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In this 3D printing process, the little dot of blue light triggers a chemical reaction that makes the resin harden into plastic.

Credit: Tracy H. Schloemer and Arynn O. Gallegos

Making 3D printing truly 3D

Juan Siliezar

Harvard Staff Writer

Researchers from Rowland Institute eliminate need for 2D layering

Don’t be fooled by the name. While 3D printers do print tangible objects (and quite well), how they do the job doesn’t actually happen in 3D, but rather in regular old 2D.

Working to change that is a group of former and current researchers from the Rowland Institute at Harvard.

First, here’s how 3D printing works: The printers lay down flat layers of resin, which will harden into plastic after being exposed to laser light, on top of each other, again and again from the bottom to the top. Eventually, the object, such as a skull , takes shape. But if a piece of the print overhangs, like a bridge or a wing of a plane, it requires some type of flat support structure to actually print, or the resin will fall apart.

The researchers present a method to help the printers live up to their names and deliver a “true” 3D form of printing. In a new paper in Nature, they describe a technique of volumetric 3D printing that goes beyond the bottom-up, layered approach. The process eliminates the need for support structures because the resin it creates is self-supporting.

“What we were wondering is, could we actually print entire volumes without needing to do all these complicated steps?” said Daniel N. Congreve, an assistant professor at Stanford and former fellow at the Rowland Institute, where the bulk of the research took place. “Our goal was to use simply a laser moving around to truly pattern in three dimensions and not be limited by this sort of layer-by-layer nature of things.”

The key component in their novel design is turning red light into blue light by adding what’s known as an upconversion process to the resin, the light reactive liquid used in 3D printers that hardens into plastic.

In 3D printing, resin hardens in a flat and straight line along the path of the light. Here, the researchers use nano capsules to add chemicals so that it only reacts to a certain kind of light — a blue light at the focal point of the laser that’s created by the upconversion process. This beam is scanned in three dimensions, so it prints that way without needing to be layered onto something. The resulting resin has a greater viscosity than in the traditional method, so it can stand support-free once it’s printed.

“We designed the resin, we designed the system so that the red light does nothing,” Congreve said. “But that little dot of blue light triggers a chemical reaction that makes the resin harden and turn into plastic. Basically, what that means is you have this laser passing all the way through the system and only at that little blue do you get the polymerization, [only there] do you get the printing happening. We just scan that blue dot around in three dimensions and anywhere that blue dot hits it polymerizes and you get your 3D printing.”

The researchers used their printer to produce a 3D Harvard logo, Stanford logo, and a small boat, a standard yet difficult test for 3D printers because of the boat’s small size and fine details like overhanging portholes and open cabin spaces.

The researchers, who included Christopher Stokes from the Rowland Institute, plan to continue developing the system for speed and to refine it to print even finer details. The potential of volumetric 3D printing is seen as a game changer, because it will eliminate the need for complex support structures and dramatically speed up the process when it reaches its full potential. Think of the “replicator” from “Star Trek” that materializes objects all at once.

But right now, the researchers know they have quite a ways to go.

“We’re really just starting to scratch the surface of what this new technique could do,” Congreve said.

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Advancements in 3D printing have made it easier for designers and engineers to customize projects, create physical prototypes at different scales, and produce structures that can’t be made with more traditional manufacturing techniques. But the technology still faces limitations – the process is slow and requires specific materials which, for the most part, must be used one at a time.

A model of Kyiv’s Saint Sophia Cathedral in the blue and yellow of the Ukrainian flag, made using the iCLIP method for 3D printing, which allows for the use of multiple types – or colors – of resin in a single object. (Image credit: William Pan)

Researchers at Stanford have developed a method of 3D printing that promises to create prints faster, using multiple types of resin in a single object. Their design, published recently in Science Advances , is 5 to 10 times faster than the quickest high-resolution printing method currently available and could potentially allow researchers to use thicker resins with better mechanical and electrical properties.

“This new technology will help to fully realize the potential of 3D printing,” says Joseph DeSimone , the Sanjiv Sam Gambhir Professor in Translational Medicine and professor of radiology and of chemical engineering at Stanford and corresponding author on the paper. “It will allow us to print much faster, helping to usher in a new era of digital manufacturing, as well as to enable the fabrication of complex, multi-material objects in a single step.”

Controlling the flow of resin

The new design improves on a method of 3D printing created by DeSimone and his colleagues in 2015 called continuous liquid interface production, or CLIP. CLIP printing looks like it belongs in a science fiction movie – a rising platform smoothly pulls the object, seemingly fully formed, from a thin pool of resin. The resin at the surface is hardened into the right shape by a sequence of UV images projected through the pool, while a layer of oxygen prevents curing at the bottom of the pool and creates a “dead zone” where the resin remains in liquid form.

The dead zone is the key to CLIP’s speed. As the solid piece rises, the liquid resin is supposed to fill in behind it, allowing for smooth, continuous printing. But this doesn’t always happen, especially if the piece rises too quickly or the resin is particularly viscous. With this new method, called injection CLIP, or iCLIP, the researchers have mounted syringe pumps on top of the rising platform to add additional resin at key points.

“The resin flow in CLIP is a very passive process – you’re just pulling the object up and hoping that suction can bring material to the area where it’s needed,” says Gabriel Lipkowitz, a PhD student in mechanical engineering at Stanford and lead author on the paper. “With this new technology, we actively inject resin onto the areas of the printer where it’s needed.”

The resin is delivered through conduits that are printed simultaneously with the design. The conduits can be removed after the object is completed or they can be incorporated into the design the same way that veins and arteries are built into our own body.

Multi-material printing

By injecting additional resin separately, iCLIP presents the opportunity to print with multiple types of resin over the course of the printing process – each new resin simply requires its own syringe. The researchers tested the printer with as many as three different syringes, each filled with resin dyed a different color. They successfully printed models of famous buildings from several countries in the color of each country’s flag, including Saint Sophia Cathedral in the blue and yellow of the Ukrainian flag and Independence Hall in American red, white, and blue.

“The ability to make objects with variegated material or mechanical properties is a holy grail of 3D printing,” Lipkowitz says. “The applications range from very efficient energy-absorbing structures to objects with different optical properties and advanced sensors.”

Having successfully demonstrated that iCLIP has the potential to print with multiple resins, DeSimone, Lipkowitz, and their colleagues are working on software to optimize the design of the fluid distribution network for each printed piece. They want to ensure that designers have fine control over the boundaries between resin types and potentially speed up the printing process even further.

“A designer shouldn’t have to understand fluid dynamics to print an object extremely quickly,” Lipkowitz says. “We’re trying to create efficient software that can take a part that a designer wants to print and automatically generate not only the distribution network, but also determine the flow rates to administer different resins to achieve a multi-material goal.”

DeSimone is a member of Stanford Bio-X , the Wu Tsai Human Performance Alliance , and the Stanford Cancer Institute ; he is a faculty fellow of Stanford’s Sarafan ChEM-H ; and he holds appointments in the departments of Radiology and Chemical Engineering.

Additional Stanford co-authors of this research include Eric S. G. Shaqfeh , the Lester Levi Carter Professor in the School of Engineering and professor of chemical engineering and of mechanical engineering; senior research scientist Maria T. Dulay; postdoctoral scholars Kaiwen Hsiao and Brian Lee; graduate students Tim Samuelson, Ian Coates, and Harrison Lin; and undergraduate student William Pan. Other co-authors are from Sungkyunkwan University and Digital Light Innovations.

This work was funded by the Precourt Institute for Energy at Stanford, the Stanford Woods Institute for the Environment , and the National Science Foundation.

To read all stories about Stanford science, subscribe to the biweekly Stanford Science Digest .

Media Contacts

Jill Wu, Stanford University School of Engineering: (386) 383-6061, [email protected]

From nano to macro: Nanoscale 3D printing that is fast, smooth, and scalable - Mechanical Engineering - Purdue University

Purdue University

From nano to macro: Nanoscale 3D printing that is fast, smooth, and scalable

Additive manufacturing – also called 3D printing – has revolutionized many fields, and has spurred researchers to investigate manufacturing techniques at the micro- and nano-scale. One such technique is multi-photon lithography, where a volume of resin is exposed to a series of focused high-intensity laser pulses, which causes the resin at the focal point to solidify almost instantly. By moving the laser and/or the resin, 3D shapes can be built.

In a new paper published in Light: Science & Applications , a Purdue team led by Xianfan Xu , the James J. and Carol L. Shuttleworth Professor of Mechanical Engineering, has combined multi-photon lithography with spatiotemporal focusing of femtosecond laser pulses to demonstrate rapid, continuous printing of complex 3D structures.

research a 3d printing

“Multi-photon lithography has been studied for more than 20 years,” said Paul Somers, PhD student in Mechanical Engineering , and lead author of the paper. “It has great potential, but it’s still slow. Our goal is to speed it up and scale it up, so that it can be used to manufacture useful structures with high speed and high fidelity.”

To achieve this goal, they use spatiotemporal focusing. A digital micro-mirror device (an array of tiny mirrors controlled by a computer) separates the laser into multiple wavelengths of light and then recombines them, which accurately pinpoints the area of the resin they want to solidify. With this technique, they can print an entire 2D layer instantly, while physically moving the platform up and printing another horizontal layer.

“You see this with typical 3D printers, where it deposits a layer of plastic, and then moves up to deposit another layer, leaving you with jagged edges,” Somers said. “But our technique is continuous. The platform doesn’t stop and start; it moves continuously, so rather than distinct layers, it’s one smooth shape all the way up. This allows us to print much faster, with no layering artifacts, and make complex shapes that traditional 3D printing can’t do.”

They demonstrated this technique by printing complex rounded shapes like a trefoil knot, and a replica of the Cloud Gate sculpture in Chicago – each printed in less than a second, with no jagged edges or other artifacts.

research a 3d printing

Because of the size of their mirror array, the layer size was restricted to 25 microns by 44 microns. To counter this restriction, they combined multiple tiny structures into one larger structure. In one printing session, they printed more than 74,000 of the tiny shapes into a 42 x 42 x 42 unit cube, nearly 1 millimeter in width. This demonstrated that multi-photon lithography has the potential to build highly complex structures, with customized designs, in a practical time frame.

“Imagine a doctor wants to bio-engineer a custom scaffolding for tissue cells to grow on,” Somers said. “With this technique, we can rapidly build multiple nanostructures into a complex macroscale object. We can achieve the same detailed properties of the nanostructures, but build them into objects that are useful in the real world, in a practical timeframe.”

“To make nanomanufacturing practical, we have to optimize time and scale,” Xu said. “Creating a single nanostructure in a lab, over several days, just doesn’t scale. With this technique, we can make nanoscale 3D printing practical for biomedicine, microrobotics, optics, consumer products, and more.”

The team also includes Liang Pan , Associate Professor of Mechanical Engineering ; and Bryan Boudouris , Professor of Chemical Engineering . All research takes place at the Birck Nanotechnology Center . This work was supported by the National Science Foundation through their Scalable Nanomanufacturing Program, award number 1634832 .

Writer: Jared Pike, [email protected] , 765-496-0374

Source: Xianfan Xu, [email protected] , 765-494-5639

Rapid, Continuous Projection Multi-photon 3D Printing Enabled by Spatiotemporal Focusing of Femtosecond Pulses

Paul Somers, Zihao Liang, Jason E. Johnson, Bryan W. Boudouris, Liang Pan, Xianfan Xu

There is demand for scaling up 3D printing throughput, especially for the multi-photon 3D printing process that provides sub-micrometer structuring capabilities required in diverse fields. In this work, high-speed projection multi-photon printing is combined with spatiotemporal focusing for fabrication of 3D structures in a rapid, layer-by-layer, and continuous manner. Spatiotemporal focusing confines printing to thin layers, thereby achieving print thicknesses on the micron and submicron scale. Through projection of dynamically varying patterns with no pause between patterns, a continuous fabrication process is established. A numerical model for computing spatiotemporal focusing and imaging is also presented which is verified by optical imaging and printing results. Complex 3D structures with smooth features are fabricated, with millimeter scale printing realized at a rate above 10 -3 mm 3 s -1 . This method is further scalable, indicating its potential to make fabrications of 3D structures with micro/nanoscale features in a practical time scale a reality.

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A new era in 3-D printing

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Seok Kim, a postdoc in Professor Nicholas Fang’s lab, holds up a 3-D-printed porous substrate that could be used as a catalytic reactor to remove toxic gases in cars and power plants.

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In the mid-15th century, a new technology that would change the course of history was invented. Johannes Gutenberg’s printing press, with its movable type, promoted the dissemination of information and ideas that is widely recognized as a major contributing factor for the Renaissance.

Over 500 years later, a new type of printing was invented in the labs of MIT. Emanuel Sachs, professor of mechanical engineering, invented a process known as binder jet printing. In binder jet printing, an inkjet printhead selectively drops a liquid binder material into a powder bed — creating a three-dimensional object layer by layer.

Sachs coined a new name for this process: 3-D printing. “My father was a publisher and my mother was an editor,” explains Sachs. “Growing up, my father would take me to the printing presses where his books were made, which influenced my decision to name the process 3-D printing.”

Sachs’ binder jet printing process was one of several technologies developed in the 1980s and '90s in the field now known as additive manufacturing, a term that has come to describe a wide variety of layer-based production technologies. Over the past three decades, there has been an explosion in additive manufacturing research. These technologies have the potential to transform the way countless products are designed and manufactured. One of the most immediate applications of 3-D printing has been the rapid prototyping of products. “It takes a long time to prototype using traditional manufacturing methods,” explains Sachs. 3-D printing has transformed this process, enabling rapid iteration and testing during the product development process.

This flexibility has been a game-changer for designers. “You can now create dozens of designs in CAD, input them into a 3-D printer, and in a matter of hours you have all your prototypes,” adds Maria Yang, professor of mechanical engineering and director of MIT’s Ideation Laboratory. “It gives you a level of design exploration that simply wasn’t possible before.”

Throughout MIT’s Department of Mechanical Engineering, many faculty members have been finding new ways to incorporate 3-D printing across a vast array of research areas. Whether it’s printing metal parts for airplanes, printing objects on a nanoscale, or advancing drug discovery by printing complex biomaterial scaffolds, these researchers are testing the limits of 3-D printing technologies in ways that could have lasting impact across industries.

Improving speed, cost, and accuracy

There are several technological hurdles that have prevented additive manufacturing from having an impact on the level of Gutenberg’s printing press. A. John Hart, associate professor of mechanical engineering and director of MIT’s Laboratory for Manufacturing and Productivity, focuses much of his research on addressing those issues.

“One of the most important barriers to making 3-D printing accessible to designers, engineers, and manufacturers across the product life cycle is the speed, cost, and quality of each process,” explains Hart.

His research seeks to overcome these barriers, and to enable the next generation of 3-D printers that can be used in the factories of the future. For this to be accomplished, synergy among machine design, materials processing, and computation is required.

To work toward achieving this synergy, Hart’s research group examined the processes involved in the most well-known style of 3-D printing: extrusion. In extrusion, plastic is melted and squeezed through a nozzle in a printhead.

“We analyzed the process in terms of its fundamental limits — how the polymer could be heated and become molten, how much force is required to push the material through the nozzle, and the speed at which the printhead moves around,” adds Hart.

With these new insights, Hart and his team designed a new printer that operated at speeds 10 times faster than existing printers. A gear that would have taken one to two hours to print could now be ready in five to 10 minutes. This drastic increase in speed is the result of a novel printhead design that Hart hopes will one day be commercialized for both desktop and industrial printers.

While this new technology could improve our ability to print plastics quickly, printing metals requires a different approach. For metals, precise quality control is especially important for industrial use of 3-D printing. Metal 3-D printing has been used to create objects ranging from airplane fuel nozzles to hip implants, yet it is only just beginning to become mainstream. Items made using metal 3-D printing are particularly susceptible to cracks and flaws due to the large thermal gradients inherent in the process.

To solve this problem, Hart is embedding quality control within the printers themselves. “We are building instrumentation and algorithms that monitor the printing process and detect if there are any mistakes — as small as a few micrometers — as the objects are being printed,” Hart explains.

This monitoring is complemented by advanced simulations, including models that can predict how the powder used as the feedstock for printing is distributed and can also identify how to modify the printing process to account for variations.

Hart’s group has been pioneering the use of new materials in 3-D printing. He has developed methods for printing with cellulose, the world’s most abundant polymer, as well as carbon nanotubes, nanomaterials that could be used in flexible electronics and low-cost radio frequency tags.

When it comes to 3-D printing on a nanoscale, Hart’s colleague Nicholas Xuanlai Fang, professor of mechanical engineering, has been pushing the limits of how small these materials can be.

Printing nanomaterials using light

Inspired by the semiconductor and silicon chip industries, Fang has developed a 3-D printing technology that enables printing on a nanoscale. As a PhD student, Fang first got interested in 3-D printing while looking for a more efficient way to make the microsensors and micropumps used for drug delivery.

“Before 3-D printing, you needed expensive facilities to make these microsensors,” explains Fang. “Back then, you’d send design layouts to a silicon manufacturer, then you’d wait four to six months before getting your chip back.” The process was so time-intensive it took one of his labmates four years to get eight small wafers.

As advances in 3-D printing technologies made manufacturing processes for larger products cheaper and more efficient, Fang began to research how these technologies might be used on a much smaller scale.

He turned to a 3-D printing process known as stereolithography. In stereolithography, light is sent through a lens and causes molecules to harden into three-dimensional polymers — a  process known as photopolymerization.

The size of objects that could be printed using stereolithography were limited by the wavelength of the light being sent through the optic lens — or the so-called diffraction limit — which is roughly 400 nanometers. Fang and his team were the first researchers to break this limit.

“We essentially took the precision of optical technology and applied it to 3-D printing,” says Fang. The process, known as projection micro-stereolithography, transforms a beam of light into a series of wavy patterns. The wavy patterns are transferred through silver to produce fine lines as small as 40 nm, which is 10 times smaller than the diffraction limit and 100 times smaller than the width of a strand of hair.

The ability to pattern features this small using 3-D printing holds countless applications. One use for the technology Fang has been researching is the creation of a small foam-like structure that could be used as a substrate for catalytic conversion in automotive engines. This structure could treat greenhouse gases on a molecular level in the moments after an engine starts.

“When you first start your engine, it’s the most problematic for volatile organic components and toxic gases. If we were to heat up this catalytic convertor quickly, we could treat those gases more effectively,” he explains.

Fang has also created a new class of 3-D printed metamaterials using projection micro-stereolithography. These materials are composed of complex structures and geometries. Unlike most solid materials, the metamaterials don’t expand with heat and don’t shrink with cold.

“These metamaterials could be used in circuit boards to prevent overheating or in camera lenses to ensure there is no shrinkage that could cause a lens in a drone or UAV to lose focus,” says Fang.

More recently, Fang has partnered with Linda Griffith, School of Engineering Teaching Innovation Professor of Biological and Mechanical Engineering, to apply projection micro-stereolithography to the field of bioengineering.

Growing human tissue with the help of 3-D printing

Human cells aren’t programmed to grow in a two-dimensional petri dish. While cells taken from a human host might multiply, once they become thick enough they essentially starve to death without a constant supply of blood. This has proved particularly problematic in the field of tissue engineering, where doctors and researchers are interested in growing tissue in a dish to use in organ transplants.

For the cells to grow in a healthy way and organize into tissue in vitro, they need to be placed on a structure or ‘scaffold.’  In the 1990s, Griffith, an expert in tissue engineering and regenerative medicine, turned to a nascent technology to create these scaffolds — 3-D printing.

“I knew that to replicate complex human physiology in vitro, we needed to make microstructures within the scaffolds to carry nutrients to cells and mimic the mechanical stresses present in the actual organ,” explains Griffith.

She co-invented a 3-D printing process to make scaffolds from the same biodegradable material used in sutures. Tiny complex networks of channels with a branching architecture were printed within the structure of these scaffolds. Blood could travel through the channels, allowing cells to grow and eventually start to form tissue. 

Over the past two decades, this process has been used across various fields of medicine, including bone regeneration and growing cartilage in the shape of a human ear. While Griffith and her collaborators originally set out to regenerate a liver, much of their research has focused on how the liver interacts with drugs.

“Once we successfully grew liver tissue, the next step was tackling the challenge of getting useful predicative drug development information from it,” adds Griffith.

To develop more complex scaffolds that provide better predicative information, Griffith collaborated with Fang on applying his nano-3-D printing technologies to tissue engineering. Together, they have built a custom projection micro-stereolithography machine that can print high-resolution scaffolds known as liver mesophysiological systems (LMS). Micro-stereolithography printing allows the scaffolds that make up LMS to have channels as small as 40 microns wide. These small channels enable perfusion of the bioartificial organ at an elevated flow rate, which allows oxygen to diffuse throughout the densely packed cell mass.

“By printing these microstructures in more minute detail, we are getting closer to a system that gives us accurate information about drug development problems like liver inflammation and drug toxicity, in addition to useful data about single-cell cancer metastasis,” says Griffith.

Given the liver’s central role in processing and metabolizing drugs, the ability to mimic its function in a lab has the potential to revolutionize the field of drug discovery.

Griffith’s team is also applying their projection micro-stereolithography technique to create scaffolds for growing induced pluripotent stem cells into human-like brain tissue. “By growing these stem cells in the 3-D printed scaffolds, we are hoping to be able to create the next generation of more mature brain organoids in order to study complex diseases like Alzheimer's,” explains Pierre Sphabmixay, a mechanical engineering PhD candidate in Griffith’s lab.

Partnering with Industry

For 3-D printing to make a lasting impact on how products are both designed and manufactured, researchers need to work closely with industry. To help bridge this gap, the MIT Center for Additive and Digital Advanced Production Technologies (APT) was launched in late 2018.

“The idea was to intersect additive manufacturing research, industrial development, and education across disciplines all under the umbrella of MIT,” explains Hart, who founded and serves as director of APT. “We hope that APT will help accelerate the adoption of 3-D printing, and allow us to better focus our research toward true breakthroughs beyond what can be imagined today.”

Since APT launched in November 2018, MIT and the twelve company founding members — that include companies such as ArcelorMittal, Autodesk, Bosch, Formlabs, General Motors, and the Volkswagen Group — have met both at a large tradeshow in Germany and on campus. Most recently, they convened at MIT for a workshop on scalable workforce training for additive manufacturing.

“We’ve created a collaborative nexus for APT’s members to unite and solve common problems that are currently limiting the adoption of 3-D printing — and more broadly, new concepts in digitally-driven production — at a large scale,” adds Haden Quinlan, program manager of APT.  Many also consider Boston the epicenter of 3-D printing innovation and entrepreneurship, thanks in part to several fast-growing local startups founded by MIT faculty and alumni.

Efforts like APT, coupled with the groundbreaking work being done in the sphere of additive manufacturing at MIT, could reshape the relationship between research, design and manufacturing for new products across industries.

Designers could quickly prototype and iterate the design of products. Safer, more accurate metal hinges could be printed for use in airplanes or cars. Metamaterials could be printed to form electronic chips that don’t overheat. Entire organs could be grown from donor cells on 3-D printed scaffolds. While these technologies may not spark the next Renaissance as the printing press did, they offer solutions to some of the biggest problems society faces in the 21st century.

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Microfilaments made using a new 3D printing method, shown in gray in this illustration, form a structure that cells, shown in color, can adhere to. The shapes formed by the filaments determine the very uniform shapes of cells.

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Associate Professor A. John Hart (right), doctoral student Adam Stevens SM ’15, and their colleagues have designed a 3-D printer that can deposit material 10 times faster than today’s desktop models can. The team has also developed a novel process for 3-D printing using cellulose, a widely available natural polymer.

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Push print: Pioneering the 3D-printing techniques of tomorrow

Professor Moridi operates a monitor on a large 3D printer

This feature appears in the winter 2022 edition of Cornell Engineering Magazine .

In his early years at Cornell, Larry Bonassar, the Daljit S. and Elaine Sarkaria Professor in Biomedical Engineering, and his colleagues engineered a process for making printable materials that can also carry living cells. “If you do it right, the material is literally alive when it comes off the printer,” he says. That innovation opened the door for a pioneering career in biomedical research that, for two decades and counting, has largely been centered around 3D printing.

The Bonassar group initially printed cartilage, an a-vascular tissue that does not normally have blood vessels. In 2017, the researchers received some attention for 3D printing human ears, which are essentially pure cartilage. “The idea that you could grow cartilage in the right shape and use it to replace a body part was first brought up in the mid ’90s,” Bonassar says. “But the technology that’s necessary to do it, the engineering to do it, requires the precision and the reproducibility of something like a printing process. That also makes it customizable and scalable.”

bonassar holding a 3d printed ear

3D printing is one of the great engineering innovations of the early 21st century. It has been applied to everything from biomedicine to architecture, and scientists continue to explore the full range of possibilities enabled by the process. Much has been achieved, but — if predictions hold true — there is much more to come. As researchers devise processes and techniques to push 3D printing technology to the next level for a range of materials, many next-generation breakthroughs are likely to emerge from Cornell Engineering.

Bonassar and his colleagues, for example, have applied their expertise to printing increasingly complicated cartilage. Once they had practiced on the ear, they turned to intervertebral discs—the soft tissues between vertebrae in the spine—which have different types of cartilage on the outside and inside of the disc. The overall goal is to eventually replace diseased or injured cartilage in human beings with 3D printed implants. “Living 3D-printed body parts like these have not yet been implanted in humans,” Bonassar says. “But I expect clinical trials to start in the very near future.”

In the meantime, the Bonassar group is developing a new generation tissue printer that can monitor itself by taking measurements on the material as it is depositing it. “The real challenge is quality control,” Bonassar explains. “We’re working on closed-loop control: a printer that is able to count cells and determine their viability while we’re depositing them and that can confirm the implant is sterile as we’re making it, so that in the end, we make exactly what we wanted to make.”

Quality Control

Monitoring and controlling the printing process is an issue across the spectrum of 3D printing, also known as additive manufacturing. It is central to the research of Atieh Moridi, assistant professor in the Sibley School of Mechanical and Aerospace Engineering. In an effort to better understand the complex physics of the 3D printing process, Moridi uses the Cornell High-Energy Synchrotron Source (CHESS), a high-intensity X-ray research facility, to watch while a 3D printer lays down deposits of metallic materials. She is able to follow the fabrication process in more detail than ever before and to identify defects as they occur.

two researchers stand next to a large 3d printer

That work led to a National Science Foundation CAREER Award. But even while Moridi is making waves with her CHESS-assisted monitoring techniques, she is well aware that a sophisticated research facility like CHESS is not available in industry settings. To boost the adoption of 3D printing by manufacturers, she sought to create a cheaper, more accessible monitoring technique. As part of that endeavor, she now serves as mentor to a NASA University Student Research Challenge project that seeks to combine the results of CHESS X-rays with those of acoustic emission sensors to identify errors during the additive manufacturing process.

“We want to acquire signals from both of these sources and correlate them, what I call concurrent watching and listening to the additive manufacturing process” Moridi says. “We watch with the synchrotron, acquiring hard-proof physics, and we listen with acoustic emission sensors. If there’s a defect, we will hear that in the acoustic signal, and we will know what that means because we are watching the process with X-rays.”

The overall project goal is to build up a database of signals correlated to specific types of defects. “We can essentially train people so when they listen to the additive manufacturing process, they will know if this is a good print or a bad print, or if this is a good layer or a defective layer,” Moridi says. “If there is a defective layer, in the future we hope to be able to add some corrective measures during the printing process, maybe remove the defective layer and redo it.”

Moridi is also researching 3D printing at lower temperatures, known as cold-spray printing. This technique avoids the residual stresses that can weaken a part printed with the current melt-based processes used for metal additive manufacturing. “Normally we rely on melting to fuse powder particles together,” she explains. “In this project, we use kinetic energy for bonding, rather than thermal energy; essentially we’re printing at supersonic speeds that smash the materials together and cause fusing of the particles.”

particles spray from a printer head

In the course of that research, the Moridi group also explored the ramifications of intentionally printing defects, causing the resulting structure to be porous. They then tested the feasibility of using the porous structures, made of titanium alloy, as biomedical implants specifically for encouraging new bone cells to grow inside them. “We showed that cells actually like these kinds of structures” she says. “The porous networks give enough space for bone to grow inside the pores and integrate the implant so there is less incidence of implant loosening.”

Also, unlike solid metallic implants—which are many times stiffer than bone and therefore bear more of the load, weakening the surrounding bone in the process—the porous implants can be printed to match bone strength, Moridi says. Both the bone and the implant then carry equal amounts of the load.

Scaling up the size of 3D printed materials — from the dimensions of a human ear to the size of, say, an office building —  is another challenge of the technology. Sriramya Duddukuri Nair, assistant professor of civil and environmental engineering, is looking into the potential of layer-by-layer printing to solve some of the most pressing 21st century construction issues. Nair, who specializes in novel cementitious materials, is attracted to the technique for its flexibility as well as its potential for real-time quality control.

The traditional process for constructing large-scale structures from concrete depends on building a wooden formwork first and then filling it in with concrete. These frameworks limit the shapes that structural members can assume. They also often end up in landfills after one use, especially if they are created to hold a specialized shape specific to a particular architectural or structural component.

researchers gather around a concrete printer

“But with 3D printing, you’re not limited in the shape the form can take because it removes the need to use formwork,” she says. “It gives you more flexibility on the shape, and it increases ease of construction. 3D printing is here to revolutionize our way of thinking about structures and to open up new possibilities.”

Like Bonassar in biomedical engineering, Nair has identified the need for better printing materials. In Nair’s case, the desired material is steel-fiber-reinforced concrete, which is able to withstand heavier loads. Unlike Bonassar’s focus on perfecting bio ink, however, Nair’s conundrum is how to engineer the printing head, or extruder, so that it can handle the thick material.

The problem came to light when the Nair group began to shop around for a 3D concrete printing system for Cornell’s Bovay Civil Infrastructure Laboratory Complex. “The printing heads available can only print with cement, sand and flexible polymeric fibers,” Nair says. “You can’t print with steel fibers. So, there are a lot of challenges on what can be printed because of the pumping systems and the extruder head capabilities.”

The Nair group has taken on the challenge of engineering a new extruder head capable of printing with steel-fiber-reinforced concrete. At the same time, Nair will be joining with Greg McLaskey, assistant professor of civil and environmental engineering, who specializes in work with ultrasonic sensors, to develop a method for real-time evaluation of 3D printed concrete so that errors can be identified and fixed as they happen.

concrete pouring from a printer head

Further down the line, autonomous robotic 3D printers may be employed to build housing and infrastructure, Nair says, which could result in construction jobs becoming safer and less stressful on the human body. “There’s predicted to be a shortage of construction workers in the future because these types of jobs are physically hard and don’t pay well,” she says. “With autonomous 3D printing, construction jobs may become more skilled and higher paying because workers will be handling robots and using data to analyze if everything is going to plan.”

Looking Forward

Advances in 3D printing are expected to continue accelerating at scales both large and small. For Bonassar, the big frontier in 3D tissue printing is figuring out how to print vasculated tissues like kidney, liver or brain. Breakthroughs in that area will probably incorporate advances in cell-based therapy—the infusion of stem cells and other types of reprogrammed cells directly into the body, he says.

“With direct infusion of cells, the challenge is how to be sure that the cells are going where you want them to, that they’re staying where you want them to engraft, and that they are organizing relative to each other in the way you want,” Bonassar says. “The beauty of 3D printing is that you can address all of those issues at once. You can arrange them in the material the way you want, and you can use materials that will engraft in the target area of the body and encourage blood vessels to grow so that the cells stay alive and connect with the rest of the system.”

Meanwhile, others are thinking about what the future of 3D printing means for the production of larger structures. “For example, do we need all those dense solids that make up a bridge? Probably not,” Moridi says. “They are like that because we can’t affordably make these structures hollow. There are endless opportunities to exploit 3D printing processes, and we are just starting to scratch the surface of what’s possible.”

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Sustainable 3D Printing: Design Opportunities and Research Perspectives

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  • Emilio Rossi 17 , 18 ,
  • Massimo Di Nicolantonio 18 ,
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As 3D Printing process, technologies and tools are rapidly becoming pervasive and used both in industrial and in non-industrial contexts, the risk to have new unsustainable printing processes and production’s behaviours is high and, potentially, can led to the increasing of environmental emergency (unsustainable growth). On the other hand, Design for Sustainability works, since late 80’s, on the mitigation of production’s environmental foot-print and, recently, on the development of socio-technical systems and distributed hybrid solutions empowering both environmental aspects and socio-economic ones. This paper investigates the new concept of Sustainable 3D Printing using recent Design for Sustainability’s research theories and design approaches, in order to evaluate, and later describes, promising design opportunities and research perspectives that can be used and taken into account, simultaneously, by designers, researchers, entrepreneurs and policymakers to support the societal transition toward sustainable ways of design, production and consumption.

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Acknowledgements

This paper shows the first relevant results of a 2018 ongoing research project conducted by authors on the experimentation of Design for Sustainability in 3D Printing domain. While all authors have contributed equally in the development of results here presented, the writing of various paragraphs is attributed to: Emilio Rossi (4 Results), Massimo Di Nicolantonio (3 Methodology), Paola Barcarolo (1 Introduction) and Jessica Lagatta (Abstract and 2 Aims). Moreover, Emilio Rossi and Massimo Di Nicolantonio contributed equally for the writing of paragraph 5 (Conclusions).

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Rossi, E., Di Nicolantonio, M., Barcarolo, P., Lagatta, J. (2020). Sustainable 3D Printing: Design Opportunities and Research Perspectives. In: Di Nicolantonio, M., Rossi, E., Alexander, T. (eds) Advances in Additive Manufacturing, Modeling Systems and 3D Prototyping. AHFE 2019. Advances in Intelligent Systems and Computing, vol 975. Springer, Cham. https://doi.org/10.1007/978-3-030-20216-3_1

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  • 02 January 2019

Five innovative ways to use 3D printing in the laboratory

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Valentine Ananikov, a chemist at the Zelinsky Institute of Organic Chemistry in Moscow, runs chemical reactions so delicate that just a trace of metal nanoparticles, smaller than a bacterium, could change his results. So when his laboratory finishes an experiment, rigorous cleaning is required. Or at least, it used to be. In 2016, Ananikov began creating disposable reaction vessels instead. To do that, he relies on a technology that has captured the imagination of do-it-yourself hackers, engineers and scientists alike: 3D printing.

In 3D printing, also known as additive manufacturing, a 3D computer model is transformed into a physical object layer by layer, like icing a cake. Ananikov’s team uses the technology to create bespoke chemical reactors in days, rather than waiting weeks or more for them to be made and shipped by an outside vendor. More importantly, the cost of 3D printing plastic is so low that the group can afford to treat the equipment as consumables to be used once and then thrown away, with no clean-up required. “For research labs dealing with interdisciplinary projects,” Ananikov says, “3D printing is a kind of standard tool nowadays.”

3D printers have been widely adopted by members of the ‘maker culture’ for education and creating innovative objects. But they are increasingly becoming standard equipment in scientific laboratories, as well. Researchers can use them to replace broken instrument parts, build custom sample holders and model everything from biological molecules to oil-bearing rocks. And clinicians can use them to create implants and teaching models.

Objects can be 3D printed using several technologies, but one of the most widespread is fused-filament fabrication (FFF), also called fused-deposition modelling. In FFF printers, a narrow, coloured filament — typically plastic wire — is heated and extruded, forming a shape a layer at a time. By contrast, older stereolithography printers use a tank of liquid light-activated resin that is hardened into precise shapes with a laser. FFF printers tend to produce less detailed objects than stereolithography printers, but are easier and cheaper to use.

Commercial FFF printers can be acquired for anything from hundreds to thousands of dollars. Or researchers can build the hardware themselves with kits or designs from the open-source RepRap project for just a few hundred dollars.

3D printing isn’t new: stereolithography printers have existed since the 1980s. But falling prices have made the technology widely available. Below are four ways in which researchers have taken advantage of 3D printing.

Equipment on the go

Julian Stirling, a physicist at the University of Bath, UK, is part of a team that designed light microscopes that can be made with 3D-printed plastic components. The idea is to build them in the field in Tanzania and use them to diagnose malaria by searching for parasites in blood. Tanzania has a shortage of knowledgeable mechanics and local components for repairing scientific equipment, he says, and importing components can be expensive and time-consuming. By 3D printing parts, local doctors and scientists can repair their microscopes more quickly and cheaply. A local firm in Tanzania has even created FFF printers from electronic waste and other local materials, he adds.

Several websites, including Thingiverse and MyMiniFactory, provide forums for scientists to share computer models of printable components. But in Stirling’s experience, models on these sites are often incomplete, lacking either documentation for a particular project or key files for modifying the designs. As a result, his team creates its builds from scratch, using an open-source programming language called OpenSCAD. Their microscopes can be entirely 3D printed except for the camera, motors and lenses.

When it comes to 3D printing, it’s easy to make mistakes, Stirling says. But because the technology is fast and inexpensive, it’s simple to iterate on designs. “This experience can only be built up by trial and error,” he notes.

Practice has taught Stirling that there’s a big difference between using a 3D printer in the laboratory and doing so in the field. 3D printing plastic filament in Tanzania’s humid climate is typically harder than in a climate-controlled laboratory because the humidity affects the plastic filament, leading to more failed prints. Furthermore, power cuts are not uncommon, and only some printers can resume printing a half-finished object after power is restored. There’s not much that Stirling and his team can do about the climate, but they do use uninterruptable power supplies to ensure their print jobs run to completion, he says.

Life-like organs

Ahmed Ghazi, a urological surgeon at the University of Rochester Medical Center in New York, uses 3D printing to create non-functional human organs, which surgeons can use to practice robot-assisted surgery. For relatively simple procedures, such as removing a spleen, there is little need for such practice. But more complex procedures, such as excising a tumour, can vary wildly from patient to patient. As Ghazi notes, “Tumours are not in textbooks.”

Ghazi starts with 3D computer-assisted tomography scans of the patient’s tissue, then feeds the data into the commercial medical modelling software Mimics, from Materialise in Leuven, Belgium, and Meshmixer, a free tool from Autodesk in San Rafael, California, to create 3D models. He then prints those models as hollow plastic moulds using an FFF printer, inserts blood-vessel replicas that will connect to a fake-blood pump, and injects the mould with a hydrogel that will solidify into an object with organ-like stiffness. The resulting structures are realistic enough for surgeons to practice their procedures with real-world consequences, including bleeding.

Ghazi says that he and his team use these models for up to four surgery cases a week. In each case, they create two copies of the models and pick the most accurate representation. And they’re training other doctors to apply the technology in fields such as heart and liver surgery. “This is definitely something that’s catching on a lot more,” Ghazi says.

But imperfections remain. The moulds produced by FFF printers often feature tiny ridges and pits, says Ghazi. Such defects are often too small to see with the naked eye, but are plainly visible to the robotic camera, which could affect the surgeon’s experience. Ghazi’s solution is to spread a layer of room-temperature wax over the inside of the mould, which fills in the ridges and pits, thus smoothing out the final product. “Those little things make a difference,” he says.

Replica rocks

For Mehdi Ostadhassan, a petroleum engineer at the University of North Dakota in Grand Forks, 3D printing provides a tool for optimizing the extraction of oil and gas from rock.

Ostadhassan prints ‘rocks’ using programs such as OpenSCAD and the commercial 3D computer-aided design software AutoCAD (from Autodesk) in combination with various 3D printers and materials. These rock models have realistic physical properties, including tiny, detailed pores, and Ostadhassan puts them under physical stress to better understand how liquid flows through their real-life equivalents.

To create the most realistic rocks, Ostadhassan uses a range of printing approaches, including binder-jet technology, in which a liquid binding agent is applied layer by layer to gypsum powder or silica sand. The process produces objects with mechanical properties that closely mimic those of real rocks. But unbound powder can also get stuck in the pores, Ostadhassan says, diminishing the quality of the final product. And for some experiments, he needs to apply a water-repelling treatment to get the ‘wettability’ right. Stereolithography printers are better at printing rocks with detailed pores to enable the study of liquid-flow properties, but the models they produce are not as strong as binder-jet-printed rocks.

As such, Ostadhassan is collaborating with other researchers to develop a custom printer that can mimic those pores and cracks but still produce models with the same mechanical strength as real rocks.

Heavy metal

Today’s 3D printers can output a range of materials — but not all of them. “The material for 3D printing is very, very limited,” says Yang Yang, chief executive of UniMaker in Shenzhen, China, which makes 3D printers for scientific use. But research in the space is intense, and change is coming. One hot growth area is bioprinting, for use in creating structured biological materials. Jin-Ye Wang, a biomedical scientist at Shanghai Jiao Tong University in China, says that her institution has acquired one such device for use in the classroom. These bioprinters blend cells and hydrogels to create structures such as bones and tumour models.

Another growth area, Yang says, is metals. Metal-capable printers use a beam of electrons or a laser to melt metal powders in defined patterns. Jeremy Bourhill, a physicist at the University of Western Australia in Perth who researches dark matter, is studying the use of laser-based 3D metal printers to build a mesh of superconducting niobium. This could be used to block strong magnetic fields that would interfere with dark-matter detection, Bourhill says.

Using conventional machining to create the mesh would require toxic lubricants and waste a substantial amount of niobium, which is expensive. So Bourhill’s team is using high-powered lasers to melt and fuse cross-sections of metal powder together. But because the melting point of niobium is about 2,500 °C, the process requires considerable amounts of power. “Niobium’s a really tough material,” Bourhill says.

Once upon a time, researchers such as Bourhill would have been limited in their options. But with the increased availability of 3D printers, a fundamental shift has occurred, says Yusheng Shi, a materials engineer at the Huazhong University of Science and Technology in Wuhan, China: 3D printing is enabling personalized manufacturing, supplanting centralized manufacturing. As these examples show, researchers have just scratched the surface of what they can do with that power.

Nature 565 , 123-124 (2019)

doi: https://doi.org/10.1038/d41586-018-07853-5

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Suita Campus, Osaka University in Osaka, Japan

Immunology Frontier Research Center, Osaka University

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The 3-D Printing Revolution

  • Richard D’Aveni

research a 3d printing

The use of 3-D printing, also known as additive manufacturing, has moved well beyond prototyping, rapid tooling, trinkets, and toys. Companies such as GE, Lockheed Martin, and BMW are switching to it for industrial production at scale. More companies will follow as the range of printable materials continues to expand. Already available are basic plastics, photosensitive resins, ceramics, cement, glass, numerous metals, thermoplastic composites (some infused with carbon nanotubes and fibers), and even stem cells. In this article the author makes the case that additive manufacturing will gain ground quickly, given advantages such as greater flexibility, fewer assembly steps and other cost savings, and enhanced product-design possibilities.

Managers, D’Aveni writes, should now be engaging with strategic questions on three levels: Sellers of tangible products should ask how their offerings could be improved, whether by themselves or by competitors. Industrial enterprises should revisit their operations to determine what network of supply chain assets and what mix of old and new processes will be optimal. And leaders must consider the strategic implications as whole commercial ecosystems begin to form around the new realities of 3-D printing.

Many of the biggest players already in the business of additive manufacturing are vying to develop the platforms on which other companies will build and connect. Platform owners will be powerful because production itself is likely to become commoditized over time. Those facilitating connections in the digital ecosystem will sit in the middle of a tremendous volume of industrial transactions, collecting and selling valuable information.

HBR Reprint R1505B

It’s happening, and it will transform your operations and strategy.

Idea in Brief

The breakthrough.

Additive manufacturing, or 3-D printing, is poised to transform the industrial economy. Its extreme flexibility not only allows for easy customization of goods but also eliminates assembly and inventories and enables products to be redesigned for higher performance.

The Challenge

Management teams should be reconsidering their strategies along three dimensions: (1) How might our offerings be enhanced, either by us or by competitors? (2) How should we reconfigure our operations, given the myriad new options for fabricating products and parts? (3) How will our commercial ecosystem evolve?

The Big Play

Inevitably, powerful platforms will arise to establish standards and facilitate exchanges among the designers, makers, and movers of 3-D-printed goods. The most successful of these will prosper mightily.

Industrial 3-D printing is at a tipping point, about to go mainstream in a big way. Most executives and many engineers don’t realize it, but this technology has moved well beyond prototyping, rapid tooling, trinkets, and toys. “Additive manufacturing” is creating durable and safe products for sale to real customers in moderate to large quantities.

  • RD Richard D’Aveni is the Bakala Professor of Strategy at Dartmouth College’s Tuck School of Business.

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  • v.39(10); 2014 Oct

Medical Applications for 3D Printing: Current and Projected Uses

3D printing is expected to revolutionize health care through uses in tissue and organ fabrication; creation of customized prosthetics, implants, and anatomical models; and pharmaceutical research regarding drug dosage forms, delivery, and discovery.

INTRODUCTION

Medical applications for 3D printing are expanding rapidly and are expected to revolutionize health care. 1 Medical uses for 3D printing, both actual and potential, can be organized into several broad categories, including: tissue and organ fabrication; creation of customized prosthetics, implants, and anatomical models; and pharmaceutical research regarding drug dosage forms, delivery, and discovery. 2 The application of 3D printing in medicine can provide many benefits, including: the customization and personalization of medical products, drugs, and equipment; cost-effectiveness; increased productivity; the democratization of design and manufacturing; and enhanced collaboration. 1 , 3 – 6 However, it should be cautioned that despite recent significant and exciting medical advances involving 3D printing, notable scientific and regulatory challenges remain and the most transformative applications for this technology will need time to evolve. 3 – 5 , 7

WHAT IS 3D PRINTING?

Three-dimensional (3D) printing is a manufacturing method in which objects are made by fusing or depositing materials—such as plastic, metal, ceramics, powders, liquids, or even living cells—in layers to produce a 3D object. 1 , 8 , 9 This process is also referred to as additive manufacturing (AM), rapid prototyping (RP), or solid free-form technology (SFF). 6 Some 3D printers are similar to traditional inkjet printers; however, the end product differs in that a 3D object is produced. 1 3D printing is expected to revolutionize medicine and other fields, not unlike the way the printing press transformed publishing. 1

There are about two dozen 3D printing processes, which use varying printer technologies, speeds, and resolutions, and hundreds of materials. 9 These technologies can build a 3D object in almost any shape imaginable as defined in a computer-aided design (CAD) file ( Figure 1 ). 9 In a basic setup, the 3D printer first follows the instructions in the CAD file to build the foundation for the object, moving the printhead along the x–y plane. 5 The printer then continues to follow the instructions, moving the printhead along the z-axis to build the object vertically layer by layer. 5 It is important to note that two-dimensional (2D) radiographic images, such as x-rays, magnetic resonance imaging (MRI), or computerized tomography (CT) scans, can be converted to digital 3D print files, allowing the creation of complex, customized anatomical and medical structures ( Figure 2 ). 3 , 5 , 10

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A 3D printer uses instructions in a digital file to create a physical object. 12

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Radiographic images can be converted to 3D print files to create complex, customized anatomical and medical structures. 12

THE HISTORY OF 3D PRINTING

Charles Hull invented 3D printing, which he called “stereolithography,” in the early 1980s. 1 Hull, who has a bachelor’s degree in engineering physics, was working on making plastic objects from photopolymers at the company Ultra Violet Products in California. 6 Stereolithography uses an .stl file format to interpret the data in a CAD file, allowing these instructions to be communicated electronically to the 3D printer. 6 Along with shape, the instructions in the .stl file may also include information such as the color, texture, and thickness of the object to be printed. 6

Hull later founded the company 3D Systems, which developed the first 3D printer, called a “stereolithography apparatus.” 6 In 1988, 3D Systems introduced the first commercially available 3D printer, the SLA-250. 6 Many other companies have since developed 3D printers for commercial applications, such as DTM Corporation, Z Corporation, Solidscape, and Objet Geometries. 6 Hull’s work, as well as advances made by other researchers, has revolutionized manufacturing, and is poised to do the same in many other fields—including medicine. 6

OVERVIEW OF CURRENT APPLICATIONS

Commercial uses.

3D printing has been used by the manufacturing industry for decades, primarily to produce product prototypes. 1 , 9 Many manufacturers use large, fast 3D printers called “rapid prototyping machines” to create models and molds. 11 A large number of .stl files are available for commercial purposes. 1 Many of these printed objects are comparable to traditionally manufactured items. 1

Companies that use 3D printing for commercial medical applications have also emerged. 2 These include: Helisys, Ultimateker, and Organovo, a company that uses 3D printing to fabricate living human tissue. 2 At present, however, the impact of 3D printing in medicine remains small. 1 3D printing is currently a $700 million industry, with only $11 million (1.6%) invested in medical applications. 1 In the next 10 years, however, 3D printing is expected to grow into an $8.9 billion industry, with $1.9 billion (21%) projected to be spent on medical applications. 1

Consumer Uses

3D printing technology is rapidly becoming easy and inexpensive enough to be used by consumers. 9 , 11 The accessibility of downloadable software from online repositories of 3D printing designs has proliferated, largely due to expanding applications and decreased cost. 2 , 4 , 11 It is now possible to print anything, from guns, clothing, and car parts to designer jewelry. 2 Thousands of premade designs for 3D items are available for download, many of them for free. 11

Since 2006, two open-source 3D printers have become available to the public, Fab@Home ( www.fabathome.org ) and RepRap ( www.reprap.org/wiki/RepRap ). 6 , 9 The availability of these open-source printers greatly lowered the barrier of entry for people who want to explore and develop new ideas for 3D printing. 9 These open-source systems allow anyone with a budget of about $1,000 to build a 3D printer and start experimenting with new processes and materials. 9

This low-cost hardware and growing interest from hobbyists has spurred rapid growth in the consumer 3D printer market. 11 A relatively sophisticated 3D printer costs about $2,500 to $3,000, and simpler models can be purchased for as little as $300 to $400. 8 , 11 For consumers who have difficulty printing 3D models themselves, several popular 3D printing services have emerged, such as Shapeways, ( www.shapeways.com ), Thingiverse ( www.thingiverse.com ), MyMiniFactory ( www.myminifactory.com ), and Threeding ( www.threeding.com ). 11

COMMON TYPES OF 3D PRINTERS

All 3D printing processes offer advantages and disadvantages. 3 The type of 3D printer chosen for an application often depends on the materials to be used and how the layers in the finished product are bonded. 11 The three most commonly used 3D printer technologies in medical applications are: selective laser sintering (SLS), thermal inkjet (TIJ) printing, and fused deposition modeling (FDM). 10 , 11 A brief discussion of each of these technologies follows.

Selective Laser Sintering

An SLS printer uses powdered material as the substrate for printing new objects. 11 A laser draws the shape of the object in the powder, fusing it together. 11 Then a new layer of powder is laid down and the process repeats, building each layer, one by one, to form the object. 11 Laser sintering can be used to create metal, plastic, and ceramic objects. 11 The degree of detail is limited only by the precision of the laser and the fineness of the powder, so it is possible to create especially detailed and delicate structures with this type of printer. 11

Thermal Inkjet Printing

Inkjet printing is a “noncontact” technique that uses thermal, electromagnetic, or piezoelectric technology to deposit tiny droplets of “ink” (actual ink or other materials) onto a substrate according to digital instructions. 10 In inkjet printing, droplet deposition is usually done by using heat or mechanical compression to eject the ink drops. 10 In TIJ printers, heating the printhead creates small air bubbles that collapse, creating pressure pulses that eject ink drops from nozzles in volumes as small as 10 to 150 picoliters. 10 Droplet size can be varied by adjusting the applied temperature gradient, pulse frequency, and ink viscosity. 10

TIJ printers are particularly promising for use in tissue engineering and regenerative medicine. 10 , 13 Because of their digital precision, control, versatility, and benign effect on mammalian cells, this technology is already being applied to print simple 2D and 3D tissues and organs (also known as bioprinting). 10 TIJ printers may also prove ideal for other sophisticated uses, such as drug delivery and gene transfection during tissue construction. 10

Fused Deposition Modeling

FDM printers are much more common and inexpensive than the SLS type. 11 An FDM printer uses a printhead similar to an inkjet printer. 11 However, instead of ink, beads of heated plastic are released from the printhead as it moves, building the object in thin layers. 4 , 11 This process is repeated over and over, allowing precise control of the amount and location of each deposit to shape each layer. 4 Since the material is heated as it is extruded, it fuses or bonds to the layers below. 4 As each layer of plastic cools, it hardens, gradually creating the solid object as the layers build. 11 Depending on the complexity and cost of an FDM printer, it may have enhanced features such as multiple printheads. 11 FDM printers can use a variety of plastics. 11 In fact, 3D FDM printed parts are often made from the same thermoplastics that are used in traditional injection molding or machining, so they have similar stability, durability, and mechanical properties. 4

BENEFITS OF 3D PRINTING IN MEDICAL APPLICATIONS

Customization and personalization.

The greatest advantage that 3D printers provide in medical applications is the freedom to produce custom-made medical products and equipment. 3 For example, the use of 3D printing to customize prosthetics and implants can provide great value for both patients and physicians. 3 In addition, 3D printing can produce made-to-order jigs and fixtures for use in operating rooms. 4 Custom-made implants, fixtures, and surgical tools can have a positive impact in terms of the time required for surgery, patient recovery time, and the success of the surgery or implant. 4 It is also anticipated that 3D printing technologies will eventually allow drug dosage forms, release profiles, and dispensing to be customized for each patient. 5

Increased Cost Efficiency

Another important benefit offered by 3D printing is the ability to produce items cheaply. 1 Traditional manufacturing methods remain less expensive for large-scale production; however, the cost of 3D printing is becoming more and more competitive for small production runs. 1 This is especially true for small-sized standard implants or prosthetics, such as those used for spinal, dental, or craniofacial disorders. 3 The cost to custom-print a 3D object is minimal, with the first item being as inexpensive as the last. 1 This is especially advantageous for companies that have low production volumes or that produce parts or products that are highly complex or require frequent modifications. 4

3D printing can also reduce manufacturing costs by decreasing the use of unnecessary resources. 5 For example, a pharmaceutical tablet weighing 10 mg could potentially be custom-fabricated on demand as a 1-mg tablet. 5 Some drugs may also be printed in dosage forms that are easier and more cost-effective to deliver to patients. 5

Enhanced Productivity

“Fast” in 3D printing means that a product can be made within several hours. 4 That makes 3D printing technology much faster than traditional methods of making items such as prosthetics and implants, which require milling, forging, and a long delivery time. 3 In addition to speed, other qualities, such as the resolution, accuracy, reliability, and repeatability of 3D printing technologies, are also improving. 3

Democratization and Collaboration

Another beneficial feature offered by 3D printing is the democratization of the design and manufacturing of goods. 4 An increasing array of materials is becoming available for use in 3D printing, and they are decreasing in cost. 4 This allows more people, including those in medical fields, to use little more than a 3D printer and their imaginations to design and produce novel products for personal or commercial use. 4

The nature of 3D printing data files also offers an unprecedented opportunity for sharing among researchers. 6 Rather than trying to reproduce parameters that are described in scientific journals, researchers can access downloadable .stl files that are available in open-source databases. 6 By doing so, they can use a 3D printer to create an exact replica of a medical model or device, allowing the precise sharing of designs. 6 Toward this end, the National Institutes of Health established the 3D Print Exchange ( 3dprint.nih.gov ) in 2014 to promote open-source sharing of 3D print files for medical and anatomical models, custom labware, and replicas of proteins, viruses, and bacteria ( Figure 3 ). 12

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The NIH 3D print exchange is a free online resource for sharing medical and scientific 3D print files and tutorials. 12

MEDICAL APPLICATIONS FOR 3D PRINTING

3D printing has been applied in medicine since the early 2000s, when the technology was first used to make dental implants and custom prosthetics. 6 , 10 Since then, the medical applications for 3D printing have evolved considerably. Recently published reviews describe the use of 3D printing to produce bones, ears, exoskeletons, windpipes, a jaw bone, eyeglasses, cell cultures, stem cells, blood vessels, vascular networks, tissues, and organs, as well as novel dosage forms and drug delivery devices. 1 , 3 , 11 The current medical uses of 3D printing can be organized into several broad categories: tissue and organ fabrication; creating prosthetics, implants, and anatomical models; and pharmaceutical research concerning drug discovery, delivery, and dosage forms. 2 A discussion of these medical applications follows.

Bioprinting Tissues and Organs

Tissue or organ failure due to aging, diseases, accidents, and birth defects is a critical medical problem. 10 Current treatment for organ failure relies mostly on organ transplants from living or deceased donors. 10 However, there is a chronic shortage of human organs available for transplant. 1 , 10 In 2009, 154,324 patients in the U.S. were waiting for an organ. 10 Only 27,996 of them (18%) received an organ transplant, and 8,863 (25 per day) died while on the waiting list. 10 As of early 2014, approximately 120,000 people in the U.S. were awaiting an organ transplant. 1 Organ transplant surgery and follow-up is also expensive, costing more than $300 billion in 2012. 10 An additional problem is that organ transplantation involves the often difficult task of finding a donor who is a tissue match. 1 This problem could likely be eliminated by using cells taken from the organ transplant patient’s own body to build a replacement organ. 1 , 13 This would minimize the risk of tissue rejection, as well as the need to take lifelong immunosuppressants. 1 , 13

Therapies based on tissue engineering and regenerative medicine are being pursued as a potential solution for the organ donor shortage. 1 , 10 The traditional tissue engineering strategy is to isolate stem cells from small tissue samples, mix them with growth factors, multiply them in the laboratory, and seed the cells onto scaffolds that direct cell proliferation and differentiation into functioning tissues. 7 , 10 , 13 Although still in its infancy, 3D bioprinting offers additional important advantages beyond this traditional regenerative method (which essentially provides scaffold support alone), such as: highly precise cell placement and high digital control of speed, resolution, cell concentration, drop volume, and diameter of printed cells. 10 , 13 Organ printing takes advantage of 3D printing technology to produce cells, biomaterials, and cell-laden biomaterials individually or in tandem, layer by layer, directly creating 3D tissue-like structures. 13 Various materials are available to build the scaffolds, depending on the desired strength, porosity, and type of tissue, with hydrogels usually considered to be most suitable for producing soft tissues. 6 , 7

Although 3D bioprinting systems can be laser-based, inkjet-based, or extrusion-based, inkjet-based bioprinting is most common. 13 This method deposits “bioink,” droplets of living cells or biomaterials, onto a substrate according to digital instructions to reproduce human tissues or organs. 13 Multiple printheads can be used to deposit different cell types (organ-specific, blood vessel, muscle cells), a necessary feature for fabricating whole heterocellular tissues and organs. 13 A process for bioprinting organs has emerged: 1) create a blueprint of an organ with its vascular architecture; 2) generate a bioprinting process plan; 3) isolate stem cells; 4) differentiate the stem cells into organ-specific cells; 5) prepare bioink reservoirs with organ-specific cells, blood vessel cells, and support medium and load them into the printer; 6) bioprint; and 7) place the bioprinted organ in a bioreactor prior to transplantation. 13 Laser printers have also been employed in the cell printing process, in which laser energy is used to excite the cells in a particular pattern, providing spatial control of the cellular environment. 13

Although tissue and organ bioprinting is still in its infancy, many studies have provided proof of concept. Researchers have used 3D printers to create a knee meniscus, heart valve, spinal disk, other types of cartilage and bone, and an artificial ear. 4 , 6 , 7 Cui and colleagues applied inkjet 3D printing technology to repair human articular cartilage. 13 Wang et al used 3D bioprinting technology to deposit different cells within various biocompatible hydrogels to produce an artificial liver. 13 Doctors at the University of Michigan published a case study in the New England Journal of Medicine reporting that use of a 3D printer and CT images of a patient’s airway enabled them to fabricate a precisely modeled, bioresorbable tracheal splint that was surgically implanted in a baby with tracheobronchomalacia. 7 The baby recovered, and full resorption of the splint is expected to occur within three years. 7

A number of biotech companies have focused on creating tissues and organs for medical research. 7 It may be possible to rapidly screen new potential therapeutic drugs on patient tissue, greatly cutting research costs and time. 1 Scientists at Organovo are developing strips of printed liver tissue for this purpose; soon, they expect the material will be advanced enough to use in screening new drug treatments. 7 Other researchers are working on techniques to grow complete human organs that can be used for screening purposes during drug discovery. 6 An organ created from a patient’s own stem cells could also be used to screen treatments to determine if a drug will be effective for that individual. 3

Challenges in Building 3D Vascularized Organs

Proof-of-concept studies regarding bioprinting have been performed successfully, but the organs that have been produced are miniature and relatively simple. 1 , 9 , 10 They are also often avascular, aneural, alymphatic, thin, or hollow, and are nourished by the diffusion from host vasculature. 1 , 6 , 9 , 10 However, when the thickness of the engineered tissue exceeds 150–200 micro meters, it surpasses the limitation for oxygen diffusion between host and transplanted tissue. 10 As a result, bioprinting complex 3D organs will require building precise multicellular structures with vascular network integration, which has not yet been done. 6

Most organs needed for transplantation are thick and complex, such as the kidney, liver, and heart. 11 Cells in these large organ structures cannot maintain their metabolic functions without vascularization, which is normally provided by blood vessels. 13 Therefore, functional vasculature must be bioprinted into fabricated organs to supply the cells with oxygen/gas exchange, nutrients, growth factors, and waste-product removal—all of which are needed for maturation during perfusion. 10 , 13 Although the conventional tissue engineering approach is not now capable of creating complex vascularized organs, bioprinting shows promise in resolving this critical limitation. 10 The precise placement of multiple cell types is required to fabricate thick and complex organs, and for the simultaneous construction of the integrated vascular or microvascular system that is critical for these organs to function. 10

TIJ printers are considered to be the most promising for this use. However, various 3D printing techniques and materials have been applied successfully to create vasculature as simple as a single channel, as well as more complex geometries, such as bifurcated or branched channels. 6 , 10 , 13 Recently, collaborators from a network of academic institutions, including the University of Sydney, Harvard University, Stanford University, and the Massachusetts Institute of Technology, announced that they had bioprinted a functional and perfusable network of capillaries, an achievement that represents a significant stride toward overcoming this problem. 14

Customized Implants and Prostheses

Implants and prostheses can be made in nearly any imaginable geometry through the translation of x-ray, MRI, or CT scans into digital .stl 3D print files. 2 , 3 , 6 In this way, 3D printing has been used successfully in the health care sector to make both standard and complex customized prosthetic limbs and surgical implants, sometimes within 24 hours. 3 , 7 , 9 This approach has been used to fabricate dental, spinal, and hip implants. 3 Previously, before implants could be used clinically, they had to be validated, which is very time-consuming. 3

The ability to quickly produce custom implants and prostheses solves a clear and persistent problem in orthopedics, where standard implants are often not sufficient for some patients, particularly in complex cases. 3 Previously, surgeons had to perform bone graft surgeries or use scalpels and drills to modify implants by shaving pieces of metal and plastic to a desired shape, size, and fit. 3 , 7 This is also true in neurosurgery: Skulls have irregular shapes, so it is hard to standardize a cranial implant. 3 In victims of head injury, where bone is removed to give the brain room to swell, the cranial plate that is later fitted must be perfect. 9 Although some plates are milled, more and more are created using 3D printers, which makes it much easier to customize the fit and design. 3

There have been many other commercial and clinical successes regarding the 3D printing of prostheses and implants. 2 , 3 , 6 A research team at the BIOMED Research Institute in Belgium successfully implanted the first 3D-printed titanium mandibular prosthesis. 2 The implant was made by using a laser to successively melt thin layers of titanium powders. 2 In 2013, Oxford Performance Materials received FDA approval for a 3D-printed polyetherketoneketone (PEKK) skull implant, which was first successfully implanted that year. 2 Another company, LayerWise, manufactures 3D-printed titanium orthopedic, maxillofacial, spinal, and dental implants. 6 An anatomically correct 3D-printed prosthetic ear capable of detecting electromagnetic frequencies has been fabricated using silicon, chondrocytes, and silver nanoparticles. 6 There is a growing trend toward making 3D-printed implants out of a variety of metals and polymers, and more recently implants have even been printed with live cells. 9

3D printing has already had a transformative effect on hearing aid manufacturing. 3 Today, 99% of hearing aids that fit into the ear are custom-made using 3D printing. 3 Everyone’s ear canal is shaped differently, and the use of 3D printing allows custom-shaped devices to be produced efficiently and cost-effectively. 3 The introduction of customized 3D-printed hearing aids to the market was facilitated by the fact that class I medical devices for external use are subject to fewer regulatory restrictions. 3 Invisalign braces are another successful commercial use of 3D printing, with 50,000 printed every day. 9 These clear, removable, 3D-printed orthodontic braces are custom-made and unique to each user. 9 This product provides a good example of how 3D printing can be used efficiently and profitably to make single, customized, complex items. 9

Anatomical Models for Surgical Preparation

The individual variances and complexities of the human body make the use of 3D-printed models ideal for surgical preparation ( Figure 4 ). 2 Having a tangible model of a patient’s anatomy available for a physician to study or use to simulate surgery is preferable to relying solely on MRI or CT scans, which aren’t as instructive since they are viewed in 2D on a flat screen. 6 The use of 3D-printed models for surgical training is also preferable to training on cadavers, which present problems with respect to availability and cost. 3 Cadavers also often lack the appropriate pathology, so they provide more of a lesson in anatomy than a representation of a surgical patient. 3

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Researchers at the National Library of Medicine generate digital files from clinical data, such as CT scans, that are used to make custom 3D-printed surgical and medical models. 12

3D-printed neuroanatomical models can be particularly helpful to neurosurgeons by providing a representation of some of the most complicated structures in the human body ( Figure 5 ). 2 The intricate, sometimes obscured relationships between cranial nerves, vessels, cerebral structures, and skull architecture can be difficult to interpret based solely on radiographic 2D images. 2 Even a small error in navigating this complex anatomy can have potentially devastating consequences. 2 A realistic 3D model reflecting the relationship between a lesion and normal brain structures can be helpful in determining the safest surgical corridor and can also be useful for the neurosurgeon to rehearse challenging cases. 2 Complex spinal deformities can also be studied better through the use of a 3D model. 2 High-quality 3D anatomical models with the right pathology for training doctors in performing colonoscopies are also vital, since colorectal cancer is the second leading cause of cancer-related deaths in the U.S. 3 , 15

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A 3D model used for surgical planning by neurosurgeons at the Walter Reed National Military Medical Center. 12

Although still largely exploratory, 3D-printed models have been used in numerous cases to gain insight into a patient’s specific anatomy prior to a medical procedure. 6 Pioneering surgeons at Japan’s Kobe University Hospital have used 3D-printed models to plan liver transplantations. 2 They use replicas of a patient’s organs to determine how to best carve a donor liver with minimal tissue loss to fit the recipient’s abdominal cavity. 2 These 3D models are made of partially transparent, low-cost acrylic resin or polyvinyl alcohol—materials that have a water content and texture similar to living tissues, allowing a more realistic penetration by the surgical blades. 2

Other surgeons have used a 3D-printed model of a calcified aorta for surgical planning of plaque removal. 6 A premature infant’s airway was also reconstructed in order to study aerosol drug delivery to the lungs. 6 It has been reported that an orthopedic surgery trainee used CT image scans and 3D modeling software to create print files representing a patient’s bones. 11 The files were then sent to Shapeways to print custom models used for planning surgery. 11 The cost for 3D printing was a fraction of what it would normally cost to have custom models made, and the turn-around time was faster. 11

3D-printed models can be useful beyond surgical planning. 6 Recently, a polypeptide chain model was 3D printed in such a way that it could fold into secondary structures because of the inclusion of bond rotational barriers and degrees of freedom considerations. 6 Similar models could be utilized to aid the understanding of other types of biological or biochemical structures ( Figure 6 ). 6 Pre- and post-comprehension study results have shown that students are better able to conceptualize molecular structures when such 3D models are used. 6

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A 3D-printed representation of an influenza hemagglutinin trimer. 12

Custom 3D-Printed Dosage Forms and Drug Delivery Devices

3D printing technologies are already being used in pharmaceutical research and fabrication, and they promise to be transformative. 5 Advantages of 3D printing include precise control of droplet size and dose, high reproducibility, and the ability to produce dosage forms with complex drug-release profiles. 5

Complex drug manufacturing processes could also be standardized through use of 3D printing to make them simpler and more viable. 3 3D printing technology could be very important in the development of personalized medicine, too. 3

Personalized Drug Dosing

The purpose of drug development should be to increase efficacy and decrease the risk of adverse reactions, a goal that can potentially be achieved through the application of 3D printing to produce personalized medications. 3 , 5 , 16

Oral tablets are the most popular drug dosage form because of ease of manufacture, pain avoidance, accurate dosing, and good patient compliance. 16 However, no viable method is available that could routinely be used to make personalized solid dosage forms, such as tablets. 16 Oral tablets are currently prepared via well-established processes such as mixing, milling, and dry and wet granulation of powdered ingredients that are formed into tablets through compression or molds. 16 Each of these manufacturing steps can introduce difficulties, such as drug degradation and form change, possibly leading to problems with formulation or batch failures. 16 In addition, these traditional manufacturing processes are unsuitable for creating personalized medicines and restrict the ability to create customized dosage forms with highly complex geometries, novel drug-release profiles, and prolonged stability. 16

Personalized 3D-printed drugs may particularly benefit patients who are known to have a pharmacogenetic polymorphism or who use medications with narrow therapeutic indices. 5 Pharmacists could analyze a patient’s pharmacogenetic profile, as well as other characteristics such as age, race, or gender, to determine an optimal medication dose. 5 A pharmacist could then print and dispense the personalized medication via an automated 3D printing system. 5 If necessary, the dose could be adjusted further based on clinical response. 5

3D printing also has the potential to produce personalized medicines in entirely new formulations—such as pills that include multiple active ingredients, either as a single blend or as complex multilayer or multireservoir printed tablets. 16 Patients who have multiple chronic diseases could have their medications printed in one multidose form that is fabricated at the point of care. 16 Providing patients with an accurate, personalized dose of multiple medications in a single tablet could potentially improve patient compliance. 16 Ideally, compounding pharmacies could dispense 3D-printed drugs, since their customers are already familiar with purchasing customized medications. 5

Unique Dosage Forms

The primary 3D printing technologies used for pharmaceutical production are inkjet-based or inkjet powder-based 3D printing. 5 Whether another material or a powder is used as the substrate is what differentiates 3D inkjet printing from powder-based 3D inkjet printing. 5

In inkjet-based drug fabrication, inkjet printers are used to spray formulations of medications and binders in small droplets at precise speeds, motions, and sizes onto a substrate. 5 The most commonly used substrates include different types of cellulose, coated or uncoated paper, microporous bioceramics, glass scaffolds, metal alloys, and potato starch films, among others. 5 Investigators have further improved this technology by spraying uniform “ink” droplets onto a liquid film that encapsulates it, forming microparticles and nanoparticles. 5 Such matrices can be used to deliver small hydrophobic molecules and growth factors. 5 In powder-based 3D printing drug fabrication, the inkjet printer head sprays the “ink” onto the powder foundation. 5 When the ink contacts the powder, it hardens and creates a solid dosage form, layer by layer. 5 The ink can include active ingredients as well as binders and other inactive ingredients. 5 After the 3D-printed dosage form is dry, the solid object is removed from the surrounding loose powder substrate. 5

These technologies offer the ability to create limitless dosage forms that are likely to challenge conventional drug fabrication. 5 3D printers have already been used to produce many novel dosage forms, such as: microcapsules, hyaluronan-based synthetic extracellular matrices, antibiotic printed micropatterns, mesoporous bioactive glass scaffolds, nanosuspensions, and multilayered drug delivery devices. 5 Ink formulations used in 3D drug printing have included a variety of active ingredients, such as: steroidal anti-inflammatory drugs, acetaminophen, theophylline, caffeine, vancomycin, ofloxacin, tetracycline, dexamethasone, paclitaxel, folic acid, and others. 5 Inactive ingredients used in 3D drug printing have included: poly(lacticco-glycolic acid), ethanol-dimethyl sulfoxide, surfactants (such as Tween 20), Kollidon SR, glycerin, cellulose, propylene glycol, methanol, acetone, and others. 5

Complex Drug-Release Profiles

The creation of medications with complex drug-release profiles is one of the most researched uses of 3D printing. 5 Traditional compressed dosage forms are often made from a homogeneous mixture of active and inactive ingredients, and are thus frequently limited to a simple drug-release profile. 6 However, 3D printers can print binder onto a matrix powder bed in layers typically 200 micro meters thick, creating a barrier between the active ingredients to facilitate controlled drug release. 6 3D-printed dosage forms can also be fabricated in complex geometries that are porous and loaded with multiple drugs throughout, surrounded by barrier layers that modulate release. 6

Implantable drug delivery devices with novel drug-release profiles can also be created using 3D printing. 6 Unlike traditional systemic treatments that can affect nonafflicted tissue, these devices can be implanted to provide direct treatment to the area involved. 6 Bone infections are one example where direct treatment with a drug implant is more desirable than systemic treatment. 6 Fortunately, powder-based 3D-printed bone scaffolding can be created in high-resolution models with complex geometries that mimic the natural bone extracellular matrix. 5 The printing of medications with customized drug-release profiles into such bone implant scaffolds has been studied. 5 One example is the printing of a multilayered bone implant with a distinct drug-release profile alternating between rifampicin and isoniazid in a pulse release mechanism. 5 3D printing has also been used to print antibiotic micropatterns on paper, which have been used as drug implants to eradicate Staphylococcus epidermidis . 5

In other research concerning drug-release profiles, chlorpheniramine maleate was 3D printed onto a cellulose powder substrate in amounts as small as 10 to 12 moles to demonstrate that even a minute quantity of drug could be released at a specified time. 5 This study displayed improved accuracy for the release of very small drug doses compared with conventionally manufactured medications. 5 Dexamethasone has been printed in a dosage form with a two-stage release profile. 5 Levofloxacin has been 3D printed as an implantable drug delivery device with pulsatile and steady-state release mechanisms. 5

BARRIERS AND CONTROVERSIES

Unrealistic expectations and hype.

Despite the many potential advantages that 3D printing may provide, expectations of the technology are often exaggerated by the media, governments, and even researchers. 3 This promotes unrealistic projections, especially regarding how soon some of the more exciting possibilities—such as organ printing—will become a reality. 3 Although progress is being made toward these and other goals, they are not expected to happen soon. 3 , 4 3D printing will require vision, money, and time for the technology to evolve into the anticipated applications. 3 While it is certain that the biomedical sector will be one of the most fertile fields for 3D printing innovations, it is important to appreciate what has already been achieved without expecting that rapid advances toward the most sophisticated applications will occur overnight. 3

Safety and Security

3D printing has given rise to safety and security issues that merit serious concern. 8 , 11 3D printers have already been employed for criminal purposes, such as printing illegal items like guns and gun magazines, master keys, and ATM skimmers. 7 , 11 These occurrences have highlighted the lack of regulation of 3D printing technology. 7 In theory, 3D printing could also be used to counterfeit substandard medical devices or medications. 12 Although 3D printing should not be banned, its safety over the long term will clearly need to be monitored. 7

In 2012, in response to the news that a functioning plastic handgun had been 3D printed, several local and state legislators introduced bills banning access to this technology. 8 However, such fear-based policy responses could stifle the culture of openness necessary for 3D printing to thrive. 8 Such a ban could push 3D printing underground at the expense of important scientific, medical, and other advances. 8 There have already been reports of “garage biology” being conducted that could potentially lead to innovations in the life sciences. 8 However, it is being conducted in secrecy to avoid interference from law enforcement—even though the research is legal. 8

Patent and Copyright Concerns

Manufacturing applications of 3D printing have been subject to patent, industrial design, copyright, and trademark law for decades. 11 However, there is limited experience regarding how these laws should apply to the use of 3D printing by individuals to manufacture items for personal use, nonprofit distribution, or commercial sale. 11 Patents with a finite duration usually provide legal protection for proprietary manufacturing processes, composition of matter, and machines. 11 To sell or distribute a 3D-printed version of a patented item, a person would have to negotiate a license with the patent owner, since distribution of the item without permission would violate patent law. 11

Copyright is also an issue encountered in 3D printing. 11 The fact that copyrights traditionally don’t apply to functional objects beyond their aesthetic value may limit the significance in this area. 11 However, that does not mean that concerns about copyrights are inconsequential. 11 In at least one case, a designer filed a copyright takedown notice demanding that a 3D print file repository remove another participant’s design because the complainant considered the design to infringe on his copyright. 11

Regulatory Concerns

Securing approval from regulators is another significant barrier that may impede the widespread medical application of 3D printing. 5 , 7 A number of fairly simple 3D-printed medical devices have received the FDA’s 510(k) approval. 17 However, fulfilling more demanding FDA regulatory requirements could be a hurdle that may impede the availability of 3D-printed medical products on a large scale. 5 , 17 For example, the need for large randomized controlled trials, which require time and funding, could present a barrier to the availability of 3D-printed drug dosage forms. 5 In addition, manufacturing regulations and state legal requirements could impose obstacles regarding the dispensing of 3D-printed medications. 5 3D drug printers must also be legally defined as manufacturing or compounding equipment to better determine what laws they are subject to. 5

Ultimately, the regulatory decisions that are made should be based on sound science and technology. 8 With this goal in mind, the FDA recently created a working group to assess technical and regulatory considerations regarding 3D printing. 17 The FDA is also sponsoring a 3D printing workshop and webinar regarding technical considerations of 3D-printed medical devices, which will be held on October 8 and 9, 2014. 17 , 18 Members of industry and academia have been invited to participate so that they may help shape future regulatory guidance. 17 , 18

FUTURE TRENDS

3D printing is expected to play an important role in the trend toward personalized medicine, through its use in customizing nutritional products, organs, and drugs. 3 , 9 3D printing is expected to be especially common in pharmacy settings. 5 The manufacturing and distribution of drugs by pharmaceutical companies could conceivably be replaced by emailing databases of medication formulations to pharmacies for on-demand drug printing. 1 This would cause existing drug manufacturing and distribution methods to change drastically and become more cost-effective. 1 If most common medications become available in this way, patients might be able to reduce their medication burden to one polypill per day, which would promote patient adherence. 5

The most advanced 3D printing application that is anticipated is the bioprinting of complex organs. 3 , 11 It has been estimated that we are less than 20 years from a fully functioning printable heart. 8 Although, due to challenges in printing vascular networks, the reality of printed organs is still some way off, the progress that has been made is promising. 3 , 7 As the technology advances, it is expected that complex heterogeneous tissues, such as liver and kidney tissues, will be fabricated successfully. 9 This will open the door to making viable live implants, as well as printed tissue and organ models for use in drug discovery. 9 It may also be possible to print out a patient’s tissue as a strip that can be used in tests to determine what medication will be most effective. 1 In the future, it could even be possible to take stem cells from a child’s baby teeth for lifelong use as a tool kit for growing and developing replacement tissues and organs. 3

In situ printing, in which implants or living organs are printed in the human body during operations, is another anticipated future trend. 13 Through use of 3D bioprinting, cells, growth factors, and biomaterial scaffolding can be deposited to repair lesions of various types and thicknesses with precise digital control. 10 In situ bioprinting for repairing external organs, such as skin, has already taken place. 13 In one case, a 3D printer was used to fill a skin lesion with keratinocytes and fibroblasts, in stratified zones throughout the wound bed. 13 This approach could possibly advance to use for in situ repair of partially damaged, diseased, or malfunctioning internal organs. 13 A handheld 3D printer for use in situ for direct tissue repair is an anticipated innovation in this area. 10 Advancements in robotic bioprinters and robot-assisted surgery may also be integral to the evolution of this technology. 13

3D printing has become a useful and potentially transformative tool in a number of different fields, including medicine. 6 As printer performance, resolution, and available materials have increased, so have the applications. 6 Researchers continue to improve existing medical applications that use 3D printing technology and to explore new ones. 6 The medical advances that have been made using 3D printing are already significant and exciting, but some of the more revolutionary applications, such as organ printing, will need time to evolve. 3

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What Is Medical 3D Printing—and How Is it Regulated?

As health providers find new ways to apply manufacturing technology, fda oversight must evolve.

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Advances in 3D printing, also called additive manufacturing, are capturing attention in the health care field because of their potential to improve treatment for certain medical conditions. A radiologist, for instance, might create an exact replica of a patient’s spine to help plan a surgery; a dentist could scan a broken tooth to make a crown that fits precisely into the patient’s mouth. In both instances, the doctors can use 3D printing to make products that specifically match a patient’s anatomy.

And the technology is not limited to planning surgeries or producing customized dental restorations such as crowns; 3D printing has enabled the production of customized prosthetic limbs, cranial implants, or orthopedic implants such as hips and knees. At the same time, its potential to change the manufacturing of medical products—particularly high-risk devices such as implants—could affect patient safety, creating new challenges for Food and Drug Administration (FDA) oversight.

This issue brief explains how medical 3D printing is used in health care, how FDA regulates the products that are made, and what regulatory questions the agency faces.

What is 3D printing and how is it used in health care?

Unlike traditional methods, in which products are created by shaping raw material into a final form through carving, grinding, or molding, 3D printing is an additive manufacturing technique that creates three-dimensional objects by building successive layers of raw material such as metals, plastics, and ceramics. The objects are produced from a digital file, rendered from a magnetic resonance image (MRI) or a computer-aided design (CAD) drawing, which allows the manufacturer to easily make changes or adapt the product as desired. 1 3D printing approaches can differ in terms of how the layers are deposited and in the type of materials used. 2 A variety of 3D printers are available on the market, ranging from inexpensive models aimed at consumers and capable of printing small, simple parts, to commercial grade printers that produce significantly larger and more complex products.

To date, most FDA-reviewed products developed via 3D printing have been medical devices such as orthopedic implants; more than 100 have been reviewed. 3 Such a manufacturing approach offers several clinical advantages. For example, manufacturers have used 3D printing technologies to create devices with complex geometries such as knee replacements with a porous structure, which can facilitate tissue growth and integration. 4 3D printing also provides the ability to create a whole product or device component at once while other manufacturing techniques may require several parts to be fabricated separately and screwed or welded together.

Because this type of manufacturing does not rely on molds or multiple pieces of specialized equipment and designs can rapidly be modified, 3D printing can also be used for creating patient-matched products based on the patient’s anatomy. Examples include joint replacements, cranial implants, and dental restorations. 5 While some large-scale manufacturers are creating and marketing these products, this level of customization is also being used at the site of patient care in what is called point-of-care manufacturing. This on-demand creation of 3D-printed medical products is based on a patient’s imaging data. Medical devices that are printed at the point of care include patient-matched anatomical models, prosthetics, and surgical guides, which are tools that help guide surgeons on where to cut during an operation. The number of U.S. hospitals with a centralized 3D printing facility has grown rapidly in the past decade, from just three in 2010 to more than 100 by 2019. 6 As the technology evolves, this point-of-care model may become even more widespread.

3D printing also has potential applications in other product areas. For example, research is underway to use 3D printing to manufacture pharmaceuticals with the potential for unique dosage forms or formulations, including those that might enable slower or faster absorption. FDA approved one such 3D-printed drug in 2015, an epilepsy treatment formulated to deliver a large dose of the active ingredient that can disintegrate quickly in water. 7 3D printing could also one day be used to make personalized treatments that combine multiple drugs into one pill, or a “polypill.” 8 Additionally, researchers are using bioprinters to create cellular and tissue constructs, such as skin grafts 9 and organs, 10 but these applications are still in experimental phases. 11

How is 3D printing regulated?

FDA does not regulate 3D printers themselves; instead, FDA regulates the medical products made via 3D printing. The type of regulatory review required depends on the kind of product being made, the intended use of the product, and the potential risks posed to patients. Devices—the most common type of product made using 3D printing at this time—are regulated by FDA’s Center for Devices and Radiological Health and are classified into one of three regulatory categories, or classes. (The agency may also regulate the imaging devices and software components involved in the production of these devices, but these are reviewed separately.)

FDA classifies devices based on their level of risk and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. 12 Class I devices are low risk and include products such as bandages and handheld surgical instruments. Class II devices are considered moderate risk and include items such as infusion pumps, while Class III devices, which are considered high risk, include products that are life-supporting or life-sustaining, substantially important in preventing impairment of human health, or present an unreasonable risk of illness or injury. A pacemaker is an example of a Class III device. 13

Regulatory scrutiny increases with each corresponding class. Most Class I and some Class II devices are exempt from undergoing FDA review prior to entering the market, known as premarket review; however, they must comply with manufacturing and quality control standards. Most Class II devices undergo what is known as a 510(k) review (named for the relevant section of the Federal Food, Drug, and Cosmetic Act), in which a manufacturer demonstrates that its device is “substantially equivalent” to an existing device on the market, reducing the need for extensive clinical research. Class III devices must submit a full application for premarket approval that includes data from clinical trials. 14 FDA then determines whether sufficient scientific evidence exists to demonstrate that the new device is safe and effective for its intended use. 15

FDA also maintains an exemption for custom devices. A custom device may be exempt from 510(k) or premarket approval submissions if it meets certain requirements articulated under Section 520(b) of the Federal Food, Drug, and Cosmetic Act. These requirements include, for example, that the manufacturer makes no more than five units of the device per year, and that it is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat. 16 In addition, FDA has the option to issue emergency use authorizations as it did in response to the COVID-19 pandemic for certain 3D-printed ventilator devices. 17

All devices, unless specifically exempted, are expected by FDA to adhere to current good manufacturing practices, known as the quality system regulations that are intended to ensure a finished device meets required specifications and is produced to an adequate level of quality. 18

In 2017, FDA released guidance on the type of information that should be included for 3D-printed device application submissions, including for patient-matched devices such as joint replacements and cranial implants. The document represents FDA’s initial thinking, and provides information on device and manufacturing process and testing considerations. 19 However, the guidance does not specifically address point-of-care manufacturing, which is a potentially significant gap given the rapid uptake of 3D printers by hospitals over the past few years. FDA has also cleared software programs that are specifically intended to generate 3D models of a patient’s anatomy; 20 however, it is up to the actual medical facility to use that software within the scope of its intended use—and to use it correctly.

Although specific guidance from FDA does not yet exist for 3D printing in the drug or biologic domains, these products are subject to regulation under existing pathways through FDA’s Center for Drug Evaluation and Research (CDER) or FDA’s Center for Biologics Evaluation and Research (CBER). Each product type is associated with unique regulatory challenges that both centers are evaluating. CDER’s Office of Pharmaceutical Quality is conducting its own research to understand the potential role of 3D printing in developing drugs and has been coordinating with pharmaceutical manufacturers to utilize this technology. 21 CBER has also interacted with stakeholders who are researching the use of 3D printing for biological materials, such as human tissue. In 2017, former FDA Commissioner Scott Gottlieb said that FDA planned to review the regulatory issues associated with bioprinting to see whether additional guidance would be necessary outside of the regulatory framework for regenerative medicine products. 22 However, no subsequent updates on this review have emerged.

For medical 3D printing that occurs outside the scope of FDA regulation, little formal oversight exists. State medical boards may be able to exert some oversight if 3D printing by a particular provider is putting patients at risk; however, these boards typically react to filed complaints, rather than conduct proactive investigations. At least one medical professional organization, the Radiological Society of North America, has released guidelines for utilizing 3D printing at the point of care, which includes recommendations on how to consistently and safely produce 3D-printed anatomical models generated from medical imaging, as well as criteria for the clinical appropriateness of using 3D-printed anatomical models for diagnostic use. 23 Other professional societies may follow suit as 3D printing becomes more frequent in clinical applications; however, such guidelines do not have the force of regulation.

Challenges for FDA oversight

3D printing presents unique opportunities for biomedical research and medical product development, but it also poses new risks and oversight challenges because it allows for the decentralized manufacturing of highly customized products—even high-risk products such as implantable devices—by organizations or individuals that may have limited experience with FDA regulations. The agency is responsible for ensuring that manufacturers comply with good manufacturing practices and that the products they create meet the statutory requirements for safety and effectiveness. When used by registered drug, biologic, or device manufacturers in centralized facilities subject to FDA inspection, 3D printing is not unlike other manufacturing techniques. With respect to 3D printing of medical devices in particular, FDA staff have stated that “[t]he overarching view is that it’s a manufacturing technology, not something that exotic from what we’ve seen before.” 24

However, when 3D printing is used to manufacture a medical product at the point of care, oversight responsibility can become less clear. It is not yet apparent how the agency should adapt its regulatory requirements to ensure that these 3D-printed products are safe and effective for their intended use. FDA does not directly regulate the practice of medicine, which is overseen primarily by state medical boards. Rather, the agency’s jurisdiction covers medical products. In some clinical scenarios where 3D printing might be used, such as the printing of an anatomical model that is used to plan surgery, or perhaps one day the printing of human tissue for transplantation, the distinction between product and practice is not always easy to discern.

In recognition of this complexity, FDA’s Center for Devices and Radiological Health is developing a risk-based framework that includes five potential scenarios in which 3D printing can be used for point-of-care manufacturing of medical devices. (See Table 1.) 25

Table 1. Conceptual Framework for 3D Printing at the Point of Care

Scenario Description
A) Minimal risk 3D printing by a health care professional Devices falling under this scenario would pose minimal risk of harm to patients. This standard still needs to be defined by FDA but might include models used for patient education or counseling.
B) Device designed by manufacturer using validated process: turnkey system Under this scenario, manufacturers would sell a ready-to-use package or system to a point-of-care facility, most likely including software, hardware, and process parameters. The manufacturer would need to receive clearance or approval from FDA for its product to be used at the point of care, which would require a demonstration that product specifications can be met when 3D-printed by the end user. The health care facility would be responsible for printing the product within the manufacturer’s cleared or approved specifications, and for using the product for its cleared or approved intended use.
C) Device designed by manufacturer using validated process: additional health care professional capability requirements This is similar to the previous scenario, except that the point-of-care facility might undergo more complex manufacturing or post-printing processes. The cleared or approved device would likely have labeling that included additional instructions for the end user, and the clearance process may also include requirements for on‐site testing and training from the manufacturer to facilitate appropriate 3D printing by the health care facility. The facility would also need trained personnel and appropriate equipment.
D) Manufacturer is co-located at the point of care This scenario would occur when a device manufacturer is located at the same point-of-care facility or as close as possible. The manufacturer would be responsible for most or all aspects of 3D printing, including using its own personnel and equipment.
E) Health care facility becomes a manufacturer A point-of-care facility that wishes to print devices outside of the minimal-risk classification but wants control over its own operations would fall under this scenario. The health care facility would become a 3D printing manufacturer, and thus would likely be responsible for all regulatory requirements, and for device development, design, and testing.

Sources: U.S. Food and Drug Administration, Center for Devices and Radiological Health Additive Manufacturing Working Group; The American Society of Mechanical Engineers

Balancing innovation and safety at the point of care

Questions remain related to each regulatory scenario for point-of-care manufacturing. For example, it is unclear how “minimal risk” should be evaluated or determined. Should only Class I devices be considered minimal risk or is this determination independent of classification? Is off-label use considered minimal risk? Under the scenarios that involve a close collaboration between a device manufacturer and a health care facility, such as scenarios B and C, who assumes legal liability in cases in which patients may be harmed? Who ensures device quality, given that a specific 3D-printed device depends on many factors that will vary from one health care facility to another (including personnel, equipment, and materials)? Co-locating a manufacturer with a health care facility raises questions about the distinction between the manufacturer and the facility, in addition to liability concerns. Finally, many health care facilities may be ill-prepared to meet all the regulatory requirements necessary for device manufacturers, such as quality system regulations. 26

More broadly, challenges will emerge in determining how FDA should deploy its limited inspection and enforcement resources, especially as these technologies become more widespread and manufacturing of 3D-printed devices becomes more decentralized. Furthermore, as the technology advances and potentially enables the development of customized treatments, including drugs and biological products, FDA’s other centers will need to weigh in on 3D printing. The agency may need to define a new regulatory framework that ensures the safety and effectiveness of these individualized products.

3D printing offers significant promise in the health care field, particularly because of its ability to produce highly customized products at the point of care. However, this scenario also presents challenges for adequate oversight. As 3D printing is adopted more widely, regulatory oversight must adapt in order to keep pace and ensure that the benefits of this technology outweigh the potential risks.

  • U.S. Food and Drug Administration, “3D Printing of Medical Devices,” last modified March 26, 2020, https://www.fda.gov/medical-devices/products-and-medical-procedures/3d-printing-medical-devices .
  • SME, “Additive Manufacturing Glossary,” accessed July 17, 2020, https://www.sme.org/technologies/additive-manufacturing-glossary/ .
  • U.S. Food and Drug Administration, “Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA Ushering in New Era of 3D Printing of Medical Products; Provides Guidance to Manufacturers of Medical Device,” news release, Dec. 4, 2017, https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-fda-ushering-new-era-3d-printing-medical-products .
  • L. Ricles et al., “Regulating 3D-Printed Medical Products,” Science Translational Medicine 10, no. 461 (2018), https://pubmed.ncbi.nlm.nih.gov/30282697/ .
  • M. Di Prima et al., “Additively Manufactured Medical Products—the FDA Perspective,” 3D Printing in Medicine 2 , no. 1 (2016), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6027614/ .
  • SME, “Physicians as Manufacturers: The Rise of Point-of-Care Manufacturing” (Medical Manufacturing Innovations), https://www.sme.org/globalassets/sme.org/media/white-papers-and-reports/3d_printing_fuels_the_rise.pdf ; T. Pietila, “How Medical 3D Printing Is Gaining Ground in Top Hospitals,” Materialise , June 11, 2019, https://www.materialise.com/en/blog/3D-printing-hospitals .
  • Aprecia Pharmaceuticals Company, “FDA Approves the First 3D Printed Drug Product,” news release, Aug. 3, 2015, https://www.aprecia.com/news/fda-approves-the-first-3d-printed-drug-product .
  • U.S. Food and Drug Administration, “CDER Researchers Explore the Promise and Potential of 3D Printed Pharmaceuticals,” last modified Dec. 11, 2017, https://www.fda.gov/drugs/news-events-human-drugs/cder-researchers-explore-promise-and-potential-3d-printed-pharmaceuticals .
  • Wake Forest School of Medicine, “Printing Skin Cells on Burn Wounds,” https://school.wakehealth.edu/Research/Institutes-and-Centers/Wake-Forest-Institute-for-Regenerative-Medicine/Research/Military-Applications/Printing-Skin-Cells-on-Burn-Wounds .
  • C. Kelly, “3D-Printed Organs Nearing Clinical Trials,” The American Society of Mechanical Engineers, March 3, 2020, https://www.asme.org/topics-resources/content/3d-printed-organs-nearing-clinical-trials .
  • Di Prima et al., “Additively Manufactured Medical Products.”
  • U.S. Food and Drug Administration, “Overview of Medical Device Classification and Reclassification,” last modified Dec. 19, 2017, https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification .
  • U.S. Food and Drug Administration, Code of Federal Regulations Title 21 Volume 8, 21 CFR 860.3 (2019), https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=860.3 ; U.S. Food and Drug Administration, “Classify Your Medical Device,” last modified Feb. 7, 2020, https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device ; J. Jin, “FDA Authorization of Medical Devices,” JAMA 311, no. 4 (2014): 435, https://jamanetwork.com/journals/jama/fullarticle/1817798 .
  • U.S. Food and Drug Administration, Code of Federal Regulations Title 21 Volume 8; U.S. Food and Drug Administration, Code of Federal Regulations Title 21, 21 CFR Part 814 (2019), https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814 . See also Jin, “FDA Authorization of Medical Devices.”
  • U.S. Food and Drug Administration, Code of Federal Regulations Title 21; U.S. Food and Drug Administration, “Premarket Approval (PMA),” last modified May 16, 2019, https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma .
  • Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 520(b); U.S. Food and Drug Administration, Code of Federal Regulations Title 21, 21 CFR 807.85 (2019), https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=807.85 .
  • Prisma Health, “Innovative Ventilator Device Developed by Prisma Health to Quickly Increase Ventilator Capacity for COVID-19 Patients,” news release, March 25, 2020, https://www.ghs.org/healthcenter/ghsblog/prisma-health-ventilator-covid19/ .
  • U.S. Food and Drug Administration, Code of Federal Regulations Title 21 Part 820, 21 CFR Part 820 (2019), https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 ; Di Prima et al., “Additively Manufactured Medical Products.”
  • U.S. Food and Drug Administration, “Technical Considerations for Additive Manufactured Medical Devices—Guidance for Industry and Food and Drug Administration Staff,” Dec. 5, 2017, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-additive-manufactured-medical-devices .
  • U.S. Food and Drug Administration, “Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA Ushering in New Era of 3D Printing of Medical Products.”
  • L. Chepelev et al., “Radiological Society of North America (RSNA) 3D Printing Special Interest Group (SIG): Guidelines for Medical 3D Printing and Appropriateness for Clinical Scenarios,” 3D Printing in Medicine 4 , no. 11 (2018), https://threedmedprint.biomedcentral.com/articles/10.1186/s41205-018-0030-y .
  • J. Hartford, “FDA’s View on 3-D Printing Medical Devices,” Medical Device and Diagnostic Industry, Feb. 11, 2015, https://www.mddionline.com/3d-printing/fdas-view-3-d-printing-medical-devices .
  • U.S. Food and Drug Administration, Center for Devices and Radiological Health Additive Manufacturing Working Group, “3D Printing Medical Devices at Point of Care” (The American Society of Mechanical Engineers, 2020), https://cdn2.hubspot.net/hubfs/5268583/AMWG-FDA - 3DP at PoC V2.pdf?hsCtaTracking=8b212dad-9d50-4054-92a7-cdaeb1b27dec%7C1cbbfc11-6402-46e4-9a76-16a681e6d84a .
  • The American Society of Mechanical Engineers, “3D Printing of Medical Devices at Point of Care: A Discussion of a Conceptual Framework,” https://resources.asme.org/poc3dp-debrief .

3d rendering 3d printer with resin hand

FDA's Regulatory Framework for 3D Printing of Medical Devices

To plan for the surgical separation of conjoined twin girls in 2020, surgeons at the University of Michigan C.S. Mott Children’s Hospital needed realistic, life-size models of their patients’ shared organs.

3D printer

3D Printing of Medical Equipment Is Only a Stopgap

For the past several months, the COVID-19 pandemic has placed unique pressure on the U.S. health care system and led to significant spikes in demand for hospital beds, personal protective equipment (PPE) for health care workers, and other essential medical products. At the same time, the public health emergency has had a significant impact on the global supply chain.

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A new 3D printing method promises faster, multi-material creations

A 3D printed model of Kyiv’s Saint Sophia Cathedral in the blue and yellow of the Ukrainian flag.

Advancements in 3D printing have made it easier for designers and engineers to customize projects, create physical prototypes at different scales, and produce structures that can’t be made with more traditional manufacturing techniques. But the technology still faces limitations – the process is slow and requires specific materials which, for the most part, must be used one at a time.

Researchers at Stanford have developed a method of 3D printing that promises to create prints faster, using multiple types of resin in a single object. Their design, published recently in Science Advances , is 5 to 10 times faster than the quickest high-resolution printing method currently available and could potentially allow researchers to use thicker resins with better mechanical and electrical properties.

“This new technology will help to fully realize the potential of 3D printing,” says Joseph DeSimone , the Sanjiv Sam Gambhir Professor in Translational Medicine and professor of radiology and of chemical engineering at Stanford and corresponding author on the paper. “It will allow us to print much faster, helping to usher in a new era of digital manufacturing, as well as to enable the fabrication of complex, multi-material objects in a single step.”

Controlling the flow of resin

The new design improves on a method of 3D printing created by DeSimone and his colleagues in 2015 called continuous liquid interface production, or CLIP. CLIP printing looks like it belongs in a science fiction movie – a rising platform smoothly pulls the object, seemingly fully formed, from a thin pool of resin. The resin at the surface is hardened into the right shape by a sequence of UV images projected through the pool, while a layer of oxygen prevents curing at the bottom of the pool and creates a “dead zone” where the resin remains in liquid form.

The dead zone is the key to CLIP’s speed. As the solid piece rises, the liquid resin is supposed to fill in behind it, allowing for smooth, continuous printing. But this doesn’t always happen, especially if the piece rises too quickly or the resin is particularly viscous. With this new method, called injection CLIP, or iCLIP, the researchers have mounted syringe pumps on top of the rising platform to add additional resin at key points.

“The resin flow in CLIP is a very passive process – you’re just pulling the object up and hoping that suction can bring material to the area where it’s needed,” says Gabriel Lipkowitz, a PhD student in mechanical engineering at Stanford and lead author on the paper. “With this new technology, we actively inject resin onto the areas of the printer where it’s needed.”

The resin is delivered through conduits that are printed simultaneously with the design. The conduits can be removed after the object is completed or they can be incorporated into the design the same way that veins and arteries are built into our own body.

Multi-material printing

By injecting additional resin separately, iCLIP presents the opportunity to print with multiple types of resin over the course of the printing process – each new resin simply requires its own syringe. The researchers tested the printer with as many as three different syringes, each filled with resin dyed a different color. They successfully printed models of famous buildings from several countries in the color of each country’s flag, including Saint Sophia Cathedral in the blue and yellow of the Ukrainian flag and Independence Hall in American red, white, and blue.

“The ability to make objects with variegated material or mechanical properties is a holy grail of 3D printing,” Lipkowitz says. “The applications range from very efficient energy-absorbing structures to objects with different optical properties and advanced sensors.”

Having successfully demonstrated that iCLIP has the potential to print with multiple resins, DeSimone, Lipkowitz, and their colleagues are working on software to optimize the design of the fluid distribution network for each printed piece. They want to ensure that designers have fine control over the boundaries between resin types and potentially speed up the printing process even further.

“A designer shouldn’t have to understand fluid dynamics to print an object extremely quickly,” Lipkowitz says. “We’re trying to create efficient software that can take a part that a designer wants to print and automatically generate not only the distribution network, but also determine the flow rates to administer different resins to achieve a multi-material goal.”

Related:  Joseph DeSimone , the Sanjiv Sam Gambhir Professor of Translational Medicine, professor of chemical engineering and, by courtesy, of chemistry and of operations, information and technology at the Graduate School of Business and member of Stanford Bio-X

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Rachel Berkowitz is a freelance science writer and editor with a Ph.D. in geophysics from the University of Cambridge.

3 metal rods pointed onto a glass plate on top of a metal plate with holes in it

A 3D printing method from researchers at the University of Notre Dame can deposit glass at 15 cubic millimeters per second.

For centuries, humans have heated, blown, and stretched glass into everything from useful household items to intricate story-telling windows. Now researchers at the University of Notre Dame in Indiana are working to adapt artisan glass-blowing techniques to a robotic platform. Instead of a torch and a pair of flame-resistant gloves, they used a laser and a computer-controlled stage. And they’re showing that it works for creating the transparent solid structures needed in optical, microfluidic, and photonic devices.

Ed Kinzel is an associate professor of aerospace and mechanical engineering at the University of Notre Dame. His goal is to capture the geometric freedom of the handblown glass approach with the precision of modern 3D printing . “I would argue that there are no good ways to rapidly prototype with glass,” says Kinzel. If you want a glass geometry different than that which comes up in commercial chemistry apparatus, you would go to a scientific glass blower—and pay the price in both money and time. That’s not the case for metals and many polymers, where computer numerical control (CNC) can rapidly create individual parts with complicated geometries, one at a time. A machine that allows rapid manufacturing of glass can bridge that gap.

But the very properties that make silicate-based glasses desirable for scientific equipment and consumer products—high thermal stability, stiffness, optical transparency, and chemical inertness—put the material out of reach of most additive manufacturing processes. For example, high molten viscosity makes it hard to get rid of bubbles in powderbed processes, and glass’s transparency from near ultraviolet to near infrared wavelengths means that they do not absorb the high-energy continous wave lasers that are common in melt-and-solidify layering approaches.

How to 3D Print Glass

One additive approach starts with fully formed glass and fuses it under the application of heat—workable for glasses with lower processing temperatures, and for lower-resolution components. But the seams that form between adjacent tracks limit the transparency and make it difficult to create fully dense structures. Another successful approach, that’s even been commercialized , deposits silica-precursor slurries combined with a photopolymer into a pattern, then dries and densifies the resulting structure through prolonged heating. This approach has “created some awesome objects but may struggle to make larger or sparse structures,” says Kinzel.

That’s where digital glass forming comes in. Kinzel and his colleagues developed a technique that uses a laser to heat the surface of a glass rod, an approach that some companies are already using to produce glass products. Other teams, including Kinzel and his colleagues, independently arrived at a similar approach in 2014, and they’re adapting it to use for specialized applications.

In Kinzel’s lab, a carbon dioxide laser locally melts a small-diameter glass filament, so it can be deformed. The researchers construct 3D shapes by moving a fused quartz substrate on a 4-axis CNC platform relative to the intersection of the filament and the laser beam. The molten glass is controllably shaped by the interaction with the substrate and pressure from the unheated portion of the filament , as well as by gravity and surface tension. Applying pneumatic pressure directed down the glass feedstock allowed the team to apply this process to hollow glass rods to create both on-substrate 2D shapes and free-standing 3D spiral structures.

Improving the 3D Printing Process for Glass

By carefully tweaking the properties of the scan rate, laser power, and the filament feed rates, Kinzel and colleagues Luis Deutsch Garcia and Horacio Ahuett Garza at the Monterrey Institute of Technology and Higher Education in Mexico have progressed from slowly printing hollow-tube structures to rapidly creating dense, perfectly transparent 3D solids. In volumetric heating, a laser beam in a coaxial configuration heats a soda lime glass filament that is itself transparent to the laser—but lacing it with dopants changes the optical penetration depth. Experiments showed it possible to fabricate fully dense, smooth, bubble-free 2D and 3D geometries on the scale of tens-of-millimeters at a deposition rate of 15 cubic millimeters per second. This was limited by current stage performance, and models predict that ultimate performance may be much higher.

“Precisely creating glass structures is hard,” says Kinzel. Lenses can, of course, be subtractively manufactured—magnetically or mechanically grinding a surface down to perfection—and tools exist for precision-forming glass lenses for high-volume manufacturing. But free-surface, free-form glass structures are generally limited to one-dimensional sheets or fibers. “We believe there are applications such as lightweight, high strength lattices, that would benefit from glasses properties but would be very challenging to produce by an artisan and would benefit from high precision,” says Kinzel.

The team has also demonstrated their ability to create optical waveguides, where 125-micrometer-diameter fiber feedstock deposited on a substrate maintain optical transmission around curves of a sufficient diameter. To create photonic circuits, however, two deposited fibers must be coupled together such that evanescent waves from one fiber core can be coupled into another. “We’ve been able to create simple optics and are working toward printing photonic structures,” says Kinzel.

The work was presented in July at Optica’s Advanced Photonics conference in Quebec. The researchers further discuss the technical details in a June paper in the Journal of Manufacturing Processes.

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Rachel Berkowitz is a freelance science writer and editor with a Ph.D. in geophysics from the University of Cambridge. She is a corresponding editor at the American Physical Society's Physics Magazine. Her work has appeared in Scientific American , New Scientist , Science News , Physics Today , and the newsrooms of several U.S. national laboratories.

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Self-improving AI method increases 3D‑printing efficiency

The nozzle of a 3D printer as it creates the model of a prostate.

PULLMAN, Wash. — An artificial intelligence algorithm can allow researchers to more efficiently use 3D printing to manufacture intricate structures.

The Washington State University study, published in the journal Advanced Materials Technologies , could allow for more seamless use of 3D printing for complex designs in everything from artificial organs to flexible electronics and wearable biosensors. As part of the study, the algorithm learned to identify, and then print, the best versions of kidney and prostate organ models, printing out 60 continually improving versions.

“You can optimize the results, saving time, cost and labor,” said Kaiyan Qiu, co-corresponding author on the paper and Berry Assistant Professor in the WSU School of Mechanical and Materials Engineering.

The use of 3D printing has been growing in recent years, allowing industrial engineers to quickly convert customized designs on a computer to a wide range of products — including wearable devices, batteries and aerospace parts.

But for engineers, trying to develop the correct settings for their printing projects is cumbersome and inefficient. Engineers have to decide on materials, the printer configuration and the dispensing pressure of the nozzle, for instance — all of which affect the final product.

“The sheer number of potential combinations is overwhelming, and each trial costs time and money,” said Jana Doppa, co-corresponding author and Huie-Rogers Endowed Chair Associate Professor of Computer Science at WSU.

Qiu has done research for several years in developing complex, lifelike 3D-printed models of human organs. They can be used, for instance, in training surgeons or evaluating implant devices, but the models have to include the mechanical and physical properties of the real-life organ, including veins, arteries, channels and other detailed structures.

Qiu, Doppa, and their students used an AI technique called Bayesian Optimization to train and find the optimized 3D-printing settings. Once it was trained, the researchers were able to optimize three different objectives for their organ models — the geometry precision of the model, its weight or how porous it is and the printing time. Porosity of the organ model is important for surgery practice, for instance, because the model’s mechanical properties can change depending on its density.

“It’s hard to balance all the objectives, but we were able to strike a favorable balance and achieve the best possible printing of a quality object, regardless of the printing type or material shape,” said co-first author Eric Chen, a WSU visiting student working in Qiu’s group in the School of Mechanical and Materials Engineering. 

Alaleh Ahmadian, co-first author and WSU graduate student in the School of Electrical Engineering and Computer Science, added that the researchers were able to look at all the objectives in a balanced manner for favorable results and that the project benefited from its interdisciplinary perspective.

“It is very rewarding to work on interdisciplinary research by performing physical lab experiments to create real world impact,” she said.

The researchers first trained the computer program to print out a surgical rehearsal model of a prostate. Because the algorithm is broadly generalizable, they could easily change it with small tunings to print out a kidney model.

 “That means that this method can be used to manufacture other more complicated biomedical devices, and even to other fields,” said Qiu.

The work was funded by the National Science Foundation, WSU Startup and Cougar Cage Funds.

Media Contacts

  • Kaiyan Qui , WSU School of Mechanical and Materials Engineering , 509-335-3223 , [email protected]
  • Jana Doppa , WSU School of Electrical Engineering and Computer Science , 509-335-1846 , [email protected]
  • Sara Zaske , WSU News & Media Relations , 509-335-4846 , [email protected]

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Manufacturing and Additive Design of Electric Machines by 3D Printing

NREL's crosscutting research on advanced design optimization for three-dimensional (3D) printing of electric machines could enable next-generation, lightweight offshore wind turbine generators with reduced use of critical materials.

The research will transform the manufacturing infrastructure needed to meet the deployment goals for offshore wind in the United States.

2D and 3D models of magnets for wind turbines

Project Background

At NREL, researchers are working on Manufacturing and Additive Design of Electric Machines by 3D Printing (MADE3D™), a 5-year project that began in 2020. The project, funded through the U.S. Department of Energy’s (DOE’s) Wind Energy Technologies Office, is a collaboration among researchers at national laboratories (NREL and Oak Ridge National Laboratory), government agencies (NASA-Glenn Research Center), and industry (Bergey WindPower).

As the United States transitions to a large-scale clean energy economy with diverse renewable energy sources with minimal land impact, offshore wind will be a crucial player. With an ambitious target of 30 GW of wind power installation by 2030, and a surge in interest for larger turbines beyond 12 MW, innovations are needed in design and domestic manufacture of large turbines. We also need to address challenges of transportability and weight of large components and reduce raw material demand, considering soaring prices and supply chain shortages with limited manufacturing infrastructure. A needed area of innovation is efficient, reliable, high-power, dense generators with reduced rare-earth content. Direct-drive generators are popular but tend to use large amounts of magnets (>1T/MW) and scale disproportionately in terms of mass. This makes them prohibitively expensive (such generators can weigh over 300 tons and span more than 10 meters in diameter and introduce challenges for lifting and transportation by shipping vessels). Traditional design and manufacturing methods for lightweighting such generators offer limited opportunities to conserve rare-earth minerals and use processes that are environmentally unfriendly and result in excessive material waste.

Designing and manufacturing with supply chain considerations is more important than ever. Therefore, several wind original equipment manufacturers have announced new manufacturing facilities near port locations to reduce costs. They are pursuing new, efficient materials and designs to reduce critical material usage—especially of rare earth magnets, electrical steel, and  copper—which could alleviate challenges in foreign sourcing of raw materials. As performance gaps exist with alternative materials, we need to find new ways of designing lightweight wind turbine generators with reduced rare-earth magnets that can match the performance of existing generators. Efforts are needed to enable such designs by innovative manufacturing with domestically sourced, cheaper magnet materials for wind turbines.

The goal of the MADE3D project is to enable better-performing electric machines that are lightweight and free of critical rare-earth elements by leveraging advances in magnet and metal additive manufacturing. Project researchers are doing this by exploring the full design space and improving near-net shaping using new powerful machine learning-enabled software and multimaterial additive manufacturing methods. The MADE3D team's efforts target high-power-density motors and generators in technologies across industries, including:

  • Large offshore wind turbines
  • Electric aircrafts
  • Naval platforms and ships
  • Electric drives in cars and other automobiles.

The team approached the project in multiple steps.

  • It examined the potential for weight reduction using advanced optimization techniques for a 15-MW and 15-kW direct drive generator.
  • It developed two new methods for magnetic topology optimization leveraging 3D-printed magnet materials: aIt s grid-based topology optimization and a grid-free shape optimization.
  • It made available a new magnetic topology optimization software, MADE3D-Advanced Machine Learning © , which uses physics-informed machine learning models for training and generator performance prediction for new topologies for a given target torque and mass reduction. The toolset greatly accelerates the design space exploration in identifying new, advanced designs that are lightweight and can be single or multimaterial.
  • The MADE3D-Advanced Machine Learning toolset helped identify a more than 15-ton reduction in rotor electrical steel mass (more than 50% reduction in rotor electrical steel mass) from the baseline 15-MW direct drive generator.
  • The toolset was extended on a commercial baseline 15-kW generator by Bergey Wind Power Co. and helped identify up to 35% magnet mass reduction with 1% improvement in efficiency when compared to the baseline machine . Further, the presence of polymer binder in printed magnets make them up to 30% cheaper than sintered magnets. From a raw-materials cost perspective, this will serve as a major incentive to use polymer-bonded magnets in wind turbine generators.
  • It advanced Dy-free NdFeB polymer-bonded magnets with a 75% volume higher magnetic loading and an energy product of up to 20 MGOe using the BAAM system. Further research with reduced polymer loading and metal additives can pave the way for higher energy products of up to 30 MGOe.
  • It advanced laser powder bed-based printing technology for printing electrical steel laminates for a 15-kW generator with properties comparable to baseline electrical steel laminates.
  • It developed a new extrusion-based printing, followed by insert molding, for multimaterial printing of magnets with electrical steel. The method will simplify the magnet assembly process by eliminating the need for adhesives.
  • It evaluated candidate conductors (copper, silver-coated copper and silver, and compounded silver and copper) and insulation materials. It also developed a method for multimaterial printing of electrical conductors with insulation using a direct-ink write method.
  • It evaluated the technical readiness of state-of-the-art commercial printers, the material handling capabilities, and the gaps and challenges in scaling the lab-developed processes for printing stator laminations, electrical conductors, rotor core, and magnets.
  • Identified indirect additive manufacturing (sand printing followed by casting) as the most cost-effective production for rotor core. Current costs to print stator laminations are high, owing to high energy consumption for laser power and scan speed for achieving the best magnetic properties. Further R&D on print parameter optimization can help lower printing costs.

The team is looking ahead to next steps to get the technologies developed to commercialization:

  • 2025–2027: Design, build, and validate a proof-of-concept prototype electric machine with reduced rare-earth magnets
  • 2027–2030: Expand to other industries by advancing magnet and conductor technologies.
  • 2030–Beyond: Integrate into production lines for industry adoption.

This project received feedback and inputs from an expert advisory board comprising experts from the industry, including General Electric Vernova, Siemens Technology Corp., ABB, and Arnold Magnetics. The team is continuing to work with government agencies (DOE Wind Energy Technologies Office, DOE Advanced Materials and Manufacturing Technologies Offices, and NASA-Glenn), original equipment manufacturers (Bergey WindPower), 3D printer manufacturers (Renishaw, Volunteer Aerospace, ExOne, and Additive Drives), and GmBH.

NREL: DiLea Bindel, Ganesh Vijaykumar, Jonathan Keller, Andrew Glaws, Miles Skinner, Hannes Labuschagne, Lee Jay Fingersh Oak Ridge National Laboratory: Parans Paranthaman, Haobo Wang, Willie Kemp, Tej Nath Lamichhane, Kaustubh Mungale, Uday Vaidya NASA-Glenn: Michael Halbig, Mrityunjay Singh, Zachary Tuchfeld Bergey Wind Power Co.: Tod Hanley, Mike Bergey

A software record, SWR-20-70 for MADE3D-AML has been asserted with a closed-source copyright.

A nonprovisional patent application—invention disclosure record number: 2532 with the United States Patent and Trademark Office.

U.S. Patent No. 11,993,834 Issued: May 28, 2024 , “Indirect Additive Manufacturing Process For Fabricating Bonded Soft Magnets.”

Publications

Advanced Permanent Magnet Generator Topologies Using Multimaterial Shape Optimization and 3D Printing , 12th International Conference on Power Electronics, Machines and Drives (2024)

Advanced Multimaterial Shape Optimization Methods As Applied To Advanced Manufacturing of Wind Turbine Generators , Wind Energy (2024)

Novel Method For Overmolding of NdFeB Bonded Magnets Into a 3D-Printed Rotor , IEEE Transactions on Magnetics (2024)

Advanced Permanent Magnet Generator Topologies Using Multimaterial Shape Optimization and 3D Printing , NREL Presentation (2023)

An Assessment of Additively Manufactured Bonded Permanent Magnets for a Distributed Wind Generator , IEEE International Electric Machines and Drives Conference (2023)

A New Shape Optimization Approach for Lightweighting Electric Machines Inspired By Additive Manufacturing , Joint MMM-Intermag Conference (2022)

Review of Additive Manufacturing of Permanent Magnets for Electrical Machines: A Prospective on Wind Turbine , Materials Today Physics (2022)

MADE3D: Enabling the Next Generation of High-Torque Density Wind Generators by Additive Design and 3D Printing , Springer Nature (2021)

View all NREL publications about MADE3D research .

Latha Sethuraman

Researcher IV, Electrical Engineering

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Multi-dimensional printing and scanning develops

Back

3-dimensional (3D) printing is a process of making three-dimensional objects from a digital file. The 3D-printed object is created by using additive processes laying down successive layers of material until the object is created. In fact, also so called “ volumetric 3D printing” is being researched, where entire structures can be formed without the need for layer-by-layer fabrication. Presently, a portable 3D printer one may hold in the hand is even being researched, i.e a tiny device to enable a user to rapidly create customized, low-cost objects on the go, e.g. a fastener to repair a wobbly wheel or a component for a critical medical device. The key to success is apparently use of visible-light-curable resins and visible-light-emitting chips to create a chip-based 3D printer.

3-dimensional (3D) scanning involves capturing real-world objects and converting them into digital models. It has become an indispensable tool in various fields, not least in medicine, but also in fields like design and manufacturing. By specialized scanners one creates accurate 3D representations of physical objects. These scanners work by capturing surface data (usually in the form of point clouds) and then reconstructing a detailed 3D model.

The technologies for both printing and scanning continues to develop, and now, incredibly, the idea of time as a 4 th dimension is in a way also introduced here.

By adding the dimension of time, 4D takes printing and scanning a step further. Instead of capturing a static object, 4D scanners record changes over time.

With 4D printing , the resulting 3D shape can morph into different forms in response to environmental stimulus, with the 4th dimension being the time-dependent shape change after the printing. Likewise with 4D scanning , for example in medical imaging, 4D ultrasound scans allow one to visualize moving structures like a beating heart or a developing fetus. This dynamic aspect clearly provides valuable insights for diagnosis, research, and monitoring.

With both printing and scanning, 3D and 4D have diverse applications and are playing pivotal roles as initial steps in these emerging and indispensable technologies.

Further information about portable 3D-printer may be found e.g here and about 4D-printing e.g. here .

(Article is based on the various articles available on the internet and edited by T.Sollie)

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Materials Horizons

3d and 4d printing of mxene-based composites: from fundamentals to emerging applications.

The advent of three- and four-dimensional (3D) and (4D) printing technologies has significantly advanced the fabrication of advanced materials, with MXene-based composites emerging as a particularly promising class due to their exceptional electrical, mechanical, and chemical properties. This review explores the fundamentals of MXenes and their composites, examining their unique characteristics and the underlying principles of their synthesis and processing. We highlight the transformative potential of 3D and 4D printing techniques in tailoring MXene-based materials for a wide array of applications. In the realm of tissue regeneration, MXene composites offer enhanced biocompatibility and mechanical strength, making them ideal for scaffolds and implants. For drug delivery, the high surface area and tunable surface chemistry of MXenes enable precise control over drug release profiles. In energy storage, MXene-based electrodes exhibit superior conductivity and capacity, paving the way for next-generation batteries and supercapacitors. Additionally, the sensitivity and selectivity of MXene composites make them excellent candidates for various (bio)sensing applications, from environmental monitoring to biomedical diagnostics. By integrating the dynamic capabilities of 4D printing, which introduces time-dependent shape transformations, MXene-based composites can further adapt to complex and evolving functional requirements. This review provides a comprehensive overview of the current state of research, identifies key challenges, and discusses future directions for the development and application of 3D and 4D printed MXene-based composites. Through this exploration, we aim to underscore the significant impact of these advanced materials and technologies on diverse scientific and industrial fields.

  • This article is part of the themed collection: Recent Review Articles

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A. Bigham, A. Zarepour, A. Khosravi, S. Iravani and A. Zarrabi, Mater. Horiz. , 2024, Accepted Manuscript , DOI: 10.1039/D4MH01056F

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  17. Medical Applications for 3D Printing: Current and Projected Uses

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  23. A new 3D printing method promises faster, multi-material creations

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  24. A new strategy for manufacturing, modeling, and optimization of 3D

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