Day-by-Day Conference Schedule
Participants in the MD&M conference programs can immerse themselves in a variety of topics, including medical compliance, software validation, intellectual property, materials, packaging, and much more
Up-to-date information on the conference sessions can be found at www.mdmwest.com.
MONDAY, FEBRUARY 8
Session 100
Marketing a Medical Device in the United States
Overview of Regulatory Requirements
Aileen Velez-Cabassa, FDA
Premarket Clearance and Approval
Marjorie Shulman, FDA
Unapproved Devices
Invited FDA Speaker
FDA Import Process (PREDICT)
Daniel Solis, FDA
Session 101
Current Topics on Software Validation
Chair: David Vogel, PhD, Intertech Engineering Associates Inc.
Compliance Basics
John Murray, FDA
Software Verification and Validation
David Vogel
The Role of Risk Management, Use Error Analysis, Human Factors in Validation
Carl Wyrwa, Beckman-Coulter
FDA Facts and Myths
John Murray
Medical Device Software Validation
David Vogel
Quality System Software Validation Production and Process Controls
Carl Wyrwa
Life Cycles and Their Role in Validation
David Vogel
Compare and Contrast Device Software Design Validation (820.30(g)) and Production and Process Controls—Automated Systems Software Validation (820.70(i))
Carl Wyrwa
External Standards: 80002 and 62304
John Murray
Software Compliance Update and Outlook
John Murray
Session 102
Integrating Quality Engineering throughout the Organization and Product Life Cycle
Chair: Jason Knight, Medtronic; and Richard DeRisio, Abbott Medical Optics
Introduction
Richard DeRisio
How to Manage Quality Goals and Communications
Jason Knight
Integrating HALT with the Medical Product Life Cycle
Mike Silverman, Ops a la Carte
Life Cycle Quality Engineering
David Rothkopf, MEDIcept
Root Cause Analysis and Failure Analysis
Tom Weaver, Weaver Consulting LLC
Statistical Engineering and Managing Sample Sizes
John Haury, PhD, Genentech
Warning Letter Review: How QE Done Well Can Prevent 483 Citations
Richard DeRisio
Panel Wrap-Up
Session 103
Medical Packaging Update
Chair: Kevin Zacharias, Oliver-Tolas Healthcare Packaging
MDPTC Update
Invited Speaker
Distribution Testing
Scott Levy, Distribution Dynamics Lab (DDL)
Panel Discussion—Distribution Testing
Medical Device Packaging International Standards Update
Michael L. Troedel, Troedel & Associates
ISO 11607 Update
Michael Scholla, DuPont Protection Technologies
The Challenges of Implementing Biopolymer Packaging Materials
Don Krebs, CPP, Edwards Lifesciences
General Effects of EtO and Radiation Sterilization
Lisa Foster, Sterigenics
Seal Integrity and Verification for Sterile Medical Device Packaging
Jane Severin, Oliver-Tolas Healthcare Packaging
Session 104
Product Development: Early and Sustained Activity
Chair: Les Halberg, Alfred Mann Foundation
Market and Business Diligence
Carla Mann Woods, Alfred Mann Foundation
IP Diligence
Technology Diligence
Chris Reiser, Boston Scientific Corp.
Reimbursement Diligence
Nancy Reaven, Strategic Health Resources
Clinical Diligence
Omid Khodai, Alcon
Regulatory Diligence
Panel Discussion
TUESDAY, FEBRUARY 9
Session 200
The Future Is Now: Anticipating a New Era of FDA Enforcement
Chair: Michael Barile, Barile & Associates
Change at FDA: How Will This Change Affect FDA’s Expectations for Your Quality System?
Don Abbey, CareFusion
How Will FDA’s Changing Expectations Impact Management’s Responsibility?
Brian R. Burns, Boston Scientific Corp.
Risk Management: FDA Requirements and the Changing Enforcement Environment
Michael Barile
■ Background
■ Learning from Recent Enforcement Action
■ How to “Converge” to FDA’s Interpretation of Regulatory Requirements
■ Review of Several Warning Letters and FDA Guidance Documents
■ Assuring Compliance in the Changing Regulatory Environment
■ Summary of Lessons Learned
■ Staying Calibrated to Industry Norms
Change at FDA: How Will This Affect FDA’s Expectations for Large Multidivisional Organizations?
Javad Seyedzadeh, Gambro
Session 201
Managing Challenges in the Supply Chain
Chair: Sue Jacobs, QMS Consulting Inc.
Supplier Controls: An FDA Perspective
Kimberly A. Trautman, FDA (via call in)
Planning and the Supply Chain
Sue Jacobs
Global Supply Chain
Jon Mulberg, LifeScan
■ What Are the Issues Facing Global Device Manufacturers?
■ What are the Challenges?
■ How Can You Manage the Communication and Achieve Consistency?
■ How Do You Evaluate an Internal Supplier?
A Small Supplier Perspective
Francine Lasky, Scientific Device Laboratory
Panel Discussion—Facing the Challenges
Facilitator: Sue Jacobs
Panelists: Francine Lasky and Jon Mulberg
Session 202
Design Testing: Achieving Optimal Results with Less Effort
Chair: Andrew Snow, Momentum Solutions
Understanding the Path to Optimal Results
Andrew Snow
Using Risk-Based Methods to Drive Efficient, Compliant Product Verification
Todd Hansell, Covidien
Software Validation Tools for Discovering Hidden Quality Problems
David James, Precision V&V Services
Strategies for Usability Verification Tests
Anne Mickelson, Minnetronix
Wrap-Up Q&A and Panel Discussion
Session 203
Selecting and Using Materials for Innovative Medical Devices
Bioabsorbable Polymers for Medical Devices
Bruce Anneaux, PhD; and Josh Ridley, Zeus Inc.
Nitinol
Ming H. Wu, PhD, Edwards Lifesciences
Coatings
Sean Stucke, SurModics
Surfaces
Angela Y. Craig, Evans Analytical Group LLC
Challenges and Experiences in Using New Materials: A Panel Discussion
Chair: Robert Ward, DSM PTG
Panelists: Henry Klyce, Spartek Medical; and Michael Hogendijk, Articulinx Inc.
Risk Management and Assessment in Sourcing and Working with New Materials
Invited Speaker
Receiving Product Approval: An FDA Perspective
FDA Invited
Next-Generation Medical Devices
Melissa M. Reynolds, Colorado State University
■ Biocompatible Surfaces
■ Polymer Coatings
■ Safety
■ Localized Delivery
Session 204
Achieving Excellence in Innovation
Chair: Larry Schmitt, PhD, Inovo Technologies Inc.
Innovation Today Roundtable
■ Why Innovate, What Is innovation, Who Innovates?
■ What and Who Are the Drivers in Medical Manufacturing Today?
■ What Are the Challenges Medical Innovators Face?
■ The Innovation Landscape and Process Framework
Finding Opportunities
James Geiger, MD, University of Michigan Health Systems
Open Innovation Methods
Katherine C. Holland and John Krachenfels, IBM
Design Thinking
Michelle L. Moran, Baxter Healthcare Corp.
Evaluation and Selection
Mike Hess, Medtronic
Becoming Innovative
Larry Schmitt
■ Individual Innovativeness—The Skills and Abilities of an Innovator
■ Leadership and Process—Keys to an Innovative Culture in an FDA Regulatory Environment
■ Sharing of Experiences
Panel Discussion: The Coming Healthcare Reform—How to Innovate within that Framework
