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3D printing has been an enabling technology for personalized aligners and other dental devices for years, but at the beginning of 2024, Align Technology, maker of “Invisalign” aligners, made an unusual move to secure manufacturing capacity for this application: The company acquired a 3D printing technology supplier, Cubicure.

Headquartered in Vienna, Austria, Cubicure is a developer and manufacturer of 3D printers for Hot Lithography, a style of vat photopolymerization that uses heat to enable the 3D printing of viscous materials. While Align Technology has applied 3D printing for more than two decades to create the molds used to form Invisalign trays customized to each patient, Hot Lithography offers a manufacturing technology suitable for 3D printing devices for direct patient contact.

I had the chance to interview Srini Kaza, Align Technology’s executive vice president of product research and development, via email this spring. An edited version of the exchange is below:

Additive Manufacturing Media (AMM): When did Align Technology begin using additive manufacturing, and in what ways?

Srini Kaza (SK): Additive manufacturing is at the heart of the Invisalign manufacturing process. Invisalign devices have always been built with 3D printed molds. It is the foundation of our production technology. It has been the key technology that enabled the development of this disruptive product 25 years ago since the beginning of the company. We have developed and grown this technology over the years to create the [company that is the] largest consumer [of] additive manufacturing printers and materials in the world today as far as we know. While we have always used SLA based 3D printers, the equipment and process have gone through many evolutions over the years. The acquisition of Cubicure will strengthen Align’s existing intellectual property portfolio and know-how in direct 3D printing of appliances.

AMM: Can you provide a sense of the scale at which Align Technology is 3D printing today?

SK: Align can produce a million custom devices a day. 

AMM: Where does 3D printing take place? Is there a central manufacturing facility or is capacity distributed among locations?

Align’s mass-customization capabilities include the world’s largest 3D printing operations. Manufacturing is distributed among multiple locations: Juarez, Mexico; Xiyang, China; and Wroclaw, Poland.

AMM: What is distinctive about Cubicure’s Hot Lithography technology? What makes this process well-suited for dental applications?

SK: Cubicure’s patented Hot Lithography technology uses a special heating and coating mechanism that enables the processing of highly viscous resins to produce particularly tough and temperature-resistant polymers. This high-precision 3D printing process facilitates the unprecedented additive manufacturing of resilient components with an astonishing first-of-its-kind material quality performance.

We intend to use the Cubicure technology to print medical-grade devices that will directly go into the mouth. Products for dental applications need a unique combination of high modulus and elasticity, aesthetic properties, high safety profile and scalability. Cubicure’s process gives us the ability to create and process such polymers.

Cubicure’s Hot Lithography process is available in two different machine platforms, the smaller Caligma and the Cerion unit seen here. Source: Cubicure

AMM: It’s unusual for an OEM to acquire a technology provider. What motivated the company to pursue acquisition of Cubicure? Why was this step necessary?

SK: The acquisition of Cubicure will strengthen Align’s existing intellectual property portfolio and know-how in direct 3D printing of appliances. Integration with Cubicure will also extend and scale Align’s printing, materials, and manufacturing capabilities for our 3D printed product portfolio. While Align may be considered by some to be an OEM, we are the largest single user of 3D printing technology in the world and therefore our needs are unique.

AMM: How does the Cubicure acquisition advance the use of AM for Align Technology?

SK: The acquisition of Cubicure will support and scale Align’s strategic innovation roadmap and strengthen the Align Digital Platform, the company’s integrated suite of unique, proprietary technologies and services delivered as as seamless, end-to-end solution for patients, consumers, orthodontists, dentists, and labs/partners. 

Cubicure will also extend and scale Align’s printing, materials, and manufacturing capabilities for our 3D printed product portfolio which now includes the Invisalign Palatal Expander (IPE) system, Align’s first direct 3D printed orthodontic device and a safe, comfortable and clinically effective alternative to traditional palatal expanders.

AMM: What is the Invisalign Palatal Expander system? How have these items been made previously, and why is 3D printing them beneficial?

SK: Invisalign Palatal Expanders (IPE) are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw) with primary, mixed or permanent dentition during treatment of growing patients. The Invisalign Palatal Expander System consists of a series of removable devices staged in small increments of movement to expand a patient’s narrow maxilla to a position determined by their treating doctor.

Each direct 3D printed device is customized to the patient’s unique anatomy based on an iTero digital scan. A palatal expansion treatment plan and device design are then developed using Align’s proprietary AI-driven orthodontic software.

The IPE is Align’s first direct 3D printed orthodontic device, announced on September 6, 2023. The Invisalign Palatal Expander System is a clinically effective alternative to metal palatal expanders that require manually turning a screw in the device in the mouth daily to achieve expansion.

Directly 3D printing these devices allows us to take advantage of the full power of 3D printing around shape customization.

This power allows us to create unique, custom devices, with shape customization for each patient to deliver the optimal force system and comfort and therefore highly predictable results.

Invisalign palate expander

Align’s Invisalign Palate Expander (IPE) achieved U.S. FDA 510(k) clearance in 2023 and is the company’s first end-use product to be directly 3D printed. Source: Align Technology

AMM: What is the advantage of a 3D printed palatal expander compared to traditional metal expanders? 

The Invisalign Palatal Expander System is a gamechanger in orthodontic treatment of young patients, as it alleviates the most common challenges with traditional palatal expansion done with a fixed metal expansion device, including maintaining proper hygiene, emergency appointments, avoiding food being stuck underneath the expander, anxiety in turning the screw, and the parent’s fear of causing pain to the child in treatment. The innovation is clinically effective and designed to be easy to use and not as painful to wear compared to traditional palatal expanders. 3D printing the devices allows us to truly customize the design of the device for each patient for the best performance, fit and comfort.

Cubicure’s Cerion machine is intended for high-volume production of precision parts, including mass customized items such as aligners. Align Technology will continue to support existing users of Cubicure machines while also applying the technology to its own products. Source: Cubicure

AMM: What does the acquisition mean for other Cubicure technology users? Are the company’s products still available to outside buyers?

SK: We intend to support Cubicure’s existing partners and also explore other opportunities in the future. The big opportunity immediately in front of us, however, is with Align’s mass-produced products.

AMM: News releases about this acquisition have mentioned direct printing of aligners as one outcome (versus molds to form aligners). Where does this stand? Why is direct printing of these devices advantageous?

SK: Direct 3D printing enables Align to create 3D printed solutions without the added step of first creating a mold, making 3D printing more sustainable and efficient. We are exploring opportunities in this.

AMM: Why is 3D printing beneficial for aligners and other orthodontic/dental devices? What long-term promise does Align Technology see in this manufacturing process?

SK: 3D printing technology has played a significant role in helping meet the increasing demand for clear aligner treatment and a customized end product. 3D printing technology has come a long way and it continues to be ripe for innovation. We have already seen its great potential to bring life-changing advancements to industries including dentistry and orthodontics. Continued research and development in 3D printing will bring even more customization and efficiency to the future of the 3D printing process.

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