3D Printing in Healthcare: Applications, Benefits, and Challenges

Posted on 21-May-2024


1. Introduction

The phrase "medicine and healthcare" refers to a broad range of procedures and practices pertaining to the diagnosis, treatment, cure, and relief of abnormal states or illness symptoms. It also covers the exploration or analysis of physical and mental health.

The term "healthcare" refers to not only the activities and services involved in preserving or enhancing people's health, but also the entire system of support for the medical professionals who provide that care, including therapists and pharmacists, as well as the engineers who create and produce the goods utilized in the healthcare sector.

In contrast with traditional methods, 3D printing is a manufacturing technique that uses an additive process to create three-dimensional products. Using materials like polymers, metals, and ceramics, 3D printing creates objects layer by layer as an alternative to sculpting raw materials through subtractive operations like grinding, cutting, or machining. These products are created using digital data, frequently using computer-aided design (CAD) or magnetic resonance imaging (MRI) designs, providing flexibility for adjustments as needed.

In the medical field, 3D printing is frequently utilized to produce elaborate scaffolds that closely resemble the structure of actual tissues or organs. Tissue regeneration is aided by these scaffolds because they give cells a surface to attach to and grow on. For some products, 3D printing may not always be faster than conventional manufacturing methods, although it can speed up the production of several medical components and equipment. An increasing number of products are being made depending on the anatomy unique to each patient; they can be found through both large-scale manufacturers and point-of-care 3D printing facilities in medical settings.
 

1.1 Uses of 3D Printing in Medical Industry

By making it possible to create intricate and customized medical solutions, 3D printing is revolutionizing the medical companies. One of its main applications is in the creation of prosthetics and implants that are customized for each patient, fitting their particular anatomy to improve comfort and functionality. All things considered, 3D printing in the medical field improves patient outcomes, lowers surgical risks, and speeds up the creation of medical devices, leading to important breakthroughs in healthcare.

Figure 1.   Flowchart for uses of 3D Printing in Medical Industry


Source: Secondary sources & Pragma Market Research Analysis


Patient specific surgical models - Anatomical models that are 3D printed using patient scan data are becoming increasingly helpful tools in the personalized, precision medicine of today. Visual and tactile reference models can improve understanding and interaction among OR teams as well as with patients, especially as cases get more complex and operating room efficiency becomes more crucial for routine situations. With 3D printing, creating patient-specific, tactile reference models from CT and MRI scans is simple and reasonably priced.

Figure 2.   Demonstration of Patient specific surgical models


Custom medical devices- Rapid prototyping is now almost synonymous with 3D printing. In-house 3D printing has changed product development due to its low cost and ease of usage. Numerous medical tool makers have embraced this technology to create innovative surgical instruments and medical gadgets. More than 90% of the top 50 medical device companies both directly 3D prints medical devices and utilize 3D printing to produce precise prototypes, fixtures, and jigs to make testing easier.

1.2 Medical 3D Printing Technologies

The medical industry has undergone a revolution owing to 3D printing technologies, sometimes referred to as additive manufacturing, which have made it possible to create intricate, patient-specific implants, prosthetics, medical devices, tissues, and even organs. By layering objects together from digital models, these technologies enable quick prototyping and accurate customization.

In the field of medical 3D printing, the most widely utilized technologies are direct metal laser sintering (DMLS) and selective laser melting (SLM) for metal parts, and stereolithography (SLA), selective laser sintering (SLS), and fused deposition modeling (FDM) for plastic parts.
 

There are several types of 3D printing technologies:

• Stereolithography (SLA)

Using a technique known as photopolymerization, SLA 3D printers cure liquid resin into rigid plastic using a laser. In light of its great resolution, accuracy, and material diversity, SLA is one of the most widely used procedures in the medical field. Among all plastic 3D printing processes, SLA parts feature the highest resolution and accuracy, the clearest details, and the smoothest surface finish. However, SLA's adaptability is its primary advantage. In order to match the attributes of conventional, engineering, and industrial thermoplastics, SLA resin formulas provide a broad variety of optical, mechanical, and thermal capabilities.

• Selective Laser Sintering (SLS)

SLS 3D printers fuse tiny powdered polymer particles together using a powerful laser. Complex mechanical parts can be printed using SLS since the unfused powder supports the part during the process and does not require additional support structures. Typically used in industrial settings, SLS is the most popular polymer additive manufacturing method due to its exceptional mechanical part-making capabilities. SLS components can also be sterilizable and biocompatible, depending on the material, which makes them perfect for wearables, orthotics, medical equipment, prototypes, and surgical guides.

• Fused Deposition Modeling (FDM)

Fused Filament Manufacturing (FFM) is a 3D printing process that creates objects by melting and extruding thermoplastic filament, which is deposited layer by layer in the build area by a printer nozzle. Due in large part to the rise of enthusiast 3D printers, FDM is the most popular type of 3D printing among consumers. Professionals, however, also like using industrial FDM printers. Several common thermoplastics, including ABS, PLA, and their blends, are compatible with FDM technology. As a result, materials and entry costs are minimal. Simple proof-of-concept models and inexpensive prototyping of simpler pieces are best suited for FDM. Additionally, some FDM materials are biocompatible.

• Direct Metal Laser Sintering (DMLS) and Selective Laser Menting (SLM)

Similar to SLS printers, direct metal laser sintering (DMLS) and selective laser melting (SLM) 3D printers fuse metal powder particles together layer by layer by utilizing a laser rather than polymers. Strong, precise, and intricate metal items can be produced with DMLS and SLM 3D printers, which makes this method perfect for a range of medical applications.

The primary benefit of these methods is undoubtedly the materials, as metal components and high-performing end-use medical equipment may be produced by DMLS and SLM 3D printers. The final products are robust, long-lasting, and biocompatible, and these technologies are capable of reproducing complex shapes. They can be utilized to make dentures, personalized implants for trauma or cancer therapy, hip, knee, and spine implants, as well as orthopaedic and medical technology products.

Source: Formlabs and Pragma Market Research Analysis
 

2. Applications of 3D printing in healthcare

In the medical field, 3D printing has completely changed the process of making implants and prostheses that are customized for each patient, greatly enhancing fit, comfort, and functionality. To improve surgical accuracy and lower risks, surgeons use 3D-printed anatomical models for accurate preoperative planning and simulation. 3D printing is used in dentistry to create individualized crowns, bridges, and orthodontic appliances for each patient. Bioprinting holds great significance in regenerative medicine as it facilitates the manufacture of tissues and organs, which could potentially address the organ shortage and advance transplant therapy.  

Moreover, 3D printing makes it easier to create customized medications and drug delivery systems, allowing for specialized therapies that are catered to the needs of individual patients. Custom medical gadgets, such hearing aids and surgical instruments, improve patient care and surgical precision, while educational models made by 3D printing offer highly accurate representations of human anatomy for medical education.

Some of the applications are:

• Surgical planning:
Surgical planning is one of the emerging potential uses for 3D printing. This involves leveraging the understanding gained by researching the anatomy and physiology of deviations in anatomical specimens like the spinal cord or pelvis, as well as complex organs like the brain or heart, to plan surgeries. Before performing surgery, surgeons can use 3D models to evaluate the damaged organs, test out different strategies, and gain practical expertise. This procedure drastically reduces the length of the operation and, in the end, yields better results for the patients, surgeons, and healthcare providers.

Medical education and training:
The use of cadaveric materials in the education of new medical doctors has generated debate. This is brought on by both the expense of the procedures and ethical concerns. In many circumstances, including those where using a cadaver is not an option, 3D printing technology may offer an innovative and effective substitute by accurately replicating complicated anatomical organs using high resolution CT imaging. Furthermore, training facilities benefit greatly from 3D printing's capacity to create multiple replicas of any anatomical subject in various sizes.

Organ printing:
Human organ and tissue structures are already produced by 3D printing for research purposes. These can be combined with biocompatible microfluidics to build extremely intricate structures that replicate the capabilities of real human organs. The next stage is printing organs in the operating room that can be implanted into human donors or even printed organs within the body itself. Despite being less developed than some of the other technologies, this one has the power to completely change medicine and render existing artificial organs and organ transplants unnecessary.

Drug delivery:
A shift in drug distribution is inevitable as 3D printing becomes a crucial component of pharmaceuticals. Medications can be printed with numerous immediate release and sustained release layers, allowing the dosage profile to be adjusted, in addition to specific doses for each individual. In addition to allowing for individualized care, this may aid patients who are taking a lot of medication by lowering the quantity of tablets they need to consume. Additionally, there is work being done on 3D printed medication delivery systems that precisely match a patient's anatomy.

 

3. Benefits & Challenges of 3D printing

Personalized medical devices production is one of the main advantages of 3D printing in the medical field. This implies that equipment can be customized to fit a patient's body exactly, increasing treatment success rates and improving user comfort. Lastly, models for surgical planning can be made via 3D printing. Surgeons may find this useful in planning intricate surgeries and in practicing techniques before executing them on patients. Lastly, models for surgical planning can be made via 3D printing. Surgeons may find this useful in planning intricate surgeries and in practicing techniques before executing them on patients.

Some of the benefits of 3D printing in medical industry are as follows:

Complex operations:
Future medical professionals benefit greatly from 3D printing as it helps with training and operation preparation. While 2D graphics are helpful, they don't accurately depict human parts and offer limited vision. Conversely, 3D printing produces models that resemble real human parts and appear realistic. As a result, the operational procedure is more precise and efficient.

Advance Technology:
 Trainee physicians can work with organs that have been 3D printed. When compared to training on animal organs, for instance, this is far more accurate. The quality of skills doctors learn throughout training and patient care is improved by practicing on human-like, 3D printed parts.

Intricate care:
Low-cost prosthetics are produced by 3D printers in places where people need them, such as war-torn nations. For those who cannot afford to purchase a prosthetic, they offer an economical alternative. In distant locations and countries racked by poverty, inexpensive medical equipment is especially crucial. In certain places, the quality of the road system makes it impossible to transport medical supplies. The required equipment may be printed more easily in those villages thanks to 3D printing, eliminating the need for frequent transportation.

• Expensive procedures and long waiting times:
It is possible to 3D print lab and medical supplies using 3D printing. It is feasible to 3D print the equipment's plastic components. By doing this, costs and waiting times for new medical devices from outside vendors are significantly decreased. Additionally, it is simpler to manufacture and apply in other ways. This increases equipment accessibility and makes it easier for low-income or difficult-to-reach places to obtain 3D printed medical supplies.

• Customization:
The old method of creating prosthetics is quite costly because each one needs to be customized for the user. Users can choose from a variety of prosthetic designs, shapes, sizes, and colors because of 3D printers. Each product that is 3D printed becomes unique as a result. Prosthetics are become more affordable and readily accessible since the advent of 3D printers.

One of the industries where 3D printing holds the greatest promise is healthcare. With this technology, prosthetics, implants, and personalized medical devices may be made, and human tissue can be fabricated for transplantation.
 

Some of the challenges are mentioned below:

• Diseconomy of scale:
In many places, 3D printing technologies are still in their infancy. When it comes to delivery speed, subtractive manufacturing techniques continue to outperform additive manufacturing technology. Making patient-specific solutions requires more time and money in a hospital or clinic. Apart from creating personalized anatomical structures, engineers require time for post-processing tasks. Therefore, 3D printed medical devices are frequently seen too costly by patients. In order to make 3D-printed medical devices widely available, healthcare organizations need to concentrate on attaining economies of scale.

Difficulty to mimic:
One of the most important applications of 3D printing technology in the medical field is bioprinting. Sophisticated medical 3D printers are used by numerous clinics and hospitals to create biomedical components for patients by combining growth factors, biomaterials, and cells. Yet, the degree to which printed biomedical components resemble real organs will determine how well bioprinting initiatives turn out. A lot of researchers are complaining that the spray nozzles on medical 3D printers are too large. By modifying the amount of bioink used, the broader spray nozzles affect the precision and effectiveness of printed biomedical parts. Additionally, they find it difficult to precisely combine synthetic and natural polymers to form bioinks.

Dimensional accuracy:
Dimensional precision is a differentiator for both 3D printing materials and machines. For example, SLS 3D printing technology produces products with more resolution, accuracy, and precision than FDM 3D printing. In a similar vein, technicians create objects with precise dimensions by substituting SLA material for flexible resin. When producing biomedical parts and medical devices using 3D printing, specialists must guarantee perfect dimensional accuracy. Apart from creating precise illustrations, they also need to oversee and improve the whole 3D printing procedure. Therefore, in order to guarantee the dimensional accuracy of 3D-printed biomedical items, the appropriate combination of 3D printing equipment, materials, and support structures must be used.

Lack of regulation and standardization:
One of the main issues with 3D printing in healthcare is that there are not any widely recognized standards or laws. Medical facilities that want to transition from subtractive to additive manufacturing can select from a large range of 3D printing supplies and equipment. However, none of the 3D printers for medical use have received approval from regulatory bodies such as the Food and Drug Administration (FDA). Furthermore, there are no legal restrictions on the features and layout of medical 3D printers. The legal dangers that healthcare companies face is increased by the absence of laws and uniformity.

 

4. Overview

Healthcare 3D printing has become a ground-breaking technology with a wide range of uses and advantages. Its most recent developments span a wide spectrum of medical specialties, from novel medications to customized implants. The use of 3D printing to create patient-specific anatomical models, which helps surgeons with preoperative planning and improves surgical precision, is one of the most important recent advancements. Furthermore, 3D printing has made it easier to create prosthetics and implants that are specifically intended for each patient's unique anatomy, improving quality of life and functional outcomes. Beyond its use in surgery, 3D printing has become more widespread in the pharmaceutical industry, where it is used to create customized dosage forms and drug formulas.

More effective medicines could result from this invention, especially in fields like neurology and oncology where accurate dosing is essential. Furthermore, 3D bioprinting has become a revolutionary method that makes it possible to create living organs and tissues for regenerative medicine and transplantation. This innovative method has the power to transform the transplantation business and solve the organ shortage problem. Ultimately, the use of 3D printing in healthcare is a paradigm change that offers unmatched chances for better patient outcomes, individualized medication, and scientific growth in the field of medicine.
 

4.1 History

The fascinating path of 3D printing in healthcare illustrates the revolutionary potential of technology in the medical field. With its ability to create complex structures layer by layer, additive manufacturing, or 3D printing, first gained popularity in the healthcare industry in the 1980s as an innovative manufacturing process. Its application in the beginning was mostly restricted to the development of anatomical models for surgical planning and instruction. However, as technology developed, so did the uses of it in medicine.

The revolutionary method of 3D printing is expanding quickly and finding application in many different fields. Since 3D printing first appeared in the early 1980s, its history has advanced dramatically. By 2021, we will be able to print nearly anything that our imaginations are capable of making up, and in the context of the coronavirus pandemic, this technology has shown to be both ingenious and essential in the battle against the rapidly spreading virus.

Figure 3.   Historical Map of 3D Printing 

 

4.2 Future Outlook

The transformative potential of 3D printing in the medical field cannot be overstated. The bar for serious medical innovation has been lifted by the increasing accessibility and falling costs of additive manufacturing technology, and it is increasingly clear that 3D printing services will play a significant role in the medical revolution of the years to come. Since 3D printing allows for on-demand manufacturing, medical researchers can utilize it to quickly adapt to changing demands and produce low-volume objects for particular uses.
However, making effective use of 3D printing technology necessitates giving considerable thought to the materials to use, the printing process, and the workflows to implement.
 

5. Market Analysis

5.1. Segmentation

The segmentation for 3D printing in healthcare is given as below:

By Component

  • Systems
  • Materials
  • Polymers
  • Metal alloys
  • Ceramics
  • Others
  • Services

By Technology

  • Droplet deposition
  • Photopolymerization
  • Laser Beam Melting
  • Electronic Beam Melting
  • Laminated Object Manufacturing
  • Others

By Application

  • External wearable devices
  • Hearing aids
  • Dental products
  • Prosthesis & orthotics
  • Implants
  • Surgical implants
  • Orthopaedic implants
  • Others
  • Tissue Engineering

By End User

  • Biotechnology & Pharmaceutical Companies
  • Medical & Surgical centres
  • Others

5.2. Key Players

Carbon, Inc., GE Healthcare, FormLabs, CELLINK, Boson Machines, Organavo Holdings Inc, Anatomics Pty Ltd., Renishaw plc, Stratasys, 3D Systems, Inc., CYFUSE BIOMEDICAL K.K.

 

6. Recent Developments

Some of the developments and advancements of 3D printing are mentioned as below:

• In November 2023, Harvard University and MIT collaborated as a resulted in the creation of bio printed liver tissues that mimic the human liver's functions. These tissues are being used to test the effects of new drugs, potentially reducing the reliance on animal testing and speeding up the drug development process.

•  In May 2023, Open Bionics announced the release of a new line of customizable 3D-printed prosthetic limbs. These prosthetics are designed to be affordable and accessible, providing enhanced mobility and functionality for amputees.

• In February 222, 3D Systems announced that it has entered into an agreement to acquire Kumovis. With this acquisition, 3D Systems will broaden its addressable market for customized healthcare applications by including a distinctive extrusion technique into its already robust polymer printing healthcare portfolio.

 

7. Regulatory Framework

The globally healthcare market has extensive and diverse regulatory criteria for 3D printing; nevertheless, they all place a strong emphasis on quality control, safety, and efficacy. Under the current medical device frameworks in the US, the FDA regulates 3D-printed medical devices by classifying them according to risk and requiring premarket notification (510(k)) or approval (PMA). Implants designed specifically for a patient are examples of custom devices that have to abide by quality system requirements and may require clinical data to be used. Under the Medical Device Regulation (MDR), which likewise requires strict conformity evaluations, risk management, and clinical review, the European Union adheres to comparable regulatory processes.

3D-printed medical equipment in China is regulated by the National Medical Products Administration (NMPA), which also mandates their registration, technical evaluation, and adherence to local regulations. In order to ensure that 3D-printed products meet safety and performance criteria, Japan's Pharmaceuticals and Medical products Agency (PMDA) implements regulations that frequently align with worldwide standards. A concerted effort is being made worldwide to standardize rules, with groups such as ASTM International and the International Organization for Standardization (ISO) creating particular criteria for the 3D printing of medical devices.

 

8. Market Dynamics  

8.1. Opportunities

O1: Advanced research and development by creating precise models

O2: Reduced cost associated with producing custom medical devices and implants

8.2 Challenges

C1: High costs of printer and other equipment

C2: Stringent regulatory laws

 

9. Conclusion

The use of 3D printing has grown in popularity across a number of industries, including medicine. These days, a lot of health researchers are using 3D printing to investigate novel medical technologies and applications.

The healthcare industry has found 3D printing technology to be a useful tool due to its precision and versatility. Its capacity to create individualized, patient-specific solutions, improve surgical results, and encourage creative research keeps pushing the limits of contemporary medicine and opening up new avenues for patient care and medical progress.

More medical professionals are using 3D printing as the cost of high-performance printers decreases. They can use it to rapidly and affordably produce customized devices, create anatomical models that are tailored to each patient, find innovative clinical solutions, and develop new treatments that are tailored to each patient's needs.

By improving accessibility, precision, and personalization of medical treatments, 3D printing's incorporation into the healthcare industry can have revolutionary effects. It improves surgical results, spurs innovation, and finances cutting-edge research, all of which contribute to better patient care and more effective healthcare delivery.

The medical industry has undergone a revolution due to additive manufacturing, also known as 3D printing, which has made it possible to create intricate, highly customized medical solutions that are suited to the demands of each unique patient. Its uses include making exact anatomical models for surgical planning and training, as well as patient-specific implants and prosthetics that provide improved fit, comfort, and functionality.

This technology is essential to dental applications since it makes it possible to quickly fabricate orthodontic devices, crowns, and bridges. Bioprinting is revolutionizing the production of tissues and organs in regenerative medicine, which may help address the organ shortage and revolutionize transplant care. Numerous advantages of 3D printing for healthcare include enhanced patient outcomes through personalization, lower costs associated with producing customized medical devices, and faster innovation because of the technology's capacity for rapid prototyping.

Furthermore, it facilitates the development of precise disease models and the testing of novel treatments, both of which promote medical research. Nevertheless, there are still issues to be resolved, like making sure 3D-printed materials are biocompatible and long-lasting, adhering to strict regulations, and the expensive price of sophisticated 3D printing supplies and equipment. Despite these obstacles, the ongoing development of 3D printing technology is encouraging for the future of personalized medicine and better healthcare in general.


PMR Research.
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