The Largest Medtech
Event in the Nation
HUNDREDS OF
SUPPLIERS
IN-DEPTH
EDUCATION
MILLIONS OF
FRESH IDEAS
VALUABLE
CONNECTIONS
Exhibition & Conferences:
February 10–12, 2015
Anaheim Convention Center | Anaheim, CA
Get your badge today!
MDMwest.com/conf15
Join the
Conversation:
#UBMwest
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during registration. Share with your colleagues!
MD&M West has the answers you need today
and the inspiration for tomorrow.
A Legacy of Progress
For 30 years, MD&M West has connected the medtech community
with the most cutting-edge technologies and revolutionary ideas
in the world of medical design and manufacturing. From wireless
medicine and regulatory challenges to 3D printing and Affordable
Healthcare Act opportunities, see how MD&M West 2015 is at
the forefront of the changes that will affect the next 30 years of
medical device design and manufacturing.
A glimpse of what you will see in action at MD&M West:
XX
XX
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XX
XX
Manufacturing Equipment
Cleanroom & Sterilization
Contract Manufacturing
Design Services
Electronic Components
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Medical Grade Materials
Packaging & Labeling
3D Printing
Testing & QA/QC
And so much more….
See why people have been
coming back for 30 years...
I always find this show useful, whether for inspiration, information,
or renewing contacts with colleagues.
Our company has attended for the last ten years and with each
passing year we have seen the event grow both in quality and
quantity of potential business partners. We have not only received
valuable information but also were able to expand our business
through their customers.
It was my first time to MD&M and I was surprised and pleased with
the amount of information, suppliers and products on display in
one location.
At MD&M West, there is inspiration around every corner—
and with related events taking place at the same time, your
opportunities for fresh ideas are multiplied:
What’s Happening at MD&M West?
EXPO HIGHLIGHTS
000+ Medtech Suppliers
1
2 ,200+ Suppliers Across All 8 Expos
Speed Networking to Find New Connections
Keynotes & Panel Discussions at the Center Stage
Tech Updates at the Tech Theater
Guided Innovation Tours of the Show Floor
Special 30th Anniversary Events to celebrate, and look
ahead at what the future holds for medtech
Golden Mousetrap Awards—An awards ceremony
recognizing innovations and innovators driving new products
CONFERENCE HIGHLIGHTS
I n-depth education featuring three tracks across three
full days
Keynote by Babak Parviz, Ph.D., Vice President,
Amazon, Former Google[x] Director
World-class speaking faculty of more than 75 industry
thought-leaders
Hands-On! More panel discussions and interactive
sessions than ever
Key Topics Covered: 3D printing, design control, risk
management, quality, outsourcing, and wireless devices
Innovation in Design Boot Camp—1-day intensive summit
to take your innovation to the next level
2200+
SUPPLIERS
ACROSS ALL
8 EVENTS
Register Today at MDMwest.com/conf15 and then Invite Your Colleagues to Join You
Free Expo Pass for a Colleague
Free Expo Pass for a Colleague
Exhibition & Conferences:
Exhibition & Conferences:
February 10–12, 2015
February 10–12, 2015
Anaheim Convention Center
Anaheim, CA
Anaheim Convention Center
Anaheim, CA
Register today at MDMwest.com/conf15
Register today at MDMwest.com/conf15
Use source code Save95 to waive the $95 fee.
Use source code Save95 to waive the $95 fee.
Experience the Energy of a LIVE Event
Meet Top Suppliers
It’s simply more effective to ask questions and get immediate
answers in person. Take this opportunity to share your
challenges, see your options, and collaborate with industry
experts. Here is a small sample of who will be at MD&M West:
XX B Braun
OEM Division
XX Donatelle
XX Heraeus
XX Machine
Solutions
XX MedPlast
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Nexeo Solutions
Parker Hannifin
Phillips-Medisize
Qosina
Rofin–Sinar
Royal Mater
Grinders
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XX
XX
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Tegra Medical
Vention
Teleflex OEM
Zeus
Plus hundreds
more!
Unique and fun speakers and panel
discussions on the show floor. All are
FREE with your badge. What to expect:
XX Multiple presentations each day
XX Keynote speakers, including Ben Heck,
of element14’s The Ben Heck Show
XX Panel discussion with leading
innovators under 30, and another with
exhibitors who have been with MD&M
since the beginning… 30 years ago!
XX Live product teardowns of popular consumer products
by Dozuki, a division of iFixit. Past teardowns have included
smartphones, tablets and wearables.
Network With Your Peers!
Tuesday, February 10 & Wednesday, February 11 at 2:15 p.m.
Everyone can benefit from new
connections. Make the most of
your time at MD&M West and
meet like-minded professionals
at this fun, complimentary
event. Gain industry knowledge,
establish new alliances, learn
about new processes, and
build relationships with your
industry peers.
Showcasing the latest technology
from those who are developing it.
Listen to technology and product briefs
from suppliers highlighting their newest
innovations at a theater dedicated to
design and manufacturing topics.
Check MDMwest.com/conf15 for
the full schedule.
Sign up for a FREE Speed Networking session and get matched
with relevant professionals, according to your preferences.
Details at MDMwest.com/conf15.
Read what last year’s participants had to say:
Quite a unique experience. Fast paced. Good networking
opportunities for future product development.
Well organized, great exposure to folks with similar ideas/needs.
Great way to network. I enjoyed it!
This is a peer-to-peer networking session. No solicitation of services
or products please.
Get a behind-the-scenes tour of the
latest technology on the show floor.
Walk with a field expert pointing out
the newest technology, innovations,
and industry trends. Past tour topics
included 3D Printing and Go Mobile.
With only 20 spaces available for each
tour, you’ll want to arrive early to secure
your spot. Check the schedule at
MDMwest.com/conf15.
Register Today at MDMwest.com/conf15 and then Invite Your Colleagues to Join You
Free Expo Pass for a Colleague
Free Expo Pass for a Colleague
XX
XX
XX
XX
XX
XX
XX
XX
XX
XX
Collaborate with top industry suppliers… in person!
Get your hands on the latest technologies, materials, and products
Access leading education at the MD&M Conference (upgrade required)
Find fresh ideas from 7 other co-located events
Network with industry peers
Collaborate with top industry suppliers… in person!
Get your hands on the latest technologies, materials, and products
Access leading education at the MD&M Conference (upgrade required)
Find fresh ideas from 7 other co-located events
Network with industry peers
Register today at MDMwest.com/conf15
Register today at MDMwest.com/conf15
Use source code Save95 to waive the $95 fee.
Use source code Save95 to waive the $95 fee.
2015 Conference Program
How Today’s Designs Affect
Tomorrow’s Medtech Success
30 Years at the Cutting Edge of Medtech Education
From concept to market, the MD&M West Conference covers topics from the entire design spectrum in an innovative,
streamlined format. With keynote speakers, interactive presentations, and panel discussions, the MD&M West
Conference is your chance to get up to speed with the latest developments that are transforming medtech while
networking with the people that are leading the change.
Choose from three comprehensive conference tracks:
XX Disruptive Innovation in Design of Medical Devices
XX Managing Risk, Quality and Validation
XX Speed to Market, Scale Up, & Post Market Compliance
BOOK TODAY!
OVER 75
EXPERT SPEAKERS
CONFIRMED!
Turn the page to see full details.
Featured Speakers
Early Bird Discounts
end on 1/16
Babak Parviz, Ph.D.,
Vice President,
AMAZON, Former
GOOGLE Director
Mark A. Phelps,
Senior Director, Technology &
Product Development,
MEDTRONIC
Seyed Khorashahi,
Director, Software
Engineering,
COVIDIEN
Scott DeFelice,
President & CEO,
OXFORD PERFORMANCE
MATERIALS
Eric Bergman,
Human Factors Engineering
Director,
FRESENIUS MEDICAL CARE
Amnon Ptashek,
Chief Architect,
WESTECH MEDICAL
TECHNOLOGIES
Steven K.Pollack, Ph.D.,
Director of the Office of
Science & Engineering Labs,
FDA
William MacFarland,
Director of Division of
Enforcement, CDRH,
FDA
Anne DeGheest,
Managing Director,
HEALTHTECH CAPITAL
Jay Radcliffe,
Senior Security Consultant
& Researcher,
RAPID7
Conference Agenda-At-A-Glance
Don’t miss these sessions!
DAILY KEYNOTE
AT 9:30 A.M.!
Day One – Tuesday, February 10th
10:00 -4:00
MD&M Track A
Disruptive Innovation in
Design of Medical Devices
The New Wireless
Frontier
Innovations in Wireless
Capabilities, Interoperability,
and Sensor Technologies
in Medical Devices
1 A
MD&M Track B
Managing Risk, Quality,
and Validation
Refining Your Risk
Management & CAPA
Procedures
MD&M Track C
Speed to Market, Scale
Up & Post Market Compliance
Enter the 3D
Printing Era
1 A
The Industrial
Internet of Things
Preparing for a Revolution in
Manufacturing
A New Dawn in Medical
Device Design &
Manufacturing
WestPack
Packaging Strategy
Seminar Series
Latest Packaging Tactics &
Innovations to Drive CostEffectiveness
1 A
S 1 A
S 1 A
10:00 -4:00
Day Two – Wednesday, February 11th
Designing the
Next-Gen Medical
Device
Taking Control
of Quality
IDEO Design Workshop, and
Innovation Leader Round
Table
Securing Finance,
Scaling-Up From
Concept to Market, and
Best Practices in Lean
Manufacturing
Dealing with Inspections,
Managing Suppliers, and
Improving Your QMS
1 A
1 A
Innovations in
3D Printing
New Materials, Tools, and
Processes that are Changing
the Future of Prototyping and
Manufacturing
S 1 A
S 1 A
PAC™ Ultimate Packaging
Optimization Course
1-Day Intensive
Workshop
1 A
Integrated Quality
Management—Part 1
In collaboration
with ASQ
A
10:00 -4:00
Day Three – Thursday, February 12th
Designing for the User
Improving User
Experience, Usability
Engineering, and
Design Controls
= Medical
Best Practices in
Process Validation
and Biocompatibility
Testing
1 A
= Design & Manufacturing
Post Market
Compliance Check-up
1 A
= Packaging
= Quality
How to Avoid Warning
Letters, Submission Reviews,
and UDI Updates
S 1 A
Innovation in Design
1-Day Boot Camp
Techniques for Simpler, More
Intuitive Design
1 A
Integrated Quality
Management—Part 2
In collaboration
with ASQ
A
S = Book by Session 1 = Book with One Day Pass A = Book with the All-Access Pass
2015 MD&M West Conference Program
Tuesday, February 10
Track A - The New Wireless
Frontier
Track B - Refining Your Risk
Management & CAPA Procedures
9:30 a.m.–
10:00 a.m.
KEYNOTE ADDRESS
Computers we can wear
Babak Parviz, Ph.D., Vice President, Amazon, Former Google[x] Director
10:00 a.m.–
11:45 a.m.
Designing Devices Towards
Consumerization, Wireless
Capabilities and Wearable Technology
Creating and Implementing a Fully
Compliant CAPA System
10:00 – 10:30
Avoiding and responding to a CAPA
specific warning letter
Designing for simplicity – Making
products customers will love to buy
10:00 – 10:30
Bringing life to your functional prototypes
through 3D printing
Sridhar Iyengar, Co-Founder and Chief
Technology Officer, Misfit Wearables
10:30 – 11:15
10:30 – 11:15
10:30 – 11:15
Wireless medical device design
considerations for reimbursement,
security and data management
CAPA gap analysis: Tell me something I
don’t know about CAPA!
PANEL DISCUSSION
Integrating 3D printing into your
established processes
11:15 – 11:45
Remote patient monitoring devices: The
good, the great and the exceptional!
David Albert, Founder & Chief Medical Officer,
AliveCor
Brian Russell, VP Business Development
Wireless, Respiratory and Monitoring Solutions,
Covidien
James Moon, Chief Technology Officer, Sotera
Wireless
Integrating Advanced Sensor
Technology and Power Management
into your Device Design
1:00 – 1:40
Better, faster, stronger: Advances in new
intelligent feedback systems and sensor
technology
Stephen O’Driscoll, Google(x) Scientist, Google,
Assistant Professor, UC Davis
Marcelo Lemego, Sensor Expert
1:40 - 2:00
The shrinking secret sauce recipe: How
to decrease size whilst increasing power
Mark A. Phelps, Senior Director, Technology &
Product Development, Medtronic
2:00 – 2:30
Energy harvesting for self-powered
medical devices
Diane Kulisek, Director Quality & Performance
Improvement, Bruiri Biometrics
11:15 – 11:45
PANEL DISCUSSION
Rebooting your CAPA
Kevin Posey, Director of Quality, CardiacAssist
Marcelo Trevino, Senior Regulatory Compliance
Manager, Medtronic
Diane Kulisek, Director Quality & Performance
Improvement, Bruiri Biometrics
Integrating Your Medical Device
into an Interconnected Wireless
Ecosystem
2:45 – 3:30
PANEL DISCUSSION: Which platform is
best for different device portfolios and
will a single platform emerge?
Moderator: Andrew Malcolmson, Director,
Integrated Patient Intelligence (Vital Sync),
Covidien
Michael Mesinger, Director of Mobile and Cloud
Software, Dexcom
Amnon Ptashek, Chief Architect, WESTECH
Medical Technologies
Paul Krause, Director, Connectivity Systems
Engineering, Medtronic
3:30 – 4:00
A practical guide to gain mobile medical
app regulatory approval
Bakul Patel, Senior Policy Advisor, CDRH FDA
Ronald Litke, Senior Development Engineer,
Orchid Orthopedic Solutions
11:15 – 11:45
Using 3D printing for complex, highvolume medical devices
Gene Kulesha, Director Platform Technology
Engineering, Stryker
TRACK C IS BOOKABLE
BY SESSION!
PRICES START AT $179
Building Robust Risk Management
Part 1
3D Printing Materials Guide For
Medical Devices
1:00 – 1:40
1:00 – 1:40
Updating your risk management protocol
when using a new material
Material developments for 3D printing:
From biocompatible polymers to metals
Kevin Posey, Director of Quality, CardiacAssist
Scott Hollister, Ph.D., Professor, Biomedical
Engineering, Associate Professor, Surgery,
Professor, Mechanical Engineering, University of
Michigan
1:40 - 2:00
Refining software risk management when
designing your medical device
Seyed Khorashahi, Director, Software
Engineering, Covidien
2:00 – 2:30
ISO 9001 2015 update: The major
changes heightened towards risk
Walt Murray, Director of Quality & Compliance
Services, MasterControl
Greg Hutchins, Director, CERM Academy of
Risk
Max Donelan, Chief Scientific Officer, Bionic
Power, Associate Professor, Biomedical Physiology
& Kinesiology, Simon Fraser University
2:45 p.m.–
4:00 p.m.
Accelerating Speed to Market
through Effective Prototyping and 3D
Printing
Jay Jariwala, Quality System Specialist,
Regulatory Compliance Officer, Office of
Compliance, FDA
Anand Iyer, Ph.D., MBA, Chief Data Science
Officer, WellDoc
Shahid N. Shah, CEO, Netspective
Communications
Steve Abrahamson, Director, Product Security
Engineering, GE Healthcare
1:00 p.m.–
2:30 p.m.
10:00 – 10:30
Track C - Enter the 3D Printing Era
1:40 – 2:00
Development of an advanced 3D printed
scaffold for skeletal reconstruction
Scott DeFelice, President & Chief Executive
Officer, Oxford Performance Materials
2:00 – 2:30
The realities, myths and future potential
of bioprinting
Ibrahim T. Ozbolat, Ph.D., Assistant Professor,
Mechanical & Industrial Engineering Department,
The University of Iowa
Building Robust Risk Management
Part 2
Addressing the Regulatory and Legal
Challenges of 3D Printing
2:45 – 4:00
2:45 – 3:30
Risk Control of ISO 14971
PANEL DISCUSSION
The FDA and 3D printing waltz
A distinguished group of risk management experts
will explore why the industry continues to struggle
with ISO 14971, and will provide complete take
away solutions to overcome the most common
challenges with this standard through practical
case study projects.
David Vogel, Ph.D., Founder and President,
Intertech Engineering Associates
Orlando Guillory, Director of Quality Engineering,
Edwards LifeSciences
Steven K.Pollack, Ph.D., Director of the Office of
Science & Engineering Labs, FDA
William Brodbeck, Director, Regulatory Affairs,
STERIS Corp.
Colleen Wivell, Biomedical Engineering Manager,
Materialise
3:30 – 4:00
Overcoming the legal and intellectual
property concerns with 3D printed
products and devices
Paven Malhorta, Partner, Keker & Van Nest LLP
Wednesday, February 11
Track A - Designing the Next-Gen
Medical Device
Track B - Taking Control of Quality
9:30 a.m.–
10:00 a.m.
KEYNOTE ADDRESS
Andy Christensen, Vice President, Personalized Surgery & Medical Devices, 3D Systems
10:00 a.m.–
11:45 a.m.
IDEO DESIGN WORKSHOP - PART 1
Design Research & Inspiration
10:00 – 11:45
Improve your ability to deliver great
design by learning and practicing key
elements of the IDEO design process
Recently, IDEO received its 18th MDEA award—
more than any other company in the world, and
the award -winning design team wants to share it’s
learning with the MD&M community.
Whether you are working on upgrading an existing
device or creating a completely novel offering,
this hands-on workshop will provide you with
some new tools and perspectives in how to deliver
disruptive human-centered products to the market.
§§ Design research: Uncovering user needs
through in-context observations and analogous
inspiration
§§ Synthesizing insights: Identifying patterns
and human-centered insights that will set the
foundation for the product design
Brian Mason, Director, Design for Health, IDEO
1:00 p.m.–
2:30 p.m.
How to Audit Proof your Processes
and Effectively Prepare for an
Inspection
10:00 – 10:45
PANEL DISCUSSION:
Being audit ready at all times in an
inconsistent inspection environment
10:45 – 11:05
How to survive an FDA inspection
Dawn Haake, Senior Director Global Quality
Assurance, NuVasive
11:05 – 11:45
CDRH Quality Update 2015
Hear directly from the FDA where this in-depth
presentation and Q&A forum will provide more
clarity on quality updates for this coming year.
§§ Enforcement trends
§§ Quality initiative
• Quality information for inspections
• Quality library of successful practices
William MacFarland, Director of Division of
Enforcement, CDRH, FDA
IDEO DESIGN WORKSHOP - PART 2
Ideation and Prototyping
Improving your Supplier Quality
1:00 – 2:30
PANEL DISCUSSION
Building an airtight supplier quality
agreement
§§ Brainstorming: Learn seven rules that
unlock the creative power of a brainstorming
session, to generate a huge range of ideas,
opportunities, and concepts—tips you will for
sure take back and change how your teams
brainstorm
§§ Prototyping: Experience the incredibly
effective way of making ideas tangible, learning
through making, and quickly getting key
feedback to learn (or fail) early
§§ Feedback: Tools for prioritizing feedback and
other design constraints in play
Brian Mason, Director, Design for Health, IDEO
1:00 – 1:50
1:50 – 2:10
Protecting your Intellectual Property (IP)
when working with your suppliers
Mircea Tipescu, Intellectual Property Attorney,
Brinks, Gilson & Lione
2:10 – 2:30
Exploring the significant changes of
Notified Bodies unannounced audits
Paul Brooks, Senior Vice President, Healthcare
Solutions, BSI Group
Track C - Securing Finance,
Scaling-Up, and Lean Mfg
Financing, Funding and Start-Ups
10:00 – 10:45
Startup Shark Tank California
3 hammerhead financiers will grill 4 Californian
medical device start-ups on why they should be
given finance. Only 1 startup will come out alive.
The sharks and the audience will decide…
Anne DeGheest, Managing Director, Healthtech
Capital
Mudit K Jain, Managing Director, Synergy
Lifescience
10:45 – 11:05
How to secure funding from a Financier’s
perspective
11:05 – 11:45
PANEL DISCUSSION
Learn the secrets to a successful startup
David Mills, President & CEO, Dallen Medical
Richard Meyst, President & CEO, Fallbrook
Engineering
Charlie W Chi, Ph.D., President & CEO,
Somersault Orthopedics
Strategies for Successful Scale-Up
from Design to Manufacturing
1:00 – 1:50
PANEL DISCUSSION
The outsourcing tipping scale: Making it
work for you
Ivan Lai, Supply Chain Director, St. Jude Medical
Noreen King, Founder & President, Evolve
Manufacturing Technologies
Barry Kazemi, CEO, Life Science Outsourcing
1:50 – 2:10
Reducing hidden development and
supply chain costs when scaling up your
product
Irina Cantez, Director Global Strategic Sourcing,
DJO Global
2:10 – 2:30
Streamlining your scale-up processes to
accelerate speed to market
Eric Steuben, Vice President, Operations, Asante
Solutions, Inc.
2:45 p.m.–
4:00 p.m.
IDEO DESIGN WORKSHOP - PART 3
Innovation Thought Leadership Round
Table Discussion
Effectively Implementing a Quality
Management System
Lean Manufacturing: Beyond the
Basics
2:45 – 4:00
2:45 – 4:00
The importance of a global quality
As time permits, bring your specific challenges or
management system: Drug device
questions from inside your design teams, cubicles, combination product case study and
lab benches, or fieldwork… and we will engage in a workshop
2:45 – 4:00
discussion with leading industry innovators about
how you can use design thinking and create novel
medical device concepts in disruptive ways.
Brian Mason, Director, Design for Health, IDEO,
and Panel of medtech innovation experts
James Wabby, Director, Quality Systems and Risk
Management (Medical Devices and Combination
Products), Allergan
Applying lean manufacturing principles
to medical device development
§§ Discussing lean manufacturing methodologies
and case studies to understand customer
needs, reduce risk, improve process
control and use failure analysis to improve
manufacturing
§§ Understanding how a lean transformation can
engage the workforce with an effort to remain
agile, dynamic and successful
Thursday, February 12
Track A - Designing for the User
Track B - Best Practices in Process
Validation and Biocompatibility
Testing
Track C - Post Market Compliance
Check-up
9:30 a.m.–
10:00 a.m.
KEYNOTE ADDRESS
The Hackers Guide to the Galaxy
Jay Radcliffe, Senior Security Consultant & Researcher, Rapid 7
10:00 a.m.–
11:45 a.m.
Improving User Experience and
Usability Engineering
Overhauling your Process Validation
Part 1
How to Avoid Product Warning
Letters and Recalls
10:00 – 10:45
10:00 – 10:45
10:00 – 10:45
PANEL DISCUSSION:
How to design a robust usability study
and understand the relationship between
usability testing, risk management, and
product development
Standardizing your validation master plan Effectively responding to 483’s and
Robert Launsby, President, Launsby Consulting warning letters
Eric Bergman, Human Factors Engineering
Director, Fresenius Medical Care
Merrick Kossack, Manager, Human Factors
Engineering, Intuitive Surgical
Tressa Daniels, User Interaction Design Manager,
CareFusion
Joely Gardner, Ph.D., Professor of User
Experience & Usability, Cal State Fullerton
10:45 – 11:15
The ‘How To’ in implementing and
executing IEC 62366
Edmond Israelski, Ph.D., Director Human
Factors, Abbvie
11:15 – 11:45
Back to the future: Usability in the Year
2045
Thomas Oesterle, President, MedHouse
Innovations
Kristen Grumet, Executive Director, Medical
Devices, NSF International
10:45 – 11:15
10:45 – 11:15
Improving quality through a DoE
approach to process validation
Robert Launsby, President, Launsby Consulting
Thomas Oesterle, President, MedHouse
Innovations
11:15 – 11:45
Validation project management rapid
workshop
PANEL DISCUSSION: Preparing for an
effective response to warning letters and
review of medical device recalls
11:15 – 11:45
Insight: FDA’s review & classification of
medical device recalls
Jessica Paulsen, Biomedical Engineer, FDA
Now to get your hands dirty with some process
validation practical work. Bounce ideas off
your peers, benchmark your process validation
procedures and work out your validation kinks to
take back to the office.
Robert Launsby, President, Launsby Consulting
Thomas Oesterle, President, MedHouse
Innovations
Stuart Karten, Founder and President, Karten
Design
1:00 p.m.–
2:30 p.m.
Designing for Better: Hospital
Collaboration, Usability and Design
Control
Overhauling your Process Validation
Part 2
Regulations for the Engineer: Aiming
for First Time Submission Approval
1:00 – 1:30
1:00 – 1:30
1:00 – 1:30
Validating software used for process
automation
Anticipating the correct submission
requirements for PMA, 510(k) and IDE
PANEL DISCUSSION: Straight from the
hospital’s mouth: Improving collaboration Vincent DeFrank, Software Validation Manager,
Philips Healthcare
between the end user and manufacturer
Andra Blomkalns, M.D., University of Cincinnati
Andrew Schaudt, Director of Usability Services,
MedStar Health
Ross Donaldson, M.D., Harbor-UCLA Medical
Center
Raj Khandwalla, M.D., Cedars-Sinai Medical
Group and Cedars-Sinai Heart Institute
William B. Armstrong, M.D., University of
California
1:30 – 2:00
Prioritizing Human Factor considerations
in design control
Andra Blomkalns, M.D., Associate Professor &
Vice Chair, University of Cincinnati
2:00 – 2:30
Dissecting verification, validation and
transfer phases to improve your current
design control protocols
1:30 – 2:00
Global validation programs: Sharing the
knowledge
Regina Rohe, Senior Director, Global Validation,
bioMerieux
2:00 – 2:30
ROUNDTABLE DISCUSSION: Process
Validation Question Time
Now to get all your questions answered!
This expert panel of speakers will talk through
some real life case studies and discuss how
successful process validation procedures and
techniques will keep you on track with FDA’s
Quality System Regulation and the Process
Validation Guidance
David Amor, Managing Partner, MEDgineering
2:45 p.m.–
4:00 p.m.
Practical Applications of Design
Control
2:45 – 4:00
Complying with Biocompatibility
Testing Standards and Guidance to
get your Product to Market Faster
Design control tune-up check
2:45 – 4:00
Finish off your MD&M West Conference experience
with a practical Design Control workshop which
will give you more hands-on knowledge on how
to identify noncompliance areas and implement
improvements to accelerate speed to market.
David Amor, Managing Partner, MEDgineering
Edward Reverdy, Ph.D., Director of Global
Toxicology & Biocompatibility, Covidien
Biocompatibility testing: All you need to
know in 75 mins!
§§ Understanding the FDA’s current 510(k)
modifications document and the standard
§§ Developing a PMA submission strategy
§§ Determining what must be included in an IDE
application
§§ Clarification on other alternative pathways
including CDE and HDE
§§ Discussing the advantages and challenges for
each regulatory pathway
Phil Phillips, President, Phillips Consulting Group
1:30 – 2:30
WORKSHOP: Getting your submission
approved in under 1 hour
Now that you are even more familiar with the
various submission processes, you will be given
group projects to get your teeth into. 3 real life
case studies that didn’t gain approval first time
round – what lessons can you learn from these
previous errors?
Michael Drues, Ph.D., Vascular Sciences
UDI: What’s in Store for 2015 and
Beyond?
2:45 – 4:00
Looking past the regulation:
Understanding how UDI will impact your
department in 2015
This dedicated UDI session will take both a
retrospective look back on the September 2014
deadline for class III medical devices to address
how effective the implementation has been, but
will also detail what lessons can be learned for the
approaching 2015 deadline.
To celebrate the end of a successful MD&M West Conference,
we will be giving away a free 3D printer. It’s well worth the wait!
©UBM Canon 2014. Program accurate at time of print. UBM reserves the right
to alter venue, speakers and/or content.
Passes & Pricing—
Select the Pass that is Right for You!
Expo Only
Pass
FREE!
Access to thousands of
exhibitors on the expo floor
Access to lectures in the
Tech Theater and Center
Stage
Complimentary Speed
Networking feature
EARLY BIRD DISCOUNTS
END ON 1/16
BOOK TODAY!
1 Day
All-Access
Expo Pass
+ 1 Session
$199
VIP
All-Access Pass
$499
(Good for ALL Days)
$1099
$179 Early Bird
$449 Early Bird
Includes everything in the
Expo Only Pass, PLUS:
Includes everything in the
Expo + 1 Session Pass, PLUS:
One conference session*
Unlimited Attendance
to any of the educational
sessions on the day selected
from all conference tracks on
the day selected
Digital download of
presentation materials
Choose Expo
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Choose 1 Day
Download the Mobile App—
It’s More than an Event Guide
$999 Early Bird
Everything included in the
Expo Only Pass, PLUS:
Unlimited attendance to
ALL educational sessions
from all conference tracks
across all 3 days
Choose All-Access
February 10, 2015
5:00 p.m.
Anaheim Marriott | Anaheim, CA
Plan ahead with this free tool!
Exhibitor listings: Arrange meetings with
exhibitors before their schedules ﬁll up.
Keyword searches: Instantly ﬁnd products,
colleagues, and exhibitors by keyword.
Personalized agenda: Create your own
schedule of ‘must see’ conference sessions,
Tech Theater talks, keynotes, and meetings.
Floor plan: Navigate the entire event
on-the-go.
Network: Share your experience and
engage with like-minded individuals in realtime through the community activity feed.
GoldenMousetraps.com
Come celebrate the people, companies, and technologies
that are driving progress in today’s U.S. design and
manufacturing industries.
Design News will announce winners in 16 tech categories, in
addition to the Rising Engineering Star, and Gadget Freak
of the Year, plus present a Lifetime Achievement Award to
Babak Parviz, VP, AMAZON, and more! Hosted by
Ben Heck from element14’s The Ben Heck Show.
Tickets are FREE, but donations will benefit FIRST.
RSVP when you register for MD&M West.
In Partnership with:
Donations will Benefit:
Look for details at
MDMwest.com/conf15
MD&M West Exhibition & Conferences Information:
Expo Dates & Hours:
Tuesday–Wednesday
February 10–11, 2015
10:00 a.m.–5:00 p.m.
Registration opens at 8:00 a.m.
Thursday, February 12, 2015
10:00 a.m.–4:00 p.m.
Registration opens at 8:30 a.m.
Hall E opens at 9:30 a.m. each day.
Conference Dates & Hours:
Location:
Produced and Managed by:
Travel & Hotel:
Tuesday-Thursday
February 10-12, 2015
9:30 a.m.-4:00 p.m.
UBM Canon
2901 28th Street, Suite 100
Santa Monica, CA 90405
UBMcanon.com
Anaheim Convention Center
800 W. Katella Avenue
Anaheim, CA 92802
For travel discounts, hotel reservations, and
more, visit MDMwest.com/conf15
twitter.com/MDM_Events
For more information, visit
MDMwest.com/conf15
29419_W_MDM15