The COVID-19 pandemic, which brought the world to a standstill in 2020, has led to a significant increase in investment in developing faster and more efficient testing methods for medical devices. This is to support the emergence of breakthrough medical innovations.
Medical devices need rigorous verification and validation due to their potential impact on people’s lives. Quality assurance (QA) for medical devices encompasses both hardware-level validation and software testing. It also includes performing quality checks to assess the devices’ interoperability, usability, reliability and accessibility.
As medical devices become more dependent on software, it’s becoming appropriate to use modern software development approaches, like DevOps quality assurance. This approach combines DevOps methods with QA, which can improve the quality of the resulting software. Better still, it can reduce the time it takes to develop it.
In this article, we’ll talk about DevOps quality assurance and how it’s upping the pace of medical device software testing.
Let’s get started.
DevOps quality assurance: A great approach to safeguard your medical devices
The future of DevOps practices and technologies looks promising. More than 83% of IT decision-makers implement DevOps practices to unlock higher business value according to a report by Global Market Insights.
Put simply, DevOps practices:
- Enhance the quality of software deployment
- Help you release software more frequently
- Improve cooperation and collaboration between teams
So, what exactly is DevOps quality assurance?
Back in the day, development and testing were siloed processes carried out independently. But with the emergence of DevOps, the collaborative integration of these two processes began. The intention was to speed up delivery time and make everyone, from developers and testers to other stakeholders, responsible for the end result. This was a big win for QA teams working with developers and chasing an early deployment.
Today, DevOps quality assurance helps to avoid conflicting priorities between teams and improve communication. It also enables parallel testing. In DevOps, parallel testing refers to the practice of running multiple tests concurrently, rather than sequentially. It’s a way to speed up the feedback loop between development and testing so that teams can quickly find and fix issues as they arise.
DevOps quality assurance also makes software quality and timely delivery the joint responsibility of both the QA and Dev teams throughout the software development lifecycle.
The goal here is to achieve a faster time to market, by making sure that all aspects of the software work as intended, and the testing process is efficient and easy.
The need for DevOps quality assurance in medical devices testing
It’s clear that all software must be free of defects. But with medical software, there’s an added responsibility to ensure the safety of patients
DevOps quality assurance allows for the early and continuous testing of software code for medical devices during the software development process. This can save you from major headaches like:
- Expensive FDA (Food and Drug Administration) product recalls
- Delays around product releases or software updates
- Compromised security
- Data privacy issues
- Threats to patient safety
DevOps can be used to ensure that the software used in medical devices is developed and maintained in a secure and compliant manner. This can involve incorporating security testing and reviews into the development process, automating verification & validation checks and deployments, and continuously monitoring and improving the performance and functionality of the device throughout its lifecycle.
For example, a medical device manufacturer may use DevOps QA practices to:
- Implement testing and code reviews as part of their continuous integration and delivery (CI/CD) pipeline to catch and fix defects early in the development process.
- Use automated tools that scan the device’s software for vulnerabilities and perform security assessments.
- Put in place configuration management and infrastructure as code (IaC) practices to ensure that the device’s software and infrastructure are deployed consistently and securely.
- Monitor the device’s performance continuously to flag and address issues in real time, as and when they are detected, allowing developers to respond quickly.
The purpose of using DevOps QA in the medical device industry is to speed up the process of creating and maintaining software that is secure, compliant, and meets the needs of both patients and healthcare professionals.
DevOps quality assurance enables early and continuous testing of software code for medical devices during the software development process. This helps to prevent problems such as expensive FDA product recalls, delays in product releases or updates, compromised security, data privacy issues, and threats to patient safety.
By implementing DevOps quality assurance, medical device manufacturers can improve the quality, security, and compliance of their software, while getting new products, features and updates to market faster.