Robert Herrmann, Ph.D.

Robert Herrmann, Ph.D.

Director, Regulatory Affairs
Background

Dr. Herrmann is a biomedical engineer with 20+ years of experience in the development and regulation of neurovascular and cardiovascular medical devices. He has extensive knowledge vascular device development activities including bench, animal and clinical testing to drive regulatory strategies for new neurological medical devices. Specific device therapeutic areas include intracranial aneurysms, acute stroke, chronic subdural hematoma, idiopathic intracranial hypertension, arteriovenous fistulas, and hydrocephalus. He has 6 years of FDA experience in the neurovascular device area, reviewing premarket applications (PMAs and 510ks), clinical study applications (IDEs) and post-market issues (recalls, safety signals). Prior to the FDA, Dr. Herrmann has worked with both small and large medical device firms in the development of both neurovascular and cardiovascular devices.

Education

Dr. Herrmann holds a Doctor of Philosophy and Master of Science in Biomedical Engineering from Duke University. He also received a Bachelor of Science degree in Chemical Engineering from the University of Virginia.

Experience

Prior to MCRA, Dr. Herrmann spent 6 years at FDA in the Center for Devices and Radiological Health (CDRH). Dr. Herrmann worked primarily on neurointerventional devices as a Lead Reviewer and Team Lead, reviewing pre- and post-market applications.  Devices covered by the Neurointerventional team included treatments for intracranial aneurysms, acute stroke, chronic subdural hematoma, idiopathic intracranial hypertension, arteriovenous fistulas, and hydrocephalus He also has significant interactions on applications for the clinical use of drug- and biologic-based device combination products.

Prior to the FDA, Dr. Herrmann was the Vice President of Engineering at Evasc Medical Systems, a small medical device company that developed the eCLIPs implantable aneurysm treatment device and a range of other endovascular devices used in the peripheral vasculature.  Additional experience includes engineering management activities at Angiotech Pharmaceuticals, focusing primarily on the manufacturing, testing and regulatory approval for a novel line of sutures used in general and cosmetic surgery.  At Boston Scientific, Dr. Herrmann was a research scientist developing novel drug eluting formulations for use on cardiovascular stents, completing due diligence efforts and developing new animal and cell culture models for drug eluting stent evaluations.

Overview

Robert joined MCRA on August 2, 2021 as Director, Neurointerventional Regulatory Affairs. At MCRA, Robert provides guidance on regulatory strategies and submission development for MCRA’s neurology clients. His work includes 510(k), Pre-Submissions, Investigational Device Exemptions (IDE), and Premarket Approvals (PMA).

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