Integra Systems, Inc., conducted a webcast on Thursday October 13, 2011 was sponsored by www.gersonlehrmangroup.com.
Over 70 attendees were on-line which consisted of a variety of medical device companies..many interesting questions came up. The abstract for this webcast was as follows: “The world of medical device connectivity through wireless and enterprise networking is nothing new today; but it simply has become the accepted requirement in 2011 and beyond. In light of this acceptance, the wireless and networking technology change process is driving forward in rapid stance. This almost daily technology “sea change” places demands on the medical device company to incorporate the right connectivity technology in their device, but also how to deploy those networked devices in the enterprise. This is important to not only ensure security and quality of service requirements, but also to be accepted as enterprise grade. The web based event that follows will focus on three main areas of knowledge transfer.”
a. What are the available wireless connectivity solutions in the marketplace available to the medical device company and the value add /non value add of each?
b. In terms of regulatory, both for an IDE and FDA 510k submission, how should the medical device company structure their testing for submission requirements?
c. In light of IEC 80001, how should the medical device company, (that now has the approved wireless device), go forward with the best of practice deployment guidelines in the hospital?
Client(s): Laurence McGrath, JPMorgan Asset Management, Andrew Carmen, Illumina, Inc., Ramesh Venkataraman, Telllabs Operations, Inc.; Spencer Fan, Primavera Capital Group.
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