Reliability is crucial in medtech product design.
Mitch Maiman, Intelligent Product Solutions
Products designed by Intelligent Product Solutions include the AdhereTech smart pill bottle, according to IPS.Image courtesy of IPS
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 considerationsThe issues around…