How Automation Boosts Medical Device Testing Efficiency

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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). 

The findings show that 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, which ensures that a device and its potential hazards are minimized, should be a top priority for device manufacturers. 

However, this does not always seem to be the case. 

According to Vantage Market Research, the Global Medical Device Testing Industry overview will 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 more extensive timelines as it calls for exhaustive processes for identifying defects and ensuring compliance. 

If a medical device is not FDA-approved, it is recalled from the market, resulting in significant losses. Medical devices must function flawlessly, so test solutions must be precise, accurate, and repeatable. 

Why Does Medical Device Automation Matter? 

A combination of clinical knowledge and technical expertise is required to comprehensively cover all test cases and compliance mandates—this is where automation comes into the picture. 

Medical device automation testing ensures you comply with FDA and other compliance agencies’ regulations and 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 significant 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 essential 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 adequate 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 quickly embrace cloud computing with the help of trained QA resources from digital assurance services enterprises. 

The Advantages of Medical Devices Automation  

Automation is a potent 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. 

Data-driven tests: 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 more extensive 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 and 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 identify and resolve issues quickly. 

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 launch products to market confidently. 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 services are 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 challenging 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 services 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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