Whilst there is much discussion on how to apply connectivity and smart devices to therapies, there is far less dialogue concerning the challenges inherent to the digital architecture needed to make such innovations work in practice. Andreas Schneider introduces YDS SmartServices™, Ypsomed’s digital turnkey solution to effectively embed smart devices in a broader digital ecosystem.
The self-injection industry is experiencing a transition from purely mechanical devices to digitally enhanced, connected smart drug delivery systems. Novel approaches to the self-management of diabetes highlight this emerging paradigm shift. For instance, smart self-injection pens may support patients with capturing information about dosage and timing of insulin administration. Mobile applications remind patients to monitor blood glucose levels regularly or assist in the calculation of prandial insulin doses.
CONNECTIVITY & SMARTPILOT™
Although diabetes management has a history of pioneering patient-centric drug delivery technologies, the concept of connected drug delivery has applications well beyond the administration of insulin. Other chronic disease states that similarly require repeated self-administration of drug products also benefit from novel connected technologies, for example SmartPilot™ for YpsoMate®, a reusable connected add-on module with built-in sensor technology and wireless communication capabilities for the two-step autoinjector YpsoMate® (Figure 1). SmartPilot™ is used across molecular entities and disease areas both in clinical trials and as part of commercial product lifecycle management. The sensor concept has been developed so the standard proven autoinjector platform is compatible with SmartPilot™ without further modification.
The connected reusable add-on not only tracks injection date, time and success, but also provides advanced real-time guidance throughout the injection process. As such, it supports patients at each use step – including advice on the holding time – and confirms that the correct medication is being injected.
Streamlined connected device innovations, such as the SmartPilot™ for the YpsoMate® autoinjector, will provide innovative functionalities for patients, which digital health organisations can link with therapy-specific value propositions. While significant efforts are being made to link device functionality with disease-specific behavioural interventions or use cases, there still remains the key challenge of embedding connected devices into an end-to-end internet of things (IoT) ecosystem. This raises questions like:
- How to constantly monitor connected devices once launched across regions?
- How to control access to different smart devices?
- How to easily integrate smart devices with a therapy app?
- How to make therapy-relevant adherence and smart device performance data available?
The pharmaceutical industry has been focusing extensively on the therapy and paying less attention to the device-oriented domain of connected drug delivery systems. This has resulted in a fragmented and distorted understanding of effectively embedding connected devices in a broader IoT ecosystem. Here we will present YDS SmartServices™: a turnkey digital solution that provides three key digital services to simplify adherence monitoring providing secure end-to-end smart device integration (Figure 2).
Firstly, YDS SmartServices™ simplifies access to adherence and smart device performance data, shifting the integration point to a standard web-based application-programming interface (API) as shown in Figure 3. Integration via web-based APIs reflects the emerging good practice for reading and writing data to services and third-party applications.
The web-based API connects the device domain with the therapy-oriented domain of connected drug delivery systems. Therapy-relevant adherence data that would normally be time consuming to obtain can instead be accessed easily. As such, the web-based API reflects the starting point for pharmaceutical partners to build therapy-specific mobile applications and to realise therapy-specific use cases and behavioural interventions in order to provide the most value to the targeted patient population.
Secondly, another device-oriented challenge is that the pharmaceutical industry has not systematically implemented therapy-agnostic digital lifecycle management services. It is the very connected nature of smart drug delivery devices that has a dramatic impact on launching, maintaining and retiring such devices during clinical trials or commercial use. Smart devices require constant monitoring once introduced across regions. Organisations must continually improve and collect data around smart device performance. YDS SmartServices™ offers a set of digital lifecycle management services in order to provide complete insights into and control of smart devices (Figure 4).
YDS SmartServices™ supports all five lifecycle management processes, independent of disease area:
- Plan: Design and testing of end-to-end connectivity systems.
- Provide: Effortless advanced onboarding and managed access to secure device usage data.
- Configure: Effective implementation of network security.
- Monitoring: 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.
Thirdly, YDS SmartServices™ provides true end-to-end security for the entire product system, controlling both device and cloud (Figure 5). In so doing, the managed digital services not only meet the requirements concerning data privacy and security (e.g. HIPAA, GDPR, 21 CFR Part 11) but also act as differentiating factor to gain patient trust and motivate long-term usage of smart drug delivery systems.
Soaring interest in smart drug delivery is urging the healthcare industry to fully understand the complexities related to embedding such connected smart devices into broader digital ecosystems. However, such device-domain challenges have received limited attention to date. The industry has been more concerned with the development of therapy-oriented use cases and linking device technology with disease-specific behavioural interventions.
This article calls for enlarging the scope from therapy-oriented to device-oriented challenges. Focusing on digital lifecycle management services, ease-of-integration and end-to-end security, YDS SmartServices™ addresses these often neglected device-oriented challenges independent of specific therapies. Leveraging Ypsomed’s experience in and insights from the global marketing of a diabetes management IoT ecosystem, YDS SmartServices™ has established an industry-leading reference IoT architecture for embedding smart devices into digital ecosystems. In so doing, YDS SmartServices™ offers a new means to simplify and secure therapy-relevant adherence monitoring (Figure 6).