Leveraging IoT for Medical Device Software
Internet of Things
The RND Group recently implemented an Internet of Things (IoT) solution to manage a fleet of medical devices that perform diagnostic tests and push raw test data to the cloud.
Our solution integrates cloud-based services giving technicians the ability to calculate results from data stored in the cloud by their IoT Devices. The following graphic shows how it works:
Benefits of an IoT system
Employing an IoT System has the following added benefits:
- Reduced software complexity
- Simplified operator interface
- Greater access to data
- Simplify the processes to mine data, keep records, and create reports
Concerns from the client
This project presented us with a unique opportunity to build and deploy some of the most crucial components of medical device software in the cloud. We were able to successfully deploy result calculation algorithms and specimen chain of custody tracking.
With this great opportunity came many new challenges and concerns. The most prominent being cloud-specific requirements:
- Maintaining data integrity between devices and the cloud
- Security of data transmission
- Security of all data
- Managing scalability and performance when multiple devices are communicating with the cloud
- Maintaining high availability and fault tolerance of the cloud software
- Detecting and managing changes to the software stack performed by the cloud provider after the solution has been verified
Addressing the concerns
To find solutions to all these areas of concern, the RND Group used the same proven approach that has been successful for the past 20 years. To meet these challenges, we performed a risk-based assessment and created explicit requirements the software must meet for each challenge.
The cloud-specific requirements were then combined with application-specific requirements to ensure no parts of the software get over-looked. The risk-based approach drove the software design decisions and guided the testing strategies needed to verify all requirements had been met.
This project was centralized around the Amazon Web Services cloud, along with other supporting technology. The following information goes into more detail about what these technologies are and how they are used, showcasing our capability to meet all challenges.
Used for at-scale device data ingestion, device fleet provisioning, access policies and X.509 security management
Protocol for lightweight, secure, bi-directional communication
AWS IoT Device Shadow and AWS Lambda
Used for managing the state of each medical device represented by an IoT device
Used for highly-available, partitioned storage
Used for serverless computing and microservice-based architecture to process raw results data from IoT devices
Application level CRC signing of messages
Used for data integrity checking of all device to cloud communication
AWS RDS (encrypted PostgreSQL) database
Used for secure data storage
AWS API Gateway
Used for web application and 3rd party integrations access to cloud data
Terraform infrastructure as code software
Used for reproducible, automated, deployment of the AWS stack to multiple environments such as DEV / Test / Prod
Used for scalability testing of data ingestion
Used for containerized composition, orchestration, isolation and immutability of results calculation pipeline algorithms
The deployment of this solution is currently in-progress. At full deployment, the solution will support thousands of IOT devices, producing millions of results annually. Up to 2500 simultaneous users will be able access the system. Data will be archived in a staged fashion with on-line and near-line data access, and in off-line storage over the next 20 years.
The RND Group is providing full life cycle software services on this project, including:
- Requirements definition
- Software design
- Software implementation
- Software verification
- Software unit and integration testing
- Deployment and management of the solution in the cloud
With over 20 years of experience in regulated software engineering, we’ve built a heritage and reputation for building specialized software with precision and care. The RND Group can point with pride to products that have been successfully introduced into the medical device marketplace
Your project deserves a specialist.
Contact us to see how we can assist with your project here.