Medical device recalls are on the rise. This, in part, has been attributed to increasing complexity like integrated software, but it is also a result of modern device longevity expectations outpacing the regulatory guidance and the predictive capability of current science.i Material longevity is especially important in implantable devices like pacemakers, defibrillators, and neurostimulators where components cannot easily be replaced or serviced and, with new battery technology, have the capability of lasting more than 20 years. In this talk, I will describe our success in predicting in vivo polymer stability using quantitatively accelerated in vitro testing. I will also outline the scientific challenges that remain. Until accelerated predictive testing can fully describe in vivo degradation reactions, including the rate of mechanical property change, new polymer material advancements will be limited in their ability to impact to the long-term medical device implant space.
Kim Chaffin is a Sr. Distinguished Scientist, Bakken Fellow and Technical Fellow in the Strategic and Scientific Operations at Medtronic, plc. Kim has responsibility for leading the enterprise wide technology forecasting effort as well as directing research projects within the corporate research organization. In her technology forecasting role, Kim works with the four business groups to predict the technology areas that will be critical to the future of the enterprise. In her research role, Kim is a recognized expert in material thermodynamics and characterization, especially as it relates to structure-property relationships that govern long-term stability and performance. Kim has a Ph.D. in Chemical Engineering from the University of Minnesota (Advisor: Frank S. Bates) and master's and bachelor's degrees in Chemical Engineering from the University of Michigan. She is a licensed Professional Engineer in the state of Minnesota. She is an inventor on 15 issued patents and an author on many peer reviewed publications. In late 2016, Kim returned to Minneapolis after a four assignment in Switzerland. Kim's husband, Paul, is a General Manager and SVP at Ecolab. Together they have two teenagers, Cole, a freshman in Mechanical Engineering at the University of Michigan, and Julia, a high school sophomore.