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.
Marker
Method on the disc
Stage
What it can change
25-OH vitamin D
Fluorescence immunoassay (reader D8)
v1
Vitamin D3 dose, up to the ceiling
Ferritin
Fluorescence immunoassay
v1
Iron: clinician gate never started automatically; read alongside CRP
Total cholesterol · HDL · triglycerides
Enzymatic colour change, absorbance (D7). LDL is calculated
v1
Omega-3 (EPA+DHA) suggestion. Out-of-range lipids trigger a doctor referral, not a supplement
HbA1c · glucose
Immunoassay / enzymatic absorbance
v1
No supplement change. Flags and referral only
CRP
Immunoturbidimetric absorbance
v1
Context only: a high CRP freezes ferritin-driven changes
Vitamin B12 · TSH
Fluorescence immunoassay
v2
B12 dose. TSH: referral only
Omega-3 index · magnesium · zinc · full blood count
Dried blood spot card posted to a partner lab, or a blood-centre booking
mail-in
Arrives 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
ID
Part
Specification
Reference / source
Qty
Top shell
PC/ABS, UL 94 V-0, 2.5 mm wall, matte texture, resists 70 % IPA and 0.5 % hypochlorite wipes
Injection-moulded, custom tool
1
Base chassis + ballast
PC/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 feet
Custom
1
Motorised disc tray
Glass-filled PC tray, 150 × 150 mm, Ø132 mm disc pocket, front bezel sits flush with the shell
Custom
1
Tray stepper + lead screw
15 mm PM stepper, M3 lead screw, 60 mm travel, optical end-stop
24 RGB LEDs under an opal diffuser around a capacitive start button. Shows progress, then green, amber or red
WS2812-class LEDs
1
Power board + DC inlet
Locking 24 V DC inlet, eFuse, reverse-polarity protection, 5 V / 3.3 V buck regulators, separate motor rail
TI TPS25940 eFuse
1
External medical power supply
100–240 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 socket
Mean Well GSM60B24
1
Environment + level sensors
Temperature and humidity (refuses to run outside 15–32 °C) and an accelerometer (refuses to spin if tilted more than 2°)
Sensirion SHT45 · ST LIS2DW12
1
Tray interlock
Hall sensor and magnet. The spindle can't start unless the tray is closed and latched
TI DRV5032
1
Speaker
28 mm, 1 W, for spoken step-by-step prompts and alerts
Generic
1
Disc identity reader
NFC reader for the disc tag plus a 2D camera for the printed lot code, giving two independent ways to reject an expired or reused disc
ST ST25R3916
1
Optics gantry
Machined 6061 aluminium bridge that holds D7 and D8 at a fixed read radius, with alignment dowels
CNC, custom
1
HC · Test disc + sampler (single use) per test
ID
Part
Specification
Reference / source
Qty
Disc body
Ø120 × 5 mm optical-grade COC, two moulded halves, 12 radial channels, 10 read cuvettes plus 2 on-board control wells
Topas COC 5013, custom tool
1
Plasma separation chamber
Spinning 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 cells
Moulded into C1
—
Freeze-dried reagent beads
One dried bead per assay well, stable at room temperature. Includes 2 control beads that must read in range, or the whole test is voided
Authenticating NFC tag holding the lot calibration curve, expiry date and a single-use flag, with a printed 2D code as backup
NXP NTAG 424 DNA
1
Sample inlet + cap
Hinged snap cap. The inlet only accepts the sampler cartridge one way round
Moulded
1
Waste chamber
Absorbent pad sealed inside the disc, so no liquid ever leaves it
Cellulose pad
1
Fingertip sampler cartridge
Single-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 one
Partner-sourced lancet + custom channel
1
Return / disposal pouch
Sealed biohazard pouch for the used disc and sampler cartridge. The needle retracts, so nothing sharp is exposed
UN3373-style pouch
1
HS · Bio Sync Dose dispenser 17 line items
ID
Part
Specification
Reference / source
Qty
Base housing
PC/ABS lower body, 200 × 100 × 200 mm, holding the electronics, load cell and drawer
Custom tool
1
Smoked lid + solenoid lock
Tinted PC dome that locks shut and opens only from the app or a 6-digit PIN (child-resistant)
12 V latching solenoid
1
Carousel plate
Ø150 mm POM plate with 10 bays and indexing notches
Custom
1
Supplement canisters
40 cc clear Tritan tube, desiccant in the cap, tamper seal. Filled and sealed at the factory by the supplement partner, and never refilled by hand
Custom + partner fill
10
Carousel stepper
NEMA 14 stepper with home sensor
ADI TMC2209 driver
1
Canister reader
NFC reader that identifies each canister's product, strength, lot and expiry
ST ST25R3916
1
Singulation wheel
Pocket wheel that releases one unit at a time, with swappable inserts for size 00 / 0 / 1 capsules and tablets
Custom POM
1
Singulator motor
N20 geared DC motor with encoder
Generic
1
Drop chute
Smooth PC chute into the cup
Custom
1
Dual count gates
Two independent IR break-beam pairs that must agree on the count
Generic IR emitter/receiver pairs
2
Reject flap + bin
A count mismatch diverts to a sealed reject bin before the cup; a wrong cup weight (S13) keeps the drawer locked and alerts the app
Micro servo
1
Dose cup drawer
Removable cup. A presence sensor records when the dose is taken
Custom
1
Load cell
100 g single-point load cell with a 24-bit ADC that checks the cup weight matches the expected units; a mismatch keeps the drawer locked
TI ADS1232
1
Main board
Wi-Fi + BLE MCU, secure element, RTC
Espressif ESP32-S3-WROOM-1 · ATECC608B
1
Backup battery
2S Li-ion 18650 pack with BMS, keeping doses on schedule for 48 h without mains
IEC 62133 certified cells
1
Humidity guard
Humidity sensor and a replaceable desiccant bay. Alerts before supplements degrade
Sensirion SHT45
1
Status display + button
Small display showing today's dose, with a single "dispense now" button
Generic
1
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
Endpoint
Status
Role
POST /api/bio-sync/devices/claim
new
Binds a device certificate to the signed-in member
POST /api/bio-sync/results
new
Checks 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/:reportId
exists
Member confirms the result, exactly as for uploaded lab PDFs
GET /api/blood-test/reports · /trends
exists
History and charts light up automatically
GET /api/biomarker-trends
exists
Trend analysis and prediction
POST /api/optimize-supplements
exists
Luna-assisted reasoning. It may explain a plan but must not be the source of a dose number
POST /api/bio-sync/dose-plan
new
Fixed-rules engine: confirmed report + health profile + current stack → proposed plan inside the ceilings
POST /api/bio-sync/dose-plan/:id/approve
new
Member approval, with clinician co-sign when flagged. Produces the signed plan
GET /api/bio-sync/dispenser/:deviceId/plan
new
Dispenser pulls the signed plan and refuses anything unsigned
POST /api/bio-sync/dispenser/:deviceId/events
new
Dispensed, taken, missed and rejected events. These feed adherence and the streak
GET /api/supplement-vendors
exists
Canister refills are ordered from verified vendors
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.
Nutrient
Adult upper limit (stricter of US NIH ODS and EFSA)
Automatic ceiling
Rule
Vitamin D3
100 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
Iron
40 mg (EFSA)
0 mg
clinician gate never started automatically. Low ferritin with a high CRP means "see a doctor"
Zinc
25 mg (EFSA)
12 mg
Pair with copper if the course runs past 8 weeks
Magnesium (supplemental)
250 mg (EFSA)
125 mg
Blocked if the profile lists kidney disease
Vitamin B6
12 mg (EFSA)
6 mg
Uses the stricter EFSA figure
Selenium
255 µg (EFSA)
100 µg
Never automatic if a multivitamin canister already contains it
Vitamin A (preformed)
3,000 µg
not dispensed
Excluded: pregnancy risk
Copper
5 mg (EFSA)
2 mg
Only alongside a long zinc course, and never with a copper-containing multivitamin
Omega-3 (EPA+DHA)
5 g (FDA)
2 g
Blocked 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
Inspect incoming parts. Check boards, motors, optics and shells against drawings, working in an ESD-controlled area.All HD parts
Build the base. Press the ballast plate into the chassis and fit the four feet.D2
Fit power. Mount the power board and DC inlet and torque to spec.D13
Fit the main board on its standoffs, with the radio module and secure element fitted.D9 · D10
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
Bond the heater plate and fit both NTCs with thermal compound.D6
Assemble the tray with its stepper and lead screw, then set the end-stop.D3 · D4
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
Fit the sensors: interlock, environment/level, disc reader and speaker.D15 · D16 · D17 · D18
Build the top shell with the display and light ring, then route the flex cables.D1 · D11 · D12
Close the shell, torque the screws and apply the tamper label.D1 · D2
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
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
Run a control disc with known concentrations. Every marker must read within tolerance.C1 control lot
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
Inspect incoming parts. Pay particular attention to canister seals and NFC tags.All HS parts
Build the base: main board, battery pack with BMS, then the humidity guard.S1 · S14 · S15 · S16
Fit the load cell and calibrate it with 10 g and 50 g reference weights.S13Check: ±0.05 g repeatability
Fit the drawer and cup with the presence sensor.S12
Fit the chute, count gates and reject flap and bin.S9 · S10 · S11
Fit the singulation wheel and motor with the default size-0 insert.S7 · S8
Fit the carousel stepper, plate and NFC reader, then home the carousel.S3 · S5 · S6
Fit the status display, lid and solenoid lock.S17 · S2
Provision the unit. Flash signed firmware and generate the device key.S14
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
Test the outage and lock. Cut mains and a scheduled dose must still dispense. With the lid locked, canisters must not be reachable.
Label and pack. Ship with no canisters; they arrive sealed from the supplement partner.
Disc production line · per lot
Mould both COC halves and inspect the optical windows for scratches and haze.C1 · C2 · C7
Dispense the reagent beads into their wells in an ISO 8 cleanroom kept below 10 % RH, and place the waste pad.C3 · C7
Bond the halves by laser or ultrasonic welding, then heat-seal the foil.C4
Encode the NFC tag with the lot calibration and expiry, and print the 2D code.C5
Leak-test a sample from every lot.
Pouch each disc with desiccant under a nitrogen flush, and pair it with a sampler cartridge and disposal pouch.K1 · K2
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
ISO 13485: quality management system for medical devices
ISO 14971: risk management across both devices
IEC 60601-1: electrical safety, plus -1-2 EMC and -1-11 use in the home
IEC 61010-2-101: safety of IVD equipment (confirm which applies with the test lab)
IEC 62304: medical device software lifecycle
IEC 62366-1: usability engineering with lay users
ISO 10993: biocompatibility of the sampler cartridge's skin contact
Radio: FCC Part 15, RED (EU), UKCA. A pre-certified module saves most of this work
16 CFR 1700 / ISO 8317: child-resistant packaging for canisters and lid
Open decisions
Six choices that change the plan
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.
First market: US, UK or EU?Each has a different regulator, clinical study and timeline, so pick one to go first.
Final v1 panel.The eight markers above are the recommendation. Each marker added is another assay to validate.
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.
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.
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.