Clintelli is an open-source hardware and software IoT platform for clinical monitoring of patients. Imagine the Clintelli vest (the wearable/hardware component of the project) as your personal, wearable, affordable and lightweight health monitor. Clintelli’s vest main focus is measuring and analysing Electrocardiogram data, but will also include later sensors for Blood pressure, body temperature and more.
- Easy to use wearable IoT technology
- Easily configurable and customizable based on the requirements of clinical monitoring of the patient (personalized patient care)
- Easily attachable modules (medical sensors)
- Support for a variety of medical sensors: ECG, Blood Pressure, Body temperature, IMU
- Connection with smartphones to configure the wearable and display sensor measurements
- Connection with the Cloud for data storage, analysis and Machine Learning
- Can be used for personalized analytics (precision medicine)
- Cloud software easily deployable to any Cloud provider
- Powerful hardware enabled by Cortex-M4 Microcontroller
- End-to-end security both in hardware (cryptographic chip) and in software (digital certificates, encryption) to protect the valuable private medical data
- Expose data via REST APIs for other third-party HealthTech applications
- Interface with EMR (Electronic Medical Records) systems using the FHIR standard
- Low cost hardware, affordable healthcare
- Personalized patient care
- Ideal for remote clinical monitoring (telemedicine) and elderly care
- Easy to use
- Small in size
- Integrated solution
- Very early stage product
- Not many cardiac diseases are supported
- Research & Development phases:
- Research on IoT, Wearables, Medical Devices and ECG
- Fast prototyping with the development board NodeMCU and Arduino code
- Setting up the Cloud infrastructure for brokering sensor data
- Develop Android application for communicating via Bluetooth with the prototype
- Implement a Deep Neural Network for Atrial Fibrillation Classification using Tensorflow, which will later be used for analysing the measured ECG data (see also https://github.com/nickarad/AF-Classification )
- Research on Microcontrollers and Medical sensors used in production
- Design the Clintelli board schematics according to project requirements and datasheets’ specifications. Initial main components are Microcontroller, Cryptographic chip, ECG sensor, WiFi & Bluetooth, voltage regulators etc.
- Start designing PCB layout and iterate until first version minimum requirements are met and mechanical and electrical constraints are resolved.
- Send first PCB designs for a small batch-manufacturing (5-10 samples) for testing purposes
- Manually solder electronic components or order PCB assembly together with the PCB fabrication
- Test PCB quality, test the design for short-circuits and malfunctions
- Design plastic cover packaging to house and protect the first version of the Clintelli PCB and the battery.
- Generate Bills Of Materials (BOMs) from KiCAD and FreeCAD and make first price estimations for the end-product (materials, Integrated Circuits & Electronics supply, PCB manufacturing, plastic cover fabrication etc.)
- Future steps
- Test for RoHS compliance (https://www.rohsguide.com/ )
- Research and prepare for FDA compliance
- Include more medical sensors in the designs
- Improve energy consumption and reduce size
- Reiterate Clintelli-board designs for leveraging Flex PCB technology
Research and Development for Clintelli are very important, but in order for this product to have an actual impact on people's lives and health it must be easily deployable into production, efficiently reproducible and scalable.
The Clintelli vest is considered a medical device, which means that before being made available to market, it must be thoroughly tested (pilot phase) and approved by Medical Device Inspection agencies like FDA (Food & Drug Administration) and EMA (European Medicines Agency) and meet certain quality requirements.
Market... Read more »