Growing experience with the use of 3D printing in orthopedics, plus declining cost differences between 3DP and traditionally manufactured implants, are enabling device manufacturers to expand the applications of 3DP in the musculoskeletal sector.
3D printing (3DP, also known as additive manufacturing) is making notable strides in penetrating the musculoskeletal device industry. It is no longer only being used for anatomical models to aid in surgical planning and the one-off custom implant for revisions with significant bone loss. It is now being applied to a surprisingly large percentage of off-the-shelf (OTS) implants, and early adopters see growing potential with this technology to enable more real-time or short-lead time printing of patient-specific implants across a broader range of procedures, from trauma fixation to joint replacement solutions.
The consulting firm Health Advances and the University of California, San Francisco Department of Orthopaedic Surgery convened a forum of thought leaders on March 14, during the annual meeting of the American Academy of Orthopedic Surgeons (AAOS), to examine the future for 3DP in the musculoskeletal sector. The panel, titled “From Printer to Patient: How Will 3DP Reshape Musculoskeletal OEM, CMO, and Provider Roles?” was moderated by Paula Ness Speers, co-founder and managing director of Health Advances LLC, and Aenor Sawyer, MD, Chief Health Innovation Officer, Translational Research Institute for Space Health, Director UCSF Skeletal Health Service, Department of Orthopaedic Surgery, and Co-Director, UCSF Center for Advanced 3D+ Technologies. Lisa Lattanza, MD, Professor and Vice Chair of the Department of Orthopaedic Surgery and Chief of the Division of Hand and Upper Extremity Surgery at UCSF (Lattanza is moving as of September 1 to Yale School of Medicine/Yale New Haven Hospital to become Chair of the Department of Orthopaedics and Rehabilitation); Douglas Leach, Managing Director, Biomechanical Innovation, HSS Global Innovation Institute at the Hospital for Special Surgery (HSS); Alan Dang, MD, a Health Sciences Associate Clinical Professor of Orthopaedic Surgery at UCSF and a staff spine surgeon at the San Francisco VA Health Center, along with Yarmela Pavlovic, a partner in Hogan Lovells’ FDA Medical Device Group, participated as panelists.
There is now early clinical evidence stemming from a Conformis Inc. registry study that patient-specific implants can lead to better clinical outcomes (see sidebar, “Clinical and Economic Value of Patient-Specific Implants: Conformis as a Case Study.”). And when all the supply chain economics of traditional implant manufacturing, inventory build and shipping logistics are considered, 3DP-produced implants are rapidly approaching cost parity for all but the highest-volume implants. These developments led to discussion among the panelists of the potential to manufacture implants onsite or near hospitals and the identification of two examples where this is already unfolding, as well as the expansion of 3DP beyond patient-specific-implants to off-the-shelf applications.
The adoption curve illustrated in Figure 1 shows that additive manufacturing has proven its value in dental implants and other MSK (muscoloskeletal) applications are following close behind. While 3D anatomical models have not been a part of routine surgical workflow historically—due in part to early concerns about cost and the lack of expertise with the technical skills and software required to translate 2D images into manipulatable and printable 3DP images and objects—their value in improving pre-operative planning that enables intraoperative efficiencies and improved post-operative outcomes is becoming clearer, setting up the technology for broader adoption. 3DP of patient-specific and OTS implants are close behind, and will likely see rapid growth through the next five years. As manufacturers and surgeons adjust to these new technologies and associated applications, there is no doubt additive manufacturing will be a strong force in musculoskeletal care in the coming years.
By Paula Ness Speers, Masha Dumanis, Brandon Wade, Matthew Barnes, and Aenor Sawyer, MD | MedTech Strategist
Image Credit: LimaCorporate