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: sfasaofficers@gmail.com)
Time |
September
20th, Thursday, 4:30pm - 6pm (4:30-5pm pre seminar social, 5-6pm for seminar+QA) |
|
|
Location |
Exponent¨,
149 Commonwealth Drive, Menlo Park, CA 94025 Silicon
Valley Conference room, on the first floor just footsteps beyond the lobby |
|
|
Speaker |
Duane
Steffey, PhD, Director, Statistical and Data
Sciences, Exponent¨ |
|
|
Title |
Statistical
Issues in the Product Life Cycle of Implantable Medical Devices |
Abstract:
Implantable
medical devices, such as cardiovascular stents and orthopedic joint
replacements, offer the possibility of increasing both the longevity and
quality of peopleÕs 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.
Return to Bay Area ASA Homepage