What is 3D Printing? How is it Taking the

Healthcare Industry by Storm?

3D printing is an additive manufacturing method in which a digital blueprint is followed to create a 3-dimensional object, layer-by-layer, using materials such as metals, plastics, and ceramics.

While there are 3D printing companies printing these objects on a large-scale basis, on-demand production of medical products is happening at the site of patient care in what is called point-of-care manufacturing. These products are manufactured as per the patient’s physical and personal requirements. They are lighter, stronger, and safer compared to those made using traditional manufacturing methods. Their production requires less time – what used to take weeklong to produce, now takes less than a day. Today, the number of hospitals with in-house 3D printing facilities is steadily increasing. In the U.S., the numbers of hospitals rose from 5754 in 2010 to 6093 in 2020, as per the statistics by the American Hospital Association (AHA) (see Figure 1). Even the FDA has been regularly approving medical products made using 3D printing technology.

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3D Printing Technology

Applications, Trends, & Challenges

Implants and Prosthetics

3D metal printing helps in the production of durable implants with better match and performance for knees, spine, hips, and skulls. Using Electron Beam Melting (EBM), metal is melted layer by layer with the help of an electron beam, thus producing precise implants. These implants mimic the sponginess of regular bone tissue, enabling their assimilation into a bone structure. On the other hand, 3D printed oncology prosthetics are widely used by oncologists to build different human body parts that are no more functional as a result of the effect of cancer. Prostheses are available everywhere in predefined sizes, but to have them customized through traditional means requires thousands of dollars and extended time. This affects children who outgrow their prostheses and need customized replacement parts. In the year 2016, Lyman Connor and Eduardo Salcedo created Lyman’s Mano-matic prosthesis which offers 3D-printed bionic prosthetics to patients who can’t afford the regular prosthetics. They cost less and take less time to manufacture.

Digital Dentistry

In Dentistry, 3D printing is used in the manufacture of dentures, surgical guides, bridge models, and invisible aligners. Earlier, these clear aligners were produced using a combination of manual and milling processes that were cumbersome. The 3D printing technique has sped up the process as customized molds can be manufactured from digital scans of patients.

According to reports, the 3D-printed dental implants industry is set to attain nearly USD 8.8 billion by the end of 2027 with over 450 million dentistry devices and restorations manufactured every year.

Anatomical Models

With the help of 3D printers, specialists can produce exact replicas of parts of the human body using MRI and CT scans, such as 3D printed thumb, enabling surgeons to prepare for complicated surgeries in advance. For instance, in 2016, a kid in Ireland had to be operated on to improve rotation in his forearm. CT scans and X-rays showed bone deformity. But the surgeon decided to print a 3D model of the affected part to further investigate. He found that there was something else that prevented the arm rotation and not the deformed bones, as shown by the scans. Once the real reason was discovered, the operation took less than 30 minutes to complete, instead of 4 hours for the osteotomy, initially planned. The patient was able to gain 90% rotation in his arms in 4 weeks. The recovery time, pain, and scarring reduced considerably.

A 2020 report upheld the use of 3D anatomical models as surgical guides and stated that it reduced the surgical time by more than 60 minutes to 2.5 hours, resulting in savings of around USD 3,500 per surgery.

Medical Devices

A vast majority of the top 50 medical device companies are using 3D printing to generate accurate prototypes of medical devices. This technology is playing a vital role in the rapid deployment of medical equipment, thereby overcoming supply chain issues. Surgical instruments such as scalpel handles, forceps, and clamps are 3D-printed using raw materials like stainless steel, nylon, titanium alloys, or nickel, as per a surgeon’s requirements. These instruments are helping doctors perform better surgeries with greater efficiencies. Endocon GmbH, a German medical device producer, is using a metal 3D printer to create surgical tools for hip cup removal. Previously, this procedure was done using a chisel, which could damage tissue and bones. Endocon’s endoCupcut, a tool made of stainless steel alloy, can cut along the acetabular cup in three minutes with greater accuracy.

In the Fight Against the Covid-19 pandemic

The use of 3D printing for manufacturing different single-use disposable medical equipment was noted to be significantly high. Using 3D printing technology and the use of medical plastics, different products were manufactured for use by healthcare workers as well as patients (see Figure 2). The healthcare 3D printing market grew drastically during the global pandemic as there was intense pressure on medical establishments to roll out personal protective equipment (PPE) and medical devices quickly. A team from Oregon Health & Science University responded to the worldwide shortage of ventilators by developing low-cost ventilators that could be quickly manufactured using 3D-printing technology.

Regenerative Medicine

Around the world, the number of patients requiring organs is escalating, while there is a shortage of donor organs available. Regenerative medicine aims to create organs for transplants using scaffolds, biomaterials, or cells, reducing the dependence on organ donors. In 2019, scientists at Tel Aviv University created the first 3D heart using a patient's biological materials. The tiny replica was the size of a rabbit’s heart. They believe that the same technology can be used to create the larger human hearts. Although many obstacles need to be overcome to 3D bioprint and transplant complex organs such as the heart or liver, organs such as the bladder have been developed and transplanted since the beginning of the 21st century.

Precision Medicine

3D printers at pharmacies and hospitals can enable pharmacists, physicians, and nurses to administer the dose and delivery system of the drugs based on the patient’s weight, age, lifestyle, and gender. Aprecia Pharmaceuticals’ Spritam that treats epilepsy is the first FDA-approved 3D printed drug. Patients with several afflictions have to take multiple medications at different hours of the day, which can make it hard to maintain a schedule. 3D-printed Polypills contain many drug compartments and release profiles and can handle different medication dosage as well as interactions between drugs, eliminating the need for scheduling and close monitoring.

Streamlined R&D, Removing the Need for Animal Testing

The pharmaceutical industry spends over USD 55 billion every year on research and development. With bioprinting, researchers can replicate organs and other parts of the human body to test the efficacy of a drug without having to experiment on an animal or a human body. Bioprinted tissues and organs are being widely used to increase the success rate of clinical trials, reducing the damage caused to animals, while streamlining and speeding up the entire R&D process.

Artificial Intelligence in 3D printing

There is a major overhaul in the way companies are managing manufacturing operations with the integration of AI into 3D printing. From product design and development to its manufacture and utilization, AI technology can optimize the entire supply chain. By automating the printing process, AI can minimize the possibility of human errors.

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Role of FDA in Regulating

3D Printing Technology in Healthcare

The United States Food and Drug Administration (FDA) regulates the products made using 3D printing, and not the 3D printers themselves. The regulatory purview depends on the type of product that is printed by the use of different types of materials (see Figure 3), its use, and its associated safety risks.

3D printing poses oversight challenges because of the decentralized manufacturing of customized products such as 3D printing medical implants by organizations or individuals that may have limited knowledge of FDA regulations. The FDA works hard to ensure that manufacturers abide by ethical manufacturing practices and that the products meet safety standards. But, when 3D printing is done at the point of care, oversight can be challenging.

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Reimbursement Challenges

An FDA-approved 3D-printed spinal implant may be eligible for reimbursement, but the 3D models of a patient’s anatomy printed before the surgery may not be. This lack of reimbursement can be a major hindrance for hospitals planning to set up 3D printing labs.Fortunately, healthcare organizations are striving to change the status quo. The American Medical Association (AMA) recently approved four Category III Current Procedural Terminology (CPT) codes that address reimbursement for 3D-printed anatomical models and personalized 3D-printed cutting or drilling tools.

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The Global Outlook for 3D Printing

Technology in Healthcare

The growth of 3D printing in the healthcare market is expected to be driven by the increasing demand for implants and prosthetics worldwide, and the growing need amongst the healthcare service providers to lower the costs of healthcare services (see Figure 4). With developers creating products on demand, inventory levels will go down dramatically. For instance, U.S. hospitals generate more than 2.2 million tons of medical waste every year. A large proportion of this ‘waste’ is unused medical supplies and equipment. Sometimes these perfectly usable medical products are not even taken out of their packaging before they are replaced by newer models.

Asia Pacific region is making tremendous progress in the 3D printing market. It is projected to spend over USD 3.5 billion on 3D printing in the next couple of years and grow at the highest rate of 18.5%, compared to North America and Europe. Till recently, the region was reluctant to adopt 3D printing fully, but growing interest in the technology from manufacturing companies and the launch of many strategies and policies by the governments have driven several countries within the region to create a favorable habitat for the growth of 3D printing.

China is the leader in 3D printing among Asian countries. Its market was worth USD 1.75 billion in 2018. Apart from China, South Korea seems to be a huge market for 3D printing. There is still a lot of untapped potential for the large-scale adoption and growth of 3D printing in the Asia Pacific region.