Unified, holistic medical data collection and analysis platform
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.