Is Flutter Suitable for Medical Device Software?

The answer is yes.

And no.

Let us explain. Flutter has emerged as one of the most popular frameworks for cross-platform mobile app development. It enables developers to build visually stunning, high-performance applications for iOS, Android, web, and desktop using a single codebase. 

However, while it shines in many areas, its suitability for medical device software is a more complex question. Medical device software has unique requirements, including real-time performance, regulatory compliance, safety-critical systems, and long-term support—all of which must be carefully considered when choosing a development framework.

Here’s a look at the pros and cons of using Flutter for medical device software.

Pros of Using Flutter for Medical Device Software

1. Cross-Platform Development

One of Flutter’s standout features is its ability to build applications for multiple platforms—iOS, Android, web, and desktop—using a single codebase. This reduces the need for maintaining separate codebases for each platform, significantly saving time and resources. This is particularly valuable for medical device manufacturers who want to deploy apps on various devices (e.g., tablet-based user interfaces, mobile apps, or embedded screens) without rewriting code for each platform.

• Efficiency: Flutter allows for faster development cycles, making it easier to roll out updates and fixes across multiple platforms simultaneously.
• Consistency: Using a single codebase ensures a consistent user experience (UX) and user interface (UI) across different devices. This is crucial for medical devices, where consistency in interface design can lead to better usability and fewer errors.

2. Fast Prototyping and Iteration

Flutter’s hot reload feature is one of the key reasons developers love working with it. This feature allows developers to see changes to the code in real time without restarting the application, which is incredibly helpful when iterating through different ideas or refining UI elements.

• Rapid Prototyping: In medical device development, the ability to quickly prototype and iterate on user interfaces can be crucial during the early design and testing phases. Developers can experiment with different layouts, adjust user flows, and get real-time feedback from stakeholders—clinicians, engineers, or users.
• UI Customization: Flutter’s extensive set of widgets and highly customizable UI components lets developers create rich, tailored interfaces for medical devices. Custom controls such as touch-based input, large data displays, and alert systems can be easily implemented.

3. Strong UI Capabilities

In the medical field, user interfaces are often critical. A well-designed UI can be the difference between a successful intervention and a miscommunication that puts patients at risk. Flutter offers excellent support for building clean, visually appealing, and responsive user interfaces.

• Rich Interactivity: Flutter’s widget-based system makes it easy to create interactive elements such as real-time graphs, patient data displays, touch controls, and more. This is vital for medical devices where operators, clinicians, and patients need to view and interact with data in a seamless and intuitive way.
• Custom Animations: Flutter also excels in delivering smooth animations and transitions. Medical devices often require dynamic displays, like a real-time ECG graph or spike alerts for vital signs, and Flutter’s built-in tools make this easy to implement.

4. Growing Ecosystem and Community

Flutter is backed by Google, and its open-source nature means that it has a growing and active community. This ecosystem provides a wealth of libraries, plugins, and third-party tools that can speed up development. As Flutter continues to mature, more libraries and integrations are likely to emerge, further improving its utility for developers in various industries.

• Community Support: The large developer community actively shares knowledge, tutorials, and plugins, making it easier for teams to overcome development challenges. This can be helpful for medical device developers who need to integrate with specific hardware or software systems.
• Cost Efficiency: By allowing developers to maintain a single codebase for multiple platforms, Flutter helps reduce both development and maintenance costs. This is especially advantageous for medical devices that require apps on mobile, tablet, and embedded systems.

Cons of Using Flutter for Medical Device Software

1. Real-Time Performance and Safety-Critical Systems

While Flutter excels in building cross-platform applications, it is not suited for real-time systems where low latency and deterministic performance are critical. Real-time systems are essential for many medical devices, like pacemakers, infusion pumps, or patient monitoring systems.

• Regulatory Standards: Medical devices must comply with strict regulatory standards (e.g., FDA approval, IEC 62304). These standards often require systems to meet specific performance metrics, something that frameworks like Qt (which support low-level access and real-time behavior) can handle better than Flutter.

For mission-critical applications where real-time data processing is a must, Flutter may not be the best choice. For example, if you’re developing a life-sustaining device that must process sensor data in real-time to adjust treatment, low-latency, deterministic performance is a non-negotiable requirement.

2. Limited Hardware Access

Medical devices often need to interact directly with specialized hardware, such as sensors, actuators, or medical imaging equipment. Flutter’s abstraction layer, while great for building user interfaces, is not designed to provide low-level access to hardware.

• Native Code Integration: While Flutter allows for communication with native code through platform channels, this adds complexity, especially when dealing with custom hardware interfaces. Developers may need to write and maintain separate native code for each platform (iOS, Android) in addition to the Flutter app.
• Hardware Control: In applications that require precise control over hardware components (e.g., ECG monitors, ultrasound machines), Flutter's abstraction may not offer the necessary flexibility, making it less ideal for tightly integrated embedded systems.

3. Regulatory Compliance and Certification

Developing medical device software comes with strict regulatory requirements. In the U.S., for example, software must meet FDA standards for medical devices. Flutter, as a newer framework, does not have the same level of built-in compliance features as more established frameworks like Qt or C++/RTOS environments.

• Validation and Verification: Flutter does not provide native tools or libraries for compliance with medical standards like ISO 13485 or IEC 62304. Developing software that meets these standards can be challenging and costly, as it requires rigorous validation and verification processes.
• Certification: Flutter also lacks formal certifications for medical-grade software, meaning developers would need to invest significant resources to validate their code and ensure it meets the required standards, potentially lengthening the time-to-market.

Given that regulatory approval can take years and involves complex documentation and testing, using a framework without proven compliance can significantly increase development time and complexity.

4. Long-Term Support and Maintenance

Medical devices often have long life cycles—sometimes 10 to 20 years or more. The long-term viability of the underlying development framework is crucial. Flutter, while growing rapidly, is still relatively new, and its future in embedded systems and mission-critical applications remains uncertain.

• Longevity Concerns: Over the course of a device's life, developers must ensure ongoing support, security patches, and updates. Relying on a newer framework that may not have the same level of long-term support as established technologies could introduce risks.

5. Memory and Resource Constraints

Many medical devices—especially portable ones—operate under strict resource constraints, such as limited memory and processing power. Flutter, while optimized for mobile and web applications, tends to have a larger memory footprint compared to more lightweight, native solutions.

• Embedded Systems: For embedded systems with tight memory limits, Flutter’s resource demands might pose challenges, especially if the device is expected to run on limited processing power or battery.

The Takeaway

The takeaway is this: While Flutter offers an approachable and efficient solution for building user interfaces, it may not always meet the stringent reliability requirements of medical device software that is often needed for critical, time-sensitive functions. For projects where decoupling safety-critical logic from the UI is not feasible, Flutter can be a good choice, providing a streamlined development process. However, for more complex applications that demand time-tested reliability and robust performance, Qt remains the gold standard in the medical space.

At ICS, we specialize in navigating the complexities of both frameworks, ensuring that your project is built with the right tools for its specific needs—whether it’s the simplicity of Flutter or the precision of Qt. Let us guide you through the process, making sure your medical device software is both effective and compliant.