Testing of medical devices poses a considerable challenge in terms of cost, effort and time. This is a critical and challenging phase of the product development lifecycle; especially when we have to meet the stringent guidelines imposed by medical device regulations such as IEC 62304 and ISO 14971.

Manual testing can be very expensive and time-consuming, contributing to as high as 60% of the development cost. This is where automation steps in. The benefits of cost saving through automation significantly outweigh the initial investment.

However, there are important considerations when it comes to automation of testing and other activities after the code is checked-in. Here are a few:

  1. The automation tool that is introduced should be treated as NPS (Non-Product Software) and hence should undergo a formal tool validation process. The tool should support requirement traceability, which is again a key regulatory requirement. Hence, integrating the automation tool within the overall test management setup is important.
  2. Modern day applications are expected to run in a cross-platform environment. Hence there is a need for cross-platform test framework as well.
  3. Test cases often have scenarios that involve multiple form-factors such as desktop, mobile, web and even firmware based HMI, to complete a given workflow. Having a mechanism to seamlessly drive these tests in an automated fashion can be extremely beneficial in use-case driven testing.
  4. Integration with many medical device specific test tools are used (e.g.: image comparisons, image quality analysis, compliance tests for DICOM, HL7 and IHE) is an important consideration. The ease of adding and editing test cases will enhance productivity.
  5. Adherence to an automation testing methodology (tools, procedure and processes) that is independent of the underlying tools, thereby eliminating the need to maintain engineers with various tool-specific skillsets will make the process very scalable.
  6. The test automation setup should be integrated with a Continuous Integration (CI) environment. Continuous testing provides for an early feedback mechanism on the quality of the product, eliminating the costly proposition of detecting defects far later in the lifecycle.
  7. Management of ‘golden data sets’ is another key consideration in the test automation setup.
  8. With the devices being released globally, the need for cost effective localization testing is assuming greater importance. The automation platform should be able to customize each test run with ease.

Hope these 8 tips help you, I would love to hear your reactions and suggestions to my blog. Thank you.

Written by Satish Kumar

on 06 Dec 2017

Satish has about 20 years of Healthcare & Medical Device engineering expertise in the area of systems engineering, services development, R&D and Product Development. He had led large globally distributed teams across India, USA, UK, Germany, Australia, and Japan for some of the leading medical devices organizations. At QuEST, Satish focuses on enhancing diagnosis quality and enhance patient experience through new-age imaging applications, diagnostic imaging modalities, and digital technologies.