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

[email protected]

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


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


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


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


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


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


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


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


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


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


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


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


MICHAEL BACA


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


AMERICAN MEDICAL DEVICE SUMMIT 2018 - Generis · AMERICAN MEDICAL DEVICE SUMMIT 2018 OCTOBER...

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