Unlike traditional methods, in which products are created by shaping raw material into a final form through machining, carving, grinding, or molding, 3D printing is an additive manufacturing technique that creates three-dimensional objects by building successive layers of raw material such as metals, plastics, and ceramics.
The first 3D printing prototype was attempted by Dr. Kodama for his development of a rapid prototyping technique in 1980. The growing demand for prototyping has significantly reduced the price of 3D printing over the years and it has promoted high growth for service providers, 3D printing engineering and consulting services, and 3D printing materials. Currently, the primary markets for 3D printing include automobile parts, industrial, machinery, and heavy-duty machinery. However, it is anticipated that 3D printing is soon going to dominate the manufacturing industry across the globe for 3D printing functional parts. The rapid speed of 3D printing technology as compared to that of the conventional manufacturing process and the flexibility offered by the technology, make it a boon to achieve growing opportunities in many fields of application.
The availability of industry-grade 3D printing materials has further contributed to the rise of 3D printing in the healthcare industry. In this sector, the objects are produced from a digital file, rendered from a computed tomography scan (CT) and/or a computer-aided design (CAD) drawing which allows the manufacturer to easily make changes or adapt the product as desired. Based on deposition techniques, 3D printing technology catering to the healthcare domain has been divided into Binder jetting, Wire Direct Energy Deposition (laser metal deposition using wire), Powder Injection Technology Laser Engineered Net Shaping, Direct Metal Deposition) and the most extensively used Powder Bed Fusion (Selective Laser Melting, Electron Beam Melting, Direct Metal Laser Sintering) [1-2].
3D printed medical devices are increasing year after year. Owing to the ability of personalized medical solutions, print implants, prosthetics, devices for tissue engineering, and many other medical solutions, the use of 3D printing in the healthcare sector is expected to grow quickly. Nowadays, it is easy to find commercial solutions for instrumentation like splints or surgical guides to assist with the proper surgical placement of a device; Implants like reconstruction plates, osteosynthesis, cranial plates, joint replacements, and external prostheses like hands.
Like devices made using other manufacturing processes, devices made using 3D printing technology are subject to regulatory requirements. As different countries are releasing their regulations, it helps the industry to be on the right track to obtain the authorization to sell products. In 2016, the FDA issued draft guidance on the Technical Considerations for Additive Manufactured Devices to advise manufacturers who are producing devices through 3D printing techniques. It provides manufacturers with recommendations for device design, manufacturing, and testing considerations when developing 3D printed devices. The standard not only focuses on the process validation but also the software validation. And to be more precise, not just the software that is linked to product manufacturing but also the validation of the software that is related to the Quality Management System or to anything related to production from beginning to the end [3].
According to BIS research, in terms of value, the global 3D printing plastics market is expected to grow at a Compound Annual Growth Rate (CAGR) of 20.5% from 2018 to 2023 [1]. This growth is attributed to the reliable properties of 3D printing plastics, their cost-effectiveness as compared to that of the metals, growing end-use industries, increasing application areas, and emerging economy which have all led to the surging demand for 3D printing plastics. Particularly, the 3D printing market revenue in healthcare applications such as prosthetics, medical implants along with other applications is expected to cross $3.89 billion by 2022, at an estimated Compound Annual Growth Rate (CAGR) of 21.9%, calculated between 2016 and 2022 [2].
In terms of consumables, biocompatible materials that can withstand sterilisation, including high-performance thermoplastics like Ultem, PEEK, nylon and also metals like stainless steel, nickel and titanium alloys have been developed. The widespread acceptance of plastic materials in healthcare, consumer electronics, automotive, fashion and aesthetics, aerospace and defense, and education applications, among others, is due to their reliability, cost-effectiveness, and huge investment by government and federal agencies.
Plastics can be used in powder as well as filament form. Powder form plastic is used for Selective Laser Sintering process (SLS) and the filament form is used for Fused Filament Fabrication Process (also known as Fused Deposition Molding). Plastic-based 3D filaments occupied the largest market share globally in 2017. These are generally thermoplastics that are heated and extruded from the extruder nozzle, thereby creating a low-cost 3D printed object or model. There are various types of plastic-based filaments used in 3D printing. These include Polylactic Acid (PLA), Acrylonitrile Butadiene Styrene (ABS), Poly Vinyl Alcohol (PVA), High Impact Polystyrene (HIPS), Polyethylene terephthalate glycol (PETG), Poly Carbonates (PC), and others. The most commonly used plastic-based filaments are PLA, ABS, PVA, and PC. Due to the ease of availability, high tensile impact and flexural strength, and cost-effective option, plastic-based filaments are used widely in applications requiring rapid prototyping to create low-cost models. [1].
3D printing technology is already making a massive impact in the healthcare industry, but its potential in the coming years is staggering. The complex, customized medical implants will be delivered without substantial infrastructure investments or long delivery lead times, making custom the new standard.
References
[1] BIS Research. (2016). Global 3D Printing Materials Market – Analysis and Forecast 2016-2022 (No. MC00394SA). https://bisresearch.com/industry-report/global-3dp-materials-market-report-forecast.html
[2] BIS Research. (2016). Global 3D Printing Healthcare Market Estimation And Forecast 2016–2022 (No. MC00358SA). https://bisresearch.com/industry-report/3d-printing-healthcare-market-research-report-forecast-605.html
[3] U.S Food and Drugs Administration FDA. (2017, April 12). FDA’s Role in 3D Printing. 3d-Printing-Medical-Devices-Fdas-Role-3d-Printing. https://www.fda.gov/medical-devices/3d-printing-medical-devices/medical-applications-3d-printing