3D Printing in Medicine and Healthcare
3D printing, or additive manufacturing, dates back to the 1980s. Since its invention, it has found uses in a wide range of industries, specifically in the medical and healthcare industry where it has shown great potential. It has found uses in the development of replacement organs, prosthetics, and medical equipment, among other applications.
In this article, we’ll take a closer look at the different uses of additive manufacturing in the medical industry. We’ll discuss the advantages, disadvantages, and challenges associated with this technology in the medical industry, and also touch on FDA regulations concerning the safety of additive manufacturing products used in the medical industry. Lastly, we’ll discuss other current and potential applications for additive manufacturing.
“Medicine and healthcare” is an umbrella term that refers to the procedures and practices related to the prevention, treatment, cure, and relief of abnormal conditions or the symptoms of diseases. It also includes the investigation or study of mental and physical well-being.
The practice of “medicine” is the term that is used to refer to the practice of preventing, diagnosing, and treating illnesses and injuries. It involves a wide range of activities, from prescribing medications and performing surgeries to providing counseling and advice on healthy lifestyle habits.
"Healthcare" includes not only the activities and services related to the maintenance or improvement of people's health, the entire support structure for the professionals delivering that care, such as pharmacists and therapists — and the engineers designing and manufacturing the products used in the healthcare industry.
Today, 3D printing plays a significant role in the medicine and healthcare industry. Here are some specific ways in which it is helping:
- Personalized Prosthetics: 3D printing allows for the creation of customized prosthetics that perfectly match an individual's unique anatomy. Personalized prosthetics aim to provide better comfort and functionality.
- Surgical Planning and Practice: Surgeons can use 3D printed models to practice complex procedures before performing them on a patient. This reduces the risk of errors during surgery and improves outcomes.
- Medical Devices: Medical devices, such as surgical tools and implants, can be produced with 3D printing machines. This allows for greater precision and customization, leading to better outcomes for patients.
- Organ and Tissue Printing: Researchers are working on 3D printing organs, like livers and kidneys, and tissues, potentially creating a new approach to treating diseases and injuries.
- Pharmaceutical Printing: 3D printing can also be used to create customized medication dosages and formulations. It improves patient adherence and reduces side effects. For example, the FDA approved an epilepsy drug (Spritam) which is produced through 3D printers. The drug is printed layer by layer using the powdered drug. This makes the drug easier to dissolve than average pills.
- Medical Education: 3D printing allows for the creation of anatomical models that can be used in medical education to enhance understanding and learning.
3D printers have had an enormous impact on the healthcare industry. The following are ways that additive manufacturing is being used in the medicine and healthcare industry:
- Implants and Prosthetics: Additive manufacturing answers a need for customized medical devices which cannot be met with conventional medical equipment. Dental implants were one of the earliest medically approved applications of 3D technology. Dental implants paved the way for the FDA's (Food and Drug Administration) authorization of 3D technology to create other complex implants. Additive manufacturing is used for 3D-printed braces for teeth, hearing aids, and custom prosthetics. Since 3D printing allows for individualized prosthetics, it improves how the prosthetics fit and function. Some people even 3D printers have had an enormous impact on the healthcare industry.
- Anatomical Models: 3D printing has immense potential in the creation of anatomical replicas. Doctors are increasingly utilizing 3D-printed models, generated from patient scan data, to improve the diagnosis of illnesses, clarify treatment decisions, and even practice surgical interventions in advance of actual procedures. These models provide doctors with a clear understanding of complex patient anatomy that may be difficult to visualize using traditional methods, particularly during minimally invasive procedures. They also aid in the precise sizing of medical devices. Additionally, doctors can use these models to explain upcoming medical procedures to patients and their families, as well as communicate surgical steps to colleagues.
- Medical Equipment and Surgical Tools: Doctors can use 3D printing to produce surgical tools that accurately follow a patient's unique anatomy. Traditionally, surgical tools were made of materials such as aluminum or titanium. With additive manufacturing in healthcare, doctors can now create tools with improved precision, resulting in better postoperative outcomes.
One significant advantage is the ability to rapidly make precise design adjustments to medical equipment and surgical tools based on feedback from surgeons. This allows doctors to test and improve the design of surgical tools before producing the final version. For more information, see our guide on 3D Printing in Prosthetics.
The FDA regulates 3D printing in medicine and healthcare in a similar way to other medical devices. However, the agency doesn’t regulate the 3D printers themselves. Rather, they regulate the medical devices the printers produce and the manufacturing processes involved in creating those products. The FDA's primary aim is to ensure that 3D-printed medical devices and products are safe, effective, and of high quality for patients.
The regulatory review process required depends on the product type, intended usage, and potential risks associated with it. These are classified based on risk level into one of three categories. Low-risk devices fall under Class I, moderate-risk devices under Class II, and high-risk devices under Class III. The classification of a device determines the level of regulatory scrutiny required.
While there is currently no specific FDA guidance for 3D printing in the drug or biologic domain, any products in these domains are still regulated by other existing oversight pathways through the FDA's Center for Drug Evaluation and Research, or the Center for Biologics Evaluation and Research.
Little formal management exists for medical 3D printing outside FDA regulations. Medical boards on the state level may have some form of oversight when patients are at risk from, let’s say, a specific 3D printing provider, but they typically only react to complaints rather than proactively investigate. Thus far, the majority of FDA-reviewed products that have been created through 3D printing have been medical devices like orthopedic implants, with over 100 such products having undergone review. For more information, see our guide on 3D Printing Types.
There are several advantages of 3D printing in the medicine and healthcare industry, including:
- Personalization: Enables the production of patient-specific anatomical models and medical devices that are tailored to an individual's unique needs. This personalization allows for more precise treatment and better outcomes.
- Improved Visualization: Create detailed models of complex anatomical structures that may be difficult to visualize using traditional 2D images. This can aid in the diagnosis of illnesses and the planning of surgical interventions.
- Reduced Surgical Time: Providing surgeons with a 3D-printed model of a patient's anatomy prior to surgery allows them to better plan and rehearse the procedure. This can lead to shorter surgical times, which reduces the risk of complications and improves patient outcomes.
- Increased Efficiency: Streamlines the production of medical devices, prosthetics, and implants. This reduces the time and cost associated with traditional manufacturing methods, while also improving the quality and precision of the final product. However, individualized products may take more time than ‘one-size-fits-all’ items, like surgical equipment, for example; however, 3D printing is still way faster and more cost and production efficient than conventional methods.
- Innovation: Allows for rapid prototyping and testing of new medical devices and treatments, which can accelerate the development of innovative solutions for patients.
While 3D printing has many advantages in the medicine and healthcare industry, there are also some potential disadvantages, including:
- Investment Cost: Investing in a 3D printer can be expensive, as well as the cost of materials, which can be a barrier for some healthcare providers and patients. However, the cost savings in terms of less material waste, energy savings, and time efficiency, do justify its use for some manufacturers.
- Limited Materials: While 3D printing can produce a wide variety of materials, there are limitations to the types of materials that can be used for medical applications.
- Quality Control: Ensuring the quality and consistency of 3D-printed medical products can be challenging, especially when producing complex structures or patient-specific devices. This can raise concerns about the safety and efficacy of these products.
- Regulatory Challenges: The regulatory framework for 3D printing in medicine and healthcare is still evolving. Ensuring compliance with regulatory standards can also be time-consuming and expensive.
- Lack of Standardization: There is a lack of standardization in terms of software, hardware, and materials. This can make it difficult to compare products and ensure consistency in manufacturing and quality control.
There are many other commercial applications of 3D printing beyond medicine and healthcare, including:
- Aerospace: 3D printing is used to produce lightweight, high-strength components for aerospace applications, including rocket engines and satellite parts.
- Automotive: Car manufacturers use 3D printing to produce prototypes, customized parts, and even entire vehicles. Vehicle components can be 3D printed and assembled, this includes engine components, interior design components, etc.
- Architecture: Architects use 3D printing to create scale models of buildings and urban environments, allowing for more accurate and detailed planning.
- Education: 3D printing is used in educational settings to teach students about engineering, design, and manufacturing, and to allow them to create their own designs.
- Jewelry: 3D printing is used to create custom jewelry designs with intricate details and unique shapes.
- Art: 3D printing is used in the creation of sculptures, installations, and other forms of art, allowing artists to experiment with new materials and shapes.
For more information, see our guide on the 10 Applications and Examples of 3D Printing Uses.
The main challenges for FDA oversight of 3D printing in the medical industry are related to the decentralized manufacturing of customized medical products using 3D printing technology. Organizations or individuals who might have limited experience with following FDA regulations can manufacture implantable medical devices or other medical products using 3D printing. When 3D printing is used in centralized facilities by registered manufacturers subject to FDA inspection, oversight responsibility is clear. However, oversight becomes less clear when 3D-printed medical products are manufactured at the point of care.
The FDA is responsible for ensuring that manufacturers comply with good manufacturing practices and that the products they create meet the statutory requirements for safety and effectiveness. The agency needs to adapt regulatory requirements to ensure that 3D-printed medical products are fit for their intended use and safe for patients.
It is also important to note that the actual practice of medicine is primarily overseen by medical boards, rather than the FDA. However, in certain clinical scenarios which use 3D printing, it may not always be easy to distinguish between the product and the practice of medicine.
The safety of 3D printing technology in medicine and healthcare depends on a number of factors, including: the materials used, the design of the product, and the production process. In general, 3D printing technology is considered safe when used appropriately and in accordance with established guidelines and standards. For example, medical devices produced through 3D printing must meet the same safety and efficacy standards as those produced through traditional manufacturing methods. However, there are some potential safety concerns associated with 3D printing in medicine and healthcare. For example, there is a risk of contamination if the printing process is not properly controlled or if the materials used are not sterile. There is also a risk of mechanical failure if the product is not designed and produced correctly.
To address these concerns, regulatory agencies such as the FDA have established guidelines and standards for the design, production, and testing of 3D-printed medical devices. Healthcare providers and manufacturers must follow these guidelines to ensure the safety and efficacy of their products.
Yes, medicine and healthcare greatly benefit from 3D printing technology. The medical industry has been one of the early adopters of 3D printing technology, and the benefits are numerous. The ability to create customized and patient-specific medical devices, prosthetics, implants, and models with 3D printing technology has revolutionized the way healthcare providers approach patient care. This technology has enabled faster production, reduced costs, and improved patient outcomes.
Moreover, 3D printing technology has allowed for greater accuracy in surgical planning and improved medical education. 3D-printed models of patient anatomy can be used to plan surgical procedures, and medical students and residents can learn about anatomy, surgical procedures, and medical devices through the use of 3D-printed models. 3D printing technology has also facilitated the development of new and innovative medical devices and products, and it has allowed for greater accessibility to medical devices and prosthetics, especially in remote or low-income areas.
Yes, 3D-printed artificial limbs can be strong and durable. Their strength depends on several factors such as the materials used, the design of the limb, and the intended use of the limb. With advancements in 3D printing technology and materials, it is now possible to create prosthetics and orthotics that are just as strong and durable as conventionally manufactured ones. For example, 3D-printed prosthetics can be made using materials such as titanium or carbon fiber, which are known for their strength and durability.
No, not all materials used by 3D printers are safe for medical use. However, there are a number of materials that have been approved for use in medical applications. For example, biocompatible materials such as medical-grade titanium and cobalt-chromium alloys are used in the production of implants and other medical devices. There are also biocompatible polymers like polyethylene terephthalate glycol (PETG) and polylactic acid (PLA) that are commonly used in the production of medical devices, prosthetics, and orthotics.
It is important to note that the safety of materials used in 3D printing depends on several factors beyond their chemical composition, such as the intended use of the product, the type of printer, the printing process, and the quality of the materials. Materials that are not properly tested or approved for medical use can potentially cause harm to patients.
This article presented 3D printing in medicine, explained it, and discussed its various applications. To learn more about 3D printing in medicine, contact a Xometry representative.
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