Past EventFDA Requirements for Marketing Medical Devices

This month you will learn the facts on regulations affecting marketing of medical devices from three perspectives: an FDA representative, a European health industry consultant and a successful medical device entrepreneur.

Panelists; Ries Robinson, Chairman Inlight Solutions; and by remote broadcast – David Arvelo Small Business Representative for the Southwest Regional Office, FDA; and Emmanuel Grimaud, Partner, Perfea Innovation

David Arvelo is the Small Business Representative for the Southwest Region of the Food and Drug Administration

In this capacity he offers assistance to the FDA-regulated industry in general. His services includes response to industry and entrepreneur inquiries, presenting, developing, and promoting FDA training to the industry, and performing non-regulatory on-site visits to FDA-regulated firms upon request and as resources allow. David has a Bachelors Degree in Science in Chemistry from the University of Puerto Rico in Mayagüez and graduate studies from Texas A&M University. He is currently working on a Masters Degree at the University of Arkansas in Fayetteville. He started his FDA career in 1990 as a Chemist in the Dallas District Laboratory. He worked for the Office of the Texas State Chemist for 2 years prior to working for the FDA. David is a member and former Regulatory Co-Chair of the FDA Medical Device Industry Coalition, current 1st Vice-President of the North Texas Society of Government Meeting Planners, member of the Association of Food and Drug Officials, and member of the Mid-Continental Association of Food and Drug Officials.

Emmanuael Grimaud, Stratety Consultant is a partner at Perfea Innovation.

Mr Grimaud has proven records of achievement in restructuring and privatizing public services and negotiating international agreements as senior public servant in Defense, Health and Industry, startup and development of business as an entrepreneur and strategy, Lean and Value-based process streamlining, design and reengineering.

Emmanuel’s customer service and talent in interacting at Board level and on the shop floor allows him to deliver high value and well-accepted solutions in complex and multifactorial environments.

Emmanuel possesses a General Engineering degree from Ecole Ploytechnique in Paris as well as an engineering degree in Aeronautics and Space from ENSAE in Touluse France. Further studies in Radiation Physics and Bioengineering lead him to earn a PhD.

M. Ries Robinson, M.D., Chairman

Dr. Robinson has served as Chairman of the Board, Chief Executive Officer, President and Director of Research for the Inlight Solutions since its inception. He initiated research into noninvasive blood chemistry monitoring in collaboration with Dr. R. Philip Eaton of the University of New Mexico School of Medicine (UNM-SOM) and Dr. David Haaland of Sandia National Laboratories in 1988. Since that time, Dr. Robinson has co-authored several comprehensive US patents and patent applications to which the Company now holds exclusive rights. Dr. Robinson has authored several peer-reviewed technical articles, received the Distinguished Achievement Award from the New Mexico Inventor of the Year Program in 1992, and was named the New Mexico Inventor of the Year in 1994.

Dr. Robinson graduated from Stanford University in 1987 with a B.S/M.S. degree in Mechanical Engineering with an emphasis in controls engineering. He served as a biomedical engineer for Nellcor, Inc. in 1988. Dr. Robinson received an M.D. degree from UNM-SOM in 1991 and undertook extensive additional studies in electrical and systems engineering. Dr. Robinson completed a post-doctoral research fellowship with a joint research appointment at Sandia and UNM-SOM in 1992.

Thanks to our host and co-sponsor:

STC.UNM (STC) is a nonprofit corporation formed and owned entirely by the University of New Mexico Board of Regents (UNM). We are a 501(c)(3) non-profit corporation with an independent board of directors. Located on UNM’s south campus at the Science & Technology Park in Albuquerque, New Mexico, STC has proximity to research and development and laboratory facilities and other technology based companies, many of which are the creation of STC. STC also collaborates with researchers at New Mexico’s two national labs—Sandia National Laboratories and Los Alamos National Laboratory—located nearby. The mission of STC is to support UNM and its partners as the source of innovation management and commercial development. Our vision is to play a vital role in New Mexico’s economic development and to be an innovator in technology commercialization worldwide