Improving Supply Chain Quality Through Software Testing in Regulatory Systems
By: Rajani Gangarapu
Tags: Software Testing, Software Development, Testing, Software, Supply Chain

Photo by Fotis Fotopoulos on Unsplash

As a Software Test Engineer for the past 7 years with experience of working in Regulatory Applications, I have observed how testing plays a prominent role in the software development life cycle and the importance of testing in each phase. I have witnessed cases where the software released to production without proper testing has resulted in more cost, and rework.

When it comes to Regulatory applications, it always has tough deadlines and frequent releases to compete with the current market products. If the software is released to production without being fully tested this may result in damage to the company brand.

I strongly feel that software testing is very important to produce a quality/defect-free product to the supply chain and reduce the risk of defects in later stages of the product life cycle. The importance of finding a bug in software is to prevent a defect from reaching the production line. It’s difficult to solve the issue once it hits the production line, resulting in scrappage of product. The risk of the defect reaching customers is higher in the medical device industry, where it may cost human life.

Software Testing’s Role in Medical Devices:

• Testing plays a prominent role in regulatory projects, such as banking and medical device sectors

• Ensures compliance testing with various regulations such as HIPAA, PCI DSS, and FDA, etc.

• Software Testing ensures the product behaves as designed as per the requirement specified by the client

• Testing provides accurate evidence and storage of tests, print screens to support tests — protect you and your company’s credibility (for audit purposes)

• Reduces the risk of defective products being shipped to the customer

• Software testing ensures rules and regulations are validated against a product in the initial stage of the product lifecycle

• Ensures healthcare CRMs, patient mobile apps, medical devices software, and Patient Database management systems work seamlessly under various scenarios

Different Software Testing types that can use in medical devices products

· Test Automation

· Security Testing

· Regression testing

· Performance testing

· Functional Testing

· Usability Testing

· Compatibility testing

Benefits of Software Testing in Medical Devices:

• Testing helps Functional and Application Integration Services for continuous product releases

• Early adoption of QA in the Development cycle with parallel establishment of the test set up (test cases and data) and execution provides the Accuracy in requirement and Reveals if any requirement gaps in the FSDs.

• Patient safety and customer satisfaction

• Software testing helps to validate the labels and barcodes against the medical devices' work orders.

• It helps to test the integrated third-party systems by using different web API and automation tools.

• Software Testing helps to find the bugs in the code in the initial stage of the product life cycle.

• Prevent product recalls.

• Protect a company’s credibility by keeping evidence of testing

• Security and privacy — audit trails with sign-in information storage.

• Saves time and money.

Risk of not performing Software Testing in Medical Devices:

• Company reputation could potentially be damaged

• Financial loss

• Defect product could cause lawsuits

• Product recalls could cause more re-work

• Falling behind in the marketplace

• Potential cost to human life

Why Quality Assurance is Critical for Medical Device Testing

Speed and quality are the core essentials for serving the healthcare sector effectively. Digitization is one of the major breakthroughs that healthcare has witnessed. It implies connecting people and devices and deriving meaningful inferences from the data generated to offer better services. Quality Assurance and Testing are enabling enterprises to answer these questions and implement better digital strategies for the sector.

Technology is the biggest transformation point in the healthcare sector, wherein applications are being created to deliver service anytime anywhere and connected medical devices are helping experts to deliver their services even from a distance. There are a growing number of healthcare products such as wearables and a number of applications associated with them. These products have a big market and have a tremendous impact on the economy. Consequently, healthcare products need to deliver accuracy and precision, which is possible with robust testing and quality assurance.

Moreover, the idea of home healthcare is changing the way healthcare functions, which demands easy and quick access to healthcare. On-demand medical assistance is a new paradigm in the healthcare segment. Home healthcare is a rising trend and is expected to grow in the coming years.

There are some evident reasons for comprehensive testing in the healthcare sector. Let’s look at a few.

Interoperability of medical devices

Healthcare involves medical devices and applications that need to interoperate and connect to deliver the required experience to the user. The sector has a huge demand for interoperability, regulatory compliance, security, and data privacy. There is a need for healthcare application testing that involves technical expertise, major time and resources, and costs. This has to be done diligently, as it determines business sustainability and also involves compliance issues.

This requires rigorous testing and a thought-through quality assurance plan. These tests need to be recorded and repeated for audit and compliance purposes. Test automation is implemented to create a strong QA environment and ensure that every aspect of the product/application is tested to assure interoperability. For instance, healthcare wearables interact with users via mobile applications. If both the wearable and the application do not work in sync, they might not show accurate results. With the innovation around IoT and smart devices, there is a need for medical devices, software control, and application to integrate with the core software.

Functional Validation of the Software

Across healthcare products and applications, it is important to ensure that the software is fit enough to deliver the required performance and service. For instance, consider a hospital application that helps patients to generate reports with a secure login. The application must be functional all the time to deliver the required service accurately.

Software testing helps to validate business workflows and take performance measures to ensure the desired results. This is done by monitoring the strategy, implementation, and execution on every defined parameter. Consequently, this helps in ensuring the highest quality output within shorter development cycles. Quality Assurance further ensures comprehensive coverage across all the scenarios and setups, which helps achieve complete testing.

Security of the Applications

Healthcare applications have sensitive data about patients and their health-related information. It can lead to a major breach if the applications are hacked for information. Security Testing with Penetration Testing helps to make application hack-proof and sustainable in the challenging digital scenario. Validation and authentication of user log-ins, testing against firewalls, and encrypting user data are some key measures. Quality Assurance and testing are essential to ensure the security of these applications.

Healthcare applications or products need to adhere to the stringent Health Insurance Portability and Accountability Act (HIPAA) requirements that ensure the protection of Patient Health Information. With effective QA all the information flow across channels can be eased out and kept secure.

Big Data testing in Healthcare

Healthcare is a highly data-intensive sector with tons of patient information and health conditions. This data is essential for healthcare institutions and associated segments to devise the right strategy and build relevant products. Big Data solutions are implemented to derive the right inferences and data points. It helps in making informed decisions regarding drug inventions, disease cures, research, and development, and much more for the healthcare sector.

Big Data solutions need to be implemented effectively within the organization’s ecosystem. This requires Big Data testing for flawless implementation, which leads to expected outcomes.

Usability Testing in Healthcare

Usability Testing is critical in the Healthcare sector. For instance, there are various features and user scenarios that pharmacists and nurses face innumerable times during the working hours. These tasks can be eased out with automation and adding features that can simplify the tedious process. The User Interface and User Experience of healthcare-related apps and medical devices can also be enhanced with much-needed Usability Testing methods.

Effective Implementation and Productivity

Healthcare systems need to ensure increased efficiency and productivity in order to serve the patients in a better way. Applications are getting complex and it is important to ensure that they function effectively without any interruptions or interventions. Quality Assurance ensures that all the nodes of the application work seamlessly to provide a holistic experience to the users. This ensures productivity and sustainable growth to the players in the healthcare segment.

End-to-end requirements traceability and their complete coverage

Business, compliance, and risk treatment requirements should be mapped with technical requirements and test design documents, and this mapping should be reflected in a requirements traceability matrix. This would not only help you ensure that all technical requirements are covered with test cases but also speed up the testing process and facilitate debugging.

Automated Testing:

This form of testing is taken up to ease the testing process and overcome manual tasks to ensure quality at speed. The automated testing makes the QA process faster, more accurate, and complete. Primarily, the process includes stimulating the target device, monitor the device response, record the results, control the entire process using automation, and declare results.

While opting for the test automation system, the testing teams need to adopt the strategies based on the test options achieved in each medical device development stage. In case, the testing strategy is for complex devices that use extreme voltage and current, then it is essential to break down the test specifications into hardware and software requirements based on the interfaces as hardware and software. This will prevent the testing teams from facing any sort of challenge in the test automation environment.

Conclusion

Security of patient data, secure interface for the applications, good turnaround time, interoperability of medical devices, and flawless performance are some key areas that the healthcare sector has to deal with on a daily basis. Quality Assurance and Testing helps healthcare organizations to deliver relevant solutions to the patients or any kind of consumers.

Reference: https://www.cigniti.com/blog/top-6-reasons-healthcare-sector-needs-qa-testing/