Leveraging IoT for Medical Device Software

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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:

IoT Diagram

 

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
  • Detecting and managing changes to the software stack performed by the cloud provider after the solution has been verifies

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.

Technologies used

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.

AWS IoT
Used for at-scale device data ingestion, device fleet provisioning, access policies and X.509 security management

MQTT
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

AWS S3
Used for highly-available, partitioned storage

AWS Lambda
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

AWS EC2
Used for scalability testing of data ingestion

AWS ECR/ECS
Used for containerized composition, orchestration, isolation and immutability of results calculation pipeline algorithms

Results

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:

  • Analysis
  • Requirements definition
  • Software design
  • Software implementation
  • Software verification
  • Software unit and integration testing
  • Deployment and management of the solution in the cloud

 

The result of this cooperative effort is a cloud solution developed using design control procedures required by the FDA that is state of the art in terms of use of cloud technology, web-based user interface and functionality.

 

 

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.

Capabilities Applied

  • FDA Part 820, Part 11
  • ISO 13485, HIPAA, IEC 62304
  • Software life cycle processes
  • Cloud development and deployment
  • API definition and development
  • Third-party API integration
  • Requirements development and management
  • Project management
  • Software verification

Software

  • Java 8
  • JavaScript
  • Angular 4
  • Node.js
  • JSON

Technologies Used

  • AWS IoT
  • AWS IAM
  • AWS S3
  • AWS Lambda
  • AWS RDS (PostgreSQL)
  • AWS API Gateway
  • AWS EC2
  • AWS SNS
  • AWS Kinesis
  • AWS SQS
  • AWS ECR / ECS
  • Serverless Framework
  • Docker