MCRA Expands into Anesthesia and Critical Care Therapy Specializations, Hires FDA Assistant Director

WASHINGTON, Nov. 14, 2022 /PRNewswire/ -- MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance and Japan Distribution Logistics (DMAH) support is pleased to announce the addition of anesthesia and critical care as new therapy specializations, led by former FDA Assistant Director Todd Courtney. With the growth in the number of medical devices for anesthesia and critical care, MCRA has hired Mr. Courtney as the Vice President of Anesthesia Regulatory Affairs.

Mr. Courtney joins MCRA from the US Food and Drug Administration (FDA), where he spent over 15 years with the Center for Devices and Radiological Health, most recently as Assistant Director of the Anesthesia Devices Team. In this role, Mr. Courtney led his team through the total product lifecycle review of marketing submissions for anesthesia technologies. In addition, Mr. Courtney's time at the FDA includes positions as FDA Fellow at Fogarty Innovation, Acting Branch Chief for the Circulatory Support Devices Branch and Lead Reviewer for the Peripheral Interventional Devices Branch. These experiences have allowed Mr. Courtney to work closely with medical teams and stakeholders across various medical device submission types to provide thorough and expert feedback throughout the submissions process.

At MCRA, Mr. Courtney will lead the Anesthesia, Respiratory, and Sleep Team under the Regulatory Affairs division. This team will provide expert consultation to clients on medical device submissions in the anesthesia and critical care space. These consultations include regulatory strategy, design and review of clinical testing plans and working interactively with clients to overcome FDA questions and issues. Mr. Courtney and his team will work closely with all stakeholders, including FDA, to provide strategic feedback and expertise to MCRA regulatory clients to create successful outcomes.

David Lown, MCRA's President said "With the growth in anesthesia-based medical devices, MCRA is proud to expand its therapy specializations to include anesthesia and critical care. By hiring Todd Courtney as the Vice President of Anesthesia Regulatory Affairs, we can now lead these clients through the medical device submission process, a space where MCRA maintains a consistent track record of success, with 17 PMA approvals to date. We are thrilled to have Todd Courtney join MCRA as the Vice President of Anesthesia Regulatory Affairs." 

Glenn Stiegman, Senior Vice President of Clinical and Regulatory Affairs at MCRA said "As the number of submissions related to anesthesia, respiratory, and sleep products continue to grow, we at MCRA wanted to provide the same vigor of regulatory expertise and leadership to these clients as we do across our other therapy areas. With Todd Courtney on board, our regulatory offerings now encompass this critical space. Todd's 15 years of experience at the FDA has provided him with a well-rounded and respected standing in the realm of anesthesia devices, but also circulatory and peripheral interventional devices, as he led in-depth reviews in each division. Todd's vision, expertise and resounding leadership will be of great benefit to our clients as they work on anesthesia and critical care device submissions."

Mr. Courtney said, "I am extremely excited to join the team at MCRA to use my knowledge of regulatory science to assist clients large and small in navigating the at-times challenging, and always evolving, regulatory landscape. This will contribute to bringing safe, effective, and innovative technologies to the public in a dynamic and collaborative manner."

MCRA is proud to continue supporting innovation in the medical device industry by helping clients navigate regulatory submissions in the anesthesia and critical care space, both at the FDA and globally.

About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its clients industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics to provide a dynamic, market-leading effort from innovation conception 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, New York, NY, and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices and 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 specialized in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com

For more information, please contact:
Alyssa Howard, Vice President, Business Development
Phone: 215.870.3952 | Email: ahoward@mcra.com

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SOURCE MCRA, LLC