Medical Device Prototyping & CNC Machining
Precision-machined surgical instruments, diagnostic housings, drug delivery components, and implant fixtures — ISO 13485 quality management, full material traceability, biocompatible material expertise.
Your design verification testing is scheduled in four weeks — and the surgical instrument handle you need requires PEEK with Ra ≤ 0.4 µm on all patient-contact surfaces, documented material traceability back to the resin lot, and a CMM inspection report your quality team can attach to the DHF. The machining vendor you select determines whether that DVT timeline holds or slips, and whether the dimensional data is rigorous enough for your 510(k) submission.
KUSLA Prototype machines medical device components from concept models through pilot production — surgical instruments, diagnostic equipment housings, drug delivery mechanism parts, and wearable device enclosures. Every medical project runs under ISO 13485-certified processes with incoming material verification, in-process inspection, and full lot traceability documentation.
Medical Device Components We Machine
KUSLA machines components across FDA Class I and Class II device categories, spanning surgical, diagnostic, drug delivery, and wearable health monitoring applications.
We machined a batch of PEEK surgical instrument handles for a DVT build — 12 units, each requiring Ra ≤ 0.4 µm on the grip surface and ±0.015 mm on the instrument coupling bore. PEEK machines well but generates heat fast — we ran at 200 m/min with diamond-coated end mills and 0.05 mm/tooth feed to keep the surface temperature below the glass transition point at 143°C. The tricky part was the internal fluid channel: 2.5 mm diameter, 65 mm deep, requiring chip evacuation without coolant contamination of the bore surface. We used peck drilling with 0.8 mm retract intervals and air blast instead of flood coolant. All 12 handles passed CMM inspection and the customer attached our dimensional report directly to their 510(k) submission.
Not sure which biocompatible material fits your device classification? Send your drawing for a free material and sterilization compatibility recommendation.
Get Material RecommendationBiocompatible & Medical-Grade Materials
Material selection for medical devices balances mechanical performance, sterilization compatibility, and regulatory requirements. KUSLA stocks and machines materials meeting ISO 10993 biocompatibility and USP Class VI classification.
Medical Device Categories KUSLA Supports
Surgical Instruments
Handles, retractors, cutting guides, rongeurs, and alignment jigs for minimally invasive and open surgery.
Diagnostic Equipment
Enclosures, control panels, fluid channels, and sensor housings for imaging, IVD, and point-of-care devices.
Drug Delivery Devices
Pen injector housings, inhaler bodies, pump casings, and metering mechanisms for precise dosing.
Wearable Health Monitors
Sensor housings, charging cradles, skin-contact interfaces, and snap-fit enclosures for continuous monitoring.
Orthopedic Fixtures
Drill guides, alignment jigs, bone plate fixtures, and external fixation components for surgical planning.
Lab & Clinical Equipment
Sample trays, centrifuge rotors, sterilization racks, reagent handling parts for clinical and research labs.
Manufacturing Processes for Medical Prototypes
CNC Machining
Functional prototypes, surgical instruments, enclosures. Metals, PEEK, PC, POM, Ultem. Tolerances to ±0.01 mm. Parts in 5–10 days.
3D Printing
Concept models, complex geometries, patient-specific guides. SLA resin, SLS nylon, metal DMLS. Parts in 24–72 hours.
Injection Molding
EVT/DVT parts, pilot production. Cleanroom environments. PP, PC, ABS, LSR silicone. Tooling in 2–4 weeks.
Urethane Casting
Low-volume housings, overmolded grips, cosmetic covers. Production-grade PU resins. 10–100 units in 7–12 days.
Sheet Metal
Equipment brackets, EMI shields, chassis enclosures. SS 304/316L, aluminum. Laser cut + CNC bent.
Pilot Production
50–5,000 unit bridge runs. Production-grade quality with full lot traceability and FAI documentation.
Frequently Asked Questions
KUSLA holds ISO 9001:2015 and ISO 13485 certifications. Medical injection molding is performed in cleanroom environments. Full material traceability, incoming inspection, CMM dimensional reporting, and first-article inspection (FAI) documentation are standard with every medical order.
Yes. KUSLA routinely machines PEEK (Victrex 450G and Invibio PEEK-OPTIMA for implant-grade applications) and Ti-6Al-4V (Grade 5) for surgical instrument prototypes. PEEK is machined with diamond-coated tools at controlled temperatures to prevent degradation. Titanium is machined on 5-axis centers with TiAlN-coated carbide tooling and high-pressure coolant.
Standard CNC finish is Ra 0.8–1.6 µm. For patient-contact surfaces, KUSLA achieves Ra ≤ 0.4 µm through fine-pass machining and polishing. Mirror polish (Ra ≤ 0.1 µm) is available for stainless steel surgical instruments. Electropolishing is available for 316L components requiring both low Ra and improved corrosion resistance.
KUSLA provides dimensional inspection reports (CMM data with GD&T verification), material certifications (mill certs, CoC, CoA), process documentation, and FAI reports in formats compatible with most quality management systems. Customers routinely attach KUSLA inspection data to their DHF and 510(k) submissions.
Mutual NDAs are signed before any design files are received. All project data is stored on access-controlled servers, and engineering teams are assigned on a need-to-know basis. KUSLA does not share customer designs, specifications, or project details with any third party.