3D Printed
The medical device industry is an early adopter of additive manufacturing, commonly known as 3D printing. Surgical, orthopedic and dental implants, as well as medical instruments are among the current examples of successful additive manufacturing.
Recently, doctors at the University of Michigan's C.S. Mott Children's Hospital implanted a 3D printed bioresorbable split to restore a baby's breathing. The 18-month-old, Garrett Peterson, had such severe breathing problems that he had been tethered to ventilators at the hospital his entire life and needed to be resuscitated 4-5 times a day. As his condition declined, Garrett's parents read an article about the first baby saved by a 3D-printed device at U-M. The parents contacted the U-M team and confirmed Garrett was a good candidate for the procedure. Using provisions for emergency clearance from the FDA, U-M doctors created custom tracheal splints directly from a CT scan of Garrett's airways, integrating an image-based computer model with laser-based 3D printing to produce the splint. After being implanted, the devices provided enough support to allow Garrett to ventilate both lungs. Eventually, as his airways grow he is expected to come off the ventilator completely and in about three years, the supporting splint will be reabsorbed into the body. With the global market for implants in particular growing to meet the demand of a larger elderly population and an active athletic younger population, additive manufacturing offers a cost-effective way to meet this growing need. In addition to cost savings, additive manufacturing offers the use of technologically advanced materials; rapid development and prototyping, on-demand manufacturing; comparatively easy construction of complex lattices, forms, and shapes; and implants customized for an individual patient. For many of the same reasons additive manufacturing is receiving a lot of attention in the aerospace industry. The principles of additive manufacturing are simple. A computer makes a digital model of an object is made, and then slices it layer by layer. The 3D printer then deposits the construction material, which can be anything from a plastic polymer to an advanced metal alloy. While the principles are simple, the actual process is far more complicated depending upon the design and the materials being used. The FDA’s Office of Science and Engineering Laboratories continue to investigate the implications of additive manufacturing on future medical device design and construction, and their corresponding regulation. For more information about 3D technology and how the University of Michigan team created the splints that saved Garrett Peterson's life, see the YouTube videos below. [1] http://www.uofmhealth.org/news/archive/201403/babys-life-saved-after-3d-printed-devices-were-implanted-u 3D Printing Alerts |
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FDA to Hold Public Workshop on 3D Printing Medical Devices
05/17/2014
In a May 19, 2014 Federal Register notice, FDA announces that it will hold a public workshop October 8-9, 2014, on the technical considerations of additive manufacturing, also known as 3-D printing. "The purpose of this workshop is to provide a forum for FDA, medical device manufacturers, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3-D printing. " To permit the widest possible opportunities for public input, the agency is also soliciting electronic or written comments on all workshop topics.
3-D printing is a fast-growing new manufacturing technique that builds devices from computerized blueprints or models, by laying material only where it is needed. Through 3-D printing, designers can quickly create a medical device that is anatomically modeled to a specific patient. As discussed in a recent MedWarn Alert, 3D-printed medical devices have already been used successfully in patients. As medical applications for 3D printing technology continue to grow, the regulation these devices pose important questions for regulators including: whether each device would be required to be registered with FDA; how to ensure process verification and validation for devices produced in individual or small batches; how small design changes could affect the safety of a device; and whether materials used in the printing process might affect durability and strength of the device.
To begin to address such issues, FDA's proposed list of discussion topics include:
[1] "Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing; Public Workshop; Request for Comments," Federal Register, May 19, 2014.
[2] "Growing Trend: 3D-Printing Medical Devices," MedWarn, April 2, 2014.
05/17/2014
In a May 19, 2014 Federal Register notice, FDA announces that it will hold a public workshop October 8-9, 2014, on the technical considerations of additive manufacturing, also known as 3-D printing. "The purpose of this workshop is to provide a forum for FDA, medical device manufacturers, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3-D printing. " To permit the widest possible opportunities for public input, the agency is also soliciting electronic or written comments on all workshop topics.
3-D printing is a fast-growing new manufacturing technique that builds devices from computerized blueprints or models, by laying material only where it is needed. Through 3-D printing, designers can quickly create a medical device that is anatomically modeled to a specific patient. As discussed in a recent MedWarn Alert, 3D-printed medical devices have already been used successfully in patients. As medical applications for 3D printing technology continue to grow, the regulation these devices pose important questions for regulators including: whether each device would be required to be registered with FDA; how to ensure process verification and validation for devices produced in individual or small batches; how small design changes could affect the safety of a device; and whether materials used in the printing process might affect durability and strength of the device.
To begin to address such issues, FDA's proposed list of discussion topics include:
- Preprinting considerations, including but not limited to:
- material chemistry;
- physical properties;
- recyclability;
- part reproducibility; and
- process validation.
- Printing considerations, including but not limited to:
- printing process characterization;
- software used in the process;
- post-processing steps (hot isostatic pressing, curing); and
- additional machining.
- Post-printing considerations, including but not limited to:
- cleaning/excess material removal;
- effect of complexity on sterilization and biocompatibility;
- final device mechanics;
- design envelope; and
- verification.
[1] "Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing; Public Workshop; Request for Comments," Federal Register, May 19, 2014.
[2] "Growing Trend: 3D-Printing Medical Devices," MedWarn, April 2, 2014.