Available Until: October 24, 2012
Complimentary Webinar Sponsored by: Fish & Richardson
The digital age is changing the nature of health care delivery. We are witnessing explosive growth in medical devices that use wireless technologies, some implanted and some worn on the body, to control bodily functions and to measure an array of physiological parameters. As microprocessors become smaller and more powerful, wireless technologies may one day be able to monitor or control nearly every bodily function and movement. Accompanying the tremendous growth in wireless technology is the use of software to control these sophisticated devices – in addition to some not-so-sophisticated applications.
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. We will also hear from CardioNet, the world's leader in Mobile Cardiac Outpatient Telemetry (MCOT), regarding its experience bringing its wireless heart monitor to market.
Other topics for discussion:
- FCC regulation of licensed and unlicensed wireless medical devices
- Current and proposed rules for wireless medical device use in the U.S. and at the international level
- FDA’s key concerns regarding wireless technologies
- Software as a regulated medical device
- Provisional patent applications with the USPTO
Methods of treatment or diagnosis
- Joint research and development for wireless medical technologies
Keith A. Barritt, Principal, Fish & Richardson
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.
Charles Gropper, Senior Vice President, Research and Development, CardioNet, Inc.
Charles Gropper joined CardioNet in January 2008. Charles brings nearly 30 years of experience in the design and development of medical devices. Prior to CardioNet, Charles most recently served as Vice President, Engineering at HepaHope, Inc., working on the design of an artificial liver system from 2005 to 2008. Prior to his experience with HepaHope, Charles has held several senior engineering management positions with such companies as Cameron Health, Inc., Cardiac Science, Inc. Datascope Corp., and Bear Medical Systems. Charles received his undergraduate degree in Biomedical Engineering from Rensselaer Polytechnic Institute and an MBA from California State University, Fullerton.
William E. Hunter, Principal, Fish & Richardson
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.
Terry G. Mahn, Principal, Fish & Richardson
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.