american medical device summit 2019...• deciding when to submit a 510(k) for a software change to...

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

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


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


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 Innova-

tion

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


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


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

GREGORY PIERCE

Deputy Ombudsman CDRH Innova-

tion

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


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

Deputy Director for 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 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


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:


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


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


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

LINDA PETERS

EVP and Chief Regulatory Officer


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


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


2:20 pm – 2:55 pm

DESIGN FUSING TOGETHER DESIGN

REQUIREMENTS AND CONSUMER

NEEDS

• Why user feedback is vital for

stages of development

• Sharing best practices for drafting

design requirements

• Assessing risks and embedding

consumers needs into the design

requirements

PRODUCT DEVELOPMENT MEDICAL DEVICE DEVELOPMENT AND

THE SURGE OF HEALTH CARE-RELATED

MOBILE DEVICE APPS

• Mobile apps purpose: Serving as an

accessory to support, supplement,

and augment an existing medical

device

• Transforming a mobile platform for

medical use

• Sharing a risk-based approach to

ensure the safety and effectiveness

of mobile apps paired with devices

• Building a model that can be rolled

out for future products

QUALITY/REGULATORY 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

INNOVATION NEW APPROACHES TO INNOVATION:

HOW ATYPICAL MEDICAL DEVICE

TECHNOLOGY WILL BECOME MORE

TYPICAL

• How disruptive innovators can

handle system complexity and

navigate the regulatory

environment

• Why nontraditional companies

need to develop open

communication to share all data

• Why new device technology

requires health care providers to

change their processes

• Key considerations: pacing

your organization with new device

technologies, customizing

workflows and projecting for

a wider need for devices

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

Deputy Director for Regulatory

Affairs

american medical device summit 2019...• deciding when to submit a 510(k) for a software change to...

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