How Stryker Hopes to Win with Additive Manufacturing
While Stryker has launched 3D-printed medical implants in the past, it recently made significant investments in additive manufacturing technology that it hopes will make it a leader in the medical technology industry.
Stryker, one of the largest medical technology companies in the world, has been at the forefront of medical device innovation during its 80-year history. However, additive manufacturing, or 3D printing, is expected to transform the industry over the next decade. In response to this trend, Stryker, one of the largest medical technology companies in the world, announced in March 2016 it would invest $400 million to develop an additive manufacturing facility in Cook, Ireland [1]. While the investment was a strong indication of Stryker’s commitment to the new technology, the company will now have to show surgeons and the broader healthcare community that this and its other investments in additive manufacturing will result in useful, sustainable product innovation.
Using additive manufacturing to develop implants and other medical devices can have numerous benefits. Like for most manufacturing industries, additive manufacturing in medical devices results in faster prototyping. However, there are additional benefits that are unique to the medical device industry. 3D-printed implants can more closely mimic natural bone and be made with complex porous designs that fuse more easily with other bone structures. Patient-matched 3D-printed devices can also be customized to a patient’s specific anatomy, a key contributor to the growing the field of personalized medicine. Scientists are also exploring the possibility of using 3D printing to develop living organs such as hearts and livers [2].
Stryker has been researching additive manufacturing since 2001, but only recently has the company commercialized products [3]. The research has resulted in AMagine, Stryker’s proprietary approach to implant creation using additive manufacturing. Recent product launches have included 3D-printed baseplates and patellas in their Triathlon knee replacement product and the 3D-printed Tritanium TL Curved Posterior Lumbar Cage, a hollow-bodied spinal implant that received FDA approval in March 2018 (see figure 1) [4]. While the company has gained some traction so far, it recently made several investments to accelerate their 3D printing technology. First, using the additive manufacturing facility in Cook, the company hopes to create a center of excellence to aggregate its 3D printing technology; according to Stryker’s CEO Kevin Lobo, its previous technology was dispersed in several locations [5]. In order to further advance its additive manufacturing product development, Stryker announced a partnership with GE Additive in June 2017 in which GE will provide new 3-D printing machines, materials and services for Stryker [6]. Finally, in August 2018, Stryker acquired K2M, a leader in 3D-printed spine implants, for $1.4 billion [7].
Despite these investments in additive manufacturing, Stryker faces significant competition from others in the space. For instance, Medtronic, a large medical device company, launched a new titanium 3D printed platform for spinal implants in May 2018 [8], and DePuy Synthes, a subsidiary of Johnson and Johnson, launched Titanium 3D-printed implants for use in facial reconstruction in 2017 [9]. In order to differentiate versus competitors in the market, Stryker must 1) acquire startups developing new technology in the additive manufacturing medical space, and 2) move towards on-demand implant production through generative design technology.
One startup, Osseus Fusion Systems, founded in 2012, received FDA approval for its family of 3D printed spinal implant devices in September 2018. Their Aries titanium implants are some of the most porous on the market, allowing for better fusion to other bone structures [10]. Another, Camber Spine, founded in 2010, launched a series of 3D-printed spinal implants after receiving FDA approval in 2017 [11]. Either of these companies is a promising acquisition candidate to expand Stryker’s spine portfolio and development of 3D-printed products.
Stryker must also capitalize on generative design, the next wave for additive manufacturing where machine learning can be used to generate products based on required solutions rather than prescriptive specifications [12]. For Stryker, this means having surgeons indicate what functions an implant needs to fulfill and then filling that order with a 3D-printed implant. To build this capability into its 3D-printing production process, Stryker must invest in software technology that can be used by surgeons to produce 3D-printed objects. This will also require the company to deepen relationships with surgeons to develop an iterative product feedback loop.
Stryker has made significant progress developing innovative medical implants by using additive manufacturing technology. However, surgeons, Stryker’s primary customers, will have to change behavior in response to these developments. Specifically, additive manufacturing will result in the development of more products via faster prototyping and move the hospital closer to becoming a manufacturing facility, such as at the Mayo Clinic where doctors work with engineers to print devices [13]. How will Stryker position itself among the surgical community to promote their new additive manufacturing processes and products and ultimately drive uptake?
(Word count: 770)
Figure 1: Tritanium TL Curved Posterior Lumbar Cage [14]
References:
[1] Arundhati Parmar. “Stryker CEO: New 3-D Printing Manufacturing Plant will be in Ireland,” MD+DI, March 4, 2016, https://www.mddionline.com/stryker-ceo-new-3-d-printing-manufacturing-plant-will-be-ireland.
[2] U.S. Food and Drug Administration, “Medical Applications of 3D Printing,”
https://www.fda.gov/medicaldevices/productsandmedicalprocedures/3dprintingofmedicaldevices/ucm500539.htm, accesesed November 2018.
[3] Tritanium PL Posterior Lumbar Cage: More than Surface Deep, Stryker corporate brochure, pg. 2.
[4] “Stryker’s Spine Division Receives FDA Clearance for 3D-Printed Tritanium TL Curved Posterior Lumbar Cage,” press release, March 7, 2018, on Business Wire, https://www.businesswire.com/news/home/20180307005081/en/Stryker%E2%80%99s-Spine-Division-Receives-FDA-Clearance-3D-Printed.
[5] Arundhati Parmar. “Stryker CEO: New 3-D Printing Manufacturing Plant will be in Ireland,” MD+DI, March 4, 2016, https://www.mddionline.com/stryker-ceo-new-3-d-printing-manufacturing-plant-will-be-ireland.
[6] “GE Additive and Stryker Announce Additive Manufacturing Partnership,” press release, June 14, 2017, on Business Wire, https://www.businesswire.com/news/home/20170614005386/en/GE-Additive-Stryker-Announce-Additive-Manufacturing-Partnership.
[7] “Stryker announces definitive agreement to acquire K2M,” press release, August 30, 2018, on Stryker website, https://www.stryker.com/content/dam/stryker/about/news/pdf/18-23.pdf.
[8] Sarah Saunders. “Medtronic Launches New Titanium 3D Printing Platform for Spinal Surgery Implants,” 3D Print, May 3, 2018, https://3dprint.com/212279/medtronic-launches-tionic.
[9] “TRUMATCH® Titanium 3D-Printed Implants Launch in the U.S.,” press release, September 11, 2017, on Depuy Synthes website, https://www.depuysynthes.com/about/news-press/qs/trumatchsupsup-titanium-3d-printed-implants-launch-in-the-us.
[10] Tess Boissonneault. “Osseus Fusion Systems receives FDA clearance for 3D printed Aries titanium spinal implants,” 3D Printing Media Network, August 24, 2018, https://www.3dprintingmedia.network/osseus-fusion-systems-fda-clearance-aries.
[11] “Camber Spine Announces FDA Clearance and National Launch of SPIRA™ Open Matrx ALIF,” press release, August 15, 2017, on Camber Spine website, https://www.cambermedtech.com/news/2017/8/15/camber-spine-announces-fda-clearance-and-national-launch-of-spira-open-matrix-alif.
[12] Ravi Akella. “What Generative Design Is and Why It’s the Future of Manufacturing,” New Equipment Digest, March 16, 2018, https://www.newequipment.com/research-and-development/what-generative-design-and-why-its-future-manufacturing.
[13] Alwyn Scott. “Printing body parts in hospital shows 3D tech’s growing reach,” Reuters, May 3, 2018,
https://www.reuters.com/article/us-ge-additive/printing-body-parts-in-hospital-shows-3d-techs-growing-reach-idUSKBN1I42R0?il=0.
[14] Stryker, “Tritanium TL Curved Posterior Lumbar Cage,” https://www.stryker.com/us/en/spine/products/tritanium-tl.html, accessed November 2018.
This was a very fascinating article about the benefit of additive manufacturing in healthcare. I absolutely agree with the fact that as time moves on, we will need to incorporate use of these tools in the medical training curriculum to better prepare our surgeons for upcoming advances. Generative design is also more possible with the increasing use of EMRs and EHRs augmenting the learning process. I do wonder though whether the costs of such procedures would increase or decrease with time – on one hand, the product is better and can cause longer-term cost efficiencies, while on the other hand, allowing too much customization always comes at a cost.
One way to increase uptake could be to work with government regulators and the payer network to ensure that these procedures are covered, fully or partially, under the current insurance coverage programs. Another way would be to work with government again to subsidize the cost of procuring raw materials or equipment basis the application (defense vs civilian).
This is super interesting! There is another post on Medtronic’s approach to additive manufacturing, which is more conservative and restricted to the R&D space. It is interesting to put Medtronic and Stryker together and examine their additive manufacturing strategy. I wonder how the patients and the surgeons are reacting to the products that Stryker is pushing to the market?
Thank you for sharing this — really fascinating application of 3D printing! One potential application for this that comes to mind would be having a 3D printer in a hospital, so that the hospital can print out individualized medical devices for patients on site rather than needing to send in specifications to have them made in a factory. I could see this being useful in contexts where the patient needs emergency surgery and doesn’t have the time to wait for a part to be printed and shipped to a hospital. I wonder if costs would of the printer would ever come down far enough to make this a reality.
Thank you again for sharing!
It’s interesting to think about how a company approaches branding these novel approaches given some of the history of its other products. Stryker had a slate of recalls in the early 2010s over some of its knee replacement guides, which didn’t function properly and triggered an FDA Class I recall, which to my understanding is one of the most serious recall repercussions it can apply (see https://www.fiercebiotech.com/medical-devices/fda-slaps-most-serious-label-stryker-s-surgical-recall). Much of the discussion around surgeon buy-in makes me wonder what kinds of exposure to the product would be necessary for key opinion leaders to become advocates for using this.
While I’m not as versed on the technical details of these machines, I am curious whether these printers can cost-effectively produce all the types of materials needed (imitating bone, soft tissue, biological elements, etc.) enough to be housed on-site in places like hospitals for versatile types of models. To the point above it is definitely intriguing to think about possible advantages to offering this kind of customization closer to the user.
In many different fields of healthcare the idea of “near-patient” solutions is heavily promoted. As salaries rise also in rural areas of the world, e.g. in some parts of China and India, the demand for more sophisticated medical treatments increase in these regions at the same time. How can the quality of treatments can be improved in inaccessible areas? — With systems which can be run next to the patient and do not require any external labs or services. For example, more and more automated testing devices allow the doctor to perform in-vitro tests (e.g. blood tests) right in front of the patient. Thus, the question arises if 3D printing could allow the surgeon to print the implant just when it is needed during the surgery. Certainly, many regulatory, legal and practical points need to be addressed, e.g. who would be responsible that the implant meets quality standards, would the 3D printing system require approvals such as FDA, could the doctor better treat another patient while he is printing parts, etc.? However, given the progress 3D printing makes, this idea seems not so unrealistic.
From the operational perspective, because 3D printers used in additive manufacturing are versatile in that they are not limited to a specific product or model, Stryker will have the ability to lower the cost by producing multiple products/models on a set of printers, maximizing the utilization rate.
Another key benefit would be the ability to tweak the dimensions of the products so that it is specifically tailored to the individual, as opposed to using a standardized shape. Especially in orthopedics, this would increase customer satisfaction and can be done with virtually no manufacturing cost increase.
You did a wonderful job with this write-up — thanks so much for sharing your insights here! This was an incredible read.
One thing I would address is your point about generative design (the idea of generating products via additive manufacturing based on required solutions rather than prescriptive specifications). Presumably, generative design will be an important step in customizing orthopedic implants to suit specific patient needs. However, the question remains as to whether these patient-specific implants are necessary from a clinical perspective. I think that studies will be needed to assess whether the additional cost of a personalized implant are warranted. If it turns out that these personalized implants have a greater lifespan / longevity than standard orthopedic implants, than the argument can be made that the additional cost is worth it. However, if this is not the case, then I question whether patient-specific implants are necessary. I believe that orthopedic surgeons must have access to cost-effectiveness data before deciding whether they want to use these implants in practice. It is possible that generative design — while incredibly promising — will not actually be supported by sufficient evidence in this instance.