The global market for 3D-printed medical devices is expected to grow from $2.1 billion in 2023 to $4.5 billion by 2029, with a CAGR of 14.7% from 2024 to 2029. What is fueling this dramatic increase?
 
Additive manufacturing (AM), or 3D printing, is transforming healthcare by enabling the creation of more complex and personalized medical devices. The shift towards AM in healthcare is driven by the confluence of technological advancements, material innovations, software improvements, and evolving regulatory landscapes. Let’s explore how each of these contributes to making AM more cost-effective and accessible across a broader range of applications.
 

Enhance Printing Speed and Precision with Technological Advancements

3D printers continue to become more accurate and efficient across platforms, including Selective Laser Sintering, Stereolithography, Extrusion, and Laser Powder Bed Fusion. Multi-laser technologies—especially when combined with build strategies that require fewer post-processing steps—are expediting production and expanding applications beyond small devices such as titanium spine cages to implants, personalized instrumentation, and models for total joint and pelvic replacement surgeries.
 

Expand Device Portfolios Leveraging Material Innovation

More options for printable materials are also expanding opportunities. CoCr and PEEK, for instance, are now able to be 3D-printed monolithically and with the same integrated lattice structures seen in Titanium devices. These porous structures are designed to support bony ingrowth and ultimately, faster recovery. However, these new materials also offer unique benefits such as smooth articulation in the joint space with CoCr implants as well as a high durability and a modulus similar to bone experienced with PEEK implants.
 
Additionally, 3D-printed materials can be combined with those used in traditional processes to create hybrid devices. Another novel application is using bioresorbable materials for bone plates and other implants, enabling patients to avoid long-term monitoring.
 

Streamline Design & Production via Software Improvements

AI-powered software is also accelerating 3D-printing workflows. Deep learning (DL) algorithms are embedded throughout the manufacturing process to automate steps and streamline production. This applies to image segmentation, 3D modeling, and design software, predicting device design parameters and saving design engineers and even surgeons time when developing patient-specific solutions and surgical plans. AI and DL are also integrated into the software that optimizes the build files for efficient and reliable 3D printing.
 

Gain the Advantage with Evolving Regulatory Landscapes

The development of industry standards and guidelines for AM has provided a framework for quality assurance and compliance. As regulatory bodies across the globe become more knowledgeable about the capabilities of 3D printing, guidance becomes clearer, and the review window shrinks. Finally, with clinical evidence validating device properties that meet or exceed standards, access to existing device master files as well as favorable biocompatibility testing results, manufacturers can further accelerate clearances and commercialization.
 
In conclusion, as 3D-printing technologies and expertise continue to advance and regulatory frameworks mature, AM is poised to play an increasingly important role in manufacturing and innovation in Orthopaedics.
 
Thinking about AM for your next product development challenge? Start a conversation with one of the experts at 3D Systems at www.3dsystems.com/medical-devices.