YDS SmartServices – Simplifying adherence monitoring
Need to integrate smart devices into broader digital ecosystems
- Tracking: Connected real-time tracking of injection date, time and success e.g. use errors
- Guidance: Advanced guidance throughout the injection process e.g. advice on holding time
- Transmission: Seamless transmission of relevant data across communication protocols and interfaces
Challenges related to smart devices Need to address device-related complexities independent of therapies
How to …
- constantly monitor smart devices once launched across regions?
- control access to different smart devices?
- easily integrate smart devices with a dedicated therapy app?
- configure and remotely push updates to smart devices?
- secure device-to-cloud communication for therapy-relevant data?
- ensure integrity of adherence and smart device performance data?
End-to-end turnkey solution
YDS SmartServices simplify adherence monitoring Three digital services address device-related challenges
YDS SmartServices provide an end-to-end secured turnkey digital solution that simplifies the development process and supports the market introduction of smart devices across therapy-specific use cases. YDS SmartServices are based on three distinct yet interrelated digital services:
Service 1: Ease-of-integration
Connect device domain with third-party therapy data Standard application programming interface (API)
YDS SmartServices simplify access to adherence and connected device performance data by moving the integration point to a standard web-based application programming interface (API). The standard API connects the device domain to the therapy domain. Therapy-relevant data that would be time-consuming to obtain can be easily accessed:
- Standard interface to read and write data to other services
- API to build therapy-specific apps
- No need to deal with complex smart device protocols and security topics
Service 2: Smart device life cycle management
Insights into smart devices during clinical trials and commercial use Enabling smart device life cycle management
YDS SmartServices offer a set of digital life cycle management services in order to provide complete insights into and control of smart devices. The services support all five life cycle management processes, independent of therapy areas:
- Plan: Design and testing of end-to-end connectivity ecosystems
- Provide: Effortless advanced on-boarding and managed access to secure device usage data
- Configure: Effective implementation and update of network security
- Monitor: Real-time analysis and interpretation of smart device performance
- Retire: Controlled end-of-life management of smart devices, e.g. after successful completion of a clinical trial
Service 3: Securing device-to-cloud communication
Providing end-to-end security Security-by-design for the entire product system
YDS SmartServices provide true end-to-end security for the entire product system, controlling both device and cloud. In so doing, the digital services not only meet requirements concerning data privacy and security but also act as differentiating factor to gain patient trust and motivate long-term usage of smart drug delivery systems.
- Manages both device and cloud to implement true end-to-end security
- Meets relevant requirements around data privacy and security
Scalable and configurable digital services
Digital solution to meet specific costumer demand Flexible service levels and pricing models
- Scale digital services according to device volume, functionality and region
- Flexible service levels to support clinical trial conduct and commercial launch
- YDS SmartServices leveraged across device platforms and connectivity standards
YDS SmartServices high-level architecture
Introducing a turnkey integrated connected health system Linking the device to the therapy domain
Leveraging Ypsomed’s experience in the global marketing of diabetes management systems, YDS SmartServices establish an industry-leading reference architecture for embedding smart devices into digital ecosystems.
- Compliant with relevant industry standards e.g. HIPAA, GDPR, 21 CFR Part 11
- ISO13485 certified meeting medical device quality system regulations
- Design history file (DHF) to facilitate submission to regulatory agencies
- Leverage Ypsomed experience in design control and DHF management of device-related aspects