What Is Medical 3D Printing and How Is it Regulated?

What does 3D printing medical technology mean for the future of the pharmaceutical industry?


The popularity of 3D printing has continued to increase as improvements in technology continue to make it more accurate, faster, and more affordable. However, one of the fastest areas of growth is 3D printing in the medical field. It is proving to be a huge growth area, but what’s it all about?


In the following article, we’re going to take a closer look at how 3d printing for medical use works, what its future and potential applications are, and discuss some of the current regulations surrounding 3D printing for medical use.


medical 3d printing process

What Is Medical 3D Printing?


The continued development of 3D printing in the medical field is like an unstoppable force that is inevitably continuing to roll forward. However, we should say that medical 3D printing is just the core component of a process which is known as additive manufacturing. This process involves producing a three-dimensional object from a digital file.


3D printing in the medical industry has been around for a while. You have probably seen people printing novel items at home using their own three-dimensional printers, which they have purchased online.


Currently, there’s a lot of focus on improving this technology. One of the biggest roadblocks of three-dimensional printing is slow speed. Only when the objects are printed faster, the potential of 3D printing in the medical field will be significantly increased. which will potentially lead to higher achievements in the pharmaceuticals industry.


engineers developing new medical 3d printing technology

Engineers at the University of Buffalo have been working on a hydrogen-based technology that could be as much as fifty times faster than conventional 3D printing methods. Engineers hope that this new technology could push us towards 3D-printed human organs and tissues, which would ultimately help to reduce the pressure on the already highly stressed organ donation system.


3D printing medical technology could and will revolutionize drug creation and also the production of printed medical equipment. In addition, 3D printing for medical use could also optimize the supply chain, offer new ways to treat current medical issues, and offer personalized medical services such as customized medicines.


How Does Medical 3D Printing Work?


Medical 3D printing companies apply this innovative technology in numerous ways. One of the most common ones is customizable medications. Hopefully, if the medical 3D printing technology evolves fast enough, society will stop struggling with organ donation shortages in the near future.

3d heart printed

To put the process of three-dimensional printing in simple words: it is the process of creating a 3D object by layering successive layers of raw material on top of each other. There are a variety of different materials which can be used for it. Objects are chosen from different digital files that are typically designed using computer-aided designs or CADs.


3D printing isn’t just limited to medical devices; however, medical and pharmaceutical applications are becoming a large area of focus for many medical 3D printing companies. Some of the devices being produced include orthopedic and cranial implants, dental restorations, external prosthetics, and even surgical instruments.


Not only are medical items such as prosthetics becoming popular, but 3D-printed customizable pharmaceutical drugs are also a massive area of focus right now. This is because 3D printing medical technology goes hand in hand with customizable medication. You can learn more about the impact that breakthroughs in customizable medication are happening on our blog, Individualized and Customized Medicine’s Important Role in the Future of Healthcare.


Point-of-care (PoC) 3D printing manufacturing has jumped forward in leaps and bounds. Rather than medical devices being manufactured by the manufacturer, many hospitals or healthcare organizations are printing medical devices on demand. CAD files are created based on MRI and CT scan images and sent to the central production area, and customized devices are created using 3D printing technology.


Over the next five years, many experts have estimated that the 3D medical devices and medical 3D printing industry is expected to increase as much as 22.5%. This increase is primarily due to the popularity of customizable implants and devices and advancements in 3D printing technology, which will make it faster, cheaper, and more accurate, as well as research and development into exciting new applications.


The Top Applications for Medical 3D Printing


Medical and pharmaceutical companies all around the world come up with numerous ways to use three-dimensional printing technology. Let's see what the most popular applications of this technology are.


1. Surgical Planning and Training


Imagine that before going into surgery, your surgeon can practice the surgery they’re going to undertake on an exact physical replica of your body or organ. Using CAD files created from your MRI or CT scans, surgeons can now print exact replicas of your heart, lungs, kidneys, or even your brain. They can then carefully plan out each step of the surgery they’re going to undertake.


This will result in more accurate surgeries, less time spent in the operating room, faster recovery, and lower costs.


2. Manufacturing and Design of Medical Devices and Surgical Instruments



medical 3d printing: surgical appliances

Already being used widely in the healthcare industry, 3D-printed surgical instruments such as medical clamps, forceps, retractors, knife handles, and needle drivers are extremely popular. They don’t face as much regulation as human organs or other devices, which makes them easy and fast to print in the medical industry. It also allows surgeons to customize devices for specific operations and patients.


3. Prostheses, Implants, and Molds


While there is a wide variety of different prostheses available, getting customized sizes is extremely expensive and can also be time-consuming. This is a particular problem facing younger patients as their bodies are still growing and developing, and it means that they need constant resizing and adjustment.


3D printing allows companies to produce 100% customized devices quickly and cheaply. Not only that, but customized prostheses are fitted better, offer greater performance, and have a longer life span.


4. Wide Variety of Dental Applications


If you have ever had to have any sort of dental work done, you’re probably familiar with the process of getting manual molds done on your teeth, mouth, or jaw. These molds are then sent away to have the dental application produced. Often, they then need to be fitted and adjusted before the final product is complete, with the patient undertaking multiple fittings to get the product correct.


Many people in the dental industry are now utilizing 3D printing technology to produce dental implants directly from scans and x-rays of the patient’s mouth or teeth.


5. 3D Printing of Biomaterials


Tissue engineers from around the world have been working on the process of 3D printing blood arteries, heart valves, bones, human ears, noses, synthetic organs, and even synthetic skin. Although we’re not seeing all of these applications used in a practical sense yet, the future of 3D-printed organs is very near, and we’ll most likely see them being used in practical applications within the decade.


According to OrganDonor.gov, there are approximately 106,000 men, women, and children waiting on the transplant list. Unfortunately, 17 people in the United States die every day waiting for an organ transplant. 3D printing of biomaterials such as organs would take immense pressure off the organ donor list and potentially save thousands of lives.


6. 3D Printing of Customizable Medications and Drugs


Suppose you have ever had to take a medication which helps one issue while exasperating another or triggers adverse side effects. In that case, customizable medication should be at the top of your list of exciting new products. Imagine being able to take a customized medication that delivers the results required but that doesn’t come with negative side effects.

medical 3d printing: drugs pills tablets

3D Printing Medical Technology makes it possible to customize medications to suit a preferred delivery method and a specific situation and potentially eliminate some adverse side effects for specific groups of patients. We have come a long way over the last century, but the approach of ‘one size fits all’ we currently have with medications is very outdated. Fortunately, companies such as Laxxon Medical are working tirelessly to produce customized pharmaceuticals, and thanks to 3D printing, these medications are much closer than you think!


What Are the Regulations on 3D Printed Medical Devices, Pharmaceuticals, and Biomaterials?


As 3D printing medical technology improves and it becomes a more affordable and reliable alternative to traditional manufacturing methods, we’re seeing more and more medical 3D devices becoming available. However, that doesn’t mean that anyone with a 3D printer can start making and selling medical devices.


Globally, there are various ways that 3D printing in the medical industry is regulated. For example, in the United States of America, the FDA currently regulates the medical products produced using 3D printing but doesn’t regulate the 3D printers themselves. How products are regulated depends on the type of product being produced, its intended use, and the risk that it poses to the patient.


3D-printed medical products in the US are regulated as follows:

  1. Medical devices are regulated by the FDA Center for Devices and Radiological Health (CDRH).

  2. Biologics are regulated by the FDA Center for Biologics Evaluation and Research (CBER).

  3. Drugs and pharmaceuticals are regulated by the FDA Center for Drug Evaluation and Research (CDER).

Below we’ll take a closer look at each of these different areas.


3D Printed Medical Devices


Medical devices are currently the most common type of product made using 3D printing technology. Therefore, the FDA expects that all devices will adhere to current good manufacturing practices and that finished devices will meet all quality specifications.

The CDRH requires all 3D-printed medical devices to be classified based on their risk levels and regulatory controls to deliver reasonable assurances of effectiveness and safety. The higher the risk to the patient, the higher the level of scrutiny on the device. These devices are classified into three different regulatory categories:

  • Class I Devices (Low Risk) – This would include products such as bandages and handheld surgical instruments. Provided they comply with manufacturing and quality control standards, most of these devices are exempt from FDA review.

  • Class II Devices (Moderate Risk) – Items, including infusion pumps, fall into the Class II category. Some devices in the Class II category are exempt from FDA review. Still, most of them are under a 510(k) review, which compares them against a device already available on the market, reducing the amount of clinical research and evaluation required.

  • Class III Devices (Moderate to High Risk) – Any products which are considered life-supporting or life-sustaining fall under this category. A good example of a Class III device is a pacemaker. The FDA rigorously tests and evaluates any Class III devices to ensure that they are safe and effective for their intended use before they are made available.


3D Printed Drugs and Pharmaceuticals


Currently, there isn’t any specific FDA guidance on this category of 3D-printed products. However, CDER’s Office of Pharmaceutical Quality is conducting extensive research to better understand the role of 3D printing in new and existing drugs. The CDER has also worked with pharmaceutical companies to test 3D printing technology.


3D Printed Biologics


The CBER is interacting with all stakeholders currently researching 3D printing of biological materials, including human tissue, to better understand the challenges faced. The FDA is also currently reviewing all of the issues associated with 3D bioprinting to evaluate the necessity of additional guidance on the subject.


Conclusion


As you can see, the world of medical 3D printing is fascinating and holds a lot of potential for future applications in the medical industry. As the technology and machines responsible for 3D printing improve, we’re going to see more and more 3D-printed medical products entering the market.


3D printing in the medical field is moving forward in leaps and bounds, and as technology improves, so does the number of different ways that we can utilize 3D printing in the medical industry.


If you have any questions about three-dimensional printing and how it applies in the medical industry or would like to learn more about 3D-printed pharmaceuticals, please don’t hesitate to reach out or comment below.

 

Laxxon Medical is dedicated to engineering patented 3D pharmaceutical solutions which optimize products and benefit patients. Our goal is to bring medical 3D printing to a whole new level and establish SPID®-Technology as a manufacturing process that has the individual and the pharmaceutical partner in mind.



To keep up to date with the latest 3D printing and SPID®-Technology news and announcements, follow us on Twitter and LinkedIn.



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