AMERICAN MEDICAL DEVICE SUMMIT 2018 - Generis · AMERICAN MEDICAL DEVICE SUMMIT 2018 OCTOBER...
Transcript of AMERICAN MEDICAL DEVICE SUMMIT 2018 - Generis · AMERICAN MEDICAL DEVICE SUMMIT 2018 OCTOBER...
AMERICAN MEDICAL DEVICE SUMMIT 2018
OCTOBER 24–25, 2018
THE WESTIN LOMBARD YORKTOWN CENTER • LOMBARD, IL
amdsummit.com
+1-416-298-7005
TOMORROW’S CONNECTION TODAY
Driving business performance through process and technological innovation
PROGRAM
American Medical Device Summit 2018 Program • Page 1
MICHAEL HILL
VP, Corporate Science, Technology and Clinical Affairs
Medtronic
REGISTRATION & GROUP BREAKFAST
CHAIR’S WELCOME ADDRESS
TOM WESTRICK
VP, Chief Quality Officer and Head of Regulatory Affairs
GE Healthcare
LEADERSHIP SPOTLIGHT TRANSFORMING THE QUALITY PROFESSIONAL: THE TOM WESTRICK STORY
• The transition from finance to Chief Quality Officer: The Tom Westrick story
• Innovating the quality ecosystem from the perspective of the regulator and the patient
• Build quality into processes at every step of the value chain to lower costs, risks and design better products
• Driving better business results and improving your bottom line through a patient-centric approach
7:00 am – 7:55 am
8:00 am – 8:10 am
8:10 am – 8:50 am
8:50 am – 9:30 am
PROGRAM DAY ONE
MICHAEL BACA
Former VP, Quality/ Regulatory/ Clinical
PRE-EVENT HAPPY HOUR JOIN US FOR THE PRE-EVENT HAPPY HOUR OCTOBER 23RD, 2018 AT 6:00PM–7:00PM
OPENING KEYNOTE INNOVATING COLLABORATIVELY TO TRANSFORM HEALTHCARE
• Reforming your future business model for disruption: transitioning from volume-to-value-based care
• Striking a healthy balance between external vs. internal organizational growth: relying on multiple sources to achieve design innovation
• Eliminate the cost burden stigma through driving valued based healthcare as an economic growth driver
• Implement design processes that drive cost-efficiency, speed-to-market and user friendly devices
ANDY PARTRIDGE
Senior Director, APAC-EMEIA Manufacturing
MAC MCKEEN
Fellow, Regulatory Science
American Medical Device Summit 2018 Program • Page 2
10:15 am – 11:55 am
PRE-ARRANGED ONE-TO-ONE NETWORKING & REFRESHMENTS
EXECUTIVE SPOTLIGHT LEVERAGING ARTIFICIAL AND BUSINESS INTELLIGENCE TO DRIVE PRODUCTIVITY IMPROVEMENT
• Manufacturing Case Study: 300% productivity improvement in a capacity-constrained environment
• Distribution Warehouse Case Study: 250% productivity improvement, reduced headcount from 30 to 12 in pick and pack team
• Common drivers for success:
• Leveraged Artificial and Business Intelligence to deploy automated systems to detect abnormal performance
• Deployed an automated management alarm and escalation system; used emails and text messages to accelerate response to performance-impacting events
• Created real-time management dashboards and alerts, tailored for each role
9:30 am – 10:10 am
12:00 pm – 12:35 pm
MARK WEHDE
Section Head of Technology Devel-
opment
Mayo Clinic Division of Engineering
TECHNOLOGY A PROACTIVE APPROACH FOR
CYBERSECURITY FOR MEDICAL DEVICES
NOW AND IN THE FUTURE
• Applying concepts of security risk
management to medical device design
• Proactive and reactive program
capabilities
• Collaborative approaches with health
delivery organizations
• Lessons learned from the WannaCry
attack
STEVE ABRAHAMSON
Senior Director, Product Cybersecurity
JAIME VELEZ
Co-Founding Partner Operations & Quality Systems Improvement Expert
&
ADAM BURKE
President
Kalabur
QUALITY SOFTWARE PRE-CERT PILOT PROGRAM
STATUS UPDATE
• Pre-Cert pilot goals and objectives
• FDA perspective
• Pre-Cert pilot program logistics
• Point of contact
• Engagement plan and schedule
•
• Site visits and data collection:
excellence principles and common
validating perspectives
CATHERINE BAHR
Digital Health Expert
CDHR/ OCD
DESIGN BLURRING THE BOUNDARIES
BETWEEN ENGINEERS AND
PHYSICIANS: PULLING BACK THE
CURTAINS ON INNOVATION AT MAYO
CLINIC
• A look at how engineers at Mayo
Clinic have teamed with
physicians for over 100 years and
found new ways to better care for
our patients
• How this dedicated engineering
group is unique and allows
innovation to be intentionally
driven by the organization’s
strategic plan
• A historical perspective on
medical device innovation at
Mayo Clinic
• Exploring an intentional,
collaborative approach to medical
device development
• A case study using the latest
in ethnographic
research, multidisciplinary
teamwork, advanced computer
modeling and 3D metal printed
rapid prototyping
PRODUCT STRATEGY BUILDING THE FUTURE OF
HEALTHCARE STARTING NOW
• Sharing high-value drivers of the
future
• Expanding precision in medicine,
while joining an upcoming
transformation of care delivery
(from precise diagnosis and
prevention up to individualized
treatment)
• Improving patient experience, while
setting patients as consumers
• Fostering digitalization into an era
of novel competencies for
healthcare leaders and
professionals
LUIS LASALVIA, MD
VP & Global Medical Office
American Medical Device Summit 2018 Program • Page 3
12:40 pm – 1:15 pm
WORKSHOP MODERNIZING QUALITY
MANAGEMENT SYSTEMS FOR MEDICAL
DEVICE MANUFACTURERS
• The QT9 Quality Management
Software’s easy approach to a full
eQMS implementation
• How to invest and see a return on
investment
• Innovation in quality management
technology
• End frustration through paperless
quality automation
BRANT ENGELHART
President
WORKSHOP WHY MEDICAL DEVICE
MANUFACTURERS NEED TO DELIVER
INNOVATIVE PRODUCTS TO CREATE
EFFICIENCIES IN THE DELIVERY OF CARE
• How to reduce time to market and
the complexity of product lifecycle
management
• Develop a proactive monitoring and
management improves reliability
and corrects potential failures
before they become a reality
• Case study: A detailed look at why
medical device manufacturers need
to deliver innovative products to
improve quality
WORKSHOP REDUCE SUPPLIER RISK, REDUCE
ORGANIZATIONAL RISK: THE IMPACT OF
SUPPLIER MANAGEMENT ON THE
ORGANIZATION AND THE ROLE OF
QUALITY
• Gain an understanding of supplier
risk, and its role in broader
enterprise risk ecosystem
• Review the medical device regulatory
landscape regarding supplier control
• Review how appropriate supplier
management processes reduce risk
and the critical role that quality
management plays in that process
• Review effective monitoring and
measurement tools for supplier risk
management
• Understand the business benefits of
an effective supplier management
program
WORKSHOP MODEL-BASED DESIGN,
DEVELOPMENT & TESTING: AN
APPROACH TO SAFETY, SPEED &
ENHANCED QUALITY
• Learn about a better design for
complex, safety critical and
distributed systems
• A look at the overall improvement
in the quality of the product, better
documentation and evidence of
compliance with standards
• How you can have a faster time to
market by reusing a verified model
• How you can reduce overall project
cost by reducing the testing
schedule of the project, capturing
the error in an earlier stage and be
able to automate the testing
environment
DON SCHLIDT
President & CEO
KARI MILLER
Regulatory and Product
Management Leader
NOLAN WANNER
Principal System Engineer
HARIKRISHNAN RAMARAJU
Sr. Business Development Manager
American Medical Device Summit 2018 Program • Page 4
1:20 pm – 2:20 pm
LUNCH & LEARN ROUND-TABLE DISCUSSIONS
HOW TO STAY ON TOP OF GLOBAL REGULATORY
REQUIREMENTS
EVA L. PETERSEN
VP, International Sales
UNDERSTANDING SUPPLIER CAPABILITY TO ASSURE
PRODUCT SAFETY
GILBERTO JIMENEZ
Field Engineering Director
MEDICAL DEVICE INTERCONNECT – STAYING AHEAD
OF TECHNOLOGY ADVANCES
MIKE ANDERSON
Director, Business Development
& Medical Sales
MEDICAL DEVICE MATERIAL STRATEGIES: MOVING
BEYOND “OFF-THE-RACK” POLYMERS
DR. STEPHEN SPIELGELBERG
President
CREATIVE STRATEGIES TO COMBAT LEAD TIMES AND
SCHEDULE RISK IN A DYNAMIC ELECTRONIC
COMPONENT MARKET OF CONSOLIDATIONS AND
ALLOCATIONS
NICOLE RUSSO
President/CEO
FLEXIBLE AND ADAPTABLE OUTSOURCING MODELS
FOR LIFECYCLE MANAGEMENT
SATHISHBABU RAMACHANDRAN
Medical Technology &
Healthcare, Mechanical System
ADVANTAGES & OPPORTUNITIES WITH THE NEW EU
MEDICAL DEVICE REGULATION
STEVEN LEPKE
President
FAILING FAST: CREATING SUCCESS THROUGH
PLANNED SETBACKS IN TODAY’S MEDICAL DEVICE
MANUFACTURING INDUSTRY
MIKE MONTANA
Senior Business Development
Manager
GUIDED QMS FOR EVERYONE
HILDE VIROUX
AVP, Regulatory
“WHEN THINGS GO SIDEWAYS...” HOW TO HANDLE
THE BIG CRISES THAT HAPPEN WHILE DEVELOPING
BREAKTHROUGH PRODUCTS
JUDSON VANN
VP, Sales & Marketing
STORAGE AND DISTRIBUTION OF TEMPERATURE
SENSITIVE MEDICAL DEVICES. HOW DO YOU KNOW
WHAT’S HAPPENING TO YOUR PRODUCT AFTER IT
HAS LEFT YOUR FACILITY?
JEFF CHAMPAGNE
VP
JOHN PEYTON
VP
WHAT ARE TODAY'S CHALLENGES TO DEVELOP
SUSTAINABLE PACKAGING SOLUTIONS? HOW
DOES YOUR COMPANY DEAL WITH THEM?
PHILIP BREDT
GM
ASK THE EXPERT – MDR AND LIFECYCLE
MANAGEMENT
ERIC CLAUDE
VP, Product Development
American Medical Device Summit 2018 Program • Page 5
3:50 pm – 5:10 pm
PRE-ARRANGED ONE-TO-ONE NETWORKING & REFRESHMENTS
WORKSHOP OVERCOMING COMMON OBSTACLES IN
THE PRODUCT APPROVAL PROCESS
FOR ACCESSING GLOBAL MARKETS
• Why competing in an evolving and
interconnected global market
requires a solid understanding of
the various technical and regulatory
requirements for medical devices
• Common obstacles faced in today’s
product development process
• Tips on how to make the product
development process more efficient
• How to avoid costly delays in
product launches and access global
3:10 pm – 3:45 pm
WORKSHOP EU MDR’S IMPACT ON LABELS
• EU MDR label requirements
compared with MDD and AIMDD
• Comparison of EU MDR & FDA UDI
• Medical device label – Before and
after EU MDR
• Touch your labels once strategy
• Labeling that can adapt to a
changing world
WORKSHOP KEY ATTRIBUTES DRIVING A ROBUST
SOFTWARE SUITE FOR MEDICAL
ELECTRONICS MANUFACTURING
• Leverage standalone and
integrated software to drive key
metrics
• Enhance customer visibility and
factory efficiency with real-time
OTD and quality data
• Eliminate manual data and field
returns risk
• Experiment with software
innovations in Beta
WORKSHOP HARMONIZATION OF AGILE SOFTWARE
DEVELOPMENT AND FDA MEDICAL
DEVICE DESIGN CONTROL
REQUIREMENTS FOR SAMD AND
DIGITAL HEALTH SOFTWARE
• The goal of this presentation is to
provide a strategy to develop SaMD
and software as part of medical
device or combination product
systems in compliance to the FDA
Design Control requirements
• Step through 21 CFR 820.30 Design
Control requirements and Agile
development principles in parallel
and present a least burdensome
approach NAYSAHN SAEED
Global Business Director
SIMON JONES
VP, Global Products
NICOLE RUSSO
President/CEO
LORI-ANN WOODARD
Director, Medical Device in
Compliance
PRODUCT STRATEGY THE IMPACT OF R&D AND MEDICAL
DEVICE TRENDS ON SMALL TO MID-SIZE
ORGANIZATIONS
• How to simply take advantage of
changing industry dynamics as a
small to the mid-size medical device
company
• How to increase strategic
relationships
• Developing an approach to increase
focus on R&D and understanding
outsourcing as an opportunity
within the medical device industry
QUALITY/ REGULATORY DEVELOPING A CULTURE THAT VALUES
REGULATORY LEADERSHIP
• Why leadership remains the No. 1
talent issue facing organizations
around the world
• Exploring the need for “leaders at all
levels” as a critical issue identified in
the Global Human Capital Trends
survey
• How developing leaders in the face
of new challenges, such as
development within various
generations, demand for global
influence, and rapidly changing
technologies can be daunting
• Case study: Discover one company’s
INNOVATION SEEING MEDICAL DEVICES THROUGH A
SERVICE LENS
• Tangible ways to use data, machine
learning and AI to think differently
about your services ecosystem
• Leveraging the XaaS model to
reconsider how you design devices
with recurring revenue
opportunities built-in
• Designing for serviceability, quick
tips you can use now plus longer-
term ideas
GRACE HSIA
Co-Founder & CEO
RAINA DAURIA
VP, WW Regulatory Affairs
CHETAN MAKAM
VP, Global Services
2:25 pm – 3:05 pm
DESIGN CONCEPT TO COMMERCIALIZATION:
OPTIMIZING YOUR PRODUCT
DEVELOPMENT STRATEGY
• Pathways to connect designers
with manufacturing for improved
downstream risk management
• Design strategy that incorporates
supply chain sustainability
• When to employ external expertise
in the concept to
commercialization process
• Critical considerations in medical
device design and development
ANDY PARTRIDGE
Senior Director, APAC-EMEIA
Manufacturing
American Medical Device Summit 2018 Program • Page 6
CHAIR’S CLOSING REMARKS
NETWORKING DRINKS RECEPTION
7:15 pm – 7:20 pm
MICHAEL BACA
Former VP, Quality / Regulatory / Clinical
Sponsored by:
SCOTT PLEAU
SVP, Global Operations
CLOSING KEYNOTE TRANSFORMING CULTURE: AN INTEGRAL ELEMENT TO BUSINESS TRANSFORMATION
• How Baxter is transforming its culture – companywide and in manufacturing operations
• Transformation is imperative to meet the needs of our many stakeholders and to be successful in a changing business environment
• How cultural change and recognition can change culture
• What are the keys to cultural transformation?
5:55 pm – 6:35 pm
6:35 pm – 7:15 pm
LEADERSHIP SPOTLIGHT DEVELOPING A STRATEGIC MEDICAL DEVICE CLEARANCE & APPROVAL PLAN
• Identify benefits and challenges of various regulatory markets, alongside an analysis on potential modifications to 510k policy
• FDA perspective on predicate device criterial: examining predicate device selection tools and techniques
• Understanding checklists and timelines for FDA refuse-to-accept policy, best practices for internal submission review
MARJORIE SHULMAN
Director, Premarket Notification Program
7:20 pm – 8:20 pm
EXECUTIVE SPOTLIGHT EU MDR BUSINESS OPPORTUNITY AND IMPLEMENTATION CHALLENGES
• How compliance with the EU MDR can help to grow the business, even though it is usually identified with cost effort
• A look at my extensive experience in EU MDR implementation at various companies
• Examining the challenges and pitfalls that are seen across the board, and how they can be prevented easily
HILDE VIROUX
AVP, Regulatory
5:15 pm – 5:55 pm
American Medical Device Summit 2018 Program • Page 7
NETWORKING & BREAKFAST
CHAIR’S OPENING REMARKS & REVIEW OF DAY ONE
7:00 am – 7:55 am
7:55 am – 8:05 am
PROGRAM DAY TWO
GRACE HSIA
CO-FOUNDER & CEO
KIMBERLY TRAUTMAN
EVP, MEDICAL DEVICE INTERNATIONAL SERVICES
RAINA DAURIA
VP, WW REGULATORY AFFAIRS
MICHAEL BACA
Former VP, Quality / Regulatory / Clinical
MARJORIE SHULMAN
DIRECTOR, PREMARKET NOTIFICATION PROGRAM
We invite our attendees to network at a Women in Leadership Breakfast Brief with discussion from inspirational leaders in the medical device industry. Seating is
limited.
WOMEN IN LEADERSHIP ROUNDTABLE
CARMINE JABRI
PhD, MSJ, MSQM, President & CEO
THE NEW EUMDR AND WHAT YOU NEED TO KNOW DEVOPS & VIRTUALIZATION: ACCELERATING TIME TO MARKET FOR MEDI-
CAL DEVICES
RAJ GHATE
CEO
PROTECTING CONNECTED HEALTH APPLICATIONS FROM THE INSIDE OUT 5 KEY CHALLENGES TO OVERCOME FOR SMART, CONNECTED MEDICAL
DEVICES
MATT CLEMENS
Security Solutions Architect
LISA BECKER
ASSOCIATE DIRECTOR, CLINICAL QUALITY ASSURANCE
BREAKFAST BRIEFS
PHILLIP SIMULIS
CEO
GEDIMINAS JOMANTAS
Arxan Client
American Medical Device Summit 2018 Program • Page 8
8:45 am – 9:25 am
GUSTAVO PEREZ-FERNANDEZ
President & CEO
8:00 am – 8:45 am
EXECUTIVE SPOTLIGHT CONNECTING DESIGN TO EXECUTION IN A LEAN SYSTEM
• Understanding the lost opportunities of not applying lean: Leak analysis
• What is the missing link between functional support areas and daily operations
• Lessons learned on driving lean through the organizational culture
• Lean and its impact on organizational speed: Short-term and long-term
WILLIAM OWAD
SVP, Operational Excellence
9:25 am – 10:05 am
KEYNOTE CDRH STRATEGIC PRIORITIES: HOT TOPICS FOR AN EVOLVING REGULATORY CLIMATE
• Update on 2017-2018 priorities and preview of 2019-2020
• Case for quality: Realizing what we can achieve when we work together
• Benefit: Risk guidance: Impact on compliance and enforcement decisions
CAPT SEAN BOYD
Deputy Director for Regulatory Affairs
EXECUTIVE SPOTLIGHT AI AND MEDICAL DEVICES:MANAGING PATIENT EXPECTATIONS IN A DIGITAL WORLD AND THE NEED FOR UNIFYING EXPERIENCES
• A deep dive into the evolving healthcare ecosystem & its implications for medical device companies
• How to build a digital core and framework for patient-centric healthcare solutions
• Exploring technology drivers transforming digital healthcare
American Medical Device Summit 2018 Program • Page 9
WORKSHOP A PROGRAMMATIC APPROACH TO EU
MDR COMPLIANCE
• Assess your product portfolio to
determine priority
• Develop a plan that takes into
account prioritization of your
current products and pipeline
• Execute the plan and ensure that
project controls are in place to
manage and monitor your progress
• Revise processes and procedures to
ensure a sustainable process
WORKSHOP SUCCESSFULLY NAVIGATING COMMON
PRODUCT COMMERCIALIZATION
PITFALLS
• When the difficult and costly
development process is coming to
fruition, the pressure is on to
deliver the product to patients in
need
• Navigate the complexities of the
commercial launch process - the
complex regulatory submission
process, market access barriers,
supply chain challenges, and many
other challenges
• Mitigate risks that, if mismanaged,
can result in missed opportunities
for patients and loss of market
share to competitors
WORKSHOP MAXIMIZE PERFORMANCE / MINIMIZE
RISK: NAVIGATING PACKAGING FOR
MEDICAL DEVICES
• Trends in Device Packaging
• Classes of Devices and Package
Selection
• Methods of Sterilization and
Package Selection
• Cost of a Field Failure
• Sustainability and Package Selection
• Balancing Performance versus Cost
versus Risk
WORKSHOP SOFTWARE DESIGN AND
IMPLEMENTATION FOR TODAY’S FDA/
CE -MDR SUBMISSION
• Quality, Cybersecurity & Safety, the
cornerstones of the product
submissions for 2018, and…always!
• Developing testable requirements
and code. Design and code for
testing and traceability, and
eliminate bugs along the way
• Documentation and deliverables-
Short falls and pit falls- how to
navigate around them and create a
submission with the right
traceability and objective evidence.
• Cost effectiveness- It is possible to
make a better product and reduce
costs at the same time by
understanding the best practices
• How to implement best practices
into your design process, or update
your current product road-map and
designing it in for the current
environment
EYAL GOLAN
Project Management Consultant
TOM RYNKIEWICZ
VP, RA/ QA
JAMES BANKO
VP, Sales
BILL STAMM
VP, Software Services
10:10 am – 10:45 am
10:50 am – 11:50 am
NETWORKING DRINKS RECEPTION
American Medical Device Summit 2018 Program • Page 10
12:35 pm – 1:10 pm
WORKSHOP LEADING EFFECTIVELY THROUGH
TIMES OF CONSTANT CHANGE
• Effective leadership during times of
change is critical to - execute
change successfully; create and
manage cross functional teams;
redefine the patient experience and
deliver on expectations.
• Understand the biggest driver of
change – leader and employee
behavior
• Improve business results by
leveraging 4 Core Elements
• Take a Change Risk Assessment to
uncover opportunities where your
organization can improve
WORKSHOP ARE YOU READY FOR MDR?
• The MDR is the single largest change
to medical device regulations in
Europe since CE Marking was
introduced in 1993; are medical
device companies ready to tackle
this new regulation?
• Dive into the main regulation
changes
• Explore the effects of the new
requirements on medical device
companies
• Walk through the timeline of MDR
transition and implementation
WORKSHOP BEST PRACTICES FOR MAKING THE
DIGITAL FACTORY REAL
• Why some lose focus on the goal;
Business outcome
• Building a roadmap for success in
areas in areas such as eDHR
• Cultural changes when moving from
paper systems to digital
WORKSHOP PREPARING FOR THE CLINICAL
EVIDENCE REQUIREMENTS OF THE EU
MDR
• Understand what EU MDR
compliance means with respect to
clinical evidence that will be
required for your devices and how it
will affect your business
• Develop clinical evaluation plans
and post market clinical follow-up
(PMCF) plans to enable
comprehensive benefit-risk
assessments
• Partner with a regulatory medical
writing agency to ensure
compliance and increase speed to
BEATA WILKINSON
Medical Director, Regulatory Writing
GARY EVANS
Director, Business Development &
Customer Solutions
KIM HUGGINS
Partner
PETER ROSE
Managing Director- Europe
DESIGN CHANGE MANAGEMENT AS A
STRATEGIC GROWTH INITIATIVE
• Identify the need for
Organizational Change
Management
• The 5 strategic pillars of OCM
• A balanced matrix in your R&D
organization: Why it works so well
• Working on the right things: The
basics of Project
Portfolio Management
PRODUCT STRATEGY J&J GLOBAL EXTERNAL INNOVATION:
OUR MODEL, CLINICAL FOCUS AREAS,
AND JLABS DEEP DIVES
• GEI – A comprehensive global
solution to support innovation
• Disease area strongholds for medical
device, pharma, and consumer
businesses
• JLABS – Model, resources, and
performance
• A representative anecdote
demonstrating the leverage, and
acceleration JLABS can bring to a
start-up
REGULATORY GLOBAL REGULATORY INTELLIGENCE:
EVALUATING THE DEVELOPMENTS TO
THE EU MDR
• Exploring regulatory challenges
regarding the tracking, monitoring
and interpretation of new regulations
of the ever-changing global regulatory
landscape, specifically the new EU
MDR
• Advice for companies to help them to
ensure that they have the right
resources and support to
appropriately interpret and
implement the new EU MDR
• Building a regulatory framework that
outlines a step-by- step guide for your
post-market transition period
• How firms are assessing the
interpretation of the new
requirements: What is the internal
project structure (is there PMO
support), what is the cost structure
INNOVATION ENTERING AN ERA OF VALUE BASED
HEALTH CARE: A CASE STUDY ON THE
TYRX DEVICE
• A case study on how the TYRX
absorbable antibacterial envelope
will reduce infection and reduce
costs
• A look at how innovation leads to
better quality standards through
accountability and a patient-centric
focus
• Examining the future of health care
through the partnership with the
Lehigh Valley Hospital Network
NORBERT LEINFELLNER
VP, Product Development Engi-
neering
NICHOLAS MOURLAS
Senior Director New Ventures
MICHAEL SANTALUCIA
VP, Global Regulatory Affairs
JORIE SOSKIN
Sr. Director & General Manager, Med-
tronic Infection Control
11:55 am – 12:30 pm
American Medical Device Summit 2018 Program • Page 11
LUNCH & LEARN ROUND-TABLE DISCUSSIONS
1:15 pm – 2:15 pm
DRIVING AGILE ADOPTION FOR THE DEVELOPMENT
OF MEDICAL DEVICES
HOW TO CREATE AN ORGANIZATION OPEN,
CURIOUS, AND COMMITTED TO LEARNING
OPTIMIZING YOUR PRODUCT DEVELOPMENT
STRATEGY
THE BIGGEST CHALLENGE FOR SMALL-TO-MID-SIZE
MEDICAL DEVICE COMPANIES
BESAINT MEHTA SAHNI
Senior Program Manager
MARK WEHDE
Section Head of Technology
Development
Mayo Clinic Division
of Engineering
VALERIE OBENCHAIN
Founder and CEO
IMPLEMENTATION AND EXECUTION OF MAJOR
REGULATORY CHANGES WITH A SPECIFIC FOCUS ON
EU MDR AND EURASIA REGULATIONS
LAILA GURNEY
Senior Executive, Global Regu-
latory Affairs
CHARACTERISTICS TO CONSIDER WHEN SELECTING
CONTRACT MANUFACTURERS
HOW TO INTERACT PRO-ACTIVELY WITH
REGULATORS IN A POST MARKET SETTING
MANJU PARKHE
VP, Operations & Contract
Manufacturing
ARTIFICIAL INTELLIGENCE WIFM: SMART MEDICAL
DEVICE, SMART MANUFACTURING LINE AND SMART
SUPPLY CHAIN
SHANE MAO
Global Surgical Franchise
Head, Manufacturing Science
IS HIGHER EDUCATION PREPARING THE NEXT
GENERATION FOR THE MEDICAL DEVICE
WORKFORCE?
MAC MCKEEN
Fellow, Regulatory Science
BART VAN DEN BRAND
VP, Quality Americas
ANDY PARTRIDGE
Senior Director, APAC-EMEIA
Manufacturing
American Medical Device Summit 2018 Program • Page 12
2:20 pm – 2:55 pm
DESIGN SMART DEVICE DESIGN THINKING: USER-CENTERED
DESIGN TO DRIVE BREAKTHROUGH PATIENT
OUTCOMES
• Dealing with today’s dynamic healthcare
environment must start with a new
understanding of the patient
• We must disrupt current patient engagement
models with new levels of patient intimacy to
drive new innovation
• These techniques translate to breakthroughs
such as smart devices
• Patient engagement is an ongoing journey to
truly improve lives
ASHISH ATREJA, MD, MPH
Chief Innovation Officer, Medicine
REGULATORY ADDRESSING AN UNMET NEED:TRANSITIONING
ADULT DEVICES TO ACCOMMODATE THE PEDIATRIC
POPULATION; A LOOK AT CHALLENGES AND
TRENDS
• Examining device and design consideration
• an outline of key factors specific to the pediatric
population
• How to acquire funds for pediatric devices;
battling the return on investment hurdle
• Tips for clearing your pediatric device through
FDA pathways
LISA BECKER
Associate Director, Clinical
Quality Assurance
CARLOS URREA
VP, Medical Affairs
2:55 pm – 3:35 pm
PRODUCT STRATEGY UNDERSTANDING FDA’S ROLE IN SUPPORTING
MEDICAL DEVICE INNOVATION TO IMPROVE PUBLIC
HEALTH
• Communicating and interacting with FDA earlier
in the development process
• Special programs and initiatives to address
critical and unmet needs
• Engaging payers and healthcare technology
assessment organizations to support coverage
and adoption
KEN SKODACEK
CDRH Deputy Ombudsman,
CDRH Innovation
RYAN A. TERRY
GVP, Connectivity Solutions
INNOVATION SPOTLIGHT CONNECTED ASSETS IN REGULATED ENVIRONMENT (CARE)
• Key considerations for driving connectivity in a regulated environment
• Ways to generate value from analytics and decision-making systems to drive business and clinical objectives
• Steps to quantify ROI for smart-connected devices
• How connectivity and interoperability drive evolution of collaborative platforms for OEMs, payers, providers, and patients
American Medical Device Summit 2018 Program • Page 13
MICHAEL BACA
Former VP, Quality/ Regulatory/ Clinical
3:40 pm – 4:20 pm
CLOSING PANEL ADDRESSING THE 2018 OBSTACLES: EXPLORING REGULATORY CHALLENGES & OPPORTUNITIES
• Assessing real-time detection: What measures can regulators, healthcare providers, and device manufacturers take to protect the public from malware attacks?
• With the “Emerging Signals” guidance issued by FDA, what are some of the challenges and benefits to the early notification to the public of potential adverse
events?
• With upwards of over 100 countries with local regulatory requirements for medical devices, what are some of the greatest challenges
ASHISH ATREJA, MD, MPH
Chief Innovation Officer, Medicine
CAPT SEAN BOYD
Deputy Director for Regulatory Affairs
CHAIR’S CONCLUDING REMARKS & CLOSE OF SUMMIT
4:20 pm – 4:25 pm
MICHAEL BACA
Former VP, Quality/ Regulatory/ Clinical