• MCRA has hired Dr. John Doucet, Former US Food and Drug Administration (FDA) Policy Lead, Breakthrough Device Program as Senior Director, Neurology Regulatory Affairs.
• The hiring of John supports two important growth areas for MCRA, including the expansion of its specialization in Neurology as well as its experience with the Breakthrough Device Designation pathway.
WASHINGTON, October 8, 2020 /PRNewswire/ -- MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating US and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, and Quality Assurance, is pleased to announce the hiring of Dr. John Doucet, Former US Food and Drug Administration (FDA) Policy Lead, Breakthrough Device Program. In his prior role, John managed the Breakthrough Device Program, where he oversaw all aspects of the program, was involved in the granting or denial of all Breakthrough designation requests, and served as the Center for Devices and Radiological Health’s (CDRH’s) expert for internal and external stakeholders regarding the regulatory standard for obtaining the Breakthrough designation for a medical device.
In addition to John’s leadership role with the FDA Breakthrough Designation Device Program, John also served in additional roles at the FDA, including Acting Director of the IDE Program, Lead Reviewer of Neurology and Physical Medicine Devices, Acting Branch Chief of Neurostimulation Devices Psychiatry Branch, and Policy Analyst of Office of Device Evaluation. The hiring of John supports two important growth areas for MCRA including the expansion of its Neurology division as well as its experience with the Breakthrough Device Designation pathway.
John joined MCRA as Senior Director, Neurology Regulatory Affairs. He has extensive knowledge of medical device regulatory pathways to drive technology from conception to market. He is a neuroscientist and biomedical engineer with 10+ years of FDA experience in medical device regulation, 13+ years of Johns Hopkins experience in discovery science, and 6+ years of management experience at FDA and Johns Hopkins School of Medicine. At MCRA, John will provide guidance on regulatory strategy and submission development for MCRA’s neurology clients, as well as interact on breakthrough device designation submissions and strategies across all therapies.
John Doucet said, “I am happy to join MCRA’s integrated team of deeply experienced experts. I look forward to this opportunity to provide value to MCRA’s medical device clients by creating tailored and efficient regulatory pathways to bring new technologies to market, and thus promote patients' access to safe and effective products as quickly as possible.”
Glenn Stiegman, MCRA’s SVP, Clinical and Regulatory Affairs said, “MCRA is the leading advisory firm in assisting clients with US regulatory initiatives. We are very pleased that John has joined our firm and will guide our clients in continuing the advancement of technology innovation. John brings tremendous value given his wealth of experience, knowledge, and leadership on the Breakthrough Device
Designation program and is also a leading neurological device expert. With the influx of breakthrough designations and their impact on companies and reimbursement, we understand John’s role being critical to continue assisting clients with their innovative products that will help thousands of patients.”
About MCRA, LLC: MCRA is a leading medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA's value contribution rests within in its industry experience at integrating five business value creators: regulatory, reimbursement, clinical research, 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 expertise for its clients. MCRA has offices in Washington, DC, Manchester, 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.
About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specialized in venture capital, private equity and merchant banking for the neuromusculoskeletal industry.
For more information, please visit the company's website at www.mcra.com or contact:
Alyssa Howard
Senior Director, Business Development
Phone: 215.870.3952
Email: ahoward@mcra.com
MCRA's world class know-how and execution unlocks barriers, advancing our clients mission to better the availability of quality medical care to patients around the world.