1. Healthcare

AGENDA AT A GLANCE
DAY 1: FEBRUARY 10TH, 2015
9:30 –
10:00
TRACK A:
Disruptive
Innovation in
Design of
Medical Devices
TRACK B:
Managing Risk,
Quality and
Validation
TRACK C:
Speed to Market,
Scale Up & Post
Market
Compliance
10:00 – 11:45
Designing
Devices Towards
Consumerization,
Wireless
Capabilities and
Wearable
Technology
1:00 – 2:30
Integrating
Building Robust
Advanced Sensor Risk Management
Technology and
Part 1
Power
Management into
your Device
Design
2:45– 4:00
KEYNOTE ADDRESS
Computers we can wear
Creating and
Implementing a
Fully Compliant
CAPA System
Integrating your
Medical Device
into an
Interconnected
Wireless
Ecosystem
DAY 2: FEBRUARY 11TH, 2015
TRACK A:
Disruptive
Innovation in
Design of
Medical Devices
TRACK B:
Managing Risk,
Quality and
Validation
TRACK C:
Speed to Market,
Scale Up & Post
Market
Compliance
KEYNOTE ADDRESS
Personalizing Surgery: 3D Printing and The Digital Thread
DAY 3: FEBRUARY 12TH, 2015
TRACK A:
Disruptive
Innovation in
Design of
Medical Devices
TRACK B:
Managing Risk,
Quality and
Validation
TRACK C:
Speed to Market,
Scale Up & Post
Market
Compliance
KEYNOTE ADDRESS
The Hackers Guide to the Galaxy
Accelerating
Speed to Market
through Effective
Prototyping and
3D Printing
IDEO DESIGN
WORKSHOP
PART 1:
Design research
and inspiration
How to Audit Proof Financing, Funding
your Processes
and Start-Ups
and Effectively
Prepare for an
Inspection
Improving User
Experience and
Usability
Engineering
Overhauling your
Process
Validation Part 1
How to Avoid
Product Warning
Letters and
Recalls
3D Printing
Materials Guide
For Medical
Devices
IDEO DESIGN
WORKSHOP
PART 2:
Ideation and
prototyping
Improving your
Supplier Quality
Strategies for
Successful ScaleUp from Design to
Manufacturing
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
IDEO DESIGN
WORKSHOP
PART 3:
Innovation
thought
leadership round
table discussion
Effectively
Implementing a
Quality
Management
System
Lean
Manufacturing:
Beyond the Basics
Practical
Applications of
Design Control
Complying with
UDI: What’s in
Biocompatibility
store for 2015 and
Testing Standards beyond?
and Guidance to
get your Product
to Market Faster
Building Robust
Addressing the
Risk Management Regulatory and
Part 2
Legal Challenges
of 3D Printing
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DAY ONE – TUESDAY, FEBRUARY 10th
TRACK A: Disruptive Innovation in Design of
Medical Devices
TRACK B: Managing Risk, Quality and
Validation
TRACK C: Speed to Market, Scale Up & Post
Market Compliance
THE NEW WIRELESS FRONTIER: Innovations
in Wireless Capabilities, Interoperability, and
Sensor Technologies in Medical Devices
REFINING YOUR RISK MANAGEMENT AND
CAPA PROCEDURES
ENTER THE 3D ERA:
A New Dawn in Medical Device Design &
Manufacturing
CHAIR: Liam Pender, Ph.D., President & Chief
Executive Officer, EGRET TECHNOLOGIES
CHAIR: Geoff Hutchins, Chief Operations
Officer, REGULATORY COMPLIANCE
ASSOCIATES
CHAIR: Donovan Weber, Chief Operating
Officer, FORECAST3D
9:30AM
–
10:00AM
KEYNOTE ADDRESS
Computers we can wear
Babak Parviz, Ph.D., Vice President, Amazon | Former Google[x] Director
10:00AM
–
11:45AM
This industry juggernaut, creator of Google Glass and Google Contact Lens, will open the conference with a look into the current and future wearable
technologies taking hold of the medical device and healthcare industries.
Designing Devices Towards
Creating and Implementing a Fully Compliant
Accelerating Speed to Market through
Consumerization, Wireless Capabilities and
CAPA System
Effective Prototyping and 3D Printing
Wearable Technology
10:00 – 10:30
Designing for simplicity – Making products
customers will love to buy
Examples of where a simple design can be
disruptive
Examining current devices that apply the
disruptive innovation principles
Determining how much the current
regulatory landscape disrupts disruptive
innovation
Exploring how to break the mold with a
simpler next generation device
Sridhar Iyengar, Co-Founder and Chief
Technology Officer, MISFIT WEARABLES
10:00 – 10:30
Avoiding and responding to a CAPA specific
warning letter
Corrective and preventative action deficiencies
have accounted for an increasing number of
warning letters. Some may argue that CAPA
discrepancies are overtaking 510k/ PMA
submission regulatory headaches. This
interactive presentation will help you effectively
respond to a warning letter and help you avoid
any future CAPA associated warning letters.
Jay Jariwala, Quality System Specialist,
Regulatory Compliance Officer, Office of
Compliance, FDA
10:30 – 11:15
Wireless medical device design
considerations for reimbursement, security
and data management
Will the “wireless” distinction in medical
devices mean anything in 5 years or will it
just be ubiquitous and table stakes?
What will the wireless landscape look like in
10:30 – 11:15
CAPA gap analysis: Tell me something I don’t
know about CAPA!
This concentrated but intensive workshop will
help you identify the most common CAPA
shortfalls and eliminate your chance of receiving
a CAPA associated warning letter.
Uncovering the usual CAPA tripwires
10:00 – 10:30
Bringing life to your functional prototypes
through 3D printing
Insightful real life industry case studies
demonstrating how 3D printing prototyping
can cultivate innovation
Evaluating the cost implications of 3D
printing prototypes versus traditional
methods
Overcoming design challenges by utilizing
additive manufacturing
Justin Conway, Product Development Engineer,
Orchid Orthopedic Solutions
10:30 – 11:15
PANEL DISCUSSION
Integrating 3D printing into your established
processes
Over the last 12 months, most medical device
companies have dipped their toe cautiously in the
3D printing pool. Going into 2015, companies are
getting ready/are already integrating 3D printing
capabilities into their processes. This panel
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5 years?
Most devices are standalone these days
and are reimbursed based on medical
necessity or protocols. Will that be the same
in the next few years or will device
connectivity with EHRs change the
reimbursement landscape?
What is ONC and the FDA likely to require
in terms of cybersecurity and what will that
mean to medical device designs?
Assuming big data and analytics progress
continues unabated, what changes to device
designs are required for improved data
capture and management?
Shahid N. Shah, Chief Executive Officer,
Netspective Communications | Influential
Blogger, HealthcareGuy.com
-
Steve Abrahamson, Director, Product Security
Engineering, GE Healthcare
Melissa Masters, RAC, Director of Electrical
Software and Systems Engineering, Battelle
Memorial Institute
11:15 – 11:45
Remote patient monitoring devices for the
Aging Population and for Chronic Diseases:
The good, the great and the exceptional!
Gain real-life insights from three leading remote
patient monitoring manufacturers and one
medical design innovation consultancy giving
detailed case studies on how they overcame
design and engineering challenges for their
remote patient monitoring devices for the aging
population and chronic diseases.
David Albert, M.D., Founder & Chief Medical
Officer, AliveCor
Brian Russell, Vice President Business
Development Wireless, Respiratory and
Monitoring Solutions, Covidien
-
Best practices in managing CAPA
investigations
Reviewing and correcting a non-conformity
Verifying CAPA implementation and
validating CAPA effectiveness
How to apply risk management in the CAPA
process
Writing appropriate recurrence control and
preventative action plans
Diane Kulisek, Director Quality & Performance
Improvement, Bruin Biometrics
11:15 – 11:45
PANEL DISCUSSION
Rebooting your CAPA
An esteemed panel of CAPA experts will share
their best practices and lessons learned on
implementing a successful CAPA system
Implementing a compliant CAPA system that
brings business value
Aligning regulatory requirements with the
GHTF CAPA guidance
Discussing performance of CAPA
investigational tools currently available
Kevin Posey, Executive Quality/Regulatory
Consultant, MAETRICS
brings together a wealth of knowledge discussing
the vital checkpoints of integrating 3D printing
into your departments design and/or
manufacturing methods
Discussing where the medical device
industry is now and where is it heading
How to successfully collaborate with 3D
printer vendors and material suppliers
Converting 3D printing into business value
Are you solving a clinical problem by 3D
printing your product or device?
Tyler Reid, Manufacturing Application Manager,
GoEngineer
Dave Flynn, Senior Business Development
Manager, Materialise
Justin Conway, Product Development Engineer,
Orchid Orthopedic Solutions
Ross Tsukashima, Engineering Director,
Revision Optics
Eric Utley, Additive Manufacturing Application
Specialist, PROTO LABS
11:15 – 11:45
Using 3D printing for complex, high volume
medical devices
Marcelo Trevino, Senior Regulatory Compliance Exploring the major obstacles for the
Manager, Medtronic
medical device industry when integrating 3D
printing into the development and
Diane Kulisek, Director Quality & Performance,
manufacturing life cycles
Bruin Biometrics
Evaluating the potential to streamline and
Andrew Harrison, Vice President & General
accelerate your concept to market time line
Counsel, Regulatory Compliance Associates
How will 3D printing impact your
manufacturing bottom line?
Determining the opportunities of using 3D
printing for tooling and production when
manufacturing medical devices
Naomi Murray, Senior Manager, Additive
Manufacturing, Stryker
James Moon, Chief Technology Officer,
Sotera Wireless
Craig Scherer, Co-Founder & Senior Partner
Insight Product Development
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1:00PM
–
2:30PM
Integrating Advanced Sensor Technology and
Power Management into your Device Design
Building Robust Risk Management
Part 1
3D Printing Materials Guide For Medical
Devices
1:00 – 1:40
Better, Faster, Stronger: Advances in new
intelligent feedback systems and sensor
technology and how to practically build this
into your design plans
Keeping up with technology upgrades and
continuous product innovations in sensors to
maximize their current and future
capabilities
Exploring soft sensors, self-calibration and
wireless communication for monitoring and
control applications
Practical issues behind incorporating
multiple sensors into medical devices
New applications in pressure sensor
technology, new semiconductor chip and
low power sensor technologies
Saeed Azimi, CEO & President, Dynosense
1:00 – 1:40
1:00 – 1:40
Updating your risk management protocol
Material developments for 3D printing: From
when using a new material
biocompatible polymers to metals
Overcoming the risk management
Exploring the various materials currently
challenges of evaluating and implementing
available for 3D printed medical devices
new materials within your medical device
Discovering the range of available materials
and finishes for single or multi-material use
Determining if and when you need to
change your risk analysis protocol for a new Addressing sterilization testing and
material
longevity concerns with new materials
What new materials have been added to
Reducing costs using new materials in the
RoHS?
rapid prototyping process
Kevin Posey, Executive Quality/Regulatory
Mobilizing new materials straight into
Consultant, MAETRICS
production
Scott Hollister, Ph.D., Professor, Biomedical
1:40 - 2:00
Engineering, Associate Professor, Surgery,
Refining software risk management when
Professor, Mechanical Engineering, University
designing your medical device
of Michigan
How to successfully embed your software
risk management into your overall risk
1:40 – 2:00
1:40 - 2:00
management practice
Development of an advanced 3D printed
Use of miniaturized implantable devices for
Developing your software with international scaffold for skeletal reconstruction
patient empowered health care
regulations in mind
OPM manufactures FDA cleared PEKK
Focusing on current and future
implants using a 3D printing technique
Best practices in preparing documentation
miniaturization challenges with batteries and
for medical device software
3D printed PEKK suitable for load bearing
battery-pored medical devices
applications (VBR)
What software process improvement risk
Detailing new developments in rechargeable
management model is best for your device? Ability to manufacture implantable devices
and primary cell systems to enable
with complex geometries is driving
Best practices in documenting risk
increased longevity
management
innovation for the next generation of
Assuring that your battery meets the unique
devices
Combining results from various risk
requirements for its application whilst
Severine Zygmont, Co-Founder, Oxford
analysis tools such as FMEA, FTA, etc.
performing reliably and safety
Performance Materials
Seyed Khorashahi, Director, Software
Todd M. Zielinski, Ph.D., Senior Principal
Engineering, Covidien
Scientist, MEDTRONIC
2:00 – 2:30
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People Power: biomechanical energy
harvesting for portable devices
How much power is available to from the
human body?
What can be powered with human
energy harvesting?
What is the state-of-the-art in
biomechanical energy harvesting?
Max Donelan, Chief Scientific Officer, Bionic
Power | Associate Professor, Department of
Biomedical Physiology & Kinesiology, Simon
Fraser University
2:00 – 2:30
ISO 9001 2015 update: The major changes
heightened towards risk
Managing the transition when the new
standard is published in 2015
Discussing the new requirements for
review, documentation updates and risk
management
Analyzing outcomes as a result of risk
management changes
Exploring the more risk-driven approach
and actions to address risk
Walt Murray, Director of Quality & Compliance
Services, MASTERCONTROL
2:00 – 2:30
The realities, myths and future potential of
bioprinting
Latest in organ printing technologies and
applications in tissue engineering and
regenerative medicine
Uncovering the limitations and challenges of
this technology
Detailing breakthroughs in printing human
stem cells
Practicalities of taking a quantum leap into
the commercial arena
Ibrahim T. Ozbolat, Ph.D., Assistant Professor,
Mechanical & Industrial Engineering Department,
The University of Iowa
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2:45PM
–
4:00PM
Integrating your Medical Device into an
Interconnected Wireless Ecosystem
Building Robust Risk Management
Part 2
Addressing the Regulatory and Legal
Challenges of 3D Printing
2:45 – 3:30
Panel Debate: Future medical device
communication: Which platform is best for
different device portfolios and will a single
platform emerge?
Addressing the connectivity conundrum WiFi, Bluetooth or Cellular for different types
of devices?
Debating the best approach to incorporate
cloud – needs a bit more detail
Discussing if and how Bluetooth and 802.11
Wi-Fi can co-exist
Understanding what are the most optimal
RFs for short range and long range devices
Tips for overcoming the security concerns of
cloud storage and overall data management
MODERATOR: Andrew Malcolmson, Director,
Integrated Patient Intelligence (Vital Sync),
Covidien
2:45 – 4:00
ROUND TABLE
Risk Control of ISO 14971
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.
Detailing how to establish and maintain a
more robust risk management program
Going beyond Failure Modes and Effects
Analysis – Exploring the most effective risk
assessment methods
Discussing the updated change of the use
of risk control of ISO 14971 amendment 2
David Vogel, Ph.D., Founder and President,
Intertech Engineering Associates
2:45 – 3:30
PANEL DISCUSSION
The FDA and 3D printing waltz
Discussing the current and future role of the
FDA in additive manufacturing regulations
Detailing the types of medical devices that
the FDA have cleared/approved to date
Addressing the potential technical concerns
with 3D printing including mechanical
properties, biocompatibility, process
validation and interactive design
Determining which technical assessments
should be considered for review
Steven K. Pollack, Ph.D., Director of the Office
of Science & Engineering Labs, FDA
Michael Mensinger, 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
Exploring the most important takeaways
from the Mobile Medical Apps Guidance
Best practices for developing apps and
getting them approved quickly per FDA
What is the definition of a mobile medical
app?
Determining what current technologies and
development platforms are best to support a
medical device app
Understanding the requirements for device
approval and what is meant by enforcement
discretion
Bakul Patel, Senior Policy Advisor, CDRH FDA
Orlando Guillory, Director of Quality
Engineering, Edwards LifeSciences
Walt Murray, Director of Quality & Compliance
Services, MasterControl
Seyed Khorashahi, Director, Software
Engineering, COVIDIEN
William Brodbeck, Director, Regulatory Affairs,
STERIS Corporation
Dave Flynn, Senior Business Development
Manager, MATERIALISE
Severine Zygmont, Co-Founder, Oxford
Performance Materials
3:30 – 4:00
Legal and intellectual property concerns
associated with 3D printing
Overview of patent, copyright, and trade
secret law
Review of current litigation involving 3D
printing companies
Exploring steps your company should be
considering both from an offensive and
defensive perspective to address
intellectual property concerns
Reese Nguyen, Associate Attorney, KEKER &
VAN NEST LLP
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DAY TWO – WEDNESDAY, FEBRUARY 11th
TRACK A: Disruptive innovation in Design of
Medical Devices
TRACK B: Managing Risk, Quality and
Validation
TRACK C: Speed to Market, Scale Up & Post
Market Compliance
DESIGNING THE NEXT-GEN MEDICAL
DEVICE: IDEO DESIGN WORKSHOP AND
ROUND TABLE
TAKING CONTROL OF QUALITY: Dealing with
Inspections, Managing Suppliers, and Improving
your QMS
Securing Finance, Scaling-Up from Concept to
Market, and Best Practices in Lean
Manufacturing
CHAIR: Brian Mason, Director, Design for
Health, IDEO
9:30AM
–
10:00AM
CHAIR: Andrew Harrison, Vice President &
General Counsel, Regulatory Compliance
Associates
KEYNOTE ADDRESS
Personalizing Surgery: 3D Printing and The Digital Thread
Andy Christensen, Vice President, Personalized Surgery & Medical Devices, 3D Systems Corporation
The Founder and CEO of Medical Modeling, who’s company pioneered 3D printing-centric personalized surgery and patient-specific medical device
solutions, will present the potential of a new 3D printing technology that will transform the healthcare industry.
10:00AM
–
11:45AM
IDEO DESIGN WORKSHOP PART 1: Design
research and inspiration
Improve your ability to deliver great design
by learning and practicing key elements of
the IDEO design process
IDEO, the global design and innovation firm, has
a history of delivering impactful, compelling,
human-centered design to the world of medical
and consumer products. Recently, IDEO
received its 18th MDEA award—more than any
other company in the world.
How to Audit Proof your Processes and
Effectively Prepare for an Inspection
Financing, Funding and Start-Ups
10:00 – 10:45
Being audit ready at all times in an
inconsistent inspection environment
What have been the most problematic
aspects of FDA audits and inspections over
the last 12 months?
Defining what true inspection readiness is to
pass any inspection with flying colors
Focusing your quality programs on the right
thing to overcome inspection
inconsistencies
Discussing if and why audit and inspection
challenges going to overtake 510(k) and
PMA submission headaches?
Uwe Degenhardt, Director, Quality Compliance,
EDWARDS LIFESCIENCES
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.
At MD&M, IDEO will lead a fully interactive
design workshop allowing the participants to flex
their creative muscles and learn how to uncover
and prioritize unmet user needs, brainstorm
novel and creative solutions, and quickly
prototype experiments to test concepts. The
Dennett F. Kouri, Jr., JD, Senior Director,
workshop will use case studies of existing
Quality, Regulatory & Clinical, EDWARDS
products on the market to describe the steps and
LIFESCIENCES
tools of the design process.
The sharks and the audience will decide…
Anne DeGheest, Managing Director, Healthtech
Capital
David M. Anderson, Managing Director,
GE CAPITAL
Rik Vandevenne, Director of Capital Funds,
River Cities Capital Funds
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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
A great group of innovators and designers led by
Brian Mason, Director, Design for Health, IDEO
Megan Huston, Business Development
Associate, IDEO
Jason Wilkins, Senior Mechanical Engineer,
IDEO
10:45 – 11:05
How to survive an FDA inspection
Step by step instructions on how to get a
green light first time from the FDA
Examining the importance of a mock
inspection
Best practices in improving your internal
auditing and reliability testing protocols
It’s all in the prep: Internal pre-audits and
tighter controls on data and documents
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
o Quality information for inspections
o Quality library of successful practices
William MacFarland, Director of Division of
Enforcement, CDRH, FDA
10:45 – 11:05
How to secure funding from a Financier’s
perspective
Overview of investment trends in early and
late stage start ups
Discussing the real impact of the
reimbursement strategy on finding finance
Making sure you have a strong capital
efficient business model
Discussing future VC finance strategies and
what they look for in a medical device start
up for long-term success
Rik Vandevenne, Director of Capital Funds,
River Cities Capital Funds
11:05 – 11:45
PANEL DISCUSSION
Learn the secrets to a successful startup
An already thriving group of startups will give the
audience a closer look at what differentiates
them from the many startups who have failed
within the medical device industry.
David Mills, President & Chief Executive Officer,
Dallen Medical
Richard Meyst, President & Chief Executive
Officer, Fallbrook Engineering
Charlie W Chi, Ph.D., President & Chief
Executive Officer, Somersault Orthopedics
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1:00PM
–
2:30PM
IDEO DESIGN WORKSHOP PART 2: Ideation
and prototyping
Improving your Supplier Quality
Strategies for Successful Scale-Up from
Design to Manufacturing
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
A great group of innovators and designers led by
Brian Mason, Director, Design for Health, IDEO
1:00 – 1:50
PANEL DISCUSSION
Building an airtight supplier quality
agreement
Detailing best practices in supplier quality
audit plans
Best practices in how to renegotiate your
supplier contracts
Supplier risk management – how to comply
with changing compliance
Discussing FDA guidance for CMO quality
agreements
David Parkin, Senior Supplier Quality Lead,
VOLCANO CORPORATION
Megan Huston, Business Development
Associate, IDEO
Gus Rathgeber, Ph.D., Director of Global
Supplier Quality & Vascular Products, DJO
GLOBAL
1:00 – 1:50
PANEL DISCUSSION
The outsourcing tipping scale: Making it work
for you
Evaluating the pros and cons of this ever
changing outsourcing/inhousing landscape
Best methods in utilizing CMO’s expertise
Discussing how the digital health
movement will bring about new outsourcing
partnerships
Gaining insight into future outsourcing
trends in the BRIC markets
Utilizing the CMO’s capabilities to improve
time to market
MODERATOR: Shriram Venkataramana,
Manager, China MedTech Insights,
Decision Resource Group
Jeffrey Ray, Principal Engineer, Supplier
Quality, CareFusion
Noreen King, Founder & President,
Evolve Manufacturing Technologies
Marindy Waldron, Senior Manager, Supply
Chain, Procurement and New Projects, St. Jude
Medical
Barry Kazemi, Chief Executive Officer,
Life Science Outsourcing
-
Jason Wilkins, Senior Mechanical Engineer,
IDEO
Jarod Oldham, Global Supplier Assurance
Manager, St. Jude Medical
Julia Wall, Consulting Analyst,
Decision Resources Group
1:50 – 2:10
Minimizing supply chain costs on new
1:50 – 2:10
launches and product redesigns
Protecting your Intellectual Property (IP)
Understanding the impact of launch on
when working with your suppliers
existing products, materials, and suppliers
Conducting Intellectual Property due
Streamlining cross-functional NPI and
diligence and protection strategies for large
redesign projects to minimize costs of
and small companies
transition
Gaining insight into foreign filing
Choosing agile suppliers to support ramp
considerations, licensing and distribution
up of product demand
Updates on technology confidentiality and
Irina
Cantez,
Director Global Strategic Sourcing,
branding strategies
DJO
Global
Mircea Tipescu, Intellectual Property Attorney,
BRINKS, GILSON & LIONE
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2:10 – 2:30
Reviewing the significant developments in EU
Medical Devices Regulation and Notified
Bodies unannounced visits
- Learn the latest on the future for the
proposed EU Medical Device Regulation
replacing the current Directive
- Evaluating the proposed changes to
understand the implications for device
manufacturers
- Making sure your processes support EU
expectations and increased scrutiny
- Understanding and being prepared for
NB unannounced visits now occurring for
CE Marking
Paul Brooks, Senior Vice President, Healthcare
Solutions, BSI Group
2:10 – 2:30
Streamlining your scale-up processes to
accelerate speed to market
Exploring top 10 must do best practices
to shorten concept-to-market time
Increasing your efficiency with your
current technology
Acquiring and agreeing on stable and
sufficient product requirements before
embarking on development
Incorporating user needs and risk
management at the start of a product
development plan
Eric Steuben, Vice President, Operations,
Asante Solutions, Inc.
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2:45PM
–
4:00PM
IDEO DESIGN WORKSHOP PART 3:
Innovation thought leadership round table
discussion
Effectively Implementing a Quality
Management System
Lean Manufacturing: Beyond the Basics
As time permits, bring your specific challenges or
questions from inside your design teams,
cubicles, lab benches, or fieldwork… and we will
engage in a discussion with leading innovation
experts about how you can use design thinking
and create novel medical device concepts in
disruptive ways.
Brian Mason, Director, Design for Health, IDEO
The importance of a global Quality
Management System: Drug Device
Combination product case study and
workshop
The global market for DDC products is expected
to grow to $115.1 billion. With many medical
device manufacturers partnering with Pharma
companies or growing their own DDC portfolio,
making sure you have a strong DDC QMS in
place should be a priority.
This hands-on workshop will discuss examples
of internal and external supplier relationship
challenges and opportunities in exploring
combination product development strategies, as
well as the regulatory strategy of DDCs to
comply with 21 CFR 210/211 and 21 CFR 820.
James Wabby, Director, Quality Systems and
Risk Management (Medical Devices and
Combination Products), Allergan
Lean Transformation for Medical Device
Development and Manufacturing
Identifying why most lean programs fail to
produce lasting results
Explaining why a lean transformation model
should be based on Key Process Indicators
(KPI) and Key Behavioral Indicators (KBI)
Exploring how strategy deployment and A-3
thinking can be used to cascade metrics and
goals down to the front lines
Explaining how to operationalize lean daily
management and daily Kaizen using A-3
and the Improvement Kata
Darren Dolcemascolo, Senior Partner,
EMS Consulting Group
William Pratt, Director of Creative Design,
KINAMED
Matt Duncan, President, Morphix Design
Kenny Dang, Vice President, Global Innovation
& Development, Lombard Medical
Technologies
Ken Flaherty, Lead Lean Transformation
Consultant, EMS Consulting Group
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DAY THREE – THURSDAY, FEBRUARY 12th
TRACK A: Disruptive Innovation in Design
of Medical Devices
TRACK B: Managing Risk, Quality and
Validation
TRACK C: Speed to Market, Scale Up & Post
Market Compliance
DESIGNING FOR THE USER:
Improving User Experience, Usability
Engineering, and Design Controls
BEST PRACTICES IN PROCESS VALIDATION
AND BIOCOMPATIBILITY TESTING
POST MARKET COMPLIANCE CHECK-UP:
How to avoid warning letters, submission reviews,
and UDI updates
CHAIR: Andrew Schaudt, Director of
Usability Services, MEDSTAR HEALTH
9:30AM
–
10:00AM
10:00AM
–
11:45AM
CHAIR: Suhas Kulkarni, President, FIMMTECH CHAIR: Elaine H Tseng, Partner, King & Spalding
KEYNOTE ADDRESS
The Hackers Guide to the Galaxy
Jay Radcliffe, Senior Security Consultant & Researcher, Rapid 7
The cybersecurity expert famously known for hacking his own insulin pump in 2011, takes to the stage to question how medical device security has
progressed over the last 4 years.
Improving User Experience and Usability
Overhauling your Process Validation Part 1
How to Avoid Product Warning Letters and
Engineering
Recalls
10:00 – 10:45
10:00 – 10:45
10:00 – 10:45
PANEL DISCUSSION:
Standardizing your validation master plan
Effectively responding to 483’s and warning
How to design a robust usability study and
letters
Covering the key principals of process
understand the relationship between
validation and addressing the main issues
Making sure you are not a repeat offender
usability testing, risk management, and
the industry continues to struggle with
Gain insights from interactive case studies and
product development
examples from other compliance initiatives
Defining the regulatory definition of process
Designing your study and exploring what
validation
Highlighting the key 2013/2014 warning letter
variables you want to incorporate
Encompassing different products and
findings
Top tricks in early identification of use
devices under 1 validation plan
Identifying the appropriate course of action
errors
and preparing for a timely response
Designing a better reliability test program
Kristen Grumet, Executive Director, Medical
Discussing how to best document and
and QC testing after validation
apply task analysis and use error analysis Using process validation for ISO 14971 risk Devices, NSF International
Addressing the constraints of usability
reduction
10:45 – 11:15
testing
Robert Launsby, President,
Preparing for an effective review and response
Launsby Consulting
Making a strong business case for
of medical device recalls
Human Factors and demonstrating how it Thomas Oesterle, President,
How to survive and manage a successful
can directly reduce the bottom line
MedHouse Innovations
recall
Eric Bergman, Human Factors Engineering
Determining when a recall is needed
10:45 – 11:15
Director, Fresenius Medical Care
Minimizing the current and potential risk
WORKSHOP: Improving quality through a
Merrick Kossack, Manager, Human Factors
Doris
M. Apel, Recalls Manager, Varian Medical
DoE approach to process validation
Engineering, Intuitive Surgical
Systems
Exploring the advantages of the DoE
Tressa Daniels, User Interaction Design
approach versus one factor at a time
Manager, CareFusion
Making sure QSR 820 Part 21 and ISO
Joely Gardner, Ph.D., Professor of User
13485 are met
Experience & Usability, Cal State Fullerton
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10:45 – 11:15
The ‘How To’ in implementing and
executing IEC 62366
How to practice usability above and
beyond IEC 62366
Gaining insight into real world case
studies on how to follow this new
standard
Simplifying the standard and detailing
essential details for Part 1 and Part 2
Getting to grips on how to obtain FDA
approval in Human Factors and usability
testing
Edmond Israelski, Ph.D. Director Human
Factors, Abbvie
-
How can DoE highlight opportunities to
improve quality?
Using DoE to demonstrate what variables
can be tolerated
Robert Launsby, President,
Launsby Consulting
Thomas Oesterle, President,
MedHouse Innovations
11:15 – 11:45
Validation project management rapid
workshop
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
11:15 – 11:45
Insight: FDA’s Review & Classification of
Medical Device Recalls
Discussing the fundamentals of medical
device recalls
Examining the roles and responsibilities
associated with a medical device recall
Exploring recall related challenges and best
practices
Jessica Paulsen, Biomedical Engineer, FDA
11:15 – 11:45
Back to the Future: Usability in the Year
2045
Since MD&M West launched 30 years ago, the
Thomas Oesterle, President,
medical device industry has seen staggering
MedHouse Innovations
change. Stuart Karten, product designer and
30-year industry veteran, will transport you to
the future to imagine what the next 30 years
has in store. Come learn how successful
medical device companies can create positive
user and patient experiences that adapt to
tomorrow’s needs.
What human factors challenges will
shape the industry?
Who will use medical devices, and how
will their lives, abilities, and expectations
change?
What’s in store for the burgeoning field of
wireless, wearable devices?
Stuart Karten, Founder and President,
Karten Design
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1:00PM
–
2:30PM
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 – 1:45
PANEL DISCUSSION: Straight from the
hospital’s mouth: Improving collaboration
between the end user and manufacturer
A panel of physicians will discuss the benefits
of bringing the end user into the design stage.
This discussion will emphasize the importance
of physician feedback: is this considered at the
design phase? What is the interaction between
engineer and doctor? How can you strengthen
your relationship with your end users?
MODERATOR: Andrew Schaudt, Director of
Usability Services, MedStar Health
1:00 – 1:30
1:00 – 1:30
Validating software used for process
Developing a regulatory strategy for fulfilling
automation
FDA regulatory requirements
Participate in this hands-on session to problem
Recognizing regulatory opportunities for
solve the toughest software process automation
achieving company objectives
‘glitches’.
Understanding the advantages and
What kind of software needs to be
disadvantages associated with the pathways
validated?
to market
21 CFR 820.70(i) requirements of software Anticipating submission requirements for
validation for process automation
PMA, 510(k), de novo classification and IDE
Exploring the 21 CFR Part 11 demands
Understanding FDA requirements for device
Vincent DeFrank, Software Validation Manager,
modifications
Philips Healthcare
Developing and implementing an effective
submission strategy
1:30 – 2:00
Ross Donaldson, MD, MPH, CTropMed,
Phil Phillips, President, Phillips Consulting
Global validation programs: Sharing the
FACER, Director of Emergency Medicine,
Group
knowledge
Global Health Program, Harbor-UCLA
Proving the importance and cost saving
Medical Center
1:30 – 2:30
opportunities
WORKSHOP: Getting your submission
Raj Khandwalla, MD, MA, FACC, Director of
Discussing
the
benefits
of
transforming
approved in under 1 hour
Cardiovascular Education Cedars Sinai
your
global
validation
paper
processes
to
Now that you are even more familiar with the
Medical Foundation, Cedars-Sinai Medical
electronic
various submission processes, you will be given
Group and Cedars-Sinai Heart Institute
Exploring the best electronic validation
group projects to get your teeth into. 3 real life case
William B. Armstrong, M.D, Professor of
systems available
studies that didn’t gain approval first time round –
Clinical Otolaryngology-HNS, Chair, Dept.
Is there still a language barrier?
what lessons can you learn from these previous
Otolaryngology-HNS, UNIVERSITY OF
Regina Rohe, Senior Director, Global
errors?
CALIFORNIA
Validation, bioMerieux
Elaine H Tseng, Partner, King & Spalding
1:45 – 2:30
2:00 – 2:30
Prioritizing Human Factor considerations in ROUNDTABLE DISCUSSION: Process
design control
Validation Question Time
Best practices in building Human Factors Now to get all your questions answered!
into your design control program
This expert panel of speakers will talk through
Identifying the vital role that human
some real life case studies and discuss how
factors plays in designing a safe and
successful process validation procedures and
effective device
techniques will keep you on track with FDA’s
What is the FDA looking for?
Quality System Regulation and the Process
Exploring Human Factors Engineering
Validation Guidance.
processes related to Design Control in 21 Robert Launsby, President,
CFR 820
Launsby Consulting
Dennis Rubenacker, Senior Partner,
Thomas Oesterle, President,
NOBLITT & RUELAND
MedHouse Innovations
Vincent DeFrank, Software Validation Manager,
Philips Healthcare
Regina Rohe, Senior Director, Global
Validation, bioMerieux
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2:45PM
–
4:00PM
4:00PM
–
4:15PM
Practical Applications of Design Control
Complying with Biocompatibility Testing
Standards and Guidance to get your Product
to Market Faster
UDI: What’s in store for 2015 and beyond?
Design control tune-up check
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.
Evaluating different methods of managing
the design control process
Focusing on design controls related to
risk management
Understanding the benefits of early
implementation and creating innovative
test plans
Avoiding a slowdown in development and
increase in costs
Updates on where the FDA is commonly
finding noncompliance issues
Making sure your regulatory processes fit
hand in hand with your design control
procedures
David Amor, Managing Partner,
MEDgineering
Biocompatibility testing: All you need to
know in 75 mins!
This intensive end of day workshop will give you
the latest information on how to comply with the
new standards. Go back to your office
invigorated and up to speed with everything you
need to know about biocompatibility testing.
Insightful guide to the newest FDA
guidance document on biocompatibility
What are the main challenges of ISO
10993-1 and how can they be overcome?
Exploring FDA expectations for
biocompatibility testing
Determining which biocompatible tests are
best for your products and devices
Improving your risk management strategies
for testing
Edward Reverdy, Ph.D., Director of Global
Toxicology & Biocompatibility, Boston
Scientific
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.
Exploring how class II medical device
companies can get ready for the deadline
Comparing other company UDI methodologies
to improve and re-engineer your 2015
implementation
Update on international UDI guidance
Detailing what additional software and data
management requirements will be needed for
successful UDI implementation
Discussing real case studies where UDI
implementation has resulted in better quality
and lower costs
Dawn Fowler, Senior Manager,
Labeling/Documentation/Training, Endologix
Thor Rollins, Biocompatibility Specialist,
Nelson Laboratories
To celebrate the end of a successful MD&M West Conference, we are giving away a free 3D printer. It’s well worth the wait!
Please feel free to pass on to your colleagues who wish to register! http://mdmwest.mddionline.com/conferencesseminars