AMERICAN MEDICAL DEVICE SUMMIT 2019 · keynote a holistic approach for the medical device industry:...
Transcript of AMERICAN MEDICAL DEVICE SUMMIT 2019 · keynote a holistic approach for the medical device industry:...
AMERICAN MEDICAL DEVICE SUMMIT 2019
OCTOBER 28–29, 2019
HYATT REGENCY O’HARE • CHICAGO, 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
PROGRAM DAY ONE
7:50 am – 8:00 am
ROBERT WOOD
VP, World Wide Manufacturing
PRE-EVENT HAPPY HOUR JOIN US FOR THE PRE-EVENT HAPPY HOUR OCTOBER 27, 2019 AT 6:00 PM – 7:00 PM
6:50 am – 7:50 am
REGISTRATION AND NETWORKING BREAKFAST
CHAIR’S OPENING REMARKS DESIGN CHAIR PRODUCT DEVELOPMENT CHAIR
MAC MCKEEN
Fellow, Regulatory Science
QUALITY & REGULATORY CHAIR INNOVATION CHAIR
KEYNOTE A HOLISTIC APPROACH FOR THE MEDICAL DEVICE INDUSTRY: INTEGRATION OF INNOVATION AND QUALITY
• Disrupters in healthcare, opportunities and risks
• Transforming the vision for quality
• A compliance standpoint: How to lead a quality transformation from a customer approach and as a growth enabler
• Leveraging customer and patient data to improve quality and profit
8:00 am – 8:40 am
CYNTHIA HOUGUM
SVP, Global Quality Transformation
PLENARY SMART HEALTH 2.0: THE DATA MEDICAL DEVICE RACE
• Looking at how the 21st century presents new challenges to patients, healthcare providers, payor and industry
• How demographics are changing dramatically
• Why demand for better, more complex and affordable healthcare is exploding
• The systematic utilization of ever-increasing data pool for goal-directed diagnosis and therapy provide huge opportunities
• Who will be the winner in the digital health care race
8:40 am – 9:20 am
JIJO JAMES
Chief Medical Officer, Medical Devices
KHALED MOUSSALLY
Global Head, Quality Compliance
Sponsored By:
American Medical Device Summit 2018 Program • Page 2
PLENARY HOW COMPLIANCE WITH THE EU MDR CAN HELP TO GROW THE BUSINESS
• EU MDR challenges and the 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
9:20 am – 10:00 am
HILDE VIROUX
AVP
PRE-ARRANGED 1-2-1 NETWORKING AND REFRESHMENTS
10:05 am – 11:45 am
11:50 am – 12:25 pm
DESIGN SMALL TO MID-SIZE PRODUCT
ACCELERATION: REINVENTING
NEWBORN HEALTH CARE THROUGH
EMPATHY-DRIVEN DEVICES
• How does empathy play a role in
the medical device product
development and sales life-cycle
• How to simply take advantage of
changing industry dynamics as a
small to the mid-size medical
device company
• How to increase strategic
relationships and focus on
execution
• Case study: Developing a cutting-
edge portable device
VIVEK KOPPARTHI
Co-Founder and CEO
PRODUCT DEVELOPMENT AGILE MANUFACTURING FOR MEDICAL
DEVICE PRODUCT DEVELOPMENT
• Establishing open bilateral
communication
• Ensuring design and manufacturing
process transparency
• How well your contract
manufacturer adapts to changes in
customer demands, advances in
applicable technology and new
standards/regulations
ROBERT WOOD
VP, World Wide Manufacturing
QUALITY & REGULATORY UPDATES FOR MANUFACTURERS
PREPPING FOR EU MDR/IVDR DEVICE
CERTIFICATION AND RECERTIFICATION
• Creating a checklist and a realistic
timeline
• Keeping track of the countdown to
MDR/IVDR's date of application
• Exploring the significant impacts for
medical device manufacturers
• Case study: The effect on IVD
companies who are under review
ANN VU
VP, Quality and Regulatory
Compliance
INNOVATION BRIDGING THE GAP BETWEEN
INDUSTRY AND THE FDA: HOW TO
SUPPORT MEDICAL DEVICE
INNOVATION
• Improving collaboration of staff
• Process improvements and keys to
success
• Special programs and initiatives to
address critical and unmet needs
• Sharing a hybrid perspective: From
industry to FDA
KEN SKODACEK
Deputy Ombudsman,
CDRH Innovation
American Medical Device Summit 2018 Program • Page 3
12:30 pm – 1:05 pm
WORKSHOP BENEFITS TO AUTOMATING
DOCUMENT CONTROL FOR MEDICAL
DEVICE MANUFACTURERS
• Paperless approval routings with
electronic signatures
• Embracing collaboration with users
and other quality records
• Trigger training events
automatically reducing training
gaps
• Streamline change control with
document integration
BRANT ENGELHART
Co-Founder and CEO
WORKSHOP PREPARING FOR THE CLINICAL
EVIDENCE REQUIREMENTS OF THE EU
MDR
• Companies need to plan for two
important notified body related
windows in 2019
• Understanding what EU MDR
compliance means with respect to
clinical evidence that will be
required for your devices
• How it will affect your business
• Continuing to partner with a
regulatory medical writing agency
to ensure compliance and increase
speed to market
BEATA WILKINSON
Medical Director, Regulatory Writing
WORKSHOP ADOPTING LIFE-CHANGING
TECHNOLOGIES AND EQUIPMENT FOR
MEDICAL DEVICES
• Ensuring value through results with
new technologies and equipment
• Types of analyses that are used to
promote adoption
• How to develop the right data types
to meet requirements
• Review the role of technology and
equipment, and the core challenges
of that technology
ANDY ROGERS
VP, Business Development
WORKSHOP A WINNING MEDICAL DEVICE
MANUFACTURING INNOVATION
STRATEGY
• Direct bonding: Joining dissimilar
materials without the use of
primer, solvents or adhesive
chemistry
• Biocompatibility: Barrier coatings
which are safe for contact or
implantation
• Antimicrobial: Rapid inline coatings
• Osteogenesis: Structured
topographies promoting bone
growth and healing
• Tailored surface chemistry:
Customized solutions for R&D and
process development
SPEAKER TBA
LUNCH & LEARN ROUNDTABLE DISCUSSIONS
1:10 pm – 2:10 pm
HOW TO COPE IN THE MIDST OF EXTREME CHANGE:
A CASE STUDY OF SURGICAL ROBOTICS IN A
CHANGING FDA LANDSCAPE
ACCESS TO A GLOBAL MARKET: HOW TO GET
MARKETING AND REGULATORY AFFAIRS WORKING
EFFECTIVELY TOGETHER AROUND THE WORLD
SILENCING SELF-DOUBT: HOW TO OVERCOME
IMPOSTER SYNDROME AND GAIN CONFIDENCE
STEPHANIE FITTS
VP, Regulatory Affairs, Quality
Assurance, Clinical Research
and Compliance
TIMOTHY CROFT
Director, Program Management
ILANA SHULMAN
Chief Compliance Officer
DIVING INTO THE CHALLENGES OF LEADING
CHANGE FOR LEADERSHIP
ANILA LINGAMNENI
VP, Renal R&D
HOW TO FOSTER STRATEGIC RELATIONSHIPS WITH
HOSPITAL NETWORKS
BESAINT MEHTA SAHNI
Senior Program Manager
HOW TO EMBRACE DIVERSITY AND INCLUSION
WITHIN YOUR ORGANIZATION
KELLY EMERTON
Senior Director, Product
Development
and Commercialization
American Medical Device Summit 2018 Program • Page 4
2:15 pm – 2:55 pm
DESIGN TRANSLATION TO PRACTICE: HOW TO
GET INNOVATION OUT OF THE
RESEARCH SETTING AND INTO THE
CLINICIANS HANDS
• Identifying the clinical need
through ethnographic research (a
day in their shoes)
• Rapid prototyping using
computational modeling and
additive manufacturing
• Moving to point of care additive
manufacturing of anatomical
models, cutting guides, and patient-
specific implants
MARK WEHDE
Section Head, Technology
Development
PRODUCT DEVELOPMENT DEMOGRAPHIC SHIFTS IMPACT FOR
MEDICAL DEVICE MANUFACTURERS
• An overview of how the
demographic shift will impact your
organization
• Efforts to control costs and
exploring opportunities to diversify
your reach
• Why your organization must plan
for a restructure to avoid the
pitfalls of the past
QUALITY & REGULATORY REVISING QSR TO BE MORE CLOSELY
ALIGNED WITH ISO 13485: PROPOSED
GUIDANCE DEVELOPMENT AND
RETROSPECTIVE REVIEW
• Updates from the Center for
Devices and Radiological Health
(CDRH)
• Prioritizing digital health: Five
guidances on our FY2019 list focus
on supporting continued
innovation and safety in digital
health
• Advancing device safety and
security: Addressing device-specific
safety issues or promote visibility
related to specific labeling or
testing recommendation
• Offering more flexibility and
options for premarket submissions
• Sustaining high-quality servicing,
effective oversight, and handling
uncertainty in devices
CAPT. SEAN BOYD
Deputy Director, Regulatory Affairs
INNOVATION MEDICAL DEVICE THREATS:
NAVIGATING THE NEW FRONTIER OF
CYBERSECURITY RISK
• Applying concepts of security risk
management to medical device
design
• Proactive and reactive program
capabilities
• Collaborative approaches with
health delivery organizations
• Lessons learned from past attacks
and reframing device vulnerabilities
to enable resources to protect
patients
EHREN POWELL
CIO
American Medical Device Summit 2018 Program • Page 5
3:00 pm – 3:35 pm
WORKSHOP REGIONAL CONTROL OF YOUR LABEL
PORTFOLIO FOR GLOBAL
ORGANIZATIONS
• Using EU MDR labeling
implementation to unlock the
power of a global platform
• How a 'Regulatory Rules' engine
aids compliance and reduces tribal
knowledge roadblocks
• Gaining an understanding of how
out-of-the-box print processes give
businesses the power to deploy a
labeling strategy quickly
• Leveraging your existing network
and IT assets using the right
labeling solution
RICHARD CASTLE
Global Sales Manager
WORKSHOP KEY ATTRIBUTES DRIVING A ROBUST
SOFTWARE SUITE FOR MEDICAL
ELECTRONICS MANUFACTURING
• Leverage standalone and
integrated software to drive key
metrics
• How intelligent automation is
shaking up how business gets done
• 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
KATHERINE MILLER
Director, Life Sciences
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
markets on time
RANDY SMITH
CEO
WORKSHOP SOFTWARE ENHANCEMENTS:
DISTINGUISHING TYPE AND
DEVELOPMENT TO MEET
REQUIREMENTS
• Why software has become an
important part of all products,
integrated widely into digital
platforms that serve both medical
and non-medical purposes
• Differentiating between the two
types of software related to
medical devices include software
that is integral to a medical device
(software in a medical device) and
software used in the manufacturing
• Providing a strategy to develop
SaMD and software as part of
medical device or combination
product systems
BILL STAMM
VP, Software Services
PRE-ARRANGED 1-2-1 NETWORKING AND HAPPY HOUR
3:40 pm – 5:00 pm
Sponsored By:
American Medical Device Summit 2018 Program • Page 6
5:45 pm – 6:20 pm
WORKSHOP ANTICIPATING CHANGES TO THE
STANDARDS TO ENABLE TESTING AND
ENHANCE MEDICAL DEVICE
DEVELOPMENT
• Testing methods using sound
engineering principles from
existing standards for mature
technologies or new technologies
• Developing cybersecurity
standards: Why this is now, more
than ever, important for all medical
device manufacturers
• How to simplify global market
access: Getting your products to
market faster
BLAINE TETTERTON
Marketing
WORKSHOP BUILDING STRATEGIC PARTNERSHIPS
TO DRIVE MEDICAL DEVICE
OPERATIONS
• How engineers visualize their
design and work
• Building and driving operational
teams to create plans to ensure
their design works within the
targeted infrastructure
• Why key strategic partnerships
within your organization can lead
to device innovation
FRANK NARBUT
CEO
WORKSHOP HOW MEDICAL DEVICES CAN HARNESS
THE ENERGY OF THE DIGITAL AGE
WITH SPEED AND CONFIDENCE
• From vision to reality: How digital is
at the core
• Why digital needs to be in every
part of the organization
• Fostering a culture to digital
demands for continuous disruption
• Case study: A digital transformation
ANDREAS FALKENBERG
Digital Transformation
and Innovation Expert
WORKSHOP FDA’S PARADIGM SHIFT ON SOFTWARE
VALIDATION & QUALITY METRICS
• Two cutting edge topics, both being
spearheaded by FDA:
• Software validation: How a shift
from validation to assurance is
greatly reducing time to market
• AI-based quality metrics: A demo of
how AI-based analytics is the future
of quality metrics
• Why the future is now
5:05 pm – 5:40 pm
DESIGN DRIVING DESIGN IN THE TOP
CATEGORIES: MINIATURIZATION IN
MEDICAL DEVICES
• Addressing why medical devices
are becoming smaller and more
portable to meet customer and
patient needs
• Smaller in size: A look at the
integration of wireless technology,
making them smaller and more
portable
• Lowering costs: Reducing the
length of hospital stays, material
and shipping costs
• Increasing functionality: Smaller
devices enable less invasive
procedures and less trauma for
patients
CAMERON PIRON
President
PRODUCT DEVELOPMENT HARNESSING INTERNAL AND VENDOR
CAPABILITIES TO ACCELERATE
INNOVATION
• Learn concepts to be confident in
the ability to evaluate risks to make
an investment in R&D to speed up
innovation
• Challenge the status quo – provide
pathways for new standards of care
• Case study: ivWatch technology and
product pipeline
JACLYN LAUTZ
VP, R&D
QUALITY & REGULATORY THE NEW PARADIGIM: GUIDANCE FOR
INDUSTRY AND FDA STAFF
• Deciding when to submit a 510(k)
for a software change to existing
devices
• Required submission for safety and
effectiveness
• Understanding checklists and
timelines for FDA refuse-to-accept
policy, best practices for internal
submission review
• Overcoming rejection in 510(k)
submissions; examples of
successful appeal pathways
MARJORIE SHULMAN
Director, Premarket Notification
Program
INNOVATION INNOVATION TODAY: THE GROWTH OF
THE IMPLANTABLE MEDICAL DEVICES
MARKET
• The key factors propelling the
market for implantable medical
devices
• Case study: Joint and bone
disorders that demand implants
• Opening new doors of opportunity
for the implantable medical device
market in the long run
COLLEEN RILEY
VP, Science and Technology
CHAKRI UDDARAJU
Artificial Intelligence Leader
KHALED MOUSSALLY
Global Head, Quality
American Medical Device Summit 2018 Program • Page 7
KEYNOTE EXPLORING GLOBAL WEB-CONNECTED MEDICAL DEVICES
• Establishing comprehensive, factual, and cost-effective information based on performance, capabilities, and goals for the world’s leading medical device
manufacturers
• Complement competitor analysis by providing strategic analysis, data interpretation, and insight
• Identify the latest developments in web-connected medical devices markets, and strategies employed by the major players
• Evaluate the web-connected medical devices market production development, core challenges and strategies to evade risks
6:20 pm – 6:50 pm
DAVID PACITTI
President and Head, Healthcare, North America
6:50 pm – 6:55 pm
CHAIR’S CLOSING REMARKS
7:00 pm – 8:00 pm
NETWORKING DRINKS RECEPTION Sponsored By:
DESIGN CHAIR PRODUCT DEVELOPMENT CHAIR QUALITY & REGULATORY CHAIR INNOVATION CHAIR
ROBERT WOOD
VP, World Wide Manufacturing
DESIGN CHAIR PRODUCT DEVELOPMENT CHAIR
MAC MCKEEN
Fellow, Regulatory Science
INNOVATION CHAIR
KHALED MOUSSALLY
Global Head, Quality Compliance
American Medical Device Summit 2018 Program • Page 8
PROGRAM DAY TWO
NETWORKING BREAKFAST
7:00 am – 7:55 am
ASSESSING RISK FOR NEW MEDICAL DEVICE
DEVELOPMENT AND LAUNCHES
EXPLORING THE ROLE OF A.I. AND OTHER INDUSTRY
4.0 TECHNOLOGIES IN QMS
LEARN HOW TO PROTECT DATA WITH A STANDARD
SYSTEMATIC APPROACH
KARI MILLER
Regulatory and Product Man-
agement Leader
WOMEN IN LEADERSHIP ROUNDTABLE
We invite our attendees to network at a Women in Leadership roundtable with discussion from inspirational leaders in the medical device industry. Seating is limited.
ILANA SHULMAN
Chief Compliance Officer
TANYA KLASLO
VP, Global Regulatory
Operations
PAMELA GOLDBERG
President and CEO
KELLY EMERTON
Senior Director, Product
Development and
Commercialization
JACKIE KUNZLER
SVP, Chief Quality Officer
MARJORIE SHULMAN
Director, Premarket
Notification Program
BREAKFAST BRIEFS
JEFF GRIZZEL
SEAN HART
7:55 am – 8:00 am
CHAIR’S OPENING REMARKS
KEYNOTE CREATING A DEVICE-ENABLED DIGITAL ECOSYSTEM FOR BREAKTHROUGH PATIENT OUTCOMES
• The key drivers for digital transformation: A roadmap to Hill-Rom's device-enabled digital ecosystem
• How we are leveraging our devices to create unique data and identifying unique opportunities to drive patient outcomes
• Effectively tackling pressing challenges and counterbalancing the bottom line
8:00 am – 8:45 am
BRIAN LAWRENCE
SVP and Chief Technology Officer
ROBERT WOOD
VP, World Wide Manufacturing
DESIGN CHAIR PRODUCT DEVELOPMENT CHAIR
MAC MCKEEN
Fellow, Regulatory Science
QUALITY & REGULATORY CHAIR INNOVATION CHAIR
KHALED MOUSSALLY
Global Head, Quality Compliance
Sponsored By:
American Medical Device Summit 2018 Program • Page 9
PLENARY REGULATORY DOCUMENTATION EXCELLENCE: AN OPPORTUNITY TO LEVERAGE THE REGULATIONS TO YOUR ADVANTAGE
• Upstream changes to impact the quality of the documentation
• Industry best practices
• Think globally not just for remediation
8:45 am – 9:25 am
TANYA KLASLO
VP, Global Regulatory Operations
9:25 am – 10:05 am
10:10 am – 10:45 am
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
• Developing proactive monitoring
and management to improve
reliability and correct 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
DON SCHLIDT
President and CEO
WORKSHOP HOW TO REDUCE RISK WITH DEVICE
MARKING INSPECTION
• Providing efficient inspections,
verification, and grading of marks
on medical parts
• Noting what is most important and
reducing the risk of recalls
• Ensure accurate product
identification and traceability
LORENA RUELAS
Marketing
WORKSHOP ECONOMIC OPERATORS: WHOSE
PROBLEM IS IT ANYWAY?
• Shining a light on this topic that is
crucial to EU MDR compliance
• What does EU MDR actually require
of economic operators?
• Legal responsibilities vs practical
application
• Sharing real-world insights and
experiences of EO compliance
PETER ROSE
Managing Director, Europe
WORKSHOP CONNECTED MEDICAL DEVICES:
ACCELERATED LIFECYCLE STRATEGIES
• Designing medical devices to
digitize, automate and integrate
quality and compliance processes
across the product lifecycle
• How to improve efficiency, and
accelerate time-to-market
• Providing advanced analytics,
reporting, and drill-down features
for your connected devices
JONATHAN BECKSTRAND
CEO
PLENARY LEVERAGING TECHNOLOGY AND ARTIFICIAL INTELLIGENCE TO ACCELERATE IMPROVEMENTS IN EFFECTIVENESS AND PRODUCTIVITY IN THE SUPPLY CHAIN
• What are the best investments in tools and technology for improving supply chain performance?
• Understanding normal supply variability, demand patterns and drivers of variability
• Connecting data across multiple systems to improve root cause analysis
• Planning, scheduling, and prioritizing processes based on the new understanding of supply and demand variability
• Transitioning to demand-driven production with simplified status visibility across the supply chain
• Case study: Demonstrating a quantum leap in performance through a new supply chain management approach
JAIME VELEZ
Co-Founding Partner Operations and Quality Systems Improvement Expert
American Medical Device Summit 2018 Program • Page 10
PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND REFRESHMENTS
10:50 am – 12:10 pm
12:15 am – 12:50 am
PRODUCT DEVELOPMENT STIMULATING INNOVATION:
DEVELOPING AND IMPLEMENTING
PORTABLE DEVICES
• Harnessing the power of PEMF,
innovation, and technology to
develop a safe and clinically backed
treatment
• Why helping patients across the
globe who suffer from pain and
chronic conditions matters
• Case study: Oska Pulse, an
innovative portable, shareable and
affordable device
GREG HOULGATE
Founder and Chief Product Officer
QUALITY & REGULATORY CHALLENGES FACED BY GLOBAL
ORGANIZATIONS TO COMPLY WITH
PMSR REQUIREMENTS
• Essential global regulatory
alignment needed
• Highlight the challenges and
solutions faced by the industry in a
global environment
• Best practices to streamline
compliance for successful
implementation
• A risk-based approach to PMSR
decision-making – roles and
responsibilities
KHAUDEJA BANO
Head, Medical Affairs
INNOVATION DIGITAL HEALTH INNOVATION AT
BOSTON SCIENTIFIC
• Creating new formats for robotic
development and
commercialization for medical
devices
• Designing for manufacturability,
user adoption and revolutionizing
your portfolio of products
• Case study: Lessons learned from
strategic robotic partnerships
SANDRA NAGALE
Senior Manager, Digital Health IT
DESIGN FROM GOOD TO EXCEPTIONAL: HOW
TO BUILD AND SUSTAIN A SUCCESSFUL
R&D ORGANIZATION
• The Why: Identify the need for
change
• From functional to a matrix: It’s a
journey, not an event
• Doing the right projects and doing
projects right, with the right teams
• Measure and improve: An
organizational maturity model
• Building a culture of ownership and
transparency: Goal planning and
review practices
NORBERT LEINFELLNER
VP, Product Development
Engineering
American Medical Device Summit 2018 Program • Page 11
12:55 pm – 1:30 pm
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
markets on time
NAYSAHN SAEED
Global Business Director
WORKSHOP MEDICAL DEVICE MATERIAL
STRATEGIES: MOVING BEYOND “OFF-
THE-RACK” POLYMERS
• Synthesizing, understanding and
analyzing polymers in all shapes
and forms
• Exploring additional capabilities in
electronics and programming
• Developing support and building
a healthy internal R&D structure
STEPHEN SPIEGELBERG, PH.D.
President
WORKSHOP EU MDR: ACHIEVING ON-TIME
COMPLIANCE WITH LASTING BENEFITS
• Building a program structure and
scoping the work to meet critical
requirements
• Balancing short- and long-term
risks to establish priorities
• Assessing your product portfolio to
identify changed product risk
classifications and applying
strategic decision making to
eliminate underperforming
products
• Revising processes and procedures
to meet new QMS requirements
and streamline product
SCOTT D. BABLER
Principal Consultant
WORKSHOP WRITING FOR MEDICAL DEVICES AND
THE IMPACT OF NEW REGULATIONS
• Understanding the emergence of
preprints in medical publishing
• The evolution of patient
involvement in clinical research and
publications
• Key takeaways on practical
implications of the EU General Data
Protection Regulations (GDPR)
LALITHA JONNAVITHULA
CEO
TIM EHR
Director
American Medical Device Summit 2018 Program • Page 12
LUNCH & LEARN ROUNDTABLE DISCUSSIONS
1:35 pm – 2:35 pm
ASSESING SUPPLIER CAPABILITY TO MANAGE RISK CONNECTED DEVICES: THE LATEST
ADAVANCEMENTS FOR MEDICAL DEVICES
MIKE ANDERSON
Director, Business
Development and Medical
Sales
GILBERTO JIMENEZ
Field Engineering Director
DO YOU REALLY KNOW WHAT’S HAPPENING TO
YOUR TEMPERATURE-CONTROLLED PRODUCTS
THROUGHOUT YOUR SUPPLY CHAIN?
DEVICE SECURITY STARTS AT DAY ONE :
IDENTIFYING WHERE VULNERABILITIES ARE
CREATED IN YOUR DEVELOPMENT LIFECYCLE
BUILDING A TRANSPARENT METHOD TO KEEP
ENGINEERS, SUPPLIERS AND CUSTOMERS ON THE
SAME PAGE
ANN LATHAM
CHRISTOPHER GATES
Principal System Security
Architect
AGILE AND LEAN PRINCIPLES FOR MEDICAL DEVICE
DESIGN
BERNHARD KAPPE
CEO
HOW TO MONITOR IOT DATA AND IDENTIFY ANY
RED FLAGS LEARNING HOW TO IMPROVE QUALITY SYSTEMS
AND PROCESSES
JOHN PEYTON
VP
PHILIP SIMULIS
CEO
HOW TO INTEGRATE CREATIVE DESIGN AND
ENGINEERING PERFORMANCE
JIM KASIC
CEO
BRINGING LOGISTICAL PRECISION TO HOME AND
OFFICE HEALTH CARE EXPLORING THE ROLE OF A.I. AND OTHER INDUSTRY
4.0 TECHNOLOGIES IN QMS
EVA L. PETERSEN
Solution Sales Manager
TODD SHEPHERD
Director, Global Accounts
AFTERMARKET CHALLENGES: PRODUCT RELIABILITY,
MAINTAINABILITY AND SAFETY
KEVIN BERGER
MOBILE APPLICATIONS FOR MEDICAL DEVICES
ATWELL SHEARER
VP, Engineering and Business
Development
MIKE MONTANA
Senior Business Development
Manager
A DEEP DIVE INTO LIFECYCLE MANAGEMENT
HILDE VIROUX
AVP
EXAMINING ADVANCED SOLUTIONS FOR SURGICAL
INSTRUMENTS, IN-VITRO DIAGNOSTICS,
DIAGNOSTIC IMAGING AND PATIENT MONITORING
SPEAKER TBA
American Medical Device Summit 2018 Program • Page 13
PANEL DISCUSSION COLLABORATIVE APPROACHES FOR MEDICAL DEVICES AND HEALTHCARE: INDUSTRY AND NOTIFIED BODY VIEWPOINTS
• Medical device security requires collaborative action from industry and the FDA
• The importance of the Medical Device Safety Action Plan
• Discussing the greater adoption of agile product development as opposed to the waterfall, hybrid and spiral methods
• Predictions for the future: technologies, quality/regulatory hurdles and fostering a culture of collaboration
2:40 pm – 3:15 pm
PLENARY PRACTICALLY PREPARING FOR THE TRANSITION TO THE IVDR: LARGE COMPANY PERSPECTIVE
• The key differences between the previous and new regulations
• Interpreting the guidance around common specifications and product groups
• Undertaking a gap analysis to assess where the resource should be dedicated
• Understanding and planning for the new classification requirements
• Implementation success: strategies for gaining senior management buy-in and keeping the momentum going
3:55 pm – 4:40 pm
4:40 pm – 4:45 pm
CHAIR’S REMARKS AND DELEGATE SURVEY PRIZE DRAW
MIRNA DIPANO
VP, Quality Assurance and Regulatory Affairs
3:15 pm – 3:55 pm
KEYNOTE SURGICAL TRANSFORMATIONS: HOW TECHNOLOGY LEADS TO REAL-TIME BREAKTHROUGHS IN IMPROVING PATIENT CARE
• Discussing the current landscape and the trends for technology in medical devices
• Portable, wearable, and implantable medical devices: Treating the patients of the future
• The challenges that must be addressed: From design to engineering to approval
BEN LOCWIN
SVP, Quality
CAMERON PIRON
President
HARIKRISHNAN RAMARAJU
Senior Manager, Business
Development
CAPT. SEAN BOYD
Deputy Director, Regulatory
Affairs
ROBERT WOOD
VP, World Wide Manufacturing
DESIGN CHAIR PRODUCT DEVELOPMENT CHAIR
MAC MCKEEN
Fellow, Regulatory Science
QUALITY & REGULATORY CHAIR INNOVATION CHAIR
KHALED MOUSSALLY
Global Head, Quality Compliance