2016 was a landslide year for 3D printing in the medical field. We’ve seen several new developments in research, bioprinting, surgical planning, device prototyping, and patient treatment.
Looking back, here are some of our favorite stories from the year.
3D Printed Brace Protects Super Bowl Player (Cnet)
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In February, Carolina Panthers linebacker Thomas Davis used a 3D printed brace to protect his fractured arm during Super Bowl 50. Using a scan of Davis’ arm, 3D service company Whiteclouds designed a custom shock-absorbing brace built with plastic and rubber-like materials on a Stratasys PolyJet 3D printer.
The 3D printed brace wasn’t the only option in the running to protect Davis’ arm, but it was the one the player chose over three other regular braces because of its durability, breathability and lightweight construction.
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Man Has 3D-printed Vertebrae Implanted in World-First Surgery (Mashable)
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For the first time, 3D printed vertebrae were surgically implanted after removing a high-risk tumor from the top of a patient’s spine.
A patient at the Prince of Wales Hospital in Sydney had a tumor in a particularly hard-to-get-to location – the vertebrae at the top of the neck. Surgeries requiring replacement vertebrae normally use vertebrae reconstructed from bone from another part of the body, but it is difficult to get the right fit with this method.
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Neurosurgeon Dr. Ralph Mobbs turned to 3D printing. He 3D printed vertebrae to achieve the perfect fit and minimize risk to the patient. Mobbs also used 3D models of the patient’s exact anatomy to prepare and practice for the complex procedure.
Researchers 3D Print Usable Human Bones and Muscles (Fortune)
Scientists at Wake Forest Baptist Medical Center developed a first-of-its kind bio-printer that can make bones, tissue, and muscle that can live in a human body.
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The Integrated Tissue and Organ Printing System uses a hard plastic-like tissue-building material for printing body parts and a delicate water-based gel ink that holds tissue cells in place. The printed body parts include a system of built-in channels so nutrients and oxygen from the body can flow into the new tissue after it is implanted. This keeps the printed parts alive and helps them develop into working parts of the body.
Historically bio-printed tissues haven’t been strong or large enough to actually implant into humans, so this development is expected to dramatically change the future for many on the organ transplant waiting list.
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Process for 3D Bone Printing is Discovered (RTE)
Scientists at Trinity College Dublin, Ireland developed a new method to make bone material using 3D bioprinting to build cartilage templates in the shape of missing bones for bone grafts.
This method creates a composite of bio materials and stem cells that is then implanted under the skin, where it matures in time into fully functioning replacement bone with its own blood vessels.
This has major implications for helping patients who suffer from problems caused by conditions like tumor removal, infection, injury and inherited deformities.
FDA Publishes Long-Awaited Guidance on Additively Manufactured Medical Products (FDA.gov)
In May, representatives of the Food and Drug Administration (FDA) released draft guidance to give manufacturers the agency’s initial thinking about the technical considerations for manufacturing 3D printed devices.
The draft guidance covers considerations for two major areas of medical device development:
- Design and Manufacturing Considerations: This section of the guidance provides technical considerations that should be addressed as part of fulfilling Quality System (QS) requirements for a device, as determined by its regulatory classification or regulation to which it is subject, if applicable. While this draft guidance includes manufacturing considerations, it is not intended to comprehensively address all considerations or regulatory requirements to establish a quality system for the manufacturing of a device.
- Device Testing Considerations: This section of the guidance describes the type of information that should be provided in premarket notification submissions [510(k)][/510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests and investigational device exemption (IDE) applications for a 3D printed device.
Around the same time, the FDA also published this article in the 3D Printing in Medicine Journal to further clarify the agency’s perspective.
