Medical Device Quality Metrics - Accelerate
[Pages:31]Medical Device Quality Metrics
FDA/Xavier University Initiative
MDIC Case for Quality Forum
June 28, 2016
Purpose and Outcome
Purpose:
To provide a system of metrics that
? Supports the Case for Quality ? Spans the Total Product Lifecycle ? Enables the assessment and reduction of risk to product quality
Outcome:
Identification of quality system metrics to
? Inform internal company decisions and trigger action ? Shift the Right-First-Time mentality closer to the initial days of
development
2
First Paul Karen Pat Kathy Anupam Pankit Kankshit Steve Robin Rafael Gina Kate
2014 ? 2016 Team Members (1 of 5)
Last Andreassi Archdeacon Baird Bardwell Bedi Bhalodia Bheda Binion Blankenbaker Bonilla Brackett Cadorette
Company
Fisher & Paykel Healthcare
FDA
Baxter Healthcare
Steris
AtriCure
PwC
PwC
BD
W.L. Gore & Associates
ScottCare
FDA
Steris
3
First Patrick Tony Kara Vizma Ryan Joanna Tom Chris Jeff
2014 ? 2016 Team Members (2 of 5)
Last Caines Carr Carter Carver Eavey Engelke Haueter Hoag Ireland
Company Baxter Healthcare Boston Scientific Abbott Vascular Division Carver Global Health Stryker
Boston Scientific
Clinical Innovations
Stryker
Medtronic
4
First Frank Greg Bryan Jonathan Bill Kristin Rhonda Brian Ravi
2014 ? 2016 Team Members (3 of 5)
Last
Company
Johnston
BD
Jones
BSI
Knecht
AtriCure
Lee
PwC
MacFarland
FDA
McNamara
FDA
Mecl
FDA
Motter
J&J MD&D
Nabar
Philips
5
First Steven Scott Pete Luann Marla Greg Susan Barbara Joe Gin Benjamin
2014 ? 2016 Team Members (4 of 5)
Last Niedelman Nichols Palermo Pendy Phillips Pierce Rolih Ruff Sapiente Schulz Smith
Company
King & Spalding LLP
FDA
CR Bard
Medtronic
Xavier University
Engisystems
Meridian Bioscience, Inc.
Zimmer Biomet
Medtronic
CR Bard
Biomerieux
6
First Isabel Shelley Sam Marta Monica
2014 ? 2016 Team Members (5 of 5)
Last Tejero Turcotte Venugopal Villarraga Wilkins
Company FDA DePuy Synthes PwC Exponent Abbott
Steering Committee Representative:
Joe DuPay (CVRx)
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