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Customized Test Equipment for Medical Devices

Customized Test Equipment for Medical Devices

There are multiple phases involved in the development of a product and QA and Testing is one of the most critical phases.  Since it’s the final gatekeeper before the product goes out either for certification or for production. Numerous test equipment are available in the market for various needs. You might ask, why opt for a customized testing equipment for your device then?

Need for customized test equipment arises when you are designing a new product altogether for which necessary infrastructure to carry out traditional and standardized testing doesn’t exist. Typically 60% of the work involves new product development and hence customized test equipment design is not only a requirement but also a necessity in order to take the product to market sooner. Customized test equipment also plays a huge role when one needs to add new features to existing medical devices or to re-engineer it for a different market segment. According to the Gartner group, for every 25% increase in system functionality, there is a 100% increase in complexity. As more and more advanced features are added to an existing medical device, more and more complex testing is required in order to make sure that the product is working, according to the requirement.


1.0 Circuit Board of a BP Monitor

Advantages of Customized Test Equipment

1) Reduction in testing time
For any medical device a significant amount of time is specifically assigned for testing of the equipment. The need is justified due to critical nature of the equipment. Higher time allocations are partly due to the stringent testing norms that need to be followed and partly due to the manual testing involved. Customized test equipment can reduce the overhead of manual testing to a large extent (Easily by 25 to 30%). It also helps cut down time required to move from one test equipment to another.

2) Remote testing through web
Customized test equipment gives you the flexibility to test your equipment online without being physically present at the facility. This means that multiple teams across the world can run their test cases simultaneously and also change them on the fly. Remote testing gives you the flexibility of comprehensive and rigorous testing for making your product build stable in the field.

3) Customizable Reports
Customizable online reporting with web-based analytics tools like Jaspersoft and Tableau can help you determine the actual cause of incident without having to go through multiple spreadsheets. We have seen some of our clients see and fix issues in real-time with online reporting without having to go through all test runs and wait for final results. Customized reports help you pipeline testing and bug-fixing efforts better, leading to shorter QA and Testing Cycles.

4) Ease of Upgrade
Many of the medical devices that hit the market go through an upgrade phase either pretty early in the inception phase or as part of the re-engineering effort after a longer duration. Customized test equipment, if designed taking into consideration future enhancements, can become the deciding factor for timelines required for the new product to hit the market. A well-designed test equipment will only require changes in test cases and nothing more.

The only drawback of using customized test equipment is the time involved. Although tons of time is saved during every process during the testing phase, it is not possible to envisage the amount of time saved versus the time involved in developing it at the initial phases. In order to bridge this gap better, we have been taking the effort of customized test equipment building on a case to case basis and project results based on the expected number of units going through the testing phase. This definitely gives a clear picture of time, effort and money saved by building customized test equipment.

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