Past Meetings

Focus on Health IT in FDA Regulatory ActivitiesBack

11/16/2018

Our November meeting of Health TechNet was held on Friday, November 16 at Nelson Mullins’ offices in Washington, D.C.   

Our feature topic was the increasing use of medical technology in “regulatory science,” that is, how to use advanced technology to evaluate the safety and effectiveness of new drugs both before and after FDA approval.  Our primary speaker was Pamela Goldberg an internationally recognized leader in healthcare technology innovation and entrepreneurship. As president and CEO of the Medical Device Innovation Consortium (MDIC), she provides strategic insights and guidance to help solve complex regulatory, scientific, and reimbursement challenges in the medical device industry. The FDA’s Center for Devices and Radiological Health (CDRH) and LifeScience Alley, Inc., a Minnesota trade association, executed a Memorandum of Understanding in December 2011 to work together to establish research collaborations in regulatory science. In an unparalleled era of medical device innovation, the medical technology environment is capitalizing on advances in material science, digital technology, artificial intelligence, and cutting-edge device manufacturing. While these opportunities offer patients new chances to improve their health, MDIC and FDA are collaborating on methods, resources, and tools used to help advance policies that promote access to these medical technologies. The presentation explored the partnership between MDIC and FDA, and their commitment to patient safety and med tech innovation.

Nelson Mullins partner David Main also presented information on the outcomes and meaning of the recent Congressional elections for healthcare policy and leadership, and led an active discussion of those results among members present.