THE MEDICAL DEVICE CONFERENCE May 4 – 6, 2015 | Hilton San Diego Mission Valley The 3rd Annual Meeting for the World’s Largest Medical Device Community THE 10x MEDICAL DEVICE CONFERENCE Hello! Hi, I’m Joe Hage, the leader of the 270,000-member Medical Devices Group, the world’s largest medical device community. Leading the group is a joy — never more than when we unite for our annual meeting, the 10x Medical Device Conference. Now in its 3rd year, 10x covers timely subjects affecting the entire medical device industry — not just your piece of it — and introduces you to people with the complementary skills you need to grow your business. For many, the conference is about new ideas. For others, it’s about new business. Who Should Attend? Our guests tend to be medical device company CEOs, presidents, vice presidents, directors, and senior managers, as well as business development executives from medical device consultancies. Email me at [email protected] for our confirmed guest list. YES Join us if you want to: • Discuss a range of timely subjects • Meet people outside your discipline • Make significant, lasting connections • Help others Ours is an intimate event (I limit participation to 200 guests) so I can help each guest connect with the vast resources of our group. Alumni credit the event for new jobs, answers to their toughest questions — even new clients! • Focus narrowly on your area Join us: I’ll personally make it worth your while. • Meet people who do the same things you do • Hand out a lot of business cards • Collect “leads” so you can “justify your ROI” Joe Hage This year, we’ll host the event in beautiful San Diego at the newly renovated Hilton San Diego Mission Valley. Come early and treat yourself to a weekend vacation before the event! Ask for the 10x guest rate of only $139 per night and enjoy free Internet access (normally $9.95) and $5 daily parking (normally $19). Call 800682-6099 to reserve your room. NO Stay home if you want to: Register now: MedicalDeviceEvents.com 38 SCHEDULED SPEAKERS – Including – Rhonda Rhyne Rick Baron CEO, Prevencio 10x KEYNOTE SPEAKER and Author, Keys to the Corner Office CFO, Zynerba Under Rick’s leadership, Globus was 1 of only 4 medtech IPOs in 2012 Tom Ryan Sanjeev Saxena Maurizio Vecchione Suzanne B. Schwartz SVP, Global Good Oversees IV collaboration with Bill Gates to help developing countries Director, CDRH (FDA) Emergency preparedness, operations and medical countermeasures Allison Komiyama Raymond McCauley CEO, AAHomecare President and CEO of American Association for Homecare CEO, POC Medical POC makes a diagnostic for early breast cancer detection AcKnowledge Regulatory Former FDA reviewer, expert in submissions, quality, biocompatibility Jeff Kraws Jim Pearson Michael Ullmann CEO, Crystal Research Top stock analyst, TopHat Capital co-founder, Synthetic Biologics chairman VP, McKesson Field VP, National Accounts for McKesson’s alternate site (homecare) market Chief Medical Expert Robert Bosch GmbH medtech strategy, biz dev; cardiac / general surgeon Exponential Biosciences Nanotech, genomics, and bioinformatics Mike Sperduti Principal, Emerge Sales Sales generation programs for complex medical device sales Day 1 1 8:30 AM Questions? +1 425 415 6171 K E Y N O T E P R E S E N TAT I O N 2 Registration 3 9:00 AM May 4, 2015 4 Contemporary Marketing and Sales Strategies that Work Today 5:30 PM With this informal and highly interactive presentation, Joe will discuss: 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: The three most important aspects of your online marketing strategy The promotion that moved $150,000 in incremental sales through distribution How she led two start-up life sciences companies to rapid growth, with up to 347% CAGR and 80% gross margins Whether social media makes sense for your company How, as president of a publicly traded And Mike will cover: medical device company, she sold the company at a 69% premium Setting a winning strategy for new product launches and implementing contracts How she commercialized more than 15 medical products How to turn around under-performing products/ services and territories How you can use some of her Success Strategies to bolster your career and improve the prospects for your medical device company Why inside sales is your single most important sales initiative How to build a solid pipeline of opportunities How to generate qualified appointments with high-level executives, clinicians, and related How to accelerate your sales cycle and close more sales 5 1:00 PM W E LCO M E R E C E P T I O N 6 7 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. Are you current with all the procedures? In this engaging workshop, we 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. 6:30 PM 2-Hour Reception and Showcase 2-hour reception and networking with guests from around the world Two drink tickets, light food included MANUFACTURERS SHOWC ASE Innovative device makers will show their products (see inside back page if you want to demo) and guests will cast votes. The winner gets to present on stage on Day 3. Day 2 May 5, 2015 7:15 AM Breakfast 8:15 AM Conference Opens Register now: MedicalDeviceEvents.com 12:25 PM Lunch SPONSORED BY 14 1:55 PM 8 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. Fast Round: 62304 and Medical Software Today’s most important trends for medical device software and the impact of 62304 guidance on US companies. 15 2:10 PM 5 9:20 AM 9:35AM Fast Round: Quality and Regulatory Global Market Access — A Pathway to Profitability Our expert panel will discuss how to find success outside your home market. Today’s most important quality and regulatory trends for medical device companies. 3:00PM Break Ice Cream (Very Important!) 17 9:55 AM 9 Global Good: Devices for the Poorest 4:00 PM 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 10:45 AM Fast Round: Design Engineering 4:50 PM How to Sell Your Medical Device in This Environment: Marketing Break 18 5:10 PM 19 20 TBD 21 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. 11 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 6:00 PM 13 4 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. Today’s most important design engineering and development trends for medical device companies. 12 16 Dinner (On Your Own) 7 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. 1: Meghan Alonso, Foundry Medical Innovations; 2: Karen Anderson, 10x; 3: Joe Hage, 10x; 4: Mike Sperduti, Emerge Sales; 5: Rob Packard, Medical Device Academy; 6: Leo Eisner, Eisner Safety Consultants; 7: Allison Komiyama, PhD, AcKnowledge Regulatory; 8: Suzanne B. Schwartz, FDA; 9: Maurizio Vecchione, Global Good; 10: Tom KraMer, Kablooe; 11: Seth Goldenberg, NAMSA; 12: Sanjeev Saxena, POC Medical; 13: Gunter Wessels, TIGI; 14: Nancy Knettell, The 62304 Experts; 15: Arthur Brandwood, Brandwood Biomed; 16: Dr. Peter Havel, TÜV SÜD America; 17: Anthony Chang MD, Pediatric Surgeon; 18: Dave Sheppard, Ontogenesis; 19: Eric Knudsen, ZOLL Medical; 20: Jim Pearson, McKesson; 21: TBD Day 3 May 6, 2015 7:15 AM Breakfast 8:15 AM Conference Resumes 22 8:30 AM 23 28 24 30 31 A panel with the topic on most attendees’ minds: How can we access the funds we need for the next phase in our growth? 25 How Escalating Costs are Giving Rise to Home Care and Telemedicine Break 12:15 AM Lunch 1:30 PM 26 9:45 AM 29 11:35 AM Panel: How to Secure Funding in Today’s Marketplace Medtrade Director Kevin Gaffney moderates a panel of experts to discuss how the DME industry will benefit from escalating healthcare costs. 9:30 AM Questions? +1 425 415 6171 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. Fast Round: Intellectual Property Today’s most important intellectual property and patent trends for medical device companies. 27 2:20 PM 10:05 AM Fast Round: Health Economics and Reimbursement Today’s most important health economics and reimbursement trends for medical device companies. 2:40 PM 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! 32 Individualized Medicine, Wearables, DNA, and What Apple and Google Bring to the Party Break 33 34 35 36 37 38 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? 10:40 AM Break 28 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. 22: Kevin Gaffney, Medtrade; 23: Jeremy Malecha, ResMed; 24: Mitchell Yoel, Drive Medical; 25: Jay Vreeland, Philips Respironics; 26: Doug Limbach, Shay Glenn; 27: Beth Brooks, Decision Drivers; 28: Rick Baron, Zynerba; 29: Amy Butler, OU INC; 30: Sean Schantzen, Healthfundr; 31: Jeff Kraws, Crystal Research; 32: Raymond McCauley, Exponential Biosciences; 34: Jay Kamath, Caliber Assurance Services (India); 34: Virpi Muhonen, Hospital District of Helsinki (Finland); 35: Dr. Edward Lin, HealO Medical (China); 36: Tetyana Ganicheva, Institute of Ozone Therapyl (Ukraine); 37: Michael Ullmann MD, Robert Bosch GmbH (Germany) THE 10x MEDICAL DEVICE CONFERENCE Online MedicalDeviceEvents.com Email [email protected] Phone +1 425 415 6171 Pricing Substitutions See MedicalDeviceEvents.com for current pricing. • We’ll make every effort to deliver the scheduled speakers and agenda. These may change without notice as life happens. Monday Workshops: $325 each Monday Keynote + Reception: • We’ll accommodate any dietary restrictions you have. Contact us in advance. $95 Tuesday + Wednesday Conference: $1,095-$1,995 Cancellation/Refund Policy We’ll give you a full refund if you cancel by February 28, 2015. No transaction fees — just 100 percent of your money back. It’s risk free! Tuesday Only: $795-$1,195 Cancellations between March 1 and April 16, 2015 will be refunded 50 percent of your registration fee. Or transfer your registration to another individual at no charge to either of you. Wednesday Only: $695-$1,095 Manufacturers Showcase (as Presenter): $200 Manufacturers Invited: Demo at the Showcase Do you have something to demo? Start a conversation with guests when you display your product at our reception. Each guest can “vote” for the best medical device. The winner gets to present on stage on Day 3 and gets a professionally edited video of the session. Cancellations after April 16 will not be eligible for refund. You may transfer your registration to another individual at no charge to either of you. Alternatively, you can ask for your registration to be applied to our 2016 event. The conference organizers cannot be responsible for any travel cancellation fees you may incur associated with this event. Discounts Discounts are available for groups of 3+ and a few seats are reserved for students and the unemployed. Email us for details. Sponsors Want to join as one of our conference sponsors? You’ll be featured on the website, at the conference, and in a Medical Devices Group announcement. Contact us to learn about 10x sponsorship levels and opportunities. MedicalDeviceEvents.com +1 425 415 6171
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