Balancing Market & Technology Product Needs by User Testing Early and Often

 In Human Factors & Usability Testing, Medical Product Design

After months of allocating resources to your new product development project, it has moved into the validation process and user testing. There is the knock on your door and your team approaches you with a major problem. The product has missed the mark by being too large, too heavy, or too complicated to use. It’s too late to make changes, and you realize you may need to start over.

How could this have been avoided?

By creating a product development plan that assured your product balanced the needs of the market, technology, and the user.

Medical companies tend to have a very strong understanding of the first two of these three needs: the market by having a team focused on marketing and sales, the technology and typically have a large team focused on development and testing to ensure those needs are considered. But when it comes to the third component of a strong product development plan, we have seen a common shortcoming arise where medical companies just assume knowledge of user’s needs.

The FDA has increased its expectations that companies will conduct rigorous human factors validation testing. This was evident back in 2016 when the FDA finalized their guidance document, “Applying Human Factors and Usability Engineering to Medical Devices.” Summative Usability Testing” plays a key role in the process to ensure that user needs and requirements are met. The testing occurs in the validation stage of product development after the product design has been finalized. Most companies fail to tie this in early enough and instead see it as a checkbox to mark at the end of product development. Failing to remember the third component’s needs, to keep the user in mind from the onset through completion, means that after all your hard work is finished and your money is spent, your product may be all wrong.

The takeaway here? Start early testing on your product with users to gain the key insights you need to make your medical device better “and” prevent surprises down the road. The value of user testing early and often at the development stage is that compromises can still be made to balance the big three: market, technology, and user.

The problem is things are usually weighted heavily toward the technology side which is not a surprise because influential technologists like engineers and scientists usually make up most of the development team. We find that they rarely have any interaction directly with end-users, especially out in the field where the product is actually used.

We recommend including them in observational user research so they can watch first-hand as users try to accomplish tasks with the product they are designing. Every time we do this our technology team not only comes away with practical insights that get put to use, but there’s also an increased excitement about the project across the team. Everyone has a better understanding of the purpose behind why the product is being developed in the first place. Designing the right product for the end-user becomes a personal goal rather than a journey to simply meet requirements.

Ultimately, if you do not check in with users throughout the entire development process, the marketing requirements and the technological needs will take over and the product will miss the mark. When market and technology needs are the only ones being considered, the product development team often winds up down a rabbit hole. We have seen this happen too many times — requirements are allowed to reign supreme without the context of user needs and the end product is a flop.


Learn from Others’ Medical Device Design Mistakes

  • A new infusion pump was designed and early user feedback indicated it was too large and heavy for nurses to use. The management team ignored this feedback and continued development and preparation for manufacturing. During the final user testing the results again indicated it was too large and heavy for the users and the project was cancelled costing the company millions of dollars.

  • A device that prepares nuclear medicine for patients at the end use site was ready for final summative testing. The first person participating in the summative test made mistakes that would potentially have killed them and everyone else in the room during the procedure. All issues were related to use errors which could have been avoided with early user testing. The test was canceled and the remaining 14 test participants were sent home. It took the company one and a half years to resolve issues.

The Solution is in the Prototype

A common question we get asked is how to conduct user testing early without a working prototype of the product. Our answer? Expand your definition of prototype. Most people jump to the conclusion that testing requires a highly technical or functional object created specifically for that purpose. There are several possibilities at your fingertips: test your current product using “hypothetical what ifs” or minor modifications, bench-mark test competitive products, and or build quick low-fidelity mock-ups that have limited or no functionality at all.

If your current product development project is keeping you up at night create a plan that will help you sleep soundly by balancing the market and technology requirements with the needs of your end user. Test early and often throughout the process to make sure you are developing the right product for your customer.

If you have doubts about your current project or are in the planning stages of a new one, contact us to learn how our Guideway™ Design and Development Process can help you deliver exactly the right product to your customer.

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