WellDoc BlueStar is one of the first mobile apps that is cleared by the FDA, can be prescribed by medical doctors and can be approved by insurance. It’s not a drug, but physicians can use it like one in order to help manage their patients’ Type II diabetes. This is an unusual application for wireless technology, but Iyer notes that treatment modalities through computer code are steadily evolving.
“I spent 18 years in wireless and helped build the telematics and wireless industries. In the meantime, I developed Type 2 diabetes myself and joined WellDoc in 2007. We were the first to develop software like developing a drug,” said Iyer.
“We did clinical trials, and published in peer-reviewed journals just like a pharmaceutical company would. We achieved FDA clearance, the first real-time coaching mobile app to do so. It actually carries a drug code, so to activate the app once you’ve downloaded it, you may need a prescription from your doctor. I’m involved, along with the FDA, in an organization called the IMDRF (the International Medical Device Regulators Forum) and we recently released a document about what developers need to do differently to create software that is treated as a medical device.”
Like any modern consumer product, widely used apps need to be engineered for both form and function. And when healthcare is involved, quality and patient safety take center stage.
Anand Iyer will deliver a presentation about the WellDoc BlueStar technology at the 2016 Medical Design and Manufacturing East Conference on Wednesday, June 15 at the Jacob K. Javits Center in New York, NY. His case study is among many high-value sources of information and engineering experience at MD&M East, which runs June 14-16, 2016.