Channeling the Power of Automation in Medical Device Testing

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According to Cynerio’s 2022 State of Healthcare IoT Device Security Report, 53% of internet-connected medical devices analyzed had a known vulnerability, while one-third of bedside devices had a critical risk. (Cynerio observed over 10 million medical devices at over 300 hospitals and medical facilities across the world).

As per the findings, more than half of health enterprise-connected medical devices pose security risks due to critical flaws that could jeopardize patient care. Given this scenario, software testing, ensuring that a device and its potential hazards are minimized, should be a top priority for device manufacturers.

However, this seems to be not always the case.

According to Vantage Market Research, the Global Medical Device Testing Industry overview is to Reach Over USD 12.94 Billion by 2028.

Medical devices must adhere to stringent regulations and aggressive product delivery cycles to launch a high-quality product to market. Such rigorous systems necessitate sub-level testing, which costs more and requires larger timelines as it calls for exhaustive processes for identifying defects and ensuring compliance.

If the medical device is not FDA approved, it is recalled from the market, resulting in significant losses. It is critical that medical devices function flawlessly. As a result, test solutions must be precise, accurate, and repeatable.

Why Does Automation in Medical Device Testing Matter?

To comprehensively cover all test cases and compliance mandates, a combination of clinical knowledge and technical expertise is required – this is where automation comes into the picture.

Automation testing ensures that you comply with FDA and other compliance agencies’ regulations, as well as the safety of operators and patients.

To improve your testing performance and achieve high levels of test automation, you must implement a strategy that simplifies, accelerates, and optimizes your test processes to generate higher quality code with fewer bugs.

Automated testing entails using tools to supplement the capabilities of manual testers by creating, executing, and maintaining complex test cases within a test environment. This allows for faster and more frequent test runs, which improves test coverage with up-to-date test cases.

Challenges Faced with Medical Device Testing

Device Compatibility: One of the major challenges in this domain is testing healthcare apps for web and mobile compatibility. In today’s world, most people rely on mobile platforms for almost every need. As a result, it is critical to optimize the healthcare app for a variety of mobile devices and operating systems. It is also critical that the apps be easily accessible, provide security for all information provided by the user, and assist in receiving all necessary updates.

Security Breaches: One of the critical requirements for any medical application is security. With the prevalence of cyber-attacks on various apps, any security breach will cost the company dearly. To avoid such scenarios, businesses should rely on digital assurance service providers for security testing. They have the necessary skills and security testing tools to conduct effective security and penetration testing on these medical device apps. As a result, incorporating security tests into every stage of app development will effectively assist healthcare devices in meeting the required security requirements.

Cloud Adoption: To gain a competitive advantage, every healthcare enterprise is heavily reliant on the cloud. This migration raises concerns about the network and data security of these medical device tests. If businesses are unable to overcome these obstacles, their brand may suffer. To overcome these scenarios and deal with the evolving challenges, enterprises must adopt cloud application testing and security testing practices during data migration to ensure a more secure network and the safety of cloud data. Businesses can easily embrace cloud computing with the help of trained QA resources from digital assurance services enterprises.

The Advantages of Automation in Medical Device Testing

Automation is an extremely powerful tool for the medical device testing environment because it reduces human error while also providing productivity gains and material savings. In the long run, you can significantly reduce time to market and enjoy many other benefits.

Tests that are data-driven: Healthcare applications work with data that includes patient personal information such as names, phone numbers, and data related to health records. Manual testing necessitates the time-consuming process of inputting each piece of data, which frequently results in smaller data sets or errors during test execution. By incorporating data-driven automation frameworks into your software testing practices, you can speed up the creation of test data, create larger data sets, and apply these data sets to multiple test executions.

Authenticated Validation: The security of patient medical data is a primary concern when it comes to software testing in the domain of medical devices. Test automation allows healthcare software quality assurance teams to test different cases, focusing on valid and invalid test data to make sure that the device application’s user authentication features are functional.

Test Execution Repetition: The IoT device application’s business users perform the same actions within the system on an hourly basis, day after day. Your everyday users rely on the app’s dependability to carry out their job duties on behalf of their patients. However, test cases focusing on repetitive behavior can lead to errors when performed manually. With test automation, one can run test cases as many times as necessary to ensure the accuracy of the application’s various processes.

Audit Trails Verification: Audit trails log any unauthorized activity that occurs within the application, such as unauthorized login attempts or record requests. Audit trails contain vast amounts of data, making it nearly impossible to test properly when run manually. In this case, automated test scripts are required to test for proper recording as well as detect specific instances of suspicious activity.

Reports Verification: Applications generate reports in a variety of formats, including HTML, PDF, CSV, and text, and deliver insightful performance metrics worth tracking. Furthermore, by selecting the appropriate automated functional testing tools, these reports can be automatically tested and verified across these formats, allowing your team to quickly identify and resolve issues.

Multi-Platform Verification: The objective has always been to confirm that the software application performs as expected across all device types and browsers, but when testing manually, this answer is never convincing. Automated testing can provide the undeniable results that all development teams require to confidently launch products to market. Test automation in medical device software can be used to run the application across multiple platforms and browsers, revealing any platform or OS-specific bugs.

Speedy Regression Cycles: The amount of time required for manual testing grows in direct proportion to the number of new features added to an application. Testers can use automated test cases to validate existing features alongside newly written code at a much faster rate. As a result, any differences between the features are discovered much earlier.

Cost Efficiency: The less time spent on manual adjustments and application verification, the lower your total testing cost. Because test automation can perform tests faster and earlier in the development cycle, fixes can be done sooner, allowing you to bring your product to market faster.


Medical devices are critical because they have a direct impact on patients’ health and well-being. As a result, medical device testing is an absolute necessity to ensure that these devices perform optimally while in use.

Any type of performance issue could be hazardous to the patient’s health, and in some cases, even become fatal. As a result, the healthcare industry requires automation in medical equipment testing services to ensure the dependability, safety, and effectiveness of the devices in use.

Cigniti’s TCoE aids in the resolution of some of the most difficult issues, such as device compatibility, security breaches, cloud adoption, and more.

Cigniti’s dedicated Medical Devices Testing CoE experts help verify and validate software for surgical instruments, contact lenses, ultrasound scanners, orthopedic implants, hemodialysis machines, and cardiac pacemakers.

Our experts are fully capable of helping clients test their smart, AI-based medical and healthcare devices such as Intelligent Beds, sterilization equipment, tool kits for pets, etc.

Need help? Contact our Medical Device Testing experts to learn more about channeling the power of automation in medical device testing.


  • Cigniti Technologies

    Cigniti is the world’s leading AI & IP-led Digital Assurance and Digital Engineering services company with offices in India, the USA, Canada, the UK, the UAE, Australia, South Africa, the Czech Republic, and Singapore. We help companies accelerate their digital transformation journey across various stages of digital adoption and help them achieve market leadership.

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