Ranica Arrowsmith, Associate Editor11.13.14
By now, the promises of 3-D printing are familiar. According to the hype, anyone can have a 3-D printer in their home; they can make literally anything they want. Soon, we’ll even be able to print body parts. This isn’t exactly all true. While 3-D printing certainly has evolved over the decades, today, because of the availability of consumer 3-D printers, there is a lot of hype surrounding the process that makes it hard to wade through to the science. 3-D printing is not a new phenomenon. It was introduced as a process in 1984 by Chuck Hull, founder of 3D Systems Corporation, a company still in operation today. Over the years, companies such as EOS GmbH and Materialise NV have adopted and developed additive manufacturing. They have served the medical device industry in an industrial capacity, manufacturing devices and components just as any other contract manufacturing organization (CMO) that uses traditional manufacturing, e.g. injection molding, milling, etc., would.
“Fortunately and unfortunately, there’s a hype frenzy engulfing 3-D printing,” reads a blog post by Solid Concepts Inc. “The very phrase is becoming its own controversy. There’s quite a mix-up between what the technology can and cannot do, and the mix-up stems mainly from the consumer (vs. engineering or manufacturing) market where low-cost printers are almost solely defined by extruded plastics technologies.”
These low-cost printers (which run anywhere from $1,000 to $4,000 at your local Staples) are not capable of fine layer resolutions. They also have a very limited scope—a home user only can use a small range of materials, and they are totally dependent on pre-fabricated, cookie-cutter designs that are downloadable from databases such as Thingiverse. At best, today, the home 3-D printer for the average user is a novelty item.
“This process and technology isn’t as easy to use as your inkjet printer in your office,” explained Adam Galloway, vice president of sales and marketing for Lake Bluff, Ill.-based GPI Prototype & Manufacturing Services Inc. “The software and technical acumen required to operate these machines is extremely important to having any success. The average consumer doesn’t have the patience for failures and won’t pay for it. Just to have someone come to repair or get the machine functioning properly could potentially cost 20-30 percent of what they pay for the machine. I give it another 10 years before it becomes fully functional and adopted by the masses in a meaningful way.”
“Most people believe they can unwrap the box, download their favorite design, pull out their cool scanner, and make replicas of their R2D2 doll,” James Ward, director of marketing at Dinsmore & Associates Inc., a 3-D printing services provider based in Costa Mesa, Calif., told MPO. “Not realizing that some other individual who went to college from anywhere from four to eight years and did ridiculous levels of mathematics to become an engineer designed that little plastic thing you’re about to print. That’s the big disconnect.”
Indeed, only about four or five years ago, Ward and his associates at Dinsmore would encounter a lot of misinformation even amongst medical device companies. “I don’t need posters,” or, “I already have someone who does our flyers,” potential original equipment manufacturer (OEM) clients would say when Dinsmore made its pitch for 3-D printing manufacturing services. And that’s where consumerization has its benefits. Upon the expiry of many patents on various 3-D printing processes, companies such as 3D Systems and Stratasys Ltd. that have consumer-use printers on the market have played a big part in public education, letting the world know that a process such as this does exist.
Stratasys has been in the game from the beginning. The company was founded in 1989 by S. Scott Crump and his wife Lisa Crump in Eden Prairie, Minn. The company’s extraordinary reach today—with recent acquisitions, projected to be 21 percent of the market in 2015—is rivaled only by 3D systems, which is projected to hold 25 percent of the market next year. Stratasys now owns Objet Ltd., which it acquired in 2012; Makerbot Industries, which makes popular home models as well as industrial machines, acquired in 2013; and Solid Concepts, RedEye, Harvest Technologies Inc. and GrabCAD, all acquired this year. At a recent media event held in New York, N.Y., Stratasys customers from the aerospace, automobile and consumer markets spoke about how they are using the technology to change their business. But Pete Basiliere, research vice president of imaging and print services for Stamford, Conn.-based Gartner Inc., an information technology research and advisory firm, said that what excites him most is the medical device field. “3-D printing has life-altering potential,” he said—and it’s hard to disagree with him.
"The first major patent to expire involved Stratasys’ fused deposition modeling (FDM) patent in 2009," explained Rob Connelly, vice president of additive manufacturing technologies for Maple Plain, Minn.-based Proto Labs Inc., a provider of machined and molded parts. The company uses stereolithography and laser sintering technology to produce prototype parts for its clients. "That really opened the door for the wide-spread adoption of 3-D printing due to the increase in accessibility. There was a boom in consumer desktop printers with startups developing new 3-D printing products, but more importantly for us, there was a new level of visibility about what was possible in commercial printing. Earlier this year, a patent on selective laser sintering (SLS) also expired. This has brought more accessibility and more visibility to additive manufacturing as a whole. With increasingly more engineers and designers developing parts via 3-D printing, this will ideally lead to new developments in the processes themselves. And that’s always beneficial to the industry, and the medical device space."
Although the consumerization of 3-D printing is, at this juncture, not very useful in the hands of the layman, the technology certainly is exciting in terms of the Jobs and Wozniaks of the (medical) world, i.e., individuals with technical expertise who want to tinker at home without spending a lot of capital.
“I can see [consumerization of 3-D printing] affecting the medical device industry in one way already,” Galloway said. "We get approached by surgeons who wish to modify a tool. If the surgeons are serious about making changes, they will need to learn how to design or pay for a service to develop a newly designed tool. Then they could potentially design and create their own tools/components. Potentially, a long way down the road, they could do the same thing for an implant.”
At the Heart of Things
Materialise, based in Leuven, Belgium, currently is on that life-altering edge of medicine analysts like Basiliere talk about. This year, Materialise made a plastic heart, and it’s going to market.
In July, a baby boy was born with a complex form of congenital heart disease (CHD) in which both the aorta and pulmonary arteries arise from the right ventricle. Also present was a large hole in the heart called a ventricular septal defect. On the first day of his life, an extremely low-dose chest CT (computed tomography) scan was acquired to better understand the complex 3-D relationships of the heart and defects. From the images alone it was difficult for the doctors to formulate the optimal surgical plan, especially considering that the baby’s heart was no bigger than a walnut—so they sought out a firm with 3-D printing capabilities to find a solution. They turned to Materialise.
Starting with the baby’s image data, Todd Pietila, cardiovascular business development manager at Materialise, created a 3-D model of his heart using the Mimics Innovation Suite of software. The team at New York-Presbyterian/Morgan Stanley Children’s Hospital worked closely with Pietila to achieve an accurate reconstruction of the heart, which would allow the surgical team to best visualize the complex defect. The result was a 3-D representation of the heart with the small details of the congenital defects captured accurately.
The file then was 3-D printed at the medical production facility at Materialise’s U.S. headquarters in Plymouth, Mich. The project is a demonstration of one of the 3-D printing processes’ biggest claims to fame, which is speed. Only two days after receiving the data, a replica of the baby’s heart was delivered to the hospital.
The complex 3-D relationships of the newborn’s defects were not apparent from the ultrasound and scan data alone. Fortunately, with the 3-D printed model in hand, the team of clinicians at New York-Presbyterian/Morgan Stanley Children’s Hospital found an ideal solution for repairing all of the defects during one procedure, instead of three or four surgeries.
“The baby’s heart had holes, which are not uncommon with CHD, but the heart chambers were also in an unusual formation, rather like a maze,” said Emile Bacha, M.D., a congenital heart surgeon and director of congenital and pediatric cardiac surgery at the hospital. “In the past we had to stop the heart and look inside to decide what to do. With this technique [using a 3-D printed model], it was like we had a road map to guide us.”
Bacha performed the surgery when the week-old baby weighed a little more than 7 lbs. His single-procedure approach allowed the baby to avoid the typical series of palliative operations, which can be life-threatening. The clinical outcome was ideal and the baby is on his way to a healthy life.
The 3-D printed heart model also allowed the surgeons to explain the baby’s condition and their plan to the worried parents. By seeing the model and understanding what needed to be done, the parents became as confident as the surgical team.
“In discussing the necessary surgery with the doctors it was unclear how it would be performed and if it would be accomplished with one or two surgeries,” the baby’s father said. “We were told that they are working on getting a 3-D-printed model of our son’s heart, which the team hoped would clarify the surgical plan. Upon receiving the model, everything changed. After studying the model, the surgeon got a clearer picture of what needed to be done and was very optimistic that he could do the repair in one surgery. Our baby was saved from subsequent surgeries and interventions and all the side effects and developmental delays that come with it. This is truly an amazing advancement in surgical planning and outcome. We are so thankful.”
Now, clinicians at New York-Presbyterian/Morgan Stanley Children’s Hospital are working with Materialise on additional cases.
“After the success of this surgery, it’s hard to imagine entering an operating room for another complex case without the aid of a 3-D printed model,” Bacha said. “It’s definitely going to be standard of care in the future and we’re happy to be leading the way.”
Materialise had been working for about three years on printing flexible models such as this heart, Joroen Dille, Materialise’s director of orthopedics, told MPO. The company used PolyJet technology from Stratasys to create a product that isn’t totally rigid.
PolyJet 3-D printing is similar to inkjet printing (i.e., the kind of regular desktop printer we use to print documents), but instead of jetting drops of ink onto paper, PolyJet 3D Printers jet layers of curable liquid photopolymer onto a build tray. The process follows three basic steps. In pre-processing, build-preparation software automatically calculates the placement of photopolymers and support material from a 3-D CAD (computer aided design) file. The second step is production, where the 3-D printer jets and instantly cures tiny droplets of liquid photopolymer with ultraviolet light. Fine layers accumulate on the build tray to create a precise 3-D model or part. Where overhangs or complex shapes require support, the 3-D printer jets a removable gel-like support material. Then comes support removal, where the user removes the support materials by hand or with water. Models and parts are ready to handle and use right out of the 3-D printer, with no post-curing needed.
“What is very interesting with this machine is that you can use different material properties,” said Dille. “You can use hard and soft materials, and the machine can mix those two materials together while printing, enabling you to create different flexibilities in your model. It’s one of those unique things you can do with additive manufacturing—creating an object that can be very rigid in some parts and flexible in others. It’s these kind of applications, like the model of the baby’s heart, that show the opportunities and solutions this technology can provide.”
One Size Fits One
“The real promise of 3-D printing isn’t about manufacturing products for everyone. It’s about manufacturing products for just one person.” So says Liz Ganes, senior editor of technology trends and innovation for Re/Code, an independent tech news site that covers topics on the cutting edge of technology today.
Dinsmore’s Ward challenged MPO to do the difficult work of wading through the hype and write about the facts of 3-D printing. “I’m hoping to see more articles that are based around the factual world that is 3-D printing,” he said. “With all the hype, apparently next thing you know the world owns 3-D printed guns and that’s what everyone’s talking about.”
He is referring to the so-called “world’s first 3-D printed gun,” which high-tech gunsmithing group Defense Distributed announced last year, sending the public into a frenzy of speculation. Could everyone now just make their own gun at home with the push of a button? It didn’t help that the group named their product the “Liberator.”
The answer is no.
The device is complex and requires a considerable amount of expertise to design and manufacture. As the experts note, a considerable level of engineering and technical expertise is needed to create even the most basic of devices, and since we haven’t been inundated with plastic, functional guns just yet, it’s safe to say that won’t be a problem too soon.
But we shouldn’t be too quick to dismiss the power 3-D printing as a manufacturing process can give an average home user. Derek Mathers, business development manager for Worrell Design Inc., a Minneapolis, Minn.-based industrial design and product development company told MPO about a layman he encountered at a U.S. Food and Drug Administration (FDA) summit recently who taught himself how to use SolidWorks 3-D design software. He used the technology to customize functional fingers for his son who was born without any. Not only was he able to customize the design for his son, but he is disseminating the design for anyone to tweak and customize for their own needs. MPO’s sister publication Orthopedic Design & Technology has covered stories such as Zero Point Frontiers Corporation’s development of a prosthetic hand for pediatric use in the past, and last month’s MPO featured a story on a group of engineers, doctors and entrepreneurs who are fitting 3-D printed prosthetics for Sudanese amputees. Part of this group’s goal also is to teach local users how to use the 3-D printing technology so they can print their own products after the team leaves.
The takeaway from stories such as this is twofold. Additive manufacturing isn’t some new fad that “anyone” can just pick up and start making anything with. However, in the hand of experts or someone who is willing to spend a lot of time learning its functionality, truly exciting innovation can occur. Secondly, the process allows for true customization of devices, which opens the door not only to serving patients better (a prosthetic truly fit to one’s body instead of a one-size-fits-most model) but also to serving severely underserved populations, such as pediatric patients and poor/remote populations.
As Gartner’s Basiliere pointed out in New York, the number one reason people don’t wear hearing aids despite needing them, sometimes badly, is fit. Most hearing aids aren’t fit to the individual ear, and are therefore uncomfortable. Basiliere wears hearing aids, so he should know. But the ones he wears were 3-D printed based on molds of his ear canals.
“The true benefit of 3-D printing over other methods of manufacturing is the customization to the individual,” said Ward. But he also pointed out the problem of regulation that benefit brings: “That’s also the barrier that the U.S. Food and Drug Administration is going to frown upon because the FDA likes consistency, measurability, and repeatability. This technology that you can change on the fly, customize and change according to body type—it’s still kind of the wild west in truth in terms of the medical side. There are still a lot of questions around how to standardize 3-D printing.”
“One of the most powerful tenets of 3-D printing is that complexity is free, and becomes a user delight,” Worrell’s Mathers said, agreeing with Ward. But he sees a bright side to that on-the-fly customization. “In any traditional manufacturing process, complex structures incur significant switching costs due to massive shifts in the production line—whereas with 3-D printing, if you have a part that requires complex geometry, you can actually use less material to achieve the same result.”
"There is growing 3-D printing application for custom devices, with one of the largest segments being patient-specific instruments," added Proto Labs' Connelly. "These are surgical guides or cutting tools that are made from patient anatomical data, used to improve the outcome of some surgical procedures. Additive is uniquely able to service this need due to its ability to quickly and accurately make custom geometry that might not be possible to make in a conventional manufacturing process."
3-D+
3-D + the home user = innovation.
3-D + CMO = speed and complexity.
3-D + traditional manufacturing = wait, we can do that?
Often, additive manufacturing is discussed in terms of the “other” way to manufacture. Traditional manufacturing, such as injection molding or machining, is the “old way.” This is a misconception. The volume that injection molding offers, for instance, is an indispensable asset, and one which 3-D printing cannot quite match just yet. Companies such as Worrell, however, are merging the two processes, printing molds that can then be used in injection molding.
Speed often is touted as one of the best benefits of 3-D printing. Molded devices and components are dependent on their molds, and if there is a change in design, waiting for a mold to be made can take weeks to months. Printing a new design, on the other hand, can be done immediately, as all it requires is tweaking the design software. Injection molds also represent the greatest cost in a production process.
“Now that we’re able to print molds for the devices we develop, we’re able to get people to market sometimes two months ahead of time, instead of our clients (large medical device OEMs) spending weeks and significant capital on bridge tooling, our clients get to use those weeks to validate their design and submit to the FDA,” Mathers said.
The company developed its 3-D injection molding (3D IM) in partnership with Stratasys, and the two companies announced their collaboration on Oct. 30. Since 3-D printing injection mold tools for medical devices, Worrell reports that it is producing injection molded prototypes using final production materials in 95 percent less time and at 70 percent less cost compared with traditional aluminum molds.
“We were recently approached by medical device start-up, MedTG, to design and engineer a dual-flow needleless blood collection system that reduced the need for multiple injections, thereby increasing patient comfort and hospital efficiency,” said Worrell CEO Kai Worrell in a press release. “Utilizing 3D IM to prototype the device, we were able to reduce the costs associated with traditional tooling by approximately 70 percent, as well as cutting times by 95 percent.”
“We use our PolyJet printer to blend two digital materials, which results in a mold with really high heat deflection and can take a lot of impact or pressure,” Mathers explained. “So, instead of just printing the prototype, we’ll actually print the injection mold the prototype will be shot in, enabling us to go right into injection molding within a couple hours as opposed to having to wait weeks or sometimes months just to get to tooling. When engineers have finished developing their design concept and want to move to verification and validation testing, they traditionally have to invest in metal molds in order to get to that next phase. It is a long and arduous process—usually six to eight weeks—to get those molds made, and can cost them tens and hundreds of thousands of dollars just to get that first run of parts to validate their design. Since we can now produce production-level parts for our human factors engineers in just days, we are able to get our products into market much faster.”
As Mathers puts it, this integrates 3-D printing “seamlessly” into traditional manufacturing technologies.
The fact is, 3-D printing is fast and relatively cheap, which is what makes it great for prototyping. These characteristics also make it very attractive for tail-to-head manufacturing for finished devices as well, except for the process still not being able to hold the same tight tolerances as other techniques, such as CNC (computer numerical control) machining. Traditional manufacturing still is very much needed and desired in the medical device space, but in partnership with 3-D printing, both processes are elevated.
* * *
So, has sophistication risen among OEMs who previously thought 3-D printing had something to do with posters? In its place—small run, innovative, complex designs and prototypes—3-D printing is becoming a mainstay in medical device manufacturing.
“I’m starting to see demands grow,” said Tim Warden, vice president of sales and business development at 3D Material Technologies LLC, a division of ARC Group Worldwide Inc. “Over the last three to five years, a lot of people were not really sure if the technology was going to take, or whether it was realistic. With a lot of big players in aerospace and medical device getting involved with the technology, you’re starting to see customers realize that this will be another validated manufacturing process going forward. You’ll see more and more applications using 3-D printing in the medical device industry. I don’t believe, however, that it will replace every technology out there. There are some people out there that believe that 3-D printing is the cure all. Realistically, it will just be another application/tool for engineers to use for their designing and manufacturing process.”
“Fortunately and unfortunately, there’s a hype frenzy engulfing 3-D printing,” reads a blog post by Solid Concepts Inc. “The very phrase is becoming its own controversy. There’s quite a mix-up between what the technology can and cannot do, and the mix-up stems mainly from the consumer (vs. engineering or manufacturing) market where low-cost printers are almost solely defined by extruded plastics technologies.”
These low-cost printers (which run anywhere from $1,000 to $4,000 at your local Staples) are not capable of fine layer resolutions. They also have a very limited scope—a home user only can use a small range of materials, and they are totally dependent on pre-fabricated, cookie-cutter designs that are downloadable from databases such as Thingiverse. At best, today, the home 3-D printer for the average user is a novelty item.
“This process and technology isn’t as easy to use as your inkjet printer in your office,” explained Adam Galloway, vice president of sales and marketing for Lake Bluff, Ill.-based GPI Prototype & Manufacturing Services Inc. “The software and technical acumen required to operate these machines is extremely important to having any success. The average consumer doesn’t have the patience for failures and won’t pay for it. Just to have someone come to repair or get the machine functioning properly could potentially cost 20-30 percent of what they pay for the machine. I give it another 10 years before it becomes fully functional and adopted by the masses in a meaningful way.”
“Most people believe they can unwrap the box, download their favorite design, pull out their cool scanner, and make replicas of their R2D2 doll,” James Ward, director of marketing at Dinsmore & Associates Inc., a 3-D printing services provider based in Costa Mesa, Calif., told MPO. “Not realizing that some other individual who went to college from anywhere from four to eight years and did ridiculous levels of mathematics to become an engineer designed that little plastic thing you’re about to print. That’s the big disconnect.”
Indeed, only about four or five years ago, Ward and his associates at Dinsmore would encounter a lot of misinformation even amongst medical device companies. “I don’t need posters,” or, “I already have someone who does our flyers,” potential original equipment manufacturer (OEM) clients would say when Dinsmore made its pitch for 3-D printing manufacturing services. And that’s where consumerization has its benefits. Upon the expiry of many patents on various 3-D printing processes, companies such as 3D Systems and Stratasys Ltd. that have consumer-use printers on the market have played a big part in public education, letting the world know that a process such as this does exist.
Stratasys has been in the game from the beginning. The company was founded in 1989 by S. Scott Crump and his wife Lisa Crump in Eden Prairie, Minn. The company’s extraordinary reach today—with recent acquisitions, projected to be 21 percent of the market in 2015—is rivaled only by 3D systems, which is projected to hold 25 percent of the market next year. Stratasys now owns Objet Ltd., which it acquired in 2012; Makerbot Industries, which makes popular home models as well as industrial machines, acquired in 2013; and Solid Concepts, RedEye, Harvest Technologies Inc. and GrabCAD, all acquired this year. At a recent media event held in New York, N.Y., Stratasys customers from the aerospace, automobile and consumer markets spoke about how they are using the technology to change their business. But Pete Basiliere, research vice president of imaging and print services for Stamford, Conn.-based Gartner Inc., an information technology research and advisory firm, said that what excites him most is the medical device field. “3-D printing has life-altering potential,” he said—and it’s hard to disagree with him.
"The first major patent to expire involved Stratasys’ fused deposition modeling (FDM) patent in 2009," explained Rob Connelly, vice president of additive manufacturing technologies for Maple Plain, Minn.-based Proto Labs Inc., a provider of machined and molded parts. The company uses stereolithography and laser sintering technology to produce prototype parts for its clients. "That really opened the door for the wide-spread adoption of 3-D printing due to the increase in accessibility. There was a boom in consumer desktop printers with startups developing new 3-D printing products, but more importantly for us, there was a new level of visibility about what was possible in commercial printing. Earlier this year, a patent on selective laser sintering (SLS) also expired. This has brought more accessibility and more visibility to additive manufacturing as a whole. With increasingly more engineers and designers developing parts via 3-D printing, this will ideally lead to new developments in the processes themselves. And that’s always beneficial to the industry, and the medical device space."
Although the consumerization of 3-D printing is, at this juncture, not very useful in the hands of the layman, the technology certainly is exciting in terms of the Jobs and Wozniaks of the (medical) world, i.e., individuals with technical expertise who want to tinker at home without spending a lot of capital.
“I can see [consumerization of 3-D printing] affecting the medical device industry in one way already,” Galloway said. "We get approached by surgeons who wish to modify a tool. If the surgeons are serious about making changes, they will need to learn how to design or pay for a service to develop a newly designed tool. Then they could potentially design and create their own tools/components. Potentially, a long way down the road, they could do the same thing for an implant.”
At the Heart of Things
Materialise, based in Leuven, Belgium, currently is on that life-altering edge of medicine analysts like Basiliere talk about. This year, Materialise made a plastic heart, and it’s going to market.
In July, a baby boy was born with a complex form of congenital heart disease (CHD) in which both the aorta and pulmonary arteries arise from the right ventricle. Also present was a large hole in the heart called a ventricular septal defect. On the first day of his life, an extremely low-dose chest CT (computed tomography) scan was acquired to better understand the complex 3-D relationships of the heart and defects. From the images alone it was difficult for the doctors to formulate the optimal surgical plan, especially considering that the baby’s heart was no bigger than a walnut—so they sought out a firm with 3-D printing capabilities to find a solution. They turned to Materialise.
Starting with the baby’s image data, Todd Pietila, cardiovascular business development manager at Materialise, created a 3-D model of his heart using the Mimics Innovation Suite of software. The team at New York-Presbyterian/Morgan Stanley Children’s Hospital worked closely with Pietila to achieve an accurate reconstruction of the heart, which would allow the surgical team to best visualize the complex defect. The result was a 3-D representation of the heart with the small details of the congenital defects captured accurately.
The file then was 3-D printed at the medical production facility at Materialise’s U.S. headquarters in Plymouth, Mich. The project is a demonstration of one of the 3-D printing processes’ biggest claims to fame, which is speed. Only two days after receiving the data, a replica of the baby’s heart was delivered to the hospital.
The complex 3-D relationships of the newborn’s defects were not apparent from the ultrasound and scan data alone. Fortunately, with the 3-D printed model in hand, the team of clinicians at New York-Presbyterian/Morgan Stanley Children’s Hospital found an ideal solution for repairing all of the defects during one procedure, instead of three or four surgeries.
“The baby’s heart had holes, which are not uncommon with CHD, but the heart chambers were also in an unusual formation, rather like a maze,” said Emile Bacha, M.D., a congenital heart surgeon and director of congenital and pediatric cardiac surgery at the hospital. “In the past we had to stop the heart and look inside to decide what to do. With this technique [using a 3-D printed model], it was like we had a road map to guide us.”
Bacha performed the surgery when the week-old baby weighed a little more than 7 lbs. His single-procedure approach allowed the baby to avoid the typical series of palliative operations, which can be life-threatening. The clinical outcome was ideal and the baby is on his way to a healthy life.
The 3-D printed heart model also allowed the surgeons to explain the baby’s condition and their plan to the worried parents. By seeing the model and understanding what needed to be done, the parents became as confident as the surgical team.
“In discussing the necessary surgery with the doctors it was unclear how it would be performed and if it would be accomplished with one or two surgeries,” the baby’s father said. “We were told that they are working on getting a 3-D-printed model of our son’s heart, which the team hoped would clarify the surgical plan. Upon receiving the model, everything changed. After studying the model, the surgeon got a clearer picture of what needed to be done and was very optimistic that he could do the repair in one surgery. Our baby was saved from subsequent surgeries and interventions and all the side effects and developmental delays that come with it. This is truly an amazing advancement in surgical planning and outcome. We are so thankful.”
Now, clinicians at New York-Presbyterian/Morgan Stanley Children’s Hospital are working with Materialise on additional cases.
“After the success of this surgery, it’s hard to imagine entering an operating room for another complex case without the aid of a 3-D printed model,” Bacha said. “It’s definitely going to be standard of care in the future and we’re happy to be leading the way.”
Materialise had been working for about three years on printing flexible models such as this heart, Joroen Dille, Materialise’s director of orthopedics, told MPO. The company used PolyJet technology from Stratasys to create a product that isn’t totally rigid.
PolyJet 3-D printing is similar to inkjet printing (i.e., the kind of regular desktop printer we use to print documents), but instead of jetting drops of ink onto paper, PolyJet 3D Printers jet layers of curable liquid photopolymer onto a build tray. The process follows three basic steps. In pre-processing, build-preparation software automatically calculates the placement of photopolymers and support material from a 3-D CAD (computer aided design) file. The second step is production, where the 3-D printer jets and instantly cures tiny droplets of liquid photopolymer with ultraviolet light. Fine layers accumulate on the build tray to create a precise 3-D model or part. Where overhangs or complex shapes require support, the 3-D printer jets a removable gel-like support material. Then comes support removal, where the user removes the support materials by hand or with water. Models and parts are ready to handle and use right out of the 3-D printer, with no post-curing needed.
“What is very interesting with this machine is that you can use different material properties,” said Dille. “You can use hard and soft materials, and the machine can mix those two materials together while printing, enabling you to create different flexibilities in your model. It’s one of those unique things you can do with additive manufacturing—creating an object that can be very rigid in some parts and flexible in others. It’s these kind of applications, like the model of the baby’s heart, that show the opportunities and solutions this technology can provide.”
One Size Fits One
“The real promise of 3-D printing isn’t about manufacturing products for everyone. It’s about manufacturing products for just one person.” So says Liz Ganes, senior editor of technology trends and innovation for Re/Code, an independent tech news site that covers topics on the cutting edge of technology today.
Dinsmore’s Ward challenged MPO to do the difficult work of wading through the hype and write about the facts of 3-D printing. “I’m hoping to see more articles that are based around the factual world that is 3-D printing,” he said. “With all the hype, apparently next thing you know the world owns 3-D printed guns and that’s what everyone’s talking about.”
He is referring to the so-called “world’s first 3-D printed gun,” which high-tech gunsmithing group Defense Distributed announced last year, sending the public into a frenzy of speculation. Could everyone now just make their own gun at home with the push of a button? It didn’t help that the group named their product the “Liberator.”
The answer is no.
The device is complex and requires a considerable amount of expertise to design and manufacture. As the experts note, a considerable level of engineering and technical expertise is needed to create even the most basic of devices, and since we haven’t been inundated with plastic, functional guns just yet, it’s safe to say that won’t be a problem too soon.
But we shouldn’t be too quick to dismiss the power 3-D printing as a manufacturing process can give an average home user. Derek Mathers, business development manager for Worrell Design Inc., a Minneapolis, Minn.-based industrial design and product development company told MPO about a layman he encountered at a U.S. Food and Drug Administration (FDA) summit recently who taught himself how to use SolidWorks 3-D design software. He used the technology to customize functional fingers for his son who was born without any. Not only was he able to customize the design for his son, but he is disseminating the design for anyone to tweak and customize for their own needs. MPO’s sister publication Orthopedic Design & Technology has covered stories such as Zero Point Frontiers Corporation’s development of a prosthetic hand for pediatric use in the past, and last month’s MPO featured a story on a group of engineers, doctors and entrepreneurs who are fitting 3-D printed prosthetics for Sudanese amputees. Part of this group’s goal also is to teach local users how to use the 3-D printing technology so they can print their own products after the team leaves.
The takeaway from stories such as this is twofold. Additive manufacturing isn’t some new fad that “anyone” can just pick up and start making anything with. However, in the hand of experts or someone who is willing to spend a lot of time learning its functionality, truly exciting innovation can occur. Secondly, the process allows for true customization of devices, which opens the door not only to serving patients better (a prosthetic truly fit to one’s body instead of a one-size-fits-most model) but also to serving severely underserved populations, such as pediatric patients and poor/remote populations.
As Gartner’s Basiliere pointed out in New York, the number one reason people don’t wear hearing aids despite needing them, sometimes badly, is fit. Most hearing aids aren’t fit to the individual ear, and are therefore uncomfortable. Basiliere wears hearing aids, so he should know. But the ones he wears were 3-D printed based on molds of his ear canals.
“The true benefit of 3-D printing over other methods of manufacturing is the customization to the individual,” said Ward. But he also pointed out the problem of regulation that benefit brings: “That’s also the barrier that the U.S. Food and Drug Administration is going to frown upon because the FDA likes consistency, measurability, and repeatability. This technology that you can change on the fly, customize and change according to body type—it’s still kind of the wild west in truth in terms of the medical side. There are still a lot of questions around how to standardize 3-D printing.”
“One of the most powerful tenets of 3-D printing is that complexity is free, and becomes a user delight,” Worrell’s Mathers said, agreeing with Ward. But he sees a bright side to that on-the-fly customization. “In any traditional manufacturing process, complex structures incur significant switching costs due to massive shifts in the production line—whereas with 3-D printing, if you have a part that requires complex geometry, you can actually use less material to achieve the same result.”
"There is growing 3-D printing application for custom devices, with one of the largest segments being patient-specific instruments," added Proto Labs' Connelly. "These are surgical guides or cutting tools that are made from patient anatomical data, used to improve the outcome of some surgical procedures. Additive is uniquely able to service this need due to its ability to quickly and accurately make custom geometry that might not be possible to make in a conventional manufacturing process."
3-D+
3-D + the home user = innovation.
3-D + CMO = speed and complexity.
3-D + traditional manufacturing = wait, we can do that?
Often, additive manufacturing is discussed in terms of the “other” way to manufacture. Traditional manufacturing, such as injection molding or machining, is the “old way.” This is a misconception. The volume that injection molding offers, for instance, is an indispensable asset, and one which 3-D printing cannot quite match just yet. Companies such as Worrell, however, are merging the two processes, printing molds that can then be used in injection molding.
Speed often is touted as one of the best benefits of 3-D printing. Molded devices and components are dependent on their molds, and if there is a change in design, waiting for a mold to be made can take weeks to months. Printing a new design, on the other hand, can be done immediately, as all it requires is tweaking the design software. Injection molds also represent the greatest cost in a production process.
“Now that we’re able to print molds for the devices we develop, we’re able to get people to market sometimes two months ahead of time, instead of our clients (large medical device OEMs) spending weeks and significant capital on bridge tooling, our clients get to use those weeks to validate their design and submit to the FDA,” Mathers said.
The company developed its 3-D injection molding (3D IM) in partnership with Stratasys, and the two companies announced their collaboration on Oct. 30. Since 3-D printing injection mold tools for medical devices, Worrell reports that it is producing injection molded prototypes using final production materials in 95 percent less time and at 70 percent less cost compared with traditional aluminum molds.
“We were recently approached by medical device start-up, MedTG, to design and engineer a dual-flow needleless blood collection system that reduced the need for multiple injections, thereby increasing patient comfort and hospital efficiency,” said Worrell CEO Kai Worrell in a press release. “Utilizing 3D IM to prototype the device, we were able to reduce the costs associated with traditional tooling by approximately 70 percent, as well as cutting times by 95 percent.”
“We use our PolyJet printer to blend two digital materials, which results in a mold with really high heat deflection and can take a lot of impact or pressure,” Mathers explained. “So, instead of just printing the prototype, we’ll actually print the injection mold the prototype will be shot in, enabling us to go right into injection molding within a couple hours as opposed to having to wait weeks or sometimes months just to get to tooling. When engineers have finished developing their design concept and want to move to verification and validation testing, they traditionally have to invest in metal molds in order to get to that next phase. It is a long and arduous process—usually six to eight weeks—to get those molds made, and can cost them tens and hundreds of thousands of dollars just to get that first run of parts to validate their design. Since we can now produce production-level parts for our human factors engineers in just days, we are able to get our products into market much faster.”
As Mathers puts it, this integrates 3-D printing “seamlessly” into traditional manufacturing technologies.
The fact is, 3-D printing is fast and relatively cheap, which is what makes it great for prototyping. These characteristics also make it very attractive for tail-to-head manufacturing for finished devices as well, except for the process still not being able to hold the same tight tolerances as other techniques, such as CNC (computer numerical control) machining. Traditional manufacturing still is very much needed and desired in the medical device space, but in partnership with 3-D printing, both processes are elevated.
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So, has sophistication risen among OEMs who previously thought 3-D printing had something to do with posters? In its place—small run, innovative, complex designs and prototypes—3-D printing is becoming a mainstay in medical device manufacturing.
“I’m starting to see demands grow,” said Tim Warden, vice president of sales and business development at 3D Material Technologies LLC, a division of ARC Group Worldwide Inc. “Over the last three to five years, a lot of people were not really sure if the technology was going to take, or whether it was realistic. With a lot of big players in aerospace and medical device getting involved with the technology, you’re starting to see customers realize that this will be another validated manufacturing process going forward. You’ll see more and more applications using 3-D printing in the medical device industry. I don’t believe, however, that it will replace every technology out there. There are some people out there that believe that 3-D printing is the cure all. Realistically, it will just be another application/tool for engineers to use for their designing and manufacturing process.”