{"id":36404,"date":"2018-11-13T19:55:24","date_gmt":"2018-11-14T00:55:24","guid":{"rendered":"https:\/\/digital.hbs.edu\/platform-rctom\/submission\/3-d-printing-and-the-future-of-joint-replacement-kneerly-there-or-ready-for-total-replacement\/"},"modified":"2018-11-13T19:55:24","modified_gmt":"2018-11-14T00:55:24","slug":"3-d-printing-and-the-future-of-joint-replacement-kneerly-there-or-ready-for-total-replacement","status":"publish","type":"hck-submission","link":"https:\/\/d3.harvard.edu\/platform-rctom\/submission\/3-d-printing-and-the-future-of-joint-replacement-kneerly-there-or-ready-for-total-replacement\/","title":{"rendered":"3-D Printing and the Future of Joint Replacement: \u201cKnee\u201drly There or Ready For Total Replacement?"},"content":{"rendered":"

The global joint reconstruction and replacement industry is $15+ billion and growing.[1]<\/a> Among all total replacement procedures, total knee replacements (TKR), indicated for patients with severe osteoarthritis, make up almost 50%; nearly a million total knee replacements are expected to be conducted in the US alone in 2018.[2]<\/a><\/p>\n

Patient outcomes are excellent\u2014TKR is highly successful in reducing pain and restoring function for patients with severe osteoarthritis. Both patients and surgeons report satisfaction levels of over 90% after 12 months.[3]<\/a> Implant production is highly concentrated among five major players (Zimmer, DePuy Synthes, Stryker, Biomet, and Smith & Nephew) that collectively hold about 90% of global joint manufacturing market share.[4]<\/a><\/p>\n

So then why was joint replacement manufacturing startup ConforMIS able to raise $135 million on the day of its 2015 IPO?[5]<\/a> The answer lies in ConforMIS\u2019s additive manufacturing approach to custom-built implants.<\/p>\n

Typically, knee replacement implants are made in standardized sizes. The operating surgeon selects amongst these options weighing considerations including alignment and size.[6]<\/a><\/p>\n

By contrast, ConforMIS uses a CT scan of the patient\u2019s knee to 3D print a wax mold. An implant is then created on this mold, allowing for total customization of the implant to the patient\u2019s anatomy. In clinical trials, the ConforMIS product demonstrated better rotational alignment and tibial fit without causing overhang of the tibial tray when compared with three standardized sizes of implants.[7]<\/a><\/p>\n

While the long term implications are s yet to be seen, ConforMIS\u2019s use of additive manufacturing and bespoke implants may shorten recovery times, potentially lowering the cost of TKR. Furthermore, it may lower the cost of a customized implant, putting one within reach of patients who would otherwise be cost-prohibited.[8]<\/a> In an industry where surgeons, the key decision maker in implant selection, are driven by both product factors and vendor sales rep characteristics, ConforMIS\u2019s unique product offering may differentiate it from the entrenched players, providing a competitive advantage despite its small size.[9]<\/a><\/p>\n

Furthermore, ConforMIS\u2019s technology is already usable in developing and selling add-on products to its implants, including the iJig Instrumentation kit. Using the same CT scan that is used to generate the wax mold, ConforMIS uses 3D printing to create a fully customized surgical implementation toolkit. The tools are both customized and disposable, eliminating the need for post-op sterilization.[10]<\/a><\/p>\n

However, given the high success rate of existing implant technology, is customization of joint replacement implants even a big enough need to justify ConforMIS\u2019s investment? Or will customized implants remain a niche market for only the most complicated of cases, and if so, is ConforMIS\u2019s solution customized to the patient\u2019s existing anatomy even the most appropriate given the patient\u2019s level of deviation from the ideal?<\/p>\n

To stay at the vanguard of personalized medicine, ConforMIS may need to both continue its development of add-on materials to its customized implants and look to the more complicated issue of 3D bioprinting of biocompatible cartilage. While cartilage regeneration is a key unmet need for osteoarthritic patients, bioprinting of cartilage is still in lab stages, as commercializable biocompatibility is yet to be achieved.[11]<\/a>,[12]<\/a><\/sup> To truly be the future of the crowded joint replacement market, however, ConforMIS will need to further disrupt the TKR paradigm.<\/p>\n

(Word count: 784).<\/p>\n

[1]<\/a> Source: \u201cJoint Reconstruction and Replacement: Materials, Technologies, and Global Markets,\u201d via BCC Research, accessed November 2018.<\/p>\n

[2]<\/a> Ibid.<\/p>\n

[3]<\/a> Harris, I. A., Harris, A. M., Naylor, J. M., Adie, S., Mittal, R., & Dao, A. T. (2013). Discordance Between Patient and Surgeon Satisfaction After Total Joint Arthroplasty. The Journal of Arthroplasty, 28(5), 722\u2013727. https:\/\/doi.org\/10.1016\/j.arth.2012.07.044.<\/p>\n

[4]<\/a> Source: \u201cJoint Reconstruction and Replacement: Materials, Technologies, and Global Markets,\u201d via BCC Research, accessed November 2018.<\/p>\n

[5]<\/a> Grunewald, Scott J., \u201c3D Printed Knee Replacement Manufacturer ConforMIS (CFMS) Raises $135M As The Company Goes Public\u201d, 3DPrint.Com, July 2, 2015, https:\/\/3dprint.com\/78272\/conformis-3d-printed-knee\/, accessed November 2018.<\/p>\n

[6]<\/a> Burns, L. R., Housman, M., Booth, R., & Koenig, A. (2018). Physician preference items: what factors matter to surgeons? Does the vendor matter? Medical Devices: Evidence and Research, Volume 11, 39\u201349. https:\/\/doi.org\/10.2147\/mder.s151647.<\/p>\n

[7]<\/a> Martin, G., & Schroeder, L. (2018). In Vivo Tibial Fit and Rotational Analysis of a Customized, Patient-Specific TKA versus Off-the-Shelf TKA. The Journal of Knee Surgery. https:\/\/doi.org\/10.1055\/s-0038-1653966.<\/p>\n

[8]<\/a> Spaeth, Dennis, \u201c3D Printing is Changing the Face of Multiple Industries,\u201d ECN: Electronic Component News 61, no.9 (October 2017): 21-23.<\/p>\n

[9]<\/a> Burns et. al., Medical Devices: Evidence and Research, Volume 11, 39\u201349.<\/p>\n

[10]<\/a> Source: ConforMIS website, https:\/\/www.conformis.com\/custom-made-knee-implants\/products\/ijig\/<\/a>. Accessed November 2018.<\/p>\n

[11]<\/a> Chen, H., Malheiro, A. de B. F. B., van Blitterswijk, C., Mota, C., Wieringa, P. A., & Moroni, L. (2017). Direct Writing Electrospinning of Scaffolds with Multidimensional Fiber Architecture for Hierarchical Tissue Engineering. ACS Applied Materials & Interfaces, 9(44), 38187\u201338200. https:\/\/doi.org\/10.1021\/acsami.7b07151.<\/p>\n

[12]<\/a> Jammalamadaka, Udayabhanu and Tappa, Karthik. Recent Advances in Biomaterials for 3D Printing and Tissue Engineering. Journal of Functional Biomaterials, 9(1), 22. https:\/\/doi.org\/10.3390\/jfb9010022<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

What role is 3D printing playing in commercializable knee replacement implants?<\/p>\n","protected":false},"author":11439,"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","categories":[4102,745],"class_list":["post-36404","hck-submission","type-hck-submission","status-publish","hentry","category-3dprinting","category-surgery","hck-taxonomy-organization-conformis","hck-taxonomy-industry-medical-devices-and-supplies","hck-taxonomy-country-united-states"],"connected_submission_link":"https:\/\/d3.harvard.edu\/platform-rctom\/assignment\/rc-tom-challenge-2018\/","yoast_head":"\n3-D Printing and the Future of Joint Replacement: \u201cKnee\u201drly There or Ready For Total Replacement? - Technology and Operations Management<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/d3.harvard.edu\/platform-rctom\/submission\/3-d-printing-and-the-future-of-joint-replacement-kneerly-there-or-ready-for-total-replacement\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"3-D Printing and the Future of Joint Replacement: \u201cKnee\u201drly There or Ready For Total Replacement? 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