Medical Device 3D Printing: Should You Make the Move?

The medical device industry has grown immensely over the past several decades. But with new technological advances being made on a near-daily basis, the pace of growth is poised to extend beyond our wildest dreams.

3D printing of medical devices is a key example of this upward trajectory. From improving surgical tools to the potential of creating artificial organs and tissue, this technology has seemingly unlimited potential. 

Let’s take a look at what you need to know about how medical device 3D printing works, its applications in manufacturing, and how it is regulated in the United States.

FREE eBOOK: Click here to get your free PDF copy of The Ultimate Guide to Quality Assurance and Regulatory Affairs in Medical 3D Printing.

How does 3D printing for medical devices work?

3D printing is a method of creating physical and functional three-dimensional objects via a process called additive manufacturing. 3D printers are able to build devices layer by layer, starting from the bottom up, and can shape, mold, and print parts according to the specifications of a design file such as a computer-aided design (CAD) drawing or a Magnetic Resonance Image (MRI).

3D printing is an extremely flexible and customizable process. It can be done using virtually any raw material, and designers can easily make changes to an object without any need for additional equipment, tools, or setup. 

Naturally, it has caught the attention of the medical device community. The ability to create customized devices opens new doors for product development engineers to print patient-specific devices, such as implants that are anatomically-matched as well as other medical devices with complex internal structures. 

Though 3D printing has not become an industry standard for medical devices, many believe it could very well be the defining technology of device manufacturing. A report on the global state of 3D printed medical devices projects the market to reach $3.5 billion per year by 2026. 

Much of the hype around this trending technology is due to the disruptive nature of 3D printing, as it is a markedly cheaper solution than traditional manufacturing practices. For instance, while a typical kidney transplant operation can reach upwards of $300,000 to make, a 3D printed kidney could potentially lower that cost to under $100,000.

What kind of medical devices use 3D printing?

Thanks to the malleable nature of 3D printing, all kinds of medical devices can benefit from this technology. This means devices can be tailor-made for a patient’s specific physiology, effectively producing tools that are more effective than a mass-produced device. 

 Some areas where medical device 3D printing is applicable are:

• Customized surgical tools

• Patient-fitted prosthetics

• Customized implants

• Anatomical models 

• Fabricated tissue and organ materials

In fact, a 3D-printed implantable device is currently being used in joint replacement surgery by surgeons at Yale Medicine, who have found they speed up recovery and reduce patient pain levels.

Another area of opportunity for medical device 3D printing is “just-in-time” manufacturing of on-demand devices. This became particularly noticeable during the opening stages of the COVID-19 global pandemic. By utilizing the rapid speed of 3D printers, manufacturers were able to produce much-needed medical devices as part of the pandemic response efforts, such as:

• Face masks

• Ventilators

• PPE such as face shields and respirators

• Nasopharyngeal swabs for rapid testing

• Emergency dwellings for isolation wards

• Biomodels for training and visual aids

How is 3D printing for medical devices regulated?

Devices made using 3D printers are subject to the same regulatory requirements as those using traditional manufacturing processes. Because 3D printed medical devices span a wide spectrum of applications, there are requirements that apply to medical devices both before they are placed on the market (premarket requirements), and after they are distributed in the market (postmarket requirements). 

Medical devices that utilize additive manufacturing in some capacity are treated the same, in the eyes of regulators, as those that are entirely made from a 3D printer and are subject to the same medical device classification system requirements from FDA.

In 2016, FDA published a document titled, Technical Considerations for Additive Manufactured Devices. 

Some highlights from FDA’s guidance on additive manufactured devices include:

• Overall device design

• Design file quality

• Starting raw material type 

• Software workflows, particularly in regards to software changes and file format conversions for both for internal use and third-party partners

• Environmental conditions for printing and manufacturing

• Device descriptions for premarket application

• Quality of data during clinical tests

• Cybersecurity protections for patient-specific devices

While this document is still under development and official review, meaning there are no legally binding requirements associated with it, manufacturers should still give it a read to learn where the agency is likely headed in terms of regulating 3D printing medical devices.

FREE eBOOK: Click here to get your free PDF copy of The Ultimate Guide to Quality Assurance and Regulatory Affairs in Medical 3D Printing.

Why your QMS software needs to stay in step with 3D printing medical device innovation

With 3D printing, the medical device industry can continue to push the limits of product innovation as part of our shared mission to improve the quality of life for patients. This is true for both product development engineers looking to improve upon existing designs or those pursuing novel and innovative devices.

3D printed medical devices must be designed, executed, and meticulously managed—the same way as any other medical device—using a robust, purpose-built quality system. 

Greenlight Guru is the only QMS software that is specifically designed for the medical device industry, allowing manufacturers to demonstrate full traceability between all areas within the quality system, from design controls and risk to CAPA and audit management,  for ongoing compliance assurance with any and all regulatory requirements. 

Get your free demo of Greenlight Guru today!

Looking for a design control solution to help you bring safer medical devices to market faster with less risk? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software