Precision Additive Manufacturingfor Healthcare & Medical Devices

Forge Labs partners with medtech innovators to deliver high-performance prototypes, functional components, and short-run production parts using industrial 3D printing—all under ISO-aligned processes and cleanroom handling capabilities.

2-5 days
Prototype Lead Time
8+
Biocompatible Materials
100%
Quality Inspections
300+
Medical Projects
Healthcare & Medical Devices 3D Printing Solutions

Healthcare & Medical Devices Excellence

Supporting Innovation in Medical Manufacturing

Healthcare moves fast—and medical device innovation demands rapid prototyping, precision engineering, and materials that meet strict performance and biocompatibility criteria. At Forge Labs, we help bridge the gap between concept and production with advanced additive manufacturing solutions tailored for the healthcare sector. From ventilator components and surgical prototypes to diagnostic housings and wearable enclosures, our experience spans early-stage design validation to functional parts that meet rigorous inspection standards.

Transforming Healthcare & Medical Devices Manufacturing

Healthcare moves fast—and medical device innovation demands rapid prototyping, precision engineering, and materials that meet strict performance and biocompatibility criteria. At Forge Labs, we help bridge the gap between concept and production with advanced additive manufacturing solutions tailored for the healthcare sector. From ventilator components and surgical prototypes to diagnostic housings and wearable enclosures, our experience spans early-stage design validation to functional parts that meet rigorous inspection standards.

Key Benefits of 3D Printing in Healthcare & Medical Devices

  • Dramatically compress design and development cycles from weeks to days, accelerating time-to-market for critical medical innovations.
  • Create complex internal geometries optimized for airflow, optical performance, or precise fluid management that are impossible with traditional manufacturing.
  • Access a comprehensive range of functional materials including biocompatible, sterilizable, and regulatory-compliant options for medical applications.
  • Eliminate expensive tooling investments, enabling cost-effective iterative prototyping and economical short-run production.
  • Enable cost-efficient customization and patient-specific solutions without the traditional cost penalties of low-volume manufacturing.
  • Leverage ISO 13485-aligned manufacturing processes with cleanroom handling capabilities for medical device compliance.
Healthcare & Medical Devices Manufacturing Process 1
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Industry Standards & Compliance

Certified for Healthcare & Medical Devices Excellence

Our manufacturing processes and quality systems meet the most stringent healthcare & medical devices industry standards, ensuring your parts are ready for critical applications.

ISO-Aligned Quality Processes

All medical parts manufactured under rigorous quality inspection aligned with ISO 9001 and ISO 13485 principles with controlled protocols.

Biocompatible Materials

USP Class VI certified materials with comprehensive biocompatibility testing and documentation for medical device applications.

Cleanroom Handling Capability

Controlled environment processing available for critical medical applications requiring contamination-free manufacturing and handling.

Material Traceability & Documentation

Complete dimensional inspection reports, material certifications, and batch traceability documentation provided upon request.

Manufacturing Capabilities

Advanced Healthcare & Medical Devices Solutions

From precision prototyping to full-scale production, our comprehensive capabilities deliver results that transform healthcare & medical devices manufacturing.

Stereolithography (SLA) with USP Class VI biocompatible resins accelerates medical device development with functional prototypes suitable for clinical evaluation and human factors testing. Tolerances as tight as ±0.2mm support precise fit requirements for surgical instruments and patient interfaces. High-definition surface finish eliminates post-processing for visualization studies, while multiple biocompatible material options enable testing across device applications. Digital design iteration reduces development timelines from months to days, supporting rapid innovation cycles critical in medical device development.

Medical Device Prototyping

Technical Specifications

SLA Tolerances: ±0.2mm achievable
Biocompatible: USP Class VI resins
Turnaround: 24-48 hours
Surface Finish: High-definition
Clinical Testing: Human factors ready
Materials: 10+ medical grades

Accura ClearVue and specialized optical resins provide exceptional transparency and dimensional stability for diagnostic equipment housings, light guides, and optical assemblies. Materials achieve >95% light transmission while maintaining biocompatibility for patient-contact applications. Precision manufacturing ensures critical optical alignment features maintain tolerances throughout sterilization cycles. Custom geometries optimize light path efficiency and minimize optical losses in portable diagnostic devices. Post-processing options include optical polishing and anti-reflective coatings for enhanced performance.

Diagnostic & Imaging Equipment Components

Technical Specifications

Light Transmission: >95%
Biocompatible: USP Class VI
Tolerances: ±0.2mm optical features
Sterilization: Cycle stable
Surface Quality: Optical grade
Custom Geometries: Complex possible

Selective laser sintering (SLS) with medical-grade PA12 nylon produces complex respiratory components with smooth internal airflow channels and precise dimensional control. Material properties include chemical resistance to disinfectants, steam sterilization compatibility, and excellent fatigue resistance for cyclic pressure applications. Internal channel geometries optimize laminar airflow while minimizing pressure drops across manifolds and valve assemblies. No support structures required enables complex geometries including integrated filters, flow sensors, and pressure relief features impossible with traditional manufacturing.

Respiratory & Ventilator Components

Technical Specifications

Channel Tolerance: ±0.25mm
Material: Medical PA12 SLS
Sterilization: Steam compatible
Pressure Rating: 50+ PSI
Fatigue Life: 1M+ cycles
Surface Finish: Ra 6-10 μm

Flexible TPU materials and lightweight nylon enable patient-specific wearable device prototypes with anatomical conformance and comfort optimization. Flexible shore hardness options (70A-95A) accommodate varying compression requirements for monitoring devices, therapeutic equipment, and prosthetic interfaces. Design iteration supports anthropometric optimization across patient populations while maintaining consistent performance characteristics. Biocompatible formulations ensure skin compatibility for extended wear applications in research and clinical validation studies.

Patient-Specific & Wearable Devices

Technical Specifications

Shore Hardness: 70A-95A TPU
Biocompatible: Skin contact safe
Weight: 40-60% lighter than silicone
Flex Cycles: 100K+ without failure
Custom Fit: Patient-specific CAD
Compression: Variable zones

ISO 13485 quality management systems support cleanroom manufacturing for medical device pilot production and clinical trial components. Environmental controls maintain Class 10,000 (ISO 7) cleanliness standards with documented contamination control procedures. Material handling protocols ensure lot traceability from raw powder through final packaging with comprehensive documentation packages. Statistical process control monitoring validates dimensional consistency across production batches while maintaining full chain of custody for regulatory compliance. Cleanroom protocols accommodate volumes from 10 to 10,000+ parts with scalable quality assurance.

Cleanroom Pre-Production Runs

Technical Specifications

Cleanroom Class: ISO 7 (10,000)
Quality System: ISO 13485
Lot Traceability: Raw to finished
Production Volumes: 10-10,000+ parts
Documentation: Complete packages
Statistical Control: Validated

High-precision surgical guides and clinical instrumentation manufactured with dimensional accuracies suitable for patient-specific surgical planning and training applications. ULTEM and biocompatible materials withstand repeated sterilization cycles while maintaining dimensional stability and surface quality. Custom patient-specific geometries enable precise surgical placement of implants, optimize access angles, and reduce procedure time. Training models provide realistic tactile feedback with appropriate material properties for skill development and procedural validation in medical education programs.

Surgical & Clinical Tools

Technical Specifications

Dimensional Accuracy: ±0.2mm
Materials: ULTEM, biocompatible
Sterilization: Multiple cycle stable
Patient-Specific: CT/MRI derived
Training Models: Realistic feel
Regulatory: FDA guidance compliant

Manufacturing Technologies

Proven Technologies for Healthcare & Medical Devices

Each technology offers unique advantages for healthcare & medical devices applications. Choose the right process for your specific requirements.

Not sure which technology is right for your project?

Our application engineers can help you select the optimal manufacturing process based on your specific requirements, materials, and timeline.

Success Stories

Real results from our healthcare & medical devices partnerships

Ventilator Component Development

Rapid prototyping and production of critical ventilator manifold components during global health crisis. Delivered functional parts with smooth internal airflow channels and biocompatible materials, enabling accelerated device deployment and patient care.

72-hour prototype to production
Biocompatible material compliance
Smooth internal airflow channels
Emergency deployment ready
Read Full Case Study
Ventilator Component Development

Diagnostic Equipment Housing

Custom optical housing for portable diagnostic device featuring integrated light guides and precise optical alignment features. Achieved optical clarity requirements while maintaining impact resistance for field use applications.

Optical clarity achieved
Impact resistance maintained
Precise alignment features
Field-use durability proven
Read Full Case Study
Diagnostic Equipment Housing

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6
Industrial 3D Print Technologies
50+
Plastics, Resins & Metals