Medical devices work under strict compliances and need to meet aggressive product delivery cycles, to be able to bring a high-quality product into the market. Such rigorous systems need sub-level testing, which is time-consuming as it calls for exhaustive processes that identify defects and ensures adherence to compliance. If the medical device isn’t FDA approved, it is recalled from the market, which leads to heavy losses.
It requires a mix of clinical knowledge and technical expertise to comprehensively cover all test cases and compliance mandates – Automation is the only way to go. Automation testing ensures you comply with the regulations of FDA and other compliance agencies, and consecutively make sure safety of operators and patients.
The proliferation of the miniaturization of electronics in medical devices is also creating several potential scenarios. But there are number of pros and cons to weigh out, as it can be a time-consuming and an expensive process. It is a fast-paced world, so to quickly understand how your industry can benefit from automation, analyze the history of your system of production to determine the test processes that are useful for you. If you have identified the labor-intensive processes, then automating gets easier.
How does automation bring about a change?
- Consistency in Production
Automated medical device production reduces product variability and improves overall quality. The automated tools available today, provide highly effective error detection and in many cases, automatic correction.
- Waste reduction
With automated systems you can witness an increase in the yield from every production run, resulting in material savings.
Imagine having to deal with multiple components and processes that are too small or too difficult for humans – how easy would it be to implement automated testing for such intricate processes. It is imperative that devices for medical use have to work flawlessly. So, test solutions must be accurate, precise, and repeatable.
Furthermore, if you produce devices in high-volumes, it only makes sense to invest in automated testing to provide immediate ROI. With automation, you are assured that the repetitive tasks in the production line are taken care off, in turn allowing your resources to shift their focus and use their energies to really make a substantial contribution to the industry.
Automation is an incredibly powerful tool for medical devices testing environment, as it reduces human error, but, beyond filling labor gaps, it provides productivity gains and material savings. And, in the long run, you can significantly accelerate your time to market.
Plan and schedule an internal review in six months to a year after production begins to review the data. Once your product is on the market, you will be able to build on that momentum with an automated testing line. And, automation will also help you to ensure that the launch of your next product is streamlined and ready for market volume production.
algoQA, has generated thousands of test cases and automated test scripts that efficiently are able to detect defects across medical device productions. These are readily available to be executed, no matter what the arrangement is, thereby helping businesses deliver high-quality products that are error-free and works seamlessly in the medical space. For more information on our algoQA platform for Test Automation – Read more.