This document provides information about the Medical Device Manufacturing Summit taking place on June 25-26, 2015 at the Red Rock Resort & Spa in Las Vegas, NV. The summit will feature keynote presentations, case studies, and panels from industry experts on topics such as talent development, supply chain management, and innovation. Over 150 senior medical device executives will attend to network with solution providers and learn best practices. The invitation-only event is designed to facilitate productive business meetings and discussions in an informal setting.
Medical Device Manufacturing Summit Insights for Innovation
1. FRESH THINKING – STIMULATING INTERACTIONS – DYNAMIC PARTNERSHIPS
summits
www.marcusevans.com / page 1
Delegate Information
June 25-26, 2015 | Red Rock Resort & Spa | Las Vegas, NV
awaken genius
pioneer ideas
Developed via a profound dialogue with key market
players and our extensive proprietary research, the
Medical Device Manufacturing Summit program
offers indispensable insights.
WORLD CLASS BRIEFINGS BY THE LIKES OF
Chairperson: Robert Wood, Vice President Worldwide
Manufacturing, Oncology Systems, Varian Medical
Thomas Loarie, Executive Chairman, eMedonline
William Owad, Senior Vice President, Operational
Excellence, Cardinal Health
Robert Berger, Vice President, Contract
Manufacturing, Covidien
David Helsel, Executive Vice President, Global Operations
and Manufacturing, Haemonetics Corporation
James Robinson, Vice President, Operations,
Advanced Bionics
Todd Abraham, Vice President, Operations, Endologix
David Eaker, Vice President Corporate Preclinical
Development and Toxicology, Becton Dickinson
Jesse Freeman, Director of Operations, Biomet
Microfixation
Sam Mawley, Senior Director – Operations, Edwards
Lifesciences
Jay Sangvhi, Director of Supply Chain Management,
Medivators
Robert Di Tullio, Vice President, Regulatory Affairs,
Applied Biocode
Janice McCampbell, Vice President, R&D Engineering
Management, CareFusion
Claudio Simon, High-End Ultrasound R&D Director,
Philips Healthcare
Ryan Luby, Director of Product Development, Biomet
Microfixation
Medical device manufacturing teams are facing immense
pressure with companies continually reviewing operations
as an area for cost-savings and reductions. Manufacturing
executives must continue to achieve regulatory compliance
and high levels of quality assurance in an era where products
across the industry are becoming increasingly complex and
require highly sophisticated manufacturing processes.
Join the marcus evans social network
2. Join the marcus evans social network
summit program
Keynote Presentation
Seeing the “Bends in the Road”; Surviving during a Time of Transformative
Structural Change for MedTech and MedTech Professionals
Thomas Loarie, Executive Chairman, eMedonline
Digital and communications technologies are feeding an increasingly faster rate-of-
change, causing transformative structural changes in the global economy. The U.S. Medical
Device industry is not immune. Commoditization, revolutionary changes in the delivery and
payment of healthcare, increasing government interference limiting innovation, an aging
global population, and the threat of aggressive new market entrants threaten its global
leadership role in a growing global healthcare market are challenging all incumbents. The
victors will be those who create change by immersing themselves in the ambiguities of
the external environment, sort through them before things are settled and known, set a
path, and steer the organizations decisively into it. In his talk, Tom will examine trends and
bends in the road; then extrapolate insights for the medical device professional on how to
survive and thrive during this tumultuous period of change and opportunity. He will also
provide insights gained over thirteen years while assisting over one thousand executives,
managers, and professionals who have chosen to reinvent themselves to make better use
of their gifts in response to the changing landscape.
Keynote Presentation
Talent Acquisition, Development and Retention– Preparing for a Short-Term
Workforce While Driving Toward Longevity Using Organizational Structure,
Exposure, and Transparency
Jesse Freeman, Director of Operations, Biomet Microfixation
Ryan Luby, Director of Product Development, Biomet Microfixation
In business today, a management and salaried staff tenure of three to four years is
not uncommon. This presentation will address methodologies to mitigate the effects
of short tenured staff and discuss topics fundamental to keeping a wide range of
employees engaged and employed for a longer period of time. Key topics will include:
• Diversifying your talent pool during acquisition and onboarding
• Redefining the development/retention viewpoint using customer-oriented metrics
and methodologies
• Handling a workforce tenure of three to four years
• Driving toward longevity
• Poor and complimentary business lifecycle organizational and communication
structure
• The role of business and managerial transparency
Presentation
Contract Manufacturing and Developing Leadership
Robert Berger, Vice President, Contract Manufacturing, Covidien
The vast majority of our contract manufacturing partners are smaller companies
with limited exposure to medical devices. Using a wide variety of examples, this
presentation offers insight into our points of focus on improving Quality, Service,
and Risk Management with these partners. The critical importance of Leadership on
the shop floor is examined and approaches for its development are outlined. The
discussion then focuses on how we integrate our manufacturing partners with our
design groups that are located in emerging markets. The presentation closes with
an inside look at how we manage our contract manufacturing partners who provide
disposable medical devices.
the summit program
key topics
The primary objective of the Medical Device
Manufacturing Summit is to explore the key
aspects and issues related to manufacturing
best practices and their application as business
drivers for innovation and growth. The
Summit’s program topics have been pinpointed
and validated by senior executives from the
medical device community as the top critical
issues they face. Key issues for 2015 include:
Transitioning Regulatory Environment –
Examining FDA regulations and how to remain
compliant
Aligning Departments – Exploring the best
ways to collaborate with departments in order
to maintain and achieve the overall goal
Talent Development – Preparing and
retaining the next generation to keep the best
and brightest
Unique Device Identification – Navigating
the challenges associated with the FDA
change
Supply Chain Stability – Minimizing
disruptions and improving supply chain
management
Building a Lean Organization – Streamlining
the manufacturing process
Evaluating New Technology – How to
successfully evaluate new technologies to
adapt and remain competitive
Emerging Markets – Exploring the new
demands on the market and the impacts
of change
Supplier Relationship – Managing challenges
associated with your partnerships
summits
For first-hand delegate experiences,
click here to watch
June 25-26, 2015 | Red Rock Resort & Spa | Las Vegas, NV
www.medicalmanufacturingsummit.com / page 2
Join the marcus evans social network
3. Join the marcus evans social network
Presentation
The Marriage of Lean and MES in Medical Device Manufacturing
James Robinson, Vice President, Operations, Advanced Bionics
Focusing precious resources, managing change, and delivering on
company goals is always a challenging task. Add the requirements
of a Class 3 Medical Device environment and it is even tougher.
The goal is to use Lean and MES together as one tool to achieve
Productivity Gains while maintaining compliance and the highest
levels of Quality for products. In this presentation, James Robinson
will share the approaches used and the learnings that went into
them. Topics covered will include:
• Aligning the fundamentals of Lean with the Basics of MES
• Integrating Lean/MES into a Class 3 Medical Device
Manufacturing Environment
• How the processes have taken root and grown
Panel Discussion
Balancing Innovation and Regulatory Standards: Best Tactics
to Encourage Brilliance
Moderator: David Eaker, Vice President Corporate Preclinical
Development and Toxicology, Becton Dickinson
Robert Di Tuillo, Vice President, Regulatory Affairs, Applied Biocode
Janice McCampbell, Vice President, R&D Engineering
Management, CareFusion
Jay Sangvhi, Director of Supply Chain Management, Medivators
Many medical device companies are facing innovation restrictions
due to strict regulatory compliance codes. Innovation is crucial
to remaining ahead of the competition and competing devices.
Often times, bright and talented people are becoming uninspired
due to compliance squashing innovation. While there is a need
for regulatory standards, one needs to find a happy medium. How
do companies encourage the spirit of innovation in a regulated
environment? This panel will touch on:
• Developing best tactics for encouraging innovation while
remaining compliant
• Exploring the regulatory standards in design
• Uncovering the best solutions while discussing lessons learned
Interactive Roundtable Discussion
Employing an Effective Risk Management Process from
Cradle-to-Grave Spanning Design, Development, and Post-
Market Surveillance
Robert Di Tullio, Vice President, Regulatory Affairs, Applied Biocode
In the highly competitive and regulated world of medical devices,
a manufacturer must realize continuous quality improvement
in order to remain relevant. One cornerstone of a strong Quality
Management System is an effective Risk Management program.
Effective Risk Management not only is vital to regulatory
compliance but is an essential good business practice that helps
companies to realize increased revenues and decreased costs.
Interactive Roundtable Discussion
Project Priorities: Cross Functional Alignment
Janice McCampbell, Vice President, R&D Engineering
Management, CareFusion
Completion of a project requires cross functional engagement and
alignment. How well the organization balances conflicting goals across
the functions determines the project outcome. Developing a common
goal and vision is essential to help team members understand
the business priorities. In this roundtable, we will explore the best
strategies to:
• Develop a common goal and vision the functions can support
• Set priorities based on the business strategies as opposed to
opinions
• Balance different functional goals yet remain aligned on the
business needs
Presentation
Strategic Profit Management – A Strategic and Structured
Approach to Identifying and Executing Profit / Value
Improvement Projects
Sam Mawley, Senior Director – Operations, Edwards
Lifesciences
As price pressures increase medical device makers need to find
ways to preserve/improve gross margins by strategically reducing
cost, while delivering what customers value. This presentation will
focus on:
• Strategic planning that includes cost reduction/value
improvement objectives
• Cost reduction/value improvement project identification and
vetting processes
• Operating mechanisms that include: tracking &
countermeasure mechanisms
• Project management -- skill building and infrastructure
• Execution & value attainment management
• Ongoing project pipeline management
Interactive Roundtable Discussion
Project Management in Medical Device Product Development
Claudio Simon, High-End Ultrasound R&D Director, Philips
Healthcare
The development of new medical devices often takes multiple
years and the development can often contribute to a significant
portion of the cost of the device. One of the key enablers
to their success is proper leverage of Project Management
techniques. These include a systematic approach to planning
and managing scope, schedule, cost, quality, resources,
communications, risk, procurement and stakeholders. In this
roundtable we will share real-life examples of best practices on
how to implement these techniques.
summits
June 25-26, 2015 | Red Rock Resort & Spa | Las Vegas, NV
www.medicalmanufacturingsummit.com / page 3
Join the marcus evans social network
4. Join the marcus evans social network
the executive delegation
The Medical Device Manufacturing Summit delegates will include COOs, SVPs, EVPs,
VPs and Directors of Manufacturing and Operations and are carefully screened and
selected according to the following criteria:
• Scope of Responsibility
• Sign-off Authority
• Company Revenue
• Interest in Purchasing Products and Services
Medical Device Manufacturing Summit solution
provider companies
To ensure the success of the Medical Device Manufacturing Summit, marcus evans
is pleased to partner with an exclusive number of leading companies that can provide
valuable solutions and expertise to the attending senior-level decision-makers. Our
summit model is strongly based on our ability to acquire the most innovative and cutting
edge industry suppliers of key solutions and services for direct delivery to the delegation
and their forward thinking corporations interested in staying ahead of the market.
The number of companies in each product or solution category is strictly limited to
ensure an appropriate overall balance. These meetings provide a forum for dialogue and
information sharing, on organizational concerns and appropriate, corresponding solutions.
Medical Device Manufacturing Summit solution
provider product and service categories
summits
sample delegate schedule
Each attendee at the Medical Device
Manufacturing Summit receives a personalized
itinerary based on their priority selections of
conference sessions, business meetings and
special networking events. Below is a sample of a
personalized attendee schedule.
day 1
08:00 – 10:00 am Event Registration
10:00 – 10:15 am Chairperson Opening Remarks
10:15 – 11:00 am Opening Keynote Presentation
11:00 – 11:30 am Networking Coffee Break
11:30 – 01:00 pm Business Meetings
01:00 – 02:00 pm Networking Luncheon
02:00 – 02:45 pm Presentation
02:45 – 03:30 pm Presentation
03:30 – 03:45 pm Networking Coffee Break
03:45 – 05:15 pm Business Meetings
05:15 – 06:00 pm Presentation
06:00 – 06:45 pm Presentation
06:45 – 08:45 pm Networking Reception
day 2
07:00 – 08:00 am Networking Breakfast
08:00 – 08:45 am Presentation
08:45 – 09:30 am Presentation
09:30 – 09:45 am Networking Coffee Break
09:45 – 11:15 am Business Meetings
11:15 – 12:00 pm Panel Discussion
12:00 – 01:00 pm Networking Luncheon
01:00 – 01:45 pm Presentation
01:45 – 02:30 pm Presentation
02:30 – 02:45 pm Networking Coffee Break
02:45 – 04:15 pm Business Meetings
04:15 – 05:00 pm Closing Presentation
05:00 – 05:15 pm Chairperson’s Closing Remarks
June 25-26, 2015 | Red Rock Resort & Spa | Las Vegas, NV
Assembly, Test, Molding, Processing
& Fabricating
Automation Solutions
Business Applications (CRM, ERP, PLM,
SCM, SRM)
Clean Room Environments
CNC Equipment & Intelligent Data
Systems
Contract Manufacturing
Contract Outsourcing Services
Contract Research Organizations
Electronics Manufacturing Services
FDA & GMP Auditing & Consulting
Inventory & Warehouse Management
Solutions
Materials Handling Equipment
Motion Control
Offshore & Nearshore Manufacturing Sites
Packaging
Process & Plant Equipment & Materials
Production Optimization & Management
Solutions
Quality Control & Inspection Systems
Raw Materials
Sterilization
Supply Chain Management
Tooling, Tubing & Metal Stamping
Weighing, Counting, Batching, Packaging
& Printing
Workflow Data & Document
Management
www.medicalmanufacturingsummit.com / page 4
Join the marcus evans social network
5. June 25-26, 2015 | Red Rock Resort & Spa | Las Vegas, NV
what makes the Medical Device Manufacturing
Summit different
• A strictly invitation-only event; selection of delegates according to criteria such as
scope of responsibility and size of company
• Restricted number of delegates in order to facilitate successful networking
opportunities
• Personalized summit and meeting schedule to suit individual requirements and
provide an efficient use of time
• Keynote presentations, case studies and interactive sessions by world-class industry
experts and pioneers
• A relaxed but professional business environment, in which to explore new ideas,
strategies and technical developments with industry colleagues, experts and peers
• Access to the secured summit website, providing information on other delegates
and each solution provider prior to the event
• Individual pre-arranged one-on-one business meetings with senior representatives
from key industry solution providers
• An invitation which covers one nights’ accommodation, all Summit materials, meals
and leisure activities during the Summit
• An opportunity to relax and enjoy the superb facilities at the prestigious Red Rock
Resort and Spa
secured summit website
• Summit session overviews allow delegates to choose from a selection of summit
and interactive sessions to best suit their business needs
• Presenter biographies determine which presenters are most likely to assist in
benchmarking and improving initiatives
• Profiles of attending solution providers, offer relevant information to enable
delegates to plan their personal event schedule
• Inform delegates of social activities taking place at the event
• Post-event summit documentation provides complete documentation of all
executive presentations immediately after the Summit
PDH Accreditation
marcus evans will provide PDH certificates to all attendees post event as well as
a copy of the agenda. All attendees are asked to check with their particular state
licensing boards to ensure that PDH will be recognized by that state. It will be the
responsibility of each attendee to confirm their credit hours based on the sessions
attended on the provided agenda.
the venue
Red Rock’s serene surroundings, distinctive
décor and impeccable standard of service
ensure that your Las Vegas hotel stay is
flawless and fabulous. Exquisite hotel rooms
and suites offer an unmatched combination
of comfort, extravagance and value while
inspiring mountain vistas will transfix you
during your Las Vegas vacation, travel or
getaway. Many of the spaces are naturally-
lit and overlook the stunning Red Rock
Canyon and three-acre pool backyard.
Wow factor for your special Las Vegas
event: guaranteed!
www.redrocklasvegas.com
the organizers
The marcus evans group has over 30 years
experience in the production of premium
business events. Known globally for our
unwavering dedication to quality and
excellence, we aid our clients in achieving
their strategic goals by providing market
leading business intelligence otherwise
inaccessible to them.
At marcus evans, we craft products that
empower our clients to drive organizational
growth and achieve effective decision-
making. Our clients’ focus on continuous
improvement creates a strong basis for an
ongoing dialogue, allowing us to evolve our
abilities to address their needs successfully.
Developing major sector-focused business
events, marcus evans provides unique
networking opportunities across diverse
industries and professions. We aim to
meet all of your strategic information
requirements through premium products
delivered through a variety of media.
We consider innovation to be vital. Our
extensive proprietary analysis of our clients’
business needs enables us to equip you
with the tools you need for future success.
summits
www.medicalmanufacturingsummit.com / page 5
Join the marcus evans social network
6. June 25-26, 2015 | Red Rock Resort & Spa | Las Vegas, NV
Vice President, Operations &
Technical Services
B. Braun
Director of Manufacturing Sciences
Bayer Healthcare
Vice President, Manufacturing Operations
Becton Dickinson & Company
Director, Manufacturing Operations
Biomet 3i
VP, Manufacturing
Blickman Inc
VP, Operations
Boston Scientific
VP, Operational Excellence
Cardinal Health Inc.
Director of Manufacturing
CareFusion
Vice President, Operations Engineering
Covidien
VP of Rapid Design and Prototyping Center
Ecolab
Vice President, Manufacturing
Edwards Lifesciences Corporation
VP, Operations
Electro-Optical Sciences Inc.
General Manager, Manufacturing
Design Transfer
GE Healthcare
Director, Advanced Sourcing
Johnson & Johnson
Manufacturing Director
Kimberley-Clark Health Care
Director of Manufacturing
Lifetech Inc.
Director, Manufacturing Technology
MEDRAD
VP, Global Operations
Medtronic (ERS)
VP of Manufacturing
Pathway Medical Technologies
Director, Manufacturing
Philips
VP, Operations
Pioneer Surgical Technology
VP, IP Affairs & Business Development
St. Jude Medical Neuromodulation
Plant Manager – Head of Manufacturing
Stryker
VP, Manufacturing Technology
TriVascular Inc
Director, Global Manufacturing
Engineering
Varian Medical Systems
VP, Operations
Ventana Medical Systems Inc.
COO
Verathon Inc.
SVP, Global Operations and Supply
Chain Management
Welch Allyn Inc.
VP, Manufacturing
ZOLL Medical Corporation
testimonials
Extremely well organized and run. A pleasure
to attend and participate.
VP North America R&D
Essilor International
Extremely well run, best I have attended.
Director of Operations
Biomet Microfixation inc
This marcus evans event was high quality
and engaging in regards to both speakers
and topics.
Director, Global Operations
Acelity
This was my first marcus evans event. The
quality of speakers and sessions was excellent.
The solution providers that were invited
had products and services that I was truly
interested in.
Director of Operations
Kinetic Concepts Inc (KCI)
Terrific! The networking is one of the best
parts providing attendees with a genuine
experience.
VP, Regulatory & QA
3M Co.
The Medical Device Manufacturing Summit
was a great opportunity to learn about current
challenges and opportunities in the medical
device industry, network with key leaders
in the industry and meet one-on-one with
solution providers.
Director of Manufacturing Operations
Medtronic
The Medical Device Manufacturing Summit
had a very refreshing refocus on several key
initiatives and trends in the industry.
Vice President, Worldwide Manufacturing
Varian Medical Systems
summits
www.medicalmanufacturingsummit.com / page 6
Join the marcus evans social network
a selection of attendees from previous marcus evans
Medical Device Manufacturing summits