01
Design Flexibility & Optimization
Eliminate geometric constraints traditional machining imposes. Create complex internal structures, optimized porous surfaces, and lightweight organic shapes customized for clinical efficacy.
Precision CDMO Capabilities
Additive Manufacturing
Partner with Paragon Medical’s specialized 3D printing engineering team to transform your go-to-market strategy with FDA-compliant, high-precision medical solutions.
Accelerate Commercialization
End-to-End Medical Device Additive Manufacturing & 3D Printing
Transforming complex OEM concepts into commercial reality requires high-precision technology and deep regulatory compliance. Paragon Medical provides a fully integrated additive manufacturing platform—combining advanced metal 3D printing, secondary machining, metallurgical testing, and in-house post-processing. Our technical teams streamline global supply chains, lower total cost of ownership, and ensure seamless scalability for complex implants and specialized surgical components.
Key Benefits of Medical-Grade Additive Manufacturing
02
Rapid Prototyping to Full Scale
Compress developmental lead times by moving seamlessly from rapid functional prototyping to high-volume commercial production under a single validated ISO 13485 quality system.
03
Process Step Streamlining
Consolidate multi-part assemblies into single-piece additive designs, reducing sub-assembly risk, stack-up tolerances, inspection steps, and overall supply chain management complexity.
04
Accelerated Time-to-Market
Shorten total manufacturing lead times with integrated secondary solutions, on-site metrology, and streamlined regulatory documentation for FDA 510(k) and MDR submissions.
05
Complex Metal Part Production
Utilize Direct Metal Laser Sintering (DMLS) and Electron Beam Melting (EBM) in medical-grade Titanium (Ti-6Al-4V ELI) and Cobalt-Chrome for superior mechanical integrity.
06
Patient-Specific Solutions
Scale patient-matched implant production and patient-specific surgical guides efficiently, delivering consistent quality and reliable repeatability for targeted clinical outcomes.
Manufacturing Infrastructure
Dedicated Facilities & Proprietary Technologies
Our purpose-built additive manufacturing infrastructure offers global OEMs the technical depth and operational security needed for mission-critical medical applications.
Dedicated 3D Printing Facility
Our specialized manufacturing facility is fully optimized for regulated medical device production with complete environmental controls.
- 34,000 Sq. Ft. state-of-the-art facility in Pierceton, Indiana
- On-site Hot Isostatic Pressing (HIP) and advanced metrology
- Automated powder recovery and validated cleaning lines
- Complete traceability from raw powder to finished sterile packaging
PARAFUZE™ 3D Lattice Technology
Expedite your commercialization timelines with Paragon Medical’s proprietary PARAFUZE™ 3D printed lattice structure.
- Engineered for optimal bio-mimetic pore size and distribution
- Enhances osseointegration and long-term mechanical stability
- Pre-characterized structural profiles to accelerate regulatory approval
- Ideal for spinal interbody fusion and orthopedic reconstructive implants
Accelerating Your Ideas
Leverage our dedicated design for additive manufacturing (DfAM) engineering teams from early concept through validation.
- Dedicated Orthopedic Innovation Center for rapid iteration
- Strategic partnership with 3D Systems for cutting-edge technology
- Comprehensive verification & validation (V&V) support
- Regulatory documentation package development for fast filing
Integrated Post-Processing
In-House Hot Isostatic Pressing (HIP) Capabilities
Eliminate external vendor hand-offs and reduce supply chain lead times. Paragon Medical offers fully integrated, in-house Hot Isostatic Pressing (HIP) as a core pillar of our additive manufacturing platform.
By applying simultaneous high heat and isostatic gas pressure, our HIP processing densifies metal additive components, eliminates internal micro-voids, enhances fatigue strength, and ensures compliance with rigorous ASTM and ISO metallurgical standards for implantable devices.
Collaborative Engineering
Orthopedic Innovation Center & Prototyping
Speed to market is essential in competitive MedTech sectors. Our Orthopedic Innovation Center provides global OEMs direct access to experienced biomedical engineers, advanced DfAM software, and dedicated rapid prototyping equipment.
We work collaboratively alongside your R&D teams to refine device geometry, evaluate porous structures, perform initial biomechanical assessments, and finalize production intent designs in weeks instead of months.
Uncompromised Quality
ISO 13485 & FDA-Registered Additive Quality Management
Quality and reliability form the foundation of everything we build. Paragon Medical operates under stringent global quality management systems tailored specifically for implantable products and critical surgical tools.
ISO 13485 Certified
Our quality management systems are certified to ISO 13485 standards, ensuring full compliance throughout the device lifecycle.
FDA Registered Facilities
Our primary manufacturing sites maintain active FDA registration and strictly adhere to 21 CFR Part 820 Quality System Regulations.
Powder Traceability
Rigorous powder chemistry controls, particle size analysis, and reuse limits ensure consistent mechanical properties across build cycles.