Implants, surgical instruments, capital-equipment housings, disposables, and high-reliability electronics for medical-device platforms. From a single clinical build to validated production lots — built to your biocompatibility, sterilization, and regulatory envelope.
Medical devices fail differently from every other product category. Biocompatibility, sterilization compatibility, and regulatory traceability compound — and the parts that ship are the ones designed against all three from CAD onwards, not retrofitted to certification.
ISO 10993 isn’t a downstream qualification — it’s a material-selection problem you solve in CAD. We work from ASTM F136 ELI-grade titanium, ISO 5832-3 / -6 stainless, USP Class VI polymers from day one.
Autoclave kills POM. Gamma kills PP. EtO leaves residue. We design the housing, the seal, and the bonding stack against the actual sterilization cycle you’ll use — not against the spec sheet.
21 CFR 820, ISO 13485, MDR — each demands per-lot heat traceability, cleanroom passport, and a DHF that closes. We build the BoM into the audit pack, not into the apology email.
A modern medical-device bill of materials pulls from titanium machining, polymer IM, cleanroom PCBA, sheet metal, and biocompatible surface prep. Every part below ships from a single FabDigit cell against a single drawing pack and a single DHF.
Ti-6Al-4V ELI, Co-Cr-Mo, and 316L stainless implants and instruments. Bead-blast, passivation, and electropolish surface prep in the same cell.
Learn more USP Class VI · single-useUSP Class VI polycarbonate, PEEK, PSU, PEI molding for disposables, capital-equipment housings, fluid-path cassettes. Cleanroom-rated moulding bays.
Learn more Cart bodies · traysStainless and aluminum carts, autoclave trays, capital-equipment chassis. Passivation and electropolish on stainless; brushed or powder-coat finish.
Learn more Patient-matched · lattice cagesSLM Ti-6Al-4V ELI for porous spinal cages, dental abutments, and patient-matched cutting guides. HIP-treated where the fatigue spec demands it.
Learn more Capital equipment · disposablesIEC 60601-compliant 4 – 12 layer PCBs, conformal-coated, X-ray on every BGA. ENIG / hard-gold for fluid-adjacent boards.
Learn more DHF · DFM · sterilizationEmbedded ME / RA engineer on DHF closure, DFMEA, sterilization-method selection, and 510(k) hardware substantial-equivalence work. We can co-locate.
Learn moreWorking ranges across recent medical-device programs. Coatings row carries the moat: cleanroom passivation, electropolish, and PVD lines restricted on US/EU sites that our partner plants still run.
Composite of recent surgical-handpiece programs — high-RPM brushless drive, sealed for autoclave, sterilizable between procedures. Each callout is where engineering trade-offs actually live.
Custom 60 k RPM brushless motor, sealed-bearing both ends. Insulation system rated for 134 °C steam autoclave; encoder PCB inside the housing.
Hardened-steel planetary set with food-grade autoclave-safe grease pre-filled. Triple-lip dynamic seals; bore concentricity 0.005 mm.
Surgeon-actuated quick-connect for swap of drill bits, burrs, and saw blades. Stainless 17-4 PH, electropolished, passivated.
CNC titanium housing, bead-blasted to surgical-matte. IPX7-class sealed; ergonomic grip profile fluid-honed.
6-layer FOC motor controller, IEC 60601-compliant trace spacing, conformal-coated, hot-side designed for ≥1,000 autoclave cycles.
USP Class VI silicone-jacketed cable with autoclave-safe sealed over-mould. Custom pin-out, surgical-grade strain reliefs.
These six archetypes make up the majority of the spend on a typical medical-device program. Spec ranges below are working envelopes — your drawing tightens them.
Orthopaedic / spinal / dental titanium implants. Bead-blast or PEEK + HAp combinations available. SLM porous-lattice cages on request.
Articulating, single-action, and powered surgical instruments. 17-4 PH stainless, electropolish + passivation.
Imaging carts, infusion-pump bodies, anaesthesia front panels. Sheet aluminum or injection-moulded PSU / PEI.
Single-use fluid-path cassettes, IV-set valves, dialysis cartridges. USP Class VI PC + medical PVC + silicone over-mould.
4 – 12 layer PCBs to IEC 60601-1 isolation + creepage. Hard-gold on fluid-adjacent contacts, conformal-coated as standard.
Single-use packs — swabs, applicators, vials, syringes. USP Class VI materials, ISO 11137 / ISO 11135 sterilisation-compatible packaging.
Click any cell to see whether that sterilisation method survives that material — and what FabDigit builds at the intersection. We don’t ship parts into combinations that would fail re-sterilise; the cells marked FAIL are there to tell you the substitution we’d recommend.
Industry-typical ranges from recent engagements. Specific commitments land in your quote.
SLM Ti wins on small clinical lots because tooling cost is irrelevant. As volume ramps, conventional 5-axis CNC catches up. Investment cast is only competitive past ~ 2,000 pcs.
Three candidate implant materials. Ti-6Al-4V wins on biocompatibility + corrosion; Co-Cr-Mo wins on wear surfaces; PEEK wins on radiolucency + bone CTE match.
Freeze-to-clinical-lot for a porous Ti spinal cage. Sterilization validation runs in parallel with the cell, not behind it.
A medical program lives or dies on the DHF closing on time. The six phases below are how we keep one moving without leaving any DHF entry open at audit.
Drawings, STEP, intended-use statement land in our portal. A ME + materials engineer review them within 48 hours, flagging biocompatibility, sterilization compatibility, and tolerance choices.
First engineering units within 18 – 42 days. DHF skeleton — drawings, BoM, supplier qualification — opened on day one of the program.
10 – 300 unit clinical lot, parallel sterilization validation with your steriliser-of-record. ISO 11135 / 11137 / 17665 — we support the coupon ladder.
Surgeon feedback flows through engineering as ECNs. Substantial-equivalence comparators built into the package for 510(k); MDR/ IVDR support for EU programs.
1,000 – 10,000 units / wk inside a validated cell. Cleanroom passport per lot, traceability per heat, capability study held per quarter.
Field returns route into the CAPA pipeline. No silent ECNs — change orders are graded, validated, and shipped on plan.
Dedicated ISO 7 cleanroom-adjacent CNC cell for titanium implant work. Carbide tooling life-managed per material, climate-controlled to ±0.5 °C, and a particle count run on every shift coupon.
A composite of recent programs, anonymised to protect customer IP. Numbers are real ranges from the engagements they’re drawn from.
The customer was developing an SLM porous-titanium spinal cage with a 510(k) substantial-equivalence path. The prior vendor stack split SLM + HIP + finish-machine + sterilization across four suppliers; sterilization validation kept failing on residual particulates.
We brought SLM, HIP, finish-CNC, and surface prep into a single cell. Engineering closed the surface-prep loop in the DFM call — vapour-honed + ultrasonic-bath + passivated, audited by particle count per lot.
Clinical lot shipped on day 28. Sterilization validation passed on first cycle. 510(k) submission was made at month 7; clearance at month 11 — about three months ahead of the customer’s aggressive plan.
Environmental + OSHA rulings since 2018 have closed dozens of US-side passivation and PVD lines. Our partner plants still run them. The short list below shows up most on medical-device drawings.
Hex-Cr passivation still spec'd by some legacy implant standards on 316L and 17-4 PH stainless. Closed-loop bay, per-lot ICP audit.
Hydroxyapatite plasma-spray on titanium spinal cages, dental implants, hip stems. Strict EU MDR notified-body audit chain.
Closed-loop electropolish on stainless instruments and titanium implants. Ra ≤ 0.1 µm; particle count per lot.
PVD hard coatings on cutting edges, drill bits, burrs. Drop-in for hardened-steel inserts where geometry forbids them.
DLC on articulating instrument joints — 60+ Rockwell C with low friction, biocompatible.
Selective 24 k gold plating on biopotential electrodes and sensor contacts. Closed-loop cyanide-bath process.
ISO 13485 is held by the partner cells we deploy through; 21 CFR 820 readiness audited per program. We can ship DHF-grade traceability with the parts, and support your supplier-audit calendar.
Yes. Engineering build → clinical lot → sterilization validation → DHF closure all live in one program. We support comparator benchmark testing for substantial-equivalence packs.
Yes — SLM Ti-6Al-4V ELI with HIP is one of our highest-volume medical processes. Porous lattices to 60 – 75 % open volume, surgically-prepped surface roughness.
Resin material certs are pulled per heat lot; we run a parallel biocompatibility coupon per lot if your DHF demands it. PEEK, PSU, PEI, PC, silicone all from validated suppliers.
Cleanroom assembly + double-pouching in ISO 7 (cleanroom passport per lot). Sterilization through partner ISO 11137 (gamma) and ISO 11135 (EtO) houses; full ISO 17665 (steam) inside our partner cells.
For programs over $500 k, yes — embedded ME / RA engineer for the duration of clinical trial. Two customers currently on this model as of 2026.
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Send drawings, or send an intended-use statement + sterilisation envelope. Either way you’ll have an ME reviewing within 48 hours and a real quote on a real schedule shortly after.
