Guest Editorial: The Next Wave of Medical Devices: Personalized with Local Impact

Examples of additive manufacturing that has fundamentally reshaped the landscape of patient-specific medical devices. (Credit: 3D Systems)

The application of additive manufacturing (AM) has yielded a substantial transformation in the field of patient-specific medical devices. Bringing together 3D printing technology, materials, software, and the expertise of personnel results in workflows for personalized solutions. I believe these solutions are superior when we look at a breadth of factors, including being cost-effective, more efficient, and enabling improved quality of care and the overall patient experience. Additionally, AM also can be a stabilizing option in an uncertain geopolitical climate as it can bring production local. This mitigates the risk of supply chain disruption due to changes in foreign trade policies.

Within healthcare, AM has fundamentally reshaped the landscape of patient-specific medical devices. We have seen examples of this in craniomaxillofacial (CMF) applications for nearly 20 years. Facial reconstruction, gender-affirming surgeries, and complex conjoined twin separations have all benefited from AM solutions being available to surgeons. Healthcare facilities are increasingly adopting AM workflows to facilitate surgical planning and enhance efficiency. By implementing semi-automated personalization workflows and a central portal, hospitals can accelerate preoperative planning, potentially shortening operating room time and improving surgical results. Within this planning process, patient-specific guides and implants are designed and produced to facilitate these procedures.

AM workflows are also increasingly used for limb salvage surgeries in oncology cases. For example, if surgeons can progress more rapidly from imaging to surgery in oncology cases, they can help mitigate rapid changes within the anatomy and tumors. With the assistance of these patient-specific surgical plans, and rapidly produced cutting guides, amputations can be prevented, and lives saved.

Adoption is also growing for other joints such as shoulders and ankles. For example, ankle replacements are an incredibly complex surgery. While many surgeons use off-the-shelf implants for these procedures, they are quickly seeing the benefits of a patient-matched instrument that enables precise implant placement.

Additionally, we’re seeing the power of AM in the dental industry where novel workflows are being implemented to address all major facets of dentistry — straighten, protect, repair, and replace. Broadly, AM facilitates a range of digital dentistry applications including the production of trays, models, surgical guides, dentures, orthodontic splints, retainers, crowns, and bridges.

Since the 1990s, AM has enabled the production of patient-specific clear aligners. This has empowered orthodontists to visualize an entire treatment plan from start to finish using 3D models. The resulting aligners provide patients with increased comfort as there aren’t wires or brackets that can irritate gums and tissues. Currently, AM is used to produce a series of thermoforming molds from which the aligners are made. As we look to the near future, I believe we will see the 3D printed aligner industry moving to direct-printed aligners. With the elimination of the thermoforming molds, we will have the ability to not only accelerate production, but we can also reduce the material waste for a more sustainable solution.

Night guards are a rapidly growing market segment for dentistry driven by the need to prevent damage to teeth from night grinding, an affliction affecting millions of people around the world. Night guards are also increasingly used by physicians for the treatment of sleep apnea and related disorders. Like aligners, AM has the potential to transform production by delivering more accurate, comfortable, and efficient solutions for both dental professionals and patients. The use of digital scanning software and precision manufacturing enabled by AM not only streamlines production for dental laboratories, but also reduces waste and turnaround time, and improves the patient experience.

AM is also taking on a significant foothold in the production of dentures. Strides have been made in using AM workflows to produce dentures, but up to this point the teeth and gums have been manufactured separately and then are assembled into a single piece. Advances in 3D printing technologies and materials are now enabling the rapid production of a complete denture as one piece with superior quality and aesthetics. Blending the materials on-demand for accurate shade matching and fabricating monolithic dentures provides tremendous savings in both time and costs.

Global Reach, Local Access

As an industry, AM is experiencing advancements at a rapid pace. Innovation is enabling enhanced capabilities across the entire workflow from software and materials through 3D printing technologies. Additionally, we see 3D printers with much smaller footprints enabling the technology to be used in smaller spaces such as hospitals, ambulatory surgery centers, and dental laboratories and clinics.

This is empowering service providers to design and produce patient-specific devices in closer proximity to the patient. As a result, dependence on complex supply chains is removed to enable more efficient, economical device production and delivery. This is a perfect example of how democratizing access to application-specific AM technologies and workflows creates solutions for local communities. As we look to the future, we are creating the opportunity for more people to make an impact with additive manufacturing and transforming patient care for a better future.

This editorial was written by Gautam Gupta, PhD, Senior Vice President, Medical Devices and Dental, 3D Systems, Rock Hill, SC. For more information, visit here .