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Align Technology Inc.Case studyMasangkay, John Kenneth
I.Point of viewAlign Technology, Inc. (“We”, “Our”, or “Align”) designs, manufactures and marketsthe Invisalign system, a proprietary method for treating malocclusion, or themisalignment of teeth. Invisalign corrects malocclusion using a series of clear, nearlyinvisible, removable appliances that gently move teeth to a desired final position.Because it does not rely on the use of metal or ceramic brackets and wires,Invisalign significantly reduces the aesthetic and other limitations associated withmetal arch wires and brackets, commonly referred to as braces. We received theUnited States Food and Drug Administration (“FDA”) clearance to market Invisalignin 1998. The Invisalign system is regulated by the FDA as a Class II medical device.We distribute the vast majority of our products directly to our customers: theorthodontist and the general practitioner dentist, or GP. In order to provide theInvisalign treatment solution to their patients, orthodontists and GPs must initiallycomplete an Invisalign training course. The Invisalign system is sold in NorthAmerica, Europe, Asia Pacific, Latin America and Japan. We use a distributor modelfor the sale of our products in parts of the Asia Pacific, Latin American, and smallercountry markets in Europe, the Middle East and Africa regions. We wereincorporated in Delaware in April 1997. Our headquarters are currently located at2560 Orchard Parkway, San Jose, California95131, and our telephone number is 408-470-1000. Our international headquartersare located in Amsterdam, Netherlands. Our digital planningand software facility islocated in San Jose, Costa Rica and our aligner manufacturing facility is located inJuarez, MexicoII.Definition of ProblemsAlthough braces are generally effective in correcting a wide range of malocclusions,they are subject to many limitations and disadvantages. • Unattractive appearance. Braces call attention to the patient’s condition and treatment.In addition, braces trap food, which canfurther compromise appearance. Braces can also result in permanent discoloration ofteeth. As a result of these and other limitations,relatively few adults with malocclusion elect traditional orthodontic treatment and bracescan compromise the self esteem of youngadults and teenagers.• Oral discomfort. Braces are sharp and bulky and can abrade and irritate the interiorsurfaces of the mouth. The tightening oradjustment of braces results in root and gum soreness and discomfort, especially in thefew days immediately following anorthodontic visit.• Poor oral hygiene. Braces can make it difficult to brush and floss leaving teethvulnerable to developing decay, plaque, periodontal
disease and stains that must be taken care of after braces are removed. Additionally,the bonding of brackets to teeth can causepermanent markings on the teeth.