March 06, 2020

The Truths and Myths behind Aligners

Jeff Lowthorp

What do labs need to consider before entering the aligner market? What steps need to be taken? What are the different entryways?

The excitement behind the aligner market is contagious and it is tempting to dive right in. Labs first need to pause and consider if they intend to make the aligners in the lab or instead use an outsource manufacturer. If the desire is to manufacture the aligners in-house, then labs need to consider the high cost and time involved in getting certified to be compliant with the necessary regulatory bodies, including ISO, FDA, etc. As part of this compliance effort, it is essential to develop a robust Quality Management System, which includes the necessary validation requirements for software, manufacturing equipment, and materials. Labs will also need to invest in setting up the necessary online ecosystem so doctors can view and approve treatment proposals and manage their case flow. Labs must not underestimate the “Doctor experience doctors need an easy-to-operate interface that allows them to view, approve, and manage aligner cases.

If the lab is doing the designing themselves, they need to have technicians with a thorough understanding of orthodontic tooth movement. Since a single case treatment can take place over the course of a few months to over a year, labs need to be committed to long-term case management. They will then need to ensure continual training of their orthodontic technicians since orthodontic re-alignments have serious and long-term impacts on a patient’s life. The other option is to use an experienced ortho designer and a completely validated end-to-end workflow that includes software, design, manufacturing, and approved material can help the lab with most of the points above.

If partnering or sourcing from a provider like Argen, labs need to ask themselves — is the provider a known and reputable dental company? Do they have regulatory compliance? Are they committed to the dental industry long term? If you think about it, you are providing an ongoing treatment plan that will take many weeks or months to finish. Initial treatment proposal, treatment plan accuracy, product material quality, and patient compliance all effect the end result. Labs will need to ensure that their manufacturing partner can enable doctors to plug into the required ecosystem to help support the treatment plan.

What are the benefits to partnering with your organization?

Argen has been a trusted name in the dental industry for more than 30 years now. We are known for our superior customer service and are continually striving to develop robust training and support infrastructure for our labs. We are designed to serve as an extension of your lab, so you can take advantage of all the great tools we have to offer for clinician training and onboarding, case management and workflow, plus marketing materials and education to keep your lab up-to-date on the latest improvements in aligner orthodontics and technology. We are FDA approved and we have our 510k clearance. With all this, you can easily plug into our Clear Aligner manufacturing program and customize it to suit your needs.

With Argen, labs have the flexibility to choose from three different business models as per their needs.

  1. Argen Branded Clear Aligner — “Argen Clear Aligners”— branded by Argen and the easiest solution for labs with little overhead required.
  2. White Label — Labs will be able to use their own brand name, but will need to follow Argen’s entire regulated process and must have “manufactured by Argen” on the label (some regulatory requirements for the lab).
  3. Private Label — Lab will use their ownbrandname and Quality Management System and Argen will be a 510k regulated contract manufacturer. Labs will be required to be compliant with current regulatory requirements.

Argen Clear Aligners

What is a common misconception about the aligner market?

Most people think creating an aligner manufacturing business is easy. Making an aligner is simple but creating a scalable solution that will minimize risk to patients, and ultimately your business, requires a different level of organization especially when you are managing your costs. For example, every aligner we make is laser marked so they always go to the right person’s case, ensuring that person will be able to identify and use the right stage, and the aligner is traceable with UDI for regulatory purposes.

Will this market become oversaturated? Where do you envision your organization 10 years from now?

I think all markets can become oversaturated. This market will continue to have many new players and it is big enough to support many more.

Argen will continue to put the dental lab first. Argen clear aligners will be sold through the dental lab as we believe dental labs provide enormous value in the overall delivery of quality oral health care. As an industry leading innovator, Argen will have made several new advancements in materials and optimizing manufacturing of clear aligners. Furthermore, Argen will continue to make advancements in developing new materials that will fit a range of dental solutions such as casting, printing, and milling. Strengthening our commitment to making lab life easy, Argen will be developing technological solutions for the dental lab to improve workflow efficiencies, help improve relationships with their customers, and reduce turnaround times and costs, all while maintaining the highest quality standards.

What steps are taken to ensure patient safety?

Argen’s entire system is FDA 510k cleared and is validated end to end. Argen meets ISO 13485 standards. Every aligner, stage package, and aligner case has a UDI — Unique Device Identifier. Each aligner has a human readable set of numbers so the patient does not mix them up. They also have a scannable barcode for our manufacturing, quality control, and packaging system.

Article originally published in JDT: