Orthopaedic medical device professionals can expect to find a wealth of innovative additive manufacturing or 3D printing solutions from leading manufacturers and suppliers at RAPID + TCT, an annual event hosted by the Society of Manufacturing Engineers (SME), April 23-26 in Fort Worth, Texas.
This year, the medical focus is being expanded with the SME Medical Manufacturing Innovations series (MMI), which explores life-changing additive applications such as patient-matched implants, prosthetics, bone and tissue scaffolds, bioprinting and more.
“RAPID + TCT’s collaborative approach gives stakeholder groups an opportunity to identify challenges, develop resources and facilitate changes to support anyone using the technologies for medical/biomedical applications,” said Lauralyn McDaniel, Medical Additive Manufacturing Industry Expert at SME. “Applications are getting more complex; we’re focusing on issues ranging from working within a clinical setting for point-of-care manufacturers and regulatory/quality requirements to the developing area of tissue fabrication and bioprinting.”
The clinical side of additive will be addressed at the MMI series keynote on in an address titled, “Rise of Point-of-Care (POC) Manufacturing: Impacting More Patients with 3D Printing.”
Jonathan M. Morris, M.D. and Amy Alexander, BME, both from the Mayo Clinic, will discuss how POC manufacturing can provide patient care advantages, addressing unique obstacles of engineering within a hospital and creating the need for collaboration across disciplines.
The Mayo Clinic is viewed as a leader in POC, having established its first 3D printing lab in 2006. Today, the lab produces more than 700 anatomic models per year for complex surgeries and custom device creation.
Additive POC manufacturing has grown in the last few years, according to SME, supported by advancements in machines, materials, software and awareness.
“It’s important for medical device manufacturers to understand and adapt to POC manufacturing,” McDaniel said. “The leaders in the field are going beyond anatomical models.”
In addition to the keynote, RAPID + TCT's MMI program offers three focused workshops:
- “Regulatory and Quality System Considerations for 3D Printed Medical Devices,” addressing the needs of medical device manufacturers
- “3D Printing in Hospital,” focusing on the needs of POC manufacturers
- “Biomaterials and Bioprinting Fundamentals & Applications,” looking out to the next generation of 3D-printed products to improve patient care
Of particular interest to the orthopaedic space is the regulatory workshop led by Janelle Schrot of Materialise. Panelists include Matthew DiPrima (FDA); Kim Torluemke (3D Systems); Jenny Jones (Materialise); Beatrice Ogembo (American Preclinical Services) and Dan Fritzinger (DePuy Synthes). Attendees can expect to:
- Gain insight into FDA’s view of 3D printing as applied to medical devices
- Obtain an overview of the types of 3D-printed medical devices that have been cleared
- Understand how quality, controls, validation and verification can be accomplished with 3D printing
- Learn the latest available information on regulatory clearance processes specific to 3D printing
FDA finalized its additive manufacturing guidance in December. But plenty of questions still exist, and best practices surrounding the technology are being discussed globally every day.
“This workshop is of high interest for device manufacturers,” McDaniel said. “Standards development is critical for orthopaedic device manufacturers. Right now, while those who are engaging in additive manufacturing have developed their validation and verification processes, a lot still aren’t talking about it. There’s no benchmarking available. Independent consensus standards will be the most reliable way for device manufacturers to support and validate their processes.”
Other areas of interest to the orthopaedic space in the MMI series include:
- The latest on standards development to support your validation processes
- Economics of patient-matched knee implants
- Effect of build orientation on fatigue life
- Influence of sterilization on laser sintered polyamide material
- Functionally graded internal fracture fixation plates
- Improving fatigue life for humerus fracture fixation
- Patient-matched implants with PEEK FFF
The event has also become a yearly meeting place for workgroups such as the SME Medical Additive Manufacturing/3D Printing Workgroup and the Digital Imaging and Communications in Medicine (DICOM) Workgroup 17. DICOM is the international standard to transmit, store, retrieve, print, process and display medical imaging information.
Rapid + TCT also offers a wide variety of companies displaying the latest additive technologies on the trade show floor, featuring over 300 exhibitors.
*Article image courtesy of Arcam AB