| Tuesday, May 13th | |
| 7:45-8:50 a.m. | Breakfast & Networking Reception |
| 8:50-9:00 a.m. | OPENING REMARKS
Don Gerhardt President & CEO LifeScience Alley™ |
| 9:00-9:30 a.m. | State of the Public & Private Medical Device Markets
Jay Hare
Partner PricewaterhouseCoopers
Phil Nalbone
Managing Director of Equity Research RBC Capital Markets |
| 9:30-10:30 a.m. | The Lightning Round—Good Bad or Otherwise
The moderator will ask a variety of candid questions surrounding the current investing landscape and issues relevant to portfolio management.
Moderator:
Bill Harrington Partner Three Arch Partners
Panelists:
Mark J. Brooks Managing Director Scale Venture Partners B. Kristine Johnson President & Managing General Partner Affinity Ventures
Richard Ferrari
Co-Founder De Novo Ventures
Gordie Nye
General Partner Prism VentureWorks |
| 10:30-11:00 a.m. | Networking & Refreshment Break |
| 11:00-11:45 a.m. | Creating Innovative Device Companies
Funding a start up venture company is hard work. Learn what it takes to attract venture money and explore the key drivers that develop value between rounds of financing.
Moderator:
Shelly Wall Lanning Managing Director HealthCor Partners
Panelists:
Mike Berman Medical Device Venture Catalyst Berman Medical John Seaberg CEO NeoChord
John Deedrick
Co-Founder & Managing Director Accuitive Medical Ventures
John Sullivan
Associate Foundation Medical Partners
Jerome Edwards
CEO and Founder Veran Medical Technologies |
| 11:45-12:30 p.m. | Successful Growth Equity Investment Strategies: Building Exciting Medical Device Platform Companies
Moderator:
Steve Shapiro Technology Partner Galen Associates & Advanced Technology Ventures
Panelists:
Gerald Mattys CEO Tactile Systems Technology, Inc. Mark Wagner President & CEO Orasi Medical
Trevor Moody
General Partner Frazier Partners
Zubeen Shroff
Managing Director Galen Partners |
| 12:30-1:45 p.m. | Luncheon Hosted By: RBC Capital Markets |
| 1:45-2:30 p.m. | Dancing with the Devil
In this session, we will talk with 3 CEO’s of device companies to discuss the upside/downside of taking funding from strategic investors.
Moderator:
Kevin Wasserstein Managing Director Versant Ventures
Panelists:
James Bullock President & CEO Atritech, Inc. Sami Hamadé Partner Aberdare Ventures
Glen French
Co-Founder & Director Asthmatx, Inc. |
| 2:30-3:15 p.m. | Corporate Buyers: What’s on their shopping lists?
This session is an in-depth conversation with several decision makers at various public device companies that recently have been active participants on the M&A front. The discussion will explore questions such as:
Moderator:
Josh Baltzell Managing Director Split Rock Partners
Panelists:
Chad Cornell Director, Corporate Development Medtronic, Inc. Jack J. Kelley III, Ph.D. Director of Advanced Concept Development BD Medical Surgical Systems
Ted Davis
Vice President, Business Development Wright Medical Technology, Inc. |
| 3:15-3:45 p.m. | Networking & Refreshment Break |
| 3:45-4:45 p.m. | The Winners Circle
This session will highlight some of the prominent M&A and IPO transactions in the device space over the past year. What made these deals significant and how did they come together?
Moderator:
Michael Stroup Director, Healthcare Investment Banking – Medical Technology Group RBC Capital Markets
Award Recipients:
Ross Jaffe Managing Director Versant Ventures Accepting on behalf of Insulet Rick Randall President & CEO TranS1
David Shaw
SVP Business Development and General Counsel – Hansen Medical Former Vice President Legal Affairs, General Counsel & Secretary – Kyphon |
| 4:45-6:00 p.m. | Cocktail Reception Hosted By: Oppenheimer |
| Wednesday, May 14th | |
| 8:00-9:00 a.m. | Breakfast & Networking Reception |
| 9:00-9:45 a.m. | Doing Well by Doing Good:
What impact does the human need for therapeutics have on those funding and building better device companies?
This panel will discuss how being aware of human stories can help motivate employees, inform our thinking on clinical trials and give us more targeted marketing ideas.
Moderator:
Curt LaBelle, M.D. Vice President Investor Growth Capital, Inc.
Panelists:
Jon Snyder Venture Partner Arboretum Ventures Brad Lehrman Partner--Venture Attorney Lommen, Abdo, Cole, King & Stageberg General Partner - Portage Equity Investments II, LP |
| 9:45-10:45 a.m. | Case Studies: Persevering Through Adversity
This session will highlight war stories on successful turnarounds from venture-backed companies that experienced major challenges but came out on top.
Moderator:
Mike Kolar Co-Chair Medical Technology Industry Group Oppenheimer Wolff & Donnelly LLP
Panelists:
John J. Booth Chief Executive Officer Spineology Kevin L. Nickels President and CEO Celleration |
| 10:45-11:15 a.m. | Networking & Reception Break |
| 11:15-12:00 p.m. | FDA Fireside Chat
This session will cover questions and concerns the venture-backed companies have in interfacing with the FDA. Increasingly, the empirical observations of those small companies regulated by the FDA is that the delays with FDA approval of IDE's and product approvals/clearances is growing. The Agency's need for more clinical data is swelling. The attention to "Least Burdensome" principles is waning and FDA's willingness to compromise and seek solutions is diminishing. Is this due to the political and public pressure of recent high-profile, large company recalls involving quality and reporting issues as well as marketing-related prosecutions? Is Congress' oversight of the industry skewing FDA decision-making? Are user fees giving the Agency the staffing it needs? How can industry help the Agency get properly funded through appropriations? We will explore what avenues a company can explore within the Agency to appeal adverse Agency decisions.
Interviewer:
Mark DuVal President DuVal & Associates, P.A.
Guest Speaker:
Ashley Boam Acting Deputy Director for Science & Review Policy Office of Device Evaluation, FDA |
| 12:00-1:30 p.m. | Luncheon Hosted By: PriceWaterhouseCoopers |
| Keynote: A Look at the Future: Life as a Medical Device Company in 2020
What will the world be like for medical device companies in 2020? Vastly different than it is today, although one can see inklings of that future are apparent in today's emerging megatrends. Companies looking to succeed in this new market – only 12 years away – will want to begin planning development portfolios and strategies now to be prepared for the change.
Peter J. Claude
Partner, Life Sciences Advisory Services PricewaterhouseCoopers |
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| 1:30-5.00 p.m. | Reimbursement 2.0 Masterclass: Pricing Your Product |
| 1:30-2.30 p.m. | Integrating strategies
The key to a successful launch of a Medical Device: Integration of the reimbursement, regulatory and clinical strategies.
Barb Peterson
Founder & President Emerson Consultants, Inc. |
| 2:30-3.30 p.m. | Creating the Financial Model:
What price point will the market bear?
More often than not, companies will invest in technologies prior to knowing the current economic landscape of the procedure to the key stakeholder customers. By creating a financial analysis, companies can obtain critical intelligence including the cost to perform the procedure, with and without the technology, average payment of the procedure, and the delta of the two to determine if the technology creates a positive or negative situation for the key stakeholder. In addition, this type of analysis will reveal if price points are too low. Topics to be discussed in this session include:
Kelli Hallas
Vice President, Reimbursement Services Emerson Consultants, Inc.
Mary McGrory-Usset
Founder The Mendota Company |
| 3:30-4.00 p.m. | Networking Break |
| 4:00-5.00 p.m. | The “pass-through payment”: Navigating the CMS maze to determine if your technology is eligible.
CMS has implemented several programs in which new medical technologies, devices, drugs, biologics, and pharmaceuticals can receive additional payment. The criteria threshold and the related application process can be confusing. Topics to be discussed in this session include:
Barb Peterson
Founder & President Emerson Consultants, Inc
Kelli Hallas
Vice President, Reimbursement Services Emerson Consultants, Inc. |
| 5.00 p.m. | Program Adjourns |