Medical device software is a rapidly evolving field. The United States currently leads in this sector, producing 45% of medical device software tools, followed by Germany and South Korea. Regardless of your location, grasping the principles of medical device software engineering is essential for any manufacturing company looking to capitalize on this opportunity.
This blog will equip you with essential knowledge about the medical device software engineering process. You will discover the various roles involved in software development and some best practices to ensure success.
What’s The Difference Between Medical Device Software vs. Healthcare Software?
Medical device software specifically refers to software integrated into medical devices. Examples include software in MRI machines or insulin pumps. Healthcare software typically encompasses a broader range of applications used in the healthcare industry. It includes electronic health records (EHRs), telemedicine platforms, and healthcare analytics tools.
Healthcare software engineering focuses on developing these systems to improve patient care and operational efficiency in healthcare facilities. Unlike medical device software, healthcare software often interfaces with a range of medical and administrative systems but is not always embedded in a physical device.
The scope of this article is focused specifically on medical device software engineering, not general software engineering in healthcare. You may need to seek additional sources if you are interested in learning more about software development in healthcare beyond medical devices.
Different Types of Software for Medical Devices
There are several different types of software used in medical devices. This is because devices have different needs and different software applications are required to cater to these needs. Each software type brings a unique set of functionalities to medical devices, enhancing their precision and effectiveness.
Here are examples of the types of software seen in the medical device industry.
| Software Type | Use Cases |
| Diagnostic Software |
|
| Therapeutic Software |
|
| Monitoring Software |
|
| Data Analysis Software |
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| Patient Management Software |
|
Who is Involved in Medical Device Software Engineering?
Medical device software engineering is a collaborative process that brings together professionals with diverse skills and expertise.
Key players include:
- Software Engineers: Develop and program the software. They ensure the software meets specific functional and regulatory requirements for medical devices.
- Quality Assurance (QA) Testers: Test the software to ensure it is free of bugs and meets quality standards. They play a crucial role in ensuring the software’s reliability and safety.
- Regulatory Affairs Specialists: Ensure the software complies with all relevant healthcare regulations and standards. They navigate the complex regulatory landscape to maintain legal compliance.
- Project Managers: Oversee the development process. They coordinate the efforts of the team, manage timelines, and ensure the project stays on track.
- Clinical Engineers: Provide clinical expertise. They help to align the software’s functionality with medical needs and user requirements.
- UI/UX Designers: Design the software interface. They focus on making the software user-friendly and intuitive for healthcare professionals.
- Cybersecurity Experts: Protect the software from cyber threats. Their role is crucial in safeguarding sensitive patient data and ensuring the integrity of the software.
- Biomedical Engineers: Bridge the gap between technology and medicine. They contribute to the design and implementation of software in medical devices.
What Programming Language is Used in Medical Devices?
C, C++, Java, Python, and JavaScript are widely used in medical device software development. However, you may or may not need people on your team who know all of the above. Your predominant language(s) largely depends on what kind of software you’re developing.
C and C++ are often used for real-time medical applications like pacemakers and monitoring systems. They allow for precise control over device functions and memory management, critical for devices that require high reliability and accuracy.
Java is popular for networked applications and devices that require a high level of security. Its platform-independent nature makes it suitable for software solutions that need to operate across various systems and devices.
Python is particularly useful for any software that involves data analysis and machine learning. It’s a good choice for software that involves complex data processing, like imaging analysis and predictive analytics in diagnostic devices.
JavaScript is generally more for user interfaces. It allows developers to create intuitive and engaging interfaces for end users.
| More Insights on Medical Device Software Engineering |
Medical Device Software Development Best Practices
Prioritize Risk Management
Risk management involves analyzing how software failures could impact patient safety and device functionality. Implement strategies to mitigate these risks, ensuring the safety and reliability of the software. Regular risk assessments throughout the project keep safety as a top priority.
Follow a Structured Software Development Life Cycle (SDLC)
Adhering to a structured software development life cycle ensures that each phase of development is executed methodically. This approach allows for thorough testing and review at each stage. By following a well-defined SDLC, you can catch and rectify errors early.
Utilize & Improve Existing Software Where Possible
Leverage existing software components when possible. This practice not only saves time but also reduces the likelihood of introducing new errors. When using existing software, ensure it aligns with the current software requirements and perform necessary modifications.
Incorporate Regular Testing
Implement regular testing throughout the software development process. This includes unit testing, integration testing, and system testing. Regular testing helps identify and fix issues early, ensuring the software performs as intended.
Ensure Continuous Documentation
Maintain detailed documentation throughout the development process. This includes recording software requirements, design choices, testing procedures, and changes made. Continuous documentation is essential for regulatory compliance and aids in future software maintenance or upgrades.
Seek Professional Guidance Implementing These Best Practices & More
Whether you’re new to software development or have a long-term, full-time development team, you can always benefit from the expert advice of manufacturing professionals.The right partner can show you how to properly implement engineering best practices or show you new innovations in the field.
Vantage MedTech is glad to be your medical device software engineering partner. Our team will guide you from start to finish and help ensure that your software-powered device meets market approval. We’re familiar with several global compliance standards, so we can help you get your device to market on an international stage.
