3D printed ears could help children with ear deformities avoid complex surgery

Children with ear deformities will soon be able to get printed ears made from their own stem cells, according to a team of Wollongong researchers working on new 3D bioprinting technology.

They claim their work represents a “huge breakthrough” in the field.

Two 3D printers sit in a lab.

The bio-printer, called 3D Alek, was developed at the University of Wollongong and is now being trialled at Sydney’s Royal Prince Alfred Hospital (RPA).
Read more

Medical 3D Printing: Where Are We Now?

In 2015, market research firm Gartner projected that medical 3D printing would become the pioneering field that would drive additive manufacturing (AM) into the mainstream in two to five years. Four years have passed, so we’ve decided to examine the industry to determine if Gartner’s predictions have come true.

Gartner’s 3D printing hype cycle curve from 2017, the most recent graph made public by the firm. (Image courtesy of Gartner.)

In this article, we’ll explore a handful of medical 3D printing stories from the past year to gain perspective on the level of adoption at which the technology stands.

Read more

Radiological Society of North America post guidelines for 3D printed anatomic models

3DPI reporting from the heart of Formnext 2016. Image shows full color 3D printed anatomical hearts by Stratasys. Photo via: Michael PetchA special interest group of the Radiological Society of North America (RSNA) has posted a set of guidelines, suggesting standard approaches for 3D printing in healthcare.

Recognizing the need for evidence-based recommendations in the sector, these guidelines have been developed over a period of two years, in review of over 500 recent papers published on the topic.

As the abstracts states, “The recommendations provide guidance for approaches and tools in medical 3D printing, from image acquisition, segmentation of the desired anatomy intended for 3D printing, creation of a 3D printable model, and post-processing of 3D printed anatomic models for patient care.”

Read more

3D printing part of an ‘unparalleled period of invention’

3D printing technology applications come alive in applications ranging from developing packaging machinery to producing personalized medical devices to printing custom medications in a patient’s home.

The FDA acknowledges that “advances in material science, digital health, 3D printing, as well as other technologies continue to drive an unparalleled period of invention in medical devices.”

Plastic grippers made via 3D printing. (Photo from igus.)

The perspective comes from a Nov. 26, 2018 statement by FDA Commissioner Scott Gottlieb and Jeff Shuren, Director of the Center for Devices and Radiological Health, outlining transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices.

Read more

3D printing poised to disrupt healthcare

Osseus Fusion Systems’ 3D printed titanium spinal implants won FDA clearance earlier this year, joining more than 100 devices and one drug currently on the market manufactured on 3D printers.

FDA Commissioner Scott Gottlieb has called 3D printing a transformative technology that could disrupt medical practice, and the agency is scrambling to keep abreast of new regulatory challenges.  ​

Known as additive manufacturing, the process involves production of three-dimensional objects using a digital file. The printer layers successive images or files on top of one another until a solid 3D object is formed. The process allows designers to create 3D models of a patient’s anatomy for use in diagnosis or surgical planning. The technology is also being used to customize orthopaedic implants and accessories, prosthetics, hearing aids, dental implants and wearables, such as flexible sensors. In the future, doctors may be able to bioprint skin cells to help heal burn wounds and print out replacement organs.

Read more

3D method uses patients’ own cells to repair tissue damage

OCTOBER 17, 2018: A technician at OrganOvo works with a bioprinter in one of the labs clean rooms to create a 3-D tissue sample. Courtesy of OrganOvo.Patients waiting for an organ transplant may soon have a new treatment option — print out the organ or tissue they need using a revolutionary form of 3D printing that may one may day eliminate the need to wait on transplant donations.

Organovo, a biotech company in San Diego is leading the revolution in bioprinting and Boston area researchers are weighing the benefits of 3D-printed tissue.

“It’s about personalized and customized treatment,” said Xuanhe Zhao, a professor of mechanical engineering at Massachusetts Institute of Technology. He said 3D printing could eventually eliminate the need for transplant donations.

Read more

3D printing offers new hope for war-wounded

Advances in medical technology are giving amputees more practical and adaptable options

After seven years of war, an estimated 86,000 Syrians are coping with losing a limb to amputation, according to the World Health Organisation and disability charity Handicap International. IRIN recently spent a day in neighbouring Jordan, exploring how 3D printing technology can produce a new generation of replacement limbs that are more comfortable and adaptable than traditional prosthetics.

Read more

How ASCs can be held liable for 3D medical devices — And 5 strategies to avoid risk

3D-printed devices such as surgical instruments and implants offer treatment advantages for ASCs and hospitals but also entail liability risks if the device isn’t ‘manufactured’ properly, according to CNA Vice President of Underwriting Ryann Elliott.

The FDA defines a manufacturer as “any person who designs, manufactures, fabricates, assembles or processes a finished device.” Therefore, the FDA may be authorized to regulate and inspect healthcare facilities creating medical devices through 3D printing.

Facilities should implement these five strategies to mitigate risks:

1. Tracking. Implement procedures to track all 3D-printed products brought into the facility. Identify which physicians have the appropriate credentials and privileges to use the products.

Read more

Lessons for medical device manufacturers using 3D printing

Last month, legal practitioners, industry, and academics gathered at The Legal, Regulatory and Business Conference on 3D Printing to discuss the legal, regulatory, and business issues that arise when products are manufactured using 3D printing or additive manufacturing techniques, rather than traditional manufacturing methods.

During the conference, 3D printing was described as the digital revolution, the fourth industrial revolution, a game-changer, and a disruptive innovation. Although the conference focused on all different types of 3D-printed products and uses, it is safe to say that the printing of medical devices falls under each of these descriptors, and may comprise some of 3D printing’s most innovative uses.

Read more

3D printing to disrupt healthcare

Medical technology continues to advance all the time, with life-saving procedures and medicines that were previously unheard of. Now, Global Data believe that 3D printing could be as disruptive to healthcare as the internet has been to retail.

Article pictureThe company initiated a study for its Disruptor Tech database, and the results revealed that 3D printing could revolutionise the supply chain by limiting the gaps between sourcing, production, and distribution. 3D printing has the ability to create ‘clinical trial ready’ devices without the need for expensive tools, computer-aided manufacturing, and computer numerically controlled manufacturing. As a result of this, price is lowered and waiting times are also reduced.

Read more