rms Company now provides a complete powder to package capability to medical device OEMs through its work with additive manufacturing (AM) industry pioneer 3D Systems. Powder to package encompasses the entire manufacturing and post-processing workflow required to go from a digital file to a sterilized and packaged final product ready for the surgical suite. Over the course of four years, 3D Systems has helped rms expand its portfolio of direct metal printers from one machine to 30—backed by a process that ensures repeatability across machines and supply chains—enabling true scaled production.
“It was clear to us that 3D Systems had made inroads in healthcare with its technology, and 3D Systems has proven to be a great partner—sharing lessons learned, guiding us in how to properly use the equipment, how to look at our total quality system, and beyond.”
- Troy Olson, Director of Additive Manufacturing at rms
TRANSITION TO SCALED AM PRODUCTION OF MEDICAL DEVICES
Success with outsourcing AM in orthopedics requires that OEMs partner with contract manufacturers with deep knowledge in AM. For more than fifty years, rms has built a reputation as a premier manufacturer of medical device components using conventional subtractive manufacturing. After watching additive manufacturing develop and evolve, rms saw an opportunity to offer more to its customers through AM implants that offer functionalities that cannot be manufactured any other way.
01 Proven Healthcare Solutions
rms was methodical in its selection of additive manufacturing technology, wanting to reinforce and extend its reputation for world-class quality. After researching its options, it chose 3D Systems for the company’s track record of success in healthcare applications. As of 2021, 3D Systems has experience manufacturing over two million medical devices and has supported over 90 FDA-cleared and CE-marked devices.
3D Systems’ customer-focused approach helps medical device OEMs accelerate their go-to-market strategies for launching new products through direct partnership or through contract manufacturers like rms. 3D Systems began adding value to the collaboration early by helping rms fill knowledge gaps to ensure rms’ successful integration of additive manufacturing within its broader portfolio.
02 Technology Transfer
rms benefited from the decades of application expertise housed within 3D Systems’ Application Innovation Group to receive the best guidance possible. Consultation with 3D Systems’ healthcare team and 3D Systems’ technology transfer offering helped rms remove the guesswork from adopting AM to streamline its transition to a new manufacturing process. “3D Systems was very helpful. The learning curve was steep, but now we have the people and the know-how to deliver on the promise of AM,” said Lee Zachman, President of rms.
3D Systems helped rms remove significant time from the adoption of metal printing while ensuring print outcomes. Technology transfer leverages pre-developed print files and processes, and includes professional account management, consulting, training across pre-qualified AM production processes, and installation. It also focuses on specialized tasks like how to run the machine, program the printer, set up files for printing, part supports and orientation, and part post-processing.
03 High Quality Metal Additive
In addition to industry-specific AM expertise, 3D Systems provides an ideal additive solution in terms of print quality and material properties, which is critical for parts like the implants rms produces. The best-in-class oxygen levels (<25 ppm) and inert printing atmosphere of 3D Systems’ direct metal printing (DMP) systems ensure exceptionally strong and accurate parts with high chemical purity, and the repeatability needed to produce implants for medical device OEMs. By using the same digital data package per part, 3D Systems machines enable scalability of production by delivering the same outcome across all DMP machines with no global off-sets. rms uses a combination of legacy DMP printers and DMP Flex 350s.
04 Scalable Production
Since adding its first AM machine, rms has grown its in-house expertise tremendously. rms handles all post-printing steps to ready products for final delivery, including heat-treating, finishing, polishing, cleaning, packaging, and sterilization management, and has its own on-site laboratory for testing materials and printed test bars. By partnering with 3D Systems, this work has been supported by decades of AM experience, enabling rms to streamline and accelerate its adoption of additive manufacturing while safeguarding its investment in a new technology and process.
“We’re seeing more opportunities outside spinal implants,” said Zachman. “We’re in a very good position. We worked extremely hard to get where we are.” rms recently restructured its additive department as a stand-alone business unit within rms with dedicated resources in engineering, quality, and operations leadership.