Corey Leet

Corey Leet has been in the MedTech industry for 23 years, focused on medical devices specifically in these therapeutic areas: cardiovascular devices (valves, pacemakers, stents, etc.), neuromodulation devices (spinal cord stimulation, deep brain stimulation, etc.), and wound healing therapies (topical dressings, negative pressure wound therapy, etc.). He spent 15 years in various roles (technician, study director, senior manager) at Medtronic’s preclinical research facility and 8 years in various roles (study director, senior manager, site director) at NAMSA’s preclinical laboratory in Minneapolis.

Corey served as a study director at both Medtronic and NAMSA. He has been the study director for over 300 preclinical large animal studies, including over 100 GLP studies. These studies have supported regulatory submissions (FDA, CE Mark, etc.) for a variety of devices including transcatheter aortic valves, surgical mitral valves, leadless pacemakers, spinal cord stimulation, vascular closure devices, and clot retrieval devices. In addition to his study director experience, Corey has many years of experience in operations leadership at both Medtronic and NAMSA managing a diverse team focused on large and small preclinical model surgery and care.

Corey earned his B.S. in Biology at the University of MN and his M.A. in Organizational Management at Concordia University. He is an active participant with Medical Alley, American Heart Association (AHA), and AALAS.

CORE COMPETENCIES

• Preclinical study development and execution
• Continuous Improvement Leader
• Budget development and financial management
• Exceptional interpersonal communication
• Development of organizational dashboards and KPIs
• Project management
• Data analysis
• FDA regulation experience
• Leading cross-functional teams and councils

RECENT PROJECTS

• Supported an FDA regulatory response for a client to help address FDA questions on a regulatory submission; The response was accepted by the FDA and no additional work was required to obtain FDA approval
• Supported a client pre-submission plan that was presented to the FDA
  • Included a preclinical study plan which leveraged historical study data along with a simplified GLP study proposal to achieve FDA needs
  • The plan was created to minimize the additional GLP work to keep costs low and accelerate study timelines