Reliability is crucial in medtech product design.
Mitch Maiman, Intelligent Product Solutions
Medical technology product development combines the challenges of developing high-reliability commercial equipment with a regulatory landscape and discipline similar to DoD/aerospace systems.
The need for high reliability in medical technology products is obvious. Even in the lowest risk Class I devices, reliability is imperative. With Class III devices, the risk profile is so high that the highest standards of a rigorous design, verification and validation regimen are required.
Here are four unique challenges embodied in the development of technology products with medical applications:1. The supreme need for human factors considerations
The issues around…