Creating a new clinical grade medical device with IoT platform.
Someshwara’s customer is an AI based med tech company based out of Atlanta, GA, US, that is working towards detecting early progression of coronary artery disease prior to a heart attack. They have re-imagined the way cardiac proteins are monitored in the blood using a non-invasive technique that finds a wrist watch form factor. This coupled with an innovative ECG wearable now provides first of a kind data representing a reversible phase of heart muscle damage, allowing cardiologists in early assessment and appropriate intervention.
The customer had a vision to detect coronary disease and built a basic prototype hardware. They approached someshwara to partner and productize the solution. There were multiple parts of the product before it can be used in a clinical setting. From research in AI model, design of backend system to support during Clinical studies and FDA submission. Being a startup with lots of unknowns, they needed a team which would go beyond just the requirements and help design a complete solution.
Someshwara team worked with the founding members to understand the needs and also work with them on creating a platform suitable for patient centric care. Developed a competent IoT platform connecting the hardware and capable for AI R&D for early cardiac detection.
Key technological achievements for the client
* Designed ingest platform which can be flexible to ingest diverse set of IoT streaming data.
* Solution optimised consume binary data and be cost effective for long durations of clinical trials
* Optimized protocol for saving battery in the wearable device. Which sleeps intermittently. Having high availability for
* Create a single data lake for analytics processing, suitable for multiple concurrent experiments to run
* Research into ECG delineation methods and imparted strong understanding of AI capabilities to founding team
* Development of AI models to filter noise & detection of various cardiac conditions
* Research into predictive models for coronary damage
* Understanding HIPAA compliance to secure patient information
* Supporting for FDA submission of clinical device
Understanding the impact of a device which could save lives, someshwara was able to mobilize work centered around the needs of the customer. Customer after approaching Someshwara was able to completely productize the model within few months relative to waiting for years. Team was able to perform critical clinical trials. Consolidated platform allowed to seamlessly collect and analyze study findings, allowing to submit the device to FDA for approval.
The device already is showing significant promise and large hospitals and clinics are waiting for the FDA clearance to start using the device. Continuing to support the team during their scaling and growth, someshwara hopes to save the lives of people across the globe.