This piece was originally published in the April 2017 issue of electroindustry.
Lauralyn McDaniel, Medical Industry Manager, SME
In the last few years, headlines have suggested that the use of additive manufacturing (AM), also known as 3D printing, in medicine is a new way to save and improve lives. The truth is, it’s not so new.
Twenty years ago, anatomical models were used for planning complicated surgeries. In 2000, hearing aid cases were 3D-printed, and within a few years they became the industry standard. Medical applications have been a leader in taking 3D printing technology far beyond product development. The combination of using medical imaging data to create patient-matched devices and the ability to manufacture structures difficult to produce with traditional technologies is compelling to an industry always looking for ways to innovate and improve care for patients.
Interest has been fueled by many factors, including the expiration of patents, beginning in 2010. As competition intensified, the effort by machine builders to bring down prices accelerated. At the same time, the availability and increased reliability of metal printers and multi-color machines expanded interest and use.
Metal printing systems allowed device manufacturers to produce porous structures for orthopedic implants that would be difficult to produce with traditional methods. For hospitals, the drop in prices and improvement in multicolor machines and materials, as well as development of supporting software for critical segmentation of medical imaging files, facilitated an investment in an area that is not yet included in reimbursable expenses by payers.
SME is a nonprofit organization that promotes advanced manufacturing technology. It has been a gathering point for users and developers of AM since 1990, when it convened an event that has come to be known as RAPID+TCT. It now counts clinical and medical device AM applications as an essential component of the annual convention. In 1997, SME published Rapid Prototyping Technology: A Unique Approach to the Diagnosis and Planning of Medical Procedures, the first book on medical applications of AM.
About 10 years ago, SME members recognized the need to develop consensus standards for additive manufacturing. Since SME is not a standards development organization (SDO), it approached ASTM, an established SDO, and created the F42 Committee on Additive Manufacturing Technologies.
The combination of using medical imaging data to create patient-matched devices and the ability to manufacture structures difficult to produce with traditional technologies is compelling to an industry always looking for ways to innovate and improve care for patients.
Spreading the Word
Despite all of this, widespread medical use of 3D printing in medicine has been fairly slow. Industry professionals, clinicians, technology developers, and researchers are working together to identify challenges and then develop tools and resources to address them through the SME Medical Additive Manufacturing/3D Printing Workgroup (SME WG).
The SME WG is addressing those challenges through several projects:
Standards and Quality Assurance
From the collection of imaging data to the use of parts, devices, and models, the workgroup has described the current state of the industry and identified gaps as the foundation for further development. Much of this work has been done supporting the Additive Manufacturing Standardization Collaborative (AMSC), a joint project with America Makes (a national accelerator for AM) and ANSI. Supporting work resulted in the creation of an open, searchable database of existing and in-development standards that were developed specifically for AM. The database can be found at www.sme.org/am3dp.
Two groups were identified for outreach: students and professionals. To share the excitement and possibilities of additive manufacturing with students, this effort will identify opportunities, develop tools and templates, and provide advice to connect with K–12 and college students.
Since many AM users are new to manufacturing, the workgroup also gathered existing information into an interactive website for professionals that helps them navigate cases and connects them to existing standards, regulatory information, technical articles, how-to information, and vendor resources.
Building Evidence for Medical Applications
Connecting all key stakeholders in clinical, scientific, and medical device fields encourages them to share best practices and identify effective methodologies and reliable protocols. This initiative lays the groundwork for producing solid evidence on 3D-printed medical devices, with a particular focus on anatomical models, patient-matched guides, and implants.
SME WG identified gaps in the Digital Imaging and Communications in Medicine (DICOM) standard, a global information technology standard under MITA’s purview that ensures the interoperability of systems used to produce and process medical images. The workgroup will integrate the needs of 3D printing into DICOM in a way that is consistent with patient privacy concerns and best practices.
Through the AMSC, SME connected with MITA to discuss the gaps and possible ways to address the needs in the existing DICOM standard. Allan Noordvyk of McKesson Imaging, volunteered and joined the SME WG. Based on his consultations, a proposal to create WG-17 3D Manufacturing was unanimously approved by the DICOM Steering Committee on December 1, 2016. Mr. Noordvyk and Justin Ryan of Phoenix Children’s Hospital, co-chair the workgroup.
Now is an exciting time to be advancing the use of AM in medicine. SME will continue to facilitate and support these efforts through collaborations and resources. To learn more, visit www.sme.org/medical-additive.