Key Objectives of Testing Software within Medical Devices

Technology plays a critical role in the healthcare industry in delivering top-quality services to patients ranging from diagnosis, treatment, telemedicine, auxiliary healthcare services, and data transmission and management, among others. However, given the fact that such technologies have a direct bearing on patients’ health, their quality should be top-notch with no room for error. Imagine a device connected to an ICU patient to measure oxygen saturation or heart beat. And if the software running the device has glitches, then the erroneous output could jeopardize the life of the patient. A scary situation indeed.

To ensure medical devices and the software running them deliver results accurately and consistently, there are a raft of regulations and standards to uphold. This is because a strict regulatory framework helps prevent low-quality medical devices from hitting the market.

How does medical software testing work in the healthcare industry

Regulatory bodies have set up high-quality standards for different types of medical devices. These standards primarily focus on high performance, safety, data transmissibility, and accuracy of diagnostics. Manufacturers should keep such compliance standards into consideration at the planning and designing stage itself. This is of utmost importance as it would be tedious and very expensive to remodel the software product in the later stages of development. The medical devices testing approach should not only be about monitoring the product’s quality during the development phase, but during transport, storage, and implementation phases as well.

A sound medical devices testing strategy involves having a clear idea of the validation criteria and the exacting regulatory standards the devices have to meet. Further, medical software testing allows companies to focus on research and development to develop new and useful solutions rather than merely fixing errors.

Types of quality assurance in the healthcare sector

There are three types of quality assurance conducted in the healthcare sector:

Medical software testing & quality assurance: This type of quality assurance includes the testing of software applications to enhance the workflow of medical procedures. The workflow may be related to a hospital management system or information management system, telemedicine or telehealth, health monitoring apps, and electronic medical records, among others.

Medical device software verification: Here, the testing includes controllers and systems that keep up with the functionality of medical devices. These controllers and systems may include AI-driven insulin pumps, diagnostic equipment, asthma monitoring devices, and many others. In this type of medical devices software validation, both hardware and software layers are checked for synchronization. It calls for compliance with the internationally recognized regulatory standard, IEC 62304.

Medical device testing: This type of medical device performance testing is only concerned with verifying and validating the performance and functioning of medical devices and their compliance with the regulatory standard, IEC 60601.

Key benefits of testing the software in medical devices

Verifying and validating the software within medical devices for various parameters delivers several key benefits, as mentioned below:

Application security: Healthcare applications may contain a lot of sensitive data about patients, namely, their health information. If it falls into the wrong hands due to a data breach, the information could be used by malevolent actors for nefarious purposes. So, it is critical to conduct medical devices security testing to identify glitches and strengthen the security of the software from potential hackers. Also, the testing aims at making the software compliant with HIPAA and other regulatory provisions for enhanced privacy and data security.

Better user experience: Complex healthcare applications need to be tested to ensure they function seamlessly and without any disruptions. This way, the applications can offer a superior user experience in terms of accurate results, seamless performance, scalability, usability, and others.

Handling big data: The healthcare industry deals with a humongous quantity of data comprising patients’ information and their health conditions. The data is important for making informed decisions related to diagnosis, treatment, cure, research, and many more. By employing big data handling techniques, the software applications can deliver expected outcomes.

Conclusion

The dynamic healthcare industry is highly techno-driven to provide hassle-free patient care and address the emerging challenges related to hospital management, diagnosis, and treatment of patients. Further, the regulatory standards for medical devices are enhanced to ensure better performance. It is through medical device validation services that the software within medical devices can be assured of quality and compliance.

James Daniel is a software Tech enthusiastic & works at Cigniti Technologies I'm having a great understanding of today's software testing quality