The experience and professionalism of our leadership is the core driver of MCRA's specialized services in regulatory, clinical, healthcare compliance, reimbursement and quality assurance. The team brings tremendous industry expertise, transaction leadership, and knowledge to our clients, and provides the backbone for the culture that makes our firm unique.
Senior Vice President, Clinical & Regulatory Affairs
MR. STIEGMAN MANAGES AND DIRECTS THE CLINICAL AND REGULATORY AFFAIRS DEPARTMENTS FOR MCRA AND ITS CLIENTS. Mr. Stiegman is responsible for management of approximately 15 clinical and regulatory professionals at MCRA. Mr. Stiegman leads the firm's regulatory submission process, strategy, analysis and development: from pre-clinical testing, to FDA submissions, to market approval and post commercialization. He also oversees the planning and execution of the clinical studies managed by MCRA's Clinical Research Organization.
Prior to joining MCRA in February 2006, Mr. Stiegman served as the Chief of the Orthopedic Devices Branch for US Food and Drug Administration. As Branch Chief, Mr. Stiegman managed a team of scientists, clinicians, and engineers in the regulation of all orthopedic devices marketed in the United States. In addition, Mr. Stiegman was responsible for overseeing all FDA guidance documents and FDA policy determinations for orthopedic devices marketed in the US. Furthermore, he assisted in and oversaw all integrity, compliance, and monitoring issues regarding the orthopedic industry in collaboration with the Office of Compliance.
Mr. Stiegman was also a member of several leveraging groups such as the Orthopedic Device Forum and Orthopedic Surgical Manufacturer Association, where he represented the FDA. As the head of the Orthopedic Devices Branch, Mr. Stiegman pursued the advancement and consistency in the regulation of all orthopedic devices. This was evident by the pursuit of reclassifying several types of orthopedic devices, developing guidance documents on state-of-the-art orthopedic devices, and educating and assisting the orthopedic community in the regulatory strategies to get devices to market.
Prior to becoming Branch Chief, Mr. Stiegman was a reviewer in the Orthopedic Devices Branch where he was the team leader on many state-of-the-art spinal technologies. He was a leader in the field of artificial disc replacements, nucleus replacements, posterior stabilization systems, and many of the current widely used fusion spinal systems. He authored a guidance document for industry on spinal systems indicated for fusion, and he also developed documents that assisted companies in getting other devices to market such as artificial disc replacements, nucleus replacements, and posterior stabilization systems. Mr. Stiegman received his Bachelor in Science at Tulane University in Biomedical Engineering and his Master in Science at Clemson University in Bioengineering with a focus on biomaterials and biomechanics.
Senior Director, Spine Regulatory Affairs
Mr. Eggleton is responsible for regulatory affairs relevant to spine devices for MCRA clients, with experience writing FDA submissions and drafting test protocols. Mr. Eggleton served as a lead reviewer in the FDA Orthopedic Devices Branch, and contributed to the development of guidance documents and ASTM technical committees regarding orthopedic device testing. Mr. Eggleton has extensive knowledge of medical device regulations and is adept at creating regulatory strategies and pathways for bringing innovative, life-changing spinal technologies to market.
Mr. Eggleton has significant experience in drafting, preparating, and submitting FDA filings including 510(k) pre-market notifications, investigational device exemptions (IDE), and pre-market approvals (PMA).
Mr. Eggleton is skilled at leveraging expertise in biomechanics, biomaterials, tissue engineering, and regulatory science to manage regulatory projects for device categories, which have included: total disc replacements, interspinous spacers, nucleus replacements, facet replacements, posterior dynamic stabilization systems, kyphoplasty/vertebroplasty, bone cements, void fillers, and spinal infusion instrumentation.
Senior Director, Orthopedic Regulatory Affairs
Ms. Rhodes is responsible for regulatory affairs relevant to general orthopedic devices (hip, knee, small bone, trauma, etc.) for MCRA’s clients. She assists clients with writing regulatory submissions, identifying the appropriate regulatory pathway for new technologies and indications, and developing regulatory, clinical, and testing strategies for new devices. She also assists clients with response strategies to FDA questions relating to 510(k)s, IDEs, PMAs, and de novo submissions.
Ms. Rhodes works closely with the clinical, quality assurance, and reimbursement specialists at MCRA to perform technology assessment and due diligence on firms buying or selling orthopedic technologies.
Prior to joining MCRA in 2007, Ms. Rhodes served as a reviewer in the FDA orthopedic devices branch for 17 years, and advised firms and inventors as they developed testing protocols for new orthopedic technologies. While at FDA she served as a lead reviewer for over 400 510(k)s, 25 IDEs, and 10 PMAs; devices include hips, knees, ankles, shoulders, elbows, wrists, toes, suture anchors, spinal systems, and fracture fixation systems. Ms. Rhodes served as an agency expert for total ankle devices. Through FDA’s pre-IDE program, she advised firms and inventors as they developed clinical protocols to study new orthopedic technologies.