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Manufacturing Process

From CT to sterile implant.

Every implant goes through five stages and thirteen quality gates. The full process runs in 5–7 working days (3 days expedited). Every implant is 100% inspected and CT-confirmed against its design STL.

Stage 1 — Clinical Intake

Capturing the patient dataset.

Inputs

  • CT (preferred) — 1 mm slice, DICOM, bone & soft-tissue windows
  • MRI — when CT is contraindicated
  • Defect description and surgical plan
  • Patient demographics and consent

Quality gates

  • Imaging protocol validation
  • Defect region-of-interest confirmation
  • Medical engineer response within 24 hours
  • Secure upload to design platform
Stage 2 — Image & Design

From DICOM to validated design.

Process

  1. Image segmentation — extract cranial anatomy from DICOM
  2. 3D reconstruction — full volumetric patient model
  3. Biomimetic design — patient-specific 1:1 surface reconstruction
  4. Gradient optimisation — load-path-driven porosity distribution
  5. FEA validation — peak von Mises < 440 MPa, micromotion < 50 µm, stress-shielding 0.7–1.3

Quality gates

  • Biomimetic match ≥ 95% against reference library
  • FEA acceptance criteria met
  • Surgeon sign-off via MEI session (screen share or in-person)
  • Design history file updated
Stage 3 — MEI Sign-off

The Medicine-Engineering Interaction.

What happens

One to two days before surgery, our medical engineer sits with the operating surgeon — in person or on screen share — to review the implant shape, the rim fit, the screw positions, and the screw trajectories. Both sign off on the design before manufacture.

The MEI session is the single most important quality gate. It collapses the traditional "try-fit, re-trim, re-try" loop of conventional cranioplasty into a single placement.

Output

  • Signed "Pre-operative Design Confirmation" document
  • Design locked for manufacture
  • Build preparation initiated
Stage 4 — Precision Manufacturing

EBM build, post-process, inspect.

EBM build

  • Vacuum < 1 × 10⁻³ mbar
  • 60 kV beam voltage, 3–30 mA current (function-graded)
  • Layer thickness 50–100 µm (default 70 µm)
  • 700 °C pre-heat (built-in)
  • Oxygen in chamber < 50 ppm
  • Powder reuse limit ≤ 20 cycles

Post-processing chain

  1. Stress relief — 730 °C / 2 h / vacuum
  2. Optional HIP — 900–950 °C / 100 MPa / 4 h / Ar
  3. Wire EDM — part separation from build plate
  4. CNC trimming — drill / tap interfaces
  5. Passivation — ASTM F86 nitric acid
  6. Multi-stage ultrasonic cleaning
  7. 100% CMM dimensional inspection (ISO 10360)
  8. CT conformity check vs. design STL (in-house)
Stage 5 — Sterile Packaging & Logistics

Sealed. Sterile. Shipped.

Packaging

  • Double-pouch in ISO Class 7 cleanroom (ISO 11607-1/-2)
  • Tyvek pouch for EO sterilisation
  • UDI carrier (human- and machine-readable)
  • Product label, IFU, traceability card

Sterilisation & logistics

  • EO sterilisation per ISO 11135 (validated cycle)
  • Validated 5-year shelf life (accelerated aging)
  • DHL / FedEx direct-to-hospital, with temperature & shock monitoring
  • ±10% size backup implant shipped together
  • Lead time 5–7 working days (3 days expedited)
Powder Management

How we keep the powder clean.

Reuse limit

Ti-6Al-4V ELI powder is reused up to 20 cycles. Beyond this, oxygen accumulation and PSD drift degrade mechanical properties.

Testing

After each cycle: sieve to recover PSD, sample for O/N/H content, sample for PSD (laser diffraction). All lots traceable to patient implants (full powder genealogy).

Recycling

Spent powder is recycled through the supplier's certified titanium-scrap loop — not landfilled.