Additive Manufacturing
Additive Manufacturing is increasingly being used in the healthcare industry, and becoming essential to the design and manufacturing of medical devices. We are fully committed to additive manufacturing. We use our expertise in fabrication and design to guide you in the steps necessary to best utilize this transformative technology.
Watershed’s Center of Excellence
Watershed’s Center of Excellence in Carlsbad, California is dedicated to additive manufacturing and design. Through the cutting-edge facility, Watershed provides OEM services to manufacturers and entrepreneurs within its accelerator programs.
The Center houses Renishaw’s RenAM 500Q and Aconity3D’s modular open-sourced laser powder bed machines, focused specifically on Titanium 6Al4V additive manufacturing, streamlined with two FDA Master Access File and a quality management system that is robust yet efficient to be compliant with FDA regulations and ISO Standards.
Working with Watershed
Watershed takes a more personal approach to additive manufacturing projects. Watershed works with clients in a variety of ways, including simple production of parts per typical criteria to the development of unique feature designs and printing methods.
Additionally, Watershed can customize unique parameter sets for specific client requirements and create a full Design History file with Regulatory Clearances.
Design for Additive Manufacturing (DfAM)
Optimizing the design specifically for additive manufacturing is critical for unlocking the full potential of the technology. At Watershed, we control the additive manufacturing process to create a symbiotic relationship with our designs.
Surface textures on specific surfaces, multicomponent assemblies, uniquely latticed bodies, fully printed threads, and many more design features, are all possible with proper DfAM.
Additive Manufacturing of Medical Products (AMMP)
With a vast understanding of FDA and ISO regulations, and a multitude of cleared 510(k)s and submitted FDA Pre-Submissions (with accompanying DHF’s), our Device Master File (MAF)* is ready to expedite technical qualifications, process controls, and even requalification of devices.
*Watershed Titanium Additive Manufacturing Capabilities per ASTM F3001-14, Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
Center of Excellence Features
Solidworks CAD
Full design capabilities for additive manufacturing CAD services, topology optimization, and generative design.
NetFABB Ultimate
One of the most powerful tools for Additive Manufacturing part preparation which includes:
- Multiple Import Capabilities – allowing compatibility with multiple CAD systems.
- Manual Mesh Repair – Allowing real-time repair of any imported structure.
- Labeling – Add 3D text features or our patent protected Structural Encoding features.
- Part hollowing – Define shell features to reduce part weight and streamline costs.
- Complex Lattice – Create lattices within a part or on its surface using any number of standard, random, or client designed lattice features.
- Lattice Optimization – Generate lattices that can withstand the required loading conditions via FEA.
- Manual support creation of multiple types – Customize support interactions for device-specific requirements or secondary operations.
- Deformation prediction and compensation shape exporter – Predict how parts will deform and automatically compensate geometries based on simulation results.
- Heat Treatment Simulation – View stress results before and after annealing parts.
- Distortion and Stress after Removal from Build Plate – Simulate the mechanical response of a part after removal from the build plate.
nTopology
Next generation design & engineering software which allows for:
- Creation of organic lattice structures to promote osseointegration and improve patient outcomes.
- The ability to leverage patient-specific geometries.
- A system approach to repeatability of processes and workflows.
Center of Excellence Equipment
RenAM 500Q
The RenAM 500Q is an ultra high productivity multi-laser AM system from Renishaw. It features four high-powered 500 W lasers to achieve significantly higher build rates and vastly improving productivity while maintaining extreme precision.
The RenAM 500Q features automated powder and waste handling systems to enable consistent process quality, and ensure the highest standards of product quality. The build volume is 250 mm x 250 mm x 350 mm.
AconityMINI
Advanced Powder Bed Laser Printer for custom parameter creation and rapid commercial production:
- Ø 90 mm Heated Build Plate
- 400 W Laser
- Minimum Layer Thickness of 10 micrometers
- Max scan speed of 4 m/s
- Dedicated material, Ti6Al4V
- Residual oxygen context is <100 ppm, but can be set to below <25 ppm
- Fully enclosed high purity argon environment
AconityOne
Advanced Powder Bed Laser Printer for custom parameter creation and higher volume commercial production:
- Ø 400 mm Heated Build Plate
- 1000 W Laser
- Minimum Layer Thickness of 10 micrometers
- Max scan speed of 4 m/s
- Dedicated material, Ti6Al4V
- Residual oxygen context is <100 ppm, but can be set to below <25 ppm
- Fully enclosed high purity argon environment
The unique lattice structures and the micro-and resulting nano-structures, designed by Watershed, have really helped grow the excitement behind our family of implants.
MedTech Company
Co-Founder
Beyond Medical Device Design
Titanium additive manufacturing is a specialized process that has implications across many industries. High-end products that require extensive manufacturing controls are perfect for additive manufacturing and the Watershed Center of Excellence.
In addition to medical, Watershed also offers services in aerospace, energy, automotive, and recreation. Watershed’s Quality System expansion efforts with AS9100 compliance and ITAR approvals are pending further commercial customer requirements.
