The Health Communications SIG Presents…
PANELISTS:
Bradley Merrill Thompson, MBA, JD
Mr. Thompson serves as counsel to Continua Health Alliance on FDA regulatory matters and loves to tackle business strategy questions. Mr. Thompson is a shareholder in the law firm of EpsteinBeckerGreen where he counsels medical device companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. For trade associations, Mr. Thompson has served as counsel to AdvaMed for payment issues and as General Counsel to the Combination Products Coalition. He has taught at Indiana University School of Law and Columbia Law School , and serves on the editorial boards for Regulatory Affairs (1991-1995), Medical Device & Diagnostic Industry (1993-present), the Food & Drug Law Journal (2007 – present) and BNA’s Medical Device Law & Industry Report (2007-present). Mr. Thompson also services as Co-Chair of the Food & Drug Law Committee of the Administrative Law Section of the American Bar Association, and as a member of the Medical Device Committee of FDLI. Mr. Thompson has authored a book entitled FDA's Regulation of Medical Devices (Interpharm Press, 1995), co-authored two chapters in a book entitled “Guide to Medicare Coverage Decision-making and Appeals” published by the American Bar Association (2002) and one chapter in “Off-Label Communications: A Guide to Sales and Marketing Compliance” published by FDLI (2008), and frequently publishes articles on such topics as FDA regulation of mobile phones and speaks at educational conferences, including those of Continua Health Alliance. Mr. Thompson was included in 100 Notable People in the Medical Device Industry (Medical Device & Diagnostics Industry, June 2004), has earned an AV rating in Martindale Hubble (its highest rating), has been named a “SuperLawyer” in Indiana , and has been elected as a Fellow in the American Bar Foundation.
Joel T. Schneider
EMC Senior Engineer, TUV SUD America Inc.
Joel T. Schneider is a senior engineer with TUV SUD America, Inc., working out of their Wild River Lab Open Area Test Site in Taylors Falls, MN. He has been with TUV SUD America for over 10 years. Joel worked in the Electromagnetic Compatibility (EMC) Department of Control Data from 1973-1984, which built the Wild River Lab in 1983. He stayed with the lab when it was sold to Amador Corporation in 1984, and again to TUV SUD America in 1989. Joel is a member of the National Association of Radio and Telecommunications Engineers (NARTE) as a certified electromagnetic compatibility technician with an accredited test laboratory endorsement, an associate member of the TCB Council, a technical certifier for TUV SUD America for EMC and R&TTE Directives, and a member of the Institute of Electrical and Electronics Engineers (IEEE).
Gunnar Trommer, Ph.D.
Vice President Global Marketing, Triage Wireless
Dr. Gunnar Trommer joined Triage Wireless in October 2008. Previously, he held management positions with Draeger Medical, a Draeger and Siemens company, including Vice President, Marketing/Product Management for Draeger’s global patient monitoring and information technology applications business. Prior to that, Dr. Trommer advised various high tech and medical device companies as a management consultant with The Boston Consulting Group. Dr. Trommer’s educational background is in engineering. He earned a Ph.D. with high honors at the renowned Technical University Aachen, Germany.
MODERATOR:
Noel C. Gillespie
Partner, Procopio
DATE:
October 29th, 2009
TIME:
7:30AM - Registration/Networking/Breakfast
8:00AM - Program Begins
9:30AM - Program Ends
LOCATION:
12531 High Bluff Drive Suite 100
San Diego CA 92130
COST:
Pre-Registration: (Please pre-register by noon on 10/28/09)
$10.00 - CommNexus Sponsor
$20.00 - Non-Sponsor
At the Door:
$20.00 - CommNexus Sponsor
$30.00 - Non-Sponsor
Students, Military & Press: FREE
Regulatory Issues for Wireless Health Companies:
How to Know What Regulations Apply, When They Apply, and What That Means For Product Development
Click Here to View Joel T. Schneider's Presentation
Click Here to View Gunnar Trommer's Presentation
In this event, the panel will explore various issues with FDA and FCC regulation and certification that arise with the convergence of health care and wireless technologies. The panel will explain the tripping point for when a device would require FDA authority, high level strategy for entering FDA space, examine places where challenges with FDA regulation exist, and provide insight into the successful completion of the process and some of the highs and lows involved. Also discussed will be issues raised by the incorporation of off the shelf radios into medical devices and how that can effect FCC certification.
Click Here to View Gunnar Trommer's Presentation
In this event, the panel will explore various issues with FDA and FCC regulation and certification that arise with the convergence of health care and wireless technologies. The panel will explain the tripping point for when a device would require FDA authority, high level strategy for entering FDA space, examine places where challenges with FDA regulation exist, and provide insight into the successful completion of the process and some of the highs and lows involved. Also discussed will be issues raised by the incorporation of off the shelf radios into medical devices and how that can effect FCC certification.
PANELISTS:
Bradley Merrill Thompson, MBA, JD
Mr. Thompson serves as counsel to Continua Health Alliance on FDA regulatory matters and loves to tackle business strategy questions. Mr. Thompson is a shareholder in the law firm of EpsteinBeckerGreen where he counsels medical device companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. For trade associations, Mr. Thompson has served as counsel to AdvaMed for payment issues and as General Counsel to the Combination Products Coalition. He has taught at Indiana University School of Law and Columbia Law School , and serves on the editorial boards for Regulatory Affairs (1991-1995), Medical Device & Diagnostic Industry (1993-present), the Food & Drug Law Journal (2007 – present) and BNA’s Medical Device Law & Industry Report (2007-present). Mr. Thompson also services as Co-Chair of the Food & Drug Law Committee of the Administrative Law Section of the American Bar Association, and as a member of the Medical Device Committee of FDLI. Mr. Thompson has authored a book entitled FDA's Regulation of Medical Devices (Interpharm Press, 1995), co-authored two chapters in a book entitled “Guide to Medicare Coverage Decision-making and Appeals” published by the American Bar Association (2002) and one chapter in “Off-Label Communications: A Guide to Sales and Marketing Compliance” published by FDLI (2008), and frequently publishes articles on such topics as FDA regulation of mobile phones and speaks at educational conferences, including those of Continua Health Alliance. Mr. Thompson was included in 100 Notable People in the Medical Device Industry (Medical Device & Diagnostics Industry, June 2004), has earned an AV rating in Martindale Hubble (its highest rating), has been named a “SuperLawyer” in Indiana , and has been elected as a Fellow in the American Bar Foundation.
Joel T. Schneider
EMC Senior Engineer, TUV SUD America Inc.
Joel T. Schneider is a senior engineer with TUV SUD America, Inc., working out of their Wild River Lab Open Area Test Site in Taylors Falls, MN. He has been with TUV SUD America for over 10 years. Joel worked in the Electromagnetic Compatibility (EMC) Department of Control Data from 1973-1984, which built the Wild River Lab in 1983. He stayed with the lab when it was sold to Amador Corporation in 1984, and again to TUV SUD America in 1989. Joel is a member of the National Association of Radio and Telecommunications Engineers (NARTE) as a certified electromagnetic compatibility technician with an accredited test laboratory endorsement, an associate member of the TCB Council, a technical certifier for TUV SUD America for EMC and R&TTE Directives, and a member of the Institute of Electrical and Electronics Engineers (IEEE).
Gunnar Trommer, Ph.D.
Vice President Global Marketing, Triage Wireless
Dr. Gunnar Trommer joined Triage Wireless in October 2008. Previously, he held management positions with Draeger Medical, a Draeger and Siemens company, including Vice President, Marketing/Product Management for Draeger’s global patient monitoring and information technology applications business. Prior to that, Dr. Trommer advised various high tech and medical device companies as a management consultant with The Boston Consulting Group. Dr. Trommer’s educational background is in engineering. He earned a Ph.D. with high honors at the renowned Technical University Aachen, Germany.
MODERATOR:
Noel C. Gillespie
Partner, Procopio
Noel Gillespie assists clients with strategic patent portfolios that protect their technology and help them achieve their business objectives. This process includes developing claim strategies that create market barriers and protect or create revenue streams, as well as preparing and prosecuting U.S. and foreign Patent Applications. Mr. Gillespie has extensive experience in dealing with telecommunications companies, including those involved with wireless, wired, and optical communications technology, medical device companies, semiconductor companies and software/Internet companies. In addition to his extensive legal experience, Mr. Gillespie has also served as Senior Design Engineer and Product Team leader for Sony Digital Telecommunications of America in San Diego, where he was responsible for the comprehensive baseband design for several CDMA handsets that used the latest Qualcomm Mobile Station Modem (MSM) chipsets. He received extensive training in CDMA and wireless communication technology and his design responsibilities fell under the areas of microprocessor circuits, audio circuits, power management circuits, and user interfaces such as keypads and LCDs. As product leader, Mr. Gillespie successfully managed a team of engineers in the completion of Sony’s Z100x single band handset. Prior to this, he was a Design Engineer and Product Team Leader at Cubic Defense Systems in San Diego, where he was responsible for the design and testing of several portable electronic systems. Mr. Gillespie successfully managed a team of engineers in the completion of Cubic’s Manworn Laser Detection System, which was part of the MILES 2000 product line. MILES 2000 is an optical communication system that is used to simulate battlefield conditions during military training exercises. Mr. Gillespie’s design responsibilities on the product included the areas of optical communications, ASICs, microprocessor circuits, user interfaces, and power management.
DATE:
October 29th, 2009
TIME:
7:30AM - Registration/Networking/Breakfast
8:00AM - Program Begins
9:30AM - Program Ends
LOCATION:
12531 High Bluff Drive Suite 100
San Diego CA 92130
COST:
Pre-Registration: (Please pre-register by noon on 10/28/09)
$10.00 - CommNexus Sponsor
$20.00 - Non-Sponsor
At the Door:
$20.00 - CommNexus Sponsor
$30.00 - Non-Sponsor
Students, Military & Press: FREE
Questions? Contact Bailey Cunning at bcunning@commnexus.org
Date:
Thursday, October 29, 20097:30AM-9:30AM
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Location:
12531 High Bluff Dr.San Diego , CA 92130
