Healthcare is one of the industries to most dramatically see changes occur due to the use of 3D printing technology. In fact, market research firm Gartner suggests that it is the medical sector that is leading the advancement of 3D printing over other industries.
3D printing has already become the dominant technology used to manufacture patient-specific hearing aids and dental aligners and, more recently, 3D printing has become increasingly leveraged for the manufacturing of patient-tailored implants and instruments for craniomaxillofacial (CMF) reconstruction and knee and hip replacements. This is clearly just the beginning for additively manufactured products in the medical space, which will one day include 3D-printed organs and patient-specific pharmaceuticals.
Among the large industrial players to adopt 3D printing for the production of medical products is Johnson & Johnson, a multinational corporation with some 250 subsidiaries across 57 countries and a market cap of $323.8 billion. While the multinational corporation’s 3D-printed orthopedic implants have been on the market for several years, Johnson & Johnson is also partnering with some of the most exciting firms in the 3D printing space, such as Carbon, HP, 3D Systems, Organovo and Materialise.
To learn more about how the corporation will leverage the technologies from these firms, I spoke with Joseph Sendra, worldwide vice president of Manufacturing Engineering and Technology for Johnson & Johnson. As one might expect from such a large multinational corporation, the executive could not divulge too much about what Johnson & Johnson is working on behind closed doors, but Sendra was able to lay out the corporation’s larger vision for 3D printing technology.
3D-Printed Implants and Instruments
3D printing has long been adopted by manufacturers as a means of prototyping during the design process, but starting several years ago, Johnson & Johnson subsidiary DePuy Synthes began using the technology to produce patient-specific instruments and implants.
Sendra described the work being performed by DePuy Synthes, “We have a product line called TRUMATCH in our orthopedic segment that consists of implants and surgical guides for CMF surgery, and resection guides for knees that are personalized today. These personalized devices have complex geometries and are provided on demand for surgical applications in the CMF space and knee surgery.”
TRUMATCH CMF uses a patient’s CT scan and then clinical engineers are able to create patient-specific implants and surgical guides. While patient-specific implants ultimately fit into a patient’s anatomy with fewer complications, surgical guides are used during an operation to direct a doctor in how to cut the bone and accurately locate the implant, taking the guesswork out of delicate procedures and reducing time in the operating room. An added benefit that 3D printing brings to patient-specific implants is the ability to fabricate complex geometries that are difficult to produce from subtractive methods.
The TRUMATCH Knee offering uses a three-dimensional computerized scan (CT) of the patient’s leg to create surgical guides that are designed based on the patient’s unique anatomy. The process, which was designed internally, has had a long term partnership with Medical Modeling, now 3D Systems. All surgical guide design, communication with surgeons and the overall product lifecycle are managed by a dedicated team based in Warsaw, Ind. Upon surgeon approval, the electronic file is securely transferred, 3D printed at 3D Systems, and then returned to DePuy Synthes for final assembly, sterilization, and shipment.
Earlier this year, DePuy Synthes TRUMATCH CMF announced the expansion of its existing partnership with Materialise, a leader in the medical 3D printing space due to its 25 years of experience as a 3D printing service provider and software developer. Materialise had already produced DePuy Synthes’ patient-specific surgical guides, but it will now also supply the Johnson & Johnson subsidiary with patient-specific CMF implants. These implants will be sold through DePuy Synthes TRUMATCH CMF Solutions in Australia and Europe, excluding France.
Sendra pointed out that, while 3D printing is an important technology for bringing patient-specific implants and instruments into existence, the software is at least equally crucial in making these designs possible. “Our focus areas include, but are not limited to, the personalization of instruments and devices and software related to patient-specific technology. Really, that’s what the additive space brings to healthcare. It’s not so much about the manufacturing technology itself. It’s about the enablement of personalized solutions specific to you and I and people like us. That's what we’re really getting in the additive space,” Sendra said.
He added, “Think of it as an ecosphere of health-care personalization anchored in 3D printing, but that 3D printing is essentially the enabler. There’s a lot more around it that’s necessary to make it happen.”
In that way, DePuy Synthes TRUMATCH CMF could not have found a better company to partner with than Materialise. In addition to fabricating individually tailored guides and implants through its large 3D printing facilities, the Belgian company has long been developing software for use with 3D printing. The firm’s MIMICS Innovation Suite allows the end user to quickly render models from CT images and to design personalized devices from the rendered patient images.
Materialise’s ProPlan CMF planning software has been developed for TruMatch CMF to allow their clinical engineers to collaborate with doctors in a virtual setting to pre-operatively plan the surgery, define the implant shape, and design the surgical guides, resulting in an output file that can be sent to a 3D printer to product an anatomic model or surgical guide. With DePuy Synthes TRUMACTH CMF , Materialise has advanced the pre-operative planning capabilities of their ProPlan CMF and Mimics software to enable surgeons to optimize their plans prior to surgery, leading to improved accuracy and efficiency in the operating room.
Given the work that Johnson & Johnson has performed with Materialise to develop this software through DePuy Synthes TRUMATCH CMF, it may be that the corporation will continue its work in software development, just as it pushes to create new 3D-printed implants and instruments.
Next Generation 3D Printing for Medicine
In order for widespread adoption of 3D printing to occur in various industries, the technology has numerous hurdles to overcome. This is just as important to the medical sector as it is to other industries, which may be why Johnson & Johnson has chosen to partner with two key companies seeking to tackle some of the issues associated with 3D printing: Carbon and HP.
Sendra, unfortunately wasn’t able to disclose how Johnson & Johnson would leverage these technologies, except to say that “Our collaborations further our commitment to harnessing new technologies to improve outcomes and reduce costs across the healthcare continuum. We’ve announced strategic partnerships to create the entire ecosystem of personalization and that’s really exciting. It lets us provide solutions to previously unimaginable problems. There are things we just couldn’t solve before, but now we can.”
Carbon’s continuous liquid interface production (CLIP) brings two new elements to the 3D printing industry, speed and engineered materials. Through the use of an oxygen-permeable window, CLIP is capable of producing objects in less than ten minutes at a time. Added to this quick rate of production is the fact that the parts are isotropic, meaning that the strength of a component is equal in all directions.
This is in stark contrast to most 3D printing technologies, most of which produce objects that are weaker along the Z-axis due to weak chemical bonds. Moreover, parts printed with CLIP materials undergo a post-print thermal curing process that makes them even stronger, resulting in mechanical properties similar to those seen in components made with injection molding.
Earlier this year, Johnson & Johnson Innovation and Janssen Pharmaceuticals, both subsidiaries of the larger multinational, announced 21 different partnerships indicating a huge swath of projects across the corporation’s consumer, medical device, and pharmaceutical divisions. Carbon was chosen to collaborate on the production of custom surgical devices.
Sendra was not able to comment on how Johnson & Johnson might implement CLIP 3D printing technology, but it’s not out of the question to think that it might involve 3D printing surgical guides on-demand. Rather than wait a week for a service bureau to ship a surgical guide to a hospital, CLIP opens the door up to next-day or even same-day delivery of 3D-printed parts, truncating the time between planning and operation even further.
While surgical planning must be carried out before an operation takes place, there’s no doubt that surgeons are still surprised when in the midst of a procedure. If surgical devices could be produced in less than ten minutes in a sterile environment, it’s also possible to imagine a day in which surgical devices could be made on the fly while a surgery is taking place. Of course, regardless of any implementation that Johnson & Johnson may have in mind, it will be necessary to use materials, parts and processes that are approved by the FDA for use in surgery.
Elle Meyer, director of life sciences at Carbon, spoke to the potential applications of CLIP on 3D printing in the medical industry: "There are enormous opportunities for 3d printing in the medical space, from dentistry to microneedles for drug delivery to personalized orthopedic devices. Carbon’s CLIP technology is enabling our partners to speed the pace of innovation, lower the cost of production, and increase the connection with end consumers by developing more customized parts.”
Meyer added, “Ultimately, we believe CLIP will enable our partners to realize better economics and better outcomes through new product innovations, and more flexible, local manufacturing operations. The value of CLIP in the medical space spans all phases of product development - from functional prototyping in the design phase, to production of jigs, fixtures, and molds in the manufacturing process, to production of final parts to support commercialization.”
HP’s Multi Jet Fusion (MJF) brings its own advantages to the table as a high throughput machine capable of producing series of objects also with strength rivaling those made with injection molding. As MJF is able to deposit functional inks into 3D-printed parts, HP aims to manufacture a 3D printer that can deposit conductive agents in order to produce components with embedded sensors.
The details regarding Johnson & Johnson’s use of MJF are also vague, but the corporation announced a partnership with HP upon the unveiling of the first MJF 3D printers earlier this year. However, Sendra made it clear that, both with Carbon and HP, the goal is personalized medicine. Together, HP and Johnson and Johnson will work to create personalized instrument and software for patient-specific healthcare devices.
So far, there’s been no insight as to whether or not these products will include embedding sensors directly into 3D-printed devices or instruments. In the near term, I would guess that the mass customization of these products is what Johnson & Johnson will be able to accomplish with MJF technology.
Bioprinting and Drug Discovery
In 2014, Johnson & Johnson’s drug discovery subsidiary Janssen Research and Development initiated preliminary collaboration discussions with what is so far the only publicly traded bioprinting firm on the market, Organovo. The SEC filing at the time indicated that JRD would work with Organovo “to evaluate the use of 3D bio-printed tissue in a drug discovery setting.”
Organovo typically uses its NovoGen MMX Bioprinter to extrude human tissue cells and hydrogel structures into a predetermined 3D shape, which is then placed into an incubator, where the tissues fuse together. In the not-so-distant future, it may be possible to 3D print complete organs for transplantation; however, in the near term, 3D-printed human tissue will allow drug companies to test medications in cells the more closely resemble the actual biological environment for which they’re destined.
Currently, Sendra said that the multinational relies on a variety of other solutions to test drug efficacy, including “2D cell cultures, cadavers, human tissue, and human clinical trials once safety has been proven to get towards efficacy.” He explained, “You can imagine that those are pretty complex approval processes and then very complex trials.”
3D-printed tissues, however, are more similar to the tissues of a human patient than existing 2D cell cultures. They can therefore provide much more accurate information about how a chemistry works, thus speeding up the drug discovery process. “It’s almost about time,” he added. “You can learn much faster what works and what doesn’t. And that’s a very exciting space for companies like ours.” In at least one study with Roche Pharmaceutical Research and Early Development, Organovo demonstrated that bioprinted human liver cells are better at assessing drug-induced toxicity than 2D cell cultures.
Sendra continued, “The value of this technology in the space has been its promise of providing a path toward true living tissue. There’s no alternative today. There isn’t another way to do it. The additive space is showing us promise of being able to do that. As a result, it enables the use of that tissue towards advanced research into drug discovery. You can imagine that you can accelerate drug discovery by creating tissue alternatives as opposed to testing them on people.”
So far, Organovo has proven capable of bioprinting liver and kidney tissue, commercializing both the liver and kidney cells for drug testing. Additionally, the firm is now licensing technology from the University of Queensland to produce “mini-kidneys” that more closely resemble real kidneys in terms of tissue complexity.
If Johnson & Johnson continues its work in the bioprinting space, there lies the potential to exploiting these tissue models for drug discovery in the near term and even more advanced uses in the future.
A 3D Printing Ecosystem
The specifics of how the medical giant is using 3D printing may be murky, but altogether, Sendra paints a picture of a corporation that is an early adopter of these advanced technologies ultimately with the goal of creating patient-centered products. Sendra further hinted at the ability to fabricate patient-specific products through distributed manufacturing as a means of reducing cost and increasing access.
“The convergence of technology and healthcare and smart innovation will have a profound impact on doctors, patients, customers and outcomes. Relying along on advances in analytics and software, 3D printing as a result enables distributed manufacturing models, patient-specific products, therapies and solutions that will lead to better outcomes and better economics along with improved global access,” Sendra said.
Sendra likened the company’s advances in 3D printing to the progress that has occurred with photography. “Remember when you used to take a photograph and go get it developed? That wasn’t that long ago, but now very few people do that. We all expect pictures on-demand, right way. And it’s that kind of transformation that we see with healthcare. That you could get a knee that’s made for you the moment that you need it. I think that all of us as patients should be expecting that from companies like ours,” Sendra said.
He concluded, “It’s hard to wrap your head around. It’s a really different future. The manufacturing technology enables the possibility to think of the future very, very differently.”