Print-a-Part: How 3D Printing is transforming Medical Device Manufacturing

Win-Win Innovation

Fueled by the trend of precision medicine, the use of new technologies such as additive manufacturing is seeing an uptick. Additive manufacturing, specifically 3D printing, allows rapid and flexible manufacturing of medical devices that are customized to patient anatomy or designed with complex internal structures[1]. Its use promises lower costs, reduced time spent in operating rooms, and improved clinical outcomes[2]. 3D printing in the medical industry is expected to become a $3.5 billion market by 2025[3]. So far, 3D printing in medical technology has focused on surgical planning models, custom-made prosthetics, and off-the-shelf implants with complex geometries. A recent Gartner report predicts increased adoption going forward – for instance, nearly 25% of surgeons are projected to use 3D-printed patient models for pre-operative training by 2021[4].

Stryker is a $65 billion medical technology company with a track record of investing in innovation, such as its $1.65 billion acquisition of robot-assisted surgical device maker MAKO Surgical Corp in 2013[5]. 3D printing is a key enabler for Stryker to develop proprietary devices with previously “unmanufacturable geometries” and improved patient outcomes. For instance, its 3D-printed spinal implant showed significant performance improvements and bone in-growth compared to alternative products in pre-clinical studies[6]. This was made possible by additive manufacturing technology that allowed the implant material to closely mimic bone.

Further, the focus on creating new geometries through 3D printing implies a lower risk of cannibalizing existing Stryker products. Developing advanced capabilities in metal 3D printing provides Stryker with a new source of business growth while allowing it to offer differentiated value to surgeons[7].

Going All-In

Stryker first explored 3D printing in 2001 through research partnerships with academic institutions, focusing on control of porosity during manufacturing. In 2015, it commercialized the new technology via the Triathlon Tritanium Knee System, while introducing 3D-printed elements into other knee surgery solutions such as the Triathlon Tritanium Cone Augments. In 2016, it launched a 3D-printed spinal implant featuring Tritanium technology. Stryker continues to expand the Tritanium line in 2018 in response to surgeon demand[8].

In 2016-17, Stryker invested in a new $400 million manufacturing facility in Ireland, dedicated to 3D printing for titanium devices[9]. It also partnered with GE Additive in 2017 to source the supply of additive technology, materials and services[10], highlighting its commitment to the platform.

Stryker continues to invest in research collaborations for new applications of 3D printing. In 2017, it invested $10 million towards a 5-year research project, for development of Just-in-Time implants that will generate customized implants in the operating room. It also partnered with 3D Systems to leverage joint capabilities in virtual surgical planning for craniomaxillofacial procedures, focusing on “accelerating innovation in the area of personalized medicine”.[11]

3D Printing: Too Democratic?

In addition to the use of 3D printing by traditional medical device manufacturers, large hospitals and research centers have begun to set up 3D printing lines in-house, allowing surgeons and research staff to create patient-matched surgical devices and prototypes at the point-of-care (POC Manufacturing). Hospitals are also forming partnerships to establish shared facilities for their POC manufacturing needs. Smaller hospitals often access similar services through contract manufacturers. [12]

In order to retain their differentiated edge in 3D printing of complex geometries, Stryker should partner with hospitals and research institutions to identify such emerging needs and usage patterns, and focus on becoming their partner of choice for development of new, patient-matched solutions. The research into JIT implants is a useful starting point. Stryker should invest both in developing both new materials and investigating new ways to manipulate these, via multiple additive manufacturing platforms and technologies.

As large hospitals and provider networks join hands to develop 3D printing hubs, how can Stryker position itself as a preferred provider of customizable products and services? Does Stryker have a sustainable competitive advantage in this space or does it risk losing business to institutions with in-house 3D printing capabilities in the long run?

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Sources:

[1] US Food and Drug Administration: Medical Devices https://www.fda.gov/medicaldevices/productsandmedicalprocedures/3dprintingofmedicaldevices/default.htm

[2] SME Annual Report 2018: Medical Additive Manufacturing/ 3D Printing

http://sme.org/uploadedFiles/Medical_Additive_Manufacturing/2018-SME-Medical-AM3DP-Annual-Report.pdf

[3] 3D printing in the medical field: four major applications revolutionising the industry.

https://www.medicaldevice-network.com/features/3d-printing-in-the-medical-field-applications/

[4] Predicts 2018: 3D Printing and Additive Manufacturing. https://www.gartner.com/doc/3834064

https://www.plasticstoday.com/medical/hospitals-will-adopt-3d-printing-large-numbers-produce-patient-specific-surgical-models/35920673258108

[5] Stryker Website: News Releases.

https://stryker.gcs-web.com/news-releases/news-release-details/stryker-announces-definitive-agreement-acquire-mako-surgical

[6] Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model, McGilvray, Kirk C. et al., The Spine Journal , Volume 18 , Issue 7 , 1250-60.

https://www.thespinejournalonline.com/article/S1529-9430(18)30076-7/fulltext?dgcid=raven_jbs_etoc_email

[7] 3D Print website. https://3dprint.com/117456/stryker-3d-printing-facility/

[8] Stryker Website: News Releases.

https://www.stryker.com/us/en/about/news/2018/stryker-to-highlight-expanding-line-of-3d-printed-tritanium–cag.html

[9] 3D Print website. https://3dprint.com/117456/stryker-3d-printing-facility/

[10] GE Additive and Stryker announce additive manufacturing partnership.

https://www.ge.com/additive/press-releases/ge-additive-and-stryker-announce-additive-manufacturing-partnership

[11] TCT Magazine. 3D Systems and Stryker partner to advance craniomaxillofacial procedures.

https://www.tctmagazine.com/3d-printing-news/3d-systems-stryker-craniomaxillofacial-procedures/

[12] SME Annual Report 2018: Medical Additive Manufacturing/ 3D Printing

http://sme.org/uploadedFiles/Medical_Additive_Manufacturing/2018-SME-Medical-AM3DP-Annual-Report.pdf

 

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15 thoughts on “Print-a-Part: How 3D Printing is transforming Medical Device Manufacturing

  1. The technology of 3D printing will bring medical device manufacturers huge advantages, allowing them to customize devices in a short time. I think Stryker is embracing the unique challenge, in that they manufacture Just-In-Time implants by responding hospitals’ demands flexibly. Also, as you pointed out, I am more interested in what are unique strengths that will lead the company to the competitive position in the future. Overall, I enjoyed your essay and am curious about where this story goes.

  2. This was a fascinating post! The concept of Just in Time 3D medical printing seems like an industry game changer — with its role in trauma cases particularly profound. I agree with POE that Stryker should focus on becoming a partner to hospitals and research centers, rather than simply a vendor. As Stryker better understands the demands of hospitals and surgeons, it can more quickly develop solutions and reduce the risk that in-house 3-D printing eclipses its own capabilities. Moreover, I see significant value in Stryker aggregating the feedback it receives from hospitals and incorporating it into its products. This type of compilation differentiates Stryker from in-house 3-D printing, which is likely to have a more limited feedback scope.

  3. Amazing insight into an incredible technology that seems like it’s already in use. I’m wondering as the process gets more democratized (to your point), how the ecosystems deals with medical device regulation and quality assurance. Right now, if Stryker sells a product, they are liable for it’s quality and performance. If now a hospital makes their own implant from their own 3D printing machine and something goes wrong down the line, who is at fault? This is probably something the FDA is going to have to grapple with as the technology becomes more widespread but as of earlier this year it feels like it is still exploratory (https://www.theexpertinstitute.com/3d-printed-medical-devices-where-does-product-liability-law-go-from-here/).

  4. I really enjoyed this post. My fear is that 3D printing capabilities, like mobile phones two decades ago, will evolve to become increasingly accessible to various stakeholders. With this potential trend in mind, and with increased ubiquity in in-house 3D printing capabilities, firms like Stryker may face an existential crises as the market begins to substitute out Stryker’s services for perhaps lower quality in-house 3D printing alternatives. One way in which Stryker could counteract this trend would be to incorporate other value-added services together with the provision of its 3D printing product to add significant measurable value for clients.

  5. Thank you for a very interesting and informing post! I had not realized that the medical field was already embracing additive technology in such a meaningful way. You mention that the benefits of 3D printing in this space include the ability to customize the implants to the patient in addition to resulting in “lower costs, reduced time spent in operating rooms, and improved clinical outcomes.” I would be curious to understand more about the link between the 3D-printed implants and the improved patient outcomes. I wonder if there is a direct link between the ability to customize the implant to the patient and the improved patient outcomes, or if the relationship is more indirect. For example, are the improved results simply a function of the fact that less time spent on the operating table means less opportunity (in terms of duration) for problems with anesthesia to occur or for a patient to develop an infection (given a patient’s open wound when being operated on)? It will also be interesting to see if the lower costs promised by the additive manufacturing in the space are at all passed on to the patient, or if the benefits of the lower costs are mostly taken advantage of by insurance companies and hospital providers instead.

  6. Very interesting article! This is the first I had heard about the use of 3D printing in the medical industry, and I can imagine how the use cases must be infinite. It sounds like Stryker truly is going all in on this costly technology, and I wonder how that will work out for them financially. On one hand, I can see that the development of prosthetics, surgical tools and other medical devices could be ramped up and and production timing and efficiency could increase. In addition, once the technology is developed, I’m sure that the price to develop these new devices might decrease (despite the heavy early investment). However, I wouldn’t be surprised if other medical device companies enter this space en masse and drive prices down. I also wonder just how customizable devices are through additive technology and whether hospitals will accept this relatively new technology.

  7. The potential of Stryker products to revolutionize healthcare supply chains is stunning. I think back to the cases involving healthcare suppliers and distributors (i.e. O&M) and this article highlights the existential threat those companies face. I believe Stryker will face significant resistance from these companies, and they must continue to extend their technological lead to stay ahead of them.

  8. I really enjoyed reading your piece about Stryker’s evolution over the past two decades in the additive manufacturing space. You point out some areas of major opportunity for the company, as well as possible limitations on their growth if they do not position themselves correctly with respect to physicians. With your suggested scenario of partnering with hospitals, I would wonder how that IP agreement would look (think MGH Enbrel case) and how to truly be partners with clinicians when the clinicians won’t be fooled by the fact that Stryker is associating themselves in part to access the clinicians’ own ideas/IP.

  9. In order for Stryker to maintain its competitive advantage over the long term, i think it will be important for the company to invest in adjacent technologies like 3D measurement / scanning systems and advanced imaging software. While 3D printing is an area of high innovation today, over time i would expect it to become commoditized like regular printing has. I wonder if the company has thought about this or have made related investments.

  10. I really enjoyed reading this article. This is a great application of 3D printing. I would be curious to learn more about how material selection would affect the cost of the medical devices. Are there ways to optimize the printing technology around a specific material or does that not affect the time and cost required for the device?

  11. One thing that Stryker can do is to look at leveraging this technology to custom implants for patients. This is one way they can differentiate from their competitors to create a close partnerships with the doctors to create customized solutions for their patients. If they are able to become closely associated with the doctor, that is an easy way for them to increase market share.

  12. I used to work at a medical center with a major in-house 3D printing service. In addition to making custom prosthetics and surgical implants, one innovative use of this technology was to enable so-called “practices swings” for medical procedures. For example, surgeons preparing for a major cranio-facial procedure would 3D print the patient’s skull from scans, add major arteries and nerves, and test the procedure in an operating room the day before the patient arrived for surgery. This “practice swing” process was still in the early stages of adoption while I was there but the program generated a huge amount of interest from the medical staff, and anecdotes from surgeons indicated that the “practice swing” did improve outcomes. More here: http://simpeds.org/simpeds3d-print/

  13. Thank you for you insightful essay. Having looked at 3D printing in my own essay, I find that the best use cases are those where customization is required. Since many medical devices that are implanted in people likely need to be customized, there should be a serious market for the use of additive manufacturing in medicine. To remain competitive, Stryker should at first identify the firms that are capable of actually producing medical grade parts and accurately modifying them, and then consider buying up these firms to maintain a competitive advantage. While I was originally fearful that 3D printing would “democratize” manufacturing and drive prices down, the actual files required and the machinery needed to produce a part are still very expensive and require significant technical knowledge. As such, the medical industry is a place I see additive manufacturing playing a large role in the near future.

  14. I really enjoyed this article and think this an impactful application of 3D printing. I’m curious to see how the shift to in-hospital JIT manufacturing is regulated by the FDA moving forward. To your point around maintaining a competitive advantage, I would think that Stryker has developed some IP around both its materials and manufacturing processes that is not extremely replicable; additionally any type of FDA support they have is a barrier to entry. Furthermore, Stryker should start to leverage its own patient-based data from other business arms as well as from its hospital partners to further customize/ develop its line of implants. These partnerships and scaled data will help it develop superior products that are difficult to replicate.

  15. This is such cool stuff. Thanks for writing about it. To me the main take-away is the tremendous advantages that this could have for patients. I hope the result is significantly more access and affordability for prosthetics and key medical implants. That does put Stryker in a potentially tough spot though. Like some of the other commenters, I wonder if Stryker are able to patent specific shapes and forms of these prosthetics. I think that they should be able to, but I expect that the democratization of manufacturing will mean that they have to innovate a lot more than they have up to this point.

    This could also have advantages for them though. For example, if hospitals can manufacture many of the products themselves Stryker could just sell the designs and the license to print them. I could see one version of the market where they continue to manufacture their most costly and high tech products and then become more of a schematic ‘publishing arm’ for the products that can be made more easily or with cheaper materials. This could end up being higher margin for them in the long run as they would not have to physically manufacture or distribute all of their product line.

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