By Michael Alabran, President of PSN Labs
Characterizing the risks of medical devices has always been a challenge. Materials are at the core of this challenge, especially as supply chain disruptions have led to the need to alter materials to continue production of critical devices. The understanding of toxicology and the effect of chemistry on the human body is evolving in real-time. When you combine all these factors into an industry that is classically slow to alter the charted course, it leads to a perfect storm. This article will explore what this means to the industry based on the belief that engineering, material selection, and biocompatibility must be considered in concert and effectively balanced throughout the entire development process.
Biological response and safety is a complicated subject, but at its core requires adherence to basic engineering and scientific principles with material selection ultimately driving the impact of the de…