Proactive PMS

Post Market Surveillance (PMS) within the medical device industry can be improved through the utilization of predictive analytics techniques that enable the reduction of patient harm through the proactive management critical to quality (CtQ) production controls associated with the underlying failure modes that are driving the post market data describing patient harm.

This proactive approach to managing patient harm extracts information from production data sets to determine patterns of variation that may predict future outcomes and trends, if nothing is done to change the underlying fundamentals that are driving the post market data.  Crucial insights are drawn from information sources associated with CtQ production controls, enabling responsible management to compare current production lot data with past production lot data, and the resultant quality of the marketed product.

Larry Mager