Smart Devices Help Ypsomed Measure Medication Adherence for Clinical Trials

Ypsomed Delivery Systems is keenly aware of the importance of medication adherence—measuring medicine intake and ensuring doses are given at the correct time. Poor medication adherence is an expensive problem, with non-adherence costing the US healthcare system nearly $300 billion annually. In fact, 50-60 percent of patients with chronic illnesses don’t take medication properly. This also has a direct impact on clinical trials; the consequences of poor adherence in clinical trials include failure to confirm efficacy, risk of harm due to misleading labels, impaired development of breakthrough drugs, and treatment failures.

In trying to find a solution for non-adherence, Ypsomed faced a complex, two-tier problem. To tackle non-adherence, a contract research organization (CRO) needs the ability to remotely manage drug administration in real time, share information on drug intake within and beyond clinical trial teams, assess and enhance adherence, and to manage trials that are multi-center and/or in multiple regions. This leads to the need for a connected solution. Yet such a connected solution presents additional challenges, such as the burden to configure and remotely push updates to smart devices. CROs also need secure device-to-cloud communication and the ability to constantly monitor smart devices launched across regions. They also need to assure access control on smart devices. These challenges require the capabilities of a cloud platform to manage.

Ypsomed sought to create a digital solution that CROs could use to monitor medication delivery in clinical trials. “Connected devices hold great promise to improve clinical trials, accelerate trials, and improve adherence,” says Andreas Schneider, PhD, Innovation & Business Development manager for Ypsomed.

Ypsomed’s goal was twofold. Their first goal was to provide connected self-injection systems for trial participants to administer medications at home. The second was to track usage of these connected self-injection devices and make that data available to stakeholders involved in clinical trials, such as CROs, investigators, and pharmaceutical companies. In addition, Ypsomed needed to ensure devices could be monitored across geographic regions, needed to store data at scale, and needed to adhere to privacy and security requirements such as HIPAA and GDPR.

In late 2018, Ypsomed turned to Philips and the HealthSuite digital platform (HSDP). Philips HSDP provides cloud services and platform as a service that allow users to connect devices, collect electronic health data, aggregate and store data, and analyze data—within healthcare regulatory, privacy, and security requirements. Philips HSDP is built on top of a breadth of AWS services including Amazon Elastic Compute Cloud (Amazon EC2) for compute, Amazon Simple Storage Service (Amazon S3) for storage, and AWS IoT Core to enable connectivity services. Using Philips HealthSuite digital platform (HSDP) on AWS in development can help users:

• Accelerate development: get development right the first time and scale faster and more systematically
• Scale to geographic, volume, and market demands
• Secure clinical data in a HITRUST-certified platform
• Enhance interoperability with hospital systems via native support for FHIR, HL7, DICOM, IHE profiles
• Build and run cloud-based solutions that help you administer faster, better clinical trials
• Integrate wearables and devices, clinical trial end user support, provisioning, patient support, and device creation

Ypsomed built their Connected Drug Delivery Solution, a solution for medication adherence monitoring and smart device management for clinical trials, using HSDP’s cloud services and platform as a service on AWS. The solution consists of Smart Pilot (connected medication injection device), Smart Services (device management) and Cockpit (dashboard showing device data). These components are powered by the YpsoCloud. YpsoCloud leverages HSDP for device connectivity, remote device management, identity and access management and device/patient data storage. It provides privacy and security and fulfills medical device data system regulatory requirements.

Ypsomed’s solutions enable clinical trial participants to self-administer medication using the SmartPilot connected medication injection device. Then CROs, and other users administering clinical trials, can use SmartServices and the Cockpit to monitor and manage those devices remotely, including tracking device performance and pushing firmware. Additionally, users can segregate the encrypted injection or patient data for third parties or CROs from device performance-oriented data. An Ypsomed customer can build its own clinical dashboard on top of this backbone or integrate with an existing clinical dashboard through a standard interface that provides ease of integration and standardized APIs.

Ypsomed reports that they accelerated their development and created the MVP of their solution from scratch in five months by building on Philips HSDP on AWS. Ypsomed also used HSDP to help enhance security, as Philips HSDP provides for HIPAA and GDPR requirements, and for technical flexibility through HSDP’s toolbox of ready-to-use cloud services that the company can lean on for future development, such as analytics. By using HSDP’s platform as a service and 24-7 operations support, Ypsomed also realized cost savings by reducing operations, infrastructure, and staffing costs.

Together, Ypsomed, Philips, and AWS support CROs in addressing poor medication adherence and enhancing clinical trials through providing tools to connect and manage devices and data on the cloud.