The Pitfalls of Medical Device Design: Lack of Design Follow-Through


As the industry changes, many considerations must be deliberated when designing a medical device. The technology required for a functioning device, customer wants and needs, and design follow-through all play a part in a medical device’s execution. Of course, designing a medical device and bringing it to market can come with certain pitfalls.


Over the next few articles, we will examine the most common pitfalls of medical device design. In this first installment, we’ll take a moment to discuss the first pitfall: the early design of a medical device but lack of follow-through throughout the design lifecycle.

Usability considerations throughout the design life cycle: early design but lack of follow-through

When companies present a product design for manufacturing, they will often undertake a good early design, but they’ll neglect to follow through as the design progresses. The initial design of the device might require changes to its implementation when it comes to writing code or performing mechanical design.

As an example, a team may hire an industrial design firm to interview end-users and consider their needs at the onset of a project. This is a positive practice to adopt; however, as the project progresses, these once-helpful findings can get swept under the rug as mere personal opinions. When this happens, space is developed for old habits to creep into the decision-making process.

Optimizing usability integration for design life cycle success

To avoid these potential pitfalls, a manufacturer needs to prioritize usability throughout the process. They must combine upfront contextual analysis, user and client needs, and usability personnel who are engaged throughout the design process. Through the use of informed opinions, the process will factor industrial, graphical, and user experience into the design.

A clear understanding of human factors feeds into well-defined development tasks such as writing requirements and preparing the FMECA. The FDA requires manufacturers to demonstrate how usability has been designed into the device and how these features were formally validated before approving a device. Human factors need to be consistently incorporated during the project’s early, middle, and late stages.

Considerations throughout the design process

Project Initiation
As the production of a medical device begins, contextual analysis should include interviews with client stakeholders and field observation. Data should be collected on user groups, user environments, and tasks. This leads to a thorough understanding of end-user needs and constraints on the design. It also allows for the creation of user needs based on real-world data.

Project Development
Design requirements are driven by the UFMEA and user needs. They provide the evidence and reasoning to develop the requirements and usability features that will work into the device’s design.

A dedicated usability engineer will help work through critical implementation details and serve as someone who always keeps the user in mind. This staffer will be responsible for asking questions such as “who is actually going to be using this, where will it be used, what do they really need?” A team member that is a dedicated usability resource will help mitigate feature creep and ensure improved safety of the design.

The involvement of a usability engineer means someone on the team tracks when it’s time for more user feedback. Well-timed testing allows the team to quickly make changes to the design before it is locked down. Rather than waiting on user testing until late in the process, thoughtful in-process testing allows the team to be more innovative with design.

Project Conclusion
With usability personnel as part of the ongoing process, staff will be ready and informed for further testing. Individuals who really know the project from beginning to end will come up with more thorough and effective testing protocols.

In addition, early integration of User Needs/UFMEA/task-informed requirements leads to a direct trace from the beginning to the end. Strong evidence will be in place that test requirements were clearly understood and appropriate testing was undertaken.

Integrating usability throughout the design life cycle facilitates a favorable end result, leading to a safer device and better patient outcomes. We’ve also discovered that good usability improves adoption rates for commercialized devices, which reduces training and sales costs and speeds ROI.

At Minnetronix, usability is fully integrated throughout the process, helping our customers avoid the pitfalls of product design—including lack of follow-through. Because we realize the benefit of an end-to-end commercialization experience, we promote whole product solutions for direct sale or distribution to health care providers.

Creating a thorough and well-rounded process with proper follow-through in each stage of the design is critical in bringing your product to market. Contact Minnetronix Medical for more information on our design process.

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