questions to evaluate

4 Questions to Ask When Evaluating IVD Usability Testing Providers

 Clearly, usability testing is important. However, it can also be complicated and time-consuming to perform effectively. There are interweaving steps and lots of things to remember along the way. It’s no wonder, then, that many product developers seek to leverage the services of third-party usability testing experts.

In this article we’ll examine the qualities that every usability testing partner should have. Remember, it’s always wise to do your homework before contracting with an outside organization. After all, you wouldn’t trust your product’s usability testing to just anybody.

How Much IVD Development Experience Do You Have?

The usability testing company’s staff members should be more than self-proclaimed experts—they should also be researchers and product developers like you. This valuable experience with the product development process and the relevant materials thereof means the organization in question can offer an initial objective assessment of your prototype’s readiness for the usability testing process. Then it can guide you through any product fixes needed as usability testing reveals deficits or opportunities.


Your usability testing partner should also have experience in obtaining FDA and other regulatory approvals for devices similar to yours. This will help avoid common pitfalls in bringing your product to market. Furthermore, FDA and other regulators essentially require usability tests to provide evidence that your product is safe and ready for users.

What Are the Relevant Features and Capabilities of Your Facility?

You get a lot of important data when you closely observe users interacting with your product. The quality of a usability testing provider’s facilities can make or break your chances of getting good, usable data in this process. Many usability testing providers feature full-scale usability testing labs in which the product (and any required supplies) can be set up just like they would be in your own location or in the real world. In such environments, your team can observe each usability testing session as it takes place via observation rooms with one-way mirrors or high-definition, camera-based observation systems. Most reputable usability testing providers invite clients to tour their facilities, workspaces, observation laboratories, and testing suites prior to testing taking place.

Know about our expertise in IVD usability testing

Do You Specialize in the Diagnostic and Life Sciences Industry?

Usability testing applies to many industries and product categories, and one size does not fit all. The basic principles behind usability testing remain the same, but consider: does the company testing a new type of bicycle wrench have enough depth of experience to help you with your state-of-the-art medical sensor?


If you are in the life sciences industry, seek a company that has long-term experience in designing and manufacturing medical devices and diagnostic tools. This developmental expertise allows usability testing providers to match the testing process and environment as closely as possible to the real-world setting and ask the right questions prior to beginning testing. For instance:

• Are some tasks typically carried out in a confined or poorly lit area? A usability testing provider with the right specialization can simulate these environments in the most effective way.

• Does your device interact with specific bodily functions or anatomic features that are difficult to approximate in a usability testing setting? A provider with the right specialization can develop supplemental devices to simulate the situation—for example, by creating a device to simulate blood for the evaluation of a blood collection device.

• Will your IVD be used by patients at home without daily physician oversight? A specialized provider will understand how usability testing of a home medical care device differs from testing in a clinical setting.

• Does the device have the potential for use-related hazards? These dangerous situations occur more often than many may realize. A specialized usability testing provider can simulate environments in which users interact with the device under stressful or distracting conditions to identify the potential for unforeseen use-related hazards.

What Level of Interaction Will I Have with Your Team and the Testing Itself?

Your team has been intimately engaged with your product since development began. Who better, then, to be involved in the usability testing process? Successful usability testing providers know that involving clients in the process is one of the best ways to leverage the combined experience and expertise of both companies. As the involved client, you will also retain a high level of control over which specific product elements are evaluated.

 

The ability to sit in on observations is so important, in fact, that it should be standard practice for the usability testing provider you work with. Being able to witness testing alongside the observers, see the study unfold as it happens, and suggest any on-the-spot changes provides enormous benefits for both the client and the testing provider. This level of client/provider transparency intensifies confidence and accountability during the usability testing process.


Additionally, clients often benefit greatly from in-person discussions about user performance with the testing teams: for instance, did they see the same issues or reactions from inside the room? And did they reach the same conclusions? Close interaction between clients and testing teams can reap huge rewards in the form of quality insights for all involved.

Summary

Usability testing is an essential element of the product development process. It is designed to discover accessibility and performance issues in your product that a typical user may encounter. Unfortunately, these deficiencies are often difficult for product developers to identify themselves. In addition, formal usability testing that’s effective is complicated and time-consuming. For these reasons, many product developers choose to work with dedicated third-party usability testing companies.

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