Product Development
April 1, 2021

Design Verification and Validation How To Do It Right

Design verification vs. validation — what’s the difference? We break it down in our latest article.
Design verification vs. validation — what’s the difference? We break it down in our latest article.

When a medical equipment developer tries to bring a new medical device to market, the device will be subject to design controls — a multi-step framework for ensuring that the device is safe to use, works as intended, and meets a clearly identified need in the market.

Design controls also help prove that the manufacturing and production processes used to create the device or product meet regulatory standards. This is important for advanced medical equipment like joint replacements, implants of any kind, enteral feeding systems, NICU medical equipment, and other devices that must meet the design control guidelines as defined by the FDA.

Two steps in the design control process — design verification and validation — are especially important, as they take place when the end of the production cycle is finally in sight for medical device manufacturers. However, the design verification testing and validation processes can quickly become time-consuming and frustrating without a strategic approach. This article will guide you through how to successfully and efficiently navigate these two stages so you can get your products to market as soon as possible.

Design Verification vs. Validation: What’s the Difference?

Design verification and validation are two sequential steps in the design control framework. The quality of the verification process, therefore, has a direct impact on that of the validation stage. While similar, the two processes differ in a few key ways.

Design verification is the process of proving that the product design outputs satisfy the input requirements specified by the design. This involves design verification testing or using the product in various activities to demonstrate that the outputs match the inputs defined during upstream design control processes. A few common design verification activities include thermal analysis, fault tree analysis of a design or process, and testing the biocompatibility of materials or package integrity.

Your device will only be as effective as the inputs you use to create it, so this is important to get right — if the outputs do not match the input requirements, then the product designs require further revision. Ultimately, the design verification step is about identifying potential errors or flaws and removing them before proceeding any further in development.

Here are some questions to consider during the design verification process:

  • Are you capturing the right user needs? Take a narrow approach rather than a general one.
  • Are the design input requirements clearly defined? Take the time to build a solid foundation — the process of establishing design inputs can take up to 30 percent of a project’s timeline in many cases. Use industry standards, regulatory guidelines, competitor’s products, and other data sources to help establish your design inputs.
  • Have you conducted enough testing? Sufficient testing is necessary to confirm that the design outputs meet the input requirements, but keep in mind that extensive testing gets expensive and can be subjective and unreliable if rushed.
  • Did design reviews reveal anything noteworthy? Keep an eye out for patterns that become apparent which may require further investigation or design revision.
  • Do your design plans have the proper level of detail? If your outputs still don’t match, consider expanding or contracting your scope.

The Next Step: Design Validation

Whereas design verification proves that the device is capable of functioning as intended, the design validation process ensures that the device actually meets the user’s needs. This means testing the product in simulated or actual use testing. However, one element of design validation that can get overlooked is that the product packaging and labeling also need to be tested. Without this or use testing, the design validation will be ineffective.

Clinical evaluation is critical to design validation. This can take the form of everything from detailed mathematical models to allowing end-users to physically interact with the device. Testing your device against similar products is key to establishing appropriate baselines, which also includes assessing how the device performs in specific environmental conditions. If a device needs to be able to move easily between rooms or must be biocompatible, this is the stage to test and document those properties.

Another key part of design validation involves creating initial production units. Think of it as a dress rehearsal — the products to be validated must be created in the production environment by proper personnel following the actual designs and specifications that will be used. This helps to demonstrate that the actual production process is viable.

Partner with Kentec Medical Today

Paying attention to this guide and the key considerations outlined above is a great way to get ahead when it comes to developing your new medical devices. However, as any development team can tell you, there’s still plenty of room for unexpected variables and complications.

That’s why partnering with Kentec Medical is the way to go. Our unique business model couples the advantages of modern manufacturing with a proven record of expertise in the advanced medical equipment manufacturing field. We believe that delivering a top-notch customer experience from the ground up is critical to supporting vital healthcare networks in their work. To learn more about how we can take the hassle out of developing your products, contact us today.

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