6 Reasons Why Quality Assurance is Important in Medical Devices  

We’re in the era of digital healthcare and witnessing the adoption of different technologies. These technologies are helping the healthcare sector to provide better care to patients.  

Right now, the medical devices market is growing at a faster pace than we could ever have imagined. MedTech firms are embracing the speed of technology change. At the same time, medical devices used to be for doctors only to use with their patients. Now they’re common in every household in the form of portable blood pressure-checking devices, BMI trackers and more.  

Doctors, patients, and even those who are healthy often depend on a device to track that their body is functioning regularly. This growth in the personal use of medical devices places responsibilities on manufacturers. They need to carry out medical device testing to check their product for functionality, performance and security. 

Importance of quality assurance for medical devices 

The global medical devices market is enormous. It’s projected to grow from $495.46 billion in 2022 to $718.92 billion by 2029. Indeed, a new device is launched every few days. To stay competitive, medical device manufacturers need to address various key factors. These include regulatory compliance, data security, performance and functionality, verification and much more. All these factors can affect the effectiveness of a device and impact patient safety.  

Digital quality assurance (QA) plays a vital role in helping businesses develop successful and helpful medical devices. It allows manufacturers to perform robust software testing of their devices. It also helps them to analyze functionality and performance quality to deliver a delightful customer experience.  

6 reasons why you should quality assure your medical devices 

There are many reasons why QA is necessary for your medical device, but here are the top six. 

  1. Extensive data management: Medical devices collect individuals’ health data. This data is stored in the cloud for analysis by clinicians or to develop new products. The health data collected by devices are used in various ways and should be maintained with proper tech hygiene. Why? Because any breaches, data loss or improper data collection will affect data management and device performance. It can also cause regulatory compliance infringements leading to possible fines. 

Managing such large amounts of data calls for manufacturers to test their medical devices for all possible vulnerabilities. This is done by QA experts who perform medical device testing to find and prevent any defects from occurring.  

  1. Compliance: For every medical device, it’s crucial to follow the latest industry regulations and standards. MedTech businesses should understand the importance of regulatory compliance and ensure that their devices meet set standards.  

This can be done by QA engineers who test devices for compliance with FDA, HIPAA regulations and more. They help deliver an efficient and technically sound medical device that is also safe for consumers.  

  1. Robust security and preventing vulnerabilities: A smooth functioning device is not enough for your users. To be successful, a device also needs to provide the best security. Hackers and other bad guys are always on the lookout for a new target. You don’t want that target to be your device. So, you need to test your medical device for robust security and give your users a product they can trust.  
  2. Prioritizing (UX) user experience: Medical devices have a diverse set of users. So, manufacturers need to provide a flawless and reliable user experience. Integrating QA into the development process helps you focus on the user. QA experts know what can affect the user experience and will test your medical device keeping in mind all these factors.  
  3. Functionality and performance analysis: The medical device testing process is designed to help manufacturers assess the functionality and performance of their devices.  

QA experts strategically plan the entire process to ensure your medical devices are resistant to failure. By testing early and often, they can report the flaws sooner in the development process and correct them. This process helps the team save time and resources while delivering a better device for patients.  

  1. Automating testing: Medical device testing is a continuous process and should start early in the development cycle. This also means testing can take time to complete. 

Test automation is a great way to make the testing process faster and more efficient. QA experts plan the process to determine which test cases can be automated and which test cases still need to be performed manually. The upshot is that you deliver a top-performing medical device that patients love in the fastest possible time.  

Key takeaways 

There are currently hundreds of thousands of different types of medical devices available on the market. But not all of them perform well for users. Your device should make the best use of technology and be efficient and failure-proof. 

Digital quality assurance can help by solving many complex problems. Integrating digital QA into your medical device development process will allow you to focus on quality as well as the user experience. As a result, you can develop a successful medical device that functions smoothly, safely and securely, delights users and gives you a higher ROI. 

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