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  1. CDRH Research Programs

Additive Manufacturing of Medical Products

Contact

LT James Coburn, MSc

Summary

Medical device companies have begun adopting additive manufacturing, also known as 3D printing, to create devices that were previously impossible to make, personalized to the patient, or both. 3D printing can create many types of medical devices from metals, plastics, hydrogels, and even biological materials. Unlike conventional manufacturing, which starts with a solid block of material that is cut and shaped (i.e., subtractive), 3D printing only places material where it is needed (i.e., additive). Most systems do this by dividing or slicing a digital design file into 2D layers, then building each layer iteratively from raw material, joining them to the layer below. 3D printing enables the creation of personalized medical devices and devices with intricate design, pushing innovation and introducing key differences from other techniques that require new quality control processes and metrics to be developed.

The Additive Manufacturing of Medical Products (AMMP) at the FDA uses state-of-the-art additive manufacturing equipment and research methods to answer questions about how the new features of this manufacturing method affect patient outcomes as well as device safety and effectiveness. It is also exploring additive manufacturing as a tool to create more realistic calibration tests for medical diagnostic devices.

We are exploring the safety and performance of 3D-printed medical devices and 3D-printed calibration assessment tools through multiple approaches:

  1. Methods to assess the cleaning of 3D printed devices: New complex structures make it more difficult to clean and assess the cleaning of 3D printed devices.
  2. 3D printing to evaluate optical imaging diagnostics: The ability to create biologically accurate shapes has opened new avenues for the assessment and calibration of optical and radiographic imaging technologies
  3. Outcome measures for patient-specific instrumentation: Patient-matching brings personalized medicine to medical devices. Patient specific cutting guides may help some people obtain better results, but may hinder good results in complex cases. New metrics are being developed to assess the trade-off.

Resources

The AMMP Lab is a core facility of shared resource that allows researchers from many areas to use the equipment and collaborate with each other to broaden the research potential within the FDA. With funding support from the FDA Office of the Chief Scientist and the FDA Critical Path Initiative, AMMP Lab researchers study the quality control processes and measurement techniques used to ensure 3D printed devices are produced consistently and performance-measured accurately. Continued investment in regulatory science projects involving such disruptive medical device technologies lays the framework for more rapid, science-based regulatory device review at the FDA. Similarly, the involvement of regulatory scientists in the research as well as the regulatory review processes can increase transparency and bi-directional communication between scientific and regulatory stakeholders internally and externally.

 

Image of a model skull with 3D-printed plate

A sample device that would be used to replace a portion of a patient's skull after trauma.


Images of how an anatomic picture is turned into a 3D-printed test piece

Images of how an anatomic picture is turned into a 3D-printed test piece, then imaged again for accuracy. Viewing from left to right – 1) image of the retina is taken, 2) image is cleaned to show only the blood vessels, 3) the part is 3D printed and filled with a blood-like solution, then 4) it is imaged through hyperspectral imaging.


Example of a patient matched cutting guide.

Example of a patient matched cutting guide used during research, showing a 3D printed bone with a cutting jig placed on top (note that the cutting surface is marked with a dark line).

Current funding sources

Office of the Chief Scientist
FDA Critical Path Initiative

Personnel

FDA Staff:
LT James Coburn
Matthew Di Prima, Ph.D.
Irada Isayeva, Ph.D.
Joshua Pfefer, Ph.D.
Katherine Vorvolakos, Ph.D.
Daniel Porter, Ph.D.

Research Fellows:
Gonzalo Mendoza, M.Sc.
Magdalene Fogarasi, M.Sc.

External collaborators

Walter Reed National Military Medical Center
University of Maryland disclaimer icon

Resource Facilities

3D-Printers
  • Objet 260 Connex 3: multi-jetted polymer printer
    • 3D-prints three simultaneous materials
    • Variable hardnesses
  • EOS P396: Selective Laser Sintering (SLS)
    • White nylon 12
    • Good impact and high fatigue resistance material
  • Form 2 and 1+: laser-based stereolithography (SLA)
    • Methacrylate-based photocuring polymers
    • Strong, detailed models with remarkable surface finish
  • KUDO3D Titan 2 HR: SLA Digital Light Processing (DLP)
    • Methacrylate-based photocuring polymers
    • Highest resolution 25 microns
  • LulzBot TAZ5 and Ultimaker 3: Fused Deposition Modeling (FDM)
    • ABS, PLA and flexible materials
    • Fast production and very low maintenance
  • Envisiontec Bioplotter
    • 5 simultaneous materials
    • Polymer solutions and melts
    • Biological solutions (including cell suspensions)
Scanning
  • NextEngine 3D laser scanner
  • Fuel3D laser scanner
Software
  • Geomagic Freeform Plus
    • Touch X Haptic Stylus
  • Solidworks Professional
  • Simpleware ScanIP
  • Materialise Magics
  • Rhino
  • ANSYS Solid Mechanics