By Gautam Gupta, VP of Business Development, 3D Systems Precision Healthcare
Medical device companies in the orthopedic and spine space are rapidly adopting 3D printing technology to introduce very innovative products to market.
3D printing technology, especially metal, for implant production allows for new and complex design features, which can lead to significant clinical benefits. In addition, development of new products can be accomplished at a rapid pace with a significant reduction in cost.
Up until now, medical device manufacturers have really only scratched the surface of how 3D additive manufacturing can deliver new products, quickly. Having said that, some true innovations have already been developed in recent years with these manufacturers in partnership with 3D Systems, including small but accurate, complex, latticed parts in metal which may promote bone ingrowth after surgery.
I foresee the next wave of innovation, as new ideas develop within the potential of 3D printing, will come in small batch manufacturing of instruments with even more ingenious and complex designs. 3D printing is the ideal method for producing these instruments because the current supply chain and manufacturing processes around this type of business are extremely inefficient in cost, capital expenditure and turnaround time.
3D Systems actively partners with many medical device companies in the orthopedic and spine space, helping them understand even greater potential brought by 3D printing. In addition, 3D Systems also has access to several bio-compatible materials that are tuned for certification.
Riding the Learning Curve
Since 3D printing technology has only recently been adopted by the industry for doing large-scale manufacturing, there is still a learning curve when it comes to using this technology. So having that experienced partner alongside helps with the following:
- Qualifying new materials: This can be a challenge at multiple levels. First, the material has to be qualified for its biocompatibility and ability to meet mechanical requirements for multiple applications. The regulatory and financial burden of such qualification and the associated time can be substantial. Although still a challenging task from a logistics and technology standpoint, it is faster, easier and less-expensive to qualify proven materials like 3D Systems’ 17-4 PH stainless steel and validate those for new printing applications.
- Validating parameters to run new materials: In regards to machine hardware engineering, validating and optimizing parameters to run new materials can be challenging and costly unless there is a business case for a clinical application that requires large scale manufacturing.
- Having the ecosystem: Securing a logistics ecosystem for reliable sourcing of such new materials at the quality required for healthcare applications can also be a challenging task.
3D Systems is uniquely positioned for such an opportunity as it offers a high degree of medical device design and production expertise, deep knowledge of 3D printing and a thorough understanding of the regulatory process to commercialization. At 3D Systems, we have two world-class ISO 13485-certified manufacturing centers located strategically in Denver, CO and Leuven, Belgium to support the customers in the US and Europe. We are supporting large-scale production of orthopedic and spine devices from these centers using our state-of-the-art metal ProX DMP 320 3D printers and this success has allowed us to gain trust and credibility with our partners in the medical device industry.
As the market develops, integration of 3D software and hardware will become more critical for improving manufacturing workflows and reducing cost for manufacturing implants and instruments. 3D Systems recently introduced a revolutionary additive manufacturing software solution to the market, 3DXpert. This software interfaces with metal 3D printers seamlessly, using CAD data files, which eliminates the need for file conversion between disparate systems and leads to better print quality and reduced file size. Another benefit of this software is the supporting and zoning strategies, which significantly reduce print time and cost. Other features work to minimize downstream machining requirements, further reducing costs and time-to-market. Such software and hardware platform integration has the potential to revolutionize the economics of manufacturing devices using 3D printing technology. These solutions integrate state-of-the-art 3D hardware and software bringing this revolutionary technology to the patient’s bedside and in the operating room.