Program

 

 

 

Tuesday, March 13, 2012

 

Time

Event

2:00 pm

Innovation in a Regulated Industry featuring William Maisel, MD 

3:45 pm

Education Panel – Challenges with Intellectual Property

 

Company Presentations

5:00 pm 

Educational Panel – Critical Issues in MedTech 1

 

Company Presentations

6:00 pm 

Cocktail Party

 

Wednesday, March 14, 2012


 

Time 

Event

9:00 am   

Investor Panel

10:30 am 

Educational Panel - Critical Issues in MedTech 2

 

Company Presentations

11:45 am

Business Development Panel

1:00 pm

Lunch

2:00 pm

Educational Panel – Challenges in Financing a Device Company

 

Company Presentations

3:00 pm

CEO Roundtable

                                                  

Program Description

 

This year the SEMDA conference is going to provide a case study of a medical device company through four panel discussions that cover a wide range of relevant topics including financing, intellectual property, product design, talent recruitment and clinical/regulatory issues.

 

Taken together, the panel sessions will tell the story of Expansion Medical, Inc., a southeastern company developing an innovating implantable stent and proprietary imaging system.  Although this is not a real entity, the stories and examples that will be talked about are all based on actual events and issues facing medical device companies of all sizes and stages.

 

Challenges with Intellectually Property

 

Description:

Like most companies, Expansion Medical, has dealt with a number of issues as they seek to protect their intellectual property, clearly one of their most valuable assets.  This session features Expansion’s world-class patent & trademark attorneys as they relay the company’s experience filing their patents, defending their trademarks, licensing their inventions and responding to litigation threats.  

 

Panel:

David Risley, Partner, Thomas, Kayden, Horstemeyer & Risley, LLP (moderator)

Kean DeCarlo, Partner, Ballard Spahr

Gregory Carlin, Principle, MeKeon Meunier

John Harbin, Partner, King & Spalding

William Warren, Partner, Sutherland

 

Critical Issues in MedTech 1

 

Description:

At the earliest stages of a company’s growth cycle, there are essential activities that must be performed and many important decision that need to be made. This panel is composed of a diverse group of experts who helped the company navigate through their initial milestones including hiring a talented management team, developing their product designs, defining their market potential and release strategy and ensuring that they are carefully protected from product liability concerns.

 

Panel:

Art Spalding, Founder, TAMM Net, Inc. (moderator)

Drue De Angelis, President, The De Angelis Group

Z. Ileana Martinez, Partner, Thompson Hines, LLP

Steve Meister, President, Big Bang

 

Critical Issues in MedTech 2

 

Description:

Maybe the most significant challenges to a growing medical device company involve those in the clinical and regulatory arena. As this panel will demonstrate, Expansion Medical successfully leveraged the talent and expertise of a group of highly regarded device specialists as they dealt with changes in the regulatory environment, the practicalities of pre-clinical testing and the design and execution of a meaningful clinical trial.

 

Panel:

Linda Braddon, Ph.D., President, Secure BioMed Evaluations (moderator)

Bob Burek, Global Medical Device Technical Manager, SGS North America, Inc.

Jane Green, President, Morley Research Consortium

Rod Lashley, Ph.D., Executive Vice President, STATKING Consulting, Inc.

Alan Minsk, Partner, Arnall Golden Gregory, LLP

 

Challenges with Financing

 

Description:

There may be no greater obstacle faced by a medical device start-up than finding adequate sources of capital. As they progressed through their lifecycle, Expansion Medical was fortunate to have the advice and counsel of an outstanding group of financial professionals who helped them pursue a variety of standard and alternative sources of money.

 

Panel:

Sheldon Kraft, President & Publisher, Micro-Cap Review (moderator)

Ross DeDeyn, Director, Duncan-Williams, Inc.

Kurt Huntzinger, CPA, Partner, Habif, Arogeti & Wynne, LLP

Rik Vandevenne, Partner, River Cities Capital

 

 

  

   

 Speakers

 


Confirmed speakers include:

 

C. David Adair, M.D. , Chairman, Chief Science Officer, and Founder, Glenveigh Medical, LLC 

Skip Baldino, President & CEO, Given Imaging

Bob Burek, Global Medical Device Technical Manager, SGS North America, Inc.

Gregory Carlin, Principal, MeKeon Meunier

Chris Cashman, President & CEO, Sanuwave

Kean DeCarlo, Partner, Ballard Spahr

Michael P. Chuisano, Vice President, Venture Investor, Johnson & Johnson Development Corporation

Bob Crutchfield, Partner, Harbert Venture Partners

Greg Davis, Founder & CEO, The MedCelerate Consulting Group

Drue De Angelis, President, The De Angelis Group

Ross DeDeyn, Director, Duncan-Williams, Inc.

Troy Drewry, President & COO, MB Innovations

Paul Fitzpatrick, CEO, Advanced Catheter Therapies, Inc. SEMDA Conference Chair

Thomas Fleetwood, President & CEO, Crosslink Ortho

Greg Fredde, Vice President, Government Affairs & Business Development, Merit Medical Systems, Inc.

Paul Gianneschi, Managing Principal and Founder, Hatch Medical, LLC

Jerry Gibson, Serial Entrepreneur, Board Member, DataPhysics Research 

Jane Green, President, Morley Research Consortium

Ashley Hancock, Executive Director, SEMDA

John Harbin, Partner, King & Spalding

Charlie Harrison, VP, Commercial Operations, Medical Compression Systems, SEMDA President-Elect

David Hartnett, VP, Bioscience-Health IT, Economic Development, Metro Atlanta Chamber, SEMDA President

John F. Hurley, Senior Executive, DLA Venture Pipeline

Kurt Huntzinger, CPA, Partner, Habif, Arogeti & Wynne, LLP

Sheldon Kraft, President & Publisher, Micro-Cap Review

Rod Lashley, Executive Vice President, STATKING Consulting, Inc.

P. Kathleen Lovell, President & CEO, Power Devices Technology

William Maisel, MD, MPH, Chief Scientist and Deputy Director, CDRH, FDA

Steve Martin, President & CEO, QSpex

Z. Ileana Martinez, Partner, Thompson Hines, LLP

Steve Meister, President, Big Bang

Alan Minsk, Partner, Arnall Golden Gregory, LLP

Robert J. Morff, Partner, Hatteras Venture Partners

Richard E. Otto, CEO, REACH Health, Inc.

David Risley, Partner, Thomas, Kayden, Horstemeyer & Risley, LLP

Kathy Lee-Sepsick, President & CEO, Femasys

Arthur Spalding, Founder, TAMM Net, Inc.

Robin Theme, Sr. Vice President, Multi-Modality Imaging, CIVCO Medical Solutions

Rik Vandevenne, Partner, River Cities Capital

William Warren, Partner, Sutherland

John White, Sr. Director, Business Development, Wright Medical Technology

Jay Yadav, MD, President & CEO, CardioMEMS, Inc.