Dr. Eunhee Cho has 15 years of experience in medical device product development and evaluation. She has worked on a wide array of product types for global medical device manufacturers, such as Abbott Laboratories, DePuy Synthes within Johnson and Johnson, and ResMed. She has acquired expertise in biocompatibility evaluation of medical devices through various experiences in her previous roles as a Subject Matter Expert (SME) and a group leader. Dr. Cho has a proven track record of successful biocompatibility evaluation and global regulatory acceptance of products, including cardiovascular products like heart valves, catheters for transcatheter aortic valve replacement (TAVR), systems for neuromodulation therapies, continuous positive airway pressure (CPAP) machine and masks for sleep apnea, chronic obstructive pulmonary disease (COPD), other respiratory conditions, orthopedic and neurosurgery products. Over the course of her career, she has also led building high-performing global technical service groups by restructuring global resources, formalizing work processes and maximizing performance efficiency with continuous improvement of workflow in an agile Kanban methodology. In addition, Dr. Eunhee Cho has two patents: Thermochromic polyvinyl alcohol-based hydrogel artery and Prosthetic heart valve with expandable microspheres.

Dr. Cho received her PhD in bioengineering at Clemson University (Clemson, SC) with a research focus on hydrogel-based nonviral gene delivery. She completed a postdoctoral research of polypeptide nanofilm-coatings for cancer diagnostic tools and applications to medicine at the University of South Florida (Tampa, FL). Later, she earned her MBA with specialization in strategic, medical industry leadership and marketing management.

CORE COMPETENCIES

• Achieving successful regulatory acceptance of new products and product changes both in the US and outside the US (OUS) by aligning biocompatibility evaluation strategies with medical device regulation shifts
• Working knowledge of international standard ISO 10993 series and ISO 18562 series, as well as FDA, EU MDR and other global medical device regulations
• Providing risk-based technical solutions to laboratory and technical service groups of SMEs in biocompatibility, materials technology and substance compliance
• Performing materials selection, manufacturing process improvement, method development, root cause investigation and shelf-life study and justification
• Maximizing performance efficiency with continuous improvement of workflow in an agile Kanban methodology
• Building high-performing global technical service groups by restructuring global resources and formalizing standard work processes

RECENT PROJECTS

• Advised leadership and associates within Laboratory Services on technical and scientific issues related to on-going and archived biological safety testing and compliance
• Supported numerous clients to develop biological safety testing plans and conditions and served as scientific and regulatory consultant to clients as needed

PUBLICATIONS

• Jeremy Zhang, Atanu Sen, Eunhee Cho, Jeoung Soo Lee, Ken Webb. (2017). Poloxamine/fibrin hybrid hydrogels for non-viral gene delivery. Journal of Tissue Engineering and Regenerative Medicine, 11(1), 246–255
• Eunhee Cho, Jeoung Soo Lee, Ken Webb. (2012). Formulation and characterization of poloxamine-based hydrogels as tissue sealants. Acta Biomaterialia, 8(6),2223-2232
• Donald T. Haynie, Eunhee Cho, Pradeep Waduge. (2011). “In and out diffusion” Hypothesis of exponential multilayer film buildup revisited. Langmuir, 27(9), 5700–5704
• Eunhee Cho, Jaishankar K Kutty, Kedar Datar, Jeoung Soo Lee, Naren R Vyavahare, Ken Webb. (2009). A novel synthetic route for the preparation of hydrolytically degradable synthetic hydrogels. Journal of Biomedical Materials Research Part A, 90A(4), 1073-1082
• Jaishankar K. Kutty, Eunhee Cho, Jeoung Soo Lee, Naren R. Vyavahare, Ken Webb. (2007). The effect of hyaluronic acid incorporation on fibroblast spreading and proliferation within PEG-diacrylate based semi-interpenetrating networks. Biomaterials, 28(33), 4928-4938
• Eun Hee Cho, Sang Gil Lee, Jeong Koo Kim. (2005). Surface modification of UHMWPE with γ-ray radiation for improving interfacial bonding strength with bone cement (II). Current Applied Physics, 5(5), 475-479
• Eun Hee Cho, Young Il Yang, Chi-Woong Mun, Jeong Koo Kim. (2005). Tissue-engineered semi-microporous segmented polyetherurethane vascular prostheses. Journal of Biomaterials Science, Polymer Edition, 16(6), 775-790