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

[email protected]

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:


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


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


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


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


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:


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


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


DESIGN CHAIR PRODUCT DEVELOPMENT CHAIR

MAC MCKEEN


INNOVATION CHAIR

KHALED MOUSSALLY



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



MAC MCKEEN



KHALED MOUSSALLY


Sponsored By:


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


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


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


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


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



MAC MCKEEN



KHALED MOUSSALLY


american medical device summit 2019 · keynote a holistic approach for the medical device industry:...

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