Dr. Merkle is a passionate regulatory strategist who is enthusiastic about helping companies bring safe and effective medical devices to the United States. Prior to joining Syntactx (now a part of NAMSA) in 2020, Dr. Merkle spent 6 years at the U.S. Food and Drug Administration (FDA) within the Center for Devices and Radiological Health (CDRH), where she was a Lead Reviewer of vascular and endovascular devices. In her role, she managed and reviewed over 650 complex regulatory submissions, including pre-submissions, investigational device exemptions (IDEs), as well as 510(k) and premarket approval (PMA) marketing submissions. She was the Lead Reviewer for a first of a kind vascular device and served as the FDA lead to a meeting of the Circulatory Systems Device Panel. She is also an adjunct professor regarding FDA regulations for various types of medical products at a university. Dr. Merkle serves as a Steering Committee Member for the Greenburg Stent Summit, a unique conference that brings together representatives from industry, clinical practice and FDA to discuss current issues in vascular surgery. Dr. Merkle received her doctoral degree from the University of Arizona in biomedical engineering with research that focused on characterizing and evaluating electrospun materials for cardiovascular applications.

CORE COMPETENCIES

• Developing an overall regulatory strategy for novel devices, including planned interactions with FDA
• Identifying options for clinical evaluation of new and modified devices, including clinical study synopsis and clinical protocol development
• Assisting in the development of non-clinical evaluation strategy, including engineering and biocompatibility evaluations to support various stages of product development (e.g., early feasibility study, pivotal study, marketing submission)
• Assisting in FDA submission preparation, including writing and reviewing of regulatory documents [e.g., pre-submissions, IDEs, Clinical Study Reports (CSRs), PMAs]
• Facilitating FDA meeting preparation, attendance and follow-up
• Providing regulatory strategy support in responding to FDA feedback and decision letters

RECENT PROJECTS

• Assisted in the writing of multiple premarket approval (PMA) applications, including justification for the totality of information to support the intended use, CSR, benefit-risk analysis, summary of safety and effectiveness data (SSED), Instructions for Use (IFU) and patient guide
• Developed the biocompatibility evaluation and clinical strategy for novel vascular surgery devices