CASE STUDY Medical Devices

Medical Tech Company Revolutionizes Treatment for Chronic Disease

This company is a bioelectronic medical technology company transforming the standard of care for chronic disease.

In the United States, peer-reviewed research estimates that 2.2% of the population suffers from essential tremor (ET). For a long time, there were only two ways to treat ET: a partially-effective prescription or brain surgery.

This medical technology company took a radically different approach — an electrotherapy-based nerve stimulating wristband with comprehensive monitoring and diagnostics. To complete the customer experience side of the solution, the company engaged Infostretch in 2020 to build out a companion mobile app and patient portal, engineer a telemetry data pipeline and set up a secure development environment.

  • Founded in 2013 by two members of Stanford’s Neuromuscular Biometrics department

    Founded in 2013 by two members of Stanford’s Neuromuscular Biometrics department

  • Received $51M Series C funding to support launch of the new biometric solution

    Received $51M Series C funding to support launch of the new biometric solution

  • Re-thinking treatments for chronic disease

    Re-thinking treatments for chronic disease

the Results

Key Outcomes

mobile application development
MOBILE APPLICATION
DEVELOPMENT
MOBILE APPLICATION
DEVELOPMENT

Out of 72 repository (aka repos), reverse engineering was completed for 31 apps in addition to current feature development.

SHIFT LEFT TESTING
SHIFT LEFT
TESTING
SHIFT LEFT
TESTING

Automated testing enabling Shift Left.

Code-on-Demand (COD)
Code-on-
Demand (COD)
Code-on-
Demand (COD)

Automated pipeline enabling developers to deploy code on demand.

REGULATORY COMPLIANCE
REGULATORY
COMPLIANCE
REGULATORY
COMPLIANCE

Enabled unit testing for other vertical (patient portal) so that it can clear the FDA regulatory requirements.

shift left testing
TESTING
REQUIREMENTS
TESTING
REQUIREMENTS

Enabled linting and code coverage in unit testing for multiple repos.

SAMD
SAMD
SAMD

Technical writing for FDA compliance enabling software-as-a-medical-device (SaMD).

OPERATIONAL EFFICIENCY
OPERATIONAL
EFFICIENCY
OPERATIONAL
EFFICIENCY

Code merge, DevOps pipeline improvements have developed capability to push the code in an automated way in less than one working day – manual processes used to take four to five days.

DIGITAL HEALTH JOURNEY
DIGITAL HEALTH
JOURNEY
DIGITAL HEALTH
JOURNEY

Enabled the patient journey on portals, apps and data, and device analytics using Google Analytics.

Our methodology

how
we did it

Infostretch works with companies across the digital lifecycle.

Go Digital
Go Digital

Accelerating the delivery of new digital initiatives with confidence

Be digital
Be digital

Creating the infrastructure and foundation to scale digital initiatives

Evolve Digital
Evolve Digital

Leveraging data and analytics to continuously improve digital delivery processes

The challenge

digitally accessible, user-friendly data

As the company was developing its new solution, it realized that it needed help in certain areas to complete its product vision. Most critically, the organization needed to make the data from the device digitally accessible and user-friendly for both patients and physicians. These requirements included:

connect iot devices for patient monitoring

Providing a way to connect to and measure patient tremor intensity from the IoT device and capture respiration belt sensor data

Bluetooth interfaces and communication protocols experts

Expertise with Bluetooth interfaces and communication protocols

next-gen devices and new product launches

Support for next-gen devices and new product launches

code development for multiple application therapy devices

Consolidation of code development for multiple companion applications with similar functionality for different clinical therapy devices (USB, UART and BLE)

verification and validation for BLE device interface

Accelerating development and V&V (verification and validation) cycle time for BLE device interface

cloud infrastructure, test automation and configuration management

Addressing inefficiencies in DevOps activities of CI/CD, cloud infrastructure, test automation and configuration management as well as framework development for health device(s)

Data security and privacy policy implementation

Data security and privacy policy implementation in accordance with PHI and other security compliance requirements

Minimal documentation to start and setup the project

Minimal documentation to start and setup the project without having any prior knowledge to the multiple applications

manage repositories

Managing more than 30+ repositories

The Solution

Building the bioelectronic device web patient portal & app management tools

The company was introduced to Infostretch based on its digital work with other life sciences and medical device companies. As a result, it felt Infostretch had the expertise that the company needed to complement and complete its development effort.

The scope of Infostretch’s engagement focused on building out the bioelectronic device web patient portal and app management tools and framework. Some of the specific deliverables included:

Development of the Patient Portal for the Device

Development of the Patient Portal for the Device

To allow patients to easily rate daily therapies, set daily goals, check history, access product information and help, and contact support. The portal also included a Google Analytics dashboard which tracked each patient’s journey.

Creation of the Device Companion Application and IoT BLE Interface

Creation of the Device Companion Application and IoT BLE Interface

Allows the patient to start the therapy session from a companion app, enabling the collection, analysis and presentation of the patient and device data.

Development of the Tremor Engine Application

Development of the Tremor Engine Application

For collecting IMU data from motion sensors at 100Hz. The application also included an algorithm to measure the patient’s tremor intensity.

Use of the BLE Framework

Use of the BLE Framework

To develop a configurable simulator capable of managing messaging protocol (standard and custom) defined between the device and the companion mobile app.

Development of the Android Application Platform

Development of the Android Application Platform

A conceptual platform approach to consolidate all companion applications into one reference app with libraries to support multiple devices. The platform facilitated easy configurations and utilized a library approach for communications and sensor interfaces.

Implementation of a Telemetry Data Pipeline

Implementation of a Telemetry Data Pipeline

Using AWS IoT Gateway and other services.

CI/CD Framework Using Multi-Branch Jenkins Pipeline

CI/CD Framework Using Multi-Branch Jenkins Pipeline

For fully automated firmware testing on real company’s health device(s).

Implementation of Security and Policy Practices

Implementation of Security and Policy Practices

By moving all development work to AWS Workspace and adhering to PHI and other security compliance requirements.

SERVICES USED:

Amazon Simple Storage Service

Amazon Simple Storage Service

AWS Support

AWS Support

Amazon Lightsail

Amazon Lightsail

AWS Lambda

AWS Lambda

Elastic Load Balancing

Elastic Load Balancing

AWS IoT

AWS IoT

Amazon Elastic Compute Cloud

Amazon Elastic
Compute Cloud

Amazon ElastiCache

Amazon ElastiCache

AWS Config

AWS Config

Amazon EC2 Container Registry (ECR)

Amazon EC2 Container Registry (ECR)

Amazon Relational Database Service

Amazon Relational Database Service

AWS Data Pipeline

AWS Data Pipeline

Amazon CloudWatch

Amazon CloudWatch

AWS Secrets Manager

AWS Secrets Manager

AWS X-Ray

AWS X-Ray

Amazon Simple Notification Service

Amazon Simple Notification Service

AWS Data Transfer

AWS Data Transfer

Amazon DynamoDB

Amazon DynamoDB

Amazon Simple Email Service

Amazon Simple Email Service

AWS Kinesis

AWS Kinesis

AWS WAF

AWS WAF

Amazon API Gateway

Amazon API Gateway

Amazon Elasticsearch Service

Amazon Elasticsearch Service

AWS CloudTrail

AWS CloudTrail

Amazon CloudFront

Amazon CloudFront

AWS CodePipeline

AWS CodePipeline

AWS Key Management Service

AWS Key Management Service

Amazon Simple Queue Service

Amazon Simple Queue Service

Amazon WorkSpaces

Amazon WorkSpaces