Healthcare 3D Printing in Orthopedics: A Frontier

Required to be innovative and design oriented, orthopedics is one of the first surgical sub-specialties in medicine that has successfully adapted 3D printing technology and served as a poster child on how a new technology can be creatively used to provide higher level of patient care.

Currently, there are four main innovative areas using 3D printing in orthopedics (Figure 1) [1]:

Figure 1. Four areas of innovations in orthopedic 3D Printing

1. Rapid prototyping for surgical planning

Rapid prototyping using 3D Printing to create surgical simulation tools have become more and more accessible, mature, and efficient for the surgeons in all specialties. [3] This is a result of significant progress made from several main areas:

• Readily available resolution medical images
• More healthcare friendly 3D processing software designed for healthcare workflow (e.g. Mimics by Materialise, Osirx)
• More affordable in-house desktop 3D printer solutions (e.g. Replicator, Form 2, Ultimaker). Part of the progress is due to multiple patent expirations, and thus lowering the price.
• More available out-source vendors. Many 3D printing service vendors are appearing in the healthcare sphere, including the more established 3D System (previously Medical Modeling), iMaterialise, to now more and more smaller vendors who focused on other verticals.

2. 3D Printing based surgical instruments

Taking advantage of the ability to create patient specific instruments and surgical guides, there have been a few relatively larger scale clinical trials focusing on this area. The long-term outcome results are still pending and routine use is still controversial [1]. However, the short-term goals include shortening operating time and increase placement accuracy have been the focus on several ongoing clinical trials. A recent clinical trial from Cleveland Clinic has demonstrated an increase in accuracy in hip procedure [4]. Nonetheless, cost and turnaround-time remain to be two main barriers to entry for smaller surgical centers to routinely use the technology.

3. 3D Printing based orthopedics metal implants

A number of medical device companies have successfully produced and marketed several metal implants that are FDA approved in the past 15 years. According to one article, there were twenty-five FDA 510(K) cleared implants that were produced using 3D printing technology. [2] Most of these implants took advantage of the fact that 3D printed structures can create personalized implants on both macro and micro-structural scales. That is, these implants not only incorporate specific size and shape costumed to the patient’s, but also incorporate the specific microstructure of the cortical and trabecular components of the bone specific to the patient. Additionally, creative designs of the bone-implant interface enable improved implant success by encouraging bone ingrowth.

4. Orthopedic implants/replacement integrating both 3D printing and bio-printing technologies

More and more attention is paid to integrating bio-printing and 3D printing technologies in the improvement of orthopedic care. Many believe that this is the future of orthopedics, if not, medicine. This is an area of active research. In orthopedics, new progress is observable frequently, ranging from creating bone replacement to 3D printed cartilage. [5,6] Although many have doubts that a market mature orthopedic product using bio-prinitng and tissue engineering is still at least a decade away, this area has demonstrated more immediate promises than more ambitious whole organ regeneration, where meeting blood supply remains a great challenge.

Our upcoming 3D printing in orthopedics conference in June [Link] will focus on not only the advancement of these technologies, but will also take a futuristic view on this interesting ecosystem including the FDA/regulatory landscape.

References:

1. Cai H, Application of 3D printing in orthopedics: status quo and opportunities in China. Ann Transl Med 2015;3(S1):S12 (doi: 10.3978/j.issn.2305–5839.2015.01.38) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4437958/
2. Madani A. Additive Manufacturing Status in the Orthopedics Industry, Avicenne Consulting | May 4, 2016. http://www.odtmag.com/contents/view_online-exclusives/2016-05-04/additive-manufacturing-status-in-the-orthopedics-industry/?sthash.KUljgw19.mjjo
3. Chen HJ, Gabriel M. A Roadmap from Ideas to Implementation — A white paper on 3D printing for Pre-surgical Application. To be published. 3DHEALS. May 2016. www.3dheals.com
4. Small T, et al. Comparison of acetabular shell position using patient specific instruments vs. standard surgical instruments: a randomized clinical trial. J Arthroplasty.2014 May;29(5):1030–7. doi: 10.1016/j.arth.2013.10.006. Epub 2013 Oct 16. http://dx.doi.org/10.1016/j.arth.2013.10.006
5. Di Bella C, Fosang A, Donati DM, Wallace GG, Choong PFM. 3D Bioprinting of Cartilage for Orthopedic Surgeons: Reading between the Lines. Frontiers in Surgery. 2015;2:39. doi:10.3389/fsurg.2015.00039.
6. Hung BP, et al. Three-Dimensional Printing of Bone Extacellular Matrix for Craniofacial Regeneration. ACS Biomater. Sci. Eng., Article DOI: 10.1021/acsbiomaterials.6b00101 Publication Date (Web): April 18, 2016