tl;dr*
Situation: A healthcare tech startup developed a bottle to monitor and manage neonate feeding and needed a solution to deliver data to the care team.
Solution: We established Low-Energy Bluetooth connectivity between the ITO sensor and Android devices, implemented AWS Cloud infrastructure to stream real-time data, and provided assistance in preparing their FDA submission.
Results: Our solution empowered healthcare providers to make informed decisions and optimize patient care in NICU settings. In addition, the client successfully submitted the FDA application and secured regulatory approval for the product launch.
*too long; didn't read
Meet Our Client: A Healthcare Technology Startup
When we first met this MedTech startup, they were in the middle of developing a new device that was especially meaningful to some of our team members: a sensor that could measure feedings in Neonatal Intensive Care Units (NICU) and provide real-time data insights to care teams. The company aimed to revolutionize the way healthcare professionals monitor and manage feeding protocols for premature infants and improve patient care and outcomes.
Their Roadblocks
Developing a revolutionary device—especially in the HealthTech space—comes with a significant set of challenges. Our client partnered with us to address some of their biggest roadblocks:
Establishing seamless connectivity between the ITO sensor device and Android devices, which was hindering the efficient transmission of data to the care team
Providing healthcare professionals with meaningful visualizations and real-time insights into key feeding markers, which was their ability to make informed decisions
Navigating the complex process of preparing a submission to the FDA for product approval and ensuring compliance with regulatory requirements and standards for medical devices
Our Solutions
Upon evaluating their challenges, we blended our product engineering expertise and advisory services to:
Enable Low-Energy Bluetooth connectivity between the ITO sensor device and Android devices, ensuring seamless data transmission and synchronization
Implement an AWS Cloud infrastructure to securely stream real-time data from the ITO sensor device
Provide guidance and assistance in preparing their FDA submission to ensure compliance with regulatory standards and facilitate a smooth approval process for product launch
The Results
We are pleased to report they were able to:
Enable healthcare professionals to access real-time visualizations and analytics of key feeding markers
Empower care teams to make informed decisions and optimize patient care in NICU settings
Successfully prepare and submit their FDA application, paving the way for the regulatory approval of their ITO sensor device and subsequent product launch in the healthcare market
Our Take
It's not every day that we get to work on a project with such personal significance for members of our team. We are honored to contribute to the successful development of a product that can meaningfully impact healthcare practices, provide immense relief for parents, and, most importantly, improve patient care and outcomes.