Highlights From 7th Medical Science Liaison/MSL Conference
10x-Program-2015
1. The 3rd Annual Meeting for the
World’s Largest Medical Device Community
M e d i cal D e v i c e
C o n f e r e n c e
The
May 4– 6, 2015 | Hilton San Diego Mission Valley
2. A message from Medical Devices
Group LeaderJoe Hage
Leading the world’s largest medical device community is a joy – never
more so than when we unite for our annual meeting, The 10x Medical
Device Conference.
First and foremost, welcome. I’m honored to see you, especially my 10x
alumni and those who travelled great distances to join us today.
Recently a friend asked, “What is your most important takeaway from a
good conference?” I answered without hesitation, “The people I meet.”
If that’s true for you too, you’re in luck.
Over these next days, you’ll engage some extraordinary people. You’ll
hear speakers from around the world and meet dozens more local
medical device professionals during our opening reception.
We’ll learn, have ice cream, and leave richer than we came: With new
perspectives, new inspiration, and new connections to realize new
opportunities.
Enjoy the event. Please let me know other ways the Medical Devices
Group can serve our community, and your business in particular.
Joe Hage
Medical Devices Group Leader
P.S. Let the world know your thoughts about 10x on our LinkedIn group
at http://medgroup.biz/how-was-10x.
P.P.S. Our fourth annual 10x event will be May 2-4, 2016 in San Diego.
hashtag #10x
THE 10x medical device conference
3. TÜV SÜD
+1 800 888 0123 info@tuvam.com www.tuv-sud.com/medicaldevice
Choose certainty.
Add value.
Ensure quality at
the heart of your
operations
Benefit from unrivalled knowledge in
the assessment of clinical evaluations,
testing, quality management
certification and market access.
Contact us now to discuss your needs
Rhonda Rhyne
CEO,Prevencio
10x KEYNOTE SPEAKER
and Author,
Keys to the Corner Office
Rhonda Rhyne has more than 20 years’ experience in executive
management and board leadership of private and public medical
technology companies. She specializes in commercializing innovative
medical technologies and is recognized as an industry leader.
Currently, Rhonda is President, CEO, and Director for Prevencio, a novel
proteomics cardiac biomarker company, and serves as Director for
OtoNexus Medical Technologies and The LaJolla Institute. You can find her
leadership book, “Keys to the Corner Office: Success Strategies for Women
by Women,” on Amazon.com.
4. Doug Limbach
Shay Glenn
Builds strategic patent
portfolios for meddev;
early-stage companies
Tim Kringel
Health Market Science
Expert in providing medical
claims and healthcare
provider data
Dr.Peter Havel
TÜV SÜD America
Global Senior Vice President for
Medical Device Certification
Anthony Chang MD
Pediatric Surgeon
Medical Director for Heart
Institute,and Medical Intel and
Innovation Institute
Allison Fulton
SidleyAustin
FDA compliance,enforcement,and
good manufacturing practices
Nancy Knettell
The 62304 Experts
Specialist in 62304 medical
device software submissions
Seth Johnson
Pride Mobility
VP of Government Affairs for this
homecare manufacturer
Rick Baron
Zynerba
Under Rick’s leadership,
Globus Medical was 1 of only 4
medtech IPOs in 2012
Jeff Kraws
Crystal Research
Top stock analyst,TopHat
Capital co-founder,
Synthetic Biologics chair
Jay Kamath
Caliber Assurance Services
India-based engineer; regulatory,
quality,development expertise
Kevin Gaffney
Medtrade
Runs largest home medical
equipment industry tradeshow
Mathew Farag
Romar Engineering
Engineering,manufacturing in
silicone,plastics and other
Matt Atwood,
ClinicalwoRx
Developing medical retail
and on-line sales channel
access to physicians
Leo Eisner
Eisner Safety Consultants
IEC 60601-1 expert,regulatory,
product safety,and compliance
Tom KraMer
Kablooe
Industrial and product design and
development for medical devices
Tetyana Ganicheva
Institute of Ozone Therapy
Pedagogical science PhD; director
for ozone therapy and equipment
Natalie Kennel
NJK & Associates
Expert in EU matters;
Canada,Australia,Europe,
Singapore submissions
Conference
Beth Brooks
Decision Drivers
Data analytics,health economics,
and outcomes research
THE 10x medical device conference
5. Robert Packard
QA/RA
CE marking,Canadian device
licensing,and 510(k) clearance
Gunter Wessels
TIGI
Dr.Wessels specializes in selling
through PPACA,ACO,
and related issues
Jim Pearson
McKesson
Field VP,National Accounts for
McKesson,focusing on homecare
Gemma Moore
Edwards Lifesciences
VP of International
RegulatoryAffairs
Tom Ryan
AAHomecare
President and CEO of American
Association for Homecare
Mitchell Yoel
Drive Medical
Expertise in business
development and
government affairs
Virpi Muhonen
Hospital District of Helsinki
Finnish senior researcher
on tissue engineering;
regenerative medicine
Dr.Edward Lin
HealO Medical
Physician-inventor of new
would therapy tech
Michael Ullmann MD
Robert Bosch GmbH
Chief Medical Expert;
biz dev; cardiac / general surgeon
Raymond McCauley
Exponential Biosciences
Nanotech,genomics,and
bioinformatics
Jeremy Malecha
ResMed
Healthcare informatics,EHR
integrations,respiratory care
Mike Sperduti
Emerge Sales
Sales generation programs for
complex medical device sales
Maurizio Vecchione
Global Good
Oversees IV collaboration
with Bill Gates to help
developing countries
Chris Mullin
NAMSA
Director of Regulatory and Quality
Services,NAMSA’s Clinical
and Consulting
Sanjeev Saxena
POC Medical
POC makes a diagnostic for early
breast cancer detection
Dave Sheppard
Ontogenesis
Global medical device channel
management and distribution
speakers
Sean Schantzen
Healthfundr
Healthfundr is a platform to
fund and support innovation
in healthcare
Suzanne B.Schwartz
FDA
Emergency Preparedness,
Operations and Medical
Countermeasures at FDA
6. 8:30 AM Registration
9:00 AM Contemporary Marketing and Sales
Strategies that Work Today
With this informal and highly interactive
presentation, Joe, Mike, and Tim will cover:
zzThe three most important aspects of your online
marketing strategy
zzThe promotion that moved $150,000 in
incremental sales through distribution
zzSetting a winning strategy for new product
launches and implementing contracts
zzWhy inside sales is your single most important
sales initiative
zzHow to generate qualified appointments with
high-level executives, clinicians, and related
zzMaster data management, physician data,
hospital and physician targeting
zzCompliance, analytics and data cleansing
zzHow to use medical claims data
1:00 PM How to Prepare a Medical Device 510(k)
Submission for the FDA
The secret to achieving regulatory approval
consistently is developing templates for technical
documentation that perfectly match the regulatory
requirements. The US FDA 510(k) process changed
tremendously in the past two years, and medical
device manufacturers need to update their
documents and procedures.
In this engaging workshop, Medical Devices Group
Advisory Board member Rob Packard, 60601
expert Leo Eisner, and former FDA reviewer Allison
Komiyama PhD will give you a new step-by-step
process for preparing a 510(k) submission. The
workshop will review recent guidance documents
released by the FDA and lessons learned from
recent submissions and interactions with FDA
reviewers.
5:30 PM Keynote Presentation
Rhonda Rhyne
Ms. Rhyne is a highly accomplished life
sciences executive and author of the book
Keys to the Corner Office: Success
Strategies for Women by Women.
Rhonda will discuss:
zzHow she led two start-up life sciences
companies to rapid growth, with up to
347% CAGR and 80% gross margins
zzHow, as president of a publicly traded
medical device company, she sold the
company at a 69% premium
zzHow she commercialized more than
15 medical products
zzHow you can use some of her Success
Strategies to bolster your career and
improve the prospects for your medical
device company
KEYNOTE PRESENTATION
W e l c o m e R e c e p t i o n
6:30 PM 2-Hour Reception and Showcase
Reception and networking with guests
from around the world
Manufacturers Showcase
Innovative device makers will show their
products and you’ll get to cast votes to
determine which manufacturer will present
on stage on Day 3.
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May 4,2015Day 1
1: Meghan Alonso, Foundry Medical Innovations; 2: Karen Anderson, 10x; 3: Joe Hage, 10x; 4: Mike Sperduti, Emerge Sales;
5: Timothy Kringel, Health Market Science; 6: Rob Packard, Medical Device Academy; 7: Leo Eisner, Eisner Safety Consultants;
8: Allison Komiyama, PhD, AcKnowledge Regulatory
8. 3
12:25 PM Lunch
1:55 PM Fast Round: 62304 and Medical Software
Today’s most important trends for medical device
software and the impact of 62304 guidance on US
companies.
2:10 PM Global Market Access — A Pathway to
Profitability
Our expert panel will discuss how to find success
outside your home market.
3:00 PM Ice Cream (Very Important!)
4:00 PM How to Sell Your Medical Device in This
Environment: Marketing
With group purchasing organizations, doctors as
employees, and information a Google search away,
our panel discusses the most effective ways to sell
your medical device in this environment.
4:50 PM Break
5:10 PM How to Sell Your Medical Device in This
Environment: Distribution
On this panel we’ll hear from manufacturers,
providers, and distributors how to get the most out
of your partnerships. We’ll discuss how to identify
and negotiate partnerships with geographically
disperse and strategically important partners
across cultural and corporate boundaries.
6:00 PM Dinner (On Your Own)
SPONSORED BY
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9: Suzanne B. Schwartz, FDA; 10: Maurizio Vecchione, Global Good; 11: Tom KraMer, Kablooe; 12: Chris Mullin, NAMSA;
13: Sanjeev Saxena, POC Medical; 14: Gunter Wessels, TIGI; 15: Natalie Kennel, NJK Associates; 16: Allison Fulton, Sidley Austin;
17: Nancy Knettell, The 62304 Experts; 18: Gemma Moore, Edwards Lifesciences; 19: Dr. Peter Havel, TÜV SÜD America;
20: Anthony Chang MD, Pediatric Surgeon, 21: Matt Atwood, ClinicalwoRx; 22: Dave Sheppard, Ontogenesis; 23: Jim Pearson, McKesson
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7:15 AM Breakfast
8:15 AM Conference Opens
8:30 AM FDA Presents: Medical Device Cybersecurity
FDA will cover device cybersecurity, a subject about
which the medical device community needs to
become much more vigilant.
9:20 AM Fast Round: Quality and Regulatory
Today’s most important quality and regulatory
trends for medical device companies.
9:35 AM Break
9:55 AM Global Good: Devices for the Poorest
How we can help Global Good, a joint venture with
Bill Gates and Intellectual Ventures, deliver medical
devices to the poorest in the world.
10:45 AM Fast Round: Design Engineering
Today’s most important design engineering and
development trends for medical device companies.
11:00 AM Fast Round: Clinical and Pre-Clinical
Today’s most important clinical and pre-clinical
trends for medical device companies.
11:15 AM Break
11:35 AM Industry Panel: Tax, ACOs, GPOs, FDA, EU
Ask our expert panel questions about topics
ranging from the device tax to accountable care
organizations, group purchasing organizations, and
working with FDA and the EU.
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May 5,2015Day 2
9. 7:15 AM Breakfast
8:15 AM Conference Resumes
8:30 AM How Escalating Costs are Giving Rise to
Home Care and Telemedicine
Medtrade Director Kevin Gaffney moderates a
panel of experts to discuss how the DME industry
will benefit from escalating healthcare costs.
9:30 AM Break
9:45 AM Fast Round: Intellectual Property
Today’s most important intellectual property and
patent trends for medical device companies.
10:05 AM Fast Round: Health Economics and
Reimbursement
Today’s most important health economics
and reimbursement trends for medical device
companies.
10:20 AM Our Most Innovative Manufacturer
The manufacturer with the most innovative
medical device at our showcase (as voted on by
attendees) will take the stage to present and
answer your questions!
10:40 AM Break
11:00 AM View from the CFO’s Office: Globus Medical
Rick is the immediate past CFO of Globus Medical
and, under his leadership, executed one of only four
medical device IPOs in all of 2012. Now the CFO
of Zynerba Pharmaceuticals, Rick will give us his
corner-office perspective on the industry.
11:35 AM Panel: How to Secure Funding in Today’s
Marketplace
A panel with the topic on most attendees’ minds:
How can we access the funds we need for the next
phase in our growth?
12:15 AM Lunch
1:30 PM Individualized Medicine, Wearables, DNA,
and What Apple and Google Bring to
the Party
One of the most frequent topics raised in our online
Medical Devices Group forum: The digitization of
healthcare and what it means to be a healthcare
company these days.
2:20 AM Break
2:40 PM International Voices: Sharing Ideas
Our international guests recap what they heard at
10x and share ideas we may have missed. Were the
conference themes universal? Which outside-the-
US issues should we be discussing?
3:30 PM Close and Real-Time Feedback
If you have time, stick around for 20 minutes and
give immediate, open feedback about the event:
What did you love? What can we improve for 2016?
24: Kevin Gaffney, Medtrade; 25: Jeremy Malecha, ResMed; 26: Mitchell Yoel, Drive Medical; 27: Tom Ryan, AAHomecare;
28: Seth Johnson, Pride Mobility; 29: Doug Limbach, Shay Glenn; 30: Beth Brooks, Decision Drivers; 31: Rick Baron, Zynerba;
32: Sean Schantzen, Healthfundr; 33: Jeff Kraws, Crystal Research; 34: Raymond McCauley, Exponential Biosciences;
35: Jay Kamath, Caliber Assurance Services (India); 36: Virpi Muhonen, Hospital District of Helsinki (Finland);
37: Dr. Edward Lin, HealO Medical (China); 38: Tetyana Ganicheva, Institute of Ozone Therapy (Ukraine);
39: Michael Ullmann MD, Robert Bosch GmbH (Germany); 40: Mathew Farag, Romar Engineering (Austrailia)
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May 6,2015Day 3
10. A medical device marketing and sales event like no other.
We’re hosting the event at the fantastic University of South
Florida Center for Advanced Medical Learning and Simulation
(CAMLS), a state-of-the art healthcare simulation and training
center in Downtown Tampa.
First, The CAMLS tour is reason enough to come. It will light your
mind to ways to reach your target audience.
Second, The lectures and workshops will take you inside
a physician’s office and the operating theater for real-life
simulations.
Third, The top-notch faculty with invited speakers from GE
Healthcare, Medtronic, Zimmer, and other names you’ll recognize
guarantees the insights will be relevant for you.
Fourth: The investor reception at USF (top 10 awarded patent
school in the U.S.) planned for the first day will introduce you
to investors and innovators with unlicensed medical device
technologies.
Keep your eye at MedicalDeviceMarketingSummit.com as we
make details available.
* Save 50 percent if you register during the 10x Conference.
The Medical Device Summit for Marketing, Sales, and
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