Community Research and Development Information Service - CORDIS

H2020

SmartECG Report Summary

Project ID: 756977

Periodic Reporting for period 1 - SmartECG (The world's first universally compatible algorithm and platform for automatic interpretation of electrocardiogram analysis data)

Reporting period: 2017-03-01 to 2018-02-28

Summary of the context and overall objectives of the project

The main objective of SmartECG is to improve speed and quality in cardiovascular disease (CVD) treatment by offering cloud service for long-term electrocardiogram (Holter-ECG) analysis. The web-browser based user interface and automatic analytics enable easy access to the service. The platform offers also telemedicine service for requesting fast consultations from cardiologists.
SmartECG supports most of the Holter-ECG devices. The universally compatible software makes the existing services smarter and enables wider range of people to be analysed faster, more thoroughly and more frequently than with the current solutions.

In order to reach the overall objective, several specific goals have to be met:
• Developing the current prototype SmartECG algorithm and platform to a market-ready service
• Scaling up the system architecture to support any number of users
• Ensuring compatibility with all leading Holter-ECG devices
• Finalising the platform for superb user experience
• Enhancing the ECG analytics for more accurate diagnostics
• Clearing market access barriers
• Achieving official validation by declaration of conformity process
• Preparing for fast market uptake and global commercialisation
• Engaging medical doctors, key-opinion leaders and other stakeholders at targeted markets through our established medical community networks and targeted dissemination
• Piloting the SmartECG with primary care and specialist physicians

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Work Package 1: Service capacity: SmartECG architecture scale-up and validation
During the reporting period, we finalized and tested the system architecture scale-up strategy, based on the evaluation done in the feasibility study. As a result, we are now prepared to support 10.000 end-users. Also, we have a specific step-by-step strategy and all contracts in place for activating necessary infrastructure upgrades at the proper expansion stage. During this work package, we also confirmed that the customer identification and data transferring method for SmartECG software are safe and meet the requirements of international standards. We successfully developed a browser-based ECG user interface for tablet mode and ensured that the user interface is compatible with mobile devices.

Work Package 2: Final product: Ensuring SmartECG interface interoperability and algorithm fine-tuning
The tasks in this work package are on-going. During the reporting period, we developed several main functions for the user dashboard. The ECG viewer for medical doctors is functional and the final layout has been designed. With the viewer, the user is able to evaluate the Holter-ECG, to investigate the events and rhythms and to visualise the time series and histogram of the beats. The results are collected to a printable medical report.
The algorithm development has focused on detecting signal artefacts, such as signal saturation or fast baseline changes. Furthermore, support for several Holter-ECG devices has been implemented.

Work Package 3: Validation and piloting: Ensuring SmartECG clearance to the market
The tasks of this work package last for the entire project and are proceeding as planned. The work done so far includes documentation for designing, planning and testing the software, as well as maintaining our quality management system at acceptable level.
Overall, the third work package guarantees that the software is safe and effective to use and complies with all relevant regulations of medical device software. The SmartECG software is developed according to the European and American legislation for medical device software. We will acquire CE marking and FDA clearance for European and American market access.

Work Package 4: Commercialisation strategy and plan
WP4 is on-going for the entire project. During the reporting period, we have already started with marketing activities to generate awareness, interest and action/leads. Sales activities to generate action and customers will start in Q3/2018, well in advance before the piloting in Q1/2019. CRM activities for customer satisfaction and loyalty have started with the launch of SmartECG Panel. We have prepared shortlists of the related stakeholders and an activity plans to follow during the second reporting period.
As a result of the work package, we will be prepared for a rapid SmartECG commercialisation, and roll-out to address a market of 50,000 end-users. To ensure fast and efficient go-to-market stage, we implement an integrated strategy for marketing, sales and Customer Relationship Management (CRM), and engage with leading Holter-ECG equipment vendors and healthcare management system operators to maximise the SmartECG compatibility and advance sales. We also engage the scientific community.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Our ambition is to provide a simple and scalable solution that enables significant improvement to CVD diagnosis and monitoring in existing medical systems. Web browser based service enables wider and more effective usage of Holter-ECG studies.
SmartECG provides a primary care level effective diagnostic tool and simple specialist consultation platform, to increase their options in treatment decision making. This will improve the healthcare efficiency and fight against the medical specialist shortage.
SmartECG platform enables effective implementation of modern natural language processing and machine learning techniques. RemoteA has extensive database for artificial intelligence development. Millions of hours of ECGs and tens of thousands of specialist reports facilitate continuous improvement of the service.

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