The Challenges of New Product Testing

Verification & Validation testing are vital components when launching a new product due to the fact that they are often necessary in order to meet regulatory requirements and stay in compliance with quality management systems such as ISO 9001 and 13485. Although frequently used together, they have two distinct meanings.

Verification asks the question “Is the device designed correctly?”, whereas Validation asks, “Has the right device been designed.” Verification is achieved by comparing design outputs to design inputs, typically via testing and inspections.  Validation answers the bigger question of whether or not the device consistently meets the needs of the user and provides the intended benefit in actual-use conditions. For a medical device, this consists of usability testing, animal studies or clinical trials depending on the class of the device.

These processes can be challenging regardless of the size of the organization or the level of experience amongst the product development team. A recent article in Medical Design Technology “Top 10 V&V Fails” examined the most common mistakes that frequently derail a Verification & Validation program.

These include:

  1. Uncontrolled test articles
  2. Inadequate design inputs
  3. Product tested is not the final design
  4. Insufficient test sample size
  5. Test tools not validated
  6. Test protocol documents are not rigorously managed
  7. Poorly developed test methods and test tools
  8. Inadequate software testing
  9. Poor test planning
  10. Testing is not comprehensive

Since bringing new products to market is one of Sparton’s primary functions and Verification & Validation testing is an important element of that process, we turned to a few of our in-house experts for their advice on this vital topic.

Jahnavi Lokre, Business Unit Director for Sparton’s design facility in Irvine, Calif. stated, “A common issue that I have encountered is the definition of good requirements.  Requirements translate the user needs into design inputs.  Having requirements that are necessary, unambiguous, testable/verifiable, unique, and complete and consistent, give a solid foundation to the design verification task.

Mike Scheidnes a Design Engineering Manager at Sparton’s new product development facility in Plymouth, Minn., advised the following: “By far the most common issue we run into is that the system requirement and its corresponding verification test are written by someone intimately familiar with the design.  We then require someone who is unacquainted with the design to execute the test. As you can imagine, a lot of questions come up.  In order to mitigate this, we have another person who is also unfamiliar with the design review the protocol for completeness and clarity. This enables the individual performing the test to do so error free and without interruption.”

Did any of your challenges make the list? Do you have any advice for tackling any of the problems listed above? Do you have one that hasn’t been discussed? Enter your thoughts in the comment section below to get the conversation started.



The Art of Design Verification and Validation: 8 Steps to Creating your Medical Device

Navigating the Medical Regulatory Landscape

Medtech Quality and Compliance: What You Need to Know


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