We ensure that you get a seamless experience based on our understanding of every level of the IoT technology stack - from web-applications via connectivity all the way down to device hardware.
Provide complete data sovereignty with on-premise solutions and end-to-end encryption of data streams. Your customers can deploy their own algorithms and manage data access rights.
Our embedded development framework ConceRTOS, IoT gateway software and the Device Hub provide a modular architecture and abstraction layers resulting in future proof and configurable solutions.
We developed firmware for medical devices up to class C. We know the required documentation effort and are comfortable to work within your existing Quality Management System.
We are integrators. Knowing the challenges of getting different systems to work with each other first hand, we make sure that our solutions provide open and robust interfaces.
See how we contribute to your wearable device project!
Seamless from Device to Data.
We are convinced that data generated by medical wearables holds huge potential to improve healthcare and clinical research. This is why we build seamless software solutions to:
- Provide market leading firmware for wearable devices
- Enable wearable manufacturers to efficiently monitor and manage their device fleet
- Enable the integration of wearables in clinical processes and digital health solutions
Over the years, our technology stack and know-how matured. We can now contribute to your wearable device project on every step of the way. Below, you find out how our solutions benefit you – from product development to operating your fleet and integrating it with the IT systems of your customers.
ConceRTOS is a modern development framework for embedded systems, which was specifically optimized for wearable devices. It consists of a hard real-time operating system (RTOS) including libraries, an OS Abstraction Layer (OSAL) and a Hardware Abstraction Layer (HAL) to provide maximum flexibility and accelerate product development.
Every aspect of the framework – from the kernel to power governors – is designed for low power applications. This makes ConceRTOS a great choice to maximize the uptime of your wearable device.
The framework includes libraries for secure Firmware-Over-The-Air updates, signal processing, data encryption and settings management. There is no need to re-invent the wheel, when you can rely on tried and proven code instead.
We have experience with developing code for medical devices up to class C and are comfortable to work within the Quality Management Systems of our customers.
Secure Device-To-Cloud Connectivity
Data captured by wearable devices is highly sensitive – especially in health-related applications. State-of-the-art data security is a necessity to launch a new product. Based on our expertise on both the device and the cloud level, we are well positioned to ensure you get it right the first time.
We can implement TLS-based end-to-end encryption for Bluetooth devices based on Public Key Infrastructure (PKI). This results in perfect forward secrecy and reduces gateways to interchangeable data pipes, which enables roaming between infinite Bluetooth gateways. Standard Bluetooth protocols only allow to establish trust from point-to-point. This means your devices would have to remember authentications for each gateway in the network.
You decide, at which point the data is decrypted – for analysis at your cloud or only once it reaches the personal data vault of your customers or the trusted server at the healthcare provider.
Integration With Web and Mobile Applications
A wearable is rarely a stand-alone solution. To implement your use case, you will most probably have to provide a mobile or web application to provide a graphical user interface to your customers. We can support you both on the device-side and the server- / mobile-side of the integration.
For web applications, the Device Hub provides an open REST API against which you can implement your graphical interface and send data from your device. Alternatively, you can use the existing dashboards of our SaaS solution.
For mobile applications, we provide libraries based on the ConceRTOS framework. Users can manage device settings and watch live-streams of the gathered data. Moreover, the mobile application can serve as a gateway for Bluetooth devices to communicate with web-servers.
Device Validation Study
If you are developing a medical device, you will have to conduct a validation study to proof the efficacy of your product. The Device Hub was developed together with clinical researchers to enable remote monitoring of trial participants with wearables. By the same token, it is a ready-made solution for you to conduct a validation study for your medical devices.
- Send your device together with a Gateway to your trial participants
- To set up the gateway at their home, participants simply need to plug it into a power source and provide the credentials for their Wifi network using our mobile application.
- The gateway will automatically gather the raw data from the wearable every time the participant comes within reach.
- The raw data is sent to the Device Hub, where you can access it for further analysis.
- The Device Hub maintains an audit log of device states and data events and provides configurable workflows to comply with regulatory requirements like GCP, HIPAA, FDA 21 CFR Part11 or ISO 13485.
Based on the Device Hub’s firmware distribution capabilities, we can enable you to automate factory programming and testing of your devices:
- Set up a distribution channel to publish your test firmware for factories. The delivery procedure for this channel can automatically combine the firmware image with the bootloader before providing a download link.
- Your manufacturer can authenticate himself with a token and pull the newest test-firmware from the Device Hub to flash devices.
- A test script will run automatically to check the functionality of the hardware.
- If successful, the script will register the new device on your Device Hub and store the test script as “birth certificate” of the digital device twin.
This setup allows you to monitor device production in real time. Moreover, you can distribute only test firmware to the factory and send the encrypted full firmware – including your “secret sauce” – directly to the device once it is up and running. This reduces the amount of trust you need to establish with your manufacturer.
Once your devices leave the factory, the Device Hub will allow you to keep devices up to date. Distribution channels for firmware updates allow making new updates available only to specific device groups. Devices subscribe to one channel (e.g. staging, beta test, production), which can be changed based on device settings.
We can also implement escalating rollout of new firmware. Like this, updates are available to a small group of devices first and only become available to additional devices over time. If you detect issues, you can stop the rollout. This ensures that you don’t spread a bug to the whole fleet at once.
Update procedures allow to define the steps undertaken by the Device Hub before providing the update link to the requesting device. This can include device-specific encryption of the update or a compatibility check to make sure the currently installed version on the device can be directly upgraded to the new version.
Once the device confirms the successful installation of an update, the Device Hub will update its digital twin accordingly.
We can also support you to implement a secure bootloader based on the embedded framework ConceRTOS, which ensures your devices automatically rolls back to the last firmware version in case the update fails.
Fleet and Data Management
In addition to firmware updates, devices can request their current settings from the Device Hub. This allows you to set a desired state for each device based on its digital twin, which the device will match the next time it syncs with the Hub via the REST API.
Every exchange between the Device Hub and devices is logged for auditability and to enable efficient customer support. User access rights to change settings or release updates can be managed per device group and workflows like a 4-eye-principle are enforceable.
The Device Hub additionally serves as your logistics center to direct the data streams sent by your devices. It makes sure that data streams are stored in the right database and can only be accessed and shared by its rightful owners.
Incoming streams are automatically enriched with metadata. This can include information taken from the digital twin of a device (e.g. settings at time of measurement) or application specific attributes like who is wearing the device or which factory is being inspected by a robot.
Integrate With Hospitals
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. It will enable the systematic integration of wearable devices in clinical workflows, such as continuous measurements of vital signs combined with early warning scores.
By integrating your device with the Device Hub, you immediately create the basis for your medical device to being used in hospital workflows.
Integrate With Clinical Research Organizations
Leitwert collaborates with the ETH Mobile Health Systems Lab to develop algorithms for clinical trials, which can be deployed on the Device Hub for real-time data analysis.
These algorithms will allow real-time data quality monitoring. This is a key requirement to conduct clinical trials with wearable devices in remote settings, since participants will measure data without any human supervision.
By integrating your device with the device-agnostic Device Hub, you can profit from these developments and create a strong value proposition towards clinical trial organizations.
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.
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.
Available as SaaS hosted in Switzerland or deployed on premise. Please contact us for server requirements and pricing.
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 tailored to fit your workflows.