James C. Makous, Ph.D.

Dr. Makous holds a Ph.D. in neuroscience from the University of Florida, and Bachelor of Science from the University of Rochester, also in neuroscience. He is a distinguished researcher and lecturer, has published in several prestigious scientific journals, and he holds 10 medical device patents. Dr. Makous serves on several NIH study sections reviewing grant applications directed at medical device development. He is considered a leading authority on the application of electricity to the brain, nerves and spinal cord for the treatment of disease. Dr. Makous has directed development of several implantable medical devices and oversaw the execution of clinical research trials conducted in support of their regulatory approval. He is an accomplished clinical engineer and is knowledgeable regarding FDA regulations and good clinical practices. Dr. Makous has extensive experience drafting clinical trial protocols and submissions for IRB/EC review as well as for US and European regulatory bodies. He has expertise with surgical tools, active implantable devices and capital equipment. In addition, he is an expert in operating room procedures and support.

Dr. Makous can help you with all stages of your medical device development.