Project description
Collection of clinical data made easy
Medical devices save lives by providing solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. The EU’s medical device sector is competitive and innovative, with over 500 000 types of medical devices and in vitro diagnostic medical devices on the EU market. However, the new EU Medical Device Regulation requires from the industry to provide more and more accurate clinical data. In this context, the EU-funded UNITY project will develop a unique medical data collection and analysis platform that integrates traditional data collection (clinical data, patient outcome, lab data) with medical image analysis. It will be the next state-of-the-art solution, tapping into the clinical diagnostics, imaging software and pharmaceutical trials markets.
Objective
Due to the new EU Medical Device Regulations, the medical device industry needs to continuously obtain more and more accurate clinical data. However, due to limited resources, high costs and long clinical trial durations this data may not be obtained, resulting in (temporary) removal of proven medical devices from the EU market, while new devices may only be available in the EU with significant delay. Hence, the industry is desperately searching for solutions to accurately document clinical evidence of existing and new treatment options in a time and cost-efficient way. We are Raylytic, a German SME from Leipzig, specialised in clinical trials and radiographic image analysis. Since 3 years we have identified the described new business opportunity and started developing UNITY: a unique medical data collection and analysis platform that integrates traditional data collection (clinical data, patient outcome, lab data) with medical image analysis. Thanks to our advances in computer vision and medical image analysis technology, UNITY will be the next state-of-the-art solution, tapping into the clinical diagnostics, imaging software and pharmaceutical trials markets. The impact of UNITY for our clinical trial clients is a cost reduction of up to 40% for the execution of clinical trials. We have identified a favourable regulatory and reimbursement pathway. With the described project we intend to prepare UNITY for FDA and CE market clearance and subsequent successful market launch by 2022. After the project and upon regulatory approval, we intend to directly follow up and sell UNITY to hospitals as a hardware-vendor independent computer-aided diagnosis solution, as they will be using the platform already in clinical trials. Through this project (estimated ROI of 14.2) the company aims to boost its competitiveness, by increasing its revenues to €3 Million and its team to 25 employees by the first year of commercialization.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- natural sciences computer and information sciences software
- natural sciences computer and information sciences artificial intelligence computer vision
- medical and health sciences medical biotechnology implants
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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H2020-EU.2.3. - INDUSTRIAL LEADERSHIP - Innovation In SMEs
MAIN PROGRAMME
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H2020-EU.3. - PRIORITY 'Societal challenges
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H2020-EU.2.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
SME-1 - SME instrument phase 1
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) H2020-EIC-SMEInst-2018-2020
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
04109 LEIPZIG
Germany
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.