Guy possesses over 16 years of industry experience supporting clinical research programs for medical devices, with a focus in cardiac surgery, cardiac rhythm management, vascular, and neuro spaces. Guy provides functional leadership in identifying market barriers and developing recommendations to address clinical evidence gaps. He joined Veranex in 2021, bringing his extensive background in clinical study development and execution to our ever-growing clinical pipeline.

At Veranex, Guy is responsible for supporting clients with setting the strategic direction and evidence pipeline as well as detailed tactical planning and execution for converting a company’s goals into actionable clinical studies. Guy directs U.S. clinical study programs, from early feasibility studies (EFS) to first-in-human (FIH)/feasibility studies (FS) to pivotal trials in pursuit of medical device commercialization. Guy’s primary functions include:

  • Participating on design teams throughout the product life cycle
  • Providing input on clinical strategy development to optimize the client’s clinical evidence goals
  • Directing clinical elements and generating clinical study documentation required for FDA regulatory agency submissions, including pre-submission packages, IRB approvals, and investigational device exemption (IDE) applications, as well as final clinical study reports for, 510(k)s, de novos, PMAs, and global regulatory agencies
  • Providing clinical study operational leadership, oversight, and support from study planning through close-out and analysis in accordance with projected timelines; this includes study/site activation activities, management of clinical study databases, formulation, and facilitation of Data Safety Monitoring Boards (DSMBs), Clinical Events Committees (CECs), and core labs with the study sponsor to ensure study success

Past companies and experience
Prior to joining Experien Group (now Veranex), Guy spent seven years at Medtronic in the neuromodulation and enabling technologies division. Most recently, Guy held the title of senior research manager of Clinical and Medical Sciences, where he demonstrated functional leadership of the Epilepsy Neuromodulation and Laser Ablation business through his diligent identification of market barriers, development of IDE pivotal trial for a high-value technology acquisition, and partnership with experts to secure positive reimbursement. Preceding his various roles at Medtronic, Guy held research and program management roles at Boston Scientific, and a clinical manager position at LivaNova, where he re-built the in-house clinical affairs team, all while managing three high-budget IDE trials, each with over 25 sites. In addition to his impressive work experience, Guy has authored publications in cardiology, physiology, and endocrinology.

Education
Guy received his B.S. in exercise and sport science, M.S. in exercise physiology, and Ph.D. in biomedical sciences from Colorado State University in Fort Collins, Colorado. Guy also completed a post-doctoral research fellowship at the University of Texas Health Science Center in San Antonio, Texas.

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