AI model certification for cardiovascular medicine
Overview: Our client is a European MedTech start-up focused on the detection of cardiovascular anomalies. The start-up’s objective is to challenge the market for ECG signal-based detection of heart pathologies, such as, but not limited to, atrial fibrillation, premature beats, subventricular tachycardia, etc, obtained from affordable wearable devices such as the Polar H10. The company required an ML-based model development and preparation for the Class 2A medical device certification, in order to ensure that their system is safe and effective for patients to use at home.
Team: Our team of experts included a Data Engineer, Data Scientists, ML Engineers and a Project Manager
Our Data Scientists collaborated with the client in order to understand their existing ECG signal processing system, as well as their computation-based algorithms. We created an automated testing tool that assessed the performance of the current solution against a range of internal and external medical data sets. Based on this analysis, we provided recommendations to improve the scope of detectable medical conditions and identified areas for improvement.
We advised the client on the certification process and prepared an action plan for the ML-related work and documentation needed for the Class 2A certification. We also provided improvement recommendations and execution support, which helped the client enhance their ECG signal processing system and algorithms. Our team completed the analysis and recommendations in less than 8 weeks, providing actionable advice, which helped the client reduce the application processing time.
ML-based signal processing model development phase
The client provided the raw ECG signal data, including labelled data with annotations of R-peaks, pathologies, as well as ‘soft’ and ‘hard’ noise segments. This labelled data was used as inputs for the models and deemed as their training set. The quality and accuracy of pathology predictions (detection) heavily depend on the cleaness of the ECG signal. This is why it is important to have robust, well-performing models in terms of accuracy and precision, which can distinguish between the clean and noisy parts of the ECG signals. Our Data Scientists developed ML-based models for ‘soft’ and ‘hard’ noise detection. Upon successfully passing the strict model performance acceptance criteria of the client, our ML Engineers created the production pipelines for training and inference and integrated it into the client’s platform and business processes. Our collaboration continues with the development of further pathology detection ML-based algorithms.
Results: Through our active collaboration with the client's team, we were able to complete the model certification preparation work in just 6 months, helping the client achieve their goal of obtaining a Class 2A certification for their AI-powered medical device system. This certification allows the client to offer their product to a wider range of customers, enabling them to provide early detection and prevention of heart-related medical conditions.