Cover Story
Game-changing 3D printing manufacturing trends for 2025
Additive manufacturing is transforming the design and production of medical devices, providing patient-tailored solutions for prosthetics and implants. We look at the latest advances. By Bernard Banga.
3D rendering of a 3D printer creating a prosthetic spine, showcasing advancements in medical technology and additive manufacturing. Credit: Phonlamai Photo / Shutterstock
As we enter 2025, 3D printing is set to be a vital driver of innovation in medical devices. The technology is continuing to transform the industry by advanced processes and materials, with artificial intelligence (AI) integration opening new possibilities for device development.
“These techniques enable significant advancements in the design of surgical guides, anatomical models for preoperative planning, and both standard and customised prosthetics and implants,” explains Frank Baur, an expert in biocompatibility and biological evaluation at Qserve Group.
Additive manufacturing now encompasses a growing array of processes for producing medical components from polymers, ceramics and metals. Whereas traditional methods often rely on subtractive techniques or moulding, additive technologies are based on depositing successive layers of material in a controlled manner.
3D printing can produce complex structures tailored to individual patients. The key benefits include shorter production timelines, optimised surgical procedures and significantly reduced postoperative complications. Advances in laser technologies are set to further enhance additive manufacturing capabilities.
Lasers and advanced materials: central to innovation
Stereolithography (SLA) uses UV lasers to solidify layers of liquid photosensitive resin. This technique achieves exceptional precision (resolution 25-50 microns) and smooth finishes and is widely used for orthopaedic applications. Advances in biocompatible resins combining flexibility and durability with accelerated cleaning and post-curing systems have cut manufacturing times by up to 40%.
Selective laser sintering (SLS) uses a high-frequency laser to fuse layers of composite polymer powder particles. Unlike SLA, SLS does not require support structures, simplifying post-processing and reducing manufacturing time by 40%. Current innovations focus on integrating advanced materials to produce lightweight, robust and durable medical components. This will unlock new possibilities for designing patient-tailored orthopaedic prosthetics and implants.
Astrocytes are a type of neural cell that builds the BBB, and Excellio plans to derive exosomes from them to make them even better at targeting the brain. Credit: ART-ur / Shutterstock
Towards bioresorbable implants: a promising development
Laser powder bed fusion (LPBF) is a cutting-edge technology for manufacturing metallic implants, using machines with up to six high-energy lasers for layer-by-layer fusion of advanced alloy powders. LPBF produces lightweight, mechanically robust and biocompatible implants with porous structures that promote osseointegration, and has a precision of 50-100 microns, making it an ideal solution for customised orthopaedic and cranial implants.
A notable recent publication on arXiv from a team led by Damien Tourret at the IMDEA Materials Institute in Spain describes a rapidly solidifying microstructure for bioresorbable orthopaedic implants, manufactured additively using an innovative magnesium alloy that ‘offers low density and an elastic modulus similar to human bone, reducing stress at the bone-implant interface’. This technology shows great promise for temporary implants used in bone repair or orthopaedic devices. Such implants naturally resorb over time, supporting optimal tissue healing while eliminating the need for subsequent surgical removal.
4D printing and bioprinting: adaptive and living devices
Three types of printers are used in medical device manufacturing: 4D printers, bioprinters and 5D/6D systems. 4D printers incorporate smart materials to create adaptive implants that respond to bodily stimuli. Leading companies including 3D Systems, Cellink and IMDEA Materials Institute have developed orthopaedic implants and smart implantable devices that enhance osseointegration and reduce postoperative complications. These devices, including stents and heart valves, adjust to physiological changes for improved efficacy and durability.
Bioprinting can be used to produce complex tissues and organs using bio-inks compatible with living cells. For Fabien Guillemot, director of the CNRS Laboratory of Bioprinting and Biomaterials in Rennes, ‘bioprinting offers endless possibilities for fabricating human tissues and organs’.
Guillemot has led significant research in 3D printing of cartilage, bone tissue, and vascular structures for regenerative medicine applications. He is the CEO and founder of Poietis SAS, a Pessac, France-based leader in 4D bioprinting, dedicated to "designing next-generation bioprinters for advanced tissue engineering.."
5D/6D AI printers: a technological leap
New multi-axis printers have significantly greater precision, with resolutions of up to 10 microns compared to the 50–100 microns typical of conventional 3D printers. This enables not only more intricate geometries, but also control over material orientation and integration of variable mechanical properties within a single structure.
5D printers provide greater control over material orientation during printing, and 6D printers enable sensor integration or interaction with external stimuli such as temperature or pressure within implants. These technologies, which are still under development in cutting-edge labs and companies like Materialise, 3D Systems and Stratasys, as well as academic institutions such as UC Berkeley in the US and ETH Zurich in Switzerland, could adapt to their environment in real time, paving the way for smarter, more responsive implants.
Integrating AI into these advanced technologies offers several key benefits. AI reduces production times by up to 50% while optimising design processes through real-time quality control, and enhances precision by 30% compared to traditional manual methods.
AI-generated surgical guides, in particular, significantly improve implant positioning accuracy. This translates into better clinical outcomes, with AI-optimised models for prosthetics and implants potentially reducing postoperative complications by 20% in patients undergoing complex orthopaedic procedures. AI-driven innovation in 3D-printed vascular tissues could also improve graft success rates and durability by 35%.
A growing sector facing regulatory challenges
Medical device additive manufacturing is experiencing significant growth. According to GlobalData analysis, the healthcare 3D printing market is projected to achieve a compound annual growth rate (CAGR) of 17.5% between 2024 and 2029. The Asia-Pacific region is expected to see the fastest growth, while North America remains the largest market internationally. In 2024, the global market was estimated at $1.17 billion.
Despite recent rapid expansion, additive manufacturing for medical devices has high entry costs: SLS printers can cost up to €500,000, while multi-laser LPBF machines can exceed €5 million. Manufacturers also must navigate complex regulatory hurdles, including adherence to rigorous safety and efficacy standards for medical products.
2025 outlook: standards shaping additive manufacturing in healthcare
Looking to 2025, regulatory frameworks for additive manufacturing in the medical sector are emerging as pivotal tools for standardising practices and enhancing the safety, quality and efficacy of 3D-printed medical devices.
- Classification of printing techniques: The NF ISO 17296-2 standard plays a critical role in categorising printing technologies based on the physical mechanisms used for material transformation.
- Quality management systems: The essential ISO 13485 standard ensures the implementation of quality management systems tailored to the stringent demands of the medical sector.
- Testing and process validation: The ISO/ASTM 52927:2024 standard defines core requirements for testing parts produced through additive manufacturing. It provides methodical tools for validating and monitoring printing processes, ensuring optimal device quality.
These evolving standards support the seamless integration of 3D printing into medical practices, addressing increasing demands for safety and reliability.
The role and support of regulatory authorities
The US Food and Drug Administration (FDA) issued a document in December 2017 entitled Technical Considerations for Additive Manufactured Medical Devices, which encompasses 3D printing. The FDA emphasises risk assessment, manufacturing process validation and product traceability for 3D-printed medical devices. It also maintains a dedicated webpage on 3D-printed medical devices, providing updated information on the medical applications of this technology.
The European Medicines Agency (EMA) recognises the potential of additive manufacturing for personalising medical technologies, while stressing the need to adhere to the quality and safety standards in the Medical Device Regulation (MDR). To date, the EMA has not issued specific recommendations for 3D-printed medical devices. However, during the COVID-19 pandemic, the European Commission addressed the topic. In May 2020, the Medical Device Coordination Group (MDCG) published the guidance document Conformity Assessment Procedures for 3D Printing and 3D Printed Products to be Used in a Medical Context for COVID-19.
The possibility of self-learning is made possible by the relatively lower cost of Butterfly ScanLab, given it would not be possible to provide each student with a $65,000 ultrasound system the likes of which Arnce uses in his work as an ER clinician.
“When I started using Butterfly to teach, the price point was somewhere in the $4,000 range, so it’s not out of the realm of possibility to have an ultrasound in every student’s hand, and that’s a large part of why Butterfly made sense for us.”
According to Arnce, students who have gone through the KCU POCUS curriculum stand out when applying for residencies due to their competency in using the technology.
“When you’re looking at an applicant, distinguishing one candidate from another comes down to how students perform when they’re on audition rotations during residency.
“I’ve had multiple students who’ve thanked me for the POCUS training, because they were, for instance, working in the ER and had a trauma come in, and other residents couldn’t get the scan, but they could.
“If POCUS is a skill you already have, it’s one less thing you need to learn, and it’s one thing that you do better than your peers, and so it puts individuals in the driver’s seat in terms of future success,” Arnce concludes.
Students scan patients and the AI labels for them what they’re seeing, so they can literally teach themselves.
Dr Robert Arnce
Caption. Credit:
Phillip Day. Credit: Scotgold Resources
Total annual production
Australia could be one of the main beneficiaries of this dramatic increase in demand, where private companies and local governments alike are eager to expand the country’s nascent rare earths production. In 2021, Australia produced the fourth-most rare earths in the world. It’s total annual production of 19,958 tonnes remains significantly less than the mammoth 152,407 tonnes produced by China, but a dramatic improvement over the 1,995 tonnes produced domestically in 2011.
The dominance of China in the rare earths space has also encouraged other countries, notably the US, to look further afield for rare earth deposits to diversify their supply of the increasingly vital minerals. With the US eager to ringfence rare earth production within its allies as part of the Inflation Reduction Act, including potentially allowing the Department of Defense to invest in Australian rare earths, there could be an unexpected windfall for Australian rare earths producers.