Statistical Issues in the Product Life Cycle of Implantable Medical Devices


Pre-register via email strongly recommended (send your name and affiliation via email to:



September 20th, Thursday, 4:30pm - 6pm (4:30-5pm pre seminar social, 5-6pm for seminar+QA)




Exponent®, 149 Commonwealth Drive, Menlo Park, CA  94025

Silicon Valley Conference room, on the first floor just footsteps beyond the lobby




Duane Steffey, PhD, Director, Statistical and Data Sciences, Exponent®




Statistical Issues in the Product Life Cycle of Implantable Medical Devices




Implantable medical devices, such as cardiovascular stents and orthopedic joint replacements, offer the possibility of increasing both the longevity and quality of people’s lives.  During product development, statisticians may be involved in designing and analyzing engineering tests conducted under accelerated conditions to assess device susceptibility to corrosion or fatigue under in vivo conditions.  Such tests complement clinical studies of device efficacy and safety, in which Bayesian ideas find growing acceptance as viable alternatives to traditional approaches.  Statistical methods for controlling the production process and end-of-line quality, as well as data mining tools for troubleshooting problems, find application in the large-scale manufacture of devices.  The potential severity of adverse events involving FDA-approved devices have stimulated ongoing research to develop more useful data sources and more effective analytic methods for timely and accurate post-market safety surveillance.  This talk will address the role of the applied statistician at various stages of the product life cycle, touching on novel methodological aspects and pertinent regulatory considerations.


Any question or seminar suggestion is welcome.



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