The medical industry has been a leader in developing applications for additive manufacturing/3D printing (AM/3DP), and for more than just prototyping and product development. Anatomical models built from medical imaging data have helped surgeons understand and plan complicated surgeries for 20 years, first taking hold with bony reconstructions. Hearing aid cases matched to a patient’s ear canal were first produced in 2000 and within a few years became the industry standard. Patient-matched surgical cutting guides have become part of several orthopedic implant kits produced by device manufacturers.
These same manufacturers are using AM as a production process to more effectively create critical porous surface structures needed for in-bone growth of hip, knee, and other replacements. In the last few years, patient-matched implants like the tracheal splint to treat TBM (tracheobronchomalacia) developed at the University of Michigan have demonstrated the opportunity for AM/3DP produced devices to treat rare diseases. Precision medicine, matching treatment precisely to patient, has also bolstered the value of AM/3DP.
Despite this success, growth has been slow. In medicine, any new device or tool must clear several areas before sales growth can occur, including regulatory, clinical effectiveness and safety, and reimbursement by payors once established as a standard of care. To address these areas, collaboration is needed between clinicians, engineers, researchers, regulators, and technology developers.
One challenge is the distributed production of some AM/3DP applications, particularly for anatomical models. Typically, a device manufacturer has complete control of the process and the ability to conduct controlled studies to demonstrate safety and effectiveness. With many anatomical models produced at the point-of-care, the ability for coordinated studies requires collaboration. An example of this is the 3DHEART (3D Hearts Enabling A Randomized Trial), a clinical trial to study the use of models in pre-operative planning for pediatric heart surgery. The study is being led by physicians from New York-Presbyterian/Morgan Stanley Children’s Hospital, Children’s Hospital of Philadelphia, Children’s National Medical Center, and Phoenix Children’s Hospital, with up to 20 additional sites in the US with in-kind support, printing of the models, from Stratasys.
Many are watching the 3DHEART effort to understand how it addresses experience of surgeons. Once a surgeon uses a model as part of his preparation, he’s far less willing to conduct similar surgeries without a model. The RSNA (Radiological Society of North America) 3D Printing Special Interest Group (SIG) is leading a collaborative effort to develop appropriateness guidelines for different conditions and surgeries. Based on the experience of physicians using models for many years, the guidelines indicate whether a model is usually appropriate, may be appropriate, or likely not appropriate, and are consistent with other radiology appropriateness guidelines established for the use of medical imaging. One goal of the guidelines is to support models becoming a standard of care and, therefore, reimbursable.
The RSNA 3DP SIG is also collaborating with the FDA to better understand how regulations apply to point-of-care manufacturers. For most devices, regulatory compliance means the ability to validate your manufacturing process, often facilitated by established standards. The Additive Manufacturing Standardization Collaborative (AMSC) is working to accelerate the development of standards. Led by America Makes and ANSI, more than 200 AM/3DP experts and several Standards Development Organizations (SDOs) are working together to identify needed standards and priorities for development. With the support of the SME Medical AM/3DP Workgroup, the standards roadmap addresses many needs of the medical community, including integration of AM/3DP needs with existing DICOM (Digital Imaging and Communications in Medicine) standards. Collaborating with the DICOM committee, the SME workgroup identified needs and supported the creation of a DICOM workgroup to update the standard to better meet the needs of AM/3DP.
Other collaborations are underway, but more are needed. With the diverse expertise needed—clinical and engineering—collaboration is the key. For those who have experienced the impact AM/3DP can have to change and even save lives, there is a desire to help even more patients. If you’re one of those people, get involved. Visit the SME Medical AM/3DP Workgroup website for more information and links to groups leading just some of these initiatives.