CompanyGraph
Align Technology, Inc.
ALGN · United States
Turns a digital scan of your teeth into a custom set of clear plastic aligners that gradually straighten them.
Align Technology converts a digital scan of a patient's teeth — taken with its own iTero scanner — into a sequence of custom polyurethane aligners, with software called ClinCheck calculating exactly what shape each aligner needs to be to nudge each tooth toward the next position in the plan. ClinCheck was trained on millions of past cases where the predicted tooth movement, the manufactured aligner, and the actual clinical outcome were all recorded together, so each new case makes the predictions a little more accurate — and a competitor starting from scratch cannot buy that history by purchasing the same forming equipment. Because orthodontists must go through Invisalign certification and build their own experience in ClinCheck before they can treat patients confidently, and because practices that install an iTero scanner rebuild their entire workflow around it, switching to a rival platform means scrapping both the hardware and the clinical familiarity at once. The biggest risk to the whole system is regulatory: if the FDA begins treating ClinCheck as a software product that needs fresh approval every time its algorithm is updated, Align would lose the ability to keep feeding new case outcomes back into the model, and the compounding accuracy that makes the dataset defensible would stop compounding.
How does this company make money?
The company charges dental practices a fee for each Invisalign case — this covers manufacturing the aligners and running the ClinCheck treatment plan. It also sells iTero scanner hardware directly to practices and then collects ongoing software subscription fees from those practices. Practices that do not buy a scanner outright can pay a fee each time they use the scanning service instead.
What makes this company hard to replace?
Orthodontists have to complete Invisalign certification training and build up their own experience using ClinCheck before they can treat patients confidently — that investment does not transfer to a competitor's platform. Practices that have installed an iTero scanner have built their whole digital workflow around it, and switching means replacing the hardware and retraining every staff member on a new system. Patients who are already partway through treatment cannot move to a competitor's aligners without scrapping their progress and starting over from the beginning.
What limits this company?
The thermoforming process — pressing plastic over a mold in a clean-room facility — can only move each tooth so far in a single aligner stage. Cases that require larger corrections need more stages, which means more manufacturing time and higher costs per patient, without the company charging proportionally more for those harder cases.
What does this company depend on?
The company cannot operate without the iTero intraoral scanner hardware and software that feeds patient data into ClinCheck. It needs FDA 510(k) clearance to legally sell Invisalign aligners in the US — lose that and the product cannot ship. It depends on medical-grade polyurethane sheets that meet USP Class VI biocompatibility standards, meaning the plastic is safe for use inside a human mouth. It also needs injection molding equipment to produce the dental models used as forming molds, and ClinCheck itself must keep running as the algorithmic core of the entire process.
Who depends on this company?
Orthodontists lose their main option for treating patients who want clear aligners instead of metal braces, and would have to go back to traditional braces for those cases. General dentists lose the ability to handle basic orthodontic work in-house — without Invisalign, they would have to send those patients to specialists. Dental laboratories lose a key digital connection point, because many labs use iTero scan data for restorative work beyond aligners, and that workflow would break.
How does this company scale?
The ClinCheck software can plan treatment for an additional patient at almost no extra cost — once built, digital algorithms replicate freely. What does not scale the same way is manufacturing: each aligner still requires a clean-room facility, specialized vacuum-forming equipment, and quality controls that cannot simply be automated away or handed to outside contractors, so adding volume means adding physical infrastructure.
What external forces can significantly affect this company?
The FDA is increasingly requiring real clinical evidence for software that guides medical decisions, which could force the company to seek new approvals every time it updates ClinCheck. Clear aligners are an elective, out-of-pocket expense for most patients, so when the economy slows and people cut discretionary spending, fewer people start treatment. The company's largest traditional patient group is teenagers, and as populations in many markets age, that group is shrinking.
Where is this company structurally vulnerable?
If the FDA reclassifies ClinCheck as an evolving software medical device — meaning each update to the algorithm must go through a fresh regulatory approval rather than the existing 510(k) clearance — the company would no longer be able to continuously retrain the software on new patient outcomes. That feedback loop is the core of what makes ClinCheck defensible. Without it, the software stops improving, and the historical dataset stops growing.