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The Future of Wireless Medical Devices


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Thursday, January 26, 2012
Product Code - LGAU02
Speaker(s): Keith A. Barritt, Fish & Richardson P.C.; William E. Hunter, Fish & Richardson P.C.; Terry G. Mahn, Fish & Richardson P.C.
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Agenda

Bringing together wireless technology and software in the medical device arena can raise intricate patent and regulatory legal issues. Our panel of experts will discuss how companies can meet the requirements of the FCC and FDA as well as the pitfalls that can occur when filing patent applications for novel wireless medical devices.

Key topics discussed will be FCC regulation of licensed and unlicensed wireless medical devices; current and proposed rules for wireless medical device use in the U.S. and internationally; the FDA’s key concerns regarding wireless technologies; software as a regulated medical device; provisional patent applications with the USPTO; methods of treatment or diagnosis; and joint research and development for wireless medical technologies.

Program Highlights:

Attendees will gain a better understanding of the following:

• FCC regulation of licensed and unlicensed wireless medical devices
• FDA’s key concerns regarding wireless technologies
• Provisional patent applications with the USPTO
• Joint research and development for wireless medical technologies

Who would benefit from attending this program?

• C-level
• In-house counsel, legal counsel
• Regulatory and government affairs
• Engineering, R&D (VP-level and above)
• Industries – medical device, software, healthcare software, health IT

Speakers

Keith A. Barritt, Fish & Richardson P.C.; William E. Hunter, Fish & Richardson P.C.; Terry G. Mahn, Fish & Richardson P.C.

Keith A. Barritt, Principal / Fish & Richardson P.C.
Keith A. Barritt is a Principal in the Washington, D.C. office of Fish & Richardson P.C. His practice is focused on all aspects of medical device regulation by the U.S. Food and Drug Administration, including obtaining marketing authorization for medical devices, use of new devices for investigational purposes, and import and export issues. Mr. Barritt has prepared and filed 510(k) pre-market notifications with the FDA for various types of medical devices, resulting in the clearance of the devices for marketing. He has also advised clients on issues involving quality system regulations, device labeling, medical device reporting obligations, recalls, device listing, establishment registration, and import/export regulations.

Mr. Barritt earned a J.D. from the University of Virginia and a B.A., cum laude, from the University of Virginia.

William E. Hunter, Principal / Fish & Richardson P.C.
Bill Hunter is a Principal in the Southern California office of Fish & Richardson P.C. His practice emphasizes patent prosecution and counseling, patent strategy and analysis, development and management of patent portfolios, patent opinions, and due diligence investigations in connection with investments, mergers and acquisitions. Mr. Hunter has significant experience in advising individuals, start-up companies, universities and research institutes, and technology and manufacturing companies, particularly assisting clients with issues involving devices and software in medical diagnosis and treatment.

Mr. Hunter earned a J.D., cum laude, from the University of California, Hastings College of the Law, and a B.S. from the University of California, San Diego.

Terry G. Mahn, Principal / Fish & Richardson P.C.
Terry G. Mahn is Managing Principal of Fish & Richardson’s Washington, D.C. office, and the Regulatory and Government Affairs Practice Group Leader. His practice is primarily before the FCC and FDA with emphasis on complex product authorizations. Mr. Mahn's FCC practice includes all facets of spectrum allocation, wireless technology and licensing, and equipment approvals. He actively participates in domestic and international product standards development, harmonization, and compliance in the areas of radio communications, EMC, electrical, medical, and RF safety. His FDA specialty involves pharmaceutical and medical device approvals with special emphasis on drug exclusivities and patent protection under Hatch-Waxman.

Mr. Mahn earned a J.D. from Catholic University of America, Columbus School of Law, and a B.S. from the University of Michigan.