DAY ONE | OCTOBER 28, 2019 · HOLISTIC APPROACH FOR THE MEDICAL DEVICE INDUSTRY CYNTHIA HOUGUM,...

DAY ONE | OCTOBER 28, 2019

6:45 am - 7:45 am

Exhibition HallREGISTRATION AND NETWORKING BREAKFAST

7:45 am - 7:55 am

Room 1CHAIR’S WELCOME AND OPENING REMARKS

ROBERT WOODVP, World Wide ManufacturingVarian Medical Systems

MARK WEHDESection Head, Technology Development, Division of EngineeringMayo Clinic

MAC MCKEENFellow, Regulatory ScienceBoston Scientific Corporation

KHALED MOUSSALLYGlobal Head, QualityCompliance Group

7:55 am - 8:30 am

Room 1INTEGRATING INNOVATION AND QUALITY: A HOLISTIC APPROACH FOR THE MEDICAL DEVICE INDUSTRY

CYNTHIA HOUGUM, PH.D.SVP, Global Quality and Business TransformationTerumo BCT

8:30 am - 9:05 am

Room 1IMPROVING PATIENT OUTCOMES THROUGH SURGICAL INNOVATION

JIJO JAMES, M.D.Chief Medical Officer, Medical DevicesJohnson & Johnson

9:05 am - 10:05 am

Room 1SECURING THE CONNECTED HEALTHCARE ECOSYSTEM

NIKESH ANAND RAJAGOPALANSolutions DirectorHCL America Inc.

10:10 am - 11:50 am

Exhibition HallREFRESHMENTS, NETWORKING AND PRE-ARRANGED 1-2-1 MEETINGS

1:15 pm - 2:15 pm

Exhibition HallLUNCH & LEARN ROUNDTABLE DISCUSSIONS AND OPEN SEATING LUNCH

On-site registration is required for roundtable discussions

ASSESSING SUPPLIER CAPABILITY TO MANAGE RISK

KARLA TOPETEField Engineering DirectorSQA Services, Inc.

CUSTOM ENGINEERED ELECTRICAL INTERCONNECTED DEVICES

MIKE ANDERSONDirector, Marketing and Business DevelopmentATL Technology

DO YOU REALLY KNOW WHAT’S HAPPENING TO YOUR TEMPERATURE-CONTROLLED PRODUCTS THROUGHOUT YOUR SUPPLY CHAIN?

MIKE MONTANASenior Business Development ManagerTemptime Corporation

DEVICE SECURITY STARTS AT DAY ONE: IDENTIFYING WHERE VULNERABILITIES ARE CREATED IN YOUR DEVELOPMENT LIFECYCLE

CHRISTOPHER GATESPrincipal System Security ArchitectVelentium

BUILDING A TRANSPARENT METHOD TO KEEP ENGINEERS, SUPPLIERS AND CUSTOMERS ON THE SAME PAGE

CHUCK SERRINVP, Industry Marketing, Medical Device and Life SciencesPropel

MOBILE APPLICATIONS FOR MEDICAL DEVICES: BEST PRACTICES FOR MANAGING PATIENT SAFETY AND REGULATORY COMPLIANCE

BERNHARD KAPPECEOOrthogonal

HOW TO MONITOR IOT DATA AND IDENTIFY ANY RED FLAGS

PHILIP SIMULISCEOSimtelligent

STAYING ON TOP OF EVER-CHANGING GLOBAL REQUIREMENTS

EVA L. PETERSENSolution Sales ManagerIQVIA Regulatory Intelligence

CONTINUED >>

11:55 am - 12:30 pm

Room 1AGILE MANUFACTURING FOR MEDICAL DEVICE PRODUCT DEVELOPMENT


Room 2PRODUCT ACCELERATION FOR SMALL AND MEDIUM-SIZED ENTERPRISES (SMES): REINVENTING NEWBORN HEALTH CARE THROUGH EMPATHY-DRIVEN DEVICES

VIVEK KOPPARTHICo-Founder and CEONeoLight

Room 3BEYOND COMPLIANCE: USING YOUR QUALITY MANAGEMENT SYSTEM AS A TOOL FOR SIMPLIFICATION

ANN VUVP, Quality and Regulatory ComplianceZimmer Biomet

Room 4BRIDGING THE GAP BETWEEN INDUSTRY AND THE FDA: HOW TO SUPPORT MEDICAL DEVICE INNOVATION

KEN SKODACEKDeputy Ombudsman, Center for Devices and Radiological HealthFDA

12:35 pm - 1:10 pm

Room 1BENEFITS OF AUTOMATING DOCUMENT CONTROL FOR MEDICAL DEVICE MANUFACTURERS

®

QT9™ Software

BRANT ENGELHARTPresidentQT9 Software

Room 2THE ART OF THE SCIENCE: CLINICAL EVALUATION REPORT (CER) AS A COMPELLING NARRATIVE

ROBERT MIKAN, M.D.Medical DirectorCactus Communications Inc.

Room 3SPEED TO CLINICAL DATA

ANDY ROGERSVP, Business DevelopmentKey Tech Inc.

Room 4CUSTOM AGILE-BASED PROJECT MANAGEMENT FOR EU-MDR AND IVDR TRANSITION

BHAVESH SHAHAEU MDR Transition LeaderTata Elxsi


1:15 pm - 2:15 pm



HOW TO INTEGRATE CREATIVE DESIGN AND ENGINEERING PERFORMANCE

JIM KASICCEOBoulder IQ

BRINGING LOGISTICAL PRECISION TO HOME AND OFFICE HEALTH CARE

TODD SHEPHERDDirector, Global AccountsdfYOUNG

A DEEP DIVE INTO LIFECYCLE MANAGEMENT

HILDE VIROUXAVPHCL America Inc.

DIGITAL SOLUTIONS FOR REGULATORY COMPLIANCE: MDR, UDI AND TRACK-AND-TRACE

ADAM ERDESKYHead, Digital SolutionsCyient

MOBILE APPLICATIONS FOR MEDICAL DEVICES

ATWELL SHEARERVP, Engineering and Business DevelopmentLogikos

SOURCING AND SELECTING THE BEST REGULATORY WRITERS AND CONSULTANTS FOR YOUR MEDICAL DEVICE OPERATIONS

EMILY STEPHENSFounder and CEOGlobal Medical Writing & Translation

REGULATORY COST MITIGATION STRATEGIES: LEVERAGING SUPPLIER CERTS, USING A PRODUCT FAMILY APPROACH TO ENABLE MULTIPLE PRODUCTS AND CRITICAL APPROVALS FOR WIRELESS

GRACE HURLEYVP, Healthcare SolutionsContec Americas Inc.

2:20 pm - 2:55 pm

Room 1PANEL DISCUSSION: THE FUTURE OF QUALITY MANAGEMENT AND FDA CASE FOR QUALITY INITIATIVES

LARRY MAGERQSM ConsultantCompliance Group

FRANCISCO VICENTYProgram Manager, Case for QualityFDA

CHAKRI UDDARAJUArtificial Intelligence LeaderCompliance Group


SCOTT MOELLERVP, Quality and RegulatoryGI Supply

Room 2TRANSLATION TO PRACTICE: HOW TO GET INNOVATION OUT OF THE RESEARCH SETTING AND INTO THE CLINICIANS HANDS


Room 3CHALLENGES FACED BY GLOBAL ORGANIZATIONS TO COMPLY WITH POSTMARKETING SAFETY REPORTING (PMSR) REQUIREMENTS

KHAUDEJA BANOHead, Medical AffairsAbbott Molecular

Room 4MEDICAL DEVICE THREATS: NAVIGATING THE NEW FRONTIER OF CYBERSECURITY RISK

JAAP QUALMVP, Product SecurityGE Healthcare

3:00 pm - 3:35 pm

Room 1REGIONAL CONTROL OF YOUR LABEL PORTFOLIO FOR GLOBAL ORGANIZATIONS

RICHARD CASTLEGlobal Sales ManagerPRISYM ID

Room 2INNOVATING THE PRODUCT LIFECYCLE WITH A LOW-CODE PLATFORM

NISHA D’AMICOSolutions ConsultantAppian Corporation

Room 3HOW TO ACHIEVE SUSTAINABLE RESULTS FROM A DIGITAL MANUFACTURING TRANSFORMATION WITHIN A REGULATED ENVIRONMENT

DAMIEN VOSSIONVP and Head, Manufacturing, Automotive and Life SciencesCapgemini Invent France

ABHISHEK KHANDELWALVP, Digital Engineering and Manufacturing ServicesCapgemini

Room 4SOFTWARE ENHANCEMENTS: DISTINGUISHING TYPE AND DEVELOPMENT TO MEET REQUIREMENTS OF SAFETY, FUNCTIONALITY AND CYBERSECURITY

BILL STAMMVP, Software ServicesGeneral Digital

3:40 pm - 5:00 pm

Exhibition HallHAPPY HOUR, NETWORKING AND PRE-ARRANGED 1-2-1 MEETINGSSponsored by


5:05 pm - 5:40 pm

Room 1LEADING THE CHARGE TO STREAMLINED SURGERY

CAMERON PIRONPresident and Co-FounderSynaptive Medical

Room 2STRATEGIES FOR ENHANCED MEDICAL DEVICES AND NEEDLES SOURCING AND PROCUREMENT

ANDERS ALBERGDirector, Strategic Sourcing, Devices and NeedlesNovo Nordisk

Room 3THE NEW PARADIGM: GUIDANCE FOR INDUSTRY AND FDA STAFF

MARJORIE SHULMANDirector, Premarket Notification ProgramFDA

Room 4HARNESSING INTERNAL AND VENDOR CAPABILITIES TO ACCELERATE MEDICAL DEVICE INNOVATION

JACLYN LAUTZ, PH.D.VP, Research and DevelopmentivWatch

5:45 pm - 6:20 pm

Room 1LEVERAGING TECHNOLOGY AND ARTIFICIAL INTELLIGENCE TO ACCELERATE IMPROVEMENTS IN EFFECTIVENESS AND PRODUCTIVITY IN THE SUPPLY CHAIN

JAIME VELEZPartnerOperations & Quality Systems Improvement Experts (OQSIE)

6:20 pm - 6:55 pm

Room 1UNDERSTANDING THE ROLE OF ARTIFICIAL INTELLIGENCE IN IMPROVING PATIENT DIAGNOSTICS AND TREATMENT

DAVID PACITTIPresident and Head, AmericasSiemens Healthineers

6:55 pm - 7:00 pm

Room 1CHAIR’S CLOSING REMARKS





7:00 pm - 8:00 pm

Exhibition HallNETWORKING DRINKS RECEPTIONSponsored by

DAY TWO | OCTOBER 29, 2019

8:05 am - 8:15 am

Room 1CHAIR’S WELCOME AND OPENING REMARKS





8:15 am - 8:50 am

Room 1CREATING A DEVICE-ENABLED DIGITAL ECOSYSTEM FOR BREAKTHROUGH PATIENT OUTCOMES

BRIAN LAWRENCESVP and Chief Technology OfficerHillrom

8:50 am - 9:25 am

Room 1REGULATORY DOCUMENTATION EXCELLENCE: AN OPPORTUNITY TO LEVERAGE THE REGULATIONS TO YOUR ADVANTAGE

TANYA KLASLOVP, Global Regulatory OperationsBecton Dickinson

7:00 am - 8:00 am

Room 4WOMEN IN LEADERSHIP ROUNDTABLE

On-site registration is required for this session

SANDRA RYANSVPThe Evanston Group

MICHELLE MORANDirector, Commercial Device EngineeringTakeda

PAMELA GOLDBERGPresident and CEOMedical Device Innovation Consortium (MDIC)

JACKIE KUNZLERSVP, Chief Quality OfficerBaxter


MARJORIE SHULMANDirector, Premarket Notification ProgramFDA

7:00 am - 8:00 am

Exhibition HallBREAKFAST BRIEFS

On-site registration is required for the breakfast briefs

ASSESSING RISK FOR NEW MEDICAL DEVICE DEVELOPMENT AND LAUNCHES

JOHN GARVEYPrincipal and CEOCompliance Architects LLC

EXPLORING THE ROLE OF A.I. AND OTHER INDUSTRY 4.0 TECHNOLOGIES IN QMS

KARI MILLERRegulatory and Product Management LeaderIQVIA Quality Compliance

DISCUSSING THE VALUE OF HUMAN FACTORS: ADDRESSING HUMAN ERROR AND RISK MITIGATION

CYNTHIA RANDOFounder and CEOSophic Synergistics

DESIGNING AND OPERATING AN INTEGRATED AUTOMATED ASSEMBLY LINE TO IMPROVE MEDICAL DEVICE SPEED TO MARKET

KEVIN WALSHVP, HealthTechCelestica

MEDICAL DEVICE RETURNS: NAVIGATING THE REGULATORY LANDSCAPE

KEN LUKESBusiness Development, Life Sciences DivisionInmark Packaging

9:30 am - 10:05 am

Room 1ANTICIPATING CHANGES TO THE STANDARDS TO ENABLE TESTING AND ENHANCE MEDICAL ELECTRICAL EQUIPMENT

PAMELA GWYNNPrincipal EngineerUnderwriters Laboratories

Room 2LEVERAGING GRANULAR DATA FOR SMARTER SUPPLY CHAINS

CHAD OWENSKPI and Manufacturing Line ExpertOptel Group

Room 3ECONOMIC OPERATORS: WHOSE PROBLEM IS IT ANYWAY?

PETER ROSEManaging Director, EuropeMaetrics

Room 4DIGITAL DHRS: MODERNIZING YOUR DEVICE HISTORY RECORDS IN THE 21ST CENTURY

DAVE EDWARDSEVP, SalesMasterControl, Inc.

10:10 am - 11:30 am

Exhibition HallREFRESHMENTS, NETWORKING AND PRE-ARRANGED 1-2-1 MEETINGS


11:35 am - 12:10 pm

Room 1FROM GOOD TO EXCEPTIONAL: HOW TO BUILD AND SUSTAIN A SUCCESSFUL R&D ORGANIZATION

NORBERT LEINFELLNERVP, Product Development EngineeringFresenius Medical Care

Room 2ADVANCING REGULATORY SCIENCE OF MEDICAL DEVICES FOR PATIENT BENEFIT

PAMELA GOLDBERGPresident and CEOMedical Device Innovation Consortium (MDIC)

Room 3REVISING QSR TO BE MORE CLOSELY ALIGNED WITH ISO 13485: PROPOSED GUIDANCE DEVELOPMENT AND RETROSPECTIVE REVIEW

CAPT SEAN BOYDDirector, Office of Regulatory Programs, Office of Product Evaluation and QualityFDA, Center for Devices and Radiological Health

Room 4DIGITAL HEALTH INNOVATION AT BOSTON SCIENTIFIC

SANDRA NAGALE, PH.D.Director, Digital Health ITBoston Scientific Corporation

12:15 pm - 12:50 pm

Room 1ASSESSING OVERALL ORGANIZATIONS CYBERSECURITY MATURITY ACROSS THE PRODUCT LIFECYCLE

LAURA ÉLANSenior Manager, CybersecurityCSA Group

Room 2A NEW VISION FOR BIOMATERIALS: CRAFTING BIODEGRADABLE HYDROGELS FOR OPHTHALMIC DEVICES

GAVIN BRAITHWAITE, PH.D.VP, ResearchCambridge Polymer Group, Inc.

Room 3EU MDR: ACHIEVING ON-TIME COMPLIANCE WITH LASTING BENEFITS

SCOTT D. BABLERPrincipal ConsultantIntegrated Project Management Company, Inc.

TIM EHRDirectorIntegrated Project Management Company, Inc.

Room 4SYSTEMATIC LITERATURE REVIEW: HOW TO EMPOWER DATA-DRIVEN DECISION MAKING

LAURIE MITCHELLPresidentCriterion Edge

12:55 pm - 1:55 pm



SILENCING SELF-DOUBT: HOW TO OVERCOME IMPOSTER SYNDROME AND GAIN CONFIDENCE

ILANA SHULMANChief Compliance OfficerHillrom

HOW TO COPE IN THE MIDST OF EXTREME CHANGE: A CASE STUDY OF SURGICAL ROBOTICS IN A CHANGING FDA LANDSCAPE

STEPHANIE FITTSVP, Regulatory Affairs, Quality Assurance, Clinical Research and ComplianceTransEnterix

DIVING INTO THE CHALLENGES OF LEADING CHANGE FOR LEADERSHIP

ANILA LINGAMNENIVP, Renal R&DBaxter

HOW TO FOSTER STRATEGIC RELATIONSHIPS WITH HOSPITAL NETWORKS

BESAINT MEHTA SAHNISenior Program ManagerAlign Technology

SOURCING AND SELECTING THE BEST TECHNOLOGIES TO ENHANCE MEDICAL DEVICE RESULTS AND ON A RAPID TIMESCALE

DEREK SWANChief Technology OfficerOptos

ACCESS TO A GLOBAL MARKET: HOW TO GET MARKETING AND REGULATORY AFFAIRS WORKING EFFECTIVELY TOGETHER AROUND THE WORLD

TIMOTHY CROFTDirector, Program ManagementHillrom

DRIVING SUSTAINABLE COMPLIANCE ACROSS A GLOBAL NETWORK WHILE PURSUING SIMPLIFICATION

HUY DOANVP, Quality Assurance and Regulatory AffairsSOL-MILLENNIUM Medical Group

DEVELOPING BEST-IN-CLASS QUALITY SYSTEMS FOR SMALL AND MEDIUM-SIZED ENTERPRISES

MARK FRIEDMAN, PH.D.VP, Regulatory Affairs and Quality AssuranceAxogen Corporation

ESTABLISHING A WORLD-CLASS HARMONIZED MEDICAL DEVICE SINGLE AUDIT PROGRAM MANAGEMENT SYSTEM

RAJ KASBEKARVP, Global Regulatory and Clinical AffairsKaz, A Helen of Troy Company

2:00 pm - 2:35 pm

Room 15 CRITICAL REQUIREMENTS FOR MEDICAL DEVICE MANUFACTURERS AS THEY TRANSITION OR GO-TO-MARKET

RICHARD ROSSVP, Technology and Product DevelopmentDedicated Computing

2:40 pm - 3:15 pm

Room 1SURGICAL TRANSFORMATIONS: HOW TECHNOLOGY LEADS TO REAL-TIME BREAKTHROUGHS IN IMPROVING PATIENT CARE

BEN LOCWINSVP, QualityLumicell

3:15 pm - 4:00 pm

Room 1ESTABLISHING COLLABORATIVE APPROACHES FOR MEDICAL DEVICE AND HEALTHCARE INNOVATION

HARIKRISHNAN RAMARAJUDirector, Business DevelopmentL&T Technology Services

CAMERON PIRONPresident and Co-FounderSynaptive Medical


CAPT SEAN BOYDDirector, Office of Regulatory Programs, Office of Product Evaluation and QualityFDA, Center for Devices and Radiological Health

ANN VUVP, Quality and Regulatory ComplianceZimmer Biomet

BRIAN LAWRENCESVP and Chief Technology OfficerHillrom


4:00 pm - 4:10 pm

Room 1CHAIR’S CLOSING REMARKS AND SURVEY PRIZE DRAW





DAY ONE | OCTOBER 28, 2019 · HOLISTIC APPROACH FOR THE MEDICAL DEVICE INDUSTRY CYNTHIA HOUGUM,...

Documents

Transcript of DAY ONE | OCTOBER 28, 2019 · HOLISTIC APPROACH FOR THE MEDICAL DEVICE INDUSTRY CYNTHIA HOUGUM,...