Innovating through Medical Device Material Obsolescence

The medical device industry is facing unprecedented levels of material obsolescence driven by a combination of environmental restrictions and technology advancements. Material substitution triggers re-registration, where legacy devices with a successful history of use are treated the same as new to the market devices. Without diluting patient safety or regulatory oversight, we are proposing material level biocompatibility and biostability assessment to support material substitution and re-registration. Given the high prevalence of a single material formulation being used across multiple device platforms, the material focused assessment has the potential to significantly reduce the testing burden as compared to device-based testing. But more importantly, the material level assessment improves the signal to noise of the analysis, providing higher confidence in the suitability of the substitute. I will discuss a recent manuscript, where we performed exhaustive chemical characterization of a series of cardiac leads that had implant times ranging from 3 to 130 months. Not only was the biocompatibility unchanged over the decade plus implant time, but the polymeric fragments detected initially did not partition into the body, reframing the immediate release bolus assumption of the toxicology assessment. I will also discuss the recently qualified medical device development tool, where accelerated material level biostability informed the extent of in vivo chemical reaction, where results were validated with 20 years of human explants. Taken together, material-based biocompatibility and biostability, rather than device based, allows for a more rigorous and abbreviated pathway for re-registration of medical devices, allowing medical device manufacturers to efficiently source alternates for obsolete materials.