Medical Device 3D Printing from Prototypes to Production Parts

Industrial 3D printing for medical device prototypes, verification builds and production parts, with 100% inspection and cleanroom post-processing and packaging.

  • Biocompatible resins, nylons and thermoplastics with supplier test data.
  • Quality systems built around your supplier audits and requirements.
  • Repeat production lots without investing in mould tooling.
Medical Device Manufacturing 3D Printing Solutions
Medical Device Manufacturing Overview

From verification builds to production lots

Medical device teams need parts long before mould tooling makes sense, and often long after: verification builds, human-factors models, assembly and test fixtures, and housings reordered lot after lot. We produce handheld device casings and handle shells, fluidic manifolds and tube fittings, small mechanism parts, clear lab and cell-culture components, diagnostic housings, wearable enclosures, surgical guides, and airflow parts for ventilator and respiratory devices, using SLA, SLS, MJF, FDM and metal printing. Every medical part is inspected, post-processing and packaging take place in our cleanroom, and medical device customers regularly audit our processes. We build our systems around what they require.

Where additive creates leverage

Geometry that moulding and machining cannot reach

Forge Labs helps teams move from design validation to production-ready parts without waiting on tooling lead times. Consolidated assemblies, lighter parts, and faster revisions give engineering teams more control over schedule, cost, and performance.

Key manufacturing benefits

  • Revise designs between verification builds without waiting on tooling changes.
  • Build internal channels for airflow, optics and fluid paths that moulding and machining cannot reach.
  • Choose materials with supplier biocompatibility data and sterilization guidance for your application.
  • Move from prototypes to pilot and repeat production lots without mould tooling.
  • Make patient-specific and size-variant parts without custom tooling cost.
  • Get 100% inspection, cleanroom post-processing and packaging, and inspection reports and material certifications on request.
Medical Device Manufacturing Manufacturing Process 1
Medical Device Manufacturing Manufacturing Process 2
Medical Device Manufacturing Manufacturing Process 3
Medical Device Manufacturing Manufacturing Process 4
Quality and compliance

Traceable manufacturing for regulated medical hardware

Medical device work depends on controlled material selection, documented inspection and traceable handling, from verification builds to production lots.

ISO 9001-aligned quality processes
Every medical part is inspected under controlled protocols aligned with ISO 9001, with statistical process control across production batches.
Built around customer audits
Medical device customers audit our processes, and we build our systems and chain-of-custody records around their requirements.
Biocompatible materials
Resins, nylons and thermoplastics with USP Class VI or ISO 10993 material data and documentation.
Cleanroom post-processing and packaging
Parts are cleaned, finished and packaged in our cleanroom for applications that need controlled handling.
Traceability and documentation
Lot records run from raw material to packaging. Dimensional inspection reports and material certifications are provided on request.
Ordering and repeat lots
Attach drawings with tolerance callouts, add first article inspection or production sampling, and reorder lots from your order history.
Manufacturing Capabilities

3D Printed Medical Device Components

The medical parts we make most often, with the processes, materials and material data behind each.

Medical Device Prototyping
Medical Device Prototyping

Verification and human factors

Medical Device Prototyping

SLA builds functional prototypes for clinical evaluation, human-factors testing and design verification, including parts in BioMed resins and ClearVue processed to the USP Class VI cleaning protocol. The high-definition surface is ready for visual review as printed, and digital revisions shorten development from months to days.

Typical parts
Human-factors models, instrument handles, verification builds
Key properties
±0.25% (min ±0.25 mm); over 10 in ±0.4% (min ±0.5 mm)
Material data
BioMed Clear, BioMed Black, ClearVue USP Class VI
Diagnostic & Imaging Equipment Components
Diagnostic & Imaging Equipment Components

Optics and diagnostics

Diagnostic & Imaging Equipment Components

Accura ClearVue and BioMed Clear produce diagnostic housings, light guides, windows and optical assemblies with high clarity and dimensional stability. Custom geometry shapes the light path to reduce optical losses in portable devices, and optical polishing and anti-reflective coatings are available.

Typical parts
Diagnostic housings, light guides, windows, optical assemblies
Key properties
87.2% light transmission (ClearVue); ±0.25 mm optical features
Material data
ClearVue USP Class VI; BioMed Clear USP Class VI and ISO 10993, steam, EtO, gamma and e-beam
Respiratory & Ventilator Components
Respiratory & Ventilator Components

Airflow and fluid path

Respiratory & Ventilator Components

SLS and MJF PA12 build respiratory manifolds, valve bodies and airflow parts for ventilator and respiratory devices. With no support structures, internal channels can be shaped for laminar flow and low pressure drop, and filters, sensor mounts and pressure-relief features can be built into one part.

Typical parts
Manifolds, valve bodies, airflow channels, tube fittings
Key properties
±0.3% (min ±0.3 mm); Ra 6–10 μm as printed
Material data
HP PA12 USP Class I–VI and ISO 10993; PA12 resists disinfectants and is steam compatible
Patient-Specific & Wearable Devices
Patient-Specific & Wearable Devices

Wearables and patient interfaces

Patient-Specific & Wearable Devices

TPU and nylon produce patient-specific wearables that conform to anatomy for monitoring devices, therapeutic equipment and prosthetic interfaces. Printed TPU from 88A to 95A covers firm to flexible zones, PolyJet Agilus30 handles softer parts, and fast iteration supports sizing across patient populations.

Typical parts
Wearable enclosures, straps, seals, prosthetic interfaces
Key properties
Shore 88A–95A TPU; no cut growth after 100,000 flex cycles (TPU 88A)
Material data
TPU 90A ISO 10993, skin contact over 30 days; TPU 88A ISO 10993-5/-10, OECD 439
Production Housings & Enclosures
Production Housings & Enclosures

Pilot and production lots

Production Housings & Enclosures

MJF, SLS and SLA produce device casings, handle shells, lids and enclosures in pilot and repeat production lots, without mould tooling. Verification builds, clinical-trial components and production lots run through the same inspection and traceability process, and repeat lots are reordered from your order history.

Typical parts
Device casings, handle shells, lids, enclosures
Key properties
Single parts to repeat production lots; 100% inspection
Material data
HP PA12 USP Class I–VI and ISO 10993-5/-10/-11
Surgical & Clinical Tools
Surgical & Clinical Tools

Surgical and clinical

Surgical & Clinical Tools

Patient-specific surgical guides, clinical instrument components and training models are made from CT- or MRI-derived geometry with the accuracy surgical planning needs. ULTEM 1010 and BioMed Clear withstand steam sterilization, DMLS 316L and titanium serve metal instrument components, and training models give realistic tactile feedback.

Typical parts
Surgical guides for implant placement planning, instrument components, training models
Key properties
±0.25 mm (SLA); CT/MRI-derived geometry
Material data
BioMed Clear and ULTEM 1010: USP Class VI and ISO 10993, steam sterilizable
Case Studies

Medical Device Manufacturing Outcomes

Real fluid components, valve hardware and device housings show how material choice, assembly features and inspection shape medical parts manufacturing.

3D Printed Medical Fluid Components: Clear Passages and Nylon Valve Parts

Case study

3D Printed Medical Fluid Components: Clear Passages and Nylon Valve Parts

Clear SLA fluid bodies and separate SLS nylon valve hardware, manufactured in batches of dozens. Passage access, printed threads and drawing-defined inspection connect the part geometry to its cleaning, assembly and finishing requirements.

Key outcomes

  • ClearVue fluid bodies and PA12 valve hardware
  • Specified cleaning and material traceability
  • Passage and mating-feature inspection
  • Nylon batch dispatched in six working days
Read the fluid components case study
3D Printed Medical Device Handles and Housings: Making the Fit Work

Case study

3D Printed Medical Device Handles and Housings: Making the Fit Work

SLA handle shells and separate SLS nylon casings bring grip, assembly fit and retaining features into physical evaluation parts. A trial pair helped check delicate nylon clips before the rest of a small production batch was printed.

Key outcomes

  • Smooth SLA handles and mechanism components
  • Nylon casings in batches of dozens
  • Initial pair printed before the balance
  • Nylon batch shipped in about one working week
Read the handles and housings case study
Manufacturing Technologies

3D Printing Technologies for Medical Device Manufacturing

Evaluate each process by geometry freedom, material options, and throughput so you can pick the right path from prototype to production.

Not sure which process fits? Our application engineers map your requirements to the right technology, material and finishing workflow before you commit to a build.

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Ready to Manufacture Your Medical Device Parts?

Upload your CAD files for an instant quote or speak with our application engineers about your specific requirements.

  • Instant pricing with automated manufacturability analysis
  • Production workflows built for repeatable quality
  • Engineering support from prototype to production
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STEP, STL, OBJ, 3MF and IGES supported

Manufacturing technologies
6
Engineering materials
50+
Part quantities
1-500+