3-D Printing: A Solution Or The Solution?

3-D printing has, in recent years, been called a “solution” in the true sense of the word. A solution to a whole 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 of 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.

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,” described the changes the technology has gone through since its inception in 1984 as “drastic.” The website On3DPrinting.com stated 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 its difficulty in 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 arena of manufacturing is accelerating fast, and this is 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, and this reality is much closer to our fingertips than it was 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 in 2008—well before Grynol’s 2013 report, 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 the 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. Organovo also began offering contracting services for toxicity testing last year, 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 now can 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.

Experts from industry gathered to give their thoughts on the current state of 3-D printing in medical device manufacturing, where they see the technology moving in the future, and how the technology has helped them address their clients’ needs. Speaking to Medical Product Outsourcing were:

• Joshua Heaps, administrator, business operations and development for PADT Inc. PADT (Phoenix Analysis & Design Technologies) provides engineering services and products for simulation, product development, and rapid prototyping (a.k.a., 3-D printing). The company is based in Tempe, Ariz.
• Kris Kent, vice president of sales and marketing for Bloomingdale, Ill.-based Bi-Link Metal Specialties Inc. The company is a mechanical component supplier with expertise in injection molding, metal stamping, rapid prototyping, and high volume assembly.
• Peter Mercelis, Ph.D., director of applied technologies, healthcare, for Rock Hill, S.C.-based 3D Systems Inc. 3D Systems makes 3-D digital design and fabrication solutions, including 3-D printers, print materials and cloud-sourced custom parts.
• Eric Utley, applications specialist, additive manufacturing, for Proto Labs Inc., which provides injection molding and CNC machining service, offering quick turn parts for prototyping, bridge tooling and short-run production. The company is based in Maple Plain, Minn.

MPO: How would you characterize the current state of 3D printing manufacturing for medical devices today?
Joshua Heaps: 3-D printing for the manufacture of medical devices has become a mature application. We see it being used in research institutions, for custom medical devices, and to make low-volume complex devices. We also see a growing interest from OEMs to understand how they can use 3-D printing in their manufacturing. Besides the creation of end-use parts, we see 3-D printing used to make tooling, fixtures, and patterns.

Kris Kent: 3-D printing is reducing costs and improving outcomes through every stage of the medical device value chain—from idea generation, research and development through product prototype and manufacturing, through user training and sales aids. Because additive manufacturing technologies, machines, and materials are evolving at such a rapid pace, it’s sometimes challenging to select the proper tool for the opportunity at hand.

A contract manufacturer to leading global medical device original equipment manufacturers (OEMs), Bi-Link employs our in-house 3-D printing capabilities and other rapid prototyping technologies to assist customers in “front-loading” problem-solving and concept testing. At our corporate headquarters in Bloomingdale, Ill. and at our two remote workspaces in Raleigh, N.C., and San Diego, Calif., we practice open innovation with our customers to collaborate and co-create, solving complex design challenges during the earliest phases of the new product development process. With 3-D printing and all the tools and resources necessary to push the boundaries on design projects, we are able to offer customers a few parts fast for unmatched insight.

The benefits of being able to see and feel the design concept as it evolves serves several purposes: It helps identify design opportunities and flaws; allows for comparison on multiple design alternatives; clarifies communication across remote and diverse team members; and assists in project management activities.

While many contract manufacturers currently outsource early-stage prototypes, Bi-Link’s investment in in-house 3-D printing and other rapid prototyping capabilities allows our customers to measurably and cost-effectively accelerate time-to-market for critical, life-saving medical devices. Design engineers obtain in a few days or even hours what would have taken weeks to produce by traditional, tooled means or to outsource to a prototype-only supplier. They may then proceed quickly though the iterative problem-solving that occurs during pre-prototype and prototype.

Peter Mercelis: A big difference in 3-D printing today in comparison with, let’s say, five years ago, is that today 3-D printing is recognized by industry as a valid technology to produce functional devices. So not only is it for prototyping or unique cases, but also for volume manufacturing production methods. That’s the case for 3-D printing of metals and some polymer materials. So we see a big difference today in the type of products being manufactured in comparison to some years ago.

In 3D Systems’ business we see a big increase in volume manufacturing of final devices—functional devices like spinal and orthopedic implants, for example. One of the most important reasons that 3-D printing became a valid volume manufacturing method is that the performance of the resulting materials can now be considered equal or even better than those from classical manufacturing methods. Like casting of metal, for example, and CNC machining.

I think that today, the hesitation to produce products with 3-D printing has disappeared, and it’s now more considered as an alternative for classical manufacturing methods that people are used to from the past.

Eric Utley: Along with the aerospace industry, the medical industry stands to gain the most from advances in 3-D printing. The medical device industry has been using 3-D printing for rapid prototyping for over two decades, but only relatively recently moved into printed end-use products. 3-D printing is uniquely suitable for creating variable, organic geometries that mimic the human form. Already, 3-D printing is used to produce end-use hearing aids and is used in the manufacturing of custom dental braces. I believe the use of 3-D printing to create functional parts will grow substantially in the coming years.

MPO: Can you discuss the ways in which the technology has advanced in recent years, specifically in the past year?
Heaps: The key change has been in materials. The maturation of metal materials in Selective Laser Melting was a major breakthrough, especially in orthopedics.

A greater selection of U.S. Food and Drug Administration (FDA)-approved plastic materials has also widened the possible applications.

Another advance that has impacted custom medical devices mostly, has brought this technology out of research and more in to practical application, is improvements in the software that takes 3-D medical imaging data and converts it into something that can be used in 3-D printing.

The accuracy and speed increases across technologies has also brought the per piece price down. Other related improvements revolve around quality and manufacturing processes that have been developed by manufacturers to support 3-D printing technology.

Kent: Multi-material/component printing has proven invaluable to the development engineers. Having the ability to mimic insert or overmolded components of hard and soft plastics, without the expense and time of traditional prototyping, even rapid prototyping, is allowing for the ability to test proof of concept with near injection molded-like properties. What is not accomplished is replicating the molding process, but these parts are still far superior to printing individual parts and gluing them together, for example. And the old problem of brittleness is gone. This capability allows the design process to advance further and with better accuracy for when the need to use actual materials, plus test the result of actual injection molding, is needed.

Mercelis: Mechanical performance and accuracy of the resulting products has improved. I think about the strength of the products, the density, resolution and surface quality of the parts produced. All those characteristics have improved over the past years. And now there’s no difference in the performance of these materials with respect to traditional methods.

The improvement of the productivity of the technology relates directly—almost linearly—to the price of the produced device, because the productivity by cubic centimeter per hour, for example, determines the build time, hence a large portion of the production cost  of the produced device. So the improvement in the production rate and the productivity of those machines translates itself almost directly to a reduction in the production costs of those devices.

And at the same time, while improving productivity, the resolution and accuracy of the technologies have also improved. This means we can also produce more detailed products and higher resolution products. One example is the production of porous bone scaffolds. Those materials were traditionally produced with foaming technologies, but that results in a non-controlled kind of porosity. But now with 3-D metal printing for example, companies are able to accurately design a micro porosity and reproduce it through 3-D printing in a digital way so that it results in a more controllable porosity and a more controllable biological behavior of the resulting materials. These bone scaffolds can be seamlessly integrated in a digital implant design, like a hip cup of a spinal fusion implant.

Utley: Direct metal laser sintering and electron beam melting—two technologies used to print metal parts—have grown tremendously in the medical industry over the last year. The manufacturing process naturally results in parts with a textured finish, which is optimal for promoting bone growth in implantables. The technology is also popular for building complex metal components that would normally be impossible to manufacture otherwise. We use the technology primarily for building prototype parts that would normally require complex computer numerical control (CNC) machining to manufacture.

MPO: Can you discuss a specific example of a 3-D-print manufactured device or product that you worked on that you find particularly compelling or interesting?
Kent: Our challenge: The principal product design engineer for a global Fortune-500 medical device manufacturer approached Bi-Link with an idea to improve the ergonomics and actuation of a current laparoscopic surgical device. Field marketing data indicated that the customer’s product was losing market share to a competitive product that surgeons felt offered advantages in both control and accuracy. A significant redesign of this high-volume instrument was underway, and pending a successful launch, the improvement would likely be incorporated into a family of devices with similar functionality. The customer engineering team had already narrowed their design ideas down to two competing concepts based on product requirements, and they needed to agree on a primary direction. Timing was of great importance as the customer hoped to launch this new product in record time.

Our solution: After several initial meetings by phone and at the customer site, Bi-Link gathered a small team of design and manufacturing engineers at their Hardware Store by Bi-Link location in Raleigh, N.C., to meet with customer representatives. There, with all the tools and resources necessary to support the team, they worked collaboratively for four full days to optimize and create functional prototypes of both designs using 3-D printed molds. During this time, the team printed more than eight prototype molds and injection molded several dozen parts. Four weeks later, and after three more prototype iterations, a “final” design was selected and approved by the customer for prototype funding.

Our result: Bi-Link is redefining the role a contract manufacturer plays in the early stages of new product development. Through the use of open innovation and our collaborative contribution of design and manufacturing knowledge, experience, resources and tools, we helped propel our customer forward through their initial concepts to an approved product design. Our ability to create rapid, cost-effective, functional prototypes for immediate team evaluation enabled us to proceed quickly through the iterative problem-solving that occurs during pre-prototype. Bi-Link’s engineer-to-engineer (E2E) support, design for manufacturing (DFM) know-how, and vertically integrated capabilities offer unmatched insight at this stage and all the way though full-scale manufacturing.

Mercelis: There was a veterinarian implant product that we manufactured in collaboration with a German company, Rita Leibinger GmbH & Co. KG. It is a project for a veterinarian implant for dogs, and it illustrated two things. One is that 3-D printing is a real volume manufacturing method, because we produce 20,000 units per year. It also shows that through 3-D printing, new types of devices can be developed that did not exist before because it is simply impossible to build them as one piece using traditional manufacturing methods. So it’s a nice illustration of how 3-D printing can enable new types of devices that did not exist before.

Utley: We print models of bones and organs for surgeons to familiarize themselves with the patient’s anatomy before performing surgery. This allows the surgeon to plan the surgery in detail and reduce the amount of time the patient is under the knife. We also 3-D print microfluidic chips for research labs around the world. The printing technology allows for unique channel paths that are not possible with more conventional methods.

MPO: What kind of advancements in the technology, as well as capabilities, are you looking forward to in the future?
Heaps: The big need for end part manufacturing is greater throughput capability. The per piece cost of devices manufactured with 3-D printing needs to come further. The additive manufacturing machines need to be moved from a prototyping batch approach to more of a continuous manufacturing approach.

We would also like to see more materials, especially PTFE (polytetrafluoroethylene), available in additive manufacturing.
Looking at the industry, we also feel that a hybrid machine that includes multiple additive manufacturing materials and robotic placement and even assembly of components is required. This is especially true for 3-D printed components that are combined with electrical components. The placing of printed circuit boards, chip packages or discrete components should be done in the devices as the part is being made. The proper application of this can remove the need to make multiple plastic or metal parts that are assembled with additional components; the entire assembly can be created in the 3-D printer, enclosing the other mechanical and electrical components as the device is being created.

Kent: Metal injection molding is the next up. Currently, there are machines capable of this, but the final products usually require additional post finishing or other treatment to be used. As it stands now, for certain applications such as aerospace, metal printing seems to fit. There is more development needed for medical applications. Having the ability to print metal and multi-types of plastic in the same unit at the same time will be a game-changing addition to the design process.

Mercelis: One that will continue for sure is the productivity increase. That is something that we but also our competitors are continuously working on. Even higher productivity would, for example, result in more large-joint applications. Today most of the applications are rather in small joint orthopedic, spinal and CMF (cranio-maxillo facial surgery) fields, because the material volume of those implants is pretty limited, hence the build time. But as we further improve the productivity, large joint applications like knee and hip implants will become more interesting from an economic perspective.

So whereas mass production of these types of implants through  3-D printing is still rather limited today,  patient-specific implant cases are used a lot, since the higher cost can be justified. But further productivity increases will broaden the application field and also enable volume manufacturing of large joint devices.

A second innovation that we expect is the introduction of new materials. On the metals side we can offer common medical device alloys like titanium and stainless steel, and cobalt chrome, But on the polymer side there’s still room for improvement. I expect that new biopolymers and biodegradable materials will come on the market in the next few years as an alternative for classical injection molding or CNC milled polymer components.

Utley: One of the largest hurdles for the medical industry in adopting additive manufacturing is the relative lack of standardization and validation. As the standards are developed and precedents set by the industry pioneers, then new applications can be explored more openly. Also, the knowledge around 3-D printing used to be quite obscure, but we are entering a new era of the technology where individuals who were exposed to the technology early in school and are now entering the workforce. This new generation of engineers and designers has much more experience with the technology and are able to design parts that take full advantage of the technology capabilities.