Transforming Clinical Trials.
The Device Hub enables you to continuously monitor the vital signs of trial participants. It automates the capturing of parameters from any device and monitors data quality in real time. Thereby, you can conduct efficient and long-term clinical trials based on Real World Data to validate medical devices, develop conventional and digital treatments and objectify outcomes.
Patient Centricity
Continuous monitoring with medical wearables reduces participant burden, increases participant retention and enables personalized care with objective outcomes based on Real World Data.
Reliability
Prevent data loss and reduce errors and improve efficiency by automating the capturing of biomarkers and manage devices remotely. Patient compliance and data quality are monitored in real time to ensure trial success.
Anywhere
Our gateway software is a robust solution to automatically capture data anywhere from any device. It can be deployed on stand-alone hardware or complement your mobile phone application.
Data Sovereignty
Maintain complete sovereignty over your data with on-premise solutions and end-to-end encryption of data streams. You have full transparency on applied algorithms and data access rights.
Open API
Avoid being locked-in by vendors. Our systems provide open interfaces to integrate with any 3rd party device, analytics tool, database or EDC system with a documented API.
Background.
Continuous and reliable data collection is a major challenge in the medical field. Wearable medical devices promise convenient, efficient and long-term clinical trials based on the continuous capturing of biomarkers during every-day life of trial participants. The Real World Data can help to overcome challenges like the increasing burden of chronic diseases with personalized treatments and objective outcomes. Automation reduces patient burden, facilitates decentralized study setups and allows complying with increasing regulatory demands in an economically viable way.
However, this approach comes with its own set of challenges:
- Wearable device manufacturers often build complete platforms and offer end-to-end solutions, which complicates the integration of systems from different suppliers in existing IT infrastructure and the alignment of workflows for study nurses.
- Participant compliance and correct device handling is hard to control outside the assisted environment of a clinic, which endangers data quality and trial success.
- The various circulating wearable devices need to be managed remotely and participants need technical support – neither is part of today’s clinical research organization’s core expertise and cost structure.
In collaboration with the University Hospital Basel and ETH Zürich, Leitwert developed the Device Hub to overcome such obstacles – a device and data management platform, which can be deployed on premise and provides open interfaces to directly integrate with 3rd party devices, analytics tools and clinical trial platforms. Processing pipelines allow for real time quality assessment of incoming data and the Study App can be customized to reflect the workflows in your trial organization. Our gateway software can be deployed on plug-and-play hardware or integrated in your mobile application – whatever is most convenient for your trial participants.
System Overview.
Study App
Clinical trial applications are a core competence of the Device Hub. It is in use for medical device validations in remote study settings, medical research and the validation of treatments in clinics.
The study app is an application specific user front-end for the administration of wearables and data before, during and after clinical trials. It provides workflows for study nurses to onboard patients, manage the device fleet and monitor the status of devices, gateways, data streams and patient compliance.
Incoming data is automatically assessed regarding quality and plausibility. Thereafter, it is reliably stored including metadata like the participant ID, sensor hardware, sensor settings and firmware version. Other metadata can be defined as required. An immutable log trail of system events ensures transparency and auditability.
Processing pipelines allow you to deploy your own algorithms to analyze and transform data streams. Alternatively, you can access or export the stored data via API to analyze it with your tool of choice.
Study Settings
The combination of Device Hub and gateways allows you to automate the readout of wearable devices worn by patients in any location. In addition to using mobile phones as interfaces for patient communication, our software can turn them into mobile gateways.
In-patients are monitored seamlessly throughout stationary clinics. Gateways are either installed in fix locations or deployed flexibly where required. The Device Hub organizes the roaming between gateways. Study nurses use application-specific user interfaces to assign devices to participants and to select the vital parameters to be monitored.
Out-patients in ambulatory- or aftercare wear their connected medical devices during their everyday life. A plug-and-play gateway at their home or a gateway application running on their mobile phone transfers the data periodically to the Device Hub, where it is available to study nurses and analytics software.
For residents in nursing homes or assisted living settings a hybrid between the in- and out-patient setup provides an optimal combination of reliability and flexibility. While gateway infrastructure at home captures data automatically, an additional mobile application ensures data transmission and communication while on the move. Application-specific user interfaces enable study nurses to assign devices to participants and select the vital signs to be monitored.
Device Hub
To systematically integrate connected wearable devices into your trial workflows, you require an interface that is capable of managing the devices remotely, directing the generated data flows and complying with industry standards. Moreover, this interface needs to be open on all sides to integrate with existing IT systems and to ensure that you can choose the best available device or algorithm for the task.
The Device Hub was co-developed with practitioners to ensure it covers these requirements. It gives you full data sovereignty and open APIs, making you dependent on no one. Of course, the Leitwert engineers are still happy to competently support device and system integrations and to build custom user interfaces based on your requirements and workflows.
Monitor your device fleet, securely distribute software updates in collaboration with the device manufacturers, assign devices to participants, manage metadata and data access to efficiently collaborate in research projects.
The Device Hub maintains an immutable audit trail and provides configurable workflows to comply with application specific regulatory requirements like GCP, HIPAA, FDA 21 CFR Part11 or ISO 13485.
Data Flow
Many wearable devices share data via Bluetooth. Additionally, mobile network reception can vary greatly inside buildings. In both cases, a gateway network in trial centers is required.
Leitwert provides gateway software that can be deployed on existing router hardware or low-cost off-the-shelf hardware like a Raspberry Pi. That piece of software interacts seamlessly with the Device Hub to monitor gateway status, organize roaming and data gapping.
The Device Hub provides processing pipelines to analyze the incoming data in real-time, enrich it with metadata and feed dashboards.
From the Device Hub, the captured data is routed flexibly to available data bases. Access management for analytics software, care providers or researchers can be managed with the Device Hub or any other system that might already be in place.
Development Partnerships.
The Device Hub is a co-development with the CMIO Office at the University Hospital Basel. A productive system is running on premise at the hospital since 2018. It is being used for clinical studies to develop new applications for wearable medical devices for patient care and treatments.
The vision is to provide an end-to-end solution for the use of wearable devices for R&D and patient care all the way from the hospital to patient’s homes.
In collaboration with ETH Mobile Health Systems Lab, Leitwert develops algorithms for clinical trials, which can be deployed on the Device Hub for real-time data analysis.
Our Offering.
Device Hub
Available as SaaS hosted in Switzerland or deployed on premise. Please contact us for server requirements and pricing.
Gateways
Available as software to be deployed on existing devices or as plug-and-play solution based on Raspberry Pi hardware. Please contact us for licensing costs.
Exploration Kit
Kick-start your digital transformation journey by renting or buying our plug-and-play technology bundle. It is optimally suited for Proof of Concepts and includes an account on our hosted Device Hub, gateways, the gateway setup app and a selection of wearables. Please contact us for pricing and availability.
Services
Leitwert engineers will support you competently all along your digital transformation. Our team operates from Zurich, Switzerland, and has extensive experience with wearable devices and customized software tools reflecting your workflows.