Helping a startup get a great night's sleep
Somna Therapeutics LLC, a medical device startup based in Wisconsin, approached Insight to develop a non-pharmacological, non-surgical solution to laryngopharyngeal reflux (LPR). This common ailment can lead to serious health complications, including pneumonia. Somna wanted to help a large population of sufferers who struggle with the many side effects of drug based therapies for this condition, and/or find the drug completely ineffective.
Based on 20 years of clinical research, the team was ready to invest resources into a purely mechanical solution to address this growing problem. The design challenge was to develop a sleep-worn appliance comfortable enough for users to be able to sleep restfully, and thereby reap its benefits.
Together the Somna and Insight teams created REZA BAND®, a solution that “applies a slight, external pressure right below the Adam’s apple, which increases the internal pressure and stops reflux from rising above the esophageal sphincter.” This device has been FDA approved and is prescribed by doctors as easily as they would prescribe a drug to counteract the effect.
Insight’s primary area of emphasis was to create a device that was easy to use and virtually undetectable during slumber. Our efforts included developing numerous rounds of physical mock-ups which were then tested to confirm their ease of donning, adjustment, use, and removal.
The objective was to create a long term wear solution that would be easily tolerated throughout the night. Several rounds of “design, build, test, refine” stages were conducted. This rigorous process ensured that the final production intent versions aligned with the client’s manufacturing capabilities and cost targets. With the final design confirmed and approved by target users through research, Insight documented the human factors recommendations for regulatory submission and created the final design transfer package directly to Somna’s manufacturer.