and each phase ends with a pass/fail check before tooling money is spent. The assembly procedures below are for the production line once the design is frozen.

Phase 0 · Foundations

Intended use and quality system

  • Write the intended-use statement and pick the first market
  • Set up an ISO 13485 quality system and an ISO 14971 risk file
  • Search for predicate devices; hold a pre-submission meeting with FDA or a notified body

GATEIntended use and regulatory route signed off

Phase 1 · Feasibility

Prove the chemistry on the bench

  • Run each assay with commercial reagents on a lab reader
  • Compare capillary with venous results on paired samples (CLSI EP09)
  • Build the first spinning discs from laser-cut PMMA

GATEBias and CV within targets for each v1 marker

Phase 2 · EVT

Engineering prototype

  • Dev boards, 3D-printed shells, CNC gantry
  • Heater control, spin profile, optics calibration
  • First version of firmware, BLE pairing and the upload path

GATE10 builds complete 200 runs with QC passing

Phase 3 · DVT

Production-intent design

  • Soft tooling for the shells and disc; custom PCBs
  • IEC 60601 and EMC pre-compliance
  • Usability studies with lay users in real kitchens (IEC 62366)

GATEDesign freeze; no open high-severity risks

Phase 4 · V&V

Verify and validate

  • Safety and EMC at an accredited lab
  • Software to IEC 62304, cybersecurity file
  • Clinical performance study with untrained users; reagent stability

GATEAll verification reports signed

Phase 5 · Clearance

Regulatory submission

  • US: 510(k) or De Novo cleared for home use (lay-user study); CLIA-waived as a result
  • EU: IVDR self-test (notified body); UK: UKCA via the MHRA
  • Dispenser: confirm its status (appliance vs. software as a medical device)

GATEClearance in the first market

Phase 6 · PVT

Pilot and ramp-up

  • Hard tooling; pilot run of 200 units
  • ISO 8 cleanroom line for dispensing beads into discs
  • End-of-line test stations; lot-release testing

GATELine yield ≥ 98 %; first lot released

Final assembly · Bio Sync Draw

  1. Inspect incoming parts. Check boards, motors, optics and shells against drawings, working in an ESD-controlled area.All HD parts
  2. Build the base. Press the ballast plate into the chassis and fit the four feet.D2
  3. Fit power. Mount the power board and DC inlet and torque to spec.D13
  4. Fit the main board on its standoffs, with the radio module and secure element fitted.D9 · D10
  5. Mount the spindle on its damped mount. Use the jig to set it perpendicular within 0.1°, then connect the encoder.D5Check: runout ≤ 10 µm on a dial gauge
  6. Bond the heater plate and fit both NTCs with thermal compound.D6
  7. Assemble the tray with its stepper and lead screw, then set the end-stop.D3 · D4
  8. Fit the gantry and optics. Align them to the cuvette radius with the alignment disc, then threadlock the screws.D19 · D7 · D8Check: alignment disc reads centre-of-cuvette on all 12 wells
  9. Fit the sensors: interlock, environment/level, disc reader and speaker.D15 · D16 · D17 · D18
  10. Build the top shell with the display and light ring, then route the flex cables.D1 · D11 · D12
  11. Close the shell, torque the screws and apply the tamper label.D1 · D2
  12. Provision the unit. Flash signed firmware and generate the device key inside the secure element at a locked provisioning station. The private key never leaves the chip.D9
  13. Run the end-of-line test. Spin speed, heater reaching 37.0 ± 0.2 °C, optics against a reference disc, fluorescence standard, radio signal strength, NFC, display and level sensor.Check: automatic pass/fail, results stored against the serial number
  14. Run a control disc with known concentrations. Every marker must read within tolerance.C1 control lot
  15. Label and pack. Apply the UDI and rating plate, then pack with the power supply, region lead, instructions and quick-start card.D14

Final assembly · Bio Sync Dose

  1. Inspect incoming parts. Pay particular attention to canister seals and NFC tags.All HS parts
  2. Build the base: main board, battery pack with BMS, then the humidity guard.S1 · S14 · S15 · S16
  3. Fit the load cell and calibrate it with 10 g and 50 g reference weights.S13Check: ±0.05 g repeatability
  4. Fit the drawer and cup with the presence sensor.S12
  5. Fit the chute, count gates and reject flap and bin.S9 · S10 · S11
  6. Fit the singulation wheel and motor with the default size-0 insert.S7 · S8
  7. Fit the carousel stepper, plate and NFC reader, then home the carousel.S3 · S5 · S6
  8. Fit the status display, lid and solenoid lock.S17 · S2
  9. Provision the unit. Flash signed firmware and generate the device key.S14
  10. Run the dispense test. Using test canisters of placebo capsules, dispense 500 units across all sizes.Check: 0 miscounts reach the cup; every injected fault goes to the reject bin
  11. Test the outage and lock. Cut mains and a scheduled dose must still dispense. With the lid locked, canisters must not be reachable.
  12. Label and pack. Ship with no canisters; they arrive sealed from the supplement partner.

Disc production line · per lot

  1. Mould both COC halves and inspect the optical windows for scratches and haze.C1 · C2 · C7
  2. Dispense the reagent beads into their wells in an ISO 8 cleanroom kept below 10 % RH, and place the waste pad.C3 · C7
  3. Bond the halves by laser or ultrasonic welding, then heat-seal the foil.C4
  4. Encode the NFC tag with the lot calibration and expiry, and print the 2D code.C5
  5. Leak-test a sample from every lot.
  6. Pouch each disc with desiccant under a nitrogen flush, and pair it with a sampler cartridge and disposal pouch.K1 · K2
  7. Release the lot only after control materials read within tolerance on reference analysers.Check: lot calibration is written to the tags only after release
Sheet 8 · Standards

Standards the manufacturer must design to

Open decisions

Six choices that change the plan

  1. Build the analyser, or license one?Licensing a cleared point-of-care disc analyser for lipids, HbA1c and CRP shortens the path. Vitamin D and ferritin, and clearance for home self-testing, still need their own validation (Phases 4–5). Building our own is the Heaven-owned route, but also the slow and expensive one.
  2. First market: US, UK or EU?Each has a different regulator, clinical study and timeline, so pick one to go first.
  3. Final v1 panel.The eight markers above are the recommendation. Each marker added is another assay to validate.
  4. Who is the clinician of record?Someone has to co-sign flagged dose plans. That could be an in-house medical director or a telehealth partner.
  5. Capsules, powders, or both?The concept film blends powders; this blueprint counts capsules. Powders need an auger doser and a scale reading to 0.01 g, and change the dispenser's parts list.
  6. Dispenser status.If it only dispenses a plan the member approved, it may count as an appliance. If it counts as acting on a diagnosis, the dose engine becomes regulated software. Get a regulatory opinion before DVT.