When Medical Device Software Fails Due to Improper Verification and Validation

Software can be an essential component of your medical device, whether you’re designing a new product or improving the functionality of an existing one. Medical device software continues to change and expand across many types of medical devices. Patient safety must be a primary concern of medical device companies.

The FDA continuously monitors and reports on medical device problems. One report, “Medical Device Recall Report FY2003 to FY2012,” points to software design as the biggest cause of medical device recalls*. Failure to implement software design controls and develop sufficient medical device software testing procedures can lead to software anomalies often requiring a correction or removal of the device. This can have an effect on patient safety, company reputation, and legal issues.

The first step to avoid software failure and FDA recall is to understand the role medical device software verification & validation (V&V) plays in design, development, and use. V&V testing is a critical part of the medical device development process. Unfortunately, V&V is often not given the proper emphasis, and the value it brings to medical device development tends to be overlooked.

Updates to software in medical devices are common, to accommodate for technology changes and user needs, and to correct existing errors. Even medical device software that has undergone V&V testing is prone to failure when a minor change occurs without repeating the appropriate level of V&V testing. Therefore, when it comes to the software in medical devices, one seemingly minor change can have drastic implications for device function and clinical performance. As such, reliance on software functionality and the regulatory need to make sure the software works as intended becomes increasingly important.

What is verification and validation and aren’t they the same thing?

Verification and validation differ from one another. Verification answers the question, “Are we building the product right?” While validation turns the last two words of the same question around, asking, “Are we building the right product?”**.

Through the verification process, a medical device developer is testing to see that the medical device software meets software specifications. Verification should occur throughout the medical device software development life cycle. On the other hand, validation tests confirm that all user needs and intended uses are met. Validation tests include, but are not limited, to usability, acceptance test, and, when available, comparing data with gold standards.

Medical Device Software Verification is conducted during the development process by individually, or collectively, checking the functionality of each software feature (input, output, calculation, etc.) to ensure that it meets the stated requirement. Software Validation is usually conducted in a clinical, or patient-care, setting by using the finished device to ensure that it functions as it is intended to (control heart rhythm, measure heart rate, improve hearing, etc.).

Medical device software is ever-evolving and medical device software developers have to continually find ways to remain competitive in the medical device industry. With the recent upsurge of new patents in the medical device industry***, just consider how much more competitive the market will be in the coming years; just another reason why maximizing V&V success is critical to your medical device software development projects.

In a future post, we’ll dig deeper and provide ideas on improving V&V success.

References

* “Medical Device Recall Report FY2003 to FY2012,” FDA Center for Devices and Radiological Health Office of Compliance, Division of Analysis and Program Operations http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM388442.pdf (accessed September 23, 2015).

** Wikipedia contributors, “Software verification,” Wikipedia, The Free Encyclopedia, https://en.wikipedia.org/w/index.php?title=Software_verification&oldid=660822426 (accessed September 23, 2015).

*** Phillips, S. “Tracking Patents and Mapping Medical Device Innovation,” Medical Device and Diagnostic Industry, August 11, 2015, http://www.mddionline.com/blog/devicetalk/tracking-patents-and-mapping-medical-device-innovation-08-12-15?cid=nl.mddi08.20150813 (accessed September 23, 2015).