The Pitfalls of Medical Device Design: Beginning and End, but No Middle

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The task of creating safe and reliable medical devices is the primary responsibility of medical device designers. Using good judgment to assess technology, evaluate consumer needs, and execute the design and development of the device is critical throughout the lifecycle of production.


Integrating usability throughout the design life cycle can greatly facilitate a favorable result, leading to a safer device and better patient outcomes. Throughout this series of articles, we have discussed the most common pitfalls of medical product design, including design follow-through and late-stage design changes. In the last installment of this series, we will discuss the often-overlooked period of production: the middle.


While usability is considered and thoroughly tested at the development and launch of a new product, a common mishap of some medical device developers is to consider the beginning and the end of production, but not the middle.

Medical device usability pitfalls: neglecting the middle stages of production

The usability of a new medical device is thoroughly considered during the device’s early conception, then rigorously tested after final validation. However, the middle of the device’s development is where mistakes might take place.

Occasionally, one firm is hired for the device’s initial design while a separate firm is engaged toward the end for usability testing. When this is the case, a well-coordinated hand-off does not always occur between the two firms. The testers are forced to re-accumulate background knowledge and potentially repeat work. Both the designers and testers may even be required to start from scratch, leading to wasted effort on both accounts.

Another common scenario, particularly for smaller firms, is when usability is involved throughout, but it is being performed by a separate contract design firm. The outside vendor may not be fully integrated into internal requirements, FMECA, or other verification techniques. This disconnect often results in reduced efficiency and higher overall costs.

The benefits of an integrated approach

To help reduce or eliminate project neglect once the beginning stages are complete, Minnetronix Medical chooses to adopt an integrated approach to device development. The pursuit of such an integrated, user-centered design approach throughout all phases of the design life cycle has many valuable benefits, including:

  • Improved product functionality and patient safety: Errors and field failures can be minimized due to careful testing of the designs.
  • Improved efficiency: Necessary changes are made during the life cycle at the appropriate time.
  • Reduced costs: Numerous expenses can be avoided, including the costs of lost productivity, ill-timed design changes, implementation challenges, etc.
  • Smoother regulatory pathways: Regulatory agencies can see the clear path from user needs to testing.
  • Increased speed to market: The use of an integrative rather than a piecemeal process can expedite successful project completion and product commercialization.
  • Higher user satisfaction and market acceptance: Customers are provided with well-designed, easy-to-use, safe products.

By incorporating user-centered design at numerous touchpoints during product development, Minnetronix strives to reduce business and development risk for our clients. Multiple touchpoints also reduce the lag at the center of a project and eliminate duplicate work, delayed delivery, and other costly issues.

We understand that medical devices are scrutinized by regulatory agencies to levels far beyond consumer products. This adds significant requirements that affect both development efforts and product costs. With increasing healthcare pricing pressures, the need to meet the demand for innovative, higher-tech medical devices becomes even more challenging.

At Minnetronix, we offer full lifestyle solutions that offer our clients expertise across the lifecycle of a device’s development¬—not just at the beginning and the end. From development through commercialization, our expertise and technology-specific processes get your device to market faster, all without sacrificing quality. Contact Minnetronix Medical to learn more.

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