Neal E. Fearnot, Ph.D.

Neal_Fearnot

Cook Group, Bloomington, IN

International Committee Member, MDEpiNet

SMART Working Group Member on subproject, EHR Minimum Data Set


Background

Dr. Fearnot has been involved in medical device research and regulatory affairs for over thirty years. He is currently Vice President of Cook Group Inc. and is focused on the scientific and business potential of new technology and regulatory affairs policy worldwide. Dr. Fearnot has served as founding President of three Cook companies: MED Institute, a full service medical device development company (1983), Cook Biotech, a tissue-engineered product manufacturer (1995), and a new, cutting-edge technology development company (2009) which he currently leads.

Dr. Fearnot holds a Ph.D. in Electrical and Biomedical Engineering from Purdue University and has authored 150 scientific publications and holds 75 patents. He has worked with other Cook engineers and scientists to develop innovative medical devices from prototype, through bench and animal testing, and through the clinical and regulatory processes. Dr. Fearnot has filed numerous FDA and foreign regulatory submissions and is active in global initiatives to improve US, EU and Asian regulations. In collaboration with regulators and physicians, he has participated in global initiatives to harmonize Good Clinical Practices for the benefit of patients worldwide.

In 2010, Dr. Fearnot was awarded AAMI’s prestigious Laufman-Greatbatch Prize, given annually to an individual or group that has made a unique and significant contribution to the advancement of medical instrumentation, service, and patient care.