3D Printing Medical Devices

3D printing is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete. Objects are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or a Magnetic Resonance Image (MRI). In the healthcare industry, the 3D printing process is used in a wide range of applications, such as producing dental crowns and bridges; developing prototypes; and manufacturing surgical guides, implants, and hearing aid devices.

The Best 3D printing medical devices market covers a number of 3D printing technologies, products (3D printers, materials, and software), and associated services, which are used for the manufacturing of three-dimensional solid objects from a digital file.

Best 3D Printing Medical Devices 2021

1. Concept Laser
2. 3D SYSTEMS
3. Stratasys 3D
4. EOS 3D
5. Arcam
6. Materialise Medical
7. SLM SOLUTIONS
8. EnvisionTEC
9. HP Multi Jet Fusion
10. RENISHAW

Market Overview

The Best 3D printing medical devices market is primarily driven by factors such as technological advancements, increasing public-private funding, easy development of customized medical products, and growing applications in the healthcare industry. On the other hand, factors such as the stringent regulatory process and the dearth of trained professionals are expected to limit market growth to a certain extent.

However, direct digital manufacturing, the reconfiguration of supply chain models of medical device manufacturers, the expiry of key patents in the coming years, and the growing demand for organ transplant are expected to provide growth opportunities for players in the market.

The applications of 3D printing technology in medicine are expanding rapidly and are expected to revolutionize healthcare. This is attributed to the continuous development of advanced 3D printers, materials, and software platforms, which offer myriads of benefits to the healthcare industry. The medical applications of 3D printing provide several benefits such as customization of medical products, drugs, and equipment; increased productivity; cost-effectiveness; and democratization of design & manufacturing. This is resulting in the increasing adoption rate of 3D printing in various medical procedures, including orthopaedic and dental implants, surgeries, prosthetic operations, and producing organs for transplantation.

The competitive leadership mapping showcased provides information for the best 3D printing medical devices. The vendors are evaluated on two different parameters: Product Offerings and Business Strategy.

This category of best 3D printing medical devices includes 3D Systems, Concept Laser, Stratasys 3D, EOS 3D, Arcam, SLM Solutions, and Materialise Medical.

This category of 3D printing medical devices includes Carbon Solutions, Renishaw, Prodways 3D, and GPI Prototype.

This category of Best 3D printing medical devices includes EnvisionTEC, HP Milti Jet Fusion, 3T RPD, FormLabs, Anatomiz3D, Organovo, and Ultimaker.

This category of 3D printing medical devices includes Tiertime 3D, Orchestrate3D, T&R BioFab, Anatomics, LIMA, PVA Med, and Biomodel.

DRIVERS

Hi-tech innovations in 3D Printing Medical Devices

To meet the rising demand for Best 3D printing medical devices in the healthcare industry, various companies are increasingly concentrating on developing new 3D-printed products and technologies. Since conventional manufacturing processes are time-consuming and costly, major corporations are working to develop new products and technologies that are both inexpensive and effective.In the past few years, major technological advancements have taken place in the field of 3D printing for several medical applications.

Additionally, training modules such as spine surgical models, hip diagnostic, and advanced knee modules are also being developed by 3D Systems to assist surgeons during surgical procedures. The increasing number of technologically advanced products launched in the market have streamlined treatments and enabled surgeons/physicians to deliver care with extreme accuracy and efficiency.

Growing applications of 3D printing medical devices in the healthcare industry

3D printing techniques have empowered medical practitioners, researchers, and medical device manufacturers due to their use in dental & orthodontic treatments, orthopedic implants, tissue engineering, and drug development. Best 3D printing medical devices is also adopted by market players for the development of customized drugs and personalized medicines. The pharmaceutical industry makes use of this technique for drug testing, clinical trials, and toxicity testing, thereby reducing the cost of animal testing.

Among all the healthcare applications, 3D printing is highly successful in dental practices, prosthetics, and hearing aids, as this technology is not only cost-effective but also provides a high degree of customization as per individual needs. The increasing adoption of 3D printing by dental laboratories is a major factor contributing to the growth of this market. Dental laboratories make use of 3D printing medical devices to increase the efficiency and precision of medical devices. It streamlines digital workflows and reduces the time by increasing the speed of information flow between a dental laboratory and the dentist.

Increasing advancements in materials research have made 3D printing more biocompatible and certified for use. E-shell 600 (trade name: Clear Guide) is one such example, which is used with the EnvisionTEC Perfactory series of 3D printers. This material is certified by the United States Pharmacopoeia (USP) Class VI testing for producing drill guides on mini desktop 3D printers. Dental temporaries is another application area of biocompatible 3D printing materials, which makes use of temporary crowns to preserve the gum architecture and enhance aesthetics.

Surgeons have also started using Best 3D printing medical devices in maxillofacial surgeries, implants, and organ transplants. In January 2016, surgeons at the Guy's and St Thomas' NHS Foundation Trust (U.K.) used 3D printing for supporting the successful transplantation of an adult kidney into a child. Likewise, in June 2016, a surgeon from London made use of 3D-printed bone models for surgical planning. The surgeon imported files into the software and made final files for the 3D printer. In June 2015, an Australian maxillofacial surgeon collaborated with the Melbourne University and 3D printing company, 3D Medical Limited (Australia), to implant a 3D-printed titanium prosthetic jaw in a patient. Through this implant, the surgeon included the missing left condyle into the prostheses, which connected the jaw bone to the skull.

Best 3D printing medical devices is used in orthopedic implants and orthopedic surgeries, which enables surgeons, doctors, and researchers to design and test methods before surgery begins. Orthopedic surgery presents challenges with extensive primary injuries with multiple bone fragmentation. Radiographs do not provide adequate information, and thus 3D printing plays a crucial role during surgical procedures. These models are used for gaining corrective osteotomies and improve detail planning in surgical procedures.

RESTRAINTS

Strict governing procedure for the authorization of 3D printing medical devices

Strict governing procedures are a key element controlling the growth of the Best 3D printing medical devices market. In the U.S., it takes around 3 to 7 years to prove the medical safety of any new device. As per law, even a new size of a previously approved device needs to go through the entire process before commercialization. If a customized product/device is manufactured, the company has to go through a long process in which every single part of the device has to be tested and approved individually. Simple 3D printed devices are approved by the FDA, but complex devices that must meet a large number of FDA specifications are a barrier to widespread adoption of 3D-printed products. In addition, state regulatory standards and production regulations obstruct the distribution of 3D-printed medicines.

Direct digital manufacturing is mainly used for developing customized products and enables users to solve high-value designs and complex engineered products. In January 2017, Materialise NV (Belgium) collaborated with Siemens AG (Germany), with the aim to streamline and simplify the design of 3D printing. Through this agreement, the companies aim to integrate Materialise’s 3D printing solutions with Siemen’s digital solutions. Likewise, in August 2016, Optomec Inc (U.S.) announced its new 3D printing technique, namely, Aerosol Jet Technology, which enables 3D polymers and composite structures at the micron scale. This direct digital method optimizes the fabrication process and reduces the manufacturing time as well as material usage. In 2015, the Information Technology Laboratory (ITL, U.S.) released a healthcare testing tool, namely, CrossEnterprise Document Sharing (XDS) standard, which facilitates document sharing meta data in healthcare. XDS standard facilitates registration, distribution, and access to patient electronic health records.

Reconfiguration of supply chain models of medical device manufacturers

3D printing offers new growth opportunities for medical device manufacturers. The market has the potential to change manufacturing and supply chain management, which is evident through its significant growth. The focus of Best 3D printing medical devices is now shifting from design and prototyping to direct manufacturing of functional parts. 3D printing provides several advantages, such as rapid prototyping and short production runs, mainly due to the higher tooling costs involved in traditional manufacturing. 3D printing helps in eliminating the tooling cost, which is involved in the traditional manufacturing process. Although traditional manufacturing costs less per unit produced, it has high upfront costs for tooling, and the production is more expensive for low-volume manufacturing. 3D printing also helps reduce the waste produced during the manufacturing process by building a part using a layer-on-layer process. Mass customization is another area where 3D printing has an advantage over conventional manufacturing, particularly for short production runs. 3D printing technologies do not have huge infrastructural requirements as is the case in conventional manufacturing; thus, these technologies are not bound to economies of scale. This means that the cost of few custom medical devices produced by 3D printing technology will be similar to the cost of manufacturing thousands of medical devices using the same conventional method. The transformation in the supply chain by using 3D printing will give middle-market companies an opportunity to tap this market.

Expiry of key patents in the 3D printing industry

Expiration of patents provides a broad margin for new investors in the 3D printing market. While 3D printing is widespread in the U.S. and Europe, other countries are increasingly focusing on adopting these techniques. Patents protect basic technologies (intellectual properties) of 3D printing products of various companies and expiring patents create an opportunity for small companies to invest in the advanced technologies and innovations which are freely available. The termination of patents leads to reductions in the cost of the technology from thousands of dollars to hundreds of dollars and offers an open-source of technology to customers. For instance, after the patent for Fused Deposition Modeling (FDM) printing expired in 2009, the price of this 3D printing technology dropped from USD 10,000 to USD 1,000 and paved the way for new 3D printing companies like Ultimaker (Netherlands) and MakerBot (U.S.) to develop cost-effective 3D printing devices.

Thus, as the cost of consumer-grade 3D printers reduces to a great extent after the expiration of a patent, it increases the adoption of these printers in the market. It also enables start-up companies to introduce products with improved quality and in larger sizes. The 3D printing industry has been witnessing continuous expiry of some of its key patents; this is expected to offer the high-growth potential for new investors in the market.

Growing demand for organ transplant

3D printing is a layer-building process which has a great potential in the medical field and allows medical professionals to replace broken bones and develop new organs for organ transplant. It enables the printing of prosthetic limbs, which can be replaced with missing or lost limbs. Traditional organ transplant involves the process of replacing a failing or damaged organ in the human body with a new organ. This process involves the risk of rejection as the human body does not accept organs, which are recognized as foreign by the body’s immune system. Organ supply is insufficient across the globe, and the waiting list for transplants is growing each day.

CHALLENGES

Socio-ethical concerns related to the use of 3D printed products

3D printing is used for the development of products for a wide range of medical applications. It is used on a large scale in developing tissues and organs, with the aim to cater to the growing demand for organ transplantation across the globe. Living cells and biomaterials are used in the 3D printing process for the development of human organs. However, the use of 3D-printed products (developed using living cells) inside the human body leads to biosafety concerns. Moreover, the use of Best 3D printing medical devices can also violate human dignity as most religions do not accept defiling of the human body. Additionally, the source of biomaterials used for developing these 3D-printed products and concerns related to waste elimination are two other major factors hindering the adoption of 3D printing among individuals.

Living cells such as stem cells are also being used for manufacturing organs and tissues using 3D printers. Several ethical issues are raised related to the use of stem cells in the 3D printing process as some stem cells are derived by destroying the human embryo. Some individuals view the human embryo as a potential life and destroying it is considered as a wrong act, even if it can save one human life.

Thus, socio-ethical concerns related to the use of 3D printing for developing tissues and organs is a major factor limiting the growth of the 3D printing market across the globe. However, with the growing efforts by government institutions and market players for increasing awareness among individuals will help the users to adopt 3D printing for a number of healthcare applications.

Dearth of trained professionals

With the increasing number of technological advancements and growing research in the field of Best 3D printing medical devices, the demand for skilled professionals to effectively operate these systems is increasing worldwide. Effective use of 3D printing technology requires continuous process monitoring. The consistency of the printing process varies in different machines due to uncontrolled process variables (such as the difference between batches and machines) and material differences. These technologies and processes require trained professionals who can understand and operate 3D printers efficiently.

Furthermore, the most important aspect of the 3D printing service is the skill of spatial object design. Designing a 3D-printed object is more complicated than actually printing the object. Likewise, 3D-printed models have complex geometrical structures, which require multiple technical support for printing. Thus, skilled professionals are required to perform these activities to avoid errors and printing failure. Furthermore, there is no accurate legal landscape to address the concerns of patients injured by medical devices printed by doctors and hospitals who print the device at their own facility.

Process control and understanding

Consistency in the additive manufacturing process is altered between machines due to the uncontrolled process variables and material differences. There are a few monitoring methods that are available to help manufacturers in meeting their specific criteria by rectifying these alterations. As there is limited data available regarding process control, the capacity to develop detailed and accurate mathematical models through additive manufacturing is difficult. These limitations in process control, pre-production, and planning often result in manufacturing failures and expensive errors.

Post-processing procedures play a major role in meeting product specifications. For instance, surface finishing in achieving a specific roughness, heat treatment, achieving dimensional tolerance, and residual stress relieving to promote specific metallurgical conditions is a difficult stage in the development process. The time factor and process control in the removal of built products and disposal of waste materials also play a major role in the 3D printing process. These factors in process control extend the manufacturing process and increase the possibility of process variance, which are major issues for many machines and processes.

3D PRINTING MEDICAL DEVICES MARKET, BY TECHNOLOGY

3D printing technology allows the layer-by-layer building of an object on the basis of available CAD (computer-aided design) data. Additive fabrication involves two basic steps—coating and selective melting. In the coating process, a material is applied over the working surface and the thickness of the layer depends on the type of technology used to manufacture the product. The selective melting step includes the process of printing the part slice with an energy source.

On the basis of technology, the Best 3D printing medical devices market is divided into six segments, namely, electron beam melting (EBM), laser beam melting (LBM), photopolymerization, droplet deposition or extrusion-based technologies, PolyJet technology, and three-dimensional printing (3DP) or adhesion bonding. The laser beam melting segment is expected to grow at the highest CAGR during the forecast period owing to the increasing application of this technology in the dental industry and for manufacturing parts for minimally invasive surgery.

LASER BEAM MELTING

Laser beam melting (LBM) is a rapidly growing 3D printing technology that allows the fabrication of complex, multifunctional metal or alloy parts by the CAD-directed melting of precursor powder beds using a laser as the source of energy. The process is very similar to electron beam melting (EBM) except in LBM, the build process begins after the build chamber reaches an operating temperature of around 100°C (212°F), which is lesser than that required for the EBM technique. One or more laser beam then selectively fuses or melts the particles at the surface in an enclosed chamber. The enclosed chamber is filled with a shielding gas, such as argon, to provide an inert atmosphere for systems to process oxygen-reactive metals like titanium and aluminium.

LBM is the most commonly used technology for the manufacture of metal and plastic parts, such as small-size prosthetics or implants, surgical instruments, and porous scaffolds in tissue engineering. It is the best-suited technology for the production of small parts, such as dental copings and hybrid parts of machines for minimally invasive surgery, due to its high accuracy. LBM is suitable for a wide range of materials available for 3D printing and it does not require post-processing of materials; however, it is not suitable for manufacturing larger medical products. It has some disadvantages over other technologies like EBM, and is found to be less efficient because the laser beams’ energy is reflected by the powder particles and this increases thermal tension, resulting in pores and cracks in the products.

DIRECT METAL LASER SINTERING

Direct metal laser sintering (DMLS) is a rapid 3D printing technology that allows the building of high-precision metal 3D models using the additive fabrication method. It gives fine feature details and is ideal for high-temperature applications, small prototypes, tough functional prototypes, and custom medical and dental parts. This technology was developed by EOS GmbH Electro Optical Systems (Germany).

The DMLS process is used to produce metal components or models, 99.99% dense, directly from available 3D CAD data and requires no post-sintering or other infiltration processes. It is not restrictive in its application and the components produced using this technology can be used as successful replacements for almost any conventionally manufactured part. In the medical sector, it is used for the fast and accurate production of standard and patient-specific implants and surgical instruments. It is also a useful process for the economical manufacturing of small series parts such as dental crowns and bridges.

This technology has certain advantages over other 3D printing technologies. In the medical field, DMLS offers the possibility of manufacturing products with complex features, such as rich metal implants or instruments. The production of 3D printed parts is also economical as tooling is not required; it allows recycling of excess raw materials, and also enables mass customization of products. The biggest strength of this process is that it produces sterile and hygienic products with high levels of surface finishing.

Additionally, in the medical industry, various materials, like stainless steel, titanium, and super alloys like cobalt chrome, are used for developing medical products, as they adhere to medical norms and requirements. The DMLS technology is best suited for developing implants and prosthetics products in medical device industry.

However, there are some limitations associated with this technology, it lacks precision when compared to other technologies and is more time consuming when it comes to surface finishing and post-processing of the product. There is also a certain size limitation of the product in the DMLS process as compared to EBM. Moreover, in the case of solid parts, there are chances of distortion in the product due to residual stress.

SELECTIVE LASER SINTERING

Selective laser sintering (SLS) uses high-power pulsed laser beams (like CO2 lasers) to melt particles, resulting in a fusion of the neighboring particles and the formation of 3D products. In this process, the fusion leads to the formation of sintered bonds among the adjacent particles instead of full melting like SLM.

SLS was first developed and patented by Dr. Carl Deckard at the University of Texas (Austin) and then commercialized by 3D Systems (previously known as the DTM Corporation) in the 1980s. In the past few decades, SLS has evolved as the common option for manufacturing end-user products in different sectors. For the medical segment, it is used for manufacturing instruments parts, functional prototypes, implants, surgical guides, and osteochondral scaffolds.

There are various manufacturing benefits of SLS technologies that are driving its market. Principally, the SLS technique can process a wide range of commercialized materials like polymers (simple and composite), plastics (nylon-based materials), ceramics, and green sand. It has a high productivity rate in comparison to other techniques for the production of customized products. It does not require supporting structures (unlike stereolithography and fused deposition modeling), because it is always covered by a sintered particle. It offers better strength and durability to products than SLA. Additionally, it does not require post-processing or infiltration of products.

However, the disadvantages of SLS include the formation of unwanted powder bonding because of high temperatures, reduced accuracy and resolution as compared to other techniques due to laser spot size, thermal degradation, and reduced strength of materials due to high temperatures.

SELECTIVE LASER MELTING

Selective laser melting (SLM) makes use of 3D CAD data as a digital information source. It also uses a high-powered laser beam as an energy source to develop 3D metal parts by fusing metallic powders. It is a rapid prototyping service that melts powders at high temperatures instead of sintering these powders. This process was initially developed by Fraunhofer Institute ILT (Germany). In March 2016, Noura Imprinting Layers Industries (NILI) (Iran) developed first SLM metal 3D printer for both industrial and research applications for the military, aerospace, and medical sector. In August 2015, a group of researchers from the Surface Technology Group (Germany) developed a highly automated selective laser melting process for producing or coating implants made up of nickel-titanium, stainless steel, or platinum.

In the medical field, it is widely used for the formation of prosthetics and implants; surgical guides; and instruments such as patient-specific hip implants, acetabular cups, series production of dental crowns and superstructures, CMF implants, and orthopedic implants with both hybrid and complex geometries. The most commonly used materials that can be processed are stainless steel, tool steel, cobalt chrome, titanium, and aluminum. The SLM technology is used for manufacturing personalized medicines, which help surgeons to improve minimally invasive surgery procedures and cater to optimal medical care needs.

SLM offers various benefits such as, improved product development cycle, ability to manufacture complex geometrical parts, customized products as per patient requirements, and optimized material usage, among others. However, like other technologies, there are a few limitations associated with it, such as the range of commercially available SLM materials is limited, insufficient surface quality of produced parts, and it is not suitable for mass production of products unlike the EBM technology.

LASERCUSING

LaserCUSING was first developed by Concept Laser GmbH - Hofmann Innovation Group in Lichtenfels (Germany) in 1998. It involves the formation of 3D parts by melting and fusing of materials on the basis of CAD data using a fiber laser. The special feature of LaserCUSING machines is the random navigation of layers progressively. It differs from other LBM techniques in two ways; it uses different types of lasers along with variable scanning strategies, and is used only for single component systems (metals). The metals that can be processed using this technique are high-grade steels, aluminum alloys, nickel-based alloys, titanium alloys, pure titanium, and precious-metal alloys.

The use of the LaserCUSING technique in healthcare is still not widespread; however, with the increasing advances and awareness related to 3D printing, the LaserCUSING technology is being adopted in the production of medical instruments and surgical implants. It is used mainly in the dental industry and for producing surgical implants or tools. Its advantages include high precision and robustness, manufacturing of solid components, and mass manufacturing of small and complex geometries with no tooling. For the dental industry, it fabricates both mound inserts and direct parts (standard or custom) such as dentures or dental prostheses to be used in dental restorations. It is beneficial in the dental industry in terms of quality, reproducibility, and economic affordability. However, this technique is only suitable for small components in short production runs. Moreover, post-processing of end products is required and the range of materials available for LaserCUSING is limited.

PHOTOPOLYMERIZATION

Photopolymerization is light-activated polymerization. It is a type of 3D printing technique in which light is used as a source of energy for the layer-wise manufacturing of products from the available CAD data. The theory behind this technique is that it uses light energy to excite molecules and initiate the polymerization of materials to form the products. This technique processes the bio-photopolymers for the manufacture of various medical products. In the medical industry, it is mainly used for manufacturing of surgical guides, orthopedic, dental, and CMF (craniomaxillofacial) guides, prosthetics and implants, porous scaffolds, and dental restorations.

Photopolymerization is one of the most precise and accurate techniques of medical 3D printing. However, its application is hindered by a limited range of available photopolymeric materials and the high temperatures involved during processing, leading to thermal degradation of materials.

Materialise NV (Belgium), 3D Systems Corporation (U.S.), and EnvisionTEC GmbH (Germany) are some of the key players engaged in offering 3D printing solutions based on the photopolymerization technology.

On the basis of different types of radiant energy used for polymerization, this market is segmented into digital light processing (DLP), stereolithography (SLA), and two-photon polymerization (2PP).

ELECTRON BEAM MELTING

Electron beam melting (EBM) is an additive (layer) manufacturing technology that was developed and commercialized by Arcam AB in Sweden. EBM uses powerful electron beams as an energy source and a metal powder as a raw material for the layer-wise production of dense metal parts. It is carried out in a vacuum condition at highly elevated temperatures. The EBM system consists of an electron optical column for generation, scanning, and focusing of electron beams over a uniformly spread metal powder. The thickness of metal layers in EBM varies from 50 to 100 μm. The layer is preheated to a temperature range of 600°C to 800°C using multiple electron beams at high current, followed by a melt scan. The melt scan runs on the 3D-CAD software model to melt only the required portion for the generation of 3D models.

This technology is generally used for building large-sized metal parts for various medical purposes such as prototypes, surgical tools, orthopedic implants (total hip implants or knee implants or acetabular cups), and others. It is technically similar to the laser sintering techniques but its products are more dense, void-free, and extremely strong.

EBM is a new technology process and has various advantages over other technologies. With a high melting rate, it is suitable for manufacturing oxygen-sensitive metals such as titanium and is free from oxidation issues as it takes place under vacuum. Unlike DMLS, it does not require additional stress or thermal treatment for obtaining the required mechanical properties in the product after fabrication. It can also process a large variety of pre-alloyed metals at a swift rate and with accuracy. EBM is the best suited 3D printing technology for manufacturing big implants that are difficult to produce with the LBM technology. Hence, in the near future, EBM may be the fastest-growing platform for 3D printing due to its higher energy density and scanning method with low operating costs. However, the lack of proper standards regarding the process and materials and the fact that it cannot be used for building porous or cellular structures, such as porous scaffolds, can limit the use of this technology.

DROPLET DEPOSITION OR EXTRUSION-BASED TECHNOLOGIES

Droplet deposition or extrusion-based technologies are a type of 3D printing technique in which the material is selectively dispensed through a nozzle or orifice to build 3D products. In this technique, molten materials are expelled from the fine nozzle or orifice so that they are deposited on the first layer and bonded to the previous layer; this process continues until the formation of the model is complete. The most commonly used droplet deposition technology is fused deposition modeling (FDM). The materials typically used in droplet deposition systems are plastics such as ABS (acrylonitrile butadiene styrene) and polycarbonate. In the medical field, this technique is mainly used for manufacturing of small implants (orthopedic, dental, and CMF) and porous scaffolds in tissue engineering.

The advantages of this technique include a reduction in waste materials, little amount of material trapped inside empty scaffolds, and better resolution and accuracy profile. However, the disadvantages associated with this technology are the limited range of available raw materials that it can function with, thermal degradation of materials due to high temperature, and nozzle size can limit the feature size of products. In addition, for tissue engineering, unlike 2PP, the cells cannot be included inside scaffolds and extra supporting structures are required for overhanging cellular strands.

The droplet deposition technologies market is further divided into three segments, namely, fused deposition modeling (FDM), multiphase jet solidification (MJS), and low-temperature deposition manufacturing (LDM).

FUSED DEPOSITION MODELING (FDM)

Fused deposition modeling (FDM), also known as fused filament fabrication, is the main droplet deposition or extrusion-based technology for 3D printing. It is a rapid prototyping and additive manufacturing technology that builds products in a layer-wise manner using thermoplastics as raw material. The metal or plastic filament brings the materials to the heating orifice or nozzle for melting it to a desirable viscosity. The melted material is then deposited in a layer-wise format on a 3D plane based on a CAD description to form the required product. This technology was developed by S. Scott Crump in the late 1980s. In the 1990s, this technique was patented and commercialized for 3D printers by the company Stratasys.

This technique is used in building functional prototypes, concept models, and end-use parts using engineering-grade, standard, and high-performance thermoplastics. FDM is the only 3D printing technology that makes use of production-grade thermoplastics for manufacturing products. This technology is well suited for applications that require high tolerance, environmental stability, toughness, and biocompatibility. Thermoplastic materials such as acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), wax, and nylon are used in the FDM technology.

In the medical field, it is a widely applied technology due to the availability of a wide range of biocompatible, strong, and sterilizable thermoplastics. It is used for 3D printing of medical models, prosthetics and implants (dental, orthopedic, and CMF), surgical instruments, and porous scaffolds in tissue engineering.

Unlike SLA and SLS, which use resins, FDM provides more durable and stable parts. Due to the use of thermoplastics, it can build strong and accurate parts at a lesser cost than the traditional approaches. However, it requires additional supporting structures for building 3D products and is mainly suitable for the manufacture of small parts.

THREE-DIMENSIONAL PRINTING (3DP) OR ADHESION BONDING OR BINDER JETTING

Three-dimensional printing (3DP) is a type of 3D printing technology that was developed by MIT (Massachusetts Institute of Technology) and Soligen, Inc. (U.S.). This process is technically similar to the SLS process except that instead of using a laser for sintering of metals, 3DP uses an inkjet printing nozzle with a binder (such as silica gel) to deposit the liquid adhesive for binding of materials. Hence, this method is also known as adhesion bonding.

The raw materials used for this process are mainly metal, resins, or ceramic powders. The process starts with the raising and leveling of material powders on the top of a build chamber to form a thin powder bed. The inkjet printing head then deposits a liquid adhesive material to the specific target regions of the powder bed based on available CAD data. The powders get bonded by the adhesive material to form a layer over it; whereas, the unbounded powder materials supports the building of layers. Once the formation of a layer is complete, it is lowered down and the formation of a new layer begins in a similar manner. This process continues until the product is entirely formed.

3DP helps companies manufacture parts in a single production run. In the medical field, it is mainly used for metal and ceramic implants, surgical instruments, dental crowns and bridges, and porous bone scaffolds.

This technique is found to be faster and easier to use than other 3D printing technologies and requires less expensive raw materials for production. However, the available range of material for medical applications is limited. This technique lacks accuracy, part strength, and surface finish as compared to other technologies.

3D PRINTING MEDICAL DEVICES MARKET, BY COMPONENT

On the basis of component, the Best 3D printing medical devices market is segmented into three categories— equipment, materials, and services & software.

EQUIPMENT

Medical products, including medical models, surgical guides, implants, and prosthetic organs, can be printed using 3D printing equipment. Such equipment is further segmented into 3D printers and 3D bioprinters. The development of technologically advanced 3D printing equipment by leading market players for a number of healthcare applications and the rising adoption of 3D printing for manufacturing medical products are the key factors driving the demand for 3D printing equipment in the healthcare industry.

3D PRINTERS

A 3D printer can print a 3D object from a digital model. 3D printing follows a unique process of adding materials in successive layers to create the end product. These printers are used to generate concept models, precision and functional prototypes, master patterns and molds for tooling, and real end-use parts.

3D BIOPRINTERS

These devices are used in bioprinting—the deposition of living cells in combination with biologically relevant substances such as collagen, fibrin, and gelatin. 3D bioprinting starts with the creation of an architectural design, which is based on the fundamental composition of organs or target tissues. This process makes use of living cells, molecules, and biomaterials for the production of complex living and non-living biological products, such as prosthetic limbs, dental fixtures, customized hearing aids, and complex structures like human tissues.

MATERIALS

The availability of a wide variety of materials for 3D printing systems has resulted in a shift in focus from rapid prototyping to 3D printing. Materials used for printing of 3D parts mainly include plastics, metal and metal alloy powders, ceramics, wax, and biomaterials. Metals and plastics are the most widely used raw materials for 3D printing in the medical and dental industries. Materials such as strong and durable plastics are used for 3D printing of surgical instruments. However, implantable metals are used for manufacturing implants such as acetabular cups and knee or hip implants. As of 2017, the global 3D printing materials market is estimated to be worth USD 169.0 million and it is projected to reach USD 369.2 million by 2022, at a CAGR of 16.9% during the forecast period. The continuous development of improved biocompatible, clean, and environmentally friendly materials for additive manufacturing and rising availability of materials are some of the key factors driving the growth of the 3D printing materials market.

SERVICES & SOFTWARE

3D printing starts with the creation of a 3D digital model using 3D software programs such as CAD or scanning software. The 3D model is segmented into layers, leading to the conversion of designs into files that can be read by the 3D printer. 3D printing software is used for creating, designing, and assembling models required in the healthcare space. This software also inspects prototypes to ensure that the required specifications have been met. The file preparation software prepares STL and SLC files to develop the product design.

With the advancement in printing technology and materials, the 3D printing service sector is gaining significant traction as a source of profit as compared to the sale of printers and materials. As 3D printing technology facilitates the easy manufacturing of products with complex geometries and offers competitive pricing compared to traditional manufacturing methods, a number of companies across several industries are expected to outsource every aspect of the process, from design to production, in the future. As a result, the 3D printing services segment is expected to witness significant growth.