Sean Fenske, Editor05.23.16
We are currently at the start of a convergence of factors that could have a disruptive impact on the orthopedic industry in terms of the types of implants that are being used to replace bones and joints, such as in total knee replacement and hip procedures. Those factors are customization capabilities, 3D printing and additive manufacturing, and material innovations. These three will eventually combine to replace the metal implants we currently see in regular use to offer a significantly more natural version.
Leveraging high resolution imaging, manufacturers like ConforMIS are already providing custom implants to surgeons that are specifically developed for each patient. The lead times still require the planning for these implant options to be weeks in advance, and currently, the company only offers customized implants for knee replacement. That will change in time, however, as the company is looking to advance the technology to suit the needs of other orthopedic areas. How long will it really be before they are making the same type of custom product for a hip implant or spinal applications?
Not everyone, however, is completely on board yet with this type of orthopedic implant. At this year’s AAOS (American Academy of Orthopaedic Surgeons) annual meeting, I overheard two orthopedic doctors discussing ConforMIS and mentioning how they were unfamiliar with the technology. While curious about the custom aspect of the solution and recognizing the benefits that it could offer, they still seemed reluctant to adopt the technology. It seemed as though a company like ConforMIS might benefit in developing an educational program where they reach out to surgeons to explain the system and exactly how the process works. Then again, perhaps they have and these two specific doctors had not reviewed it yet.
Meanwhile, 3D printing and additive manufacturing are providing new capabilities that offer an array of possibilities within the hospital itself. Many are already familiar with the prototyping solutions that are being developed with these systems. Significant savings are being enjoyed by designers who can get a physical representation of an idea within hours of entering it into a computer. Imagine the same type of solution being in every orthopedic surgical operatory around the world. Part of the surgical prep could be the doctor and the 3D printing technician reviewing a patient case and programing the system to print the required custom implant based on high resolution imaging of the actual patient’s anatomy. Instead of the implant company representative walking the custom implant into the OR on the day of the procedure as is the case with ConforMIS implants, or the hospital maintaining an inventory of implants as they do with traditional options, the 3D printing tech would deliver the implant to the surgeon after having planned it with the doctor the previous day.
While a fully custom, 3D printed solution would be fairly close to ideal, there is one factor that could really make this option the next best thing after the patient’s natural bone. That factor is the materials being used. While 3D printing of metal is making such an implant solution occurring right in the hospital seem quite plausible, an even better option would be to develop the implant in a material that more closely mimics the characteristics of bone. New advances in biomaterials will likely address this obstacle and we’ll eventually see implants that can be 3D printed that very closely resemble natural bone. Recent research out of Johns Hopkins Medicine determined that a mix of at least 30 percent pulverized natural bone with some special man-made plastic offered the best recipe for replacing missing bone. Further, researchers noted that this material would be best used if the replacement implant was fabricated with a 3D printer.
The combination of these three factors certainly provides for a clear picture of the likely future for orthopedic implants. With some additional materials modifications, there may even be pharmaceuticals added that promote healing, fight potential infection, or enhance bone growth to better incorporate with the implant.
This vision isn’t without its possible obstacles though. First, you need the regulatory support from the U.S. Food and Drug Administration. If the agency doesn’t establish a clear approval pathway for this type of cutting-edge solution, it has no hope of becoming a true clinical option. That said, the process will need to be able to be validated. That poses an array of concerns. Does that mean only one 3D printing machine supplier will have its system approved to be used in this process? Will each hospital have to have its procedures and systems approved? Further, will you get buy-in from the hospitals? Will they be willing to pay for the 3D printers required to fabricate this type of implant?
As with any advancement, questions will linger and need to be addressed. But I think the vision for the future of implants in the orthopedic sector is clear. Ultimately, it will provide better solutions for patients, and that’s what every technology should be developed to achieve.
Leveraging high resolution imaging, manufacturers like ConforMIS are already providing custom implants to surgeons that are specifically developed for each patient. The lead times still require the planning for these implant options to be weeks in advance, and currently, the company only offers customized implants for knee replacement. That will change in time, however, as the company is looking to advance the technology to suit the needs of other orthopedic areas. How long will it really be before they are making the same type of custom product for a hip implant or spinal applications?
Not everyone, however, is completely on board yet with this type of orthopedic implant. At this year’s AAOS (American Academy of Orthopaedic Surgeons) annual meeting, I overheard two orthopedic doctors discussing ConforMIS and mentioning how they were unfamiliar with the technology. While curious about the custom aspect of the solution and recognizing the benefits that it could offer, they still seemed reluctant to adopt the technology. It seemed as though a company like ConforMIS might benefit in developing an educational program where they reach out to surgeons to explain the system and exactly how the process works. Then again, perhaps they have and these two specific doctors had not reviewed it yet.
Meanwhile, 3D printing and additive manufacturing are providing new capabilities that offer an array of possibilities within the hospital itself. Many are already familiar with the prototyping solutions that are being developed with these systems. Significant savings are being enjoyed by designers who can get a physical representation of an idea within hours of entering it into a computer. Imagine the same type of solution being in every orthopedic surgical operatory around the world. Part of the surgical prep could be the doctor and the 3D printing technician reviewing a patient case and programing the system to print the required custom implant based on high resolution imaging of the actual patient’s anatomy. Instead of the implant company representative walking the custom implant into the OR on the day of the procedure as is the case with ConforMIS implants, or the hospital maintaining an inventory of implants as they do with traditional options, the 3D printing tech would deliver the implant to the surgeon after having planned it with the doctor the previous day.
While a fully custom, 3D printed solution would be fairly close to ideal, there is one factor that could really make this option the next best thing after the patient’s natural bone. That factor is the materials being used. While 3D printing of metal is making such an implant solution occurring right in the hospital seem quite plausible, an even better option would be to develop the implant in a material that more closely mimics the characteristics of bone. New advances in biomaterials will likely address this obstacle and we’ll eventually see implants that can be 3D printed that very closely resemble natural bone. Recent research out of Johns Hopkins Medicine determined that a mix of at least 30 percent pulverized natural bone with some special man-made plastic offered the best recipe for replacing missing bone. Further, researchers noted that this material would be best used if the replacement implant was fabricated with a 3D printer.
The combination of these three factors certainly provides for a clear picture of the likely future for orthopedic implants. With some additional materials modifications, there may even be pharmaceuticals added that promote healing, fight potential infection, or enhance bone growth to better incorporate with the implant.
This vision isn’t without its possible obstacles though. First, you need the regulatory support from the U.S. Food and Drug Administration. If the agency doesn’t establish a clear approval pathway for this type of cutting-edge solution, it has no hope of becoming a true clinical option. That said, the process will need to be able to be validated. That poses an array of concerns. Does that mean only one 3D printing machine supplier will have its system approved to be used in this process? Will each hospital have to have its procedures and systems approved? Further, will you get buy-in from the hospitals? Will they be willing to pay for the 3D printers required to fabricate this type of implant?
As with any advancement, questions will linger and need to be addressed. But I think the vision for the future of implants in the orthopedic sector is clear. Ultimately, it will provide better solutions for patients, and that’s what every technology should be developed to achieve.