How A Medical Device Company Transitioned From Idea to FDA Approval in 90 Days With the Silicon Labs BLE113 Bluetooth Smart Module
An emerging medical device company, had a concept for a breakthrough neonatal feeding solution and wanted to bring it to market quickly. Based on clinical trials, they knew their device needed Bluetooth connectivity, a simple interface, and an affordable price. Being in a highly regulated industry, they also understood the many complexities beyond technical design involved in their road to success. They knew a pre-certified technology stack would reduce risk of technological roadblocks and help accelerate their time to market.
After considering a wide spectrum of design options, both in-house and commercial-off-the-shelf, they chose the Silicon Labs BLE113 Bluetooth Smart Module based on its reputation in the market and its pre-certified technology stack. They intentionally chose a module and sensors that were already in large-volume, commercial applications in order to capitalize on reliable, yet affordable parts. In a matter of months, they went from concept to FDA-approval of their solution, becoming the first-ever FDA-cleared IoT medical device for the NICU.
The solution is one of the fastest medical devices ever deployed to the field. Its simple, small, Bluetooth-enabled design stands out from the expensive, standalone, legacy medical devices typically found in the NICU. With an affordable BoM and rapid adoption in the market, they are poised to increase revenue and expand their IoT medical solutions beyond the NICU. Best of all, the solution captures and stores data in the cloud, providing clinicians with objective insights to better-inform their future decision making, helping reduce stress on patients and improve infant lives.
Bluetooth Low Energy Fundamentals:
- Ultra-low power consumption: can run more than a year on a coin cell battery
- Flexible: connects to most consumer mobile devices like smart phones, tablets, and PCs
- Supported by major platforms: iOS, Android® 4.3, Windows® 8, OSX, and Linux®
- Reliable and Robust: AFH, retransmissions and 24bit CRCs
- Secure: Paring, privacy, MITM protection, and AES-128
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