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.”

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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.

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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.

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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.

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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.

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3D Printing gives rise to external organs

Printing accurate models of organs is reducing recovery time and healthcare costs.

16By taking advantage of 3D printing technology, doctors are presented with tangible, accurate models of organs. This is helping both doctors and students to perform better. Some programs and labs have been started in hospitals to try and adopt 3D printing technology. According to doctors, the program has empowered med students to invent their own solutions to healthcare challenges and helped tighten design cycles. Their products draw from training and experience with actual patients, striving to make a difference in the quality of care for future generations.

The following was derived from an interview from an interview with Todd Pietila, Materialise’s business development manager for hospital 3D printing. He talked about what models are printed, how they help, regulations, and more.

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Printing body parts in hospital shows 3D tech’s growing reach

Three-dimensional printers are letting doctors in Minnesota make simulated body parts in a hospital and a Brooklyn startup create rocket engines designed to put satellites into orbit, executives said Thursday at an event hosted by General Electric Co.

The unusual locations for additive printing, highlighted at the first such event GE has organized, showed how quickly the technology is moving beyond plastic prototypes to everyday industrial use.

Companies are now routinely printing titanium engine parts, customizing dashboards of high-end cars, turning out jewelry and eyeglass frames and developing rocket engines.

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3D printing set to add mobility to medicine manufacturing

Prof Lee Cronin: “One day people might do this in their houses but not now.”

Picture this: you need a medicine but your illness is so rare that the required drug is extremely expensive and not widely available. Or maybe you are travelling and the drug you need can’t be easily shipped all the way to you. Could three-dimensional printing offer a solution? Could a local, 3D-printed mini-factory make medicine for you?

Three-dimensional printing, which builds up layers of materials to print a product, is making its mark in the world of medical devices, opening up new ways to make implants and biocompatible scaffolds.

Using the technology to manufacture medicines is still niche, but interest is there. A 3D-printed drug has been approved by the Food and Drug Administration in the United States, and researchers are starting to prise open the potential of 3D printing low-cost equipment to build the chemicals needed for drugs.

Additive Manufacturing Strategies Summit focused on the future of 3D Printing in Medicine and Dentistry

From Charles Goulding at 3dprint.com


I had the privilege of attending a two-day Future of 3D Printing in Medicine and Dentistry conference on January 22nd and 23rd in Washington, D.C. at the Army and Navy Club. The Additive Manufacturing Strategies summit was sponsored by SmarTech Markets Publishing and 3DPrint.com.

Day 1

3D Printing Medical Devices     

Day one was entitled 3D Printed Medical Devices. The opening keynote speaker was Lee Dockstader, Director of Vertical Market Development at HP Inc., whose thorough presentation set the stage for the entire conference. Dockstader wants to develop additive manufacturing in industries including Aerospace, Automotive, Medical, Dental, Life Sciences, Consumer and Retail.

Scott Dunham, Vice President of Research at SmarTech Markets Publishing, gave a comprehensive presentation that was particularly informative on the large production volumes occurring with certain non regulated low entry barrier products. The consensus estimate is that 300,000 low barrier medical devices are now 3D printed per day. Dr. Roger Narayan, Professor of Biomedical Engineering at UNC, gave a detailed presentation on the technical and regulatory aspects of additive medical markets. 3D printing has the potential to revolutionize business models and provides access to custom and functional prosthetic and orthotic medical devices.

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Carbon helps develop low-cost, 3D-printed TB testing device for developing countries

Where you live should not determine whether you live or die, to quote Bono, lead singer of the rock band U2, but, sadly, it often does. I was reminded of Bono’s phrase as I was reading about the contribution that Silicon Valley–based 3D-printing technology company Carbon (Redwood City, CA) made to the development of a low-cost, easy-to-use in vitro diagnostic (IVD) device to test for tuberculosis (TB).

Carbon TB Cassette

Of the 10 million people that contract TB globally each year, more than 40% go undiagnosed or unreported, the vast majority of whom live in the developing world, according to the World Health Organization. To address this issue in countries with limited healthcare infrastructures, the Global Good Fund (Bellevue, WA) got to work. A collaboration between Intellectual Ventures (IV; Bellevue, WA), a private enterprise involved in the development and licensing of intellectual property, and Bill Gates, the Global Good Fund spearheaded the development of an easy-to-use, affordable early TB diagnostic device. Carbon brought its expertise to the project, which resulted in the manufacture of hundreds of these devices for use in field trials.

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