The Sleep Apnea Appliance Market: What Labs Need to Know

The sleep apnea market presents some unique challenges for a laboratory and navigating this niche can be complex. One of the main issues: because sleep apnea appliances are a Class II medical device, laboratories offering them are required to register with the FDA, pay its annual fee, and follow its Good Manufacturing Practice standards and labeling guidelines so the device can be traced if there’s a problem down the road. In addition, because these appliances are used to treat a medical condition, labs have concerns about patient safety and liability issues.

Opinions about the viability of this niche vary. Some lab owners are disappointed by their experiences in the market, citing increasing competition and slower-than-expected growth, which many attribute to the slow rate of acceptance of oral appliances in the sleep medicine community. (For related coverage, see Obstructive Sleep Apnea: The Medical/Dental Connection.)

Some...