Bridge the Gap Between User Needs & Unknown Design Inputs with Qualification Testing

 In Engineering, Medical Product Design

The first step in building a medical device is to identify the full range of user needs your product will meet. Only then can you begin actually designing a product by translating those needs into a set of specifications (or inputs). The act of translating needs into inputs is where the magic happens. It’s the product team’s opportunity to creatively explore boundaries and develop new possibilities as they work to identify the best solutions.

But there are times when you can’t easily discern the right answer for a given need. When that happens, you must find a way to select from a variety of possible solutions. In order to make the best decision, you need more than a gut feeling or personal preference. You need qualification testing.

What is Qualification Testing for Medical Device Development?

Qualification testing is a form of preliminary testing. Its purpose is to help product teams bridge the gap between a known user need and an unknown specification. Unlike verification and validation testing, qualification testing isn’t a given in the medical device development process. Rather, it’s a tool that medical device designers use to ensure that they are making appropriate design decisions.

If your team doesn’t know the answer to a particular user need, your first step is to more clearly define the way your product (or product feature) ought to behave. Next, you can start generating ideas and characterizing possible materials in support of that behavior. But how can you go from a list of possible solutions to the solution? This is exactly where qualification testing steps in.

For example, let’s say you are designing a pipette. You know your pipette will be involved in a number of different use cases. But you aren’t sure which material to use in constructing it. With qualification testing, you can compare the performance of various materials — such as glass, metal, and plastic — in the context of your anticipated use cases.

Depending on your results, you can select a material and move forward with your medical device design. Of course, the decisions you make in qualification testing will need to be verified and validated in later rounds of testing. But qualification testing is what sets you on the right course to begin with.

Note that qualification testing isn’t the same thing as characterization testing, though the two terms are sometimes conflated. Characterization testing is used to evaluate behavior, such as the properties of a particular material (its strength, compression set, etc.). Qualification testing goes further. It evaluates the performance of intended product features (or the performance of multiple characteristics together) to meet certain baseline objectives and/or specifications for a requirement.  For that reason, qualification testing is the right choice to support specification development in response to a known need.

The Benefits of Qualification Testing

Qualification testing isn’t always warranted. But under certain circumstances, it’s extremely useful. By leveraging qualification testing, your product team can:

  • Identify what a product’s specifications could or should be, especially when the best solution is unknown. For example, which materials are best suited to meet a particular user need?

  • Reduce costs by uncovering viable alternative solutions.

  • Develop a sound understanding of a product feature’s expected performance.

  • Explore ways to improve an existing product’s performance.

  • Set the stage for future product development successes.

How Do You Know It’s Time to Do Qualification Testing?

So how do you know you need qualification testing? And when exactly should you incorporate it into your project?

As soon as you have a complete list of project requirements for your planned medical device, it’s time to start thinking about qualification testing.

Chances are good that your team will be able to quickly translate many of your project requirements into clear-cut specifications. Additionally, there may be a few requirements for a solution, that are/is unknown or unclear. These are the requirements for which qualification testing is needed.

For example, if you have known specifications that you want to adjust (say, by increasing the performance or reducing cost), then you’ll want to incorporate qualification testing for these attributes as well.

If your medical device company prepares a House of Quality matrix as part of the early product planning process, that would be the perfect time to assess your need for qualification testing and schedule it in.

Before making a final decision, don’t forget to consider timing. Qualification testing is a useful tool, not a required activity. So you’ll want to balance the desire to weigh your options with the very real need to keep your project moving at a steady clip. Like all testing, qualification testing takes time to develop. You’ll need to define which variables you want to compare and how you plan to observe them. In addition, you’ll need to determine the right number of samples required to ensure your newly found answers are the right answers for the long-term needs of your product.

Qualification Testing is Critical to Building the Right Medical Device

In the end, qualification testing helps answer the biggest question of all within product development: Are you designing the right product for the right job? When a product moves from the design room to the manufacturing floor, you need to have confidence that your specifications can and will be met. With qualification testing, your team can rest easy in the secure knowledge that you’ve arrived at the best-fit specifications to meet your needs — and that those specifications are built for performance.

Qualification testing in early product development should be thought of as a tool for success, not a box to be checked. Simply put, qualification testing enables your team to make the smartest design decisions — decisions that will raise the bar on your product and help you move to the front of the pack.


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