Revolutionizing early heart disease detection: Quality assurance journey

Quality AssuranceHealthcare

TECHNOLOGIES

SERVICES

Quality Assurance Services

EXPERTISES

Project Context

Solution

Outcome

About Client
Our client is a health tech company founded in 2016 in Frankfurt am Main, Germany. It specializes in non-invasive screening for coronary and structural heart diseases.
Their flagship product combines advanced AI-based 3D vector cardiography technology with web and mobile applications, enabling early detection of pathological cardiac conditions.
The company's innovative approach leverages artificial intelligence to transform traditional cardiographic assessment, making screening more accessible and efficient for healthcare providers worldwide.
Business challenge
Our client faced critical challenges that threatened their market position and regulatory compliance. With heart disease remaining a leading global health concern, their revolutionary non-invasive technology promised a breakthrough – but only if flawlessly implemented.
Their solution addressed a critical market need: traditional heart disease detection methods typically involve invasive procedures that are costly, uncomfortable, and not widely accessible. By pioneering a non-invasive, AI-based approach that could be deployed more broadly and conveniently, our client positioned themselves to transform early diagnosis and treatment – but this opportunity hinged entirely on product reliability.
So, the stakes were high: without proper quality assurance processes, the company risked releasing unreliable medical devices that could undermine trust in their AI-based technology, compromise patient outcomes, and trigger regulatory scrutiny.
Our client needed to establish comprehensive quality assurance protocols for both their hardware cardiograph device and software applications while navigating the complex regulatory landscape of medical technology. Without addressing these challenges, they risked joining the ranks of promising healthcare innovations that never reached their full potential.

Approach
Binariks established a clear project framework grounded in medical software quality standards and user-centric delivery.
We assigned a senior QA engineer with experience in both medical software and hardware testing. Their first step was to define a structured QA methodology that would support ongoing improvement throughout the development lifecycle:
- Creating validation and testing workflows
- Establishing continuous improvement checkpoints
- Aligning QA efforts with relevant regulatory requirements
Improving hardware performance was identified as a key objective. We focused on optimizing the interaction between the AI-driven application and the client’s hardware, particularly in diverse clinical and mobile usage conditions.
To support platform accessibility, we prioritized ensuring full cross-platform compatibility, enabling smooth operation across mobile and web environments. In parallel, we worked to streamline the user interface, aiming for intuitive navigation that could support healthcare professionals in fast-paced clinical workflows.
These efforts laid the foundation for achieving the broader project objectives: improving diagnostic accuracy and reliability, ensuring regulatory readiness, and contributing to early detection capabilities that reduce strain on healthcare systems.
Implementation
The project commenced in October 2022 and concluded in December 2023, with Binariks providing dedicated QA support to guide the client through a strategic technology transition and to establish scalable quality control processes from the ground up.
At the core of the solution was the decision to shift the client's platform to a Raspberry Pi-based architecture supported by Python. This combination was selected to meet several critical objectives:
- Cost-efficiency and scalability: Raspberry Pi offers a compact, versatile, and cost-effective platform suitable for deployment in mobile and clinical environments.
- Development speed and maintainability: Python provides a clean syntax and robust ecosystem of AI and machine learning libraries, allowing rapid development and reliable testing of health tech applications.
This architecture allowed our client to improve system flexibility, reduce time-to-market, and lay the groundwork for broader scalability in future deployments.
Our QA engineer supported the development team during the transition to Raspberry Pi and Python, ensuring that platform-specific constraints were addressed through early and continuous testing.
The QA function operated as a continuous feedback loop, helping the development team refine integration between the AI algorithms and hardware, and ensuring that quality benchmarks were met consistently.

Value Delivered

Binariks' QA implementation transformed the product development cycle, delivering measurable improvements that directly addressed their initial challenges:
- Enhanced product reliability: Comprehensive test case coverage reached 80%, significantly reducing the risk of undetected issues and ensuring consistent performance of their heart disease detection technology.
- Regulatory compliance readiness: The established QA processes created verification procedures essential for healthcare technology certification, positioning the client's solution favorably for regulatory reviews.
- Cross-platform stability: Our testing frameworks ensured reliable performance across various devices and operating systems, thereby expanding the accessibility of the client's screening tools to a broader range of healthcare providers.
- Development efficiency: The systematic QA approach reduced rework by catching issues earlier in the development cycle, accelerating product refinement timelines.
- Team capability enhancement: Beyond the immediate technical improvements, the client's team gained valuable knowledge of proper QA methodologies, creating lasting organizational capability for maintaining quality standards.
The collaboration has established a foundation for future growth, with plans to resume cooperation. By addressing their quality assurance challenges, Binariks has helped position our client's innovative technology to fulfill its potential in revolutionizing the early detection of heart disease.

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