• As regulatory scrutiny over device biocompatibility increases, MCRA forms a world class team of biocompatibility experts from FDA and industry.
• Key hires Eric M. Sussman, PhD, and Claus Svane Søndergaard, PhD, recently joined MCRA to bring further FDA and industry biocompatibility experience to MCRA's recently established division.
• Dr's. Sussman and Søndergaard join MCRA's 3 former FDA biocompatibility experts, Robert A. Allen, PhD; Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA; and Veronica Fleck, M.S., RAC.

WASHINGTON, Aug. 16, 2022 /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, Quality Assurance, and Cybersecurity, is pleased to announce the formation and expansion of its biocompatibility division, led by former FDA biocompatibility reviewer Robert A. Allen, Ph.D. To support the company's growing role in providing biocompatibility consulting services across all medical device sectors, MCRA has hired Eric M. Sussman, PhD, as its Associate Director of Biocompatibility; and Claus Svane Søndergaard, PhD, as its Senior Manager of Biocompatibility.

Dr. Sussman joined MCRA from the US Food and Drug Administration (FDA), where he spent 10 years in the Office of Science and Engineering Laboratories (OSEL), most recently as a Biomedical Engineer and consultant reviewer for biocompatibility and nanotechnology.  Dr. Sussman's extensive knowledge of biocompatibility includes chemical characterization, toxicological risk assessment, nanomaterials evaluation, and both in vitro and in vivo biological testing based on the international standards (ISO 10993) and FDA guidance. Dr. Sussman is active in the international toxicology and biomaterials communities, serving in numerous leadership roles in the Society for Biomaterials (SFB) and as a member of the Society of Toxicology (SOT). Dr. Sussman led authorship of FDA's perspective on chemical characterization of medical devices in 2022.¹

Dr. Claus Svane Søndergaard, PhD joined MCRA as Senior Manager of Biocompatibility.  He is the former Manager of the Department of Discovery and Biosciences and a former Biocompatibility Specialist at Cook Biotech. There he held company-wide responsibility for biological risk assessments including biocompatibility, toxicology, viral inactivation validation, and zoonotic surveillance. 

Dr. Sussman and Dr. Søndergaard join an already established world-class biocompatibility team of 3 former FDA biocompatibility experts:

• Robert A. Allen, PhD, Associate Director of Regulatory Affairs, is a former FDA biocompatibility reviewer and pre-market lead reviewer for cardiovascular devices.
  
  
• Dr. Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA, Associate Director of Regulatory Affairs, is a former FDA biocompatibility reviewer/focal point and subject matter expert for animal studies and antimicrobial associated devices. Dr. Kazemzadeh-Narbat was also acting team lead and a pre-market and post-market lead reviewer of orthopedic and dental devices at FDA.
  
  
• Ms. Veronica Fleck, MS, RAC, Director of Regulatory Affairs, is a former FDA biocompatibility reviewer and pre-market lead reviewer for orthopedic devices.

Dr. Allen, who leads MCRA's Biocompatibility Team, said "Biocompatibility is a rapidly growing area of need in the medical device industry. We expect the need to continue growing as the international biocompatibility standards are under heavy revision, and the regulatory interpretations of these standards continue to evolve. The MCRA biocompatibility team is committed to providing clients with biocompatibility advisement that keeps up with these changing technical and regulatory expectations. Dr. Sussman's recent leadership and experience at FDA will help us provide biocompatibility advisement that is truly cutting edge. We are excited that Dr. Sussman and Dr. Søndergaard have joined our team."

Glenn Stiegman, Senior Vice President of Clinical and Regulatory Affairs at MCRA said "Biocompatibility is central to device safety, but the path to regulatory acceptance can be a complex and resource-demanding journey, even when carefully planned and executed. I am excited about the formation of the world class biocompatibility team we built at MCRA to help our clients efficiently navigate this challenging area in a way that results in thorough evaluation of the biocompatibility of their devices and successful communication with regulatory agencies."

Longstanding MCRA client, Mark Alvis, former VP of Simplify Medical said "In preparing our PMA submission, MCRA's biocompatibility experts guided our team to develop a sophisticated strategy of toxicological-based justifications rather than costly and time-consuming biocompatibility testing.  This strategy was acceptable to FDA and the product was approved."

MCRA looks forward to continuing to support innovation in the medical device industry by helping clients navigate the biocompatibility requirements both at FDA and globally.

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 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, general surgery, digital health, neurology, robotics, 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 specializes in merchant banking activities for the neuromusculoskeletal industry as a full life cycle investor, investing in all stages in companies from inception through growth. VB is dedicated to financing healthcare innovation globally. www.vbllc.com 

To reach MCRA's Biocompatibility Team, please contact:

Alyssa Howard
Vice President, Business Development
Phone: 215.870.3952
Email: ahoward@mcra.com 

¹ Sussman EM, Oktem B, Isayeva IS, Liu J, Wickramasekara S, Chandrasekar V, Nahan K, Shin HY, Zheng J. Chemical Characterization and Non-targeted Analysis of Medical Device Extracts: A Review of Current Approaches, Gaps, and Emerging Practices. ACS Biomater Sci Eng. 2022 Mar 14;8(3):939-963. doi: 10.1021/acsbiomaterials.1c01119. Epub 2022 Feb 16. PMID: 35171560.

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SOURCE MCRA, LLC