The Future of Medical Device Design

Not only is 3-D Printing or additive manufacturing one of the fastest growing industries for commercial manufacturing, but it is also becoming essential to the design and manufacturing of medical devices. Watershed Idea Foundry is fully committed to additive manufacturing and is combining its expertise in both fabrication and design to guide entrepreneurs and manufacturers through this innovative transition.
 
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 Aconity3D’s modular open-sourced laser powder bed machines to focus specifically on titanium 6Al4V additive manufacturing with the development of FDA master access files and a quality management system that will be robust but efficient to the FDA regulations and ISO standards.

Center of Excellence Features

Solidworks CAD

  • Full design capabilities and staff available for Additive Manufacturing CAD services and organic feature creation.

Patient-Specific 3D Models

  • Ability to convert medical scans into 3D renders ready for virtual animations, product design, and additive manufacturing.

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.

Center of Excellence Equipment

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

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

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 and development of unique feature designs and printing methods. Additionally, Watershed can customize Unique Parameter Sets for client specific Unique Specific Requirements and create a full Design History file with Regulatory Clearances.

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.

Examples

6mm OD Orthopedic Device Sleeve

Randomized mesh pattern developed by Watershed for Osteointegration. Image used with permission of Nvision Biomedical Technologies.

CT Scan of Cervical C4 Vertebra

Dual customized mesh patterns and Watershed logo. Optimizations included internal stress concentrations for hatch design, support design and placement, and post processing conditions.

Watershed Marketing Sample Rings

Showcasing medium feature resolution and externally structurally encoding markings for device identification.

Additive Manufacturing in Action