Robert Herrmann, Ph.D., Former U.S. Food & Drug Administration (FDA) Team Lead and Lead Reviewer for Neurointerventional and Neurosurgical Devices joins MCRA as Director, Neurointerventional Regulatory Affairs.
WASHINGTON, September 14, 2021 /PRNewswire/ -- MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance, and Cybersecurity is pleased to announce Robert Herrmann, Ph.D., Former U.S. Food and Drug Administration (FDA) Team Lead and Lead Reviewer for Neurointerventional and Neurosurgical devices has joined MCRA. Dr. Herrmann is a biomedical engineer with 20+ years of experience in the development and regulation of neurovascular and cardiovascular medical devices.
Dr. Herrmann has extensive knowledge in 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, clinical study applications and post-market issues. Dr. Herrmann also had significant interactions on applications for the clinical use of drug and biologic based device combination products during his time with the agency.
Dr. Herrmann’s professional experience also includes Vice President of Engineering at Evasc Medical Systems, a small medical device company that developed an 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.
MCRA’s Vice President, Neurological Regulatory Affairs, Tim Marjenin said “We are very pleased that Robert has joined our team at MCRA, and we know he will guide our clients in continuing the advancement of technology. Robert brings significant value from a diverse background both within industry as well as at FDA. MCRA Neuro strives to be at the forefront of innovation and the development of products that have the potential to help thousands of patients with devastating diseases and conditions, and neurointerventional devices represent a critical component of that vision.”
Dr. Herrmann said “I am very excited to join the highly distinguished team at MCRA and expand their regulatory expertise in the area of neurointerventional devices. I look forward to assisting clients to bring their new and innovative devices to patients in need.”
About MCRA, LLC: MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its clients industry experience at integrating five business value creators: regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance to provide a dynamic, market-leading effort from concept to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, and New York, NY, and serves more than 700 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices as well as medical device cybersecurity. www.mcra.com
About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specializes in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com
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