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3D Printing in Healthcare: The Future is Here

Additive manufacturing (AM) is revolutionizing a variety of industries, and healthcare is ripe for transformation. According to SME, the 3D printed medical devices market is expected to near $26 billion over the next two years. Moreover, the medical sector already accounts for 17 percent of the total AM market, and the market share is expected to grow as even more manufacturers expand beyond prototyping.

Simply put: If you’re not yet utilizing 3D printing, you’re behind the competition.

Thanks to the flexible nature of AM, manufacturers are no longer beholden to large-series productions. With 3D printing, you can help medical providers develop equipment and tools with intricate designs and geometries, allow them to better react to condensed delivery times and financial barriers, and provide functional integration — all with a patient care journey that’s more personalized than ever before.

Personalized healthcare represents one of the most significant areas of growth potential in the medical space. Using 3D printing to personalize products, tools, and devices enables you to cater to the physiological and functional aspects of individual patients and medical staff.

For example, providing customized surgical tools can enhance procedures and improve a surgeon’s dexterity or ability to serve a specific patient population. A surgeon might naturally hold a tool or device in a way that’s not standard because of their grip preference, hand size, or other physiological differences. They could also have a special surgical technique for a particular patient population which could be better served by a tool designed to meet their technique, instead of forcing them to adapt to mass-produced instruments intended for a broad patient population.

On the patient side, healthcare providers can manufacture medical devices to the exact specifications of patients. Take, for instance, customized cutting guides for knee replacements, which allow surgeons to prep and operate quicker, as well as promote recovery and healing in patients. With AM, doctors can also create functional prototypes representing a patient’s exact circumstances so they can plan operations, test different scenarios, or economically test pharmaceutical treatments.

Today’s healthcare providers are accomplishing the previously unimaginable: from incredible advancements in research for 3D printed organs and artificial bones to prosthetic limbs for para-athletes and beyond. Many 3D printed structures can even help promote the growth of tissue or replicate more complex cavities not possible with traditional injection-molded or extrusion methods.

Now is the time for manufacturers to take advantage of this growing space. And your success boils down to your approach and ability to find the best solutions to fit patient needs.

One of the common roadblocks preventing more widespread use and adoption of 3D printing is not reviewing the technology from the broad impact it can have on an organization. Focusing on one product line or use case can create roadblocks in the future when trying to multiply the technology to other platforms or new business models. For example, not thinking about the full scope of products in the pipeline when adding additive manufacturing into a quality system can cause unanticipated work for the next product’s roadmap.

EOS GmbH Krailling Photo: Tobias Hase (www.hase-fotografie.de)

Instead, approaching AM from a holistic perspective enables management to identify critical areas throughout the organization where 3D printing can improve operations. For this approach to be successful, key decision-makers and department heads representing multiple disciplines or business units need to be involved in the implementation process from the beginning.

From cutting-edge materials to high-value applications, the medical industry is prime for additive manufacturing to flourish. Learn more by attending my session, “Fireside chat: Emerging trends for 3D printing in healthcare,” on Tuesday, Feb. 11th at 10:10 a.m. during Additive Manufacturing Strategies 2020.

Laura Gilmour is the Global Medical Business Development Manager for EOS, the world’s leading technology supplier in the field of industrial 3D printing of metals and polymers. For more information, visit www.eos.info/en/.

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3D Printing Stalwarts: EOS

EOS was an early pioneer in laser powder bed fusion (PBF) technology and currently stands as a leader in the space, though there are an increasing number of entrants. The company was established by Hans Langer, who previously worked as the Director of European Operations at U.S. laser beam steering company General Scanning before founding EOS (Electro Optical Systems) in 1990.

The founder of EOS, Dr. Hans Langer.

To develop his concept for a laser-based 3D printing technology, Langer received venture capital funding from a former development manager at BMW in order to meet the auto giant’s needs for an SLA 3D printer. By 1991, he delivered the STEREOS 400 to BMW and began establishing a European footprint before releasing the STEREOS 600 and even turning a profit just a year later.

The German company continued to grow and attract international attention such that, in just its third year, EOS was sued by 3D Systems, the original inventor of SLA, for patent infringement. In an interesting move, Langer sold 75 percent of his shares to the Zeiss Optical Group, leaving Zeiss to deal with the lawsuit and Langer free to oversee the developing of its first laser sintering system, the EOSINT 350.

EOS then partnered with Electrolux RD (which it eventually acquired) to develop direct metal laser sintering (DMLS), resulting in the creation of the EOSINT M 160. In other words, over the course of just four years, EOS had developed SLA, SLS and DMLS technology, but it didn’t stop with just resins, thermoplastic powder, and metal powder. In 1995, the firm’s first sand 3D printer, the EOSINT S 350, based on its EOSINT P 350 plastic system, was launched for printing sand cores and molds for metal casting.

After Carl Zeiss Jena, of Zeiss Optical, left the business in 1997, Langer bought back the rest of his shares and ultimately sold off the STEREOS SLA line to 3D Systems, while taking over the global patenting rights for laser sintering.

EOS continued to develop its technology, becoming the first to create a laser sintering printer with two lasers for sand printing in 1996 and plastic in 2000. In the process, the company also created new materials for SLS and DMLS, including glass-filled polyamides, copper, steel, aluminum filled polyamide, CobaltChrome, the world’s first flame-retardant SLS powder, and polyaryletherketone (PAEK) family powders as well.

EOS also implemented an interesting business model during this time, licensing its DMLS technology to Trumpf and Concept Laser (now owned by GE Additive), thus allowing for further proliferation of metal PBF.

Metal parts 3D-printed with Micro Laser Sintering.

Among other collaborations and innovations, the German firm partnered with Materialise, seeing SLS and DMLS attain greater adoption through its use in 3D printing service bureaus. This really signifies some of the first batch production deployed with 3D printing. EOS also worked with 3D-Micromac AG to create a process for 3D printing small metal parts with layers as fine as 1 µm, which is unheard of in metal PBF. EOS also partnered with Cookson Precious Metals Ltd on the PRECIOUS M 080 for printing precious metals, such as gold, for the jewelry industry.

Throughout this time, DMLS, along with other flavors of metal PBF, has increased in adoption and, though it as improved, we see manufacturers like EOS work on developing enhanced process monitoring and quality control techniques. EOS was awarded ISO 9001 certification in 1998, but it wasn’t until 2007 that the company launched its EOSTATE software for in-process quality assurance. This would herald a new era of working to develop repeatability and quality control within metal PBF that is still continuing to this day.

Since entering the market three decades ago, EOS has found itself surrounded by competitors developing their own takes on metal PBF and plastic sintering. Earlier in its history, Arcam came on the scene with electron beam melting while, more recently, Velo3D has released a highly controlled version of metal PBF that it claims ensures quality and repeatability, while also reducing post-processing. As for SLS, the biggest competitor on the market now is HP with Multi Jet Fusion technology (with High-Speed Sintering to be on the market any day now).

EOS clearly remains a leader in the 3D printing space, but one wonders what will come next for the company. Will it continue to jump ahead with some unforeseen innovation or become absorbed into the quickly evolving world of metal and plastic sintering?

The Integra P400 system from EOS, which the Vulcan Labs team will be working on.

EOS certainly seems to be aiming for the former as, most recently, it worked with Finnish firm Etteplan to actually embed electronics within a DMLS part, previously impossible with metal PBF. It also acquired Stratasys spin-out Vulcan Labs earlier in the year, which will be working on EOS’s Integra P400 system, an open and modular approach to PBF that presents a quite different architecture than EOS is known for. And the integration of Additive Works simulation software into its metal 3D printing workflow should keep it ahead of the game in terms of quality control. With no outside investors on board, EOS is 100% owned by the founder of the firm. The future is certainly looking bright for the founder and EOS.

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AM POLYMERS GmbH: New Polypropylene ROLASERIT PP03O for Laser Sintering with 200 % Elongation at Break and Other New Materials

AM POLYMERS GmbH expands its powder portfolio for laser sintering with a new polypropylene powder. In contrast to most of the materials on the market, the material has exceptionally high elongation at break of more than 200 %. At the same time, the material has excellent processing conditions on common machine systems.

AM POLYMERS GmbH presents its fourth series material from the ROLASERIT® family at FORMNEXT 2019 in Frankfurt and starts the BETA phase for the newly developed ROLASERIT® PP03O. This extends the material range for laser sintering to include a material with outstanding ductility and injection moulding properties. For the first time, a lower elongation at break has not to be accepted, as is generally the case in additive manufacturing.

With an elongation at break of more than 200 %, the material is a pioneering role in the field of materials for laser sintering. Most materials only have elongations at break in the range of less than 50 %. The processing of the material has already been tested successfully and without problems on common laser sintering systems. In accordance with the company philosophy of selling only plug-and-play materials, only short running-in times on the machines are necessary. Thus, the production of customer parts is possible within a few days. The application spectrum of manufactured components is diverse and ranges from simple housings to function-integrated parts with film hinges. Based on its high ductility, the ROLASERIT® PP03O is also ideally suited for series production.

Visit us at FORMNEXT 2019 booth 11.1 A79 to learn more about ROLASERIT® PP03O.

In addition to polypropylene PP01, polyethylene PEGR01 and TPU PB01, PP03O now forms the fourth thermoplastic powder available as series material, which AM POLYMERS has developed for laser sintering or for powder bed fusion and sells under the brand name ROLASERIT®.

AM POLYMERS GmbH will also be presenting other powder materials at FORMNEXT 2019. The newly developed ROLASERIT® PP04 is designed to offer a polypropylene with increased stiffness and strength requirements compared to PP01 and PP03. The ROLASERIT® PA FLEX01 is intended for applications with a requirement profile with low stiffness and simultaneously high ductility in laser sintering. The polyamide material has been specifically optimized for this special application.

AM POLYMERS GmbH with a headquarters in Willich was founded in 2014. The company is specialized in the development, production and distribution of laser sintering materials. The company’s team can look back on many years of experience in the field of additive manufacturing. The founders, Dr.-Ing. Andreas Wegner and Prof. Dr.-Ing. habil. Gerd Witt have twelve and more than twenty years of experience in laser sintering of plastics. Timur Ünlü, a specialist of many years experience in the field of powder production, joined the company in 2018. Since 2019 a new production and development site for the production of plastic powders has been established in Willich.
In addition to the commercialized products, other important standard thermoplastics such as PA6 or PBT are developed for laser sintering. The current state of development already shows promising properties of these future products.

Contact:
AM POLYMERS GmbH
Dr.-Ing. Andreas Wegner
Hanns-Martin-Schleyer-Straße 9e
47877 Duisburg
Germany
tel.: +49 174 2174251
email: info@am-polymers.de
web: https://www.am-polymers.de

The post AM POLYMERS GmbH: New Polypropylene ROLASERIT PP03O for Laser Sintering with 200 % Elongation at Break and Other New Materials appeared first on 3DPrint.com | The Voice of 3D Printing / Additive Manufacturing.

XYZPrinting to Focus on Industrial 3D Printing: Interview with Fernando Hernandez

They told us we’d all have 3D printers on every desktop. The newspapers, the TV, all the tech blogs. All those that are now complaining that we don’t have 3D printers on every desktop. One of the companies that tried the hardest to make a 3D printer on every desktop actually happen is XYZPrinting. The company is probably the largest single manufacturer of 3D printers worldwide and ships the most systems. XYZPrinting focused on big box stores and low-cost printers. Initially, their systems seemed rather crude but amazed us all at their low price points. Bit by bit XYZ’s systems started to evolve and become feature rich much more capable systems selling in the $200 to $500 range. The firm, which is a subsidiary of a gigantic company called New Kinpo, sold tens of thousands of these printers globally (maybe around 40,000 a year). It has now told 3DPrint.com that it is to focus on the manufacturing industry and industrial printers.

The market and the margins are to be found in more automated and expensive systems. XYZ Printing already has higher priced systems on the market such as its SLA printers and some semi-industrial units. The company must have concluded that the Clone Wars were seeing so much bloodletting that the bottom end of the market was becoming a bit of a challenging place to do business. Printrbot went bankrupt after selling tens of thousands of units as well at that price point. Anet and Creality were busy demolishing themselves while hyper-aggressive marketing tactics were deployed. Influencer marketing lead to many a questionable review while hundreds of more firms started to offer i3 clones. Some are finding success in the space through volume and sheer gumption. But the past 24 months have been slaughter on the desktop really.

I for one think that XYZPrinting should really stick with their desktop systems and offer $750 or so price point capable desktop 3D printers which are easy to use and have carbon and HEPA filters. I’m contrarian and would urge them to offer more now and push hard today. A bit more resolution and this kind of printer will be the choice for schools and offices going forward. Things will pick up. A friend asked me a few days ago to recommend a cheap printer that was good and I couldn’t really. A year or two so ago I would have been able to suggest three models. It seems however that the invisible hand has convinced XYZPrinting to move upmarket to high growth and high margin industrial territory. The $1000 desktop segment is completely dominated by Prusa Originals and Flashforge. Above this segment, we’re seeing increased competition by Ultimaker S5 systems, Raise3D, and other similar systems around $5000. It will be a challenge for the company to compete in this segment. This is especially true since high-temperature systems of $20,000 or so are increasing in capabilities all the time and are doing well, capping the segment above that.

So XYZ’s efforts are certainly ambitious. The firm does have deep pockets, however: a committed CEO and a lot of engineering resources. One of their industrial systems is the PartPro 350, which is a binder jetting printer. With a build volume of 222 x 350 x 200 mm and full-color capabilities this is a high spec system up against 3D Systems, Stratasys and Mimaki. The MfgPro230 xS is a powder bed fusion system that hopes to take the fight to smaller systems such as Sinterit and emerging firms such as Farsoon and full-blown industrial solutions such as EOS. With Material Extrusion, Powder Bed Fusion, Binder Jetting, and Vat Polymerization (both DLP and SLA!) under one roof, the company may at this point be the only firm that sells all of these technologies (do let me know if that’s not true!). Tantalizingly this could make them a one-stop shop for customers and resellers. At the same time support and engaging business customers is a new game for the firm. We asked XYZPrinting’s Managing Director for EMEA Fernando Hernandez what the move means for the firm and customers.

Will you still sell printers for schools?

We will continue to sell printers for schools. We have created several education materials and dedicated software. Our products have helped us to build a big market share in the educational sector and we will be continuing to support our customers. The US is, at the moment, the most successful and advanced education market for us, and a region we will continue to service and develop printers for as well as EMEA and Asia. We are passionate about helping children develop STEAM skills.

Will you still support previous printers?

Of course! We will continue to support those customers with previous printers from our desktop range with software updates and added features, like new materials and new printing modes. We will also be releasing three new desktop printers in 2019 alongside our new range of industrial printers.

Will you develop new low-cost printers?

Although XYZprinting is scaling up, we always aim to manufacture the most cost-effective solutions without sacrificing on quality, speed or performance. In fact, our new range of industrial printers offer the best value for money in the market, boosting the penetration in the AM market for SMEs as they will be able to access advanced printing technology such as SLS for a fraction of the cost of other brands.

The PartPro350

What kinds of features will the new printers have?

XYZprinting is bringing a whole series of 3D printing solutions, each with unique features and specs. Some of the most exciting features are making our new machines more efficient. For example, our PartPro350xBC is 150% faster than other colour binder technologies and the MfgPro230 xS has a CO2 laser with a high printing volume (230mm³) and a high printing speed of up to 20mm per hour.

The shorter cooling and breakout times also means that prints are made faster but with the same precision tolerances. Features like these make this the leading range of industrial printers on the market at the moment, and with new products due to be released later this year, we are very excited to continue that.

The new printers include:

PartPro300 xT

The PartPro300 xT is the most advanced FDM printer in the brand portfolio. The heated chamber ensures a constant temperature, offering excellent performance for complex geometrics and advanced materials. It can print with multiple material types including ABS, PLA, Tough PLA, PETG, Nylon, Water-soluble PLA, Carbon Fibre and Metallic PLA. Its dual extrusion module allows the use of two different colours or materials to create more diverse product designs and strength the physical 3D models by combining two materials in one single print.

PartPro350 xBC

The PartPro350 xBC offers cutting edge printhead technology that delivers industry-leading colour part production. With speeds up to 18mm per hour for a fully loaded build volume, the PartPro350 xBC is 150% faster than other colour binder technologies. The printer offers full-colour printing in one process by integrating all steps and curing, colouring and 3D stacking at once, with CMY three-colour ink and transparent binders.

MfgPro230 xS

The MfgPro230 xS is one of largest SLS printer in market with a print volume of 230x230x230mm.

It allows you to create prints with no support material due to its SLS technology, resulting in less material being used and fewer breakages due to the isotropic mechanical properties of the technology, ensuring every print job counts. The printer can print up to one litre per hour making it one of the fastest printers on the market.

PartPro100 xP

The PartPro100 xP is a high-resolution DLP printer for those small parts where accuracy and details are critical. It uses professional grade plastic resin and features the tough surface quality that is perfect for prototyping small parts. It is the most affordable high-resolution 3D printer based on DLP technology.

EeezCure/MultiCure180

Both the Eeezcure180 and MultiCure180 are designed to optimise the mechanical properties of resin-printed models, improving the strength and performance of printed parts. The LEDs embedded in to the MultiCure180 have a wider range of UV wavelengths meaning that it is able to cure a wider range of resin materials with increased efficiency.

The Castpro 100

What 3D printing processes do you offer?

We have a range of printing processes that we can offer users with the new industrial printers. We have Fused Filament Fabrication (FFF) technology printers, full-colour bender jetting printers, and DLP, SLA and SLS technology printers, meaning that we can cater to all customer needs.

We also have a range of supporting devices such as our EeezClean family of depowering stations for powder base printers, or our range of UV post-curing solutions in the form of the EeezCure180 and the MultiCure180 which have LED diodes with a wide range of UV wavelengths to be able to cure a wider range of resins with increased efficiency.

What materials?

The FDM range of printers will support the following materials; ABS, PLA, Tough PLA, PETG, Nylon, Water-soluble, Carbon Fibre and Metallic PLA. We want to offer our clients a complete range of materials to help them to create parts and prototypes exactly how they want them. Many of these materials are made in house to ensure they are perfect for our printers and we work closely with external suppliers of other materials to make sure that they perform as well as possible when printed.

Our SLS solution can print with Nylon powder PA12 and preparing the release of our TPU. We have a wide range of resins for our DLA/SLA printers, such as castable resin, tough resin, high temperature resin and, of course, a range of general-purpose resins. For Binder Jetting we have an excellent collaboration with Memjet which offers an excellent quality on binder and colourful ink.

What will differentiate them?

Our new industrial printer range will be market leaders, both in terms of quality, speed and price. The PartPro350 xBC, for example, is 150% faster than other colour binder technology printers and the MfgPro230 xS has a higher printing speed than other similar industrial printers printing at 20mm per hour at a very decent building volume. The price for those devices are a fraction of the closest competitors, but also have higher specs.

3D printers have historically been very expensive too, and this has been a barrier to entry for many manufacturers. The printers we have developed as part of the industrial range have been developed to be cost efficient as well as time efficient whilst making sure the final print is of a high quality.

The MfgPro230 xc Powder Bed Fusion system for 56,000 euros.

Why are you making this decision?

It is a natural move for us. We have a very strong company and the R&D team have a lot to say on Industrial AM. XYZprinting has seen a growing demand among our customers for more industrial printers, and an increased market opportunity in this area generally. By expanding our range, we can ensure our printers cater for every business, from individual entrepreneurs looking for an easy and affordable way to print prototypes to automotive manufacturers looking to make high-specification parts for their vehicles.

What is XYZ’s goal in 3D printing?

We want to disrupt the market in industrial 3D printers as we did in the desktop market. We want to democratise AM to make it more accessible for SMEs.

Why should customers choose you?

There are several reasons, but I think we offer the best balance in the market in terms of quality, specifications and price. We offer the widest range of devices, not only printers but also supporting hardware and materials. Customers can find a one stop shop in XYZprinting for all their 3D printing needs. We are growing by the day and expanding our user experience with free software upgrades and improvements and releasing accessories to prolong device lifetime.

What kind of price points do you operate at?

Product	Category	Manufacturer’s suggested retail price (MSRP) (EXCL VAT)
PartPro 350 xBC	3DP	€28490
MfgPro230 xS	SLS	€56990
PartPro100 xP	DLP	€2690
PartPro 300 xT	FFF	€4999

The post XYZPrinting to Focus on Industrial 3D Printing: Interview with Fernando Hernandez appeared first on 3DPrint.com | The Voice of 3D Printing / Additive Manufacturing.

Singapore: 3D Bioprinting with Magnesium Alloys to Create Bone Scaffolds

SEM micrographs of samples sintered at different temperatures in the regime of super solidus liquid phase sintering for 5 h, a) 535 °C, b) 550 °C, c) 565 °C, d) 580 °C, e) 595 °C, and f) 610 °C.

Strides in the medical field today via 3D printing have been staggering, and especially in bioprinting, with many different technologies and materials being created. Now, researchers in Singapore are exploring the use of alloys like magnesium in fabricating scaffolding, with their findings detailed in ‘Additive manufacturing of magnesium–zinc–zirconium (ZK) alloys via capillary-mediated binderless three-dimensional printing.’

Magnesium is an alloy that can be used in 3D printing and additive manufacturing, as a third-generation biomaterial useful in tissue engineering; however, as the researchers point out, there are myriad challenges. High affinity to oxygen and a low boiling temperature are issues, along with careful consideration that must be applied when disposing of magnesium powders due to the possibility of reactions with other chemicals.

High vapor pressure can be a major obstacle in using magnesium too, leading the researchers to explore AM processes with ambient temperature. This can allow for all the benefits of powder-bed inkjet 3D printing to be enjoyed, as it can be employed at ambient temperatures, no supports are required, and powder can be fully recycled. Here, the researchers have created a new 3D printing technique including a sintering process which transforms magnesium powder and green objects into functional parts that can be used in scaffolding, producing parts with mechanical properties as strong as human bone.

The research team customized their own ink-jet 3D printer for this study, working to overcome previous challenges with the use of magnesium. Maintaining oxygen percentages at the lowest levels possible was of ‘paramount importance’:

“Conserving oxygen in green objects in low level indicates the promise of formulated solvent for AM of Mg-based alloys,” stated the researchers.

3D printed green samples showed no change at all in composition after the sintering process, leaving the team to point out that this means it is a ‘compositionally zero-sum process.’ With temperature variations, both density and stability were affected. The researchers state that dimensional precision is another element of paramount importance and is influenced when deviations occur in printing. Swelling may cause substantial problems too, resulting in shape loss of printed objects, noted at an increased sintering temperature from to 595 °C and 610 °C. Swelling can also interfere with functionality of components.

Samples after 5 h sintering at different temperature in the range of 535 °C to 610 °C.

In continuing to examine other features, the researchers found that density increases with temperature. In studying the effects of holding time on physical and mechanical properties, they also found that strength may be low even though density has become high. Overall though, for overcoming the challenges required in creating scaffolds, mechanical integrity must be present, along with balanced stiffness and strength:

“Mechanical properties of scaffolds could significantly affect cells behavior and the osteointegration between host tissues and the scaffold; premature collapse of subchondral bonearound bone defects may happen if the scaffold provides more than enough mechanical support,” said the researchers. “Thus, stiffness and strength of scaffolds should be modulated to match with those of host tissues in order to avoid post-surgery stress shielding effects and promote tissue regeneration.”

Healthy scaffolds exhibit good pore percentage, size, and shape, offering osteointegration, nutrients transportation, tissue in-growth, and waste products removal. With all those quotients in order, bone tissue regeneration is possible.

“Mg based alloys classify as a third generation of biomaterials when it comes to clinical outcomes, and capillary-mediated binderless 3D printed Mg part after sintering can provide comparable properties with bone,” stated the researchers.

In their paper, the researchers explain more about the structure of human cortical bone, a hierarchical ‘organization’ of three sizes to include:

Haversian and Volkmann vascular canals having diameter in the range of 40 to 100 μm
Osteocyte lacunae with size ranging from 10 to 30 μm
Canaliculi having diameters on an order of a few tens of nanometers

Issues in porosity can be dealt with as larger pores are created in 3D to compensate for a required percentage, thus refining scaffold for better tissue engineering with bone.

“Increasing holding time from 5 h to 20, 40, and 60 h at optimum sintering temperature of 573 °C allowed steady improvements in microstructural, physical, and mechanical properties for each additional hold time while avoiding the undesirable dimensional loss. Interconnected open-porous structures with apparent porosity of 29%, average pore size of 15 μm, compressive strength of 174 MPa, and elastic modulus of 18 GPa were achieved,” concluded the scientists. “These values are well comparable with those seen for human cortical bone types.”

There is a huge momentum between 3D printing and the medical field today, and it just keeps growing as scientists and researchers continue to work toward the holy grail of fabricating human organs. Along with that, many different types of medical implants have been created and are now improving the quality of patients lives, from facial implants to those meant to facilitate knee replacements. Tissue engineering continues to be at the forefront of 3D printing also with the range of bioinks continuing to expand.

What do you think of this news? Let us know your thoughts; join the discussion of this and other 3D printing topics at 3DPrintBoard.com.

Schematic illustrations of super-solidus liquid phase sintering process of 3D printed parts, a) total decomposition of interparticle bridges in a green sample after reaching 400 °C, b) nucleation of liquid phase along the grain boundaries and within the discrete islands throughout the grains at the temperature above the solidus, c) breaking MgO film for several particles with increasing temperature, leaking the liquid phase, forming liquid bridges among particles, and d) break down of MgO film, formation of liquid bridges between adjacent Mg particles, and growth of sinter necks diameter in the sample sintered at 573 °C for 40 h.

[Source / Images: Additive manufacturing of magnesium–zinc–zirconium (ZK) alloys via capillary-mediated binderless three-dimensional printing]

Custom 3D Printed CT-Bone Graft Implants Coming to Japan and Europe

We first heard of innovative CT-Bone technology three years ago, when Dutch company Xilloc reached an agreement with Tokyo-based Next21 K.K., the creator of CT-Bone, to bring 3D printable bone into hospitals in Europe. Back in 2001, Next 21 K.K. collaborated with the University of Tokyo and RIKEN on developmental research into the technology, which uses 3D printing to make synthetic bone grafts out of calcium-deficient HA material.

Now, after receiving an approval for manufacturing and marketing medical devices from the country’s Ministry of Health, Labor and Welfare (MHLW), the company is announcing formal approval for a new technology to 3D print synthetic bone grafts, which can both fuse and be assimilated into a patient’s existing bone.

There are currently four different types of existing bone grafts for patients with different kinds of bone defects and deformities: Autograft and Allograft (the most common), Synthetic Bone graft, and Xenograft. Custom synthetic graft materials are shaped from a heated and sintered block of material with machine tools, and is hard for natural bone tissue to absorb, which could lead to inflammation.

Autograft, which is the foremost transplant method in Japan, requires an additional surgery in order to remove a piece of bone from the patient’s leg or hip, so patients have to go through a second invasive procedure and deal with the potential risks, like damage and infection, from extended exposure. Allograft from a bone bank is the most common in the US and Europe, but as it’s harvested from cadavers, there are potential infectious and ethical conundrums to consider. Additionally, it can be hard to find a cadaver bone that’s the appropriate size and shape to match a patient’s original bone.

But, 3D printing makes it possible to reproduce the shape of the original bone with 0.1 mm accuracy, and CT-Bone also uses a curing treatment method to help with recrystallization. This the technology, as Next21 K.K. puts it, “most suitable for molding biomaterial like a bone graft.”

CT-Bone does not use a sintering process to increase mechanical strength like other synthetic bones or 3D printed ceramics do, so it actually becomes physiologically activated; this helps the material in the custom implant fuse and assimilate to the patient’s existing bone much more quickly.

While most typical bone implants are made from material like titanium or PEEK, or even cut and re-positioned bone from the patient, CT-bone is a 3D printable, calcium phosphate implant that’s actually converted into real bone by the patient’s own body.

After a CT-scan, Next21 K.K.’s biomedical engineers work with the surgeons to create a patient-specific implant (PSI), which can incorporate porosity and match the patient’s anatomy perfectly, which helps facilitate bony ingrowth and good bone-to-implant contact. It only takes a few months post-implantation for CT-Bone to unify with the patient’s existing bone.

Thanks to a subsidy from the New Energy and Industrial Technology Development Organization (NEDO), the company completed a pre-clinical study for CT-Bone, titled “Computed tomographic evaluation of novel custom-made artificial bones, “CT-bone”, applied for maxillofacial reconstruction” and performed with support from the National Institute of Biomedical Innovation, Health and Nutrition (NIBIOHN). Co-authors include Yuki Kanno from the University of Tokyo, Takashi Nakatsuka with Saitama Medical School, Hideto Saijo, Yuko Fujihara, and Hikita Atsuhiko from the university, Ung-il Chung with the university’s Graduate Schools of Engineering and Medicine, and Tsuyoshi Takato and Kazuto Hoshi with the university.

The abstract reads, “We fabricated custom-made artificial bones using three-dimensionally layered manufacturing (3D printing) process, and have applied them to patients with facial deformities. We termed this novel artificial bone the “CT-bone”. The aim of the present study was to evaluate the middle-and long-term safety and effectiveness of the CT-bones after transplantation.”

CT-Bone grafts were implanted into 23 sites on 20 patients with facial bone deformities and then evaluated through the use of CT scans post-op, minimally for one year and then maximally for seven years and three months after transplantation.

According to the paper, “No serious systemic events due to the CT-bone graft were found during the observation period (1 year postoperatively). In 4 sites of 4 patients, the CT-bones were removed due to local infection of the surgical wounds at 1-5 years postoperatively. Compatibility of the shapes between the CT-bone and the recipient bone was confirmed to be good during the operation in all of the 20 cases, implying that the CT-bones could be easily installed onto the recipient sites. During the CT evaluation (<7 years and 3 months), no apparent chronological change was seen in the shape of the CT-bones. Sufficient bone union was confirmed in 19 sites. The inner CT values of the CT-bones increased in all the sites. The longer the postoperative period, greater increases in the CT values of the CT-bones tended to be observed.”

Next21 K.K. plans to commercialize CT-bone in the Japanese market, and initiate export to other Asian countries. Having already reached a license agreement with Xilloc for local manufacturing and sales of CT-Bone in the EU, the company will also expand sales to Europe.

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[Images provided by Next21 K.K.]