Author:

Nir Danai

New Paradigms in Aligner Manufacturing

Roughly 20 years have elapsed since the commercial introduction of the first clear aligners and today they are an established and well accepted treatment modality. Not many remember but back in the early 2000’s, the Invisalign^® device was greeted with much skepticism and doubt. A great deal of clinical work and marketing efforts were needed to convince the orthodontic community that this method is here to stay. Today, in many cases, aligners have become the preferred treatment option for clinicians and patients alike.

Not surprisingly, the last two decades that have passed since Invisalign was launched also witnessed a few major technological breakthroughs, including in intra-oral scanning, processing power, 3D graphics and lately, 3D printing. The purpose of this paper is to highlight how such technological advancements are reshaping the face of the clear aligner segment.

In the early days, aligners manufacturing started from physical impressions that required shipping from the dental office to a processing center. Computing power was limited and treatment planning had to be carried out by dedicated design centers. Lastly, 3D printers were costly, bulky and complex to support, which meant that only large printing facilities could accommodate and maintain such units.

Coupled with some aggressive intellectual property strategies, the cumulative result of the above factors was the fact that very few aligner vendors have existed in the market until recently. 1st Generation companies such as Align Technologies and later, Clear Correct all provided a full service, handling all parts of the aligners supply chain, from the collection of the dental impressions all the way to production and delivery of the ready-to-wear trays.

The first major technological breakthrough in this arena happened around 2011-2013, with the introduction of the iTero^® intra-oral scanner by Align Technologies and later, the launch of the Trios^® scanner by 3Shape. At once, shipping impressions was no longer needed, empowering doctors from all over the world to offer aligner therapy in their practices. Along with the reduction in shipping costs and the increased accuracy of intra-oral scans versus conventional impressions, intra-oral scanners have truly helped boosting the business of the 1st Generation providers. From the customer’s point of view, key benefits included reduced turnaround time and fewer rejected impressions. But there was no material change in the process, with electronic scans merely replacing analog impressions.

The next wave started around 2015, with the emergence of stand-alone independent design programs and design services. Initially, software solutions like 3Shape OrthoAnalyzer^®, Orchestrate^®, Maestro Studio^® and later Arch-Form have been released, allowing a few dental labs and experienced orthodontists design their own aligners and later have them manufactured on heavy-duty 3D printers. But it was not until the introduction of per-case aligner design services such as eXceed^® or Sure Smile^® that this solution has become more widespread. The reason was that most customers were still interested in a process like the one established by 1st Gen. vendors. i.e being able to receive a ready 3D aligner plan that can either be approved or requires only minor modifications.

eXceed® Aligner Plan (clear aligners manufacturing)

The final piece in this evolutionary puzzle came a year later. In late 2016, FormLabs have launched a new desktop printer called the Form2^®. Priced below $5,000, this plug- and-play unit provided high-quality 3D prints at an affordable cost. This open the floodgates to other, similar printers such as the Moonray^® from SprintTray and later the NextDent 5100^® from 3D systems. Suddenly, 3D printers have become so easy to buy and operate, to the extent that every small dental office could own one.

Once the combination of affordable digital scanners, 3D printers and treatment planning solutions have been made available, the aligners manufacturing segment has begun to rapidly transform. From a universe dominated by a handful of large, almost-monopolistic vendors, the capability to become a clear aligner producer was now offered to every lab and dental office. Interestingly, this change also coincided with the expiry of a few fundamental aligner patents owned by Align Technologies in 2017-2018, which ultimately led the way to the launch of direct-to-consumer ventures such as Smile Direct Club and others.

Irrespective of the scanner, printer and planning solution employed, in-office or in-lab aligners manufacturing offers considerable advantages:

1. Cost — by adopting an in-office approach to aligners production, lab bills can be slashed by as much as 70% compared with traditional 1st Gen. vendor fees. According to financial reports of Align Technologies, the average selling price for a full case In the US is a approximately USD 1300. With the in-office approach, the combined expense for treatment planning, printing and vacuum forming (including labor) is below $400. This means that aligner pricing for the consumer can become more competitive, thus increasing the potential of selling such treatments;
2. Avoid Shipping — With back and forth shipping out of the equation, first aligners for any given treatment could be seated within a few days from the record-taking appointment, considerably faster than the 10-14 days turn-around offered today by traditional vendors. Less shipping also means aligners’ production becomes more environmentally-friendly.
3. Lost or Damaged Aligners — As a removable solution, one of the drawbacks with aligners versus fixed braces lies in the fact that aligners can be easily lost or damaged. Traditionally with 1st Gen. providers, under such circumstances the patient would have to pay an extra fee and wear a retainer until a new, replacement aligner is shipped from the production facility. With the in-office approach, the damaged or lost aligner can be reproduced almost immediately, making this a non-issue for both patients and clinicians.

Taken together, it is obvious that thanks to new and improved technologies aligner therapy is undergoing a radical change. From being regarded as a limited, premium-only solution, this module could quickly become the new standard for most orthodontic treatments. Considering the aesthetic nature and predictability of aligner treatments, the in-office/in-lab approach to aligners’ production may be the key in securing high-quality and affordable orthodontic corrections to larger-than-ever patient population.