- Mass Customization
- Lower Cost in Low Volumes
- Design Flexibility and Freedom
The additive nature of 3D printing allows for a device to be fully customized, layer by layer, to fit the unique needs of each patient. At the same time, metal 3D printing can save money over traditional approaches to medical device manufacturing since there are no costly molds or tooling to be purchased upfront. Further, 3D printing can enable unique design features like internal channels that would be expensive or impossible using traditional manufacturing options.
Patient-Matched Devices in 3D Printing
Using 3D printing, it is possible to create implants with very tight tolerances to meet the exact size and specification for each patient. By using the patient's medical imaging data, medical device manufacturers can create devices that exactly match the patient's anatomy.
Uploading the digital file fills the same role that tooling would with traditional methods in the sense that getting the image in place is the only “set-up” that’s required. Once the file is in place, the patient’s dimensions are reproduced, layer-by-layer, with results typically much closer to identical than would otherwise be possible.
There’s also complexity to consider. The human body is extraordinarily detailed from a structural standpoint, and those tiny intricacies can be hard to match without leveraging 3D printing. Device designers can include internal channels and nuanced surface features to allow the device to more easily bond with the surrounding bone and tissue. The result can be a smoother, more natural fit that more closely mimics the body’s function without internal devices.
Applications include joint replacements, cranio-maxillofacial devices, and stents designed to prop open the body’s natural conduits like airways and arteries. Cleveland Clinic Innovations executive director Peter O’Neill has indicated that his department has found metal additive manufacturing (AM) to be a major upgrade in this last area. Most airway stents, he said, are still mass produced, which can make them extremely difficult to insert and uncomfortable for the patient. In compassionate use cases, the 3D printed stents they’ve tried “have done amazingly well.”
Additive Manufacturing of Exo-Skeleton Prosthetic Devices
Traditional methods for fitting prosthetic devices currently rely on molding, casting, and several fitting and adjustment iterations to get a prosthetic that is comfortable for the patient. When combined with 3D scanning methods, metal 3D printing aims to simplify the process. By paring down the prosthetic to its essential function, exo-skeleton prosthetics can strip away time, cost, and weight from the part while improving functionality and comfort.
Several projects are ongoing in this area, but the highest profile example may be William Root's exo-skeleton prosthetic leg. His “Exo-Prosthetic” uses 3D scanning of the residual limb to build a picture of the full limb, then reverse laser scanning to build out the anatomy of the prosthetic. The result can be a match that’s within millimeters of the original.
Other areas of development include wearable devices like braces and cast replacements. Further, some are investigating production of titanium pins to attach prosthetic limbs. In the former category, many initiatives are in process with the goal of developing realistic safety standards to help speed these solutions to market. External-only contact should allow for rapid adoption of things like metal 3D printed braces that fit a healing surgical patient exactly.
Dental Restorative Products
One of the largest commercial successes for metal 3D printing has been in dental restorative products, such as crowns, moldings, and bridges. Only a few years ago, getting a crown was a lengthy, multi-step process. With 3D printing of metal crowns, the process has become virtually frictionless. Today, it’s common to arrive with a chipped tooth at the dentist’s office, have your mouth scanned, have a metal crown 3D printed while you wait, and have said crown set in place in a single visit.
It’s not just crowns, either. All mouths are unique, which makes the ability to manufacture directly from a just-taken image extremely valuable across a wide variety of dental inserts. Dentures, retainers, and orthodontal aligning devices are rapidly growing segments of the total metal AM market.
Dental products are uniquely suited for the 3D printing process due to their small size, high degree of customization to each patient, and complex traditional manufacturing methods. 3D-printed metal dental products can be delivered in a shorter production time, at a lower cost, and at a higher quality than traditional approaches. The increasing accessibility of this technology means a higher proportion of all restorative work will be accomplished using AM going forward.
Mass Customization in 3D Printing
Medical devices are an ideal category of technologies to be 3D printed for one simple reason: they’re used by humans. Every body is different, so custom parts are necessary for every application. It’s not far-fetched to say this is where a majority of devices designed for medical use are going over the coming decades.
With that said, there are significant regulatory hurdles to widespread adoption. The FDA, after all, takes its job seriously. While we should all be grateful for the watchful oversight, it can be hard for innovative medical professionals to stay current on the guidelines for 3D printed medical devices. As the medical community and FDA come into increasingly frequent contact with 3D printed parts, however, we can expect clearances and approvals to accelerate. A faster, cheaper, more efficient, and more effective network of device production is on the horizon.
Matt Sand is the president of 3DEO, a metal 3D-printing company based in Los Angeles. 3DEO is a supplier of low-cost metal 3D printed serial production components. Leveraging its proprietary technology, 3DEO competes head-to-head with conventional manufacturing in terms of quality, cost, and turnaround time. Prior to 3DEO, Sands worked as a venture capitalist and operating entrepreneur. He has founded several startups in a wide range of industries, from healthcare to high-technology. Sands is proud to have served as an officer in the U.S. Air Force. He holds bachelor’s degrees in computer science, mathematics, and political science from Tulane University, and an MBA from UCLA Anderson.