MD&M West 2014 Conference

Your Gateway to Inspiration

W E ST
Exposition: February 11–13, 2014
ConfErEnCE: February 10–13, 2014
Anaheim Convention Center | Anaheim, CA

What will you find at the largest
medical device event in the nation?
Q
ualifiedsuppliersreadytoanswer
yourquestions
A
hands-onexperiencethatonlyalive
eventcanprovide
Animpressiveselectionofeducational
opportunities,rangingfromengineering
basicstoexecutivestrategy

Tackle your goals and challenges
for 2014 with MDM West!

“Theshowwasveryenlightening,it’samazingtoseethe
technologyadvancesthatarebeingmade.”
—Tim Jennings, Value Stream Leader, Watlow

ConneCt With our Community:

Register Today at:

MDMwest.com/2014
27175_W_MDM14_mailer2_model3.indd 1

12/10/13 2:10 PM

11–13, 2014
10 –13, 2014

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12/10/13 2:11 PM

Expo Registration Includes...
Over 50 educational sessions on the show floor! Meet real-life masterminds, mingle with
industry insiders, see live product teardowns, get tips from hard-core geeks, discover
solutions to daily challenges, and listen to industry-leading companies.
Find out more about the underground movement of do it yourself medical devices. Learn
from the MD+DI Medical Manufacturer of the Year winner and finalists. Hear from patient
advocates about changes that can significantly improve lives. No RSVP required; just arrive
early to secure a seat!

Navigate the show floor with field experts pointing out the newest technology,
innovations, and industry trends. Explore solutions that matter now. Topics include:
Advances in Robotics, Go Mobile and Get UDI-Ready. Tours will be 60 minutes and will
each visit approximately 8 booths. RSVP at MDMwest.com/2014.

Free Event Planner and Mobile App

Plan ahead with free online planning tools. Use the event planner and companion mobile
app to network, view exhibitor listings, utilize the interactive floor plan, perform keyword
searches, and more. Visit MobileAppAnaheim.com for details.

Find More Suppliers, Products, and Unexpected Discoveries at
These Complimentary Expos Running Alongside MDM West
Admission to these other shows is free with your MDM West registration.

Regis
ter

TODA
Y

!

February 11, 2014

Anaheim Marriott | Anaheim, CA
GoldenMousetraps.com

S

eeW
HONO ho’s
RED!

MDM is part of the
MedTech World Community
MedTech World provides a single
destination for daily news, technical
information, and industry updates.
MedTech World is your gateway to
a wide variety of medical device
publications, many leading industry
events, and much more!
This community includes:

Come celebrate the companies and people who are energizing North American
manufacturing. The Golden Mousetrap Awards recognize excellence with new
products and innovative business practices. With the Rising Engineering Star
award, in partnership with Mouser Electronics, we raise a glass to someone we’re
sure you’ll see plenty more from in the future. Also Design News presents a Lifetime
Achievement Award, and more! Tickets are $45, and proceeds go to FIRST,
providing youth programs and scholarships in science and technology.


Visit ubmMedTechWorld.com

12/10/13 2:11 PM

EDUCATION | COLLABORATION | TRAINING

Early
pricin Bird
gend
s
Jan

MDM West Conference

17th

February 10–13, 2014 | Anaheim Convention Center | Anaheim, CA

Conference
sponsored by:

AttendtheLARGESTmedicaldeviceandmanufacturingeducationalconferencenotonly
conference not only
inCalifornia,butintheUS,anddiscussthemostimportantchangesthatwillimpactyour
departmentoverthenext12months.
This4day,4trackeducationalconferenceincludessessionsonmedicaldevicecreation,
postmarketcompliance,overcomingregulatoryhurdles,andgainingmomentumin
gettingyourproductssuccessfullytomarket.

MDM West Conference At-A-Glance
DESIGN,
PROTOTYPE
USABILITY
Mon, Feb 10
9:00 a .m.–4:30 p.m.

Design Concept and
Ideation

RISK, QUALITY
VALIDATION

FDA GLOBAL
REGULATIONS IN
PRACTICE

Effective Quality Control
in Action

Interpretations and
Guidance on Regulatory
Updates

MATERIAL
SUPPLIER
MANAGEMENT
Supplier and Sourcing
Management

DrinksReceptionandRobotBuildingCompetition
Tues, Feb 11
9:00 a .m.–4:30 p.m.

Designing to Accelerate
Speed to Market

Improving Risk
Management Strategies
and Procedures

Receiving First Time
Approvals for PMA and
510(K) Submissions

Medical Device
Polymers and Plastics

Wed, Feb 12
9:00 a .m.–4:30 p.m.

Human Factors and
Usability

Design Control for
Quality, Safety and
Effectiveness

Process Validation
Planning, Execution and
Reporting

Nelson Laboratories
Classroom

Thurs, Feb 13
10:15 a .m.–4:30 p.m.

eHealth and
Consumerization

Testing Methods and
Solutions

Global Product
Development and
Regulatory Requirements

Choosing Materials for
Medical Devices

NetworkingMeet-Ups

Additional educational offerings available at the event:
Sponsored by:

Feb 11–13, 2014 | Anaheim Convention Center

Applying critical concepts and enabling
technologies in design, manufacturing,
engineering and automation

FEBRUARY 10 –11, 2014 | ANAHEIM MARRIOT T

Create your own flexible schedule from thirty
2-hour Learning Labs across 3 expo days
Get access to all 30 learning labs with the
Flexi-Pass for only $449

Below are just a few of the Learning Labs available:
•
•
•
•
•
•
•
•

MaterialsTechnologyforImplantableDevices
MedicalDeviceBusinessAccelerator
CardiovascularDevicesEngineering
OrthopedicDeviceDesign
AdvancedApplicationofSensorsinMedicalDevices
MedicalAppsMobileMonitoring
NewCapabilitiesofBioresorbablePolymers
HealthcarePackagingHumanFactors

For the full agenda please visit MDMwest.com/2014


Where senior leaders meet to discuss future outlook,
collaborate and build business strategy
Whether you need to keep your finger on the pulse of
mHealth, price erosion, patient-empowering technology,
the US Medical Device Tax, consumerization, or other
pressing challenges at your level, this Executive Summit
will provide crucial perspective for meeting the demands
of this complex market.

Learn more at www.MDMexecutive.com

12/10/13 2:11 PM

track A: DESIGN, PROTOTYPE AND USABILITY

track B: RISK, QUALITY VALIDATION

DAY ONE | FEBRUARY 10


INSPIRING DESIGN CREATIVITY AND IDEATION
8:00 “FirstTimer”conferencedelegatebreakfastmeeting
9:00 Keynote address
10:10 Usingdesignthinkingmethodologytodiscovercreativesolutionsto
yourdevicedevelopmentchallenges
Stacey Chang, Associate Partner and Director, Health and Wellness, IDEO

12:00 Lunch Networking
1:00 Usingsoftwaredesigntodrivemedicaldevicedifferentiation
Christopher Miles, Vice President, Consulting Services, Foliage

1:30 Usingacustomervalue-centricperspectivetodissectcustomer
expectationsandtransformthemtoexceedcommercialexpectations
John Crombie, Principal Engineer, Ethicon

EFFECTIVE QUALITY CONTROL IN ACTION
10:10 Discussingcomplianceauditmanagementtrendsandbestpracticesto
meetlocal,internationalregulationsandnotifiedbodyexpectations
Marcelo Trevino, Senior Regulatory Compliance Manager, Medtronic

11:00 ThemistakestoavoidduringanFDAinspection

Denise Dion, Vice President, Regulatory Quality Services, EduQuest

1:00 ExecutingISO13485:2012andestablishingyourQMScriteria
Uwe Degenhardt, Division Manager, Active Medical Devices, TÜV SÜD

1:45 UpdatesontheimplementationofIEC60601-13rdEdition
Dan Modi, Director RD Surgical Instrumentation, Alcon

3:00 Innovationbeyondconceptcreation-Bringingdevicestomarket

3:00 Usingstatisticalmethodstofulfillqualityandregulatoryrequirements

3:45 Ensuringasuccessfullaunchwithanewproductdesign

3:45 Integratedprocessexcellenceformedicaldevicedevelopment

4:30 Drinksreceptionandrobotbuildingcompetition


Sanjay Shrivastava, Ph.D., Director, Global Marketing, Covidien
Tom Kramer, President, Kablooe

DAY TWO | FEBRUARY 11

ACCELERATING SPEED TO MARKET THROUGH EFFECTIVE
PROTOTYPING AND 3D PRINTING
8:00 Alumniconferencedelegatebreakfastmeeting

Gary Chung, Statistics and Data Management Manager, Covidien
John Crombie, Principal Engineer, Ethicon


IMPROVING RISK MANAGEMENT STRATEGIES AND PROCEDURES
10:10 ImpactofEN/ISO14971:2012onhowyouimplementriskmanagement
Kevin Posey, Director of Quality, CardiacAssist

10:10 Frommaking1prototypetomanufacturing1millionproducts:Howto
scale-upyourprototype

10:45 Applyingriskmanagementthroughouttheproductcycle

11:15 Theimportanceofprototyping

11:20 Riskmanagementforgammaradiationsterilization

Stacey Chang, Associate Partner and Director, Health and Wellness, IDEO
Hugh Ferguson, Director of New Product Development, Nonin Medical

1:00 3DPrintingforMedicalApplications

Roger Narayan, Professor, University of North Carolina Chapel Hill and
North Carolina State University

David Vogel, Ph.D., Founder President, Intertech Engineering Associates
Emily Craven, Manager, Sterilization Science and Production Irradiator
Engineering, Nordion

1:00 BuildingashatterproofCAPAsystem:Itdoesexist!

Dawn Haake, Senior Director Quality Assurance Compliance, NuVasive, Inc

1:45 Conference VIP Exhibition Tour: 3D Printing
Exclusive for conference delegates, join a guided tour on the trade show
floor of the most innovative companies making waves in 3D Printing

1:45 Successfullyauditingqualityprocessesbyapplyingriskmanagement
principlestoensureadequateCAPAsystems

3:00 Utilizing3Dprintinginyourdesignstages:Areyouthereyet?

3:00 Alivedissectionofariskassessmentgonewrong:Couldthishappenin
yourdepartment?

Greg Olsen, Director of Industrial Design, Cercacor

3:45 Thenextstepsinrapidmanufacturing

Bruce Bradshaw, Director of Marketing, Stratasys

4:30 Networkingmeetups
DAY THREE | FEBRUARY 12

APPLYING PRACTICAL HUMAN FACTORS ENGINEERING AND
IMPROVING USABILITY
10:10 PANEL DISCUSSION
Fromhospitaltohome:Theswitchfromtechnicalusertonontechnicaluser
11:00 BeyondthebasicsofHumanFactorsEngineering101
Andy Schaudt, Director, Medical Device Usability Division
National Center for Human Factors in Healthcare

1:00 InterpretingrequirementsforHumanFactorsvalidationtesting
Korey Johnson, Vice President, UX, GfK Custom Research LLC

1:45 Pre-ClinicalProgramStrategytoDriveInnovativeProductDesign,
UsabilitySafetytoSupportRegulatorySubmissions

Daniel L. Mooradian, Ph.D., Founder and President, The Simpatico Group LLC

3:00 Humanfactorsinriskmanagement

James Wabby, Director Quality Systems and Risk Management, Allergan

Rita McIntyre, Head, Compliance Standards Alliances
Janssen Research Development LLC


DESIGN CONTROL FOR QUALITY, SAFETY AND EFFECTIVENESS
10:10 Anatomyofasuccessfuldesignplan

Rob Packard, Founder and Instructor, Medical Device Academy

1:00 InterpretingFDAdesigncontrolguidanceandchanges

Kevin Ong, Ph.D., Managing Engineer, Medical Device Consultant, Exponent

1:45 Drugdevicecombinationdesigncontrols:Regulatorychallengesand
successfulproductdevelopment
David Maltz, Director, Device Technology, Novartis

3:00 Auditandcomplianceadventuresindesigncontrolwithasoftware
twist
Eric L. Henry, Director, Quality Systems (SW Quality, Compliance), Medtronic

Pat Baird, Principal Systems Engineer, Baxter Healthcare
Sara Waxberg, Human Factors Engineer, Baxter Healthcare

DAY FOUR | FEBRUARY 13

MAXIMIZING OPPORTUNITIES IN eHEALTH IN CONSUMERIZATION
10:10 ThecontinuingriseofmHealth

Mark R. Anderson, FHIMSS, CPHIMS , CEO, AC Group

11:00 Newtechnologydrivingtheconsumerizationofmedicaldevices
Cameron Brackett, Director of RD, Honeywell

1:00 UnravelingthechangingFDAandFCCwirelessregulations
Eben Gordon, Senior Director, Regulatory, Sotera Wireless

1:45 Wirelesstechnologyinahospitalsetting:Cuttingthecord
Stephanie Kreml, MD, Principal, Popper and Company

3:00 Overcomingthepresentandfutureconstraintsofwirelessmedical
devicetechnology
Jeffrey Johnson, CISSP, Solution Engineering Manager, Hospira

3:45 Securityconcernsofcloudconnectedwirelessmedicaldevices
RD Expert speaker from medical device manufacturer



TESTING METHOD VALIDATION PROTOCOLS AND SOLUTIONS
10:10 Testmethodvalidation:Ariskbasedapproach

Mike Silverman, Reliability Engineering Consultant, Ops A La Carte

1:00 QualificationoflaboratorytestinstrumentsbasedonFDAandUSP
requirements
David W. Vincent, CEO, Validation Technologies

1:45 Conductingaccelerated–agingteststoprovideexperimentaldatain
supportofperformanceandshelf-lifeclaims
Karl Hemmerich, President, Ageless Processing Technologies

3:00 Meetingyourelectricalsafetytestingandqualityrequirements
Richard DeRisio, Principal, The DeRisio Group LLC

12/10/13 2:11 PM

track C: FDA AND GLOBAL REGULATIONS IN PRACTICE

track D: MATERIAL AND SUPPLIER MANAGEMENT



INTERPRETATIONS AND GUIDANCE ON REGULATORY UPDATES

SUPPLIER MANAGEMENT





10:10 ExploringFDAinitiativesforFY14

10:10 Ratingandevaluatingvendorsandsuppliers

11:00 HowtoreapplyFDAfeedback:Measuretwice,cutonce

11:00 Craftingsuppliercontractsandqualityagreements

Michael Morton, Vice President, Regulatory Aff airs, Medtronic
Tim M. Lohnes, Senior Regulatory Consultant, Orchid Ortho

1:00 UDI:Keepingwiththecompliancetimelineandimplementationplan
Dawn Fowler, Senior Manager, Labeling Documentation, Endologix

1:45 UncoveringtheadvantagesanddisadvantagesofGS1andHIBCCUDI
identification
Dr. Anne Marie Belteu, Senior Business Analyst, Beckman Coulter

3:00 Regulatorystrategyforpromotionalmarketing

Wilmar Estrada, Director, Advertising Promotional Compliance, US Regulatory
Affairs, Allergan

Jonathan M. Lewis, Principle, Advanced Biomedical Consulting
Christine Bynarowicz, Advanced Supplier Development Sourcing Manager
Covidien

1:00 Aligningoperationswithstrategyinmedicaldevicemanufacturers
Michael Connerty, Managing Director Partner, L.E.K. Consulting

1:45 Supplychainmanagementandoptimization

Venkat Rajan, Industry Manager - Medical Devices, Frost Sullivan

3:00 Bestpracticesinsupplychainandprocurement

Vinay Asgekar, Senior Director, Global Supply Chain, Edwards LifeSciences

3:45 Respondingtowarningletters

3:45 Smartsourcing:Capitalizingonnewopportunities



Jonathan M. Lewis, Principle, Advanced Biomedical Consulting


NAVIGATING THROUGH THE PMA AND 510(K) SUBMISSION
PROCESSES
10:10 Uncoveringtheblindspotsin510(k)submissions

Dr. Marjorie Shulman, Director, Premarket Notification (510(k)) Section, CDRH
FDA

11:00 Preparingforyournext510(k)andobtainingasuccessfulclearance
Mark DuVal, President, DuVal Associates

1:00 Decidingwhentosubmitanew510(k)foramodifieddevice–isanew
regulatoryapproachneeded?
Mark DuVal, President, DuVal Associates

1:45 Competitiveregulatorystrategy:Actingasabarriertoentryforyour
competitors

Geetha Vaithyanathan, Doman Lead - Biologics and Medical Devices, Beroe


MEDICAL DEVICE POLYMERS AND PLASTICS
10:10 AbsorbablePolymersforDrugDelivery

Vipul Davé, Ph.D., Research Director, Fellow Global OTC Technology, McNeil
Consumer Healthcare, Johnson Johnson

10:50 NewresearchonPolycarbonateandBPA:Safeforcontinuedusein
medicaldisposables
Len Czuba, President, Czuba Enterprises, Inc.

11:20 UltraHighMolecularWeightPolyethylene:MaterialPropertiesand
Applications
Anthony Verrocchi, Medical Business Unit Engineered Materials, Celanese

1:00 TextileFibersandMedicalFabrics

Todd Blair, Director of Marketing, Biomedical Structures

3:00 GettingFDAapprovalforchangestoPMAproducts

1:45 Conference VIP Exhibition Tour: Polymers
Exclusive for conference delegates, join a guided tour on the trade show
floor of the most innovative companies in new polymer technology.
3:00 LaserMicromachiningofPolymerBasedMedicalDevices

3:45 PMAsubmissionsandapprovals:Notacookiecutterapproach

3:45 ChallengesofMedicalDeviceContractManufacturing



Michael Drues, Ph.D., President, Vascular Sciences

Janet D. Benson, Director Regulatory Affairs, US Post Approval and Core Products,
Abbott Vascular
Mary Adams, Director, Regulatory Affairs, Endologix


PROCESS VALIDATION PLANNING, EXECUTION REPORTING
10:10 Processvalidationadvancedprinciples

Thomas Oesterle, President, MedHouse Innovations, LLC

1:00 Writingarobustvalidationprotocolandidentifyinggapsincurrent
validationprograms
Vinny Sastri, President, Winovia

1:45 Lowtemperaturesterilizationprocessvalidation

Rob Packard, Founder and Instructor, Medical Device Academy

3:00 SoundRisk-BasedDecisionMakinginProcessValidation

Walt Murray, Director of Quality Compliance Consulting Services,
MasterControl

3:45 Statisticalprocessvalidationcontrol

Ken Link, Principal Project Manager, Quality Systems, NAMSA

Glenn Ogura, Executive Vice President, Resonetics
Mark Bonifacio, Principal, Bonifacio Consulting


NELSON LABORATORIES CLASSROOM
Led by Nelson Laboratories, this will be a full day classroom focusing
on ethylene oxide and radiation sterilization, packaging testing, and
cleaning validations for single use and reusable medical devices
Free to attend to all tradeshow attendees

CHOOSING MATERIALS FOR MEDICAL DEVICES
10:10 Materialselection:Findingthebalancebetweenproperties,
performanceandcost

Shane Mao, Ph.D., Director, Project Management and Raw Material Development,
Coopervision
Thomas Dietrich, Ph.D., CEO, IVAM
Rakesh Kumar, Ph.D., Vice President, Technology, Specialty Coating Systems

11:00 Havingconfidenceinyourmaterialchoices

Shane Mao, Ph.D., Director, Project Management and Raw Material Development,
Coopervision

1:00 Writingarobustvalidationprotocolandidentifyinggapsincurrent
validationprograms

James P. Vetro, Global Engineering Manager - RoHS substances, GE Healthcare

1:45 Developingnovelmaterialsformedicaldevices
Thomas Dietrich, Ph.D., CEO, IVAM

© UBM Canon 2013. Program accurate at time of print.
UBM reserves the right to alter venue, speakers and/or content.


3:00 Manufacturinganddesigningantimicrobialmedicaldevices

Rakesh Kumar, Ph.D., Vice President, Technology, Specialty Coating Systems

12/10/13 2:11 PM

track C: FDA AND GLOBAL REGULATIONS IN PRACTICE

Conference Highlights


TESTING METHOD VALIDATION PROTOCOLS AND SOLUTIONS

GainaccesstoALLtracksontheday(s)youbook.Choose
fromatotalof15daysofconferencecontentacrossthe4
daysoftheevent.Themoreyoubook,themoreyousave.

10:10 Harmonizinginternationalregulations:Thechallengesandrealities
Stephen Slavens, MICT Premarket Regulatory Affairs Director, GE Healthcare

11:00 BreakingintotheBrazilianmarket:Keyproductdevelopmentand
regulatorydriversinthisLatinAmericanmedicaldevicemarket

Morepracticaltake-awaysthaneverbeforewithover80
hands-oninteractiveworkshops,casestudiesandpanel
discussions

Derek Archila, Director Research Analysis, Medical Devices, GlobalData

1:00 Bringingmedicaldevicestoglobalmarkets:Theimportanceof
reengineeringfunctionalities
1:45 SouthKoreamarketentry:Regulatoryandreimbursementprocesses

Over10hoursofconferenceexclusivenetworkingtime
includingdrinksreceptions,sitdownlunchesbreakfast
briefingsandtradeshowtours

Bruce Wang, Managing Director, MediNova Global

3:00 GaininginsightintochangingEUmedicaldeviceregulations
Chris Sarner, Project Manager, Medical Device Certification, DEKRA

In-depthdiscussionofcriticaltopicsincluding3Dprinting
andfunctionalprototyping,UDIimplementation,RoHS
complianceand510(k)andPMAclearance

3:45 ChangeswithglobalCAPA:Whatarethestandardbodieslookingfor?
Steve Niedelman, Lead Quality Systems and Compliance Consultant
King Spalding LLP

Hearfromindustrygamechangersfromindustry,
regulatorybodiesandleadingconsultancies

Conference Pricing

Early
B
pricin ird
gend
s

Remember to register by January 17th to receive the
maximum discount!

MDM West Conference Rates
Onsite

Jan 17
th

Early Bird

Standard

expires1/17/14

1/18/14–2/10/14

1-day Pass

$649

$749

$799

2-day Pass

$999

$1,199

$1,249

3-day Pass

$1,299

$1,599

$1,649

MDM West Group Discount Rates

4-day Pass

$1,499

$1,899

$1,999

Groups of 3

10% off of standard rate

All-Access Pass*

$1,999

$2,199

$2,249

Groups of 4 or more

15% off of standard rate

Bring a colleague! Take advantage of the group
discounts available! Call (310) 445-8535

*The All Access Pass includes access to the full 4 day MDM West Conference, 30 Learning Labs and the MDM Executive Summit.

MDM is Part of the MedTech World Community

Visit ubmMedTechWorld.com

MedTech World provides a single destination for daily news, technical information,
and industry updates. MedTech World is your gateway to a wide variety of medical
device publications, many leading industry events, and much more!
This community includes:

MDM West Information
Expo Dates and Hours:
tuesday–Wednesday
February 11–12, 2014
10:00 a .m.–5:00 p.m.
Registration opens at 8:00 a .m.
Thursday, February 13, 2014
10:00 a .m.–4:00 p.m.
Registration opens at 8:30 a .m.
Please visit MDMwest.com/2014
for Conference and Learning Lab
dates and times

Official Event Partners:

Travel Hotel:
For travel discounts, hotel reservations,
and more, visit MDMwest.com/2014

Event Updates at:

witter.com/MDM_events
t
#MDMwest

27175_W_MDM14

Register Today at:


MDMwest.com/2014

12/10/13 2:11 PM

MD&M West 2014 Conference

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