Allergan is a global pharmaceutical company focused on developing, manufacturing, and commercializing branded pharmaceutical, biologic, surgical, and regenerative medicine products and devices for patients around the world. It markets a portfolio of brands and products for the central nervous system, eyes, medical aesthetics and dermatology, gastroenterology, women's health, urology, and anti-infective therapeutic categories.
Open Science, a model of research and development, defines Allergan’s approach to identifying and developing ideas and innovation to improve patient care. With this approach, the company’s development pipelines are among the broadest in the pharmaceutical industry.
For the tens of millions of people in the United States who suffer from mild dry eye, irritation and discomfort are all-too-common occurrences. Those with moderate to severe dry eye symptoms may experience diminished quality of life. Allergan, which has invested billions of dollars in new treatments for the most prevalent eye conditions including glaucoma, ocular surface disease, and retinal diseases such as diabetic macular edema and retinal vein occlusion, provides multiple treatments for a variety of ocular conditions. To tackle the challenge of dry eyes without the use of drops or other medicines, Allergan developed TrueTear Intranasal Tear Neurostimulator, an electronic medical device with the ability to connect to a user-friendly mobile application via Bluetooth.
“Allergan has been pretty bold in its exploration of digital health,” says Mike Rogers, product manager for the TrueTear mobile application. “Being willing to take a development risk in this space has been huge for Allergan and has helped us to determine what new technologies and products are actually providing value or a novel solution to an unmet need.”
For the TrueTear mobile app to succeed, the team faced many challenges, including compliance, security, regulation, and ongoing application management considerations.
“The whole system was developed under Allergan’s Quality Management System (QMS). This is the same system under which the TrueTear medical device, submitted to the U.S. Food and Drug Administration (FDA), was developed,” says Rogers.
The TrueTear team needed to produce an application that users would enjoy while maintaining the security and reliability needed to protect user data and meet stringent compliance requirements. To address this obstacle, Allergan turned to AWS technology and to Smartronix, an AWS Premier Consulting Partner, AWS Managed Service Provider Partner, and an AWS DevOps, Government, and Migration Competency Partner.
“Our excellence is focused on compliance-driven cloud for organizations who must meet high compliance standards such as HIPAA and the Payment Card Industry Data Security Standard,” says Spencer Colson, director of commercial sales for cloud services at Smartronix.
Having migrated hundreds of public-facing websites and supporting systems to AWS with the help of Smartronix in 2014, the Allergan team already understood the many benefits of running mission-critical workloads on AWS and leaving the management of their applications to the experts at Smartronix.
“We knew Smartronix had deep experience working with heavily regulated industries, and the fact that they’re an AWS Premier Partner, AWS Managed Services Provider Partner, and multiple AWS Competency holder is a big deal for us,” says Rogers.
Colson says the Allergan team initially became familiar with Smartronix because of its distinction as an AWS Competency holder and an AWS MSP. “If we’re going to tell companies that we excel at managing their cloud, then we’d better be able to demonstrate our expertise by passing rigorous audits of our capabilities, such as the AWS MSP third-party audit,” he says.
Allergan turned to Smartronix to assist with the implementation, architecture, and management of the TrueTear backend infrastructure on AWS. After completing the app, the Allergan team worked with Smartronix to develop a maintenance plan and official managed service process.
“The TrueTear team had its own AWS account, and we transferred over to Allergan’s central AWS account,” says Rogers. “Smartronix then rebuilt all of our services using AWS CloudFormation templates and got us running on Allergan’s Virtual Private Clouds and security settings. The team also helped with installation qualification work.”
The TrueTear device causes the eyes to produce their own natural tears using tiny pulses of energy. These pulses activate a natural response through a technology called neurostimulation. The mobile application provides users with data-driven intelligence to foster an understanding of their device usage patterns. Additionally, the app helps users predict their eye condition depending on the weather forecast. The application connects to the TrueTear medical device using BLE.
“I think AWS Lambda and Amazon API Gateway are incredible technologies,” says Rogers. “They make it really easy to connect to other services and give us the flexibility we need to not have to worry about sizing and load balancing.”
The application communicates with AWS through API Gateway, using calls to invoke AWS Lambda functions that process the requests as needed, reading and writing to Amazon Relational Database Service (RDS) PostGRES (serving as the as the database backend) and Amazon DynamoDB. AWS Key Management Service (KMS) encrypts data at-rest in the RDS database. Lambda also accesses data stored in Amazon Simple Storage Service (Amazon S3). Amazon CloudFront sits in front of an administration interface for the application stack. TrueTear uses Amazon Simple Email Service (Amazon SES) to email end users (when they sign up for the application, for example). Integration with Amazon Cognito manages the user pool.
Allergan also integrates technology from Okta, an Advanced APN Technology Partner and Security Competency Partner. Allergan uses APN Technology Partner and Security Competency Partner Qualys for system scanning and anti-virus technology from APN Advanced Technology Partner McAfee. AWS CloudFormation is integral for making updates and deploying to the TrueTear environment. The application also uses Amazon Elastic Compute Cloud (EC2), AWS CloudTrail, Amazon CloudWatch, Amazon Kinesis Streams, and Amazon Simple Notification Service (SNS).
For the TrueTear team, being able to offer TrueTear device users a mobile app to provide meaningful usage insights and predictive data demonstrates the potential for digital health applications to change the way patients interact with medical devices.
“Figuring out how to create new digital health tools that patients are really engaged with is both challenging and exciting,” says Rogers.
TrueTear is currently available in eye care practices across the United States. By taking advantage of AWS security standards, HIPAA-eligible services, and microservices built on products such as AWS Lambda, the TrueTear team is confident in its ability to scale and meet the needs of a growing user base.
“I believe AWS is the industry-standard when it comes to this type of technology, and that makes it easier to get up and running quickly,” says Rogers.
“It’s crucial for Allergan to have the ability to build, refine, and scale a compliance-intensive solution such as TrueTear on AWS,” says Colson. “The team hit their compliance targets, met their timing objectives, and launched a production application that’s highly available around the United States for a low cost per month. That previously would have been unimaginable for a digital health application.”
The TrueTear team has pioneered Allergan’s entry to the world of connected devices.
“We look forward to leveraging this experience as we build our broader strategies for digital health and accelerating new therapies to market with innovative technologies,” says Bill Thornton, vice president of IT research and development at Allergan. “Our relationships with Smartronix and AWS will be a key component of our digital strategy in R&D to unlock the value of real-world evidence, data and sensors, and digital biomarkers as we move ‘beyond the pill’ to disrupt the current healthcare paradigms.”
Smartronix is a Premier AWS Consulting Partner focused on delivering value to customers throughout the full customer cloud adoption lifecycle. With expertise in the areas of security and compliance, the company supports a wide range of public and private sector customers. Smartronix offerings include FAST, a comprehensive IT transformation program to help customers leverage cloud to its fullest potential. In addition to being a Premier Partner, Smartronix also holds the AWS DevOps, Government, and Migration Competencies, and is an Amazon Redshift, AWS GovCloud (US), AWS Lambda, and AWS Server Migration Service Delivery Partner.