From a test engineer’s perspective, understanding final requirements, application, and quantifiable goals for testing before a protocol or test plan is executed is crucial to the success and efficacy of a device used directly by the patient. Device design has similar requirements—understanding client needs and, ultimately, his or her goals and hopes for quality of life improvement through the utilization of a device. The greatest design obstacle lies with accomplishing intended function, expecting additional side effects, and accounting for the potential unintended artifacts.

Medical device design decisions are often driven by surgeons or physicians and created on geometry and assumed function. The understanding of quantifiable quality of life requirements—aesthetic, safety, functionality, and ease-of-use—of the patient can prove challenging. Designing a device to function as planned, while minimizing additional side effects is critical to the process. After all, people don’t know what they don’t know, making it difficult for patients to predict and quantify quality improvement expectations prior to actual usage.

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