Mr. Crist joined Biologics Consulting in 2018 with 7 years of experience as a biomedical engineer and lead reviewer at the FDA in the Office of Device Evaluation (ODE), Division of Surgical Devices (DSD), where he evaluated a wide variety of device and submission types. His experience includes review of IDEs, 510k(s), De Novos, PMAs, HDEs, Q-Submissions (Pre-Submissions), and Expedited Access Pathway (EAP) submissions. Examples of his device expertise include biosurgery products, surgical hemostats, surgical sealants, adhesion barriers, wound dressings, aesthetic and reconstructive implants, dermal fillers, surgical mesh, surgical staplers, as well as software based devices such as lipoplasty systems, negative pressure wound therapy devices, and robotically-assisted surgery devices.
While at the FDA, Mr. Crist served as a member of the Additive Manufacturing Working Group and has experience evaluating 3D-printed medical devices. He also led the Hemostatic Trauma Devices Working Group, and has experience in CFR 50.24 clinical studies with exception from informed consent for emergency research. In his review of biosurgery and polymer-based devices, he has dealt with complex biocompatibility testing to support in-situ polymerizing devices and chemical characterization to support polymer equivalency.
Prior to joining the FDA, Mr. Crist conducted 4 years of cell and tissue engineering laboratory research under Dr. Elisseeff at Johns Hopkins University’s Translation Tissue Engineering Center (TTEC). His research focused on mesenchymal stem cells and biopolymer tissue adhesives for cartilage repair, in-vitro models of osteoarthritis and osteoporosis, and the interactions of glycoengineering with stem cell behavior.
Mr. Crist received both his B.S. and M.S.E. in Biomedical Engineering from Johns Hopkins University with highest honors, in 2010 and 2011, respectively.
As a Consultant for Medical Devices with Biologics Consulting, Mr. Crist utilizes his scientific and regulatory expertise to assist clients in the following areas:
• Preparation of device submissions (Q-Sub, 510k, PMA, IDE, etc.)
• Short and long term regulatory strategy for medical devices and combination products
• Product development and preclinical testing strategies
• Animal study and clinical trial development to achieve regulatory success
• Crafting responses to FDA deficiencies and communicating with FDA on behalf of clients
M.S.E. Biomedical Engineering, Johns Hopkins University, Baltimore, MD (2011)
B.S. Biomedical Engineering, Highest Honors, Johns Hopkins University, Baltimore, MD (2010)