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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
MICHAEL BACA
Former VP, Quality / Regulatory /
Clinical
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 27TH, 2019 AT 6:00PM–7:00PM
6:50 am – 7:50 am
REGISTRATION & GROUP BREAKFAST
CHAIR’S OPENING REMARKS DESIGN CHAIR PRODUCT DEVELOPMENT CHAIR
MAC MCKEEN
Fellow, Regulatory Science
QUALITY/REGULATORY CHAIR INNOVATION CHAIR
OPENING 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
FUTURE SPOTLIGHT 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 of Quality
American Medical Device Summit 2018 Program • Page 2
TRANSFORMATION SPOTLIGHT THE HEALTHCARE MODEL TRANSFORMATION: PREDICTIONS FOR THE FUTURE
• Global healthcare tied to value-based models
• AI: Artificial intelligence and machine learning will further evolve human and machine interaction
• Digital health tech will cater out of the traditional hospital setting
• Geographic shift: How Asia is the new innovation hub for medical devices
9:20 am – 10:00 am
JAIME VELEZ
Co-Founding Partner Operations and Quality Systems Improvement Expert
PRE-ARRANGED ONE-TO-ONE NETWORKING & 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 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
INNOVATION THE OMBUDSMAN’S ROLE IN AIDING
BETTER COMMUNICATION BETWEEN
INDUSTRY AND THE FDA
• Improving collaboration of staff
• Process improvements and keys to
success
• Special programs and initiatives to
address critical and unmet needs
• How to informally help resolve
differences in opinion
KEN SKODACEK
Deputy Ombudsman CDRH
Innovation
QUALITY/REGULATORY THE DEVELOPMENT AND
MAINTENANCE OF A QUALITY
MANAGEMENT SYSTEMS THAT
PRODUCE CONSISTENTLY EXCELLENT
PRODUCTS
• Steps to incentivize quality across
all roles and to enhance your
company culture
• Evaluating and assessing the
cultural continuum, challenges, and
risks
• How to reduce regulatory burden,
add value, and progress towards
increased patient trust
• Case study: How and why we
continue to invest in quality
KHAUDEJA BANO
Head of Medical Affairs
American Medical Device Summit 2018 Program • Page 3
12:30 pm – 1:05 pm
WORKSHOP A DETAILED CASE STUDY OF GUIDED
COMPLIANCE IN ACTION
• This will be a detailed look at the
case study of guided compliance in
action
• We’ll explore the “product behind
the product” and see how guided
compliance can profoundly help
your efforts
• We’ll see how 483’s in our past can
be addressed in a manner that sets
us up for success in subsequent
NPD
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
VP, World Wide Manufacturing
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
EVP and Chief Regulatory Officer
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
LUNCH & LEARN ROUND-TABLE 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 & REGULATORY AFFAIRS WORKING
EFFECTIVELY TOGETHER AROUND THE WORLD
HOW TO FOSTER STRATEGIC RELATIONSHIPS WITH
HOSPITAL NETWORKS
STEPHANIE FITTS
VP, Regulatory Affairs, Quality
Assurance, Clinical Research
and Compliance
TIMOTHY CROFT
Director, Program Management
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 Develop-
ment
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
ANILA LINGAMNENI
VP, Renal R&D
QUALITY/REGULATORY CDRH FY 2019 PROPOSED GUIDANCE
DEVELOPMENT AND RETROSPECTIVE
REVIEW
• Updates from the Center for
Devices and Radiological Health
(CDRH)
• Prioritizing digital health: Five
guidance 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
Office Director, Office of Regulatory
Programs (ORP), Office of Product
Evaluation and Quality (OPEQ), Cen-
ter for Devices and Radiological
Health (CDRH)
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 2020 GOALS: HOW TO MAKE YOUR
LABELS COMPLY WITH THE NEW EU
MDR
• Reviewing the labeling
infrastructure to
develop organizational
preparedness
• EU MDR label requirements
compared with MDD and AIMDD
• Where are we now: A look at
current medical device labels and
how they will need to transform
• Case study: Designing new label
templates that make room for data
not previously part of the labelling
system
SIMON JONES
VP, Global Products
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 &
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 ONE-TO-ONE NETWORKING & REFRESHMENTS
3:40 pm – 5:00 pm
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
CAMERON PIRON
President
PRODUCT DEVELOPMENT HARNESSING INTERNAL AND VENDOR
CAPABILITIES TO ACCELERATE SMALL
TO MID-SIZE MEDICAL DEVICE
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
JACLYN LAUTZ
VP, R&D
QUALITY/REGULATORY THE NEW PARADIGIM: GUIDANCE FOR
INDUSTRY AND FOOD & DRUG
ADMINSTRATION 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
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
Expert in Digital Transformation and
Innovation
WORKSHOP AUTOMATION FOR MEDICAL DEVICES:
IMPROVING QUALITY, AND TIME TO
MARKET
• Improving efficiency with
integrated systems
• Increasing visibility which allows for
full traceability and reduces cost
• How automation can reduce cycle
times
• The biggest hurdle: electronic
health records
CLOSING 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 of Healthcare, North America
6:50 pm – 6:55 pm
CHAIR’S CLOSING REMARKS MICHAEL BACA
Former VP, Quality / Regulatory / Clinical
6:55 pm – 7:55 pm
NETWORKING & DRINKS RECEPTION Sponsored By:
American Medical Device Summit 2018 Program • Page 7
PROGRAM DAY TWO
NETWORKING & BREAKFAST
7:00 am – 7:55 am
ASSESSING RISK FOR NEW MEDICAL DEVICE
DEVELOPMENT AND LAUNCHES
HOW TO CAPTURE REAL, QUANTIFIED EVIDENCE OF
THE PATIENT EXPERIENCE
LEARN HOW TO PROTECT DATA WITH A STANDARD
SYSTEMATIC APPROACH
TBD
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
LINDA PETERS
EVP and Chief Regulatory
Officer
PAMELA GOLDBERG
President and CEO
KELLY EMERTON
Senior Director, Product Devel-
opment & Commercialization
JACKIE KUNZLER
SVP, Chief Quality Officer
MARJORIE SHULMAN
Director, Premarket Notifica-
tion Program
BREAKFAST BRIEFS
JEFF GRIZZEL
SEAN HART
MICHAEL BACA
Former VP, Quality / Regulatory /
Clinical
7:55 am – 8:00 am
ROBERT WOOD
VP, World Wide Manufacturing
CHAIR’S OPENING REMARKS DESIGN CHAIR PRODUCT DEVELOPMENT CHAIR
MAC MCKEEN
Fellow, Regulatory Science
QUALITY/REGULATORY CHAIR INNOVATION CHAIR
8:00 am – 8:45 am
BRIAN LAWRENCE
SVP and Chief Technology Officer
OPENING 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
American Medical Device Summit 2018 Program • Page 8
8:45 am – 9:25 am
LEADERSHIP MASTERCLASS 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
9:25 am – 10:05 am
HILDE VIROUX
AVP, Regulatory
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
• 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
DON SCHLIDT
President & 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 WALK THROUGH THE TIMELINE OF
MDR TRANSITION AND
IMPLEMENTATION
• 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
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
SPEAKER TBD
QUALITY SPOTLIGHT THE DEVELOPMENT AND MAINTENANCE OF A QUALITY MANAGEMENT SYSTEMS THAT PRODUCE CONSISTENTLY EXCELLENT PRODUCTS
• Steps to incentivize quality across all roles and to enhance your company culture
• Evaluating and assessing the cultural continuum, challenges, and risks
• How to reduce regulatory burden, add value, and progress towards increased patient trust
• Case study: How and why we continue to invest in quality
TANYA KLASLO
VP, Global Regulatory Operations
American Medical Device Summit 2018 Program • Page 9
NETWORKING & REFRESHMENTS
10:50 am – 11:50 am
11:55 am – 12:30 pm
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
VP, R&D
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
• A case study: The effect on IVD
companies who are under review
ANN VU
Director, Premarket Notification
Program
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
VP, Science and Technology
12:35 pm – 1:10 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
DR. STEPHEN SPIEGELBERG
President
WORKSHOP 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
• Integrate a program leadership
structure into the product
commercialization process to
dramatically improve results
EYAL GOLAN
Project Management 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
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
NORBERT LEINFELLNER
VP, Product Development
Engineering
American Medical Device Summit 2018 Program • Page 10
LUNCH & LEARN ROUND-TABLE DISCUSSIONS
1:15 pm – 2:15 pm
ASSESING SUPPLIER CAPABILITY TO MANAGE RISK CONNECTED DEVICES: THE LATEST
ADAVANCEMENTS FOR MEDICAL DEVICES
MIKE ANDERSON
Director, Business Develop-
ment & Medical Sales
GILBERTO JIMENEZ
Field Engineering Director
DISCUSSING GUIDELINES FOR MANUFACTURERS OF
TEMPERATURE MONITORING DEVICES
CYBERSECURITY THROUGH THE LIFECYCLES OF
YOUR MEDICAL DEVICE
BUILDING A TRANSPARENT METHOD TO KEEP
ENGINEERS, SUPPLIERS AND CUSTOMERS ON THE
SAME PAGE
ANN LATHAM
BEN TRUMBOLD
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
TOP LOGISTICS CHALLENGES FOR NEW DEVICES HOW TO INCREASE THE EFFECTIVENESS AND
EFFICIENCY OF YOUR SAFETY STUDIES
TBD
TODD SHEPHERD
Director, Global Accounts
AFTERMARKET CHALLENGES: PRODUCT RELIABILITY,
MAINTAINABILITY, AND SAFETY
KEVIN BERGER
MOBILE APPLICATIONS FOR MEDICAL DEVICES
ATWELL SHEARER
VP, Engineering and BD
MIKE MONTANA
Senior Business Development
Manager
A DEEP DIVE INTO LIFECYCLE MANAGEMENT
HILDE VIROUX
AVP, Regulatory
American Medical Device Summit 2018 Program • Page 11
2:20 pm – 2:55 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
3:00 pm – 3:40 pm
4:20 pm – 4:25 pm
CHAIR’S CLOSING REMARKS MICHAEL BACA
Former VP, Quality / Regulatory / Clinical
MIRNA DIPANO
VP, Quality Assurance and
Regulatory Affairs
EXECUTIVE SPOTLIGHT SURGICAL TRANSFORMATIONS: HOW TECHNOLOGY LEADS TO REAL-TIME BREAKTHROUGHS
• Discussing the current landscape and the trends for technology in medical devices
• Discovering and developing portable, wearable, and implantable medical devices
• The challenges that must be addressed: From design to engineering and approval
• Case study: How Lumicell is changing the landscape of cancer surgery with a hand-held imaging system that enables surgeons to identify cancer cells
BEN LOCWIN
SVP, Quality
3:40 pm – 4:20 pm
CLOSING PANEL 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
CAMERON PIRON
President CAPT SEAN BOYD
Office Director, Office of Regulatory Programs (ORP), Office of Product
Evaluation and Quality (OPEQ), Center for Devices and Radiological
Health (CDRH)