The Future of Wireless Medical Devices - FCC, FDA, and Patent Considerations

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

Speakers:

Keith A. Barritt, Principal, Fish & Richardson
Charles Gropper, Senior Vice President, Research and Development, CardioNet, Inc.
William E. Hunter, Principal, Fish & Richardson
Terry G. Mahn, Principal, Fish & Richardson