Rising competition connected medical devices, and complexity are changing the phase of the medical device industry. While the end customers are experiencing life-improving innovations, including advanced technology, automation, wireless technology in the medical device, it has immensely increased the pressure on medical devices manufacturers. Companies have to deal with challenges like cost-effectiveness, globalization, compliance, and supply chain management, impacting product quality and performance.
The industry’s transformational growth and innovation in medical products such as wearables and several applications associated with them have put an immense burden in terms of maintaining the standard quality. These products are getting popular among individuals, maintaining accuracy and precision is critical. Hence robust testing and quality assurance are essential to maintain quality standards and reliability.
Also Check:
Improving Medical device safety by Robust software testing
Businesses across a wide range of industries have created methods for incorporating quality and testing into operations at every stage of the value chain, from design to production to sales and service, resulting in long-term cost savings. Let’s understand what are the other factors that are enabling medical device CEOs to make quality assurance (QA) and testing a top-of-the-mind priority.
1. Interoperability of medical devices
Medical devices and applications have become co-dependent to deliver an enhanced experience to its user. Further data security, regulatory compliance, and privacy have increased the demand for rigorous testing and maintaining quality. If done diligently it will solve compliance issues and determine business sustainability. Robust testing and strategic quality assurance plan ensure that every aspect of a product/application quality is tested to assure interoperability. With the rise in smart devices, the QA and testing team needs to maintain software control and application integration with the core software.
2. Application Security
Health applications contain critical patient data and health-related information. Any data loss or breach of personal data can lead to serious issues. Application security testing helps in making an application hack-proof in the digital space. Personal data and health-related information are critical for patients. User encryption, user log-in authentication, and testing against firewalls are key measures undertaken to ensure the safety of the application for usage through Quality assurance and testing.
3. Efficiency and productivity
Medical device software is getting complex. Therefore, it is important to ensure that it functions effectively without any interruptions. Quality assurance and testing guarantee that all the nodes of the application work seamlessly to provide a holistic experience to the users. This ensures productivity and growth for all the players involved in the value chain.
4. Usability testing of medical device
Usability testing examines how medical equipment is utilized by patients and people who will use it once it is released to the market. This is a crucial step in the development process since it helps medical device designers to assess if the device has any usability issues, if users have an unhappy experience after or while using it, and it allows them to collect useful data.
If Usability Testing is not done early enough in the lifecycle of a medical device, it can lead to a slew of issues, including a device redesign. A change later in the device development phase could result in a lengthy FDA/CE filing, a delay in your timeline, and a negative impact on your bottom line.
5. Validation of the Software Performance
Software is playing a critical role across medical devices and applications. It has a crucial role to play in delivering the desired performance and service. Software testing aids in the validation of business procedures and the measurement of performance to assure the desired outcomes. This is accomplished by keeping a close eye on the strategy, implementation, and execution of every defined parameter. As a result, the quality output can be achieved in shorter development cycles. Quality Assurance also provides thorough coverage of all scenarios and settings, which aids in the completion of testing.
Conclusion
Patient data security, quality medical devices, and adherence to compliance are key areas that medical device manufacturers have to face. Implementing the best quality assurance and testing strategy help organization add a competitive edge and bring quality medical devices that are desired by the users.
How MicroGenesis can help in Quality assurance and testing?
We have around 16+ years of experience in building robust testing and quality assurance strategies for reputed medical device manufacturing companies. Our expertise lies in testing a range of medical device applications and tools to help you shorten your development, testing, and documentation cycle and deliver safe and quality medical products on time and within budget.
To know more about software and application development and testing of medical devices contact us:
https://www.mgtechsoft.com/contactus/