Ranica Arrowsmith, Associate Editor11.17.15
The Hubble Telescope, which was launched into space in 1990, was 44 years in the making before it was airborne. Conceived in 1946 by astronomer Lyman Spitzer’s paper “Astronomical advantages of an extraterrestrial observatory,” the incredible telescope that has refined our calculations of the age of the universe and brought us evidence of extrasolar planets around Sun-like stars has cost approximately $2.5 billion. But $1.5 billion of that amount could have been saved if not for a crucial mistake.
The day the Hubble was launched was a triumphant moment for science, and indeed for humanity. However, the first images it sent back were disappointing. They were blurry and much lower quality than expected. The telescope’s primary mirror, as it turned out, had been ground down a little too far—towards the mirror’s edge, the surface was two microns too flat, causing light reflecting off the edge of Hubble’s mirror to focus at a different point from light bouncing off closer to the center. In 1993, a repair crew took a shuttle flight up to install what amounted to eyeglasses for Hubble’s unfocused gaze: two mirrors specially designed to correct the aberration caused by the flaw, as well as other correction devices for other components. This trip cost $1.5 billion—a costly mistake.
No one now would dare dispute the value of that repair mission, as Hubble has brought us more than 45 terabytes of information from space. We can thank Hubble for knowing the Big Bang occurred about 13.7 billion years ago instead of a previous broad theory of between 10 and 20 billion years ago. We can also thank the telescope for one of the most iconic astronomical images of the 20th century—that of the “Pillars of Creation,” which shows a part of the Eagle Nebula where new stars are forming. The tallest pillar is around four light-years high. None of which could have been possible had that two micron error hadn’t been fixed. To put that into perspective, the width of an human hair ranges between 30 and 100 microns.
There is no medical device that can be said not to demand precision, accuracy, and careful design and development. However, when it comes to musculoskeletal devices and implants, one has to start thinking about how they work in the same way an aerospace engineer has to think about rocket dimensions. The human skeleton is made up of 206 bones that are all made of collagen, calcium phosphate, and calcium carbonate, which make for a rigid structure with just enough flexibility to protect against brittleness. Compare this structure to that of the heart, which is made up of smooth and very flexible muscle. An implantable pacemaker, for instance, is placed underneath the collarbone with the lead wires extending into the heart (to put it simply). Since muscle and skin tissue is extremely elastic, there is not much need for customizable sizing options.
“Anything of a medical device nature requires a whole separate set of extreme quality and procedural standards,” Bing J. Carbone, president of Shelton, Conn.-based Modern Plastics Inc., a plastics distributor that serves a variety of industries including medical, told Orthopedic Design & Technology. “Modern Plastic is both ISO 9001:2008 and ISO 13485:2003 certified, the latter being very unique for a plastics distribution company. We have earned the respect of global orthopedic and medical device manufacturers across the globe by putting quality first with dead-on accuracy and consistency in how we service our customers. As a plastics distributor, it is our job to have a vast amount of plastic stock shapes on our shelf for immediate shipment. We offer our customers cut-to-size close tolerance cutting on all of our materials. Proper material certification is essential. We have a full-time quality control director who issues all of our material certifications with each shipment. Attention to detail is critical. We are unique in the fact that we maintain our customer records for 20 years minimum and provide barcoding on all plastic materials right back to the lot and batch with the specific manufacturer.”
But take a total knee implant. A slightly too big or small implant could cause a patient’s leg to shorten or lengthen; could consequently create a limp, which could cause spinal issues; and could potentially lead to undue wear and infection of the implantation site.
Conventional knee replacement surgery works for most patients, but because knee implants come in “standardized” sizes, they are approximations, rather than exact fits, of patient knee sizes. This means orthopedic surgeons must shave down portions of a patient’s femur during the replacement procedure to make the implant fit. Today, there are customizable options, but this illustrates how orthopedic products are unique in their need for precision.
Prototyping is the first tangible iteration of an orthopedic device. There are many ways to approach developing a prototype, from creating a model that approximates only the size and shape of the final product, to creating a functional device that mimics the final product as closely as possible. No one way is wrong or right, as it depends on the purpose of the initial prototype and where in the device’s life cycle that particular prototype falls. But orthopedic devices demand a notable level of precision in design and dimension simply due to the fact that many of them end up in between rigid bone with the potential for long-term wear.
“Precision and quality are the non-negotiables I think of first when prototyping orthopedic devices,” said Michelle Fleming, vice president and general manager of SpectrumLabscom's Irving, TX-based OR (operating room) Disposables Division. “There may be some additional tolerance allowed with other types of medical devices, however there is zero room to move—even on huge volume—when prototyping and manufacturing orthopedic devices. Advanced manufacturing techniques and materials help enable tighter tolerances and the most advanced quality. Each and every device must be crafted to exact precision and consistent high quality.”
Following are some of the ways in which this precision in orthopedic device prototyping can be achieved.
The Place of 3-D Printing
3-D printing has, in recent years, been called a “solution” in the true sense of the word. It is a solution to a host of problems, including customization, manufacturing costs, manufacturability, and world peace. Well, that last one was an exaggeration—but the way 3-D printing is discussed, one might think it was true. But for all its worshippers—and detractors—3-D printing is neither the answer to all life’s problems nor a flash in the pan. The technology has been around for decades, and like every other technology, has been improving and growing with time. It is a go-to method for prototyping—in fact, another term for 3-D printing is rapid prototyping.
“DMLS—direct metal laser sintering—has gotten a lot cheaper recently,” Sachin Bhandari, director of product development for Miami, Fla.-based Turtle Mechatronics Inc., noted to ODT. DMLS is a method of 3-D printing with metals. “That’s going to be very exciting. There are a lot of things that previously you couldn’t do with metal 3-D prints that DMLS will open up. Let’s say that I wanted to make a 3-D printed implant that exactly matches your needs, or a 3-D printed plate. Out of a DMLS print, I could actually make something out of titanium that’s really going to be suitable for use. We think it’s pretty exciting and we think it will really bring down the times that you’d need to get some of these products to market.”
In 2013, Ben Grynol, a consultant with financial services firm Deloitte Touche Tohmatsu Ltd., won an inter-company award in the firm’s annual innovative thinking contest. His paper, “Disruptive manufacturing: The effects of 3-D printing,” used the word “drastic” to describe the changes the technology has gone through since its inception in 1984. The website On3DPrinting.com stated that “The 3-D printing industry is expected to change everything it touches, completely disrupting the traditional manufacturing process.” In raw numbers, that’s a translation of the fact that most projections place the growth of the 3-D printing industry at 300 percent between 2012 and 2020. We’re almost there.
One of the most commonly cited drawbacks to 3-D printing is the challenge of meeting economies of scale that older traditional manufacturing methods have been able to cultivate. 3-D printing’s main attraction is its ability to produce a relatively low number of goods at a very low cost. Once high volumes are demanded, this benefit fades away.
Grynol’s report laid out the benefits and challenges of 3-D printing side by side. On the plus side, 3-D printing offers lower cost low-volume manufacturing, shorter lead times, the ability to create new innovations and revise them quickly, the ability to create and manage just-in-time inventory, reduced investment and storage overhead, and customizability. Down sides include material limitations, and various iterations of volume considerations. But that was 2013.
As Grynol pointed out then, the growth of this area of manufacturing is accelerating fast, mainly due to a host of expiring patents on the technology. In his report, Grynol said that “Once bio-printing or the 3-D printing of human organs and tissues becomes commercially viable, patients will have access to single organs, printed using the size and organic structure they need.” We’re closing in on 2016 now, and this reality is so much closer to our fingertips than just two years ago.
Using its own proprietary three-dimensional bioprinting technology, Organovo Holdings Inc. designs and creates functional human tissues for commercial use. The San Diego, Calif.-based company was founded well before Grynol’s 2013 report (in 2008), but it was just last year that it announced the delivery of 3-D printed liver tissue to an unnamed exterior lab for experimentation. The tissue exhibited features crucial to the functioning of “real” liver tissue, such as albumin production (over 40 days), fibrinogen and transferrin production, certain inducible enzymatic activities; demonstration of appropriate response to hepatotoxic insults from acetaminophen, acetaminophen in combination with ethanol and diclofenac; and cholesterol biosynthesis. Later the same year, Organovo began offering contracting services for toxicity testing using its 3-D human liver tissue for selected clients prior to full release. Then in November 2014, the company released its exVive3D human liver tissue for preclinical drug discovery testing. Companies can now buy manufactured liver tissue for testing. Not quite a 3-D printed liver for implantation in a patient, but that reality is foreseeable now. The company aims to soon provide kidney tissue.
The Advanced Manufacturing Technology (AMTech) group at the University of Iowa College of Engineering’s Center for Computer Aided Design has also, since 2013, been working on creating human tissue. AMTech was formed to design, create, and test—both virtually and physically—a wide variety of electromechanical and biomedical components, systems, and processes. It has made steps towards solving a very difficult problem for orthopedics—growing cartilage. Cartilage is an avascular, aneural, alymphatic tissue. As such, once damaged, it cannot be regenerated or regrown naturally.
“The long-term goal of this branch is to create functioning human organs some five or 10 years from now,” Tim Marler, co-director of AMtech, said in 2013. “This is not far-fetched.”
Researchers from the University of Wollongong’s ARC Centre of Excellence for Electromaterials Science (ACES) and St. Vincent’s Hospital in Melbourne, Australia, are also making rapid advancements in bioprinting. Associate Professor Damian Myers led a project where cartilage was grown from stem cells applied to a 3-D printed scaffold. Stem cells were isolated from adipose tissue that was collected from under the kneecap. The growth required 28 days.
“We are trying to create a tissue environment that can ‘self-repair’ over many years, meaning the repaired site will not deteriorate,” Myers said. “It’s very exciting work, and we’ve done the hard yards to show that what we have cultured is what we want for use in surgery for cartilage repair.”
“Within a few years, we believe it will be possible to manufacture living tissues like skin, cartilage, arteries, and heart valves using cells and biomaterials,” said ACES Director Professor Gordon Wallace. “Using a patient’s own cells to create this tissue avoids issues of immune rejection. By 2025, it is feasible that we will be able to fabricate complete functional organs, tailored for an individual patient.”
Customizable, rapid-prototyped human tissue will, by most expert’s predictions, be a reality within a decade.
The Design Side
“Welcome to the future of CAD (computer aided design),” proclaims the website of Onshape Inc., a newly founded company that aims to bring CAD to the cloud and mobile spaces. The company was founded by John Hirschtick, who was previously CEO of SolidWorks Corp., a well-respected CAD company that is now a subsidiary of Dassault Systèmes.
CAD is the other side of prototyping, as it is where product and prototype designs are made.
“Although people have been developing CAD for a half century—and I’ve personally been at it for more than 30 years—I don’t feel like we’re done,” Hirschstick said in a blog post earlier this year. “Onshape is just the next chapter in a larger story for me. There’s no problem in CAD that’s been completely solved yet. CAD systems still aren’t fast enough, they’re not easy enough, they’re not robust enough or reliable enough. All of the core issues in CAD are still there—and I think as an industry, maybe we’re halfway done.”
Turtle Mechatronics’ Bhandari praised the structure of Onshape, and what the company is enabling for prototype design, “They are pretty unique in their approach to CADs. Normally you’ll do your solid models and save them on your desktop computer. You might check them into PDM (product data management). Onshape allows you to do all your CAD in a web browser. In a programming world, when you want to program something that you will use for prototyping, you’ll program and you’ll check it into what’s called a GitHub repository and that will manage your version control. And everybody has their own GitHub user name, they have all their own files, and they can branch code and they can do whatever it is they need to do. The new cloud-based CAD tools are structured similarly to how GitHub is structured. So I think the way that people will start collaborating on larger projects is really going to change a lot for the better. You’re going to see very disparate teams be able to get together and collaborate much more easily. So you’re going to see people from different organizations cross-functionally collaborating more, and being able to work on their models without having to be integrated into these PDM systems. You’re going to see a lot more free agents work on projects. And I think that the way that teams will collaborate will change as these tools and designs move into the cloud.”
As far as prototype design goes, Turtle Mechatronics takes a very user-focused approach. The underlying user need influences designs from the get-go, ensuring that the prototype mimics the end product as closely as possible (in what the company calls a “high fidelity” type prototype).
“We like to work closely with surgeons,” Bhandari said. “We have two classes of customers. First, are companies that need these prototypes made, and the second are surgeons. We like to work with surgeons from the conceptual stage forward and be their partners as they move towards commercialization. We really feel that the most critical thing, especially in an early-stage prototype, is identifying the underlying user need. And that may be doing things like scrubbing into surgery, and that may be prototyping the extremes. There are several types of prototypes. Oftentimes we’ll do low cost throwaways that are really meant to test the extremes. And then there’s what I would call a high fidelity prototype that’s really meant to be the same in terms of functionality in terms of the final production equivalent product. We think that in order to achieve the best final product early on—through whatever means necessary, whether it’s a low cost throwaway, or whether it’s through observation—you’ve really got to pin down the underlying user need.”
“From a raw material perspective, we need to understand the application and the function of the device and from there, we can start to determine the appropriate material selection that meets the desired properties,” said Modern Plastics’ Carbone. “For example, dimensional stability, chemical resistance, wear properties, cold and high temperature performance are some of the things we would seek to understand in order to make the best material recommendations. Other questions we’d want to have some understanding of is what certification is required; is it a Class I, Class II, or Class III device? Will the device require sterilization, and if so, what method of sterilization? Will the device be injection molded or machined? We have an incredible array of medical grade plastic materials, including permanent implantable PEEK to meet virtually any material requirement challenge.”
And how are these challenges met?
“Innovation happens on small teams,” Bhandari concluded. “Innovation at large bloated companies has oftentimes been slow—and the biggest killer is death by committee. Innovation happens when you have many cross-functional minds together. So it happens when you have a mechanical engineer, an electrical engineer, and a surgeon all in the same room observing a surgery. And it happens when everybody is really is willing to jump into each other’s field. So a mechanical engineer really makes an effort to understand the surgery and get out of his comfort zone; and likewise, the surgeon might look at this product and get out of their comfort zone to look at actual mechanisms or ways that they can set up the intelligence and the software. The sweet spot is small, cross-functional teams.”
The day the Hubble was launched was a triumphant moment for science, and indeed for humanity. However, the first images it sent back were disappointing. They were blurry and much lower quality than expected. The telescope’s primary mirror, as it turned out, had been ground down a little too far—towards the mirror’s edge, the surface was two microns too flat, causing light reflecting off the edge of Hubble’s mirror to focus at a different point from light bouncing off closer to the center. In 1993, a repair crew took a shuttle flight up to install what amounted to eyeglasses for Hubble’s unfocused gaze: two mirrors specially designed to correct the aberration caused by the flaw, as well as other correction devices for other components. This trip cost $1.5 billion—a costly mistake.
No one now would dare dispute the value of that repair mission, as Hubble has brought us more than 45 terabytes of information from space. We can thank Hubble for knowing the Big Bang occurred about 13.7 billion years ago instead of a previous broad theory of between 10 and 20 billion years ago. We can also thank the telescope for one of the most iconic astronomical images of the 20th century—that of the “Pillars of Creation,” which shows a part of the Eagle Nebula where new stars are forming. The tallest pillar is around four light-years high. None of which could have been possible had that two micron error hadn’t been fixed. To put that into perspective, the width of an human hair ranges between 30 and 100 microns.
There is no medical device that can be said not to demand precision, accuracy, and careful design and development. However, when it comes to musculoskeletal devices and implants, one has to start thinking about how they work in the same way an aerospace engineer has to think about rocket dimensions. The human skeleton is made up of 206 bones that are all made of collagen, calcium phosphate, and calcium carbonate, which make for a rigid structure with just enough flexibility to protect against brittleness. Compare this structure to that of the heart, which is made up of smooth and very flexible muscle. An implantable pacemaker, for instance, is placed underneath the collarbone with the lead wires extending into the heart (to put it simply). Since muscle and skin tissue is extremely elastic, there is not much need for customizable sizing options.
“Anything of a medical device nature requires a whole separate set of extreme quality and procedural standards,” Bing J. Carbone, president of Shelton, Conn.-based Modern Plastics Inc., a plastics distributor that serves a variety of industries including medical, told Orthopedic Design & Technology. “Modern Plastic is both ISO 9001:2008 and ISO 13485:2003 certified, the latter being very unique for a plastics distribution company. We have earned the respect of global orthopedic and medical device manufacturers across the globe by putting quality first with dead-on accuracy and consistency in how we service our customers. As a plastics distributor, it is our job to have a vast amount of plastic stock shapes on our shelf for immediate shipment. We offer our customers cut-to-size close tolerance cutting on all of our materials. Proper material certification is essential. We have a full-time quality control director who issues all of our material certifications with each shipment. Attention to detail is critical. We are unique in the fact that we maintain our customer records for 20 years minimum and provide barcoding on all plastic materials right back to the lot and batch with the specific manufacturer.”
But take a total knee implant. A slightly too big or small implant could cause a patient’s leg to shorten or lengthen; could consequently create a limp, which could cause spinal issues; and could potentially lead to undue wear and infection of the implantation site.
Conventional knee replacement surgery works for most patients, but because knee implants come in “standardized” sizes, they are approximations, rather than exact fits, of patient knee sizes. This means orthopedic surgeons must shave down portions of a patient’s femur during the replacement procedure to make the implant fit. Today, there are customizable options, but this illustrates how orthopedic products are unique in their need for precision.
Prototyping is the first tangible iteration of an orthopedic device. There are many ways to approach developing a prototype, from creating a model that approximates only the size and shape of the final product, to creating a functional device that mimics the final product as closely as possible. No one way is wrong or right, as it depends on the purpose of the initial prototype and where in the device’s life cycle that particular prototype falls. But orthopedic devices demand a notable level of precision in design and dimension simply due to the fact that many of them end up in between rigid bone with the potential for long-term wear.
“Precision and quality are the non-negotiables I think of first when prototyping orthopedic devices,” said Michelle Fleming, vice president and general manager of SpectrumLabscom's Irving, TX-based OR (operating room) Disposables Division. “There may be some additional tolerance allowed with other types of medical devices, however there is zero room to move—even on huge volume—when prototyping and manufacturing orthopedic devices. Advanced manufacturing techniques and materials help enable tighter tolerances and the most advanced quality. Each and every device must be crafted to exact precision and consistent high quality.”
Following are some of the ways in which this precision in orthopedic device prototyping can be achieved.
The Place of 3-D Printing
3-D printing has, in recent years, been called a “solution” in the true sense of the word. It is a solution to a host of problems, including customization, manufacturing costs, manufacturability, and world peace. Well, that last one was an exaggeration—but the way 3-D printing is discussed, one might think it was true. But for all its worshippers—and detractors—3-D printing is neither the answer to all life’s problems nor a flash in the pan. The technology has been around for decades, and like every other technology, has been improving and growing with time. It is a go-to method for prototyping—in fact, another term for 3-D printing is rapid prototyping.
“DMLS—direct metal laser sintering—has gotten a lot cheaper recently,” Sachin Bhandari, director of product development for Miami, Fla.-based Turtle Mechatronics Inc., noted to ODT. DMLS is a method of 3-D printing with metals. “That’s going to be very exciting. There are a lot of things that previously you couldn’t do with metal 3-D prints that DMLS will open up. Let’s say that I wanted to make a 3-D printed implant that exactly matches your needs, or a 3-D printed plate. Out of a DMLS print, I could actually make something out of titanium that’s really going to be suitable for use. We think it’s pretty exciting and we think it will really bring down the times that you’d need to get some of these products to market.”
In 2013, Ben Grynol, a consultant with financial services firm Deloitte Touche Tohmatsu Ltd., won an inter-company award in the firm’s annual innovative thinking contest. His paper, “Disruptive manufacturing: The effects of 3-D printing,” used the word “drastic” to describe the changes the technology has gone through since its inception in 1984. The website On3DPrinting.com stated that “The 3-D printing industry is expected to change everything it touches, completely disrupting the traditional manufacturing process.” In raw numbers, that’s a translation of the fact that most projections place the growth of the 3-D printing industry at 300 percent between 2012 and 2020. We’re almost there.
One of the most commonly cited drawbacks to 3-D printing is the challenge of meeting economies of scale that older traditional manufacturing methods have been able to cultivate. 3-D printing’s main attraction is its ability to produce a relatively low number of goods at a very low cost. Once high volumes are demanded, this benefit fades away.
Grynol’s report laid out the benefits and challenges of 3-D printing side by side. On the plus side, 3-D printing offers lower cost low-volume manufacturing, shorter lead times, the ability to create new innovations and revise them quickly, the ability to create and manage just-in-time inventory, reduced investment and storage overhead, and customizability. Down sides include material limitations, and various iterations of volume considerations. But that was 2013.
As Grynol pointed out then, the growth of this area of manufacturing is accelerating fast, mainly due to a host of expiring patents on the technology. In his report, Grynol said that “Once bio-printing or the 3-D printing of human organs and tissues becomes commercially viable, patients will have access to single organs, printed using the size and organic structure they need.” We’re closing in on 2016 now, and this reality is so much closer to our fingertips than just two years ago.
Using its own proprietary three-dimensional bioprinting technology, Organovo Holdings Inc. designs and creates functional human tissues for commercial use. The San Diego, Calif.-based company was founded well before Grynol’s 2013 report (in 2008), but it was just last year that it announced the delivery of 3-D printed liver tissue to an unnamed exterior lab for experimentation. The tissue exhibited features crucial to the functioning of “real” liver tissue, such as albumin production (over 40 days), fibrinogen and transferrin production, certain inducible enzymatic activities; demonstration of appropriate response to hepatotoxic insults from acetaminophen, acetaminophen in combination with ethanol and diclofenac; and cholesterol biosynthesis. Later the same year, Organovo began offering contracting services for toxicity testing using its 3-D human liver tissue for selected clients prior to full release. Then in November 2014, the company released its exVive3D human liver tissue for preclinical drug discovery testing. Companies can now buy manufactured liver tissue for testing. Not quite a 3-D printed liver for implantation in a patient, but that reality is foreseeable now. The company aims to soon provide kidney tissue.
The Advanced Manufacturing Technology (AMTech) group at the University of Iowa College of Engineering’s Center for Computer Aided Design has also, since 2013, been working on creating human tissue. AMTech was formed to design, create, and test—both virtually and physically—a wide variety of electromechanical and biomedical components, systems, and processes. It has made steps towards solving a very difficult problem for orthopedics—growing cartilage. Cartilage is an avascular, aneural, alymphatic tissue. As such, once damaged, it cannot be regenerated or regrown naturally.
“The long-term goal of this branch is to create functioning human organs some five or 10 years from now,” Tim Marler, co-director of AMtech, said in 2013. “This is not far-fetched.”
Researchers from the University of Wollongong’s ARC Centre of Excellence for Electromaterials Science (ACES) and St. Vincent’s Hospital in Melbourne, Australia, are also making rapid advancements in bioprinting. Associate Professor Damian Myers led a project where cartilage was grown from stem cells applied to a 3-D printed scaffold. Stem cells were isolated from adipose tissue that was collected from under the kneecap. The growth required 28 days.
“We are trying to create a tissue environment that can ‘self-repair’ over many years, meaning the repaired site will not deteriorate,” Myers said. “It’s very exciting work, and we’ve done the hard yards to show that what we have cultured is what we want for use in surgery for cartilage repair.”
“Within a few years, we believe it will be possible to manufacture living tissues like skin, cartilage, arteries, and heart valves using cells and biomaterials,” said ACES Director Professor Gordon Wallace. “Using a patient’s own cells to create this tissue avoids issues of immune rejection. By 2025, it is feasible that we will be able to fabricate complete functional organs, tailored for an individual patient.”
Customizable, rapid-prototyped human tissue will, by most expert’s predictions, be a reality within a decade.
The Design Side
“Welcome to the future of CAD (computer aided design),” proclaims the website of Onshape Inc., a newly founded company that aims to bring CAD to the cloud and mobile spaces. The company was founded by John Hirschtick, who was previously CEO of SolidWorks Corp., a well-respected CAD company that is now a subsidiary of Dassault Systèmes.
CAD is the other side of prototyping, as it is where product and prototype designs are made.
“Although people have been developing CAD for a half century—and I’ve personally been at it for more than 30 years—I don’t feel like we’re done,” Hirschstick said in a blog post earlier this year. “Onshape is just the next chapter in a larger story for me. There’s no problem in CAD that’s been completely solved yet. CAD systems still aren’t fast enough, they’re not easy enough, they’re not robust enough or reliable enough. All of the core issues in CAD are still there—and I think as an industry, maybe we’re halfway done.”
Turtle Mechatronics’ Bhandari praised the structure of Onshape, and what the company is enabling for prototype design, “They are pretty unique in their approach to CADs. Normally you’ll do your solid models and save them on your desktop computer. You might check them into PDM (product data management). Onshape allows you to do all your CAD in a web browser. In a programming world, when you want to program something that you will use for prototyping, you’ll program and you’ll check it into what’s called a GitHub repository and that will manage your version control. And everybody has their own GitHub user name, they have all their own files, and they can branch code and they can do whatever it is they need to do. The new cloud-based CAD tools are structured similarly to how GitHub is structured. So I think the way that people will start collaborating on larger projects is really going to change a lot for the better. You’re going to see very disparate teams be able to get together and collaborate much more easily. So you’re going to see people from different organizations cross-functionally collaborating more, and being able to work on their models without having to be integrated into these PDM systems. You’re going to see a lot more free agents work on projects. And I think that the way that teams will collaborate will change as these tools and designs move into the cloud.”
As far as prototype design goes, Turtle Mechatronics takes a very user-focused approach. The underlying user need influences designs from the get-go, ensuring that the prototype mimics the end product as closely as possible (in what the company calls a “high fidelity” type prototype).
“We like to work closely with surgeons,” Bhandari said. “We have two classes of customers. First, are companies that need these prototypes made, and the second are surgeons. We like to work with surgeons from the conceptual stage forward and be their partners as they move towards commercialization. We really feel that the most critical thing, especially in an early-stage prototype, is identifying the underlying user need. And that may be doing things like scrubbing into surgery, and that may be prototyping the extremes. There are several types of prototypes. Oftentimes we’ll do low cost throwaways that are really meant to test the extremes. And then there’s what I would call a high fidelity prototype that’s really meant to be the same in terms of functionality in terms of the final production equivalent product. We think that in order to achieve the best final product early on—through whatever means necessary, whether it’s a low cost throwaway, or whether it’s through observation—you’ve really got to pin down the underlying user need.”
“From a raw material perspective, we need to understand the application and the function of the device and from there, we can start to determine the appropriate material selection that meets the desired properties,” said Modern Plastics’ Carbone. “For example, dimensional stability, chemical resistance, wear properties, cold and high temperature performance are some of the things we would seek to understand in order to make the best material recommendations. Other questions we’d want to have some understanding of is what certification is required; is it a Class I, Class II, or Class III device? Will the device require sterilization, and if so, what method of sterilization? Will the device be injection molded or machined? We have an incredible array of medical grade plastic materials, including permanent implantable PEEK to meet virtually any material requirement challenge.”
And how are these challenges met?
“Innovation happens on small teams,” Bhandari concluded. “Innovation at large bloated companies has oftentimes been slow—and the biggest killer is death by committee. Innovation happens when you have many cross-functional minds together. So it happens when you have a mechanical engineer, an electrical engineer, and a surgeon all in the same room observing a surgery. And it happens when everybody is really is willing to jump into each other’s field. So a mechanical engineer really makes an effort to understand the surgery and get out of his comfort zone; and likewise, the surgeon might look at this product and get out of their comfort zone to look at actual mechanisms or ways that they can set up the intelligence and the software. The sweet spot is small, cross-functional teams.”