It is estimated that over four million people in the United States wear braces. If you walk into a middle school, it is highly likely that 3 out of 5 students will be wearing them. They have become a rite of passage from childhood into the teenage years. However, the development of clear aligners has significantly decreased this number. Clear aligners took the orthodontics industry by storm, beginning in the early 2000s. They provide users with flexibility that traditional braces do not have, such as the ability to remove them and the unnoticeable change in appearance. The orthodontics industry has been at the forefront of 3D printing in the past decade, creating both clear aligners and retainers. The uniqueness of clear aligners lies in the fact that they are produced en masse while being completely customized to an individual. In recent years there have been more and more companies becoming involved in the 3D printing production of clear aligners. Such companies may take advantage of the R&D Tax Credit due to their research and development as well as their use of 3D printers.
The Research & Development Tax Credit
Enacted in 1981, the now permanent Federal Research and Development (R&D) Tax Credit allows a credit that typically ranges from 4%-7% of eligible spending for new and improved products and processes. Qualified research must meet the following four criteria:
Eligible costs include US employee wages, cost of supplies consumed in the R&D process, cost of pre-production testing, US contract research expenses, and certain costs associated with developing a patent.
One of the largest 3D printing production facilities in the United States is dedicated to printing clear teeth aligners. Align Technology, the parent company of Invisalign, outfitted their facility with dozens of 3D printers that create approximately 220,000 clear aligners per day, making them the largest manufacturer of clear aligners in the country. Although it may not even seem like an accomplishment, it is significant that all 220,000 aligners are fully customized and completely different from one another. Align Technology offers a variety of aligners from Invisalign Full to Invisalign Teen and Invisalign Express. With each service, the orthodontic patient receives a custom made, 3D printed tray that is worn for a week or more. The patient then receives a new tray, with perhaps a tighter mold, and this continues until the treatment is finished.
Besides producing the aligners, Align Technology patented their own SmartTrack material used to print Invisalign. Additionally, Align Technology has software designed to map out an individual's teeth and create a course of action for straightening.
With Invisalign costing upwards of $8,000, other companies have come on the scene to provide less costly alternatives, such as Candid. Candid is able to provide clear aligners to its customers at a lower cost by removing the in-person orthodontist appointments from the treatment process. It starts with a modeling kit sent to the customer's house where they take impressions of their teeth before sending it back to Candid. The company's team of in-house orthodontists evaluates each individual case and creates a treatment plan with an interactive 3D model. Once the customer decides to go through with the treatment, they are sent all of their trays at once. The trays are 3D printed and customized to the customer and their treatment plan. Candid uses BPA-free plastic to 3D print their aligners. By 3D printing their product, Candid has already cut production costs. They are able to further lower the cost of aligners by selling their product directly to customers instead of through a dental professional. A Candid aligner is a viable option for someone with a mild to moderate orthodontic case who would not be able to afford a $5,000-$8,000 aligner.
3D Systems is one of the largest 3D printing companies in the world. Their printers can be applied to a wide range of industries including teaching and training, healthcare, and dental. 3D Systems' printers have been used in the dental industry '“ and specifically orthodontics '“ for many years. Clear aligner producers, such as Align Technology, use 3D Systems printers to make their products. Though they have a fleet of 3D printers, three are specified for orthodontic use including the ProJet 6000, ProX 800, and NextDent 5100.
Stratasys, another of the largest 3D printing companies in the world, is partnered with many companies that produce clear aligners. In fact, the Stratasys J700 Dental was specifically made for the high-volume production of clear aligners. Stratasys claims that the J700 Dental can produce up to 400 clear aligners per day. A relatively small office space filled with 10 3D printers can produce up to 4,000 clear aligners. Additionally, the Stratasys J700 Dental is designed for 24/7 use, further increasing productivity.
DynaFlex, a partner of Stratasys, has been in the orthodontics industry since 1965. They produce a wide range of dental products including orthodontic products and appliances. DynaFlex began producing clear aligners a few years back but were only able to do so in small quantities. DynaFlex invested in a Stratasys J700 Dental 3D Printer and have seen their productivity and profits increase since. Due to the success of the printer, they built a dedicated 3D Printing Center within their warehouse to be filled with J700 Dentals. DynaFlex 3D prints their clear aligners, namely EZ-Align, because it is the optimal method of providing such a custom product in a timely manner. EZ-Align is printed using a medical-grade thermoformed material called FasTrac.
Clear aligner companies are constantly attempting to create new materials to be used as “ink” for their 3D printers. These materials are a major contender for receiving R&D tax credits. Most are made out of some kind of thermoplastic, which is what allows it to be 3D printed into the arch shape. Align Technology created and patented SmartTrack, the material used to make Invisalign. Made out of a medical-grade thermoplastic, SmartTrack is intended to provide improved tooth control which leads to 50% faster treatment and 75% more predictability. It also provides greater comfort for the wearer and easy removal. Competing materials include Zendura and FasTrac. Candid uses Zendura, which claims to be crack and stain resistant, clear, and easy to work with. Companies such as Align Technology will continue to research and develop new materials that will improve clear aligners and make them more effective.
Orthodontics is one of the industries where 3D printing has made itself most useful, especially for making clear aligners. The cost effective and mass-producing option of using a 3D printing is a no-brainer for any company producing clear aligners. The 3D printing of clear aligners has brought the mass production of customizables to a height that no one has ever seen before, and it is projected to keep growing.
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Charles Goulding and Rafaella July of R&D Tax Savers discuss 3D printing and orthodontic aligners.