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Devices & Utilities 2023

3D printing | A promising market

The 3D printing ecosystem in India is poised to revolutionize healthcare delivery and personalized medicine, driving innovation and economic growth in the region.

3D printing has been established as a game-changing technology in the medical field. With the image processing and visualization capabilities of advanced software, it is now possible to convert the data from CT and MRI scans into digital 3D models and subsequently print physical parts using 3D printing.

The technology is being used to produce a wide range of medical devices, including prosthetics, implants, surgical instruments, and anatomical models for surgical planning and training. One of the major benefits of using 3D printing in the medical device industry is that it allows for the production of custom-made devices that are specifically tailored to the needs of individual patients. This can lead to better patient outcomes and improved quality of life.

It is unclear how and when 3D printing entered the Indian market. However, we can trace its roots by looking at companies that are well established and have been in this field for a significant period. The Indian 3D printing medical devices market is valued at USD 63 million in 2023 and is estimated to expand at a compound annual growth rate of 17.8 percent from 2023 to 2030, to reach USD 222 million in 2030.

Current landscape
Today, the 3D printing medical devices market is characterized by a diverse array of products and applications. Customized implants, such as hip and knee replacements, spinal cages, and dental implants, have gained traction due to their ability to enhance patient outcomes and reduce the risk of complications. Prosthetic limbs, traditionally manufactured using standardized designs, are now being produced with 3D printing techniques, offering improved comfort and functionality for users.

Moreover, the use of 3D printing in surgical planning and training has become commonplace, enabling surgeons to visualize complex anatomical structures and simulate procedures before entering the operating room. This has led to shorter surgical times, reduced risk of errors, and improved patient safety.

Printing techniques
The adoption of 3D printing in healthcare represents a paradigm shift, offering personalized solutions, rapid prototyping, and cost-effective production. Additive manufacturing has grown exponentially over the last several years for diagnostic and treatment solutions in healthcare. Some popular techniques on 3D printing’s ever-evolving role in the medical industry are:

Fused deposition modelling. FDM is the most widely used form of 3D printing at the consumer level, fuelled by the emergence of hobbyist 3D printers. Industrial FDM printers are, however, also popular with professionals.

Its open-build platform allows for printing large parts, while variable infill levels enable customization of part strength and weight. However, FDM’s resolution may be lower than other methods, resulting in reduced surface quality and intricate detail. The need for support structures in complex geometries can be challenging, and FDM’s limited ability to print with high-temperature materials restricts its use in extreme temperature applications.

Despite limitations, FDM is valuable in the medical field for its low cost and ability to print with biocompatible materials, making it suitable for prosthetics, orthotics, surgical tools, and anatomical models tailored to individual patients.

Direct ink writing. DIW which is widely used for developing functional 3D scaffolds that have robust structural integrity for the growth of target tissues/cells, has emerged as an appealing method for biomedical applications. DIW suitable for printing materials like epoxy, thermoplastics, and polydimethylsiloxane (PDMS), offers advantages such as printing in ambient conditions, high resolution and accuracy, and versatility in utilizing various materials, including biocompatible and biodegradable options. However, DIW has limitations in tuning part performance during printing and exhibits a relatively slow printing process compared to other 3D printing technologies.

Stereolithography. SLA is a highly favored 3D printing process in the medical field due to its exceptional resolution, precision, and material versatility. It is widely used for creating detailed anatomical models, prototypes of medical devices, molds, tooling, and functional end-use parts.

SLA offers a wide selection of biocompatible materials suitable for dental and medical applications, including surgical instruments and appliances requiring skin or mucosal membrane contact. SLA utilizes a laser to solidify liquid polymer, enabling the production of intricate features and complex geometries with high resolution and precision. Post-processing requirements are minimal, resulting in smooth surface finishes.

Despite its benefits, SLA has drawbacks such as slower printing speed, brittleness, and reduced mechanical strength compared to other 3D printing technologies. SLA components may also degrade over time when exposed to UV radiation.

Inkjet 3D printing is an alternative resin-curing method that utilizes a nozzle to deposit material droplets cured by UV beams, enabling fast printing of multi-material structures with support materials.

With 3D inkjet printing systems, engineers can fabricate hybrid structures that have soft and rigid components, like robotic grippers that are strong enough to grasp heavy objects but soft enough to interact safely with humans.

Selective laser sintering. SLS has gained traction beyond rapid prototyping, extending into low-volume part production and diverse applications, driven by advancements in 3D printing technology. It stands out for its ability to produce parts with exceptional mechanical strength and durability, including medical settings where biocompatible and biodegradable materials are utilized.

Furthermore, SLS enables the fabrication of parts with intricate geometries and complex internal structures, offering precision and versatility in design. Notably, the residual powder in the platform serves as support during part construction, streamlining the printing process and enabling the creation of complex assemblies.

Despite its advantages, SLS faces limitations such as slower printing speeds, potential surface roughness requiring post-processing, and sensitivity to environmental conditions.

Binder jetting. BJ is a cutting-edge 3D printing technique gaining prominence in the medical industry due to its ability to efficiently produce multicolor, multi-material, and functionally graded components. Utilizing a jetted substance to bond powder, binder jetting offers versatility in material selection, enabling the creation of complex geometries and internal structures. While it boasts high accuracy and resolution, limitations include lower mechanical properties of printed parts compared to other methods and a typically rougher surface finish. Despite these drawbacks, binder jetting finds diverse applications, from dental implants to aerospace components, showcasing its potential for advanced engineering and customized solutions.

Challenges
Despite its significant potential, the 3D printing medical devices market faces several challenges. Regulatory requirements, particularly concerning the approval and certification of 3D-printed devices, remain a major hurdle for manufacturers. Ensuring the quality, consistency, and biocompatibility of printed products is essential to ensure patient safety and regulatory compliance.

Furthermore, the scalability of 3D printing technologies for mass production needs to be addressed to meet the growing demand for customized medical devices. While additive manufacturing offers flexibility and customization advantages, achieving cost-effective large-scale production without compromising quality remains a challenge.

Outlook
Looking ahead, the future of the 3D printing medical devices market appears promising, driven by advancements in materials science, technology, and regulatory frameworks. Materials with enhanced biocompatibility, durability, and sterilization capabilities are being developed to expand the range of applications for 3D-printed medical devices.

Moreover, the integration of artificial intelligence (AI) and machine learning (ML) algorithms is poised to optimize the design and manufacturing processes, enabling rapid iteration and customization of medical devices. AI-driven algorithms can analyze patient data, such as medical imaging scans, to generate personalized designs that address individual anatomical variations and optimize implant fit and functionality.

In addition, collaborations between industry stakeholders, including healthcare providers, regulatory agencies, and technology developers, are crucial for driving innovation and standardizing practices within the 3D printing medical devices market.

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