Today, cardiovascular care differs vastly from what we had several decades ago. The adoption of IoT, smartphones, and high-speed internet coincides with strong population aging trends and the increasing need for remote patient monitoring services. Healthcare providers seek ways to supervise the people that don’t require hospitalization and, this way, reduce the load on the system. Under such circumstances, smart medical wearables that collect critical patient data outside of hospitals become the optimal choice. Healthcare market players leverage new technology to make cardiac care monitoring solutions more lightweight.
The project of our customer is one of the mobile cardiac telemetry products that revolutionize patient care. It’s the story of mobile cardiac telemetry device development from concept creation to deployment.
Discover how the medical device was designed and implemented in our case study.
The Story Behind the Project
Before contacting Empeek with an embedded software development request, the customer used a third-party patient monitoring service. The legacy solution was subscription-based and offered limited functionality. Therefore, the system was pricey and didn’t allow the healthcare provider to implement the necessary features and scale. The customer realized that the third-party solution was hampering the growth of the company.
At this point, the company decided to invest in a custom mobile cardiac telemetry device. Only custom mobile cardiac telemetry device development could allow them to meet the unique business needs. They wanted to launch a product similar to a Holter monitor that would make patients mobile. While wearing these devices, people will continue with their daily routine when the hardware tracks their heart activity and detects abnormalities. Such a cardiac care monitoring solution would become an effective alternative to in-hospital cardiology monitoring IT solutions that limit the mobility of patients.
Since the project was complex and required expertise with embedded healthcare systems, the customer outsourced it to Empeek. Outstaffing enabled the customer to launch cardiac care mobile device development within the shortest time. Empeek assembled a dedicated team of business analysts, QAs, and software engineers skilled in mobile cardiac telemetry product development.
The customer hired Empeek to develop the cardiac data collection algorithms, mobile app, and backend. Our team was asked to formulate the technical requirements for the sensor of the ECG device. Based on these specifications, the customer started the production of tailored sensors.
Empeek also had to make sure all the components of the embedded cardiac care monitoring solution work smoothly. Besides, it was important to meet FDA and HIPAA requirements. Medical hardware and software fall under strict healthcare regulations and require detailed documentation and ultimate patient data security. Empeek had to ensure compliance with cardiac care software development guidelines and best industry practices.
What Makes the Developed Cardiac Care Solution So Special
Even though there are several alternatives on the market, this solution is particularly convenient. It’s small, quick, and collects different types of health data to give the full picture of patients’ condition.
Here are the main benefits of the developed mobile application, backend, algorithms, and hardware:
- The telemetry service collects data 24/7 which provides clinicians with more accurate information. They can see how the indications change over the day to track the dynamics and make more data-driven decisions
- The ECG device is compact and mobile whereas other devices require patients to stay in a hospital for observation
- The algorithm automatically filters data to highlight the patients that have high-risk abnormalities. It also automatically categorizes abnormalities by the level of risk to show the technicians reading cardiograms who might need urgent help
- Apart from ECG data (e.g., pvc’s, pac’s, ventricular tachycardia), the sensor collects data on the temperature, body position, and blood saturation to provide additional useful insights into patients’ health
- Since the system is highly customizable, healthcare organizations can set up several categories of patients to configure data collection. The normal heart rates of sportsmen and children differ, so it’s important to take this into account.
- The system automatically assigns tasks to healthcare professionals. This enables healthcare organizations to automate many processes related to diagnostics, including notifications, automated workload distribution, and task creation.
The listed factors give valid reasons to choose the developed cardiac telemetry device over its alternatives. Whereas healthcare organizations and patients appreciate the rich functionality and mobility, the software vendor gets a considerable market advantage.
How the Medical Device Operates
This cardiac medical device development project consisted of many stages. The thing is the ECG monitor is a system that requires perfect synchronization of software and hardware. Therefore, apart from engineering tasks, Empeek assisted with custom mobile cardiac telemetry device development. Find out how the resulting solution works below.
Hardware and software
The developed mobile cardiac telemetry device is based on a portable electrocardiogram (ECG) sensor. It’s small and convenient enough to wear throughout the day under clothes. The sensor has a battery, Bluetooth, and electrodes placed at specific points on the abdomen and chest. It records the minimum and maximum electrical activity of the heart in numbers.
After this, the algorithm converts the recorded data to a cardiogram that healthcare workers can further process. A team of technicians gets dozens or hundreds of cardiograms with highlighted abnormalities. This allows them to quickly detect any problems and validate the generated cardiograms saving time.
The mobile application supplied as a part of the solution is responsible for raw sensor data collection, filtering, and transmission to the web. It also enables patients to track their heart activity and share information about their well-being to provide healthcare professionals with additional details.
The cardiac telemetry device collects data on sinus rhythm, sinus bradycardia, sinus tachycardia, intraventricular conduction delay, junctional tachycardia, heart blocks, pauses, and other critical types of heart activity. The combination of these data types allows measuring cardiac health and detecting any abnormalities.
Product Development Challenges
The primary challenge of medical device software development services is to integrate hardware and software. Empeek covered the full software development cycle and assisted with hardware design to make sure everything works smoothly. This required collaboration of different specialists within Empeek and end-to-end software development expertise.
Regulatory compliance is another complexity. To prepare the designed solution for FDA and HIPAA checks, Empeek took into consideration strict regulatory guidelines during the development process. Our team also created detailed accompanying documentation to help the customer easily get certified. When the cardiac medical device development was finished, the customer had all the necessary documents on hand.
Get In Touch
If you are a healthcare provider or software vendor looking for custom mobile cardiac telemetry device development, we can help you. The Empeek team has outstanding experience with embedded software development and other engineering projects. We have created solutions for medical emergency services, EHR and telehealth systems, and wireless patient monitoring. To see the portfolio of our projects, visit this page.
Want personal advice on your software development project? Contact us for a talk.